WO2006008034A1

WO2006008034A1 - An arrangement and a method for injection of a substance into a body organ

Info

Publication number: WO2006008034A1
Application number: PCT/EP2005/007551
Authority: WO
Inventors: Agerup Bengt
Original assignee: Q-Med Ab
Priority date: 2004-07-19
Filing date: 2005-07-12
Publication date: 2006-01-26
Also published as: SE0401880D0

Abstract

The present invention relates to a method and an arrangement (1; 101; 201; 301) for injection of a substance (5; 105; 305) into a body organ (7; 107; 307). The arrangement comprises at least two non-piercing elements (9; 109; 209; 309) each having a distal end (17; 117; 217; 317) and a proximal end (19), and at least one cannula (39; 139; 239; 339). The distal ends (17; 117; 217; 317) are movable between a first position and a second position, the distance between the distal ends (17; 117; 217; 317) being larger in the second position than in the first position for distending and/or expanding interaction between the distal ends (17; 117; 217; 317) of the non-piercing elements (9; 109; 209; 309) and the body organ (7; 107; 307). The cannula (39; 139; 239; 339) is at least partly movable relatively to the non-piercing elements (9; 109; 209; 309) from a proximal position towards a distal position for injection of the substance (5; 105; 305) into the distended and/or expanded body organ (7; 107; 307).

Description

AN ARRANGEMENT AND A METHOD FOR INJECTION OF A SUBSTANCE INTO A BODY ORGAN

Technical field

The present invention relates to an arrangement to be passed through a body cavity for injection of a substance into a body organ and a method for injection of a substance into a body organ.

Technical background

In the field of medicine there is sometimes a need for a surgeon to be able to inject a substance into a body organ, for instance approached by an arrangement passed through a body cavity. For instance, cosmetic and therapeutic treatments may be carried out by injecting an agent or a substance into an organ or tissue, by means of elongate injection needles.

The body organ or tissue to be injected by a substance may be located in a narrow space which is difficult to access. Additionally, if the organ or tissue to be reached is located deep inside the human body, special tools or equipment may be required for the execution of the injection.

Rather often, the introduction of such an injection arrangement involves discomfort for the patient subjected to the procedure. Sometimes, the procedure may also be quite stressful and traumatic for the patient.

Furthermore, supplemental equipment is often required for the introduction of the arrangement for injection, which supplemental equipment is often complex and usually requires highly trained staff. Rather often, the prior art equipments require at least two people for carrying out the injection procedure.

The special arrangement used for such an injection often requires specially designed equipment for the execution of the injection, which may make the injection arrangement expensive and complicated.

WO 02/09802, filed by the present applicant, describes an arrangement and a method for interacting with an internal body organ. The arrangement comprises a sheath in which at least two elongate structural elements are inserted. Said structural elements are arranged to be displaced relatively to the sheath so that they extend through an open distal end of the sheath and at least partly in the transverse direction away from the sheath for distending and/or expanding interaction with a body organ. In case the arrangement is used for injection of a medical agent into said body organ, the structural elements are provided as injection needles. Such an arrangement may create discomfort and inconvenience for a patient subjected to the procedure, especially when the body organ is distended and/or expanded. Even though the arrangement provides many advantages, it would be desirable to improve the injection arrangement, for instance the positioning accuracy of the injection and reduced variations in penetration depth.

Hence, there is a need for an improved arrangement for injection of a substance into a body organ, which allows for a proper positioning of the injection and a reliable determination of the penetration depth of the injection needles.

I I

Summary of the invention

Thus an object of the present invention is to provide an improved arrangement and method for injection of a substance into a body organ.

These and other objects, which will become apparent in the following description, are achieved by an arrangement and a method for injection of a substance into a body organ as defined in the independent claims.

A first aspect of the invention relates to an arrangement to be passed through a body cavity for injection of a substance into a body organ, comprising at least two non-piercing elements each having a distal end and a proximal end, and at least one cannula. The distal ends are movable between a first position and a second position, the distance between said distal ends being larger in the second position than in the first position for distending and/or expanding interaction between the distal ends of the non-piercing elements and said body organ. The cannula is at least partly movable relatively to the non-piercing elements from a proximal position towards a distal position for injection of said substance into the distended and/or expanded body organ.

According to a second aspect, the invention relates to a method for injection of a substance into a body organ. The method comprises providing at least two non-piercing elements each having a distal end and a proximal end, providing at least one cannula, inserting the at least two non-piercing elements into a body cavity, moving the non-piercing elements from a first position towards a second position so that the distance between the distal ends of the non-piercing elements is larger in the second position than in the first position for distending and/or expanding interaction between the distal end of the non-piercing elements and said body organ, and moving the at least one cannula relatively to the non-piercing elements from a proximal position towards a distal position for injection of said substance into the distended and/or expanded body organ. A particular advantage with the arrangement according to the invention is the possibility of keeping back or withholding the at least one cannula, for instance formed as an injection needle, from contact with the body organ during the introduction of the arrangement into the body cavity, as well as during the distending and/or expanding of the body organ or other tissues. In other words, the- cannula may be withheld until the substance is intended to be delivered. Avoidance of interaction between the tissues and the cannulas, during introduction of the arrangement through the body cavity and during distending and/or expanding the body organ, may provide a comfortable treatment for a patient. Thereby, the treatment may be less stressful and traumatic for the patient as compared to the use of prior arrangements.

Thus, the invention is based on the insight that the body organ may be unaffected from contact with the cannulas until the injection is administered, by introducing the at least one cannula after separate elements have distended and/or expanded the body organ.

Additionally, the invention is also based on the insight that the separation of means for the distension and/or expansion of the body organ and means for the injection of a substance into the body organ gives a suitable precision and reliability of the penetration depth for the injection. Furthermore, the said separation of said means enables a suitable positioning of the injection, since the position of the injection may be adapted to be determined by the position of the non-piercing elements.

It shall be understood that in this disclosure the terms "distal" and "proximal" are from an operator point of view and not from a patient point of view. It shall also be noted that in this disclosure the term "body cavity" may be interpreted as a natural cavity of the body, as well as a cavity generated in an artificial way, for instance by means of a surgical instrument. Hereinafter, the term "insertion direction" is used to determine the direction in which the arrangement is mainly transferred during introduction into the body cavity. The "insertion direction" may be interpreted as a geometric axis along which the arrangement is substantially transferred during said introduction into the body cavity. The movement of the non-piercing elements from a first position towards a second position, means that the distal ends of the at least two non-piercing elements are moved away from each other in a substantially transverse direction relatively to the geometric axis defined by the insertion direction of the arrangement, for instance in a substantially transverse direction relative to the direction of extension of the non-piercing elements. Thereby, the mutual distance between said distal ends of the non-piercing elements are enabled to be larger in the spread second position, compared to the first position. There are of course a number of possibilities to create this movement of the non-piercing elements, wherein only a few will be disclosed hereinafter. The arrangement according to the present invention comprises at least two non-piercing elements. Depending on the area of application, the number of non-piercing elements may vary. For instance, in some cases twelve non-piercing elements may be suitable, in others it may be preferable with less, such as four.

The non-piercing elements are in embodiments of the invention arranged to be angularly deflected in an outward direction towards the body organ into said second position. The outward direction shall be interpreted as a substantially transverse direction relative to the extension of the geometric axis defined by the insertion direction of the arrangement. In said second position the non-piercing elements, if more than two, are for example circumferentially spaced. Suitably, a distal end of the at least one cannula, in its distal position for injection of a substance, is located distally of the distal end of a corresponding non-piercing element in its second position. Furthermore, relative to the geometric axis defined by the insertion direction of the arrangement, the distal end of the at least one cannula, in its second position, can be located laterally outwardly of the distal end of the corresponding non-piercing element. The at least one cannula may on the one hand be applied with the rest of the arrangement during introduction into the body cavity and during distending and/or expanding of the body organ, or on the other hand be introduced after the body organ has been distended and/or expanded. In a further example, the at least one cannula may be introduced after the introduction of the rest of the arrangement into the body cavity, but before or while the body organ is distended or expanded. It shall be noted that the distal position of the at least one cannula refers to a position intended for injection of a substance into the body organ. In the at least one distal position of the cannula, the distal end of the cannula is exposed and extends laterally and/or distally beyond the distal end of an adjacent non-piercing element, whereby a penetration of the body organ is enabled.

