FIXATION MEANS FOR MEDICAL PERFORATION DEVICES
20220355076 · 2022-11-10
Inventors
Cpc classification
A61M39/1011
HUMAN NECESSITIES
International classification
Abstract
The present invention relates to means for fixating catheters (24), which are used in healthcare and in particular to means for fixating such catheters to a support (1).
Claims
1-17. (canceled)
18. A medical device for securing a medical article having a luer lock to the skin of a patient, the medical device comprising: a deformable base element having a first surface allowing the base element to be tightly placed on a body area near an application area of the medical article, and a second surface opposite the first surface; a body member comprising a first material and having a first side connected to the second surface of the base element, a second side opposite the first side, a front side, a back side opposite the front side, and a pair of walls; a clamping structure arranged at the second side of the body member; and a channel arranged at the second side of the body member the channel being disposed about a longitudinal axis of the medical device, creating a passage extending from the front side to the back side of the body member and being shaped so as to receive at least a portion of the luer-lock, wherein: the pair of walls of the body member at least partially encloses the channel on both sides of the channel to support the luer-lock when the medical article is inserted in the medical device; and the clamping structure comprises a second material, the second material being less soft and deformable than the first material, the clamping structure cooperating with the pair of walls to inhibit at least longitudinal and transverse movement of the medical article relative to the body member.
19. The medical device of claim 18, wherein: the channel further comprises at least one groove oriented perpendicularly within the channel; and the clamping structure at least partially fits within the at least one groove thereby cooperating with the channel to secure at least a portion of the luer-lock and inhibiting at least longitudinal and transversal movement of the medical article relative to the body member.
20. The medical device of claim 18, wherein the pair of walls are inwardly tilted to generate a downward pushing force upon the medical article.
21. The medical device of claim 18, wherein: the channel further comprises at least one protrusion arranged at the inside of the channel; and the at least one protrusion cooperates with the pair of walls and the clamping structure to secure at least a portion of the luer-lock and inhibit at least longitudinal and transversal movement of the medical article relative to the body member.
22. The medical device of claim 18, wherein: the clamping structure is located at the front side of the channel or at the back side of the channel; and the clamping structure cooperates with the channel to inhibit at least longitudinal and transversal movement of the medical article relative to the body member.
23. The medical device of claim 18, wherein the channel is angled relative to the longitudinal axis of the medical device to define an incident angle between the channel and the skin of the patient.
24. The medical device of claim 23, wherein the incident angle constitutes an angle of about 5° to 10°.
25. The medical device of claim 18, wherein the channel has a concavity formed along at least a portion of the longitudinal axis of the medical device.
26. The medical device of claim 25, wherein: the channel further includes a bottom wall; and the concavity extends upwardly from the bottom wall of the channel along a vertical axis of the channel.
27. The medical device of claim 26, wherein the cooperation of the shape of the clamping structure and the channel allows different types of medical articles containing a luer-lock to be secured within the medical device.
28. The medical device of claim 18, wherein the channel has a longitudinal shape.
29. The medical device of claim 18, wherein the channel further comprises a second groove oriented perpendicularly within the channel.
30. The medical device of claim 18, wherein the clamping structure comprises at least one clip assisting in clamping at least part of the medical article containing a luer-lock.
31. The medical device of claim 18, wherein an outer rim of the luer-lock is secured within the second groove.
32. The medical device of claim 18, wherein the first surface of the deformable base element comprises an adhesive layer for removably coupling the medical device to the skin of a patient.
33. The medical device of claim 18, wherein the pair of walls of the body member gradually decreases in height toward the outer side of the body member.
34. A kit comprising: the medical device according to claim 18; and an adhesive sheet for at least partially covering the channel of the medical device when the medical article is secured therein.
Description
BRIEF DESCRIPTION OF THE DRAWINGS
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DETAILED DESCRIPTION OF THE INVENTION
[0056] The present invention will be described with respect to particular embodiments and with reference to certain drawings, but the invention is not limited thereto. The drawings, as further described, are only schematic and are non-limiting. The dimensions and the relative dimensions do not correspond to actual reductions to practice of the invention.
