WO2022234160A1 - Surgical access port with cleaning capability - Google Patents

Surgical access port with cleaning capability Download PDF

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Publication number
WO2022234160A1
WO2022234160A1 PCT/ES2021/070318 ES2021070318W WO2022234160A1 WO 2022234160 A1 WO2022234160 A1 WO 2022234160A1 ES 2021070318 W ES2021070318 W ES 2021070318W WO 2022234160 A1 WO2022234160 A1 WO 2022234160A1
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WO
WIPO (PCT)
Prior art keywords
main body
conduit
surgical
port according
access port
Prior art date
Application number
PCT/ES2021/070318
Other languages
Spanish (es)
French (fr)
Inventor
Aritz LAZKOZ DEL CAMPO
Iker MARIÑELARENA ARRIZABALAGA
Juan ARREGUI ALTUNA
Original Assignee
Deneb Medical, S.L.
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.)
Filing date
Publication date
Application filed by Deneb Medical, S.L. filed Critical Deneb Medical, S.L.
Priority to PCT/ES2021/070318 priority Critical patent/WO2022234160A1/en
Publication of WO2022234160A1 publication Critical patent/WO2022234160A1/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
    • A61B1/00Instruments for performing medical examinations of the interior of cavities or tubes of the body by visual or photographical inspection, e.g. endoscopes; Illuminating arrangements therefor
    • A61B1/12Instruments for performing medical examinations of the interior of cavities or tubes of the body by visual or photographical inspection, e.g. endoscopes; Illuminating arrangements therefor with cooling or rinsing arrangements
    • A61B1/126Instruments for performing medical examinations of the interior of cavities or tubes of the body by visual or photographical inspection, e.g. endoscopes; Illuminating arrangements therefor with cooling or rinsing arrangements provided with means for cleaning in-use
    • 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
    • A61B17/3474Insufflating needles, e.g. Veress needles
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61BDIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B2217/00General characteristics of surgical instruments
    • A61B2217/002Auxiliary appliance
    • A61B2217/005Auxiliary appliance with suction drainage system
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61BDIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B2217/00General characteristics of surgical instruments
    • A61B2217/002Auxiliary appliance
    • A61B2217/007Auxiliary appliance with irrigation system

Definitions

  • the present invention is directed to a surgical access port or trocar capable of cleaning said surgical field during the course of minimally invasive surgery (MIS).
  • MIS minimally invasive surgery
  • Surgical access ports or trocars are a type of surgical instrument that fulfills a purely mechanical function: define the surgical field and the direction in which the surgeon acts, keeping the skin and other soft tissues out of the surgical field so as not to disturb the action. of the surgeon.
  • MIS Minimally invasive surgeries
  • intraoperative images provide key information for the success of the intervention as they allow the surgeon to decide how to act at all times.
  • these images In order to faithfully show the surgical field to the surgeon, these images must be free of debris from cut tissue, blood, saline and other unwanted elements that, however, are continuously present in the surgical field.
  • minimally invasive surgeries require continuous cleaning of the surgical field.
  • the present invention proposes a solution to the above problems by means of a surgical access port suitable for surgical interventions according to claim 1 and a system for accessing a surgical environment according to claim 14.
  • Preferred embodiments of the invention are defined in dependent claims.
  • a surgical access port is defined as an instrument used to define the surgical field in minimally invasive surgeries. These instruments are used in conjunction with a lancet with a sharp point at one end and a plurality of cylindrical tissue dilators.
  • surgical access port and trocar will be used interchangeably.
  • surgical field and surgical region will be used.
  • the surgeon makes an incision in the patient's skin, usually using a cold or monopolar scalpel, slightly larger than the diameter of the lancet. From this incision, the lancet is inserted into the patient's body to define the direction in which the surgical procedure is to be performed. By For example, in spinal surgery, the lancet is inserted until it finds hard tissue, that is, until it hits the bone that will be the starting point of the surgery. Once the lancet is inserted in the desired position, the surgeon introduces a series of concentric cylindrical tissue dilators with the lancet, which gradually increase in diameter and thus dilate the soft tissues around the lancet or dilator with a diameter immediately below.
  • the first dilator slides over the lancet to dilate the hole created by it; and the rest of the dilators, of increasing diameters, slide over each other to increase said dilation until reaching the size required by the surgery.
  • This sequence is performed by small increases in the diameter of the cylindrical dilators; preferably in approximate 2-millimeter increments.
  • the last cylinder to be inserted is the trocar - or access port - which, once inserted, is fixed to some element present in the operating room, generally the operating table.
  • the lancet and all cylindrical dilators are then removed, leaving the surgical field defined and free of surrounding soft tissue.
  • a first inventive aspect provides a surgical access port suitable for surgical interventions, comprising: a main body configured as a tubular conduit extending in an axial direction XX' and comprising: a first access opening arranged at one end of the main body , a second opening arranged at the end of the main body opposite the first opening configured to give access to a surgical region, an inner wall configured to slide over a tissue dilator, from among the tissue dilators formed by a plurality of cylinders housed one inside another plus a lancet at its core; a perimeter region configured to rest on biological tissues in the surgical region; at least one conduit, either suction or blowing, or irrigation, housed inside the main body where said conduit is detachable and removable to leave the interior of the main body diaphanous.
  • a surgical access port is described that comprises a main body and at least one conduit intended for cleaning the surgical field.
  • the main body is a tubular duct comprising two openings located at opposite ends.
  • the first opening is the one through which the surgical instruments are inserted. Said instruments pass through the main body to the second opening, which will give you access to the surgical field.
  • the main body is made of a biocompatible material; for example, medical grade stainless steel, titanium or PEEK (Polyetheretherketone) polymers.
  • the surgical access port must be able to slide over a tissue dilator of those existing in the state of the art.
  • the main body comprises an inner wall dimensioned for this purpose.
  • the main body comprises a perimeter region configured to rest on biological tissues in the surgical field.
  • the perimeter region of the main body rests on the tissues of the surgical field that are accessible at the moment when said main body has slid over a tissue dilator of the state of the art, penetrating the space previously opened by the dilators already inserted.
  • the shape of the main body of the access port does not imply that it must be cylindrical since externally it can have elements that do not hinder the passage of the dilators through its interior, being able to show a different shape from the cylindrical one with a circular section as long as the perimeter region located adjacent to the second opening is of a thickness that does not cause soft tissue rupture upon insertion, as is the case with any of the dilators. This condition is ensured by keeping the thickness of the access port limited, at least in the region intended to be in contact with the tissue to keep it separated.
  • the range of diameters of the main body of the access port is adapted for the minimally invasive surgery to be performed.
  • the main body diameter range is preferably between 15 and 26 millimeters.
  • the thickness of the wall of the main body of the access port is preferably between 0.2 and 0.6 millimeters.
  • the surgical access port comprises at least one conduit intended for cleaning the surgical field.
  • Said at least one conduit can be for suction, blowing and/or irrigation.
  • the at least one conduit evacuates debris from cut tissues, blood, saline and other unwanted elements present in the surgical field by vacuuming them and/or introducing air and/or irrigation liquid in said surgical field with a power, flow rate and/or pressure adapted for this purpose.
  • These parameters preferably, can be varied during the surgical intervention according to the cleaning requirements at each moment. These variations can be decided on time by the medical staff or previously automated.
  • the conduit(s) of the surgical access port are introduced through the first opening of the main body and are housed inside it.
  • the duct or ducts can be coupled or fixed either to the main body or to some other element that serves as an intermediate element with the main body. Thus, once they have been attached or fixed, they remain static inside the main body. In this way, once the duct or ducts are inside the main body, the surgery itself and the procedure for cleaning the surgical field can be carried out simultaneously.
  • the surgical intervention is not necessarily interrupted by the cleaning operation, which avoids prolonging the patient's stay in the operating room unnecessarily and the distractions that such interruptions can cause to the medical staff, thus minimizing the risks to which they are exposed. the patient during the intervention.
  • the at least one conduit fixed to the main body does not prevent the sliding of said main body in the last of the inserted dilators since said conduit is not present at this stage.
  • the conduit is detachable, which allows it to be fixed to the main body once it is inserted in the patient. In this way, the shape of the inner wall surface is not modified by the conduit requirement and it is possible to closely adhere to the outer wall of the last dilator to allow smooth tissue insertion.
  • the trocar of the invention enables robotic surgery to develop smoothly, without interruptions, minimizing intervention times and, consequently, leading to significant savings in resources.
  • the conduit(s) coupled to the main body - or to other additional elements of the trocar or to elements external to the trocar - are uncoupled and removed to leave their interior diaphanous. Thanks to this, the main body returns to the initial state without ducts to be able to slide over a tissue dilator of those existing in the state of the art in subsequent surgeries.
  • the present invention allows the trocar to be introduced following the traditional dilation sequence, thus fulfilling the mechanical function of current trocars, and incorporating the cleaning function, which had not been contemplated until now in this type of surgical instrument.
  • the cleaning functionality in the trocar makes it possible to automate the cleaning cycles, automatically adjust the parameters of irrigation, aspiration and/or blowing (flow, power, pressure) in different regimes throughout the procedure.
  • this automation is carried out, for example, through programmable robots and similar devices.
  • Automating the cleaning cycles and the parameter values of the duct or ducts is especially relevant in robotic surgeries since, as previously mentioned, the action of the robot - for example, by means of a cutting laser or by means of photonic systems that allow distinguish tissues - needs a clean surgical field.
  • the conduit housed inside the main body is a suction conduit and comprises a detachable vacuum connection.
  • the surgical field is cleaned by suction; that is, the unwanted elements of the surgical field are suctioned through the conduit of the surgical access port.
  • Said conduit can be coupled and uncoupled from the main body - or other elements - for which it comprises a connection or fixing, for example, by clipping.
  • the suction duct incorporates a vacuum connection that allows said suction duct to be made independent of a vacuum source necessary to carry out the suction.
  • the vacuum conduit When the vacuum conduit is coupled to the main body of the access port, the source becomes independent of the assembly that forms the access port.
  • a vacuum connection will be understood to be an element mechanical used, among others, in the hospital environment to connect ducts or pipes to other medical devices, in this case the vacuum source.
  • These connections are usually of the quick connection type, that is, those in which the coupling and, at the same time, the tightness of the coupling are ensured with an insertion manoeuvre.
  • the suction duct is elastically deformable and with a curvature such that it tends to press against the inner wall of the main body.
  • said duct must be positioned as close as possible to the internal wall of the main body. In this way, it is guaranteed that the surgeon can manipulate the surgical instruments inside the main body at the same time that the aspiration conduit performs its function.
  • the suction duct according to this embodiment is elastic and deformable, with a curvature oriented towards the inner wall of the main body. This elasticity allows that, once the conduit is housed in the main body, it always tends to be directed towards the inner wall of said main body, staying close to the inner wall with a certain force, thus making it possible to have the greatest possible space for the introduction and handling of surgical instruments in the main body.
  • the suction duct shows a concave configuration towards the interior of the main body on the opposite side to the side facing the interior wall of the main body.
  • the concave configuration of the aspiration duct towards the interior of the main body seeks to reduce the interference of said duct with the surgical instruments during the intervention and, at the same time, to ensure a high internal section of the aspiration duct.
  • This configuration minimizes the presence of the conduit inside the main body, thus maximizing the space available for the introduction and manipulation of the surgical instruments.
  • the detachable conduit - either the suction conduit, or the blowing conduit or the irrigation conduit - is fastened by clipping to the outside of the main body and outside the projection of the inside of the main body along the axial direction X-X'.
  • the conduit or one of the conduits of the trocar has a clip fixation.
  • the fixing would be positioned outside said main body.
  • the fixing would be clipped at one end of the main body itself, for example at an edge of the first opening.
  • the fixture would be clipped to an element external to the main body.
  • fixing by clipping will be understood as a clamp or clip-type fastening adapted to fix the conduit by means of pressure to another entity, such as the main body itself or to an external element, and whose insertion requires overcoming a certain force until reach its final position.
  • the clipping allows the conduit to be easily coupled and uncoupled from the main body, by exerting a little manual pressure.
