WO2016189157A1

WO2016189157A1 - Surgical drape

Info

Publication number: WO2016189157A1
Application number: PCT/EP2016/062075
Authority: WO
Inventors: Wouter Foulon; Kristoff CORTEN
Original assignee: MEDENVISION
Current assignee: MEDENVISION
Priority date: 2015-05-27
Filing date: 2016-05-27
Publication date: 2016-12-01
Anticipated expiration: 2017-11-27
Also published as: BE1023342B1

Abstract

A surgical drape consisting of one part, wherein the surgical drape comprises at least one trouser leg or sleeve, and wherein the at least one trouser leg or sleeve is folded up in such a way that one end of the trouser leg or sleeve is inside the other, such that the trouser leg or sleeve can be slid off over the limb of the patient by pulling on the end of the trouser leg or sleeve.

Description

Surgical drape

Area of application of the invention

The invention, in general, relates to systems for use in surgical procedures, as well as the use of said systems. More specifically, the present invention relates to methods and systems for shielding the surrounding area of an incision site during a surgical procedure.

Background of the invention

Good hygiene and a sterile environment are critical when performing surgical procedures, especially in open surgery. One of the measures taken is the covering of the patient with the aid of a surgical drape. The surgical drape ensures that parts of the body of the patient where the surgical procedure is not taking place are shielded from the incision site, and vice versa, so that the incision site does not come into contact with parts of the patient that have not been sterilised.

Currently, the patient is disinfected at and around the incision site to make it sterile. The area around the incision site is provided with a surgical drape. By default, a surgical drape in a standard size is used for this. The positioning of the drape and the disinfection of the patient is done by medical assistants in preparation for the surgical procedure, and often takes a long time to complete. Since this preparation needs to be done in the operating theatre, this limits the time available for surgical procedures.

Summary of the invention

It is an object of embodiments of the present invention to provide good methods and products for the preparation of a patient for surgery. It should be noted that the preparatory steps required to prepare a patient are not part of the surgical method itself and consequently, the method envisaged is not a surgical method.

It is an advantage of embodiments according to the present invention that the patient can be prepared for a surgical procedure in an efficient manner. This efficiency relates not only to the fact that a very good shielding is provided, but also to the fact that the shielding can be accomplished in a quick and simple way.

It is thus an advantage of embodiments according to the present invention that time is saved when providing the necessary shielding so that generally speaking, more time becomes available in the operating theatre and, consequently, more procedures can be performed with the same infrastructure.

It is an advantage of embodiments according to the present invention that, depending on the location on the body at which the medical procedure needs to be performed, a different type of shielding can be provided.

It is an advantage of embodiments according to the present invention that the shielding can be applied in a sterile manner.

It is an advantage of some embodiments according to the present invention that fixation elements can be provided in the shielding for the attachment of surgical retractors to keep the wound open. Since the shielding is provided around the leg or the arm of the patient, in this way, the body of the patient is also used to keep the fastening elements in place during the surgical procedure, or to move them to specific positions.

It is an advantage according to embodiments of the present invention that the chance of sterilisation errors is minimised, since the surgical drape as described allows installation within a few movements of the patient in a sterile way.

It is an advantage according to embodiments of this aspect of the present invention that fewer operations, less time and less manpower is needed to drape a patient.

It is an advantage according to embodiments of this aspect of the present invention that the limbs of the patient can be freely manipulated, while the risk of sterilisation errors is greatly reduced.

The above-mentioned object is achieved by a product and/or method according to the present invention.

The present invention relates to a surgical drape consisting of one part, wherein the surgical drape comprises at least one trouser leg or sleeve, and wherein the at least one trouser leg or sleeve is folded up in such a way that one end of the trouser leg or sleeve is inside the other, such that the trouser leg or sleeve can be slid off over the limb of the patient by pulling on the end of the trouser leg or sleeve.

The surgical drape may comprise two trouser legs folded up such that the trouser legs can be slid off over the limb of the patient by pulling on the end of the trouser legs.

The surgical drape may be made of a non-woven material.

The surgical drape may comprise an incision window.