[0057] Furthermore, the terms first, second, further 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.
[0058] Moreover, the terms base, top, front, back 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 “comprising”, 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 comprising 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 relevant components of the device are A and B, and that further components such as C may be present.
[0059] It is also to be noticed that the term “cooperating” used in the claims, for example component A cooperating with component B, should be interpreted as two components working together to ameliorate a certain effect. For example, in an embodiment of the current invention, the clamping structure cooperates (i.e. functions together) with the channel in order to inhibit movement of the medical article relative to the body member.
[0060] Besides that, when a part of the medical device is said to ‘inhibit’ movement of the medical article and unless defined otherwise, the term ‘inhibit’ should be interpreted as partially or completely reducing movement of the medical article. This term may alternatively be referred to as for example: “minimize”, “constrain” or “impede”.
[0061] Similarly, it is to be noticed that the term “removably coupled”, also used in the claims, should not be interpreted as being restricted to direct connections only. The terms “removably coupled” and “connected”, along with their derivatives, may be used. It should be understood that these terms are not intended as synonyms for each other. Thus, the scope of the expression “an element A removably coupled to an element B” should not be interpreted as elements (e.g. medical device, skin of a patient) being preferably inseparably attached to each other, but rather as a coupling which can be breached by means of a substantial pulling force. The term “connected” on the other hand, should be interpreted as describing an attachment between two elements (e.g. base element, body member) which is preferably inseparable. Thus, the scope of the expression “an element A connected to an element B” should be interpreted as an element A being preferably inseparably attached to element B.
[0062] 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, appearances of the phrases “in one embodiment” or “in an embodiment” in various places throughout this specification are not necessarily all referring to the same embodiment. 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.
[0063] 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.
[0064] 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.
[0065] 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.
[0066] The following terms are provided solely to aid in the understanding of the invention:
[0067] As used herein and unless otherwise specified, when a medical device is said to “secure a medical article to a support”, it is meant that at least a portion of the medical article is fixed to and/or stabilized to and/or positioned onto the support. Securing the medical article typically hinders, or even completely prevents, both translational and rotational movement of at least a portion of the medical article.
[0068] Besides that, as used herein and unless otherwise specified, the term “groove” is used to define a recess of the body member and more specifically of the channel, which is shaped so as to have the ability to accept different parts of the medical device (e.g. at least part of the clamping structure) and/or the medical article, (e.g. at least part of the medical article or luer-lock).
[0069] A first embodiment of the present invention relates to a medical device for securing at least part of a medical article to a support. The medical article may be a catheter, for example a central venous catheter, a peripheral venous catheter, a midline catheter, a continuous peripheral nerve block catheter or an epidural catheter. The medical device can advantageously be used in a plurality of applications.
[0070] In some embodiments, the support may be a body of a living creature. Securing the medical article to the living body advantageously reduces the risk of the medical article moving within the body or even being accidentally removed therefrom.
[0071] The medical device for securing a medical article to a support may comprise a base element having a first surface fixable to the support, e.g. living body, and a second surface opposite the first surface. It may also comprise a body member having a first side connectable with the second surface of the base element. According to embodiments of the present invention, while the first side of the body member is connected with the second surface of the base element in order to form a means for attaching the base element to a support, the second side of the body member defines a pair of walls and therebetween a channel for receiving the medical article. The body member further comprises a first material. The channel also comprises a clamping structure arranged at the second side of the body member. It was surprisingly found that the unique combination of the channel and the clamping structure may adapt to a relatively broad range of catheter sizes and catheter types, thus eliminating the need to buy and use several devices dedicated to specific catheter sizes and catheter types.
[0072] In some embodiments, the first side of the base element may be fixable to the support by means of an adhesive material. The adhesive material advantageously allows the first side to be easily fixed to the support. In preferred embodiments, the fixation may be reversible, such as by using a removable adhesive (e.g. tape, glue).