In exemplifying embodiments of the invention, a stop or a limitation of the relative movement between the at least one cannula, in the distal direction, and the non-piercing element determines a depth of penetration of the cannula into the body organ or other tissues. Thereby, the penetration of the cannula into the body organ may be controlled and substantially equivalent from time to time. The depth of penetration may be varied for different applications, for instance by arranging the limitation in a suitably way. In some embodiments, the limitation may be adjustable by the user. Alternativelyln other embodiments, several arrangements with different depths of penetration may be provided for different applications.

In exemplifying embodiments of the invention, the at least one cannula is arranged to be at least partly transferred from the proximal position towards the distal position by advancement of the cannula in the distal direction relatively to the non-piercing elements, wherein the non-piercing elements are kept substantially unmoved or fixed in relation to said body organ. The cannulas may be moved in the distal direction until their distal end, respectively reaches a position laterally and/or distally outside an adjacent non-piercing element, in a direction towards the body organ, whereby the cannula may penetrate the tissues of the body organ, or other tissues, and thereby admit administering of a substance. Potential discomfort or inconvenience for a patient subjected to an injection procedure may be reduced by keeping the non-piercing elements substantially fixed during the injection procedure. The at least one cannula will thereby for instance be moved towards the point of administering without any contact, such as sliding contact, with the tissues before the cannula distal end penetrates the body organ.

According to at least one further embodiment of the invention, the at least one cannula may be partly transferred from the proximal position towards the distal position by retraction of the non-piercing elements in a proximal direction relatively to the at least one cannula. When the distal end of the at least one cannula is exposed by the proximal retraction of the non-piercing elements, the cannula may penetrate the body organ in order to enable an injection of a substance into the body organ. Additionally, a combination of retraction of the non-piercing elements and movement of the cannula in the distal direction may be used to achieve the penetration of said body organ.

The separated movement of the non-piercing elements and the at least one cannula provides for a suitable positioning of the injection. Furthermore, the substance may be delivered close to the most extended and/or distended area of the tissues.

According to at least one exemplifying embodiment of the invention, at least one of said non-piercing elements is tubular, wherein the at least one cannula is receivable at least partly inside said tubular non-piercing element. The at least two non-piercing elements may each have an elongate shape. An essentially cylindrical wall of at least one of the non-piercing elements defines an interior passage. Furthermore, the interior passage forms an open distal end and an open proximal end. Thus, the cannula may be introduced into the tubular non-piercing element through said proximal open end and exit the non-piercing element through the open distal end. Thereby, the cannula is able to pass through the non-piercing element, from the proximal end towards the distal end. By arranging the cannula inside the tubular non-piercing element, the cannula may be withheld from contact with the body organ, or other tissues, by covering at least a distal portion of the cannula inside the non-piercing element.

In at least one embodiment, the cannula is inserted in the tubular non-piercing element when the injection arrangement is introduced through the body cavity. In other embodiments, the cannula may be introduced subsequently to the introduction of the rest of the arrangement, as mentioned above. Inside the non-piercing element, the cannula may be moved between a proximal position and a distal position. In the proximal position, the distal end of the cannula is located inside the non-piercing element and withheld from contact with the body organ or other tissues. In the distal position, the distal end of the cannula is located outside, laterally and/or distally ahead of the distal end of a corresponding non-piercing element, for enabling penetration of the body organ or other tissues. After expanding and/or distending of the body organ, as mentioned above, the cannula may be advanced in the distal direction from the proximal position towards the distal position for delivery of a substance into the body organ.

According to at least one embodiment of the invention, each non-piercing element is tubular and provided with an at least partially inserted cannula. Consequently, it shall be understood that the non-piercing elements may be either solid or tubular, if not intended to receive a cannula, for instance in case of only two out of four non-piercing elements are meant to receive a cannula.

The non-piercing elements may be optionally solid and/or tubular for an embodiment in which the at least one cannula is arranged outside the non-piercing elements, i.e. not inserted into a tubular non-piercing element.

The depth of the penetration into the body organ is preferably determined by the length of movement between the non-piercing element and the cannula. For example, a proximal end portion of the cannula may abut against a stop for the advanced movement of the cannula in the distal direction. Such a stop may be constituted by the non-piercing element itself, or other parts of the injection arrangement, e.g. a holder for the non-piercing elements and/or the at least one cannula. The stop may for instance be formed as a mechanical stop or a frictional resistance. Furthermore, the level for the stop of the penetration could be visually indicated, for instance by an indication or a marking. Furthermore, when the distal end of the cannula is moved towards said distal position, said distal end of the cannula can be adapted to pass from the inside of the non-piercing element through the distal end of the non-piercing element. When the distal end of the cannula exits the distal end of the non-piercing element, the cannula is uncovered and thereby exposed for penetration of the body organ, whereby an injection may be delivered. It shall be noted that the distal and proximal open ends of the non-piercing element preferably are arranged in the end face of the elongate non-piercing element, but may as well be arranged as apertures in the cylindrical wall of the non-piercing element. As mentioned above, the at least one cannula may be arranged outside the non-piercing elements according to at least one embodiment of the invention, i.e. the at least one cannula is not inserted into the non-piercing elements. In this case, the cannula may be withheld from contact with the body organ by locating the cannula behind the non-piercing elements, relatively to the body organ. It shall be noted that the term "behind" in this context shall be interpreted as the distal end of the cannula being located closer to a central geometrical axis defined by the insertion direction of the arrangement, than the distal end of the non-piercing elements. In some embodiments, the cannula may be kept outside the arrangement until the body organ is expanded and/or distended and subsequently introduced for delivery of a substance into the body organ. For any embodiment comprising at least one cannula located outside the non-piercing elements, the cannula may be arranged in several ways relatively to the non-piercing elements, for instance in parallel. An injection is given by moving the cannula in a distal direction until the distal end of the cannula reaches the tissue of the body organ, wherein further advancement in the distal direction allows the distal end of the cannula to penetrate said tissue. For example, the injection could be sited close to one of the distal ends of the at least two non-piercing elements which expand and/or distend the body organ, this being suitable at least in the case when the non-piercing elements are tubular and the cannula is passed through one of said non-piercing elements. However, the injection may be sited at other locations as well.

According to at least one embodiment, the at least one cannula is substantially held in its proximal position relatively to the corresponding non-piercing element when the non-piercing element is translated from its first position towards its second position. The proximal position of the cannula means in general a position wherein the cannula is withheld from contact with the tissues of the body organ. Consequently, the cannula may be inserted into the arrangement or kept outside the arrangement in its proximal position. According to at least one embodiment, the cannula, in its proximal position, is introduced inside a non-piercing element in such a way that the distal end of the cannula is kept from contact with said body organ. In some embodiments, the distal end of the cannula can be positioned inside and covered by the tubular non-piercing element in said proximal position.

Furthermore, when the cannula is arranged inside a tubular non-piercing element in the proximal position, the cannula can be arranged to at least partially follow the movement of the non-piercing element from its first position towards its second position, and vice versa. Thus, the position of the cannula may be substantially unaffected in relation to the non-piercing element. According to at least one embodiment, the non-piercing elements are adapted to be arranged in fixed relationship to the body organ, or at least intended to be kept fixed during a stage of the injection. Hence, the cannula is then movably arranged in relation to the non-piercing elements for provision of the injection. According to further embodiments, the at least one cannula may be arranged in fixed relationship to the body organ, wherein the non-piercing elements is movable for delivery of the substance into the body organ.