The surgical drape may also not comprise an incision window, but the material of the surgical drape may allow an incision window to be cut out of the surgical drape.

The surgical drape may further comprise additional flaps in the one-piece drape, which can be folded open to drape additional parts of the patient's body.

The surgical drape may further include fixation elements suitable for attaching retractors to, to keep a wound open.

The surgical drape may further comprise an additional absorbent layer.

In a further aspect, the present invention also comprises a method for the application of shielding to the body of a patient who is to undergo a surgical procedure, the method comprising:

obtaining a surgical drape consisting of one part, wherein the surgical drape comprises at least one trouser leg or sleeve, and wherein the at least one trouser leg or sleeve is folded up in such a way that one end of the trouser leg or sleeve is inside the other end of the trouser leg or sleeve, such that the trouser leg or sleeve can be slid off over the limb of the patient by pulling on the end of the trouser leg or sleeve. positioning an end of a limb into the trouser leg or sleeve of the surgical drape, and

sliding off the trouser leg or sleeve over the limb by pulling on one end of the trouser leg or sleeve.

The method may further comprise:

the folding open of additional flaps of the one-piece surgical drape, to drape additional parts of the patient. In yet another aspect, the present invention also comprises the use of a surgical drape for the sterile shielding of a patient during a surgical procedure.

Particular and preferred aspects of the invention are set out in the accompanying independent and dependent claims. Features of the dependent claims may be combined with features of the independent claims and with features of other dependent claims as appropriate and not merely as explicitly set out in the claims.

The above and other aspects of the invention will be apparent from and elucidated with reference to the embodiment(s) described hereinafter. Brief description of the drawings

FIG. 1 illustrates a part of a surgical drape with a folded up leg according to a first embodiment of the present invention.

FIG. 2 illustrates an unfolded surgical drape according to FIG. 1.

FIG. 3 illustrates a method for applying a surgical drape to prepare a patient for a surgical procedure, according to an embodiment of the present invention.

FIG. 4 illustrates an incision window for use in surgery, with a delivery system for a substance to a wound, according to an embodiment of the present invention.

The drawings are only schematic and are non-limiting. In the drawings, the size of some of the elements may be exaggerated and not drawn on scale for illustrative purposes.

Any reference signs in the claims shall not be construed as limiting the scope. In the different drawings, the same reference signs refer to the same or analogous elements.

Detailed description of illustrative embodiments

The present invention will be described with respect to particular embodiments and with reference to certain drawings but the invention is not limited thereto but only by the claims. The drawings described are only schematic and are non-limiting. In the drawings, the size of some of the elements may be exaggerated and not drawn on scale for illustrative purposes. The dimensions and the relative dimensions do not necessarily correspond to actual reductions to practice of the invention. Furthermore, the terms first, second and the like in the description and in the claims, are used for distinguishing between similar elements and not necessarily for describing a sequence, either temporally, spatially, in ranking or in any other manner. It is to be understood that the terms so used are interchangeable under appropriate circumstances and that the embodiments of the invention described herein are capable of operation in other sequences than described or illustrated herein.

Moreover, the terms top, bottom, above, front and the like in the description and the claims are used for descriptive purposes and not necessarily for describing relative positions. It is to be understood that the terms so used are interchangeable under appropriate circumstances and that the embodiments of the invention described herein are capable of operation in other orientations than described or illustrated herein.

It is to be noticed that the term 'including', used in the claims, should not be interpreted as being restricted to the means listed thereafter; it does not exclude other elements or steps. It is thus to be interpreted as specifying the presence of the stated features, integers, steps or components as referred to, but does not preclude the presence or addition of one or more other features, integers, steps or components, or groups thereof. Thus, the scope of the expression 'a device including means A and B' should not be limited to devices consisting only of components A and B. It means that with respect to the present invention, the only relevant components of the device are A and B.