[0073] The channel is an integral part of the body member and therefore comprises the same first material as the body member. The first material generally being slightly flexible and deformable in order for the pair of walls to outwardly deform when receiving the medical article, but providing a sufficient amount of rigidness for the clamping structure in order to cooperate with the clamping structure in tightly securing the medical article within the channel.
[0074] In a preferred embodiment, the cooperation between the pair of walls and the clamping structure of the medical device as defined herein allows different types of luer-lock portions (of medical articles) to be sufficiently secured and inhibited within said medical device. More specifically, the pair of walls are sufficiently flexible so that, when a medical article is inserted, the pair of walls may outwardly deform, so that different types, sizes and diameters of luer-locks may fit within the channel of the medical device. Also, the pair of walls may provide for further inhibition of movement of the luer-lock because of the slight deformability of the pair of walls, increasing the contact surface between the luer-lock part of the medical article and the pair of walls.
[0075] Furthermore, the clamping structure cooperates with the pair of walls by being sufficiently rigid to enable a tight fixation and movement inhibition of the luer-lock within the medical article. This way, the securement of at least a portion of the luer-lock by the fixation mechanism of both the pair of walls and the clamping structure works synergistically in inhibiting movement of the medical article.
[0076] In some embodiments, the first material may be solid.
[0077] In some embodiments, at least part of the first material may comprise a deformable fluid filled chamber. The chamber may for example be filled with air or any other type of gas or with a fluid. In some embodiments, more than one channel may be defined within the body member of the medical device having similar features as the ones of the channel which is described in the present invention.
[0078] In the context of the present invention, the term “clamping structure” is meant to be a complementary part of the channel of the body member, which facilitates the unique securement of a number of different sizes and types of medical articles within the channel.
[0079] The clamping structure is generally made of a second material, being less flexible and deformable than the first material.
[0080] In some embodiments, the clamping structure may be unremovably coupled to the body member.
[0081] In some embodiments, the clamping structure and the channel are spaced apart from each other.
[0082] In some embodiments, the clamping structure may be separable from the body member, allowing a plurality of differently shaped clamping structures to be inserted into the channel of the body member.
[0083] In some embodiments, the clamping structure may be oriented at the front side of the channel or at the back side of the channel. In some embodiments, the clamping structure may comprise a number of additional materials other than the abovementioned second material. In preferred embodiments, the clamping structure is made solely of the second material.
[0084] In the context of the present invention, the term “clip” is meant to be an integral part of the clamping structure, having the ability to exert a clamping force upon at least part of the medical article.
[0085] In some embodiments, the clamping structure comprises a single clip which has the ability to exert a clamping force on at least part of the medical article.
[0086] In some embodiments, the clamping structure comprises at least one clip which has the ability to be outwardly deformed independently from the clamping structure.
[0087] In some embodiments, the clamping structure comprises a plurality of clips which all differ slightly in size and shape to be able to clamp a number of different parts of the medical article. In some embodiments, the at least one clip is generally U-shaped.
[0088] In some embodiments, the at least one clip is horseshoe shaped.
[0089] In some embodiments, the at least one clip is conically shaped.
[0090] In some embodiments, the at least one clip has a similar shape as the first groove and/or the further groove in which the clip may at least partially fit.
[0091] In some embodiments, the medical article may comprise a pair of wings which may be situated outside of the channel of the body member, more specifically at the front side of the body member.
[0092] A following embodiment of the present invention relates to the channel of the medical device, further comprising at least one groove oriented perpendicularly within said channel, wherein said clamping structure at least partially fits within said at least one groove thereby cooperating with said channel to secure at least a portion of the luer-lock and inhibiting or at least reducing longitudinal and transversal movement of the medical article relative to the body member.
[0093] In some embodiments, the channel may comprise at least one groove with a clamping structure contained therein, wherein the clamping structure may be in the form of an insert.