  • this fixing by clipping must be outside the projection of the interior of the main body along the axial direction X-X' to avoid the interference of said conduit with the surgical instruments.
  • the clipping of the conduit favors said conduit being located adjacent to the inner wall of the main body to maximize the space available for the introduction and handling of surgical instruments in the main body.
  • the main body has a perimeter flange in the first opening.
  • the clipping of the suction duct, either the blowing duct or the irrigation duct is established in the perimeter flange.
  • the perimeter flange is an annular piece, for example substantially flat, whose internal diameter is equal to the diameter of the first opening of the main body.
  • This flange is integrated into the main body and is positioned in its first opening.
  • the cleaning duct comprises a fixing that is clipped to the flange once the duct is housed inside the main body.
  • the presence of the flange makes it possible to thicken the wall of the main body at one of its ends, that is, it increases the size of the area for fixing the cleaning duct to the main body to facilitate the coupling and decoupling process of the duct.
  • This flange does not prevent the sliding of the main body of the access port in the last inserted dilator nor the insertion of said main body in the patient's body since said flange is not positioned in an area where the separated tissue is found.
  • the blowing conduit or the Irrigation conduit is fixed by means of a removable fastening to a support by means of an actuator that causes movement between at least two operating positions: a first operating position where the blowing conduit is tight to the internal wall of the main body and, a second operative position where the blowing duct is distanced from the internal wall of the main body, preferably in the central position.
  • the blow pipe or the irrigation pipe is fixed to a support once it is inside the main body. Both options can occur simultaneously with a single conduit; that is, the irrigation conduit can be a blowing conduit comprising a mixing element that allows the irrigation liquid to be injected into the surgical field.
  • the irrigation conduit can be a blowing conduit comprising a mixing element that allows the irrigation liquid to be injected into the surgical field.
  • the duct or ducts are fixed to the support by means of a removable fixing in order to leave the interior of the main body diaphanous.
  • the main body would be free of conduits to slide over the corresponding dilator without any element that could interfere with said sliding.
  • the blowing and/or irrigation conduit would be introduced through it.
  • said conduit would be fixed to the actuator of the support, so preferred, by means of a tightening type fixing or a friction fixing.
  • the conduit comprises a stop that allows it to be positioned longitudinally in a corresponding housing of the actuator.
  • blow conduit and/or the irrigation conduit require more precise action. where the unwanted element is found.
  • this type of conduit can act in two different positions; either close to the internal wall of the main body or distanced from it. Preferably, this second position will be the central position of the main body.
  • the blowing or irrigation can act in different areas of the surgical field where it is desired to carry out cleaning thanks to the fact that, in an example of embodiment, they can adopt any intermediate position between the two extreme positions, thus improving the efficiency of the procedure. .
  • Movement between the two extreme positions requires that the conduit be fixed at a point on the support capable of moving between said two positions.
  • the support comprises an actuator that causes the displacement of the conduit between said two extreme positions. This displacement is rectilinear and maintains the axial orientation of the conduit at all times so that the blowing and/or irrigation are carried out in the appropriate direction with respect to the surgical field.
  • the displacement can be pre-established automatically or executed in a timely manner during the intervention.
  • the actuator pneumatically causes the conduit to move.
  • the displacement caused by the actuator is established on an intermediate rod guided in such a way that rotation with respect to its axial direction is prevented.
  • the use of an intermediate rod between the actuator and the conduit itself is contemplated; that is, the actuator causes the displacement of the rod, to which the conduit would be fixed and, in this way, the conduit would reach the two target positions.
  • this stem is guided in such a way as to prevent rotation with respect to its axial direction, which guarantees the correct direction and orientation of the conduit throughout the intervention, in particular ensuring that the blowing and/or irrigation conduit maintain its orientation.
  • the conduit is attached to the stem by a torque-type attachment or frictional attachment.
  • the duct comprises a stop that allows it to be positioned longitudinally in a corresponding housing of the stem.
  • the perimeter region is located at the proximal end of the second opening and on the outside of the main body.
  • the perimeter region of the main body is configured to rest on biological tissues on which the surgical operation is to be performed. This region is located on the outside of the main body, at the proximal end of the second opening that provides access to the surgical field.
  • This perimeter region must be sterilized and made of a material compatible with biological tissue.
  • the material of the perimeter region is medical grade stainless steel, titanium or PEEK (Polyetheretherketone) polymers.
  • the surgical access port additionally comprises a fixing element configured to fix the support to a fixed external element.
  • the main body of the trocar is attached to the bracket.
  • said joint is established between the support and the end of the main body where the first opening is located.
  • the joint is established by means of a flange located in the first opening of the main body on which the support is fixed.
  • This support comprises a fixing element configured to fix said support - and therefore the main body and the conduits of the trocar when they are housed in its interior - to a fixed external element.
  • the fixing element is an articulated arm. Examples of such a fixed external element can be the operating table, a robotic system or the patient himself.
  • This fixation allows the trocar to remain immovable and, therefore, the surgical field throughout the procedure, which is key for the surgeon to be able to access the target tissues throughout the intervention.
  • the at least one conduit is fully or partially lined with an anticoagulant material.
  • This anticoagulant material for example heparin, silicone or a hydrophilic polymer such as PEG
  • This anticoagulant coating will be present in either an aspiration line, or a blow line, or an irrigation line, or a combination of any of the foregoing.
  • said coating is partial, so that only part of the conduit - that which will come into contact with the surgical field - is covered with the anticoagulant material.
  • the inner wall of the main body is fully or partially coated with an anticoagulant material.
  • the anticoagulant material for example heparin, silicone or a hydrophilic polymer such as PEG
  • the surgical field defined by the access port would be free of clots that could penetrate the at least one conduit (aspiration, blowing, irrigation or a combination thereof) obstructing it.
  • the part of the inner wall of the main body that coincides with the external perimeter region configured to rest on biological tissues is the one that is covered by an anticoagulant material.
  • a second inventive aspect provides an access system to an environment surgical, comprising: a surgical access port according to the first inventive aspect; a set of tissue dilators formed by a plurality of cylinders housed one inside the other plus a lancet in its core where the surgical access port has the inner wall configured to slide over the dilator with a larger diameter.
  • the set of concentric cylindrical dilators and the lancet necessary to define the surgical field prior to inserting said trocar into the patient's body are provided.
  • the previously mentioned advantages for the first inventive aspect also apply to this second inventive aspect where the trocar is one more dilator, specifically the one with the largest diameter that is finally placed in the patient to allow the surgical operation.
  • FIG 1 This figure shows a trocar comprising a main body with a flange to which an aspiration duct is clipped.
  • Figure 2a-2b These figures show the trocar of Figure 1 with a support element and a blowing tube positioned in a first position ( Figure 2a) and a second position ( Figure 2b).
  • FIG. 3 This figure shows the trocar of Figure 2 with a fixation element.
  • Figure 4 In this figure the suction duct is shown in detail with a clip fixing according to Figures 1-3.
  • Figure 1 shows a surgical access port - or trocar - suitable for surgical interventions, comprising a tubular main body (1) and a cleaning conduit which, in this particular example, is an aspiration conduit (2).
  • the surgical access port comprises a blowing conduit (3) and/or an irrigation conduit.
  • the main body (1) comprises a first opening (1.1) and a second opening (1.2) arranged at both ends of the main body (1).
  • This figure also shows a perimeter flange (1.5) positioned in the first opening (1.1) of the trocar, said flange (1.5) being optional in other alternative embodiments.
  • the surgeon Prior to inserting the trocar into the patient's body, the surgeon will have defined a surgical region or field by means of a lancet and a set of tissue dilators through a procedure such as that described hereinabove.
  • the second opening (1.2) of the main body (1) is configured precisely to give access to the surgical region.
  • the surgical instrument is introduced through the first opening (1.1), passes through the interior of the main body (1) in the X-X' direction and finally comes into contact with the surgical region through the second opening (2.2).
  • the main body (1) comprises a perimeter region (1.4) configured to rest on the biological tissues (T) of said surgical region.
  • the biological tissues (T) have been schematically represented by means of a hatched region corresponding to a section of the tissue (T).
  • the main body (1) comprises an inner wall (1.3) configured to slide over a tissue dilator, understanding as such any of the tissue dilators formed by a plurality of cylinders housed one inside the other plus a lancet in its core.
  • the diameter of the inner wall (1.3) is 2 millimeters greater than the diameter of the outer wall of the cylinder with the largest diameter, which would be housed in a tight and sliding manner inside the main body (1).
  • the inner wall (1.3) is covered with an anticoagulant material.
  • Figure 1 additionally shows how the suction duct (2) remains housed inside the main body (1) coupling to the perimeter flange (1.5).
  • the coupling of the conduit is made at the very end of the main body (1), when the latter (1) does not include the perimeter flange (1.5), or else at an element external to the trocar.
  • the coupling of the suction duct (2) to the perimeter flange (1.5) is carried out by means of a fixing (2.2) by clipping.
  • Said fixing (2.2) is in the form of a clamp dimensioned to clamp the perimeter flange (1.5) by applying light manual pressure.
  • the cleaning conduit with a clip-on fixation (2.2) is for blowing (3) and/or irrigation.
  • the fixing (2.2) by clipping is attached to the end of the main body (1) when the latter (1) does not include the perimeter flange (1.5).
  • the clip-on fastener (2.2) is coupled to an external element.
  • the fixing (2.2) by clipping the suction duct (2) is outside the main body (1) and outside the projection or extension of the internal cylindrical wall of the main body (1) according to the axial direction X-X'.
  • this suction duct (2) favors its tendency to be placed adjacent to the inner wall (1.3) of the main body (1).
  • the figure shows a computer representation of the suction duct (2) with a curvature that causes this tendency for the lower end to come out of the main body. Since it is a computer representation, the view shows the suction duct (2) going through and coming out of the main body (1).
  • a real device conforming to the computer representation does not traverse a physical body as the main body (1) and simply results, thanks to the fact that it is made of an elastically deformable material, in a tendency to keep its end close to the inner wall, as if it were a spring.
  • the suction duct (2) is elastically deformable and with a curvature such that it tends to press the inner wall (1.3) of the main body (1). Additionally, the suction duct (2) has a concave configuration (2.1) towards the interior of the main body (1) on the opposite side to the side facing the inner wall (1.3) of the main body (1).
  • the aspiration conduit (2) comprises a detachable vacuum connection (2.3) to be able to connect to the conduits and pipes of other medical devices, such as a vacuum source.
  • the anterior trocar is shown with a support element (4) to which a blowing tube (3) is attached.
  • the trocar comprises an additional or alternative irrigation conduit to the blowing conduit (3).
  • the conduit is for blowing and irrigation at the same time.
  • the trocar support (4) comprises an actuator (5) capable of causing the blowing duct (3) to move between two operative positions: a first position where the blowing duct (3) is close to the internal wall of the main body (1), shown in Figure 2a, and a second operating position where the blowing duct (3) is distanced from the internal wall of the main body (1), in this case in the central position, as shown in Figure 2b.
  • actuator (5) capable of causing the blowing duct (3) to move between two operative positions: a first position where the blowing duct (3) is close to the internal wall of the main body (1), shown in Figure 2a, and a second operating position where the blowing duct (3) is distanced from the internal wall of the main body (1), in this case in the central position, as shown in Figure 2b.
  • the support (4) shown in these Figures 2a and 2b comprises an intermediate rod (3.1) that receives the movement of the actuator (5) and transmits it to the blowing duct (3).
  • the intermediate rod (3.1) is guided in such a way that rotation with respect to its axial direction is prevented.
  • the section of both the stem and the guide that allows it to slide is polygonal, specifically square.
  • the fixing of the blowing duct (3) to the intermediate rod (3.1) is carried out by means of a tightening torque.
  • FIG 3 shows the trocar of Figures 2a and 2b including an additional fixation element (4.1), in particular, an articulated arm.
  • This fixing element (4.1) allows the trocar support (4) to be fixed to a fixed external element.
  • said element is the patient's bed or the patient himself, for example, a clamp directly attached - not shown in this figure - to one of his vertebrae.