Reference throughout this specification to One embodiment' or 'an embodiment' means that a particular feature, structure or characteristic described in connection with the embodiment is included in at least one embodiment of the present invention. Thus, the appearance of the phrases 'in one embodiment' or 'in an embodiment' in various places throughout this specification do not necessarily all refer to the same embodiment, but may. Furthermore, the particular features, structures or characteristics may be combined in any suitable manner, as would be apparent to one of ordinary skill in the art from this disclosure, in one or more embodiments. Similarly, it should be appreciated that in the description of exemplary embodiments of the invention, various features of the invention are sometimes grouped together in a single embodiment, figure, or description thereof for the purpose of streamlining the disclosure and aiding in the understanding of one or more of the various inventive aspects. This method of disclosure, however, is not to be interpreted as reflecting an intention that the claimed invention requires more features than are expressly recited in each claim. Rather, as the following claims reflect, inventive aspects lie in less than all features of a single foregoing disclosed embodiment. Thus, the claims following the detailed description are hereby expressly incorporated into this detailed description, with each claim standing on its own as a separate embodiment of this invention.

Furthermore, while some embodiments described herein include some but not other features included in other embodiments, combinations of features of different embodiments are meant to be within the scope of the invention, and form different embodiments, as would be understood by those in the art. For example, in the following claims, any of the claimed embodiments can be used in any combination.

In the description provided herein, numerous specific details are set forth. However, it is understood that embodiments of the invention may be practiced without these specific details. In other instances, well-known methods, structures and techniques have not been shown in detail in order not to obscure an understanding of this description.

Where in embodiments according to the present invention reference is made to a 'folded up' trouser leg or sleeve, reference is made to a trouser leg or sleeve folded up in such a way that the one end of the trouser leg or sleeve is inside the other, such that the trouser leg or sleeve can be slid off over the limb of the patient by pulling on the end of the trouser leg or sleeve. 'Folded up' may imply that the trouser leg or sleeve is concertinaed with the aid of, for example, zigzag folds, etc.

In a first aspect, the present invention relates to a surgical drape consisting of one part, wherein the surgical drape comprises at least one trouser leg or sleeve, and wherein the at least one trouser leg or sleeve is folded up in such a way that one end of the trouser leg or sleeve is inside the other, such that the trouser leg or sleeve can be slid off over the limb of the patient by pulling on the end of the trouser leg or sleeve.

Embodiments of the present invention can be applied in different types of surgery, such as, for example, in thoracic surgery, cardiac surgery, abdominal surgery, urological surgery, gynaecological surgery, foot/hand/shoulder/back surgery, stomatological surgery, hip surgery, such as, for example, for direct anterior approach hip surgery.

It is an advantage of the folded up surgical drape that no additional elements are needed to slide the at least one trouser leg or sleeve off over the limb or limbs of the patient in a smooth manner.

The surgical drape which consists of one part and which comprises at least a trouser leg or sleeve in a folded up state for attaching it to the patient is preferably packaged in a sterile packaging so that the surgical drape may be brought into the operating theatre in a sterile manner. The material of the packaging may be any kind of material that allows for a sterile packaging.

The surgical drape is wholly or mainly made of a suitable material, such as, for example, non-woven material, for example, a non-woven cellular material, a porous paper material, a plastic material, a combination of a paper and plastic material, etc. The surgical drape may also comprise additional layers, such as, for example, an additional absorbent layer (for example, at the sides and under the sleeves or legs) to absorb blood or other fluids. The additional material, such as non-woven material, can also provide additional reinforcement against tearing and perforation.

The surgical drape may comprise additional flaps to provide shielding of other parts of the body, other than the limbs. These additional flaps are part of the one-piece shielding, and are typically also made of the suitable material as described above.

In some embodiments, the surgical drape also comprises integrated fastening points. These fastening points allow the surgeon or the assisting staff to attach one or more retractors or attributes to the surgical drape. By linking retractors or attributes to the fastening points, the incision can be kept open. In a specific embodiment, the fastening points which are integrated into the surgical drape are positioned at the height of the at least one trouser leg or sleeve. This allows the one or more retractors, which can be linked to the fastening points on the leg(s) and/or sleeve(s), to be oriented by moving the legs of the patient. In this specific embodiment, both the surgical drape and the legs become part of the wound retraction system. It is an advantage of embodiments of this aspect of the present invention that the legs/arms can be used as a wound retraction device, in that the legs/arms are free and the retractors are connected to the legs, since the moving of the legs/arms will also cause the position of the retractors to move, such that the wound will be kept open in a patient-specific manner. It is an advantage of embodiments of this aspect of the present invention that the smooth and quick wound retraction is possible and that surgery can be performed smoothly without any additional costs, such as for a specific table or additional personnel. It is an advantage of embodiments of this aspect of the present invention that the integration of a number of fastening points ensures that fewer steps are needed to create fastening points, but also that the legs/arms can be fixed to the retractors in a smooth manner and that the surgical drape, the patient and the retractors can together form a wound retraction system, for example, a self- retracting wound retraction system.