According to at least one embodiment the arrangement comprises a housing having at least one interior passage, wherein the non-piercing elements are movably arranged relatively to at least a portion of said housing. A relative position between the housing and the at least two non-piercing elements may control the deflection of the non-piercing elements when moved from the first position towards the second position, and vice versa. The range of movement of the housing relative to the non-piercing elements may effect the amount of the previously described deflection of the non-piercing elements relatively to the housing.

The housing may be formed in different ways, wherein the housing serves as a limiter or restrictor in order to keep the distal ends of the at least two non-piercing elements from deviating sideways in the first position of the non-piercing elements. As the distal ends of the non-piercing elements are moved relatively to the housing, towards the second position, the housing allows said distal ends to deflect radially for expanding and/or distending interaction with the body organ.

A person skilled in the art realizes that each of the non-piercing elements may be movably inserted and passed through a respective interior passage. In at least one embodiment of the invention, the non-piercing elements are inserted and passed through one and the same interior passage of the housing.

According to at least one embodiment of the invention, the housing has a proximal end and a distal end, wherein said distal ends of the non-piercing elements are located inside the housing in said first position and extend through said distal end of the housing in said second position. Thereby, the housing covers at least the distal ends of the non-piercing elements and hence protects the body organ or any other tissues passed by the housing from contact with the non-piercing elements. When the non-piercing elements exit the distal end of the housing, they may be uncovered and allowed to interact with the body organ or other tissues .

The housing is for instance arranged to keep the distal ends of the non-piercing elements substantially close together in their first position, and allows the mutual distance between the distal ends to increase in their second position. It shall be noted that the housing may be formed in several different ways, wherein the essential function is the ability to keep the distal ends of the non-piercing elements together in the first position and to allow at least lateral separation of said distal ends in the second position, for expanding and/or distending the body organ.

In at least one embodiment, the housing is in the form of an elongate tubular sheath having a lumen as said at least one interior passage. Even if the housing has an elongate and tubular shape, it may be provided with cross sections of different configurations. Hence, it does not has to be circular, but may be adapted depending on the particular application. For instance, the housing may have an elliptic cross section for an elliptic interior passage through the housing. The cross section may also vary along the longitudinal length of the housing.

Furthermore, the housing may be provided with any other configuration, for instance the shape of a ring or a shorter tubular element, as long as the function of keeping the distal ends of the non-piercing elements together in their first position is maintained.

Furthermore, movement of the housing relative to the non-piercing elements may allow for the previously described deflection outwards of the non-piercing elements, towards their second position. In some embodiments, at least a portion of said at least one cannula is movable inside at least a portion of said interior passage of the housing, from said proximal position towards said distal position, and vice versa. The cannula located inside the housing may be withheld from contact with the body organ or other tissues by covering at least the distal end of the cannula inside the housing when the arrangement is introduced through the body cavity. In the embodiments in which at least one cannula is positioned inside the tubular non-piercing element, the distal end of the cannula is preferably covered by the non-piercing element, which in turn is covered by the housing. In some embodiments, the non-piercing elements are arranged to be transferred from the first position towards the second position by retraction of the housing relatively to said non-piercing elements, wherein the non-piercing elements remain substantially fixed in relation to said body organ. The range of retraction of the housing may effect the amount of the previously described deflection of the non-piercing elements relatively to the housing. Hence, it is possible to control the degree of expansion of the body organ by the range of retraction of the housing. As the non-piercing elements are kept substantially fixed during retraction of the housing, the determination of the location for interaction between the non-piercing elements and the body organ may be very accurate. Furthermore, the non-piercing elements remain substantially fixed in relation to the body organ during the injection of a substance, wherein the position for penetration of the body organ by the cannula may be executed with a substantially high accuracy, in particular in the case when the cannula is moved along or inside a corresponding non-piercing element.

According to at least one embodiment of the invention, the housing is provided with a distal open end in communication with said interior passage of the housing. Thus, when the at least two non-piercing elements exit the distal end of the housing for interaction with the body organ, they all extend through the open tip or distal end of the housing. Hence, for example, they may all extend through one and the same opening, which has a relatively large diameter compared to each of the non-piercing elements. However, the diameter of the housing may be as small as is permitted, in order to keep the transverse dimension of the entire arrangement small. For example, the distal opening of the housing may be defined by the circumferential wall of the housing. According to at least one further embodiment of the invention, a distal end portion of the housing is provided with lateral openings arranged in the envelope surface of the housing for passing the non-piercing elements out from the housing. Thus, the non-piercing elements may be guided through the circumferential wall of the housing. The above mentioned deflection of the non-piercing elements may be achieved by biasing the elongate elements inside the housing in the first position, wherein the non-piercing elements may deflect radially outwardly when exiting the housing, due to an inherent outwardly directed force. In other embodiments, the non-piercing elements may be biased or bent when guided through the circumferential wall of the housing. Furthermore, said housing can be provided with at least one lateral aperture through which each of said non-piercing elements are inserted into said interior passage. Then, there can for example be one aperture for each non-piercing element to be introduced into the housing. One way of achieving the above mentioned deflection of the non-piercing elements is to arrange the housing for reception of the non-piercing elements from the side of the circumferential wall of the housing. Thereby, the non-piercing elements may be forced to bend inside the interior passage of the housing and thus become biased, striving for radial outward deflection.

For instance, the non-piercing elements may be inserted at a certain angle of inclination through the housing, e.g. at 5°-40°, at 10°-30°, or at 20°-25°, in relation to the geometrical axis defined by the insertion direction of the arrangement into the body cavity. The angle of the non-piercing elements depends on the particular application and may be varied for different uses . Furthermore, the cannula and the non-piercing elements may be located in different apertures in the case where the cannula is not inserted inside a non-piercing element. The cannula may suitably be inserted with an angle of inclination as well, e.g. at 5°-40°, at 10°-30°, or at 20°-25°, in relation to the geometrical axis defined by the insertion direction of the arrangement into the body cavity.

According to some embodiments, said at least one lateral aperture is shaped as a slot extending generally in the longitudinal direction of the housing, i.e. in the proximal to distal direction, wherein the transverse dimensions of said slot essentially corresponds to the transverse dimension of a non-piercing element inserted therethrough, so that the non-piercing element can be displaced along the length of the slot. The cross-section of the non-piercing elements and the cannula may be circular, wherein the width of the slot essentially corresponds to the diameter of the non-piercing elements. The extension of the slot shaped aperture would generally be in the longitudinal direction of the housing.

In some embodiments, each of the non-piercing elements abuts against the distal end of the slot when the distal end of the non-piercing element is in said second position. Hence, the length of the slot may limit the movement of the housing relative the non-piercing elements. If the non-piercing elements are kept in a fixed position, the housing may be moved substantially the same distance as the length of the slot. Consequently, the housing may be prevented from further displacement in the direction of the slot when an elongate non-piercing element abuts against the respective ends of the slot. Thus, the length of the aperture may also determine the length of a portion of the non-piercing elements extending outside the distal end of the housing in the second position of non-piercing elements . According to at least one embodiment of the invention, a plurality of lateral apertures are circumferentially spaced around the housing, wherein at least two of the non-piercing elements are received through different apertures, the non-piercing elements intersecting each other crosswise in said at least one interior passage. When the housing releases the non-piercing elements, generally through the distal end, the non-piercing elements may intersect each other, i.e. cross each other. For such an embodiment, the non-piercing elements will extend diagonally and substantially cross the longitudinal axis of the extension of the housing.

