JP2011512886A - Insertion device with horizontally moving parts - Google Patents

Abstract

There is a need in the art for a device that is robust, reliable, accurate, safe, hygienic and easy to handle for users that addresses the problems of the prior art. The present invention provides an insertion device for introducing a penetrating member subcutaneously.
The present invention limits the movement of a penetrating member (50) connected to the converting means (52) and the converting means (52), and moves the penetrating member (50) from the first position to the second position. Stationary housing (30) including moving part (38) including guide means (39) for guiding toward the injection site in one direction or insertion direction and guide means (32) for restricting movement of the moving part (38). ). The guide means (32) guides the moving part (38) linearly in a first direction, that is, a second direction different from the insertion direction.
[Selection] Figure 1

Description

  The present invention relates to an insertion device for inserting a medical device or a part of a medical device into a subcutaneous region or intramuscular region of a patient.

  Insertion devices (also called inserters or syringes) are commonly used in the medical field to insert medical devices, such as infusion sets, through a patient's skin to some extent automatically.

  In general, when using an inserter, the user or patient or treatment provider (eg nurse, doctor, etc.) performs the injection of a medical device (needle, cannula, sensor, etc.) Force should be applied towards the skin surface. This can cause physical or mental distress and / or discomfort, and in some cases leads to improper application of the medical device. Many people are afraid of pointed objects such as needles and other penetrating devices commonly used in medical treatment and therapy. This fear is often irrational and prevents proper medical treatment. For example, when performing self-treatment, complications may occur if necessary medications are not administered at the proper dose, and in some cases life threatening. For example, when treating diabetes in children, there is a risk that the unreasonable fear of the insertion needle, coupled with the lack of knowledge and consciousness about the consequences of applying the device and dispensing correctly, will not self-administer the required dose of insulin. is there.

  Another well-known problem with the insertion of medical devices is the risk of contamination of the penetrating member before or during application. This can easily infect a patient with an infection, for example due to a contaminated insertion needle. The longer the exposure time of such a needle, the greater the contact of the needle with the finger, for example, the contact of the needle with an unclean surface, or by contaminants carried by the air, aerosols, etc. The risk of accidental contamination increases. Depending on the nature of the contaminants (eg, viruses, bacteria, fungi, yeast, and / or prions) and the general health of the patient, the infection can quickly lead to a life-threatening situation.

  Finally, contact with contaminated used needles in a hospital environment can be life threatening and the risk of accidental exposure to contaminants in the form of used insertion needles must be reduced.

  WO2002 / 002165 discloses a needle device having a needle retraction mechanism that retracts the needle when the device is removed from the skin surface. This needle device has a penetrating member N connected to the converting means (44) and a guide means for restricting the movement of the converting means and guiding the penetrating member N in the insertion direction from the first position to the second position toward the injection site. Including an actuator (40). Furthermore, the needle device includes a stationary housing (20) with guide means for limiting the movement of the actuator (40). The actuator (40) and the attached needle N move in the same direction, ie in the insertion direction. According to the invention, the penetrating part moves relative to the moving part, and the moving part is completely separated from the penetrating part after insertion. Thereby, a moving component can be pushed to one direction with a simple spring mechanism. At this time, the penetrating member is guided in the insertion direction to the injection site. By separating the unit and direction, for example, when speed and acceleration are applied, each component can be optimally controlled individually.

WO2002 / 002165

Thus, there is a need in the art for a device that is robust, reliable, accurate, safe, hygienic and easy to handle for users that addresses the above-mentioned problems. .
The present invention provides an insertion device for introducing a penetrating member subcutaneously. “Penetration member” should be understood to be a needle, cannula, sensor, and the like. The penetrating member is typically held in place before and during insertion and is not visible to the patient and does not contact the user or patient prior to actual insertion.

The purpose of the present invention is to
A penetrating member connected to the converting means;
A moving part including guide means for restricting the movement of the conversion means and guiding the penetrating member from the first position to the second position in the first or insertion direction towards the injection site;
An insertion device comprising a stationary housing comprising guide means for restricting movement of the moving part, wherein the guide means linearly guides the moving part in a first direction, i.e. a second direction different from the insertion direction. Is to provide a device.

  According to one embodiment, the second direction is perpendicular to the first direction, but the second direction may be at any angle with respect to the first direction, usually the angle is the first direction. From 40 ° to 90 °.

  “Stationary housing” means that the housing does not move relative to the insertion location during insertion. In many cases, the contact between the guide means and the conversion means that restricts the movement of the conversion means is "sliding", which means that the contact between the guide means and the unit to be guided is continuous. That is, it is not intermittent, and is held in contact with the guide means at all positions.

  According to one embodiment, the insertion device includes guide means for limiting movement of the penetrating member to linear movement in the first direction. These guide means allow the penetrating member to enter the patient's skin in a direction linear to the insertion direction during insertion. The period defining "In-insertion" starts when the penetrating part to be inserted into the patient's skin is about to penetrate the skin surface at the injection site, and the penetrating part to be inserted is fully inserted This is the period that ends when If no guiding means are provided, the linear movement is only performed by adjusting the speed of the penetrating member. This is particularly difficult when using simple and inexpensive components.

