ES2394711B1 - INSULATOR DEVICE ADAPTED FOR MICRO-SURGERY INTERVENTIONS OR FOR MICROMANIPULATION IN WHITE ROOM AND USE OF THE SAME - Google Patents

Abstract

Isolation device adapted for microsurgery interventions or for micromanipulation in a cleanroom and use thereof. # The device according to the invention is formed from a cylinder (1) of a flexible and elastic material suitable for use in medical applications and adaptable to a surgical microscope, by suitable means, through a flat lens (4) of 0 diopters disposed at one of its ends, having, at the opposite end, an adhesive element (5) for fixing to the surgical field and presenting, spaced on the sides of the cylinder (1), multiple extensions (3) of the same flexible material intended to integrally accommodate multifunctional tips or surgical instruments, and presenting, at the upper contour away from the surgical field, two connections for flexible connecting tubes (2), one for the air inlet and the other for its outlet, both connections (2) having a filtering system.

Description

ISOLATOR DEVICE ADAPTED FOR INTERVENTIONS OF MICROSURGERY OR FOR MICROMANIPULATION IN WHITE ROOM AND USE OF THE SAME

The present invention relates to an insulating device adapted to carry out microsurgical interventions or for the manipulation of microelements in clean room, as well as to the use thereof in microsurgical interventions or in the manipulation of microelements in clean room.

More particularly, the adapted isolating device of the present invention allows microsurgical interventions to be carried out, such as cataract surgery with a femtosecond laser system, Lasik surgery to correct spherocylindrical laser ametropias, biopsies, or to develop non-surgical procedures. , such as richromontage, manipulation and industrial inspection in a white chamber, of phonma that essentially all the components and elements necessary to carry out such functions, be they microsurgical interventions or non-surgical procedures, are an integral part of the insulating device, previously prepared, already assembled and sterile, thus allowing handling to be reduced to the maximum, and, advantageously, all components that come into contact with the surgical or sterile field are disposable, and thereby reducing possible contamination.

The insulators were first described in 1977 to obtain sterile calves, later their use was extended to surgical interventions. Basically, the isolators known in the state of the art allow maintaining a sterile field where contamination is reduced as much as possible. Generally they are extensible membranes of an impermeable material that adapt to the surgical field, allow a system of filtering and sterilization of the air. they have floodgates for the introduction of surgical material, gloves for manipulation and, in some cases, an optical visualization system.

For example, EP 0224505, "Isolator for use in surgery", describes an insulator that includes an inflatable bag of flexible material through which

pumps filtered air to continuously renew the air and maintain a

positive pressure in the bag. For use in surgery, a part of the lower side thereof is made of an elastic surgical woven material that allows the components necessary to surgically intervene an individual to be introduced into the work space of the bag through an opening

in the bag that is smaller than the element so that the material

The elastic of the bag is enlarged by surrounding the element, reducing the possibility of pathogens entering the work area from outside the bubble.

Currently, the minimization of surgical interventions, simplification, the use of disposable material and the use of surgical microscopes make it necessary to design an integral isolator system that

allow to have all the necessary elements for the intervention

pre-assembled on the insulator and ready for use and subsequent disposal.

An object of the present invention is to provide an insulating device

adapted to carry out microsurgical interventions or for the

manipulation of microelements in cleanroom previously prepared, already

assembled and sterile, thus allowing handling to be reduced to

maximum, and, advantageously, being disposable all the components that come into contact with the surgical or sterile field, thereby reducing possible contamination of the surgical field.

The insulating device adapted to carry out microsurgical interventions or for the manipulation of microelements in clean room of the invention constitutes an integral design ready for use and subsequent

scrap

Another object of the present invention is the use of the device

isolator in microsurgery interventions or in the manipulation of microelements in clean room. More specifically, the use of the device

isolator in microsurgery interventions such as cataract surgery with femtosecond laser system, Lasik surgery to correct spherocyl cylindrical laser ametropias, biopsies, etc., or the use of

s insulating device in non-surgical procedures, such as assembly,

industrial manipulation and inspection in white chamber.

The insulating device of the invention is formed from a cylinder

Manufactured in a flexible and elastic material suitable for use in 10 medical applications and is perfectly adaptable to a surgical microscope.