Furthermore, said non-piercing elements may be mechanically biased inside the interior passage of the housing and strive to deflect laterally away from the circumference of the housing so as to reach the second position. As mentioned above, the non-piercing elements, for example enclosing a cannula, may be introduced into the housing from the side thereof. Because of the lateral introduction and the small diameter of the housing, the non-piercing elements and the at least one cannula will be bent as they are bounded or restricted by the wall of the housing. Consequently, they are biased or pre-tensioned, wherein a distal end exiting the distal end of the housing will deflect or spring out radially. According to a further embodiment of the invention, the at least one cannula contained in a corresponding non-piercing element is mechanically biased inside the interior passage of the housing and strive to deflect laterally away from the circumference of the housing in order to bring the non-piercing element into said second position.

The deflection of the non-piercing elements for expanding and/or distending interaction with a body organ or other tissues may for example be generated by an inherent outwardly directed force caused by the non-piercing element, or by an inherent outwardly directed force caused by the cannula. In further examples, the deflection may be generated by an inherent outwardly directed force caused by both the non-piercing element and the cannula.

Furthermore, the non-piercing elements and/or the at least one cannula may be resiliently attached to the rest of the arrangement, in order to bring the non-piercing elements deflect radially outwardly in the direction towards the second position. Accordingly, the non-piercing elements and/or the at least one cannula may be substantially stiff, wherein the attachment point of said non-piercing elements and/or said cannula may bring about a pivoting effect and cause an outwardly directed inherent force.

The at least one cannula may be adapted to be movable from one of said non-piercing elements to another one for provision of injections at various locations. In such an embodiment, one cannula could be sufficient even if several injections have to be delivered at different locations. Hence, the cannula is moved from one non-piercing element to another for injection of a substance into the body organ or other tissues.

For any embodiment comprising at least one cannula which is located outside the non-piercing elements, i.e. not inserted into a non-piercing element, one or more cannulas may be movably arranged for delivery of several administrations at different locations.

The invention has been found particularly suitable for treatment of female urine incontinence by injection of a bulking agent or substance. It is generally quite difficult to penetrate or pierce the flabby mucous membrane of the urethra. The mucous membrane is therefore often required to be smoothed out and stretched so as to facilitate the insertion of injection needles. Commonly, a balloon filled with a fluid is used for this purpose. Since at least two non-piercing elements are used, the body tissues will be expanded and/or distended, thereby facilitating the injection. The non-piercing elements used in the present invention may be made of a resilient or self-springing material, such as steel, a polymeric material or any carbon-based material. The at least one cannula, for instance provided as an injection needle, may likewise be made of a resilient or self-springing material, such as steel, a polymeric material or any carbon-based material.

The housing of the present invention may be manufactured by injection molding, for instance of a plastic material, such as polyethylene, polypropylene or any other suitably material.

However/ the scope of the present invention is by no means restricted to the mentioned material examples. Any other materials, or combinations of materials, suitable for constituting the arrangement and performing the method of the present application is contemplated within the scope of the invention.

Furthermore, the described examples and embodiments, as well as features thereof, may be combined in numerous ways without departing from the scope of the present invention.

Brief description of the drawings There will now be described in greater detail exemplifying embodiments of the invention, with particular reference to the appended drawings, in which: Figs. la-Id illustrate schematically, partly in cross section, an arrangement and the principle for an injection procedure according to some embodiments of the present invention;

Fig. 2 illustrates schematically, in an exploded perspective view, an arrangement corresponding to the one illustrated in Fig. 1; Fig. 3 illustrates schematically a cross section of the housing taken along the line III-III in Fig. 2. Fig. 4a-4b illustrate schematically, partly in cross section, further examples of an arrangement and an injection procedure according to embodiments of the present invention; Fig 5 illustrates schematically in an exploded perspective view another embodiment of the arrangement according to the invention;

Fig 6a-6d illustrate schematically, partly in cross section, yet another arrangement and injection procedure of the invention.

Detailed description of the drawings

Figs. la-Id and 2 show the principle of a first embodiment according to the present invention. Figs. Ia and 2 show an arrangement 1 to be passed through a body cavity 3 for injection of a substance 5 (see Fig. Id), preferably a gel, into a body organ. The arrangement 1 comprises four tubular non-piercing elements 9 (only two being shown for the sake of clarity) which have an elongate shape. An essentially cylindrical wall 13 of each non-piercing element 9 defines an interior passage 15 from an open distal end 17 to an open proximal end 19 of the non-piercing element 9.

The arrangement 1 further comprises a housing 21 with an interior passage 23 defined by an essentially cylindrically shaped wall. The wall of the housing 21 is provided with four lateral apertures 25 through which each of said non-piercing elements 9 is inserted into the interior passage 23 of the housing 21. It shall be noted that the number of lateral apertures 25 may vary, for instance between 2 to 12, preferably between 2 to 8, and especially 4. In this embodiment the lateral apertures 25 are in the form of elongate slots which extend essentially in parallel with the geometrical central longitudinal axis of the essentially cylindrically shaped housing 21, said axis coinciding with the central geometrical axis defined by the insertion direction of the arrangement 1. However, for a tapered shape of the housing 21, the lateral apertures 25 in the exterior wall would be provided at an angle to said central longitudinal axis. The length of each slot-shaped lateral aperture is about 35 mm and extends in a proximal direction from about 7.8 mm of the distal end 27 of the housing 21. The width of each slot shall substantially correspond to the diameter of the non-piercing elements 9 to be inserted through the slots. According to at least one embodiment the width of the slots are about 1.2 - 1.6 mm.

As seen in Fig. Ia, the distal ends 17 of the respective non-piercing elements 9 are located inside the interior passage 23 of the housing 21. The non-piercing elements 9 are inserted into the passage 23 laterally through said lateral apertures 25, wherein the non-piercing elements 9 cross each other inside the passage. The inserted non-piercing elements 9 will suitably cross the interior passage 23 of the housing 21 by extending through the central longitudinal axis of the housing 21, or at least in the vicinity of said axis. Further, the housing 21 comprises a distal open end 27 in communication with said interior passage 23. The portion of the exterior wall of the housing 21 defining the distal open end 27 may suitably be of the same thickness as the rest of the exterior wall defining the interior passage 23 of the housing 21. Thus, in this embodiment the exterior wall does not extend distally beyond said distal open end 27. However, in other embodiments, e.g. for control or guiding purposes, a portion of the housing 21 may extend past a functionally corresponding opening provided at a distal portion of the housing 21.

The housing 21, as shown in Figs. la-Id and 2, is provided with a rod member 29 at its proximal end portion, wherein the proximal end of the rod member 29 comprises a handgrip 31 intended to be used for movement of the housing 21 relatively to the non-piercing elements 9. The handgrip 31 may be formed as a ring intended to be operated with one finger, even if other forms of handgrips 31 are possible. The length of the housing 21 may be about 80 mm and the length of the rod member 29, including the hand grip 31, may be about 100 mm. The outer diameter of the housing 21 may be about 6 mm.

According to Fig. Ia, the housing 21 and the non-piercing elements 9 are received by a holder 33 in order to facilitate the handling and operation of the arrangement 1. The holder 33 has a central hole 35, through which the housing 21 extends. The hole 35 allows the housing 21 to be retracted in the proximal direction and advanced in the distal direction along the central longitudinal axis of the housing 21 by moving the rod member 29 in the desired direction. Further, the non-piercing elements 9 are guided by guides 37 provided in the form of inclined channels in the holder 33, for guiding of the respective non-piercing element 9 in a direction towards the geometrical central longitudinal axis of the housing 21.