  According to another embodiment of the insertion device, the first direction makes an angle β with respect to the surface into which the penetrating member is to be inserted, where 30 ° ≦ β ≦ 90 °. The angle β is defined as the direction in which the penetrating member moves from the point just before the penetrating member contacts the surface to which the insertion device is attached until the penetrating member is in its final position below the surface. This movement is linear. The penetrating member can be inserted at an inclination angle β. Here, 30 ° ≦ β <85 ° or 95 ° <β ≦ 150 °, and the inclination angle is usually about 45 °, ie, 30 ° ≦ β <60 ° or 120 ° ≦ β <150 °. Yes, or 40 ° ≦ β <50 ° or 130 ° ≦ β <140 °. Here, the penetration angle β is defined as an angle between the penetration movement direction of the penetration member and the surface to which the penetration member is attached.

  According to this embodiment of the insertion device, the angle β is essentially perpendicular to the surface to which the insertion device is attached. The penetration direction being essentially perpendicular to the patient's skin surface means that the penetration angle β = 90 °, which is usually slightly off from 90 °, and 85 ° ≦ β ≦ Even 95 ° is considered to be perpendicular to the skin surface.

  According to another embodiment of the insertion device, the direction of the moving part during insertion is straight and essentially parallel to the surface to which the moving part is attached. That the directions are essentially parallel means that the angle between the direction of the moving part and the mounting surface at the insertion position is approximately 0 °. Accordingly, the inclination angle α may be −45 ° <α <45 °, where the positive inclination angle α indicates a movement inclined toward the skin surface, and the negative inclination angle α indicates the skin Shows a tilted movement away from the surface. Typically, the deviation between the patient's skin and the direction of the moving part is <10 °, ie −10 ° <α <10 °. That the moving direction of the moving part is linear means that the moving part moves along a straight line from the first point to the second point.

  According to another embodiment of the insertion device, further movement of the moving part can provide a retracting movement of the holding means and / or the insertion needle. “Further movement” means that after the first movement, that is, linear movement, ends at the second point, the forward movement of the moving part is continued to the third point, and the forward movement of the moving part stops at the third point. Or, in another aspect, means that the linear movement of the moving part can be reversed or taken in the second direction.

  According to another embodiment of the insertion device, the insertion part can be attached to the base part, which can be attached to the surface on which the penetrating member is to be inserted, and the penetrating member contacts the base part during insertion To do.

  According to another embodiment of the insertion device, the penetrating member includes a cannula and a body holding the cannula, and holding means for securing the body and cannula to the insertion surface. The cannula is held so that it cannot be removed by the body. This is because the cannula is very small and difficult to handle by itself.

  According to this embodiment of the insertion device, the holding means can interact with the interaction means provided on the base part when the body of the penetrating member is inserted and held in the base part.

  According to another embodiment of the insertion device, the guide means of the moving part includes a groove in which the conversion means of the penetrating member can slide. The groove may be essentially V-shaped or U-shaped and forms a start point, an intermediate point, and an end point for at least a portion of the penetrating member or penetrating member. Further, the slope of the groove from the starting point to the middle point and the speed at which the moving part moves forward determines the insertion speed. The inclination of the groove is the direction of the line formed by the forward movement of the moving part along the surface where the x axis is arranged horizontally, i.e. the base part is arranged (the moving part is along the x axis − Moving towards ∞), the y-axis is defined with respect to a coordinate system arranged perpendicular to this surface. In such a coordinate system, the groove has a negative slope between the midpoint and the starting point, the nominal dimension of this slope affects the speed of the penetrating member being inserted, and the tighter the slope is , The insertion speed becomes faster. The tangent to the slope, or the slope when the groove is curved, i.e. not straight, is usually -1 to -2. Furthermore, the inclination of the groove from the intermediate point to the end point and the speed at which the moving part (38) moves forward determines the retracting speed. The groove has a positive slope between the midpoint and the end point, and the nominal dimension of the slope affects the speed of the penetrating member during retraction of a separate insertion needle or other part of the penetrating member, and the slope The tighter it is, the faster the withdrawal speed. The slope or tangent to the slope is usually 1 to 2.

  According to another embodiment of the insertion device, the moving part can be moved either by direct or indirect input by the user. This means that the user applies force directly to the device, i.e. either the user pushes or pulls the moving part or the user activates a spring etc., thereby pushing or pulling the moving part. It means that.

  According to this embodiment of the insertion device, the movement of the moving part can be initiated by actuation of the actuating part, which is in contact with the energy storage member and influences the state of the energy storage member during operation. Furthermore, the energy storage member may be a spring, said spring being in a relaxed state or partially relaxed before activation and being pressed or deformed after activation of the actuating component.

  According to this embodiment of the insertion device, the energy storage member provides the energy necessary to move the moving part from the start position to the stop position.

  According to one embodiment of the insertion device, the housing may include holding means for holding the moving part in the starting position, the moving part including locking means for interacting with the holding means in the starting position and operating The part includes interaction means that interact with the locking means when activated. The locking means can be released from the locking position by interaction with the interaction means of the actuating part. Further, the locking means may be in the form of a hook with an inclined surface tapered in the direction opposite to the forward movement of the operating part, and the holding means may be a part protruding from the housing. It is captured by the hook formed by the locking means.

  According to these embodiments, the forward movement of the working part is stopped by contact between the working part interaction means and the holding means for the moving part.

According to one embodiment of the present invention, the groove is provided with a flexible part (39A) between the starting point (22a) and the intermediate point (22b), the flexible part (39A). Can move in the direction opposite to the insertion direction. The flexible part (39A) has the form of a protruding pivotable part (39A),
A contact surface that contacts the conversion means (51) of the cannula part (7) during movement and pushes the cannula part (7) towards the injection site;
A non-contact surface opposite the contact surface that can move into an open cavity without contact with other components.