In a particular embodiment, integrated fastening points are also provided in additional flaps of the surgical drape. The tensile stress caused by retractors attached to these fastening points can, for example, be absorbed by linking the additional flap to fastening elements, such as, for example, rods through windows provided in the additional flap(s). Alternatively, the retractors may also be directly attached to rods that pass through the flap(s) and/or leg(s) and/or sleeve(s) and are attached to the table. An efficient system is also achieved in this embodiment, wherein additional personnel costs can be avoided. Because the number of retractors needed is also reduced, this results in a possible reduction in transport costs, sterilisation costs, logistics costs, etc. It is an advantage of embodiments according to the present invention that fastening points integrated into the surgical drape are provided in such a way that relatively large forces can be tolerated, in that the fastening points are provided at locations where the surgical drape is attached to an external reference point, such as, for example, the trouser legs around the patient or the surgical drape to external fastening means such as support poles or stands.

In a particular embodiment, the surgical drape comprises at least one trouser leg, preferably two trouser legs. FIG. 1 illustrates a part of an embodiment of the surgical drape, the leg being folded up. The leg is folded up according to a zigzag pattern as shown in FIG. 1, which allows the trouser leg to be pulled over the limb by simply pulling on an end of the trouser leg. Such a way of folding also may be referred to as in a telescopic manner. FIG. 1 shows a trouser leg 100 having a first end 102, a second end 104, and a zigzag pleated part 106. FIG. 2 illustrates a surgical drape in extended form, i.e. after the trouser legs have been slid off. The specific example relates to a surgical drape for sterile covering of the legs and abdomen before a surgical procedure. The surgical drape according to embodiments of this aspect of the present invention can preferably be used for surgery of the hips, the knees, the inguinal region, the hypogastrium and the stomach region. A specific example of surgery where the surgical drape may be used advantageously is hip surgery according to the Direct Anterior Approach (DAA). Embodiments of this aspect of the present invention are not limited thereby. A surgical drape 200 is shown provided with a first part 210 that comprises two trouser legs. In this way, both legs can be covered with one surgical drape. The surgical drape 200 from the present example furthermore also comprises a second part 220 that comprises an incision window that covers at least part of the inguinal region and the hypogastrium. The incision window can be provided over the entire hypogastrium or on both sides of the surgical drape, so that the drape can be used for both sides of the body. Alternatively, there can also be no incision window and this can be provided by the surgeon or assisting staff themselves by cutting open the drape in the necessary place. Because the stomach flap is also part of the same surgical drape, the legs and the incision area can be covered in one operation. The second part, which is also sometimes referred to as 'upper stomach flap', can be adjusted in size in some embodiments, so that it can be further unfolded along the patient (side and up to the thorax or even further). In a particular embodiment, openings can also be provided at the side of the second part to connect fastening elements to. Such openings may be, for example, telescopic windows into which fastening elements such as rods can be slid, wherein the fixing elements can be fastened to the operating table. The surgical drape may, in certain embodiments, also comprise an optional third part, which is sometimes also referred to as the 'foot flap', and which, for example, is attached initially to the rear of the trouser legs and which can partly be detached so that this part can be unfolded to the feet. This part can be used as protection layer. An optional fourth part of the surgical drape may be provided on the upper stomach flap or on the foot flap, and which can be unfolded to the side so that the upper stomach flap and the foot flap may be hermetically connected to each other.