Fig. Ia shows each of the tubular non-piercing elements 9 provided with an at least partly inserted cannula 39. According to Fig. Ia, the distal end 41 of the cannula 39 is covered inside the non-piercing element 9 close to the distal end 17 thereof. Thus, according to this and similar embodiments of the invention, the non- piercing elements 9 function as shields or protective casings, preventing or controlling the degree of interaction between the cannulas 39 and their surroundings. The tubular form of the non-piercing elements 9 facilitates the timing of such an interaction, as will be understood in the following.

In Fig Ia, the housing 21 of the arrangement 1, preferably together with the non-piercing elements 9 and the cannulas 39, is inserted into a body cavity 3 at a beginning of an injection procedure, as indicated by the arrow in the figure. The non-piercing elements 9 are during this insertion or advancement kept in the enclosed position inside the housing 21. Thus, at this stage the distal extension of the exterior wall of the housing 21 is at least equal to, and suitably past, the distal extension of the non-piercing elements 9. Further, the cannulas 39 are kept in the enclosed position inside the non-piercing elements 9. However, at this stage the cannulas 39 may protrude somewhat from the distal ends 17 of the tubular non-piercing elements 9, but should suitably not protrude through the distal open end 27 of the housing 21. The distal end 27 of the housing 21 is advanced until it reaches the point or area for injection of a substance 5 into the body organ 7, as seen in Fig. Ib. In the state according to Figs. Ia and Ib, the non-piercing elements 9 and/or the cannulas 39 are biased inside the interior passage 23 of the housing 21. In this embodiment, biased is understood to mean that the distal ends 17 of the non-piercing elements 9 and/or of the cannulas 39 are arranged to strive to deflect radially away from the central longitudinal axis of the housing 21, but are prevented from further lateral or radial motion by the wall of the housing 21.

The arrangement 1 shown in Figs. la-Id, according to at least one embodiment of the present invention, is for instance suitable for treating female urinary incontinence. Thus, the figures show the female urinary organs including a urethra 43 and parts of a urinary bladder 45. The inner or distal third part of the urethra 43, i.e. the part closest to the urinary bladder 45, has muscles for preventing urinary^' leakage . These muscles are also called the functional sphincter. When a person is incontinent, the cause is often a slack functional sphincter which does not seal the urethra 43 properly. In order to alleviate this problem it may be advisable to inject a reinforcing bulking agent. However, the present invention may of course be used in other applications as well, in which a body organ 7 is to be accessed through a body cavity 3 for injection of a substance 5.

In Fig. Ic, the housing 21 has been moved relatively to the non-piercing elements 9, for instance by retraction of the housing 21 in the proximal direction of its central longitudinal axis, while keeping the non-piercing elements 9 substantially fixed in relation to the body organ 7. Such a retraction of the housing is indicated by an arrow in the figure. Thereby, the non-piercing elements 9 extend through the distal open end 27 of the housing 21. The non-piercing elements 9, and in particular the distal ends 17, are now able to deflect outwardly in the radial direction away from the central longitudinal axis of the housing 21 for distending and/or expanding interaction between at least the distal end 17 of the non-piercing elements 9 and the body organ 7.

In the expanded state, the non-piercing elements 9 come into contact with the mucous membrane and the functional sphincter, and because of the their inherent outwardly directed radial force, they will smooth out and distend the mucous membrane. Thus, in this embodiment, in the normal free state of the non-piercing elements 9 they are substantially straight, i.e. with little or no curvature along the non-piercing elements 9. However, when they are inserted through the lateral apertures 25 and into the housing 21 and kept with their distal ends 17 inside the housing 21, the limited space inside the housing 21 forces the non-piercing elements 9 to become curved and thereby biased, as shown in Figs Ia and Ib. As they are free from the housing 21, as in Fig. Ic, the distal ends 17 of the non-piercing elements 9 strive to regain the normal straight state, thus deflecting away from said central longitudinal axis of the housing 21. Accordingly, each injection unit, comprising a non-piercing element 9 and a cannula 39, strive to deflect radially outwardly due to its biased state inside the housing 21. It shall be noted that the inherent outwardly directed force may for example be caused by the biasing of the non-piercing elements 9, or by the biasing of the cannulas 39 kept inside the non-piercing elements 9. As another example, the inherent outwardly directed force may be caused by the non-piercing elements 9 and the cannulas 39 both being biased. For instance, the inherent force is achieved by arranging at least a portion of each non-piercing elements 9 made of a resilient material, such as steel, a polymeric material or a carbon-based material.

The cannulas 39 may also be made of a substantially resilient material, preferably steel, for generation of an inherent force when biased inside the housing 21. Depending on the choice of material, the non-piercing elements 9 and/or the cannulas 39 may be configured and dimensioned for enabling said biasing effect.

Furthermore, it shall be noted that the radial deflection of the non-piercing elements 9 is related to the amount of retraction of the housing 21. The distal edges or ends of the lateral apertures 25 in the wall of the housing 21 may function as a stop for indicating a sufficiently retracted position. Preferably, a distal end portion of the non-piercing elements 9 is uncovered, and the non-piercing elements 9 abut against the wall of the housing 21 in the vicinity of the distal open end 27 of the housing 21. As can be seen for the embodiment according to Fig. Ic, the distal end 41 of each cannula 39 is still kept inside the tubular non-piercing element 9 after retraction of the housing 21. Furthermore, it may be noted that at least two of the non-piercing elements 9 cross each other inside the interior passage of the housing 21.

In Fig. Id, the cannulas 39 are advanced in the distal direction, relative to the non-piercing elements 9, in order to be driven into the body organ, or other tissues, after which a substance 5, e.g. a bulking agent, is injected by means of the cannulas 39. The advancement of the cannulas are indicated by two arrows in the figure. The cannulas 39 are preferably in the form of injection needles. Because the mucous membrane has been smoothed out by the non-piercing elements 9, it can now easily be penetrated by the cannulas 39. The proximal end 41 of the cannulas 39 are preferably provided with some kind of interface to be attached to a conventional injection mechanism, or the like. The advancement of the cannulas 39 are limited by a stop member in order to determine the depth of penetration of the cannulas 39 into the body organ 7. In Fig. Id, the advancements of the cannulas 39 in the distal direction are limited by an abutment between the proximal portion of each cannula 39 and a proximal end 19 of the corresponding non-piercing element 9. It shall be noted that said stop member may be formed in several ways, for instance as a mechanical stop, a friction force, a visible indication or in other suitable ways. If the non-piercing elements 9 would be arranged so as to not protrude proximally of the holder 33, the stop could be effected by the cannulas 39 abutting the holder 33.

After the injection of the substance 5 into the body organ 7, the cannulas 39 are retracted in a proximal direction, into a position where the distal ends 41 of the cannulas 39 yet again are covered by the corresponding non-piercing element 9. Furthermore, the housing 21 is pushed forwardly in a distal direction until the distal ends 17 of the non-piercing elements 9 are lead into the interior passage 23 of the housing 21, wherein the arrangement 1 can be taken out of the body cavity 3 without damaging the surrounding tissues. Furthermore, instead of pushing the housing 21 forwardly in order to cover the distal ends 17 of the non-piercing elements 9, the non-piercing elements 9 may be pulled back in the proximal direction. Optionally, the housing 21 is pushed forward and the non-piercing elements 9 are pulled backwards. Before pulling the arrangement 1 out from the body cavity 3, the arrangement 1 may be moved a short distance to another position, for an additional injection at a new injection site by repeating the procedure illustrated in Figs. lb-d.

The housing holder 33 for holding and guiding the housing 21 in the longitudinal direction of the housing 21 has a hole 35. The hole 35 has a transverse dimension which substantially corresponds to the transverse dimension of the housing 21, wherein said housing 21 is allowed to be at least partially passed through said hole 35. The arrangement 1 is suitably assembled by first introducing the housing 21 through the central hole 35 of the housing holder 33. Preferably, the housing 21 is pushed to its distal position where a proximal stop 47 is provided on the outside of the housing 21, at a proximal portion thereof, for interaction with the housing holder 33 so as to limit distal advancement of the housing 21 relative to the housing holder 33. According to at least one embodiment, the proximal stop 47 is provided as a bracket or a circumferential flange, which in the distal position of the housing 21 is received by a seat of the handle, for preventing the housing 21 from rotation relatively to the holder 33. According to other embodiments, the central hole 35 of the holder 33 and the exterior of the housing 21 have corresponding shapes that prevent the housing from rotation relatively to the holder.