  According to this embodiment, the contact surface may have the form of two straight lines or planes connected at an angle n near the point (D) (see FIG. 18a). Here, the cannula part (7) is in contact with the seal of the surface plate (1). Usually, 10 ° <n <45 °.

  According to another embodiment of the insertion device, the moving part may be surrounded by a housing.

  According to another embodiment of the insertion device, the base part may be attached to the mounting surface, the insertion device attaching the insertion device to the base part prior to insertion and attaching the insertion device to the base part during cannula insertion Means may be provided for releasing from the released state.

  According to this embodiment of the insertion device, the means for attaching the insertion device to the base part and removing the insertion device from the base part is a fastening means for removably locking the housing of the insertion device to the base part And release means for releasing the housing from the base part after insertion of the penetrating member. The release means includes a pressed or deformed elastic member that pushes the housing of the insertion device away from the base part when the fastening means is released. The resilient member may have the form of a leaf spring, which is positioned between the base part and the insertion device. The leaf spring deforms when the insertion device is locked against the base part.

  According to these embodiments of the insertion device, the fastening means for releasably locking the housing to the base part may comprise the form of a hard material hook that is an integral part of the housing. The hook captures the corresponding part of the base part. The hook is an integral part of the housing, which means that the hook forms a part of the housing, i.e. it is non-removably locked to the housing, e.g. formed as part of the housing wall. Means.

  According to these embodiments of the insertion device, the fastening means has the form of one or more protruding parts that fit into corresponding openings in the base part. One or more of these protruding parts can be removed from the corresponding opening of the base part by rotational movement, and the insertion device can be rotationally moved by the distance from the surface where the penetrating member is inserted. Is attached to the base part. The distance from the surface on which the penetrating member is inserted is obtained by forming an inclined proximal surface on the insertion device. The proximal surface is parallel to the surface into which the penetrating member is inserted by rotational movement.

  According to these embodiments of the insertion device, the fastening means may be flexibly connected to the stationary housing. The moving part is provided with one or more protruding parts, which are in contact with the flexibly connected fastening means during the movement of the moving part, which makes the insertion device a base. Free from parts.

According to another embodiment of the insertion device, the insertion device performs the following operations upon activation of the actuating component:
(A) Apply a load to the spring,
(B) Move the moving part from the start position to the stop position,
(C) After converting the movement of the moving part into the movement of the penetrating member, the holding means of the penetrating member is retracted.

This embodiment further includes
(D) A means for releasing the housing from the base plate when the penetrating member is inserted may be included.

  In these embodiments of the insertion device, the housing may be coupled to the base plate via coupling means. The connecting means may include at least one hinge and at least one locking member.

  In these embodiments of the insertion device, the housing may be released from the base plate by interaction of the release member and a portion of the side wall of the housing. The parts on the side wall of the housing may be flexible and can be twisted (pivoted) with respect to the rest of the housing.

  According to another embodiment of the insertion device, the penetrating member takes a first position (i) and a second position (ii) relative to the stationary housing, and the penetrating member in the first position (i) is full. It is retracted and does not protrude from the housing of the insertion device, and in the second position (ii), a portion of the penetrating member such as a cannula and / or insertion needle protrudes maximally from the housing (30). The first retracted position is the position of the penetrating member before insertion, and the second maximum protruding position is the position where the penetrating member is fully inserted. The penetrating member may further include a third position (iii). In the third position (iii), the cannula protrudes maximally from the housing and is no longer in contact with the body holding the cannula.

  According to these embodiments of the insertion device, the body of the penetrating member is held in the second position (ii) and the third position (iii) by the interaction of the holding means of the body and the interaction means of the base part. Is done.

  According to another embodiment of the insertion device, the moving part takes a first position (i *) and a second position (ii *) and possibly a third position (iii *) with respect to the housing. In the first position (i *) and possibly in the third position (iii *), the guide means holds the holding means in a position retracted from the patient's skin via the conversion means and the second position (ii) In *), the guide means holds the holding means at a position close to or in contact with the patient.

  According to this embodiment of the insertion device, the moving part comprises a holding means that is non-removably attached to the housing, a locking means that is non-removably attached to the moving part, and an interaction that is non-removably attached to the actuating part. By means, it is held in the first position (i *).

  According to another embodiment of the insertion device, the kit further comprises a base part to which the insertion device is attached at least prior to insertion and a penetrating member that can be attached to the base part and inserted by the insertion device. And a delivery part that forms a path.

[Definition]
“Parallel” or “essentially parallel” as used herein refers to a second movement in a direction, plane, item, etc. defined with respect to a first or reference plane or direction. About. The reference plane or direction is defined as an angle α = 0 °, and the second plane or direction is offset by a maximum of ± 10 ° from the first direction or reference direction α, but usually the deviation is more than ± 5 °. small.

  In this application, “horizontal” or “essentially horizontal” means that the movement in a given direction, plane, item, etc. is horizontal or essentially horizontal and parallel to the surface of the patient's skin as defined above. Or it means that they are essentially parallel. For example, the base part to which the insertion device is attached is horizontal or essentially horizontal and parallel or essentially parallel to the skin.

  In this application, “vertical” or “essentially vertical” refers to a second movement in a given direction, plane, item, etc., with respect to a reference plane or direction, where the reference plane or direction is at an angle β = 0 °. Or the second plane or direction is deviated from the first reference angle β by 80 ° to 100 °, usually 85 ° to 95 °.

  In this specification, the terms "lateral" or "essentially lateral" can be used interchangeably with vertical or essentially vertical as defined above.