For eilo, at one of its ends the insulating device has a flat O diopter lens that adapts, by suitable means of attachment, to the surgical microscope, which allows the removable and temporary fixation of the

insulating device to the microscope optics.

At the opposite end to that corresponding to microscope fixation

surgical, the insulating device has an adhesive element for its

fixation to the surgical field adaptable to the different works to be performed.

20 Spaced arrangements on the sides of the cylinder that forms the

insulating device, it has the different surgical instruments

integrated to be used in the micro-intervention or of the elements

necessary for micromanipulation in clean room. If necessary

other instruments not integrated in the insulating device of the invention, this one

25 has two optional openings that usually remain closed, but which, if necessary, open in an adaptable way to allow the introduction into the surgical field of such instruments not integrated in the device. These optional openings allow to operate through a more flexible system, without the rigidity imposed by a disposable instrument attached to the

30 external wall of the insulator.

The insulating device of the invention is conveniently connected to

an air filtration, sterilization and pressurization system that allows multiple functions. For this, the insulating device presents in the contour

upper of the elastic cylinder, two connections for flexible connection tubes, one for the air inlet and the other for its exit, both having a filtering system connections. In this way, the insulating device allows to provide sterile air free of gases, particles and germs, to maintain the shape of the insulating device without the need for a rigid structure by

a slight positive pressure, provide a positive air pressure for situations in which it is convenient, for example in case of an expulsive hemorrhage during a cataract microsurgery, clean the surgical field of substances and air particles that prevent operation

correctness of certain instruments, as well as collecting and disposing of

toxic substances harmful to operating room staff that are produced

during manipulation of the surgical field.

The objects of the invention will now be described in detail on the basis of an exemplary embodiment thereof adapted to an ocular cataract microsurgery with femtosecond laser, and with reference to the attached non-limiting figures, in which:

Figure 1:

general view of the isolating device of the invention according to a

preferred embodiment thereof.

Figure 2:

Side view of the insulating device of the invention according a

preferred embodiment thereof.

Figure 3:

View in lower floor of the insulating device the invention

according to a preferred embodiment thereof.

As seen in Figure 1, the insulating device of the present invention is formed from a cylinder (1) made of a flexible and elastic material suitable for use in medical applications and perfectly adaptable to a surgical microscope.

At one of its ends, the insulating device has a lens

flat (4) of O diopters that adapts, by suitable fastening means, to the

surgical microscope, which allows the removable and temporary fixation of the

insulating device to the microscope optics. In a preferred embodiment of the invention, the insulating device is adapted to the surgical microscope by means of a pressure or bayonet type system that allows its temporary fixation to the

microscope optics

At the opposite end to the one attached to the surgical microscope, the insulating device has an adhesive element (5) for its

fixation to the surgical field and adaptable to the different works to be performed. This

Adhesive element (5) can be of perforated type with an opening of different shapes that adapts to the different works to be carried out or of type of

incision, in which an incision of the surgical field is made before starting the microsurgery intervention.

Arranged spaced apart on the sides of the cylinder that forms the insulating device, it has multiple extensions of the same flexible material (3) designed to integrally accommodate multifunctional tips or

surgical instruments to be used in the micro-intervention. In a preferred embodiment of the invention, the insulating device has at least 3

extensions (3) and in particular 3 extensions (3) intended to accommodate multifunctional tips or surgical instruments. These surgical instruments can be from a simple biopsy needle to a multifunctional tip

connected to a non-sterile exterior control handle. In the case of a laser cataract intervention, for example, the isolating device of the invention would have at least three instruments integrated in the area

side of the cylinder that forms the device for easy access to the field

surgical.

If other instruments not integrated in the insulating device of the invention are necessary, it has at least two optional openings (6) arranged on opposite sides of the lateral surface of the cylinder (1), and at a height similar to that which is find the extensions (3), and that

they usually remain closed, but that, if necessary, open

adaptable form to allow the introduction into the surgical field of such

instruments not integrated in the device (see Figure 2). These optional openings (6) allow to operate through a more flexible system, without the rigidity imposed by a disposable instrument attached to the external wall of the insulator. These optional openings (6) allow to maintain the shape of the device

insulator, as they allow the air to escape in a controlled manner, simply by adjusting the air inlet flow to maintain a slight positive pressure. Sterility is reduced since it is not a closed system, but it is still a sterile system with positive pressure

For its connection to an air filtration, sterilization and pressurization system, the insulating device of the invention has, in the upper contour

away from the surgical field of the elastic cylinder (1), two connections to flexible connection tubes (2), one for the air inlet and the other for its exit,

both connections (2) having a filtering system.