  • the external element is a robotic system or a tracking system.

Abstract

The present invention relates to a surgical access port suitable for surgical interventions, comprising a main body configured as a tubular conduit extending in an axial direction X-X' and comprising a first access opening arranged at one end of the main body, a second opening arranged at the end of the main body opposite the first opening configured for providing access to a surgical region, an inner wall configured for sliding over a tissue dilator from among the tissue dilators formed by a plurality of cylinders housed inside one another plus a lancet in the center thereof; and a perimetral region configured for being supported on biological tissues in the surgical region; wherein the surgical access port further comprises at least one conduit which is either a suction conduit, a blowing conduit, or an irrigation conduit, housed inside the main body, wherein said conduit can be detached and removed to leave the inside of the main body unobstructed.

Description

PUERTO DE ACCESO QUIRÚRGICO CON CAPACIDAD DE LIMPIEZA CLEANABLE SURGICAL ACCESS PORT
DESCRIPCIÓN DESCRIPTION
OBJETO DE LA INVENCIÓN OBJECT OF THE INVENTION
La presente invención está dirigida a un puerto de acceso quirúrgico o trocar con capacidad de limpieza de dicho campo quirúrgico durante el transcurso de una cirugía mínimamente invasiva (MIS por sus siglas en inglés). The present invention is directed to a surgical access port or trocar capable of cleaning said surgical field during the course of minimally invasive surgery (MIS).
ANTECEDENTES DE LA INVENCIÓN BACKGROUND OF THE INVENTION
Los puertos de acceso quirúrgicos o trocares son un tipo de instrumental quirúrgico que cumple una función puramente mecánica: definir el campo quirúrgico y la dirección en la que el cirujano actúa, manteniendo la piel y otros tejidos blandos fuera del campo quirúrgico para no molestar la actuación del cirujano. Surgical access ports or trocars are a type of surgical instrument that fulfills a purely mechanical function: define the surgical field and the direction in which the surgeon acts, keeping the skin and other soft tissues out of the surgical field so as not to disturb the action. of the surgeon.
Las cirugías mínimamente invasivas (MIS) requieren la adquisición de imágenes del campo quirúrgico durante el transcurso de la cirugía. Estas imágenes intraoperatorias suponen una información clave para el éxito de la intervención ya que permiten al cirujano decidir cómo actuar en cada momento. Con el objetivo de mostrar fielmente el campo quirúrgico al cirujano, dichas imágenes han de estar libres de debris de tejidos cortados, sangre, suero salino y otros elementos indeseados que, sin embargo, están continuamente presentes en el campo quirúrgico. Así, para evitar en la medida de lo posible que estos elementos estén visibles en las imágenes, las cirugías mínimamente invasivas requieren una labor continuada de limpieza del campo quirúrgico. Minimally invasive surgeries (MIS) require the acquisition of images of the surgical field during the course of surgery. These intraoperative images provide key information for the success of the intervention as they allow the surgeon to decide how to act at all times. In order to faithfully show the surgical field to the surgeon, these images must be free of debris from cut tissue, blood, saline and other unwanted elements that, however, are continuously present in the surgical field. Thus, to avoid as much as possible that these elements are visible in the images, minimally invasive surgeries require continuous cleaning of the surgical field.
La limpieza, al igual que la propia intervención, se realiza a través de los puertos de acceso quirúrgicos. Estos puertos de acceso son tubos estrechos y largos, por lo que no resulta sencillo mantener el campo quirúrgico limpio durante toda la duración del procedimiento. Cleaning, like the procedure itself, is done through the surgical access ports. These access ports are long, narrow tubes, so it is not easy to keep the surgical field clean throughout the duration of the procedure.
En la actualidad, la limpieza del campo quirúrgico en cirugías MIS se realiza manualmente introduciendo aspiradores manuales y dispositivos manuales de irrigación, como pueden ser las jeringuillas y dispositivos similares. La introducción de estos instrumentos a través del puerto de acceso tubular, a diferencia de en procedimientos abiertos, obliga al cirujano a detener la operación como tal, por ejemplo el proceso de corte, y extraer el instrumental quirúrgico que se estuviera empleando en ese momento, por ejemplo una fresa, bisturí, monopolar o herramienta de corte. Tras la detención del procedimiento, se introduce el instrumento de limpieza para proceder con la limpieza del campo quirúrgico. Una vez se ha completado dicha limpieza, se extrae el instrumento de limpieza y se prosigue con la intervención quirúrgica. Esta secuencia que alterna cirugía y limpieza se repite varias veces durante el procedimiento, lo cual supone una interrupción constante de la intervención y está lejos de ser una solución de limpieza óptima. Además, dicha solución no es válida en cirugías MIS robotizadas ya que las labores de limpieza, como la aspiración, el soplado y la irrigación, no solo estarían constantemente interrumpiendo la labor quirúrgica del robot sino que obstaculizarían su visualización del campo quirúrgico. Currently, cleaning of the surgical field in MIS surgeries is done manually by inserting manual aspirators and manual cleaning devices. irrigation, such as syringes and similar devices. The introduction of these instruments through the tubular access port, unlike in open procedures, forces the surgeon to stop the operation as such, for example the cutting process, and remove the surgical instruments that were being used at that time, for example a bur, scalpel, monopolar or cutting tool. After stopping the procedure, the cleaning instrument is introduced to proceed with the cleaning of the surgical field. Once the cleaning is complete, the cleaning instrument is removed and the surgical procedure proceeds. This sequence of alternating surgery and cleaning is repeated several times during the procedure, which is a constant interruption of the procedure and is far from being an optimal cleaning solution. In addition, this solution is not valid in robotic MIS surgeries since cleaning tasks, such as aspiration, blowing and irrigation, would not only be constantly interrupting the surgical work of the robot but would also hinder its visualization of the surgical field.
DESCRIPCIÓN DE LA INVENCIÓN DESCRIPTION OF THE INVENTION
La presente invención propone una solución a los problemas anteriores mediante un puerto de acceso quirúrgico adecuado para intervenciones quirúrgicas según la reivindicación 1 y un sistema de acceso a un entorno quirúrgico según la reivindicación 14. En reivindicaciones dependientes se definen realizaciones preferidas de la invención. The present invention proposes a solution to the above problems by means of a surgical access port suitable for surgical interventions according to claim 1 and a system for accessing a surgical environment according to claim 14. Preferred embodiments of the invention are defined in dependent claims.
En el estado de la técnica, un puerto de acceso quirúrgico se define como un instrumento empleado para definir el campo quirúrgico en cirugías mínimamente invasivas. Estos instrumentos se emplean en conjunto con una lanceta de punta afilada en un extremo y una pluralidad de dilatadores de tejidos cilindricos. A lo largo del documento, se emplearán los términos puerto de acceso quirúrgico y trocar de manera indistinta. De igual forma, se emplearán los términos campo quirúrgico y región quirúrgica. In the state of the art, a surgical access port is defined as an instrument used to define the surgical field in minimally invasive surgeries. These instruments are used in conjunction with a lancet with a sharp point at one end and a plurality of cylindrical tissue dilators. Throughout the document, the terms surgical access port and trocar will be used interchangeably. Similarly, the terms surgical field and surgical region will be used.
En primer lugar, el cirujano realiza una incisión en la piel del paciente, generalmente mediante un bisturí frío o monopolar, de un tamaño ligeramente superior al diámetro de la lanceta. A partir de esta incisión, introduce en el cuerpo del paciente la lanceta para definir la dirección en la que se va a realizar el procedimiento quirúrgico. Por ejemplo, en una cirugía de columna, la lanceta se introduce hasta encontrar tejido duro, es decir, hasta topar con el hueso que será el punto de inicio de la cirugía. Una vez la lanceta está introducida en la posición deseada, el cirujano introduce una serie de dilatadores de tejidos cilindricos concéntricos con la lanceta, que van aumentando poco a poco su diámetro y dilatando por tanto los tejidos blandos alrededor de la lanceta o del dilatador con un diámetro inmediatamente inferior. Así, el primer dilatador, de menor diámetro, desliza sobre la lanceta para dilatar el orificio creado por la misma; y el resto de dilatadores, de diámetros crecientes, deslizan unos sobre los otros para aumentar dicha dilatación hasta alcanzar el tamaño requerido por la cirugía. Esta secuencia se realiza mediante incrementos pequeños del diámetro de los dilatadores cilindricos; preferentemente en incrementos aproximados de 2 milímetros. First, the surgeon makes an incision in the patient's skin, usually using a cold or monopolar scalpel, slightly larger than the diameter of the lancet. From this incision, the lancet is inserted into the patient's body to define the direction in which the surgical procedure is to be performed. By For example, in spinal surgery, the lancet is inserted until it finds hard tissue, that is, until it hits the bone that will be the starting point of the surgery. Once the lancet is inserted in the desired position, the surgeon introduces a series of concentric cylindrical tissue dilators with the lancet, which gradually increase in diameter and thus dilate the soft tissues around the lancet or dilator with a diameter immediately below. Thus, the first dilator, with a smaller diameter, slides over the lancet to dilate the hole created by it; and the rest of the dilators, of increasing diameters, slide over each other to increase said dilation until reaching the size required by the surgery. This sequence is performed by small increases in the diameter of the cylindrical dilators; preferably in approximate 2-millimeter increments.
El último cilindro en ser introducido es el trocar - o puerto de acceso - que, una vez introducido, se fija a algún elemento presente en la sala de operaciones, generalmente la mesa de operaciones. A continuación, se extraen la lanceta y todos los dilatadores cilindricos, dejando el campo quirúrgico definido y libre de los tejidos blandos que lo rodean. The last cylinder to be inserted is the trocar - or access port - which, once inserted, is fixed to some element present in the operating room, generally the operating table. The lancet and all cylindrical dilators are then removed, leaving the surgical field defined and free of surrounding soft tissue.
Un primer aspecto inventivo proporciona un puerto de acceso quirúrgico adecuado para intervenciones quirúrgicas, que comprende: un cuerpo principal configurado como conducto tubular que se extiende según una dirección axial X-X' y que comprende: una primera abertura de acceso dispuesta en un extremo del cuerpo principal, una segunda abertura dispuesta en el extremo del cuerpo principal opuesto a la primera abertura configurada para dar acceso a una región quirúrgica, una pared interior configurada para deslizar sobre un dilatador de tejidos, de entre los dilatadores de tejidos formados por una pluralidad de cilindros alojados uno dentro de otro más una lanceta en su núcleo; una región perimetral configurada para apoyar sobre tejidos biológicos en la región quirúrgica; al menos un conducto, o bien de aspiración o bien de soplado, o bien de irrigación, alojado en el interior del cuerpo principal donde dicho conducto es desacoplable y retirable para dejar diáfano el interior del cuerpo principal. En este primer aspecto inventivo se describe un puerto de acceso quirúrgico que comprende un cuerpo principal y al menos un conducto destinado a la limpieza del campo quirúrgico. A first inventive aspect provides a surgical access port suitable for surgical interventions, comprising: a main body configured as a tubular conduit extending in an axial direction XX' and comprising: a first access opening arranged at one end of the main body , a second opening arranged at the end of the main body opposite the first opening configured to give access to a surgical region, an inner wall configured to slide over a tissue dilator, from among the tissue dilators formed by a plurality of cylinders housed one inside another plus a lancet at its core; a perimeter region configured to rest on biological tissues in the surgical region; at least one conduit, either suction or blowing, or irrigation, housed inside the main body where said conduit is detachable and removable to leave the interior of the main body diaphanous. In this first inventive aspect, a surgical access port is described that comprises a main body and at least one conduit intended for cleaning the surgical field.
El cuerpo principal es un conducto tubular que comprende dos aberturas ubicadas en extremos opuestos. La primera abertura es aquella a través de la cual se introduce el instrumental quirúrgico. Dicho instrumental atraviesa el cuerpo principal hasta la segunda abertura, que le dará acceso al campo quirúrgico. De manera preferida, el cuerpo principal está hecho de un material biocompatible; por ejemplo, acero inoxidable de grado médico, titanio o polímeros PEEK (Polyetheretherketone). The main body is a tubular duct comprising two openings located at opposite ends. The first opening is the one through which the surgical instruments are inserted. Said instruments pass through the main body to the second opening, which will give you access to the surgical field. Preferably, the main body is made of a biocompatible material; for example, medical grade stainless steel, titanium or PEEK (Polyetheretherketone) polymers.