As used herein, the term “means” may include one or more means. This is not related to grammar, whether the verb associated with the means is singular or plural.
Embodiments of the present invention will be described in detail below with reference to the accompanying drawings. In the accompanying drawings, like reference numerals designate corresponding parts throughout the various views.

1A to 1C are cross-sectional views showing a first embodiment of an insertion device according to the present invention in three states, FIG. 1A before operation, FIG. 1B immediately after insertion, and FIG. 1C after retracting the insertion needle. It is. 2A to 2F are cross-sectional views showing a second embodiment of the insertion device in six states, FIG. 2A before operation, FIG. 2B after operation, FIG. 2C immediately after insertion, and FIG. 2D withdrawing the insertion needle. Later, FIG. 2E is a view after the inserter housing is released, and FIG. 2F is a view after the insertion device is removed from the base part. FIG. 3 shows a first embodiment of an assembly including an insertion device according to the present invention. FIG. 4 shows a second embodiment of an assembly including an insertion device according to the present invention. FIGS. 5A and 5B show a second embodiment of the assembly, where in FIG. 5A the insertion device is attached to the base part, and in FIG. 5B, the insertion device is removed from the base part. It is. FIG. 6 shows a second embodiment of the assembly without an insertion device and with the delivery part separated from the base part, A is seen from below and B is seen from above It is a figure, C is the figure seen from the top, and shows the connection component of a base part, D is the figure which looked at only the base part from the top. FIG. 7 is a longitudinal sectional view of the assembly shown in FIGS. 3 to 6 at one position of the fastening means for the insertion device. FIG. 8 is a view showing the insertion device in a state where it is not attached to the base part. FIG. 9 shows a third embodiment of the inserter to be used in the assembly in a state before insertion of the cannula part. FIG. 10 is a view of the same example inserter as FIG. 9 after insertion of the cannula part.

FIGS. 11A-11C illustrate a method of removing the inserter embodiment shown in FIGS. 9 and 10 from the base part of the assembly according to the present invention. 12A and 12B are diagrams showing examples of moving parts to be used in the assembly shown in FIGS. 9 and 10. 13A and 13B show the fourth embodiment of the inserter to be used in the assembly after insertion of the cannula part. 14A and 14B are views showing the internal components of the inserter housing of the fourth embodiment of the inserter. 15A and 15B are diagrams showing examples of moving parts to be used in the assembly shown in FIGS. 13 and 14. FIG. 16 is a diagram illustrating an example of a penetrating member that can be used in an assembly. FIG. 17 is a cross-sectional view of a second embodiment of a penetrating member that can be used in an assembly. 18a is a view of one embodiment of a moving part with increased tolerance, and FIG. 18b is a view showing from which direction the moving part 38 of FIG. 18a is viewed. FIG. 19 illustrates a drive mechanism of any exemplary embodiment of an inserter that includes a flat spring that can be used to drive a moving part forward.

1A, 1B and 1C show an embodiment of an insertion device 1 for inserting a penetrating member 50 according to the invention.
The insertion device 1 includes a housing 30, a base part 100, a moving part 38, and a penetrating member 50. For the sake of clarity, the moving part 38 is shown in a translucent state. 1A, 1B, and 1C show the penetrating member 50 in three different positions relative to the moving part 38. FIG.

  The penetrating member 50 includes a holding means 52 that holds the penetrating member 50, a conversion means 51 that is attached to the holding means 52 of the penetrating member 50, a main body 24, a cannula 22, and an insertion needle 53. The cannula 22 is a soft cannula that needs to be inserted with the aid of an insertion needle 53 according to the invention. The insertion needle 53 is attached not to the penetrating member 50 but to a part of the insertion device. The cannula 22 is attached so as not to be detached from the main body 24. Furthermore, the body 24 is provided with holding means 23 for attaching the cannula 22 to the base part 100 when the cannula 22 is fully inserted. According to this embodiment, the holding means 23 are formed as mechanical hooks that can be pushed inward, i.e. towards the center where the cannula 22 is positioned. Since these mechanical hooks are attached to the main body 24 in a flexible manner, they return to their original positions after being pressed toward the center. Flexibility is usually due to the properties of the materials used to form the body, hooks, and connections between them.

  In another embodiment of the present invention, penetrating member 50 includes a sensor or both a sensor and a cannula. In yet another embodiment of the present invention, penetrating member 50 includes one or more cannulas 22, such as multiple cannulas and / or multiple sensors.

  The housing 30 includes guide means 32 for the moving part 38 and guide means 33 for the penetrating member 50. According to this embodiment, the guide means 32 for the moving part 38 includes a surface of the inner wall of the housing 30 along which the moving part 38 can slide. The guide means 33 for the penetrating member 50 has an upright tubular shape. The moving part 38 is provided with conversion means in the form of a V-shaped opening. This opening fits snugly into the conversion means 51 of the penetrating member 50. The housing 30 is detachably connected to the base component 100 and can be removed from the base component 100 after the penetrating member 50 is inserted. When connected, the housing 30 and the base part 100 surround each of the penetrating member 50, the moving part 38, and the guide means 32, 33 for the moving part 38 and the penetrating member 50, thereby providing a unit.

  The base part 100 has an opening 101 sized to allow the penetrating member 50 or at least a part thereof, such as the cannula 22, the injection needle 53, the holding means 23, etc., to pass therethrough.