In a particular embodiment, the surgical drape is therefore a drape with four parts, i.e. a part with trouser legs (also referred to as 'a pair of trousers'), an upper stomach flap with an incision window at the level of the stomach and with a telescopic side window for the provision of external fastening elements, and a foot flap on which a side flap is attached, which interconnects the upper stomach flap and the foot flap hermetically. With such a drape, the patient is integrally covered on all sides and, moreover, the legs are integrated into the drape so that the legs can be moved freely during the surgical procedure.

While the above example has been described for a surgical drape in the form of a pair of trousers, the present invention also relates to an embodiment with one trouser leg, a surgical drape in the form of a jumper, a surgical drape with one sleeve, etc.

In a second aspect, the present invention relates to a process for the application of shielding around a position on the body where a surgical procedure will be performed. The method is particularly advantageous if it is applied with shielding as described in the first aspect.

By way of example, where embodiments of the present invention are not limited for this purpose, a method will be described according to an embodiment of the present invention with reference to FIG. 5. The method 500 for holding a wound open during surgery, as shown in FIG. 3, comprises standard and optional steps. In a first optional step 510, the shielding, i.e., the surgical drape, is removed from the packaging. The surgical drape used in the present method is a one-piece shield, which comprises at least one trouser leg or sleeve, the at least one trouser leg or sleeve being folded up such that it can be slid off over the limb of the patient. The packaging allows the surgical drape to be stored in a sterile manner prior to use. The packaging may be of any kind of material that provides a sterile packaging for shielding.

In a second step 520, the end of at least one limb, corresponding to a foot or a hand, for, respectively, a leg or an arm, is placed into the trouser leg or sleeve of the shielding.

In a third step 530, the end of the trouser leg or sleeve of the shielding is gripped, together with the hand or foot of the patient, and the folded up trouser leg or sleeve is slid off. In this way, after the sliding off, the limb is completely covered by the trouser leg or the sleeve. Moreover, it is here advantageous that the positioning of the trouser leg or sleeve can be done in an efficient manner, as well as in a sterile manner. More specifically, the specific manner of the positioning of the trouser leg or sleeve allows that few different manipulations of the shielding are needed, so that this can be done in an optimally sterile manner.

In an optional fourth step 540, optional flaps of the one-piece surgical drape are further folded open to in this way cover any adjoining positions on the body, adjoining the limb.

Once the surgical drape has been completely folded open, it is possible in an optional fifth step 550, to make an incision window in the shielding, such that an opening is provided in the area where the surgical procedure is to take place. Alternatively, an opening may already be present, which functions as an incision window, such that no additional opening needs to be made anymore. Yet another alternative is that instead of an opening, a transparent portion is provided, which also functions as an incision window.

Further optional steps may also be present. In some embodiments, one or more fastening points are provided in the shielding so that these can function as a fastening point for the positioning a retractor. The method may also have further optional steps, for example, steps that partly or fully express the functionality of one or more elements described in the first aspect.

In a particular embodiment, the method comprises the sliding off of the folded up trouser leg over a leg. The method is then specifically for the shielding of a patient during a surgical procedure of the hips, the knees, the legs, the feet, the inguinal region, the hypogastrium or the stomach region.

In another particular embodiment, the method comprises the sliding off of the folded up sleeve over an arm. The method is then specifically for the shielding of a patient during a surgical procedure of the shoulders, the arms, the hands or a position on the torso, such as the stomach, the intestines, the heart, the lungs, etc.

In another particular embodiment, the shielding comprises two trouser legs or two sleeves, such that the shielding actually comprises a pair of trousers or shirt. The sliding off is then preferably done over the two limbs simultaneously, although the invention is not limited thereby.

In one aspect, the present invention also relates to the use of a surgical drape as described above for the preparation of a patient for a surgical procedure. The various aspects can easily be combined with each other, and the combinations thus also correspond with embodiments according to the present invention.

In one aspect the present invention also relates to an incision window or a surgical drape comprising an incision window for use in surgery.