Como se ha comentado anteriormente, el puerto de acceso quirúrgico ha de poder deslizarse sobre un dilatador de tejidos de los existentes en el estado de la técnica. Para ello, el cuerpo principal comprende una pared interior dimensionada para tal fin. As mentioned above, the surgical access port must be able to slide over a tissue dilator of those existing in the state of the art. To do this, the main body comprises an inner wall dimensioned for this purpose.
En el extremo en el que se ubica la segunda abertura, el cuerpo principal comprende una región perimetral configurada para apoyar sobre tejidos biológicos en el campo quirúrgico. A lo largo del documento, se entenderá que la región perimetral del cuerpo principal se apoya sobre los tejidos del campo quirúrgico accesibles en el momento en que dicho cuerpo principal se ha deslizado sobre un dilatador de tejidos del estado de la técnica penetrando en el espacio previamente abierto por los dilatadores ya introducidos. At the end where the second opening is located, the main body comprises a perimeter region configured to rest on biological tissues in the surgical field. Throughout the document, it will be understood that the perimeter region of the main body rests on the tissues of the surgical field that are accessible at the moment when said main body has slid over a tissue dilator of the state of the art, penetrating the space previously opened by the dilators already inserted.
La forma del cuerpo principal del puerto de acceso no implica que deba ser cilindrica ya que externamente puede disponer de elementos que no entorpecen el paso de los dilatadores porsu interior, pudiendo mostrar una forma distinta a la cilindrica de sección circular siempre y cuando la región perimetral situada adyacente a la segunda abertura tenga un espesor que no genere la rotura del tejido blando en el momento de la inserción, al igual que sucede con cualquiera de los dilatadores. Esta condición se asegura manteniendo el espesor del puerto de acceso acotado, al menos, en la región destinada a estar en contacto con el tejido para mantener al mismo separado. The shape of the main body of the access port does not imply that it must be cylindrical since externally it can have elements that do not hinder the passage of the dilators through its interior, being able to show a different shape from the cylindrical one with a circular section as long as the perimeter region located adjacent to the second opening is of a thickness that does not cause soft tissue rupture upon insertion, as is the case with any of the dilators. This condition is ensured by keeping the thickness of the access port limited, at least in the region intended to be in contact with the tissue to keep it separated.
El rango de diámetros del cuerpo principal del puerto de acceso está adaptado para la cirugía mínimamente invasiva a realizar. Por ejemplo, para cirugía de columna, el rango de diámetros del cuerpo principal oscila de manera preferida entre los 15 y los 26 milímetros. Por otro lado, el grosor de la pared del cuerpo principal del puerto de acceso, de manera preferida, oscila entre los 0.2 y los 0.6 milímetros. The range of diameters of the main body of the access port is adapted for the minimally invasive surgery to be performed. For example, for spinal surgery, the main body diameter range is preferably between 15 and 26 millimeters. On the other hand, the thickness of the wall of the main body of the access port is preferably between 0.2 and 0.6 millimeters.
Además del cuerpo principal, el puerto de acceso quirúrgico según el primer aspecto inventivo comprende al menos un conducto destinado a la limpieza del campo quirúrgico. Dicho al menos un conducto puede ser de aspiración, soplado y/o de irrigación. In addition to the main body, the surgical access port according to the first inventive aspect comprises at least one conduit intended for cleaning the surgical field. Said at least one conduit can be for suction, blowing and/or irrigation.
A lo largo de este documento, se entenderá que el al menos un conducto evacúa debris de tejidos cortados, sangre, suero salino y otros elementos indeseados presentes en el campo quirúrgico aspirándolos y/o introduciendo aire y/o líquido de irrigación en dicho campo quirúrgico con una potencia, caudal y/o presión adaptados a tal fin. Estos parámetros, de manera preferida, pueden variarse durante la intervención quirúrgica según los requerimientos de limpieza en cada momento. Estas variaciones pueden decidirse puntualmente por parte del personal médico o bien automatizarse previamente. Throughout this document, it will be understood that the at least one conduit evacuates debris from cut tissues, blood, saline and other unwanted elements present in the surgical field by vacuuming them and/or introducing air and/or irrigation liquid in said surgical field with a power, flow rate and/or pressure adapted for this purpose. These parameters, preferably, can be varied during the surgical intervention according to the cleaning requirements at each moment. These variations can be decided on time by the medical staff or previously automated.
Una vez el cuerpo principal está posicionado definiendo el campo quirúrgico - esto es, se ha realizado una incisión en el paciente que posteriormente se ha dilatado con la lanceta y la pluralidad de dilatadores de tejidos y, en última instancia, se ha deslizado el cuerpo principal del puerto de acceso quirúrgico sobre el dilatador de tejidos de mayor diámetro - el o los conductos del puerto de acceso quirúrgico se introducen por la primera abertura del cuerpo principal y quedan alojados en su interior. Once the main body is positioned defining the surgical field - that is, an incision has been made in the patient which has subsequently been dilated with the lancet and the plurality of tissue dilators and, ultimately, the main body has been slid of the surgical access port on the larger diameter tissue dilator - the conduit(s) of the surgical access port are introduced through the first opening of the main body and are housed inside it.
El o los conductos pueden acoplarse o fijarse bien al cuerpo principal o bien a algún otro elemento que sirve como elemento intermedio con el cuerpo principal. Así, una vez se han acoplado o fijado, estos permanecen estáticos en el interior del cuerpo principal. De esta forma, una vez el o los conductos se encuentran en el interior del cuerpo principal, se pueden llevar a cabo de manera simultánea la cirugía como tal y el procedimiento de limpieza del campo quirúrgico. The duct or ducts can be coupled or fixed either to the main body or to some other element that serves as an intermediate element with the main body. Thus, once they have been attached or fixed, they remain static inside the main body. In this way, once the duct or ducts are inside the main body, the surgery itself and the procedure for cleaning the surgical field can be carried out simultaneously.
Gracias a esta doble funcionalidad del trocar, se garantiza que la adquisición de imagen intraoperatoria y/o las operaciones de cirugía se realizan en las mejores condiciones de limpieza posibles, lo que supone una información muy valiosa para el cirujano ya que puede visualizar en tiempo real el campo quirúrgico real sobre el que está trabajando en ese instante de tiempo. Dicho campo quirúrgico se presentará al cirujano libre de elementos indeseados, como la sangre o debris de tejidos cortados, que podrían dificultar la visibilidad de los tejidos objetivo de la cirugía. Thanks to this double functionality of the trocar, it is guaranteed that the intraoperative image acquisition and/or the surgical operations are performed in the best possible clean conditions, which is very valuable information for the surgeon since it can be visualized in real time. the actual surgical field you are working on at that instant of time. Said surgical field will be presented to the surgeon free of unwanted elements, such as blood or debris from cut tissues, which could hinder the visibility of the target tissues of the surgery.
Adicionalmente, la intervención quirúrgica no se ve necesariamente interrumpida por la operación de limpieza, lo cual evita prolongar la estancia del paciente en el quirófano innecesariamente y las distracciones que dichas interrupciones pueden provocar en el personal médico, minimizando así los riesgos a los que está expuesto el paciente durante la intervención. Additionally, the surgical intervention is not necessarily interrupted by the cleaning operation, which avoids prolonging the patient's stay in the operating room unnecessarily and the distractions that such interruptions can cause to the medical staff, thus minimizing the risks to which they are exposed. the patient during the intervention.
El al menos un conducto fijado al cuerpo principal no impide el deslizamiento de dicho cuerpo principal en el último de los dilatadores insertados dado que dicho conducto no está presente en esta etapa. El conducto es desacoplable, lo que permite fijarlo al cuerpo principal una vez éste está insertado en el paciente. De este modo, la forma de la superficie de la pared interior no se ve modificada por el requisito de existencia del conducto y es posible que se ciña perfectamente a la pared exterior del último dilatador para permitir una inserción en el tejido sin problemas. The at least one conduit fixed to the main body does not prevent the sliding of said main body in the last of the inserted dilators since said conduit is not present at this stage. The conduit is detachable, which allows it to be fixed to the main body once it is inserted in the patient. In this way, the shape of the inner wall surface is not modified by the conduit requirement and it is possible to closely adhere to the outer wall of the last dilator to allow smooth tissue insertion.
La funcionalidad de limpieza es de especial relevancia en cirugías robóticas en las que intervienen láseres de corte y sistemas fotónicos que permiten distinguir tejidos, pues su correcta actuación está ligada a la limpieza del campo quirúrgico. Así, el trocar de la invención posibilita que la cirugía robótica se desarrolle de manera fluida, sin interrupciones, permitiendo minimizar los tiempos de las intervenciones y, consecuentemente, suponiendo un ahorro importante de recursos. Cleaning functionality is especially relevant in robotic surgeries involving cutting lasers and photonic systems that allow tissue to be distinguished, since their correct performance is linked to cleaning the surgical field. Thus, the trocar of the invention enables robotic surgery to develop smoothly, without interruptions, minimizing intervention times and, consequently, leading to significant savings in resources.
Una vez se ha completado el procedimiento quirúrgico, el o los conductos acoplados al cuerpo principal - o a otros elementos adicionales del trocar o a elemento externos al trocar - se desacoplan y retiran para dejar diáfano su interior. Gracias a ello, el cuerpo principal vuelve al estado inicial sin conductos para poder deslizarse sobre un dilatador de tejidos de los existentes en el estado de la técnica en cirugías posteriores. Once the surgical procedure has been completed, the conduit(s) coupled to the main body - or to other additional elements of the trocar or to elements external to the trocar - are uncoupled and removed to leave their interior diaphanous. Thanks to this, the main body returns to the initial state without ducts to be able to slide over a tissue dilator of those existing in the state of the art in subsequent surgeries.
Es importante destacar que los incrementos de diámetro de los dilatadores de tejidos a la hora de definir el campo quirúrgico han de ser pequeños, en torno a los 2 milímetros, de forma que estos dilatadores y el trocar puedan introducirse en el cuerpo del paciente sin producir daño a los tejidos blandos. Por ello, un trocar que incorpore de manera fija y constante los tubos de aspiración, soplado e irrigación no es una solución válida puesto que la diferencia entre su diámetro interior y exterior haría imposible introducirlo en el cuerpo del paciente sin dañar los tejidos blandos. It is important to note that the increases in diameter of the tissue dilators when defining the surgical field must be small, around 2 millimeters, so that these dilators and the trocar can be introduced into the patient's body without producing soft tissue damage. Therefore, a trocar that permanently incorporates and constant suction, blowing and irrigation tubes is not a valid solution since the difference between its internal and external diameter would make it impossible to insert it into the patient's body without damaging the soft tissues.
Por el contrario, la presente invención permite introducir el trocar siguiendo la secuencia de dilatación tradicional, cumpliendo así la función mecánica de los trocares actuales, e incorporar la función de limpieza, que no se había contemplado hasta ahora en este tipo de instrumental quirúrgico. On the contrary, the present invention allows the trocar to be introduced following the traditional dilation sequence, thus fulfilling the mechanical function of current trocars, and incorporating the cleaning function, which had not been contemplated until now in this type of surgical instrument.
Por otra parte, incluir la funcionalidad de limpieza en el trocar permite automatizar los ciclos de limpieza, ajustar automáticamente los parámetros de irrigación, aspiración y/o soplado (caudal, potencia, presión) en distintos regímenes a lo largo del procedimiento. De manera preferida, esta automatización se realiza, por ejemplo, a través de autómatas programables y dispositivos similares. On the other hand, including the cleaning functionality in the trocar makes it possible to automate the cleaning cycles, automatically adjust the parameters of irrigation, aspiration and/or blowing (flow, power, pressure) in different regimes throughout the procedure. In a preferred way, this automation is carried out, for example, through programmable robots and similar devices.