  The base part 100 and the housing 30 are usually individual elements, which can be reversibly or irreversibly separated. According to the present embodiment, the opening 101 includes the interaction means 102 adapted to interact with the holding means 23 of the main body 24 of the penetrating member 50. The opening 101 may be closed and / or protected by a seal 121. The seal 121 is either removable or can be penetrated by the penetrating member 50. The seal 121 may be provided over a large area of the base component 100. When a part of the base component 100 is constituted by a mounting pad having an adhesive surface, the seal 121 is attached to the adhesive surface before use. It may be a release layer that protects.

  Due to the guide means 32 for the moving part 38, the moving part 38 moves in a controlled manner, in particular within the housing 30. In the illustrated embodiment, the moving part 38 is guided by the guide means 32 and can move essentially in parallel, ie essentially horizontally with respect to the base part 100. Such movement can be characterized as sliding movement.

  The movement performed by the moving part 38 is a longitudinal movement, that is, a linear movement with respect to the housing 30. The means used to initiate and maintain movement of the moving part 38 may be provided directly by the user, i.e. the user may push or pull the moving part 38 or by the user. It may be provided by mechanical means such as a spring that only needs to be biased.

  Guide means 33 for penetrating member 50 that is part of or connected to moving part 38 provides movement of penetrating member 50 in a direction different from the moving direction of moving part 38. This feature has at least two advantages. Firstly, the actual insertion of the penetrating member 50 is hardly affected by the action of the user when the moving part 38 is energized or pushed, and secondly, the insertion device is made smaller and more compact. it can.

  According to the embodiment of FIG. 1, the moving direction of the penetrating member 50 is essentially perpendicular to the moving direction of the moving part 38. The guide means 33 for the penetrating member 50 includes one or more parts, which provide a well-formed track or tube along which or within the penetrating member 50 slides. it can. For example, the guide means 33 may be made of a hollow cylindrical element attached to the housing 30. The penetrating member 50 is movable within the cylindrical element such that the piston moves within the cylinder along the longitudinal axis of the cylindrical element. Such movement can be described as sliding movement. This is because guidance is made by contact between the inner surface of the cylindrical element and the outer surface of the penetrating member 50. In another embodiment, the guide means 33 of the penetrating member 50 may include one or more bars that control the direction of movement of the penetrating member 50. As can be seen in FIG. 1, the guide means 33 of the penetrating member 50 extends from the inner ceiling of the housing to the base part 100 according to the present invention. The guide means 33 of the penetrating member 50 is not necessarily attached to the base component 100. The guide means 33 is usually mounted on and / or in contact with and / or connected to the base part 100. In the illustrated embodiment, the guide means 33 of the penetrating member 50 is connected to the inside (“ceiling”) and one or more sides (“walls”) of the upper surface of the housing 30.

  The conversion means or guide means 39 of the moving part 38 for the conversion means 51 of the penetrating member 50 forms a track. This trajectory extends from the start point 22a to the intermediate point 22b and ends at the end point 22c. As can be seen in FIG. 1, this trajectory is V-shaped or essentially V-shaped. In the illustrated embodiment, the guide means 39 of the moving part 38 is provided on the moving part 38 as a continuous groove or through opening. The intermediate point 22b is closer to the base part 100 than the start point 22a, closer to the base part 100 than the end point 22c, and the start point 22a is closer to the base part 100 than the end point 22c.

  It is not important how the start point 22a and the end point 22c are changed with respect to each other, i.e. the embodiment in which the end point 22c is closer to the base part 100 than the start point 22a or the start point 22a and the end point 22c to the base part 100. An embodiment with the same distance is also possible. However, the starting point 22a must be located at a predetermined distance from the base component that is large enough to hold the end of the cannula 22 and the end of the separate insertion needle 53 inside the housing 30 prior to insertion. I must.

According to the present invention and as shown in FIGS. 1A to 1C, the insertion device 1 takes the following states.
(I) A first state in which the penetrating member 50 is at the start position 22a (see FIG. 1A). In this state, the penetrating member 50 is fully retracted, does not protrude from the housing 30 of the insertion device 1, and the moving part 38 is in the starting position on the right side of the housing 30.
(Ii) A second state in which the penetrating member 50 is at the intermediate position 22b (see FIG. 1B). In this state, the parts of the penetrating member 50 to be inserted, such as the cannula 22 and / or the insertion needle 53, protrude fully from the housing 30 through the opening 101 of the base part 100, and the moving part 38 is in the housing 30. Is moved forward to an intermediate position. The penetrating member 50 is prevented from moving in the same direction as the moving part 38 by the stationary guide means 33 of the penetrating member 50, and only the “vertical direction” movement of the penetrating member 50 is allowed. The vertical direction is to be understood here as a direction perpendicular to the “horizontal direction”.
(Iii) The part to be inserted of the penetrating member 50 remains protruding from the housing 30, but the conversion means 51 is at the end point 22c together with the holding means 52 and the insertion needle 53, and the insertion needle 53 is retracted from the injection location. 3rd state (refer FIG. 1C). In this state, the moving part 38 has reached its end of movement and remains in the stationary housing. In the second position (ii) and the third position (iii), the main body 24 of the penetrating member 50 is held by the interaction between the holding means 23 of the main body 24 of the penetrating member 50 and the interaction means 102 of the base part 100. Is done.

  As shown, the horizontal forward movement of the moving part 38 is converted into an insertion movement of the penetrating member 50 and then into a retracting movement of one or more parts of the penetrating member 50. This is performed by the interaction between the guide means 39 of the moving part 38 and the conversion means 51 of the penetrating member 50.