A distal stop 49 is provided about 20 mm from the distal end 27 of the housing 21. Said distal stop 49 comprises two barbs 51 (see Fig. 3) , which for example are somewhat flexible, which allow the housing 21 to be inserted and passed through the hole 35 of the holder 33. When the barbs 51 are passed through the hole 35, the housing 21 is prevented from proximal retraction through the hole 35 since, during a retraction in the proximal direction, the housing 21 will reach a position in which the barbs 51 will abut against the holder 33.

Apart from these physical distal and proximal stops 47, 49, the movability of the housing 21 is restricted by the length of the slot-shaped lateral apertures 25 provided in the wall of the housing 21. The length of the apertures 25 define the sliding range of the housing 21, since each inserted non-piercing element 9 will abut against the ends of the apertures 25 in the distal and proximal position of the housing 21, respectively.

Fig. 3 shows a cross sectional view seen in the longitudinal direction of the housing 21, along line III-III in Fig. 2. For the sake of understanding a geometrical x-axis and a geometrical y-axis has been added in Fig. 3. In this figure, the four lateral apertures 25 are clearly distinguished. As can be seen, each aperture 25 has a radially extending first side 53 that is centered, i.e. aligned along the x-axis and y- axis, respectively. Each aperture 25 also have a second side 55 in parallel with and opposed to the first side 53. The second side 55 is placed left of the first side 53 when seen from the centre of the lumen. This has the effect that the apertures 25 will be somewhat offset from the x-axis and y-axis, respectively. Since no two apertures 25 are arranged exactly opposite to one another, the non-piercing elements 9 that are inserted are prevented from obstructing each other or becoming tangled. In Figs. 2 and 3, the two barbs 51 are also shown. They are located opposite each other and diagonally with respect to the x- and y-axis.

The housing holder 33 shown in Fig. 2 comprises an elongate stem or handle portion 57 and a substantially circular head or guiding portion 59. The handle portion 57 is shaped to be easy and comfortable to grip, for example provided with a curved shape, and has a length of about 115 mm. The guiding portion 59 is, as described above, provided with a central hole 35 for example having a diameter of 6-6.5 mm for guiding of the housing 21. Circumferentially of said hole 35, four evenly spaced lead-through channels 37 are provided for guiding a respective non-piercing element 9. Each channel 37 has a diameter substantially corresponding to the diameter of the non-piercing element 9 to be inserted through the channel 37. In the embodiment shown, the diameter of each channel 37 is about 1.2 mm. Further, the channels 37 are straight and have an angle of inclination relative to the longitudinal direction of the housing 21, such that the channels 37 converge distally, wherein said angle can for example be chosen in accordance with the particular body organ 7 to be accessed. The angle may be in the range of 5°-40°, in the range of 10-30°, or in the range of 20-25°. Accordingly, the proximal entrance of each channel 37 is located further away from the centre axis of the hole 35 in the radial direction than the distal exit of the channel 37. Thereby, the non-piercing elements 9 are directed towards said at least one interior passage 23 of the housing 21, wherein each non-piercing element 9 extends at least from said channel 37, through said aperture 25 in the housing 21, and into said at least one passage 23.

It is obvious for a person skilled in the art that even though four channels 37 are shown in the described embodiment, other number of channels 37 may be provided. For instance, it may be sufficient with two or three in some applications, and for other applications more channels may be suitable, e.g. twelve. It shall also be noted that the channels 37 do not have to be arranged symmetrically around the hole 35 of the holder 33.

The non-piercing elements 9 inserted through the channels 37 of the holder 33 may be arranged in an essentially fixed position relative to the housing holder 33 during an injection procedure. Thereby, the non-piercing elements 9 are kept in a substantially fixed position when the housing 21 is retracted in a proximal direction in order to drive the non-piercing elements 9 out through the distal open end 27 of the housing 21, resulting in a radial or angular motion.

It shall also be noted that each of the non-piercing elements 9 is essentially laterally fixed in position in relation to the apertures 25 during movement of the housing 21 from the distal position towards the proximal position, and vice versa. In this case, "fixed in position" means that essentially the same portion of the non-piercing elements 9 is to be located in the actual aperture 25. Thus, this portion of the non-piercing element 9 will become displaced along the aperture 25 as the housing 21 is moved distally or proxiinally, until the non-piercing element 9 reaches an end of the lateral aperture 25. Accordingly, said portion of the non-piercing element 9 abuts the proximal end of the corresponding aperture 25 when the housing 21 is located in its distal position and said portion abuts the distal end of the corresponding aperture 25 when the housing 21 is located in its proximal position. Consequently, regardless of the position of the housing 21 during the described movement thereof, the length of the non- piercing element 9 extending proximally outside the housing 21 will remain essentially unchanged. According to at least one embodiment, the non-piercing elements 9 are circumferentially distributed, and in some embodiments also evenly spaced, in relation to the housing 21. The number of the non-piercing elements 9 are preferably 2-12, more preferably 3-8, and especially 4. However, other numbers of non-piercing elements are also contemplated within the scope of the invention.

Figs. 4a-4c show a further embodiment of the arrangement 101 for injection of a substance 105 into a body organ 107, in accordance with the present invention. This embodiment is provided without the cannulas 139 when the arrangement 101 is introduced into a body cavity 103. The non-piercing elements 109 are during this advancement kept in the enclosed position inside the housing 121. In a similar way as previously shown in Fig. Ib, the distal end 127 of the housing 121 is advanced until it reaches the point or area for injection of a substance 105 into the body organ 107, in a similar way as previously shown in Fig. Ib. In this state, the non-piercing elements 109 are biased inside the interior passage 123 of the housing 121. In Fig. 4a, the housing 121 has been moved relatively to the non-piercing elements 109, for instance by retraction of the housing 121 in the proximal direction of its longitudinal axis, when the non-piercing elements 109 remain substantially unmoved or fixed in relation to the body organ 107. Just like in Fig. Ic, the non-piercing elements 109, and in particular the distal ends 117, are now able to deflect outwardly in the radial direction away from the central longitudinal axis of the housing 121 for distending and/or expanding interaction between at least the distal end 117 of the non-piercing elements 109 and the body organ 107. For the embodiment according to Fig. 4a, the inherent outwardly directed force is caused by the biasing of the non-piercing elements 109 when kept inside the housing 121. According to Fig. 4a, a cannula 139 is driven through one of the exposed tubular non-piercing elements 109 in a distal direction for injection of a substance 105 into the body organ 107. If several injections at different locations are needed, the cannula 139 may be moved from one non-piercing element 109 to another for an additional injection, as indicated by the arrow in Fig. 4a and shown in Figs. 4b-4c. Obviously, separate cannulas 139 may be inserted into the different non-piercing elements 109 as well, for administering of a substance 105 at different locations.

Fig.5 shows yet another embodiment of the present invention, wherein the cannulas 239 are separated from the non-piercing elements 209. Just like in the case of Figs. Ia-Ic, the arrangement 201 may be introduced into a body cavity, comprising the non-piercing elements 209 kept in the enclosed position inside the housing 221. In this state, one, or more, cannulas 239 may be held in a retracted proximal position inside cannula guiding channels 261 of the holder 233, or not introduced into said cannula guiding channels 261 at all.