Automatizar los ciclos de limpieza y los valores de los parámetros del o de los conductos es especialmente relevante en cirugías robóticas ya que, como se ha comentado previamente, la actuación del robot - por ejemplo, mediante un láser de corte o mediante sistemas fotónicos que permiten distinguir tejidos - necesita un campo quirúrgico limpio. Automating the cleaning cycles and the parameter values of the duct or ducts is especially relevant in robotic surgeries since, as previously mentioned, the action of the robot - for example, by means of a cutting laser or by means of photonic systems that allow distinguish tissues - needs a clean surgical field.
En una realización particular, el conducto alojado en el interior del cuerpo principal es un conducto de aspiración y comprende una conexión desacoplable de vacío. In a particular embodiment, the conduit housed inside the main body is a suction conduit and comprises a detachable vacuum connection.
En esta realización, la limpieza del campo quirúrgico se realiza por aspiración; esto es, los elementos indeseados del campo quirúrgicos son succionados por el conducto del puerto de acceso quirúrgico. Dicho conducto, como ya se ha comentado, puede acoplarse y desacoplarse del cuerpo principal - u otros elementos - para lo cual comprende una conexión o fijación, por ejemplo, mediante clipado. In this embodiment, the surgical field is cleaned by suction; that is, the unwanted elements of the surgical field are suctioned through the conduit of the surgical access port. Said conduit, as already mentioned, can be coupled and uncoupled from the main body - or other elements - for which it comprises a connection or fixing, for example, by clipping.
Por otro lado, el conducto de aspiración incorpora una conexión de vacío que permite independizar dicho conducto de aspiración de una fuente de vacío necesaria para llevar a cabo la aspiración. Cuando el conducto de vacío está acoplado al cuerpo principal del puerto de acceso, la fuente se independiza del conjunto que forma el puerto de acceso. A lo largo del documento, se entenderá que una conexión de vacío es un elemento mecánico empleado, entre otros, en el ámbito hospitalario para conectar conductos o canalizaciones a otros dispositivos médicos, en este caso la fuente de vacío. Estas conexiones suelen ser de tipo conexión rápida, es decir, aquellas en las que con una maniobra de inserción se asegura el acoplamiento y a la vez la estanqueidad del acoplamiento. On the other hand, the suction duct incorporates a vacuum connection that allows said suction duct to be made independent of a vacuum source necessary to carry out the suction. When the vacuum conduit is coupled to the main body of the access port, the source becomes independent of the assembly that forms the access port. Throughout the document, a vacuum connection will be understood to be an element mechanical used, among others, in the hospital environment to connect ducts or pipes to other medical devices, in this case the vacuum source. These connections are usually of the quick connection type, that is, those in which the coupling and, at the same time, the tightness of the coupling are ensured with an insertion manoeuvre.
En una realización particular, el conducto de aspiración es elásticamente deformadle y con una curvatura tal que tiene tendencia a presionar la pared interior del cuerpo principal. In a particular embodiment, the suction duct is elastically deformable and with a curvature such that it tends to press against the inner wall of the main body.
Para evitar en la medida de lo posible la interferencia del conducto de aspiración con el instrumental quirúrgico durante una intervención, dicho conducto ha de posicionarse lo más cerca posible de la pared interna del cuerpo principal. De esta forma, se garantiza que el cirujano pueda manipular el instrumental quirúrgico en el interior del cuerpo principal a la vez que el conducto de aspiración ejecuta su función. To avoid as much as possible the interference of the aspiration duct with the surgical instruments during an intervention, said duct must be positioned as close as possible to the internal wall of the main body. In this way, it is guaranteed that the surgeon can manipulate the surgical instruments inside the main body at the same time that the aspiration conduit performs its function.
A tal fin, el conducto de aspiración según esta realización es elástico y deformable, con una curvatura orientada hacia la pared interior del cuerpo principal. Esta elasticidad permite que, una vez el conducto queda alojado en el cuerpo principal, éste siempre tienda a dirigirse hacia la pared interiorde dicho cuerpo principal manteniéndose ceñido a la pared interna con una determinada fuerza, posibilitando de esta forma disponer del mayor espacio posible para la introducción y manipulación del instrumental quirúrgico en el cuerpo principal. To this end, the suction duct according to this embodiment is elastic and deformable, with a curvature oriented towards the inner wall of the main body. This elasticity allows that, once the conduit is housed in the main body, it always tends to be directed towards the inner wall of said main body, staying close to the inner wall with a certain force, thus making it possible to have the greatest possible space for the introduction and handling of surgical instruments in the main body.
En una realización particular, el conducto de aspiración muestra una configuración cóncava hacia el interior del cuerpo principal en el lado opuesto al lado enfrentado a la pared interior del cuerpo principal. In a particular embodiment, the suction duct shows a concave configuration towards the interior of the main body on the opposite side to the side facing the interior wall of the main body.
La configuración cóncava del conducto de aspiración hacia el interior del cuerpo principal busca reducir la interferencia de dicho conducto con el instrumental quirúrgico durante la intervención y, a la vez, asegurar una elevada sección interior del conducto de aspiración. Esta configuración minimiza la presencia del conducto dentro del cuerpo principal, maximizando así el espacio disponible para la introducción y manipulación del instrumental quirúrgico. En una realización particular, el conducto desacoplable - o bien el conducto de aspiración, o bien de soplado o bien de irrigación - tiene una fijación por clipado en el exterior del cuerpo principal y fuera de la proyección del interior del cuerpo principal según la dirección axial X-X'. The concave configuration of the aspiration duct towards the interior of the main body seeks to reduce the interference of said duct with the surgical instruments during the intervention and, at the same time, to ensure a high internal section of the aspiration duct. This configuration minimizes the presence of the conduit inside the main body, thus maximizing the space available for the introduction and manipulation of the surgical instruments. In a particular embodiment, the detachable conduit - either the suction conduit, or the blowing conduit or the irrigation conduit - is fastened by clipping to the outside of the main body and outside the projection of the inside of the main body along the axial direction X-X'.
En esta realización, el conducto o uno de los conductos del trocar tiene una fijación por clipado. Una vez el conducto queda alojado en el interior del cuerpo principal, la fijación se posicionaría fuera de dicho cuerpo principal. De manera preferida, la fijación se cliparía en un extremo del propio cuerpo principal, por ejemplo en un borde de la primera abertura. En otro ejemplo alternativo, la fijación se cliparía a un elemento externo al cuerpo principal. In this embodiment, the conduit or one of the conduits of the trocar has a clip fixation. Once the conduit is housed inside the main body, the fixing would be positioned outside said main body. In a preferred way, the fixing would be clipped at one end of the main body itself, for example at an edge of the first opening. In another alternative example, the fixture would be clipped to an element external to the main body.
A lo largo del documento, se entenderá por fijación por clipado una sujeción tipo pinza o clip adaptada para fijar el conducto mediante presión a otra entidad, como puede ser el propio cuerpo principal o a un elemento externo, y cuya inserción requiere superar una determinada fuerza hasta llegar a su posición final. Ventajosamente, el clipado permite acoplar y desacoplar el conducto al cuerpo principal fácilmente, ejerciendo una pequeña presión manual. Throughout the document, fixing by clipping will be understood as a clamp or clip-type fastening adapted to fix the conduit by means of pressure to another entity, such as the main body itself or to an external element, and whose insertion requires overcoming a certain force until reach its final position. Advantageously, the clipping allows the conduit to be easily coupled and uncoupled from the main body, by exerting a little manual pressure.
Adicionalmente, esta fijación por clipado ha de estar fuera de la proyección del interior del cuerpo principal según la dirección axial X-X' para evitar la interferencia de dicho conducto con el instrumental quirúrgico. De manera preferida, el clipado del conducto favorece que dicho conducto se ubique adyacente a la pared interior del cuerpo principal para maximizar el espacio disponible para la introducción y manipulación del instrumental quirúrgico en el cuerpo principal. Additionally, this fixing by clipping must be outside the projection of the interior of the main body along the axial direction X-X' to avoid the interference of said conduit with the surgical instruments. Preferably, the clipping of the conduit favors said conduit being located adjacent to the inner wall of the main body to maximize the space available for the introduction and handling of surgical instruments in the main body.
En una realización particular, el cuerpo principal tiene una valona perimetral en la primera abertura. En una realización particular, el clipado del conducto de aspiración o bien de soplado o bien de irrigación, se establece en la valona perimetral. In a particular embodiment, the main body has a perimeter flange in the first opening. In a particular embodiment, the clipping of the suction duct, either the blowing duct or the irrigation duct, is established in the perimeter flange.
A lo largo del documento, se entenderá que valona perimetral es una pieza anular, por ejemplo sustancialmente plana, cuyo diámetro interior es igual al diámetro de la primera abertura del cuerpo principal. Esta valona está integrada en el cuerpo principal y se posiciona en su primera abertura. En una realización, el conducto de limpieza comprende una fijación que se sujeta por clipado a la valona una vez el conducto está alojado en el interior del cuerpo principal. La presencia de la valona permite engrosar la pared del cuerpo principal en uno de sus extremos, es decir, aumenta el tamaño de la zona de fijación del conducto de limpieza al cuerpo principal para facilitar el proceso de acoplamiento y desacoplamiento del conducto. Esta valona no impide el deslizamiento del cuerpo principal del puerto de acceso en el último dilatador insertado ni la inserción de dicho cuerpo principal en el cuerpo del paciente ya que dicha valona no se posiciona en una zona donde se encuentre el tejido separado. Throughout the document, it will be understood that the perimeter flange is an annular piece, for example substantially flat, whose internal diameter is equal to the diameter of the first opening of the main body. This flange is integrated into the main body and is positioned in its first opening. In one embodiment, the cleaning duct comprises a fixing that is clipped to the flange once the duct is housed inside the main body. The presence of the flange makes it possible to thicken the wall of the main body at one of its ends, that is, it increases the size of the area for fixing the cleaning duct to the main body to facilitate the coupling and decoupling process of the duct. This flange does not prevent the sliding of the main body of the access port in the last inserted dilator nor the insertion of said main body in the patient's body since said flange is not positioned in an area where the separated tissue is found.
En una realización particular, el conducto de soplado o bien el conducto de Irrigación está fijado mediante una fijación retirable a un soporte por medio de un actuador que causa el desplazamiento entre al menos dos posiciones operativas: una primera posición operativa donde el conducto de soplado está ceñido a la pared interna del cuerpo principal y, una segunda posición operativa donde el conducto de soplado está distanciado de la pared interna del cuerpo principal, preferentemente en la posición central. In a particular embodiment, the blowing conduit or the Irrigation conduit is fixed by means of a removable fastening to a support by means of an actuator that causes movement between at least two operating positions: a first operating position where the blowing conduit is tight to the internal wall of the main body and, a second operative position where the blowing duct is distanced from the internal wall of the main body, preferably in the central position.
En esta realización, el conducto de soplado o el conducto de irrigación se fijan a un soporte una vez están en el interior del cuerpo principal. Ambas opciones pueden darse simultáneamente con un único conducto; es decir, el conducto de irrigación puede ser un conducto de soplado que comprenda un elemento de mezcla que permite la inyección del líquido de irrigación en el campo quirúrgico. Así, con un mismo conducto en la región del puerto de acceso se dispone de la función de soplado, de la función de irrigación y/o incluso de una función mezcla de ambas que da lugar a una nebulización sin que sea necesario que en el interior del puerto de acceso haya más conductos diferenciados. In this embodiment, the blow pipe or the irrigation pipe is fixed to a support once it is inside the main body. Both options can occur simultaneously with a single conduit; that is, the irrigation conduit can be a blowing conduit comprising a mixing element that allows the irrigation liquid to be injected into the surgical field. Thus, with the same conduit in the region of the access port, there is a blowing function, an irrigation function and/or even a mixing function of both that gives rise to nebulization without it being necessary that inside of the access port there are more differentiated ducts.