  In the first position (i), the converting means 51 of the penetrating member 50 is at the starting position 22 a of the track / guide means 39. When the moving part 38 moves in the horizontal direction while being guided by the guide means 32, the penetrating member 50 moves downward, that is, in the “vertical direction” toward the base part 100. The moving speed of the moving part 38 and the inclination of the guide means 39 determine the moving speed of the penetrating member 50 and thus the insertion speed. That is, the tighter the inclination of the guide means 39, the shorter the time for guiding the penetrating member 50 from the retract start position to the insertion position.

  In the second position (ii), the converting means 51 of the penetrating member 50 reaches the intermediate point 22 b of the guide means 39. In this respect, the direction of inclination of the guide means 39 changes from the downward direction, that is, the direction toward the base part 100, to the upward direction, that is, the direction away from the base part 100. Thus, the inclination orientation of the guide means 39 determines the moving direction of the penetrating member 50. When the moving part 38 further moves forward in the horizontal direction, the holding means 52 of the penetrating member 50 and the insertion needle 53 are retracted. If cannula 22 is a rigid self-penetrating cannula, a separate insertion needle 53 is not required and the last retracting portion of movement is not required. That is, the last line of V of the trajectory 39 can be eliminated, and the intermediate point 22b becomes the end point 22c.

  In the third position (iii), the converting means 51 of the penetrating member 50 reaches the end point 22c of the guide means 39, and the holding means 52 and the insertion needle 53 of the penetrating member 50 are fully retracted.

  As can be seen in FIG. 1, the moving part 38 does not protrude from the housing 30. The arrow displayed on the upper side of the figure indicates the moving direction of the moving part 38.

  2A to 2F show attachment means having an automatic release function. The insertion device 1 includes a housing 30, a base part 100, a moving part 38, an actuating part 11, and a penetrating member 50. Although one example of the penetrating member 50 is shown in these drawings, the penetrating member 50 may be a penetrating member similar to the penetrating member shown in FIGS. 16 and 17.

For illustration purposes, the moving part 38 is shown in a translucent state.
The housing 30 includes guide means 32 for the moving part 38. By this guide means 32, the moving part 38 can be moved between at least two positions. The housing 30 further includes guide means 33 for the penetrating member 50. By this guide means 33, the penetrating member 50 can be moved between at least two positions. The housing 30 further includes guide means 34 for the actuating part 11. By this guide means 34, the actuating part 11 can be moved between at least two positions. The housing 30 is attached to the base component 100. According to this embodiment, the attachment is releasable. The attachment is provided by the parts of the housing 30 that include the hinge 35 and the fastening means 14. They interact with the base part 100, thereby releasably attaching the housing 30 and the base part 100. The hinge 35 includes a rounded surface of at least a portion of the wall of the housing 30 that can pivot with respect to the base part 100 when placed in a groove in the base part 100. The fastening means 14 of the housing 30 interacts with the locking means 108 of the base part 100.

  Reference numeral “b” in FIG. 2C indicates the height of the housing 30 of the insertion device 1. The height “b” is empirically in the range of 5 mm to 100 mm, usually in the range of 10 mm to 50 mm, and more particularly in the range of 20 mm to 30 mm. An exemplary embodiment is 25 mm. In embodiments where the inserter is not removed after insertion, the inserter must be as low as possible and typically does not extend beyond the delivery piece 8 from the patient's skin.

  The housing 30 further includes holding means 31. The holding means 31 holds the moving part 38 at the start position by engagement with a locking means 28 provided on the moving part 38. According to this embodiment, the holding means further provide a stop for the movement of the working part 11.

  Due to the guide means 32 for the moving part 38, the moving part 38 moves relative to the housing 30 in a state in which the direction is controlled. The guide means 32 is attached to or connected to the inner surface of the housing 30 or is an integral part of the inner surface of the housing 30 and usually has a longitudinal track shape corresponding to the surface of the moving part 38. The moving part 38 can be slid along the track. In the embodiment shown, the moving part 38 can move in parallel, ie horizontally with respect to the base part 100, guided by the guide means 32. This movement is usually a sliding movement in a direction parallel to the surface of the base part 100. That is, this movement is a longitudinal movement, that is, a linear movement.

  Due to the guide means 33 for the penetrating member 50 that is part of, or connected to, or integral with the housing 30, the penetrating member 50 can only move in a clearly defined direction. This direction is different from the direction of the moving part 38. In this embodiment, the moving direction of the penetrating member 50 is essentially perpendicular to the moving direction of the moving part 38. The guide means 33 for the penetrating member 50 is usually formed by the inner surface of the housing 30. For example, the guide means 33 may be formed by the inner surface of a hollow and cylindrical element. In this case, the penetrating member 50 is movable at least between the advanced position and the retracted position so that the piston moves within the cylinder along the longitudinal axis of the cylindrical element. If the penetrating member 50 has a rectangular cross section, the “cylindrical” element must, of course, fit snugly into the cross section of the penetrating member 50 that is actually used. Such movement is a sliding movement because guidance is performed by continuous contact between the inner surface of the cylindrical element and the outer surface of the penetrating member 50. In another embodiment, the guide means 33 for the penetrating member 50 may include one or more bars that control the direction of movement of the penetrating member 50. As can be seen from the accompanying drawings, the guide means 33 for the penetrating member 50 according to this embodiment may extend from the inner ceiling of the housing to the base part 100. The guide means 33 for the penetrating member 50 is not attached to the base part 100, but may reach the base part 100, and may provide a support for the base part 100, for example.