[0094] In some embodiments, the channel may define a single groove for receiving a clamping structure.
[0095] In some embodiments, the channel may comprise at least one groove which is not meant to receive the clamping structure but is in direct contact with at least part of the medical article.
[0096] In some embodiments, the channel may define two grooves. A first groove for receiving the clamping structure and a second groove for receiving at least part of the medical article (such as the luer-lock). In preferred embodiments, all of the grooves may be oriented perpendicularly relative to the longitudinal axis of the channel.
[0097] In some embodiments, the groove for receiving at least part of the medical article may be oriented parallel relative to the longitudinal axis of the channel.
[0098] In some embodiments, the grooves for receiving the clamping structure are oriented parallel relative to the longitudinal axis of the channel and the groove for receiving at least part of the medical article is oriented perpendicular relative to the longitudinal axis of the channel.
[0099] In some embodiments, all of the grooves may be oriented parallel relative to the longitudinal axis of the channel.
[0100] In some embodiments, the channel may define a single groove which is shaped in such a way to comprise all of the necessary properties for receiving the clamping structure and at least part of the medical article.
[0101] In some embodiments, all of the at least one groove may be for example only present in the bottom wall of the channel while only part of the clamping structure is contained within the at least one groove.
[0102] In some embodiments, the clamping structure may be contained within the channel while the channel does not define any grooves.
[0103] In some embodiments, the clamping structure mainly inhibits the longitudinal movement of the medical article relative to the body member.
[0104] In some embodiments, the clamping structure inhibits both longitudinal and transversal movement of the medical article relative to the body member.
[0105] In some embodiments, the clamping structure mainly inhibits the transversal movement of the medical article relative to the body member.
[0106] In another embodiment, the pair of walls of the medical device according to the invention are inwardly tilted in order to generate a downward pushing force upon the medical article.
[0107] The fact that the pair of walls are inwardly tilted generates a partial enclose of at least a portion of the luer-lock, causing a downward pushing force upon said portion. Because of this downward pushing force, said luer-lock portion is tightly secured within the channel of the medical device.
[0108] An advantage of embodiments of the current invention wherein the pair of walls are inwardly tilted is that the luer-lock portion which is held by the pair of walls is unable to move upwardly, being in the direction of the second side of the body member.
[0109] As mentioned herein and unless provided otherwise, the “inwardly tilted” pair of walls should be understood as a being a pair of walls that point towards each other at least with the end of each wall. This way, the pair of walls are not oriented parallel relative to each other but rather create a converging shape (e.g. horseshoe shape or conical shape) towards the end of the pair of walls. Because of this inwardly tilting motion, the inwardly tilted ends of each of said pair of walls exert a downward pushing force at least upon the top side of said luer-lock portion.
[0110] In a next embodiment, the channel of the medical device according to the invention further comprises at least one protrusion arranged at the inside of said channel, wherein the at least one protrusion cooperates with said pair of walls and said clamping structure to secure at least a portion of the luer-lock and inhibit at least longitudinal and transversal movement of the medical article relative to the body member.
[0111] In some embodiments, said protrusion may be deformable. increasing the contact surface between the luer-lock part of the medical article and the protrusion.
[0112] In some embodiments, at least part of the protrusion may comprise a deformable fluid filled chamber. The chamber may for example be filled with air or any other type of gas or with a fluid.
[0113] A following embodiment of the present invention relates to the clamping structure of the medical device, being located at the front side of the channel or at the back side of the channel. The clamping structure cooperating with said channel to inhibit at least longitudinal and transversal movement of the medical article relative to the body member.
[0114] In some embodiments, the clamping structure is located directly in front of the channel.
[0115] In some embodiments, the clamping structure is located directly behind the channel.
[0116] In some embodiments, the clamping structure and the channel are lined up according to a longitudinal axis of the medical device.
[0117] In some embodiments, the diameter of the clamping structure differs from the diameter of the channel.