Once the intervention is finished, the isolating device of the invention is disconnected from the surgical microscope, from the surgical field, from the system of

air filtration and possible instrument connection systems and all the

system is discarded.

Among the advantages of the insulating device of the invention are: the elimination of the need for an operating room or cleanroom, since the device

Isolator of the invention constitutes per se a micro-operating room or miniaturized cleanroom; improvement of sterile technique and universal precautions;

improvement of storage management efficiency, since all the components necessary for the intervention are advantageously included in a single package; reduction of operating room waste, since the barriers

Physics of a surgical macrofield are minimized in a microfield; reduction of contamination risks for operating room staff, whether it is contamination by solid or gaseous waste; greater comfort for the

patient and for the operating room or clean room staff, as it avoids being

protected with

gown, mask, hat, gloves, etc .; work reduction

associated with the maintenance of an operating room or clean room, etc.

In an exemplary embodiment of the insulating device adapted to carry

S

to cape interventions microsurgical or for the handling from

microelements

in room white from the invention, East be use in a

cataract microsurgery intervention with

Femtosecond laser. In this

In this case, the insulating device is pre-assembled in a single container that contains

all

what is necessary for the surgical intervention, for after applying the

10

laser and without the need of an operating room. After cleaning and disinfection

of the surgical field, the insulating device is adapted to the surgical microscope

for its part corresponding to the flat lens

(4) and, correspondingly, to

surgical field by

its opposite part by means of the adhesive element (S). He

device

insulator be connect to the system from filtered out , sterilization Y

fifteen

air pressurization, through connections to flexible connecting pipes (2),

one at the air inlet and the other at its outlet, both connections (2) having

a filtering system The extensions (3) present in the insulating device

be

connect in East case through a tip multifunctional to the handle of

external laser control, to the irrigation handle of the irrigation and aspiration dripper

twenty

of the cataract, and in the last extension (3) it is preloaded and isolated

an intraocular lens

Claims (6)

one.

Isolation device adapted for microsurgery interventions or for

cleanroom micromanipulation characterized in that it conforms to

s

from a cylinder (1) made of a flexible and elastic material suitable

for use in medical applications and adaptable to a microscope

Surgical, by appropriate means, through a flat lens (4)

of O diopters arranged in one of its ends, arranging, in the

opposite end to the one attached to the surgical microscope,

10

of an adhesive element (5) for fixing to the surgical field and

presenting, spaced on the sides of the cylinder (1), multiple

extensions (3) of the same flexible material intended to accommodate

integral multifunctional tips or surgical instruments, as well as

presenting, in the upper contour away from the surgical field of the

fifteen

elastic cylinder (1), two connections for flexible connection tubes (2),

one for the air inlet and one for its exit, both having

connections (2) of a filtering system.

2.

Insulating device according to claim 1, characterized in that

twenty

also includes at least two optional openings (6) arranged in

opposite sides of the lateral surface of the cylinder (1) that open from

adaptable shape while maintaining the shape of the insulating device.

3.

Insulating device according to claim 2, characterized in that

2S

includes two optional openings (6) arranged on opposite sides of the

lateral surface of the cylinder (1) that open adaptively

maintaining the shape of the insulator device

Four.

Insulating device according to claim 1, characterized in that

30

It has at least 3 extensions (3) and in particular 3 extensions (3)

intended to fully accommodate multifunctional tips or

Surgical instruments.

9

ES23947 11 A l

5.

Insulating device according to claim 1, characterized in that the

insulating device

be adapts to the surgical microscope by a

pressure system or bayonet type that allows temporary fixation to

The microscope optics.

s

6.

Insulating device according to claim 1, characterized in that the

element

adhesive (5) is from kind peñorado with a opening from

different forms that adapt to the different works to be carried out or of

type of incision.

10