En esta realización, la fijación del conducto o de los conductos al soporte se realiza mediante una fijación retirable para poder dejar diáfano el interior del cuerpo principal. Así, al comienzo de una cirugía, el cuerpo principal estaría libre de conductos para deslizar sobre el dilatador correspondiente sin ningún elemento que pueda interferir en dicho deslizamiento. A continuación, una vez que que cuerpo principal del trocar ha penetrado en el paciente, se introduciría a través del mismo el conducto de soplado y/o de irrigación. Finalmente, dicho conducto se fijaría al actuador del soporte, de manera preferida, mediante una fijación tipo par de apriete o una fijación por rozamiento. Para ello, el conducto comprende un tope que permite posicionarlo longitudinalmente en un alojamiento correspondiente del actuador. In this embodiment, the duct or ducts are fixed to the support by means of a removable fixing in order to leave the interior of the main body diaphanous. Thus, at the beginning of a surgery, the main body would be free of conduits to slide over the corresponding dilator without any element that could interfere with said sliding. Next, once the main body of the trocar has entered the patient, the blowing and/or irrigation conduit would be introduced through it. Finally, said conduit would be fixed to the actuator of the support, so preferred, by means of a tightening type fixing or a friction fixing. For this, the conduit comprises a stop that allows it to be positioned longitudinally in a corresponding housing of the actuator.
A diferencia de un conducto de aspiración, que tendría la capacidad suficiente para succionar los elementos indeseados del campo quirúrgico desde su posición adyacente a la pared interna del cuerpo principal, el conducto de soplado y/o el conducto de irrigación requieren actuar de forma más precisa allí donde se encuentra dicho elemento indeseado. Unlike a suction conduit, which would have sufficient capacity to suck unwanted elements from the surgical field from its position adjacent to the internal wall of the main body, the blow conduit and/or the irrigation conduit require more precise action. where the unwanted element is found.
Para ello, la invención contempla que este tipo de conductos pueda actuar en dos posiciones diferentes; o bien ceñido a la pared interna del cuerpo principal o bien distanciado de la misma. De manera preferente, esta segunda posición será la posición central del cuerpo principal. For this, the invention contemplates that this type of conduit can act in two different positions; either close to the internal wall of the main body or distanced from it. Preferably, this second position will be the central position of the main body.
Ventajosamente, el soplado o la irrigación pueden actuar en diferentes zonas del campo quirúrgico donde se desee llevar a cabo la limpieza gracias a que, en un ejemplo de realización, pueden adoptar cualquier posición intermedia entre las dos posiciones extremas, mejorando así la eficacia del procedimiento. Advantageously, the blowing or irrigation can act in different areas of the surgical field where it is desired to carry out cleaning thanks to the fact that, in an example of embodiment, they can adopt any intermediate position between the two extreme positions, thus improving the efficiency of the procedure. .
El movimiento entre las dos posiciones extremas requiere que el conducto esté fijo en un punto del soporte capaz de moverse entre dichas dos posiciones. A tal efecto, esta realización contempla que el soporte comprenda un actuador que causa el desplazamiento del conducto entre dichas dos posiciones extremas. Este desplazamiento es rectilíneo y mantiene en todo momento la orientación axial del conducto para que el soplado y/o la irrigación se lleven a cabo en la dirección adecuada respecto del campo quirúrgico. Movement between the two extreme positions requires that the conduit be fixed at a point on the support capable of moving between said two positions. To this end, this embodiment contemplates that the support comprises an actuator that causes the displacement of the conduit between said two extreme positions. This displacement is rectilinear and maintains the axial orientation of the conduit at all times so that the blowing and/or irrigation are carried out in the appropriate direction with respect to the surgical field.
El desplazamiento puede preestablecerse de forma automática o bien ejecutarse de manera puntual durante la intervención. De manera preferida, el actuador provoca el desplazamiento del conducto de forma neumática. The displacement can be pre-established automatically or executed in a timely manner during the intervention. Preferably, the actuator pneumatically causes the conduit to move.
En una realización particular, el desplazamiento causado por el actuador se establece sobre un vástago intermedio guiado de tal modo gue se impide el giro respecto de su dirección axial. En esta realización, se contempla el uso de un vástago intermedio entre el actuador y el propio conducto; es decir, el actuador causa el desplazamiento del vástago, al que estaría fijado el conducto y, de esta forma, el conducto alcanzaría las dos posiciones objetivo. Ventajosamente, este vástago está guiado de tal modo que se impide el giro respecto de su dirección axial, lo que garantiza la correcta dirección y orientación del conducto durante toda la intervención, en particular asegurando que el conducto de soplado y/o irrigación mantengan su orientación preferentemente axial. De manera preferida, el conducto se fija al vástago mediante una fijación tipo par de apriete o una fijación por rozamiento. Para ello, el conducto comprende un tope que permite posicionarlo longitudinalmente en un alojamiento correspondiente del vástago. In a particular embodiment, the displacement caused by the actuator is established on an intermediate rod guided in such a way that rotation with respect to its axial direction is prevented. In this embodiment, the use of an intermediate rod between the actuator and the conduit itself is contemplated; that is, the actuator causes the displacement of the rod, to which the conduit would be fixed and, in this way, the conduit would reach the two target positions. Advantageously, this stem is guided in such a way as to prevent rotation with respect to its axial direction, which guarantees the correct direction and orientation of the conduit throughout the intervention, in particular ensuring that the blowing and/or irrigation conduit maintain its orientation. preferably axial. Preferably, the conduit is attached to the stem by a torque-type attachment or frictional attachment. For this, the duct comprises a stop that allows it to be positioned longitudinally in a corresponding housing of the stem.
En una realización particular, lo región perimetral se encuentra en el extremo proximal de la segunda abertura y en lo parte exterior del cuerpo principal. In a particular embodiment, the perimeter region is located at the proximal end of the second opening and on the outside of the main body.
La región perimetral del cuerpo principal está configurada para apoyar sobre tejidos biológicos sobre los que va a realizarse la operación quirúrgica. Esta región se localiza en la parte exterior del cuerpo principal, en el extremo proximal de la segunda abertura que da acceso al campo quirúrgico. Esta región perimetral ha de estar esterilizada y formada por un material compatible con el tejido biológico. En un ejemplo preferido, el material de la región perimetral es acero inoxidable de grado médico, titanio o polímeros PEEK (Polyetheretherketone). En una realización particular, el puerto de acceso guirúrgico adicionalmente comprende un elemento de fijación configurado para fijar el soporte a un elemento externo fijo. The perimeter region of the main body is configured to rest on biological tissues on which the surgical operation is to be performed. This region is located on the outside of the main body, at the proximal end of the second opening that provides access to the surgical field. This perimeter region must be sterilized and made of a material compatible with biological tissue. In a preferred example, the material of the perimeter region is medical grade stainless steel, titanium or PEEK (Polyetheretherketone) polymers. In a particular embodiment, the surgical access port additionally comprises a fixing element configured to fix the support to a fixed external element.
El cuerpo principal del trocar está unido al soporte. De manera preferida, dicha unión se establece entre el soporte y el extremo del cuerpo principal en el que se ubica la primera abertura. En un ejemplo particular, la unión se establece por medio de una valona localizada en la primera abertura del cuerpo principal sobre la cual se lleva a cabo la fijación del soporte. The main body of the trocar is attached to the bracket. Preferably, said joint is established between the support and the end of the main body where the first opening is located. In a particular example, the joint is established by means of a flange located in the first opening of the main body on which the support is fixed.
Este soporte comprende un elemento de fijación configurado para fijar dicho soporte - y por ende el cuerpo principal y los conductos del trocar cuando están alojados en su ¡nterior - a un elemento externo fijo. De manera preferida, el elemento de fijación es un brazo articulado. Ejemplos de dicho elemento externo fijo pueden ser la mesa de operaciones, un sistema robótico o el propio paciente. This support comprises a fixing element configured to fix said support - and therefore the main body and the conduits of the trocar when they are housed in its interior - to a fixed external element. Preferably, the fixing element is an articulated arm. Examples of such a fixed external element can be the operating table, a robotic system or the patient himself.
Esta fijación permite la inamovilidad del trocar y, por tanto, del campo quirúrgico durante todo el procedimiento, lo que resulta clave para que el cirujano pueda acceder a los tejidos objetivo durante toda la intervención. This fixation allows the trocar to remain immovable and, therefore, the surgical field throughout the procedure, which is key for the surgeon to be able to access the target tissues throughout the intervention.
En una realización, el ol menos un conducto está total o parcialmente recubierto por un material anticoagulante. In one embodiment, the at least one conduit is fully or partially lined with an anticoagulant material.
Este material anticoagulante (por ejemplo heparina, silicona o un polímero hidrofílico como el PEG), al entrar en contacto con la sangre, causa que ésta no se coagule y, de esta forma, se impide que la sangre coagulada penetre en el al menos un conducto y lo obstruya. Este recubrimiento anticoagulante estará presente o bien en un conducto de aspiración, o bien en un conducto de soplado, o bien en un conducto de irrigación o en una combinación de cualquiera de los anteriores. This anticoagulant material (for example heparin, silicone or a hydrophilic polymer such as PEG), when in contact with blood, causes it not to coagulate and thus prevents coagulated blood from penetrating into the at least one duct and clog it. This anticoagulant coating will be present in either an aspiration line, or a blow line, or an irrigation line, or a combination of any of the foregoing.
En un ejemplo, dicho recubrimiento es parcial, de forma que solo una parte del conducto - aquella que entrará en contacto con el campo quirúrgico - está recubierta del material anticoagulante. In one example, said coating is partial, so that only part of the conduit - that which will come into contact with the surgical field - is covered with the anticoagulant material.
En una realización, la pared interior del cuerpo principal está total o parcialmente recubierta por un material anticoagulante. In one embodiment, the inner wall of the main body is fully or partially coated with an anticoagulant material.
Como se ha comentado, el material anticoagulante (por ejemplo heparina, silicona o un polímero hidrofílico como el PEG), al entrar en contacto con la sangre, causa que ésta no se coagule. En esta realización, el campo quirúrgico definido por el puerto de acceso estaría libre de coágulos que pudieran llegar a penetrar en el al menos un conducto (de aspiración, de soplado, de irrigación o una combinación de los mismos) obstruyéndolo. En un ejemplo particular, la parte de la pared interior del cuerpo principal coincidente con la región perimetral externa configurada para apoyar sobre tejidos biológicos es la que está recubierta por un material anticoagulante. As mentioned, the anticoagulant material (for example heparin, silicone or a hydrophilic polymer such as PEG), when in contact with blood, causes it not to coagulate. In this embodiment, the surgical field defined by the access port would be free of clots that could penetrate the at least one conduit (aspiration, blowing, irrigation or a combination thereof) obstructing it. In a particular example, the part of the inner wall of the main body that coincides with the external perimeter region configured to rest on biological tissues is the one that is covered by an anticoagulant material.
Un segundo aspecto inventivo proporciona un sistema de acceso a un entorno quirúrgico, que comprende: un puerto de acceso quirúrgico según el primer aspecto inventivo; un conjunto de dilatadores de tejidos formados por una pluralidad de cilindros alojados uno dentro de otro más una lanceta en su núcleo donde el puerto de acceso quirúrgico tiene la pared interior configurada para deslizar sobre el dilatador de mayor diámetro. A second inventive aspect provides an access system to an environment surgical, comprising: a surgical access port according to the first inventive aspect; a set of tissue dilators formed by a plurality of cylinders housed one inside the other plus a lancet in its core where the surgical access port has the inner wall configured to slide over the dilator with a larger diameter.
En este segundo aspecto inventivo, además del trocar del primer aspecto inventivo, se proporciona el conjunto de dilatadores cilindricos concéntricos y la lanceta necesarios para definir el campo quirúrgico previamente a la inserción de dicho trocar en el cuerpo del paciente. Las ventajas previamente mencionadas para el primer aspecto inventivo aplican igualmente a este segundo aspecto inventivo donde el trocar es un dilatador más, específicamente el de mayor diámetro que queda finalmente situado en el paciente para permitir la operación quirúrgica. In this second inventive aspect, in addition to the trocar of the first inventive aspect, the set of concentric cylindrical dilators and the lancet necessary to define the surgical field prior to inserting said trocar into the patient's body are provided. The previously mentioned advantages for the first inventive aspect also apply to this second inventive aspect where the trocar is one more dilator, specifically the one with the largest diameter that is finally placed in the patient to allow the surgical operation.