[0118] Another embodiment of the present invention relates to the channel of the medical device, being angled relative to the longitudinal axis of the medical device to define an incident angle between the channel and the skin of the patient. The incident angle constituting an angle of about 5-10°, in particular about 7°. The angle of about 7° provides for an anti kinking feature for the catheter, thereby providing for an enhancement of the success rate of a correct catheter insertion of the medical article into the skin of the patient.
[0119] In the context of the present invention, the “angle” is formed between at least part of the catheter of the medical article and the skin of the patient.
[0120] In some embodiments, the angle may be slightly less than 5°. In other embodiments, the angle may be slightly more than 10°. In preferred embodiments, the angle may be approximately 7°.
[0121] A fifth embodiment of the present invention relates to the channel of the medical device having a concavity formed along at least a portion of the longitudinal axis of the medical device. The channel further including a bottom wall, the concavity extending upwardly from the bottom wall of the channel along a vertical axis of the channel and the channel having a longitudinal shape.
[0122] In some embodiments, the concavity is formed along the entire length of the longitudinal axis of the medical device.
[0123] In some embodiments, the channel of the medical device does not define a concavity, but a multangular shape.
[0124] In some embodiments, at least part of the channel has a circular shape.
[0125] In some embodiments, at least part of the channel has an angular shape.
[0126] A next embodiment of the present invention relates to the channel of the medical device comprising a second groove oriented perpendicularly within said channel.
[0127] In some embodiments, the second groove is oriented parallelly within the channel.
[0128] In a following embodiment of the present invention, the cooperation between the shape of the clamping structure, the channel and the second groove is described, allowing different types of medical articles, in particular containing a luer-lock, to be secured within the medical device. In the context of the present invention, the term “cooperation” indicates the utilization of the combined functionalities of multiple different shapes and features of different parts of the medical device in order to tightly secure at least part of the medical article within the medical device.
[0129] In some embodiments, the cooperation exists only between the shape of the clamping structure and the channel.
[0130] In some embodiments, part of the luer-lock of the medical article is located outside the channel of the body member.
[0131] A further embodiment of the present invention relates to the clamping structure comprising at least one clip assisting in clamping at least part of the medical article containing a luer-lock.
[0132] In the context of the present invention, the term “clip” refers to a part of the clamping structure having the ability of at least partially enclosing at least part of the medical article.
[0133] In some embodiments, the clamping structure comprises a single clip.
[0134] In some embodiments, the at least one clip is at least partially fitted within the at least one groove.
[0135] In some embodiments, the at least one clip has a similar shape as the groove in which it is at least partially fitted.
[0136] In some embodiments, the clip comprises at least two opposing posts. The at least two opposing posts may contact at least part of the luer-lock of the medical article.
[0137] In some embodiments, the clip comprises a single post.
[0138] A next embodiment of the present invention relates to the second groove of the medical device having an outer rim of the luer-lock secured therein.
[0139] In the context of the present invention, the term “rim” refers to an edged part of the luer-lock of the medical article.
[0140] In some embodiments, only part of the outer rim may be fitted within the second groove.
[0141] A further embodiment of the present invention relates to the first surface of the deformable base element of the medical device, comprising an adhesive layer for removably coupling the medical device to the skin of a patient.
[0142] In some embodiments, the adhesive layer may cover only part of the first surface of the deformable base element.
[0143] A next embodiment of the present invention relates to the pair of walls of the medical device, which gradually decrease in height towards the outer side of the body member.
[0144] In some embodiments, the pair of walls do not change in height throughout the entire width of the body member.
[0145] In some embodiments, the pair of walls do not change in height throughout the entire length of the body member.
[0146] Another embodiment of the present invention relates to a kit comprising the medical device and an adhesive sheet for at least partially covering the channel of the medical device when the medical article is secured therein.
[0147] In some embodiments, the adhesive sheet covers the entire surface of the medical device.