The incision window is a window through which surgery can take place. It comprises a transparent layer, wherein a tube shaped cavity is provided or whereto a tube shaped cavity is connected, that is fillable with a substance to be delivered to the wound during surgery. When implemented in a surgical drape, the surgical drape also comprises a part for covering a bodily part during surgery for creating a sterile environment. The tube may be positioned on/in the incision window such that, when a conventional incision as made during open surgery is made, the tube is incised at least once, but preferably multiple times at different positions in the incision window, e.g. at least two times. Incising the tube at a plurality of positions may allow for a better spreading of the substance to be delivered to the wound. The tube may run over substantially the full incision window so that independent of where in the incision window the incision is made, the tube will also be incised and the substance to be delivered can spread in the wound.

It is an advantage of embodiments of the present invention that the substance can be delivered locally at the position or positions where incisions are made.

In one particular embodiment, the tube may be run over the surface of the incision window in specific directions. The tube may be meandering, have a spiral shaped shape, be a connection of piece-wise substantially parallel portions, comprise a plurality of u-turns, etc. If there is a preferred incision direction, the shape can be chosen such that the incision crosses the channels of the tube as often as possible. An example is shown in FIG. 4 illustrating a schematic side view and top view of the system. Typical substances that are envisaged are disinfecting substances but also substances comprising medicaments or other substances that advantageously can be delivered to a wound during surgery can be used.

The tube can be, prior to installation of the incision window, a closed tube, whereby the substance to be delivered can be introduced in the tube by means of a syringe. Alternatively, also other ways of introducing the substance in the tube may be used. The tube may have an entrance port with a region or means for allowing easy delivery of the substance. It thus is an advantage of embodiments of the present invention that the substance to be delivered can but does not need to be included in the surgical drape before use. The latter allows for larger flexibility in the substances that can be used.

The tube can be made of the same material as the incision window, although the latter is not a requirement.

The incision window may have one sticky side, allowing to paste the incision window to the patient.

Claims

1. A surgical drape consisting of one part, wherein the surgical drape comprises at least one trouser leg or sleeve, and wherein the at least one trouser leg or sleeve is folded up in such a way that one end of the trouser leg or sleeve is inside the other, such that the trouser leg or sleeve can be slid off over the limb of the patient by pulling on the end of the trouser leg or sleeve.

2. A surgical drape according to claim 1, wherein the surgical drape comprises two trouser legs folded up such that the trouser legs can be slid off over the limb of the patient by pulling on the end of the trouser legs.

3. A surgical drape according to any of claims 1 or 2, wherein the at least one trouser leg or sleeve is folded up in a zigzag manner, such that it can be slid off in a telescopic manner.

4. A surgical drape according to claim 1 or 3, the surgical drape being made of a non- woven material.

5. A surgical drape according to the preceding claims, the surgical drape comprising an incision window.

6. A surgical drape according to one of claims 1 to 5, wherein the surgical drape does not comprise an incision window, but wherein the material of the surgical drape allows an incision window to be cut out of the surgical drape.

7. A surgical drape according to one of the preceding claims, the surgical drape comprising additional flaps in the one-piece drape, which can be folded open to drape additional parts of the patient's body.

8. A surgical drape according to one of the preceding claims, the surgical drape comprising further fastening elements to which to attach retractors to hold a wound open.

9. A surgical drape according to one of the preceding claims, the surgical drape further comprising an additional absorbent layer.

10. A method for the application of shielding to the body of a patient who is to undergo a surgical procedure, the method comprising: obtaining a surgical drape consisting of one part, wherein the surgical drape comprises at least one trouser leg or sleeve, and wherein the at least one trouser leg or sleeve is folded up in such a way that one end of the trouser leg or sleeve is inside the other end of the trouser leg or sleeve, such that the trouser leg or sleeve can be slid off over the limb of the patient by pulling on the end of the trouser leg or sleeve.

positioning an end of a limb into the trouser leg or sleeve of the surgical drape, and

sliding off the trouser leg or sleeve by pulling on one end of the trouser leg or sleeve.

11. A method according to claim 10, the method further comprising:

the folding open of additional flaps of the one-piece surgical drape, to drape additional parts of the patient.

12. The use of a surgical drape according to claims 1 to 9 for the sterile shielding of a patient during a surgical procedure.