Todas las características descritas en esta memoria (incluyendo las reivindicaciones, descripción y dibujos) pueden combinarse en cualquier combinación, exceptuando las combinaciones de tales características mutuamente excluyentes. DESCRIPCIÓN DE LOS DIBUJOS All features described herein (including the claims, description, and drawings) may be combined in any combination, except for mutually exclusive combinations of such features. DESCRIPTION OF THE DRAWINGS
Estas y otras características y ventajas de la invención, se pondrán más claramente de manifiesto a partir de la descripción detallada que sigue de una forma preferida de realización, dada únicamente a título de ejemplo ilustrativo y no limitativo, con referencia a las figuras que se acompañan. These and other features and advantages of the invention will become clearer from the detailed description that follows of a preferred embodiment, given solely by way of illustrative and non-limiting example, with reference to the accompanying figures. .
Figura 1 En esta figura se muestra un trocar que comprende un cuerpo principal con una valona a la que se fija un conducto de aspiración por clipado. Figura 2a-2b En estas figuras se muestra el trocar de la figura 1 con un elemento de soporte y un conducto de soplado posicionado en una primera posición (Figura 2a) y una segunda posición (Figura 2b). Figure 1 This figure shows a trocar comprising a main body with a flange to which an aspiration duct is clipped. Figure 2a-2b These figures show the trocar of Figure 1 with a support element and a blowing tube positioned in a first position (Figure 2a) and a second position (Figure 2b).
Figura 3 En esta figura se muestra el trocar de la figura 2 con un elemento de fijación. Figura 4 En esta figura se muestra en detalle el conducto de aspiración con una fijación por clipado según las Figuras 1-3. EXPOSICIÓN DETALLADA DE LA INVENCIÓN Figure 3 This figure shows the trocar of Figure 2 with a fixation element. Figure 4 In this figure the suction duct is shown in detail with a clip fixing according to Figures 1-3. DETAILED DISCLOSURE OF THE INVENTION
La Figura 1 muestra un puerto de acceso quirúrgico - o trocar - adecuado para intervenciones quirúrgicas, que comprende un cuerpo principal (1) tubular y un conducto de limpieza que, en este ejemplo particular, es un conducto de aspiración (2). En otros ejemplos, de manera alternativa o simultánea, el puerto de acceso quirúrgico comprende un conducto de soplado (3) y/o de irrigación. Figure 1 shows a surgical access port - or trocar - suitable for surgical interventions, comprising a tubular main body (1) and a cleaning conduit which, in this particular example, is an aspiration conduit (2). In other examples, alternatively or simultaneously, the surgical access port comprises a blowing conduit (3) and/or an irrigation conduit.
Como se puede apreciar en la figura, el cuerpo principal (1) comprende una primera abertura (1.1) y una segunda abertura (1.2) dispuestas en ambos extremos del cuerpo principal (1). En esta figura también se muestra una valona (1.5) perimetral posicionada en la primera abertura (1.1) del trocar, siendo dicha valona (1.5) opcional en otras realizaciones alternativas. As can be seen in the figure, the main body (1) comprises a first opening (1.1) and a second opening (1.2) arranged at both ends of the main body (1). This figure also shows a perimeter flange (1.5) positioned in the first opening (1.1) of the trocar, said flange (1.5) being optional in other alternative embodiments.
Previamente a la inserción del trocar en el cuerpo del paciente, el cirujano habrá definido una región o campo quirúrgico por medio de una lanceta y un conjunto de dilatadores de tejidos mediante un procedimiento como el descrito anteriormente en el presente documento. La segunda abertura (1.2) del cuerpo principal (1) está configurada, precisamente, para dar acceso a la región quirúrgica. En cirugías mínimamente invasivas, el instrumental quirúrgico se introduce por la primera abertura (1.1), atraviesa el interior del cuerpo principal (1) en la dirección X-X' y finalmente entra en contacto con la región quirúrgica atravesando la segunda abertura (2.2). Prior to inserting the trocar into the patient's body, the surgeon will have defined a surgical region or field by means of a lancet and a set of tissue dilators through a procedure such as that described hereinabove. The second opening (1.2) of the main body (1) is configured precisely to give access to the surgical region. In minimally invasive surgeries, the surgical instrument is introduced through the first opening (1.1), passes through the interior of the main body (1) in the X-X' direction and finally comes into contact with the surgical region through the second opening (2.2).
En el extremo en el que se localiza la segunda abertura (1.2), el cuerpo principal (1) comprende una región perimetral (1.4) configurada para apoyar sobre los tejidos (T) biológicos de dicha región quirúrgica. En esta figura 1, los tejidos (T) biológicos han sido representados esquemáticamente mediante una región rayada correspondiente a una sección del tejido (T). Por otro lado, el cuerpo principal (1) comprende una pared interior (1.3) configurada para deslizar sobre un dilatador de tejidos, entendiendo como tal cualquiera de los dilatadores de tejidos formados por una pluralidad de cilindros alojados uno dentro de otro más una lanceta en su núcleo. En este ejemplo de realización, el diámetro de la pared interior (1.3) es 2 milímetros superior al diámetro de la pared exterior del cilindro de mayor diámetro, que quedaría alojado de forma ajustada y deslizante en el interior del cuerpo principal (1). Además, en este ejemplo de realización, la pared interior (1.3) está recubierta por un material anticoagulante. At the end where the second opening (1.2) is located, the main body (1) comprises a perimeter region (1.4) configured to rest on the biological tissues (T) of said surgical region. In this figure 1, the biological tissues (T) have been schematically represented by means of a hatched region corresponding to a section of the tissue (T). On the other hand, the main body (1) comprises an inner wall (1.3) configured to slide over a tissue dilator, understanding as such any of the tissue dilators formed by a plurality of cylinders housed one inside the other plus a lancet in its core. In this example of embodiment, the diameter of the inner wall (1.3) is 2 millimeters greater than the diameter of the outer wall of the cylinder with the largest diameter, which would be housed in a tight and sliding manner inside the main body (1). In addition, in this example of embodiment, the inner wall (1.3) is covered with an anticoagulant material.
La figura 1 adicionalmente muestra cómo el conducto de aspiración (2) permanece alojado en el interior del cuerpo principal (1) acoplándose a la valona (1.5) perimetral. En realizaciones alternativas, el acople del conducto se realiza en el propio extremo del cuerpo principal (1), cuando éste (1) no comprende la valona (1.5) perimetral, o bien en un elemento externo al trocar. Figure 1 additionally shows how the suction duct (2) remains housed inside the main body (1) coupling to the perimeter flange (1.5). In alternative embodiments, the coupling of the conduit is made at the very end of the main body (1), when the latter (1) does not include the perimeter flange (1.5), or else at an element external to the trocar.
El acoplamiento del conducto de aspiración (2) a la valona perimetral (1.5) se realiza mediante una fijación (2.2) por clipado. Dicha fijación (2.2) tiene forma de pinza dimensionada para pinzar la valona perimetral (1.5) mediante la aplicación de una ligera presión manual. En ejemplos alternativos, el conducto de limpieza con una fijación (2.2) por clipado es de soplado (3) y/o de irrigación. En otro ejemplo alternativo, la fijación (2.2) por clipado se acopla al extremo del cuerpo principal (1) cuando éste (1) no comprende la valona (1.5) perimetral. En otro ejemplo alternativo, la fijación (2.2) por clipado se acopla a un elemento externo. The coupling of the suction duct (2) to the perimeter flange (1.5) is carried out by means of a fixing (2.2) by clipping. Said fixing (2.2) is in the form of a clamp dimensioned to clamp the perimeter flange (1.5) by applying light manual pressure. In alternative examples, the cleaning conduit with a clip-on fixation (2.2) is for blowing (3) and/or irrigation. In another alternative example, the fixing (2.2) by clipping is attached to the end of the main body (1) when the latter (1) does not include the perimeter flange (1.5). In another alternative example, the clip-on fastener (2.2) is coupled to an external element.
Como se muestra en la Figura 1, la fijación (2.2) por clipado del conducto de aspiración (2) está en el exterior del cuerpo principal (1) y fuera de la proyección o prolongación de la pared cilindrica interior del cuerpo principal (1) según la dirección axial X-X'. As shown in Figure 1, the fixing (2.2) by clipping the suction duct (2) is outside the main body (1) and outside the projection or extension of the internal cylindrical wall of the main body (1) according to the axial direction X-X'.
Como puede observarse, la forma y composición de este conducto de aspiración (2) favorece su tendencia a colocarse adyacente a la pared interior (1.3) del cuerpo principal (1). La figura muestra una representación por ordenador del conducto de aspiración (2) con una curvatura que causa esta tendencia al extremo inferior a salir fuera del cuerpo principal. Dado que es una representación por ordenador, la vista muestra el conducto de aspiración (2) atravesando el cuerpo principal (1) y saliendo del mismo. Un dispositivo real conforme a la representación por ordenador no atraviesa un cuerpo físico como el cuerpo principal (1) y simplemente resulta, gracias a que es de un material elásticamente deformable, en una tendencia a mantener su extremo ceñido a la pared interior, como si fuese un resorte. As can be seen, the shape and composition of this suction duct (2) favors its tendency to be placed adjacent to the inner wall (1.3) of the main body (1). The figure shows a computer representation of the suction duct (2) with a curvature that causes this tendency for the lower end to come out of the main body. Since it is a computer representation, the view shows the suction duct (2) going through and coming out of the main body (1). A real device conforming to the computer representation does not traverse a physical body as the main body (1) and simply results, thanks to the fact that it is made of an elastically deformable material, in a tendency to keep its end close to the inner wall, as if it were a spring.
Estas características pueden verse en detalle en la Figura 4. En particular, el conducto de aspiración (2) es elásticamente deformable y con una curvatura tal que tiene tendencia a presionar la pared interior (1.3) del cuerpo principal (1). Adicionalmente, el conducto de aspiración (2) presenta una configuración cóncava (2.1) hacia el interior del cuerpo principal (1) en el lado opuesto al lado enfrentado a la pared interior (1.3) del cuerpo principal (1). These characteristics can be seen in detail in Figure 4. In particular, the suction duct (2) is elastically deformable and with a curvature such that it tends to press the inner wall (1.3) of the main body (1). Additionally, the suction duct (2) has a concave configuration (2.1) towards the interior of the main body (1) on the opposite side to the side facing the inner wall (1.3) of the main body (1).
Todo ello posibilita que el conducto de aspiración (2) interfiera lo menos posible con la introducción y manipulación del instrumental quirúrgico en el cuerpo principal (1) durante la cirugía. All of this makes it possible for the aspiration duct (2) to interfere as little as possible with the introduction and manipulation of the surgical instruments in the main body (1) during surgery.
Adicionalmente, el conducto de aspiración (2) comprende una conexión (2.3) desacoplable de vacío para poder conectarse a los conductos y canalizaciones de otros dispositivos médicos, como puede ser una fuente de vacío. Additionally, the aspiration conduit (2) comprises a detachable vacuum connection (2.3) to be able to connect to the conduits and pipes of other medical devices, such as a vacuum source.
El conducto de aspiración (2) - y el resto de conductos, si los hubiera - es desacoplable y retirable para dejar diáfano el interior del cuerpo principal (1). Finalmente, también cabe mencionar que el o los conductos (2, 3) están total o parcialmente recubiertos por un material anticoagulante. The suction duct (2) - and the rest of the ducts, if any - is detachable and removable to leave the interior of the main body (1) diaphanous. Finally, it is also worth mentioning that the conduit or conduits (2, 3) are totally or partially covered by an anticoagulant material.
En las Figuras 2a y 2b se muestra el trocar anterior con un elemento de soporte (4) al que está unido un conducto de soplado (3). En un ejemplo alternativo, el trocar comprende un conducto de irrigación adicional o alternativo al conducto de soplado (3). En un ejemplo alternativo, el conducto es de soplado e irrigación al mismo tiempo. In Figures 2a and 2b the anterior trocar is shown with a support element (4) to which a blowing tube (3) is attached. In an alternative example, the trocar comprises an additional or alternative irrigation conduit to the blowing conduit (3). In an alternative example, the conduit is for blowing and irrigation at the same time.