  By means of the guide 34 of the actuating part 11, the actuating part 11 is moved in a controlled manner with respect to the housing 30. The guide means 34 is attached to the housing 30 or is integral with the housing 30. In the embodiment shown, the actuating part 11 moves parallel to the base part 100, ie horizontally with respect to the base part 100, guided by the guide means 34. According to this embodiment, the guide means 34 is formed as a part of the inner surface of the housing. The guide means 34 may be formed as a longitudinal track that guides the actuating part 11 in a well-defined direction, or may be formed as a mere inner surface of the wall of the housing 30. Such movement is usually a sliding movement. This is because the guide means 34 and the actuating part 11 are in continuous contact when moving with respect to each other. The movement is usually a linear movement. According to this embodiment, the moving direction of the working part 11 is the same as the moving direction of the moving part 38. Accordingly, the guide means 34 of the actuating part 11 may be the same as the guide means 32 of the moving part 38. That is, the set of guide means 32, 34 guides at least partially simultaneous movement of the moving part 38 and the actuating part 11.

  The moving part 38 converts the movement of the moving part 38 (this is a horizontal movement in this embodiment) into a movement in the insertion direction of the penetrating member 50, and then retracts at least the insertion needle of the penetrating member 50. Conversion means 39 is provided for converting the movement into According to this embodiment, the conversion means 39 has the form of a protruding cylindrical part 51 provided on the penetrating member 50, which corresponds to the open V-shaped track 39 of the moving part 38. The V-shaped track 39 has a size that fits snugly into the protruding part 51 of the penetrating member 50 in order to provide a clear movement path.

  The moving part 38 includes a release member 29 that separates the housing 30 or at least a portion of the housing 30 from the base part 100 by releasing the fastening means 14 of the housing from the locking means 108 of the base part 100. The release is effected by the interaction of the release member 29 with a part of the housing 30, according to this embodiment, the inner wall of the housing 30 opposite the working part 11. When the linear movement of the working part 11 is continuously performed up to the inner wall of the housing 30, the linear movement of the working part 11 ends at the inner wall of the housing 30.

  The housing includes an elastic member 36. This elastic member 36 begins to remove the housing 30 from the base part 100 when the housing fastening means 14 is released. According to the embodiment shown in FIG. 2, the elastic member 36 is an integral part of the housing 30. That is, it is attached to the housing 30 so as not to be detached. The elastic member 36 is a leaf spring having one end attached to the housing 30 and the other end pressed against the base component 100. The flexibility of the elastic member 36 is determined by the material forming this spring and the physical dimensions of this material. According to the present embodiment, the elastic member 36 is formed of the same material as the housing 30, that is, a hard plastic, and is usually formed during molding of the housing 30, but is formed of metal, It may be attached so as not to be detached from the housing 30 after molding.

Insertion of the penetrating member 50 using the insertion device 1 according to the invention is initiated by the actuation of the actuating component 11. The actuating part 11 is actuated by pushing this part towards the housing 30. The actuating part 11 includes an interaction means 41. The interaction means 41 interacts with the holding means 31 of the housing 30, thereby restricting the forward movement of the working part 11. As can be seen in FIG. 2A, the actuating component 11 projects from the housing 30 in the non-actuated state shown. Reference symbol “a” indicates the protruding length of the actuating part 11 with respect to the housing 30. The projection length of the actuating part 11 before actuation is usually in the range of 1 mm to 100 mm, or in the range of 5 mm to 50 mm, or in the range of 10 mm to 25 mm, or in the range of 15 mm to 20 mm. Is in. In the illustrated embodiment, the protruding length is 17 mm. In another embodiment of the invention, the actuating part 11 does not protrude from the housing 30 or protrudes slightly from the housing 30.
The insertion device 1 is in an inoperative state before use, such as during transportation or storage.

  According to this embodiment, the spring 45 is provided between the moving part 38 and the actuating part 11. Typically, the spring 45 is in a relaxed state during storage, thereby extending the period during which the product can be stored in a fully functional state. If the spring 45 is pressed during storage, there is a risk that the performance of the product will rapidly deteriorate. As shown in FIGS. 2A to 2F, the spring 45 may be a coil spring having two ends. The first end 46 of the spring is attached to or arranged in connection with the moving part 38, and the second end 47 is attached to or associated with the working part 11. Are arranged. The spring 45 is positioned along the moving direction of the actuating part 11. This direction is parallel to the upper surface of the base component 100.

  The function of the spring 45 is to provide energy for penetrating and / or retracting the penetrating member 50 and / or parts of the penetrating member 50. If this energy is not provided by the spring 45, the user pushes the actuating part 11 towards the housing 30 when moving the actuating part 11 horizontally, thereby moving the moving part 38 horizontally. The device user must add energy directly.

  The spring 45 in the illustrated embodiment stores energy from the actuating movement of the actuating component 11. This is because the spring 45 is pressed by this movement. During operation of the actuating part 11, the moving part 38 is stationary. When the interaction means 41 of the actuating part 11 comes into contact with the locking means 28, the moving part 38 is released from the stationary position and moves in the direction determined by the guide means 32. The forward movement of the operating part 11 stops when the interaction means 41 comes into contact with the holding means 31 of the housing 30. According to the embodiment of FIG. 2, the direction of the moving part 38 is the same as the moving direction of the actuating part 11 forward. The spring 45 releases the releasable connection between the fastening means 14 of the housing 30 and the locking means 108 of the base part 100 when the moving part 38 pressed by the spring 45 hits the inner surface of the housing 30. Pressed sufficiently to provide energy to do. This makes the wall of the housing 30 or at least a part of this wall flexible, so that this wall can be bent outward and the fastening means 14 can be released from the locking means 108 of the base part 100. Is done by. When the locking connection is released, the elastic member 36 pushes the housing 30 away from the base part 100 and the user does not need to push the insertion device 1 away from the base part 100.