[0148] In some embodiments, the adhesive sheet covers the entire body member of the medical device.
[0149] In some embodiments, the adhesive sheet covers at least part of the channel and the medical article, which is secured therein.
[0150] We now refer to
[0151] We now refer to
[0152] The body member 4 further comprises a clamping structure 13 (such as in the form of an inset) which is shaped so as to at least partially fit within the first groove 12 and the further groove 20.
[0153] The clamping structure 13 may comprise at least one clip 16 made of a second material 14. The second material 14 being less soft and deformable than the first material 5 and being sufficiently rigid so that the at least one clip 16 has the ability to cooperate with the channel 11 in securing the medical article 24. The at least one clip 16 preferably clamping the medical article 24 in order to assist in inhibiting at least longitudinal movement of the medical article 24 relative to the body member 4. The at least one clip 16 may further have a similar horseshoe shape as the first groove 12. The channel 11 may further comprise a second groove 15 oriented perpendicularly relative to the longitudinal axis of the channel 11. The second groove 15 cooperates with the clamping structure 13 and the channel 11 in order to allow different shapes and types of medical articles containing a luer-lock 24 to be secured within said medical device 18. More specifically, an outer rim of the luer-lock may be secured within said second groove 15. Furthermore, the second groove 15 may have a similar horseshoe shape as the first groove 12, assisting in the securement of at least part of the medical article 24. The second groove 15 thereby inhibiting at least longitudinal movement of the medical article 24 relative to the body member 4. The interplay between the clamping structure 13, and the channel of the body member 4 is an unique feature of the present invention, allowing a number of different shapes and sizes of medical articles 24 to be tightly secured into place. This unique feature further allows for the rapid and simple securement of the medical article 24 within the medical device 18, which is an important advantage of the present invention.
[0154] In this particular embodiment, the clamping structure 13 is at least partially fitted within the first groove 12 and the further groove 20, thereby generally conforming to the overall shape of the channel 11 and allowing further securement of the medical article.
[0155] We now refer to
[0156] We now refer to
[0157] We now refer to
[0158] We now refer to the medical devices disclosed in
[0159] We now refer to
[0160] The clamping structure 13 comprises a number of protrusions 27, which are spaced apart from each other and defined at the inside of the clamping structure 13. The protrusions 27 may comprise a deformable solid material, being able to adapt to different catheter sizes and types, such as the material of the body member 4. More specifically, the protrusions 27 may aid in the fixation and movement inhibition of different types and sizes of luer-locks.
[0161] Besides that, the protrusions 27 cooperate with the clamping structure 13 and the body member 4 in order to inhibit at least longitudinal and transversal movement of the medical article 24 relative to the body member 4. The contact between the protrusions 27 and at least part of the medical article 24 (e.g. part of the luer-lock) is of such a nature that a certain resistance arises which inhibits at least the longitudinal movement of the medical article 24. More specifically, a certain resistance may be accomplished when the luer-lock is inserted in the medical device and at least one of the protrusions 27 is deformed by at least a portion of the luer-lock, which increases the contact surface between both the luer-lock and the at least one protrusion 27. This advantage of increased contact surface is especially useful when fixating luer-locks with a ribbed outer surface. Moreover, further resistance may be accomplished when at least one of the protrusions 27 is able to hook behind, in front or above the luer-lock.
[0162] Some parts of the body member 40 are shaped in such a way to further define the conically shaped channel 11 and to enhance the securement and inhibition of movement of at least part of the medical article 24 relative to the body member 4 in a similar way as the protrusion 27 do in this particular embodiment.
[0163] The clamping structure 13, surrounding the protrusions 27 and some parts of the body member 40, complements the effect of the protrusions 27 and the body member 4 by further inhibiting the longitudinal and transversal movement of the medical article 24. The clamping structure may contact different parts of the luer-lock then those parts contacting the protrusion 27 in order to facilitate this complementary effect.
[0164] We now refer to
[0165] We now refer to
[0166]