According to Fig. 5, the holder 233 is provided with cannula guiding channels 261 for the cannulas 239 used for the injection of the substance into the body organ. The cannula guiding channels 261 are separated from the channels or guides 237 for guidance of the non-piercing elements 209. According to the embodiment shown in Fig. 5, the channels 261 for guidance of the cannulas 239 are located at least partially radially inwardly compared to the channels 237 for guidance of the non-piercing elements 209. Obviously, the channels 261 for guidance of the cannulas 239 do not necessarily have to be arranged symmetrically around the hole 235 of the holder 233 or the channels 237 for guidance of the non-piercing elements 209. It shall be noted that even if four cannula guiding channels 261 are shown, other number of cannula guiding channels 261 may be provided. For instance, it may be sufficient with two or three in some applications, and for other applications more cannula guiding channels 261 may be suitable, e.g. twelve.

The injection of a substance into the body organ 207 is executed by advancement, in the distal direction, of the cannulas 239 which are guided through the holder 233, as seen in Fig. 5. In the embodiment shown, each of the cannulas 239 is situated radially inwards compared to the non-piercing elements 209. The distal end 241 of each cannula 239 is arranged to provide the injection at essentially the same level as the location of the distal end 217 of the non-piercing elements 209. The injection may be provided at other levels as well, and the level of injection is for example determined by the guidance of the cannulas 239 through the holder 233, or by the shape of the cannulas 239. For the embodiment according to Fig. 5, the non-piercing elements 209 may be solid or tubular, wherein the inherent outwardly directed force is caused by the biasing of the non-piercing elements 209 when kept inside the housing 221. If tubular non-piercing elements 209 are provided, the user may have the option of inserting one or more cannulas into the non-piercing elements and/or insert one or more cannulas into the cannula guiding channels 261.

Figs. βa-6d show an additional embodiment of the invention. Instead of the previously shown housing with a distal open end, Figs 6a-6d illustrate an arrangement 301 comprising a distal end portion of the housing 321 that is provided with lateral openings 363 arranged in the envelope surface of the housing 321 for passage of the non-piercing elements 309 out from the housing 321. The openings 363 in the envelope surface are arranged so that the non-piercing elements 309 will be moved from the inside of the housing 321, through the openings 363, to the outside when the housing 321 is retracted from the distal position towards the proximal position. Thus, the non-piercing elements 309 passed through the openings 363 in the envelope surface of the housing 321 are able to deflect outwardly in the radial direction away from the central longitudinal axis of the housing 321 for distending and/or expanding interaction between at least the distal end 317 of the non-piercing elements 309 and the body organ 307. For the present embodiment according to Figs. 6a-6d, the inherent outwardly directed force is caused by the biasing of the non-piercing elements 309 when kept inside the housing 321. In other embodiments, the outwardly directed force may be caused by a forced deflection of the non-piercing elements 309 when passed through the respective openings 363 in the envelope surface. Just like in Fig. Id, the substance 305 is administrated by driving the cannula 339 in the distal direction into the body organ 307.

According to yet another additional embodiment of the invention, not shown, at least one of said non-piercing elements includes information transfer means, such as a sensor for chemical probing or a light guide, or sampling means. In further embodiments, such information transfer means may be provided as separate units which are insertable into tubular non-piercing elements .

The invention shall not be interpreted to only include the above described embodiments, but also combinations of features relat.ed to the different embodiments, thereby forming further embodiments. The number of non-piercing elements and the number of cannulas may be varied optionally for different applications of the invention. For instance, the injection arrangement may comprise four non-piercing elements and two cannulas.

Furthermore, the embodiment with lateral openings arranged in the envelope surface of the housing shown in Figs, βa-6 may be arranged with at least one cannula separated from the non-piercing elements, which cannula may be guided through the holder by means of cannula guiding channels.

Also, even if the previous description has stated certain dimensions, others are possible and may even be more suitable depending on what body organ is to be accessed and for what specific purpose.

Claims

1. An arrangement (1; 101; 201; 301) to be passed through a body cavity (3; 103; 303) for injection of a substance (5; 105; 305) into a body organ (7; 107; 307), comprising at least two non-piercing elements (9; 109, 209; 309) each having a distal end (17; 117; 217; 317) and a proximal end (19; 119; 219; 319), and at least one cannula (39; 139; 239; 339) , wherein said distal ends (17; 117; 217; 317) are movable between a first position and a second position, the distance between said distal ends (17; 117; 217; 317) being larger in the second position than in the first position for distending and/or expanding interaction between the distal ends (17; 117; 217; 317) of the non-piercing elements (9; 109; 209; 309) and said body organ (7; 107; 307), and wherein said cannula (39; 139; 239; 339) is at least partly movable relatively to the non-piercing elements (9; 109; 209; 309) from a proximal position towards a distal position for injection of said substance (5; 105; 305) into the distended and/or expanded body organ (7; 107; 307) .

2. The arrangement (1; 101; 201; 301) as claimed in claim 1, wherein a distal end (41; 141; 241; 341) of the at least one cannula (39; 139; 239; 339), in its distal position for injection of a substance (5; 105; 305), is located laterally and/or distally of the distal end of a corresponding non-piercing element (9; 109; 209; 309) in its second position.

3. The arrangement (1; 101; 201; 301) as claimed in claim 1 or 2, wherein the cannula (39; 139; 239; 339) is arranged to be at least partly transferred from the proximal position towards the distal position by advancement of the cannula (39; 139; 239; 339) in the distal direction relatively to the non-piercing elements (9; 109; 209; 309), wherein the non-piercing elements (9; 109; 209; 309) are substantially unmoved in relation to said body organ (7; 107; 307) .

4. The arrangement (1; 101; 201; 301) as claimed in any one of the claims 1-3, wherein at least one of said non piercing elements (9; 109; 209; 309) is tubular, wherein the at least one cannula (39; 139; 239; 339) is receivable at least partly inside said tubular non-piercing element (9; 109; 209; 309) .

5. The arrangement (1; 101; 201; 301) as claimed in any one of the claims 1-3, wherein each non-piercing element (9; 109; 209; 309) is tubular and provided with an at least partially inserted cannula (39; 139; 239; 339) .

6. The arrangement (1; 101; 201; 301) according to any one of claims 4-5, wherein, when the distal end of the cannula (39; 139; 239; 339) is moved towards said distal position, said distal end (41; 141; 241; 341) of the cannula (39; 139; 239; 339) is adapted to pass from the inside of the non-piercing element (9; 109; 209; 309) through the distal end of the non-piercing element (9; 109; 209; 309) .

7. The arrangement (1; 101; 201; 301) as claimed in any one of the claims 1-6, wherein the at least one cannula (39; 139; 239; 339) is substantially held in its proximal position relatively to the corresponding non-piercing element (9; 109; 209; 309) when the non-piercing element (9; 109; 209; 309) is translated from its first position towards its second position.

8. The arrangement (1; 101; 201; 301) as claimed in any one of the claims 1-7, further comprising a housing (21; 121; 221; 321) having at least one interior passage (23; 123; 323) , wherein the non-piercing elements (9; 109; 209; 309) are movably arranged relatively to at least a portion of said housing (21; 121; 221; 321) .

9. The arrangement (1; 101; 201; 301) as claimed in claim 8, wherein the housing (21; 121; 221; 321) has a proximal end and a distal end, wherein said distal ends of the non-piercing elements (9; 109; 209; 309) are inside the housing (21; 121; 221; 321) in said first position and extend through said distal end of the housing (21; 121; 221; 321) in said second position.

10. The arrangement (1; 101; 201; 301) as claimed in any one of the claims 8-9, wherein the housing (21; 121; 221; 321) is in the form of an elongate tubular sheath having a lumen as said at least one interior passage (23; 123; 323) .