El soporte (4) del trocar comprende un actuador (5) capaz de causar el desplazamiento del conducto de soplado (3) entre dos posiciones operativas: una primera posición donde el conducto de soplado (3) está ceñido a la pared interna del cuerpo principal (1), mostrada en la Figura 2a, y una segunda posición operativa donde el conducto de soplado (3) está distanciado de la pared interna del cuerpo principal (1), en este caso en la posición central, según muestra la Figura 2b. Estas dos posiciones extremas diferentes y cualquiera de las posiciones intermedias permiten que se lleve a cabo un soplado y/o una irrigación en diferentes zonas del campo quirúrgico, lo que aumenta la eficacia del procedimiento de limpieza. The trocar support (4) comprises an actuator (5) capable of causing the blowing duct (3) to move between two operative positions: a first position where the blowing duct (3) is close to the internal wall of the main body (1), shown in Figure 2a, and a second operating position where the blowing duct (3) is distanced from the internal wall of the main body (1), in this case in the central position, as shown in Figure 2b. These two different extreme positions and any of the intermediate positions allow blowing and/or irrigation to be carried out in different areas of the surgical field, which increases the efficiency of the cleaning procedure.
Para favorecer que el conducto de soplado (3) - o de irrigación - esté siempre orientado en la dirección correcta, el soporte (4) mostrado en estas Figuras 2a y2b comprende un vástago intermedio (3.1) que recibe el movimiento del actuador (5) y lo transmite al conducto de soplado (3). El vástago intermedio (3.1) es guiado de tal modo que se impide el giro respecto de su dirección axial. En este ejemplo de realización, la sección tanto del vástago como de la guía que permite su deslizamiento es poligonal, específicamente cuadrada. Además, en este ejemplo de realización, la fijación del conducto de soplado (3) al vástago intermedio (3.1) se realiza mediante un par de apriete. In order to ensure that the blowing conduit (3) - or irrigation - is always oriented in the correct direction, the support (4) shown in these Figures 2a and 2b comprises an intermediate rod (3.1) that receives the movement of the actuator (5) and transmits it to the blowing duct (3). The intermediate rod (3.1) is guided in such a way that rotation with respect to its axial direction is prevented. In this example of embodiment, the section of both the stem and the guide that allows it to slide is polygonal, specifically square. In addition, in this example of embodiment, the fixing of the blowing duct (3) to the intermediate rod (3.1) is carried out by means of a tightening torque.
En la Figura 3 se muestra el trocar de las Figuras 2a y 2b incluyendo un elemento de fijación (4.1) adicional, en particular, un brazo articulado. Este elemento de fijación (4.1) permite fijar el soporte (4) del trocar a un elemento externo fijo. De manera preferida, dicho elemento es la cama del paciente o el propio paciente, por ejemplo, una pinza directamente fijada - no mostrada en esta figura - a una de sus vértebras. En otro ejemplo, el elemento externo es un sistema robótico o un sistema de seguimiento. Figure 3 shows the trocar of Figures 2a and 2b including an additional fixation element (4.1), in particular, an articulated arm. This fixing element (4.1) allows the trocar support (4) to be fixed to a fixed external element. Preferably, said element is the patient's bed or the patient himself, for example, a clamp directly attached - not shown in this figure - to one of his vertebrae. In another example, the external element is a robotic system or a tracking system.

Claims

REIVINDICACIONES
1.- Puerto de acceso quirúrgico adecuado para intervenciones quirúrgicas, que comprende: - un cuerpo principal (1) configurado como conducto tubular que se extiende según una dirección axial X-X' y que comprende: una primera abertura (1.1) de acceso dispuesta en un extremo del cuerpo principal (1), una segunda abertura (1.2) dispuesta en el extremo del cuerpo principal (1) opuesto a la primera abertura (1.1) configurada para dar acceso a una región quirúrgica, una pared interior (1.3) configurada para deslizar sobre un dilatador de tejidos, de entre los dilatadores de tejidos formados por una pluralidad de cilindros alojados uno dentro de otro más una lanceta en su núcleo; una región perimetral (1.4) configurada para apoyar sobre tejidos (T) biológicos en la región quirúrgica; al menos un conducto, o bien de aspiración (2) o bien de soplado (3), o bien de irrigación, alojado en el interior del cuerpo principal (1) donde dicho conducto (2, 3) es desacoplable y retirable para dejar diáfano el interior del cuerpo principal (1). 1.- Surgical access port suitable for surgical interventions, comprising: - a main body (1) configured as a tubular conduit that extends in an axial direction X-X' and comprising: a first access opening (1.1) arranged in a end of the main body (1), a second opening (1.2) arranged at the end of the main body (1) opposite the first opening (1.1) configured to give access to a surgical region, an inner wall (1.3) configured to slide on a tissue dilator, from among the tissue dilators formed by a plurality of cylinders housed one inside the other plus a lancet in its core; a perimeter region (1.4) configured to rest on biological tissues (T) in the surgical region; at least one conduit, either suction (2) or blowing (3), or irrigation, housed inside the main body (1) where said conduit (2, 3) is detachable and removable to leave diaphanous inside the main body (1).
2.- Puerto según la reivindicación 1, donde el conducto alojado en el interior del cuerpo principal (1) es un conducto de aspiración (2) y comprende una conexión (2.3) desacoplable de vacío. 3.- Puerto según cualquiera de las reivindicaciones anteriores, donde el conducto de aspiración (2) es elásticamente deformable y con una curvatura tal que tiene tendencia a presionar la pared interior (1.2. Port according to claim 1, where the conduit housed inside the main body (1) is a suction conduit (2) and comprises a detachable vacuum connection (2.3). 3.- Port according to any of the preceding claims, where the suction duct (2) is elastically deformable and with a curvature such that it tends to press the inner wall (1.
3) del cuerpo principal (1). 3) of the main body (1).
4.- Puerto según cualquiera de las reivindicaciones anteriores, donde el conducto de aspiración (2) muestra una configuración cóncava (2.1) hacia el interior del cuerpo principal (1) en el lado opuesto al lado enfrentado a la pared interior (1.3) del cuerpo principal (1). 4. Port according to any of the preceding claims, where the suction duct (2) shows a concave configuration (2.1) towards the interior of the main body (1) on the opposite side to the side facing the interior wall (1.3) of the main body (1).
5.- Puerto según cualquiera de las reivindicaciones anteriores, donde el conducto desacoplable, o bien el conducto de aspiración (2), o bien de soplado (3) o bien de ¡rrigación, tiene una fijación (2.2) por clipado en el exterior del cuerpo principal (1) y fuera de la proyección del interior del cuerpo principal (1) según la dirección axial X-X'. 5. Port according to any of the preceding claims, where the detachable conduit, or the suction conduit (2), or the blowing conduit (3) or the irrigation, has a fixing (2.2) by clipping on the outside of the main body (1) and outside the projection of the inside of the main body (1) along the axial direction X-X'.
6.- Puerto según cualquiera de las reivindicaciones anteriores, donde el cuerpo principal (1) tiene una valona (1.5) perimetral en la primera abertura (1.1). 6. Port according to any of the preceding claims, where the main body (1) has a perimeter flange (1.5) in the first opening (1.1).
7.- Puerto según las reivindicaciones 5 y 6, donde el clipado del conducto de aspiración (2), o bien de soplado (3) o bien de irrigación, se establece en la valona perimetral (1.5). 7. Port according to claims 5 and 6, where the clipping of the suction conduit (2), either the blowing conduit (3) or the irrigation conduit, is established in the perimeter flange (1.5).
8.- Puerto según cualquiera de las reivindicaciones anteriores, donde el conducto de soplado (3) o bien el conducto de irrigación está fijado mediante una fijación retirable a un soporte (4) por medio de un actuador (5) que causa el desplazamiento entre al menos dos posiciones operativas: una primera posición operativa donde el conducto de soplado (3) está ceñido a la pared interna del cuerpo principal (1) y, una segunda posición operativa donde el conducto de soplado (3) está distanciado de la pared interna del cuerpo principal (1), preferentemente en la posición central. 8. Port according to any of the preceding claims, where the blowing conduit (3) or the irrigation conduit is fixed by means of a removable fixing to a support (4) by means of an actuator (5) that causes movement between at least two operating positions: a first operating position where the blowing duct (3) is close to the internal wall of the main body (1) and a second operating position where the blowing duct (3) is distanced from the internal wall of the main body (1), preferably in the central position.
9.- Puerto según la reivindicación 8, donde el desplazamiento causado por el actuador (5) se establece sobre un vástago intermedio (3.1) guiado de tal modo que se impide el giro respecto de su dirección axial. 9. Port according to claim 8, where the displacement caused by the actuator (5) is established on an intermediate rod (3.1) guided in such a way that rotation with respect to its axial direction is prevented.
10.- Puerto de acceso quirúrgico según cualquiera de las reivindicaciones anteriores, donde la región perimetral (1.4) se encuentra en el extremo proximal de la segunda abertura (1.2) y en la parte exterior del cuerpo principal (1). 10.- Surgical access port according to any of the preceding claims, wherein the perimeter region (1.4) is located at the proximal end of the second opening (1.2) and on the outside of the main body (1).
11.- Puerto de acceso quirúrgico según cualquiera de las reivindicaciones anteriores, que adicionalmente comprende un elemento de fijación (4.1) configurado para fijar el soporte (4) a un elemento externo fijo. 11.- Surgical access port according to any of the preceding claims, which additionally comprises a fixing element (4.1) configured to fix the support (4) to a fixed external element.
12.- Puerto de acceso quirúrgico según cualquiera de las reivindicaciones anteriores, donde el al menos un conducto está total o parcialmente recubierto por un material anticoagulante. 12.- Surgical access port according to any of the preceding claims, wherein the at least one conduit is totally or partially covered by an anticoagulant material.
13.- Puerto de acceso quirúrgico según cualquiera de las reivindicaciones anteriores, donde la pared interior (1.3) del cuerpo principal (1) está total o parcialmente recubierta por un material anticoagulante. 13.- Surgical access port according to any of the preceding claims, wherein the inner wall (1.3) of the main body (1) is totally or partially covered by an anticoagulant material.
14.- Sistema de acceso a un entorno quirúrgico, que comprende: un puerto de acceso quirúrgico según cualquiera de las reivindicaciones anteriores; un conjunto de dilatadores de tejidos formados por una pluralidad de cilindros alojados uno dentro de otro más una lanceta en su núcleo donde el puerto de acceso quirúrgico tiene la pared interior configurada para deslizar sobre el dilatador de mayor diámetro. 14.- System for access to a surgical environment, comprising: a surgical access port according to any of the preceding claims; a set of tissue dilators formed by a plurality of cylinders housed one inside the other plus a lancet in its core where the surgical access port has the inner wall configured to slide over the dilator with a larger diameter.
PCT/ES2021/070318 2021-05-07 2021-05-07 Surgical access port with cleaning capability WO2022234160A1 (en)

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Citations (3)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US20050251192A1 (en) * 2004-03-31 2005-11-10 Shluzas Alan E Access device having discrete visualization locations
WO2018165365A2 (en) * 2017-03-08 2018-09-13 Medos International Sàrl Surgical visualization systems and related methods
US10736657B2 (en) * 2017-03-08 2020-08-11 Conmed Corporation Multi-lumen tube set for gas circulation system with single lumen gas sealed access port and single lumen valve sealed access port

Patent Citations (3)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US20050251192A1 (en) * 2004-03-31 2005-11-10 Shluzas Alan E Access device having discrete visualization locations
WO2018165365A2 (en) * 2017-03-08 2018-09-13 Medos International Sàrl Surgical visualization systems and related methods
US10736657B2 (en) * 2017-03-08 2020-08-11 Conmed Corporation Multi-lumen tube set for gas circulation system with single lumen gas sealed access port and single lumen valve sealed access port

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