11. The arrangement (1; 101; 201; 301) as claimed in any one of the claims 8-10, wherein at least a portion of said at least one cannula (39; 139; 239; 339) is movable inside at least a portion of said interior passage (23; 123; 323) of the housing (21; 121; 221; 321) , from said proximal position towards said distal position, and vice versa.

12. The arrangement (1; 101; 201; 301) as claimed in any of the claims 8-11, wherein the non-piercing elements (9; 109; 209; 309) are arranged to be transferred from the first position towards the second position by retraction of the housing (21; 121; 221; 321) relatively to said non-piercing elements (9; 109; 209; 309), wherein the non-piercing elements (9; 109; 209; 309) are substantially unmoved in relation to said body organ (7; 107; 307) .

13. The arrangement (1; 101; 201; 301) as claimed in any of the claims 8-12, wherein the housing (21; 121; 221; 321) is provided with a distal open end (27; 127; 227) in communication with said interior passage (23; 123; 323) .

14. The arrangement (1; 101; 201; 301) as claimed in any one of the claims 8-13, wherein a distal end portion of the housing (21; 121; 221; 321) is provided with lateral openings (25; 125; 225; 325) arranged in the envelope surface of the housing (21; 121; 221; 321) for passing the non-piercing elements (9; 109; 209; 309) out from the housing (21; 121; 221; 321) .

15. The arrangement as claimed in any one of the claims 8-14, wherein said housing (21; 121; 221; 321) is provided with at least one lateral aperture (25; 125; 225; 325) through which each of said non-piercing elements (9; 109; 209; 309) is inserted into said interior passage (23; 123; 323) , there being preferably one aperture (25; 125; 225; 325) for each non-piercing element (9; 109; 209; 309) .

16. The arrangement (1; 101; 201; 301) as claimed in claim 15, wherein said at least one lateral aperture (25; 125; 225; 325) is shaped as a slot extending generally in the longitudinal direction of the housing (21; 121; 221; 321), i.e. in the proximal to distal direction, wherein the transverse dimensions of said slot essentially correspond to the transverse dimension of a non-piercing element (9; 109; 209; 309) inserted therethrough, so that the non-piercing element (9; 109; 209; 309) can be displaced along the length of the slot.

17. The arrangement (1; 101; 201; 301) as claimed in claim 16, wherein each of the non-piercing elements (9; 109; 209; 309) abuts against the distal end of the slot when the distal end of the non-piercing element (9; 109; 209; 309) is in said second position.

18. The arrangement (1; 101; 201; 301) as claimed in any one of the claims 15-17, wherein a plurality of lateral apertures (25; 125;^' 225; 325) are circumferentially spaced around the housing (21; 121; 221; 321), wherein at least two of the non-piercing elements (9; 109; 209; 309) are received through different apertures (25; 125; 225; 325) , the non-piercing elements (9; 109; 209; 309) intersecting each other crosswise in said at least one interior passage (23; 123; 323) .

19. The arrangement (1; 101; 201; 301) as claimed in any one of the claims 8-18, wherein the non-piercing elements (9; 109; 209; 309) are mechanically biased inside the interior passage (23; 123; 323) of the housing (21; 121; 221; 321) and strive to deflect laterally away from the circumference of the housing (21; 121; 221; 321) so as to reach the second position.

20. The arrangement (1; 101; 201; 301) as claimed in any one of the claims 8-19, wherein the at least one cannula (39; 139; 239; 339) contained in a corresponding non-piercing element (9; 109; 209; 309) is mechanically biased inside the interior passage (23; 123; 323) of the housing (21; 121; 221; 321) and strive to deflect laterally away from the circumference of the housing (21; 121; 221; 321) in order to bring the non-piercing element (9; 109; 209; 309) into said second position.

21. The arrangement (1; 101; 201; 301) as claimed in claim 4, wherein the at least one cannula (39; 139; 239; 339) is adapted to be movable from one of said non-piercing elements (9; 109; 209; 309) to another one for provision of injections at various locations.

22. A method for injection of a substance (5; 105; 305) into a body organ (7; 107; 307), comprising the steps of: providing at least two non-piercing elements (9; 109; 209; 309) each having a distal end (17; 117; 217; 317) and a proximal end (19; 119; 219; 319); providing at least one cannula (39; 139; 239; 339) ; inserting the at least two non-piercing elements (9; 109; 209; 309) into a body cavity (3); moving the non-piercing elements (9; 109; 209; 309) from a first position towards a second position so that the distance between said distal ends (17; 117; 217; 317) of the non-piercing elements (9; 109; 209; 309) is larger in the second position than in the first position for distending and/or expanding interaction between the distal ends (17; 117; 217; 317) of the non-piercing elements (9; 109; 209; 309) and said body organ (7; 107; 307); and moving the at least one cannula (39; 139; 239; 339) relatively to the non-piercing elements (9; 109; 209; 309) from a proximal position towards a distal position for injection of said substance (5; 105; 305) into the distended and/or expanded body organ (7; 107; 307) .

23. The method as claimed in claim 22, further comprising the step of: retaining the position of the at least one cannula (39; 139; 239; 339) relatively to the non-piercing elements (9; 109; 209; 309) during the movement of the non-piercing elements (9; 109; 209; 309) from said first position towards said second position.

24. The method as claimed in claim 22 or 23, wherein the movement of the cannula (39; 139; 239; 339) relatively to the non-piercing elements (9; 109; 209; 309) comprises advancing the cannula (39; 139; 239; 339) relatively to the non-piercing elements (9; 109; 209; 309) in the distal direction, wherein the non-piercing elements (9; 109; 209; 309) are substantially unmoved in relation to said body organ (7; 107; 307) .

25. The method as claimed in any one of the claims

22-24, further comprising the step of: introducing the at least one cannula (39; 139; 239;

339) within a corresponding tubular non-piercing element

(9; 109; 209; 309) .

26. The method as claimed in claim 25, further comprising the step of: arranging said at least one cannula (39; 139; 239; 339) in its proximal position within the non-piercing element (9; 109; 209; 309) so that its distal end (17;

117; 217; 317) is located inside the non-piercing element (9; 109; 209; 309) .

27. The method as claimed in any one of the claims 22-26, further comprising the step of: arranging the non-piercing elements (9; 109; 209; 309) movably inside at least a portion of a housing (21; 121; 221; 321) having at least one interior passage (23; 123; 323) .

28. The method as claimed in claim 27, further comprising the step of: arranging said distal ends (17; 117; 217; 317) of the non-piercing elements (9; 109; 209; 309) inside the housing (21; 121; 221; 321) in said first position.

29. The method as claimed in claim 27 or 28, wherein the movement of the non-piercing elements (9; 109; 209; 309) from a first position towards a second position comprises passing the distal ends (17; 117; 217; 317) of the non-piercing elements (9; 109; 209; 309) to extend through said distal end of the housing (21; 121; 221; 321) in said second position.

30. The method as claimed in any one of the claims 27-29, wherein the movement of the non-piercing elements

(9; 109; 209; 309) from a first position towards a second position comprises retracting the housing (21; 121; 221; 321) relatively to said non-piercing elements (9; 109; 209; 309) , wherein the non-piercing elements (9; 109; 209; 309) are substantially unmoved in relation to said body organ (7; 107; 307) .

31. The method as claimed in any one of the claims 27-30, wherein the provision of at least two non-piercing elements (9; 109; 209; 309) comprises introducing the non-piercing elements (9; 109; 209; 309) laterally into said at least one interior passage (23; 123; 323) of the housing (21; 121; 221; 321) , said non-piercing elements (9; 109; 209; 309) intersecting each other crosswise within said passage (23; 123; 323) .

32. The method as claimed in any one of the claims 22-31 further comprising the step of: injecting a medical substance (5; 105; 305) through said at least one cannula (39; 139; 239; 339), preferably being in the form of an injection needle, into said body organ (7; 107; 307) .