  FIG. 3 shows a first embodiment of an assembly comprising an inserter according to the invention and a dosing unit 8. One side of the base part 100 is shown such that the entire top surface of the base part 100 is covered by the dosing unit 8. The dosing unit 8 typically includes both a reservoir for a medicament such as insulin and a delivery component in the form of a pumping means such as a metering means for providing a prescribed dose of the medicament to the patient.

  4 and 5A and 5B show a second embodiment of an assembly that includes an inserter 10, a delivery piece 8, and a base piece according to the present invention. The base part includes a surface plate 1 attached to the contact surface. In this embodiment, the surface plate 1 is made of a molded plastic material, and the contact surface is the proximal side of the mounting pad 2. The attachment pad 2 is attached so as not to be detached from the surface plate 1 during manufacture of the device. The term “proximal” means the side or surface closer to the patient when the mounting pad is applied to the patient, and the term “distal” is far from the patient when the device is in the use position Means the end or surface of the surface.

  FIG. 4 is a view of an embodiment of the assembly as viewed from the side, and FIG. 5 is a view of the same embodiment as viewed from above. The penetrating member of this embodiment is included in the cannula part 7 inserted into the opening 12A of the connector part 3 of the base part. This cannula opening 12A provides a through opening for the base part. The cannula part 7 is provided with a penetrating member in the form of a cannula 22 which penetrates the surface of the patient's skin during insertion and is positioned subcutaneously or percutaneously.

  The inserter 10 holds the cannula part 7 before insertion and begins insertion by pushing the handle 11. FIG. 5 shows the direction in which the handle 11 has to be pushed in order to start the insertion of the cannula part 7. After insertion, an insertion needle (not shown) can be withdrawn into the inserter 10, after which the inserter 10 is removed from the base part, leaving the inserted cannula 22 attached to the surface plate 1. If the cannula 22 of the cannula part 7 is a rigid self-penetrating cannula, a separate insertion needle is not required and therefore it is not necessary to retract the insertion needle.

  The connector component 3 is held at a predetermined position by the surface plate 1. According to one embodiment, the surface plate 1 and at least the outer cover of the connector part 3 are formed as one part during the manufacture of the device. The connector part 3 forms a flow path between the cannula part 7 and a reservoir 6 for liquids collected from, for example, a medicine or a patient. Accordingly, the connector part 3 is provided with at least two openings, one at each end of the flow path. The first opening 13 is an inlet opening that receives fluid from the reservoir 6 or an outlet opening that delivers fluid to the reservoir 6, and the second opening 12 is an inlet opening that receives fluid from the cannula part 7, or An outlet opening for delivering fluid to the cannula part 7 (see FIGS. 6A-6D). The connecting part 3 may be provided with other openings, for example for injecting a second medicament or nutrient, or for contacting the fluid in the flow path with the sensor. In order to form a fluid tight connection between the outlet opening 12 of the connector part 3 and the cannula part 7, the outlet opening 12 of the connector part 3 is provided with an elastic seal 18 around the outlet opening 12. ing. When cannula part 7 is inserted, the cannula part press fits into cannula opening 12 and elastic seal 18 forms a complete fluid tight gasket around corresponding openings 12 and 20. In order to improve the press fit and thereby improve the fluid tight connection between the cannula part 7 and the outlet of the channel, the cross section of the cannula opening 12A is parallel to the cannula 22 during insertion, The outlet may be reduced in a plane perpendicular to the positioned surface. The cannula part 7 has a corresponding decreasing cross section.

  In the text below, the first opening 13 is referred to as the “inlet” and the second opening 12 is referred to as the “outlet”, but the direction of flow through the flow path is not critical to the present invention.

  The connector part 3 is further provided with a cannula opening 12A that fits precisely around the cannula part 7. That is, the cannula opening 12A has the same shape or contour as the cannula part 7. This contour is slightly large enough to fit into this opening after passing through the cannula part 7. When the cannula part 7 is fully inserted into the base part and the patient, the upper or distal surface of the cannula part 7 is usually at or higher than the outer surface of the connector part 3 surrounding the cannula opening 12A. Is also below. When the cannula part 7 is fully inserted into the connector part 3, the opening 20 on the side surface of the body of the cannula part 7 corresponds to the opening 12 of the flow path of the connector part 3 so that fluid can flow from one part to the other part. It can flow.

  FIG. 5B shows the embodiment of FIG. 5A with the inserter 10 removed. FIG. 5B shows a view of the device from the end that was covered by the inserter 10 before the inserter 10 was removed. From this end, a part of the fastening means 14 for attaching the inserter 10 to the base part before insertion can be seen. According to this embodiment, the fastening means 14 includes two openings 14L and 14R of the connector part 3. These openings correspond to the base parts and the two projecting parts 14PL and 14PR projecting from the side of the inserter housing towards the connector part 3 with the corresponding opening (see FIGS. 7 and 8). . When the fastening means 14L and 14R provided on the base part engage with corresponding fastening means 14PL and 14PR provided on the inserter 10, the inserter 10 is at least perpendicular to the surface plate 1 with respect to the base part. Will not be moved to. After insertion of the penetrating member, if the penetrating member is fully inserted into the base part, the inserter 10 can be removed from the base part. When removing the inserter 10 from the base part, the inserter 10 is moved in a direction parallel to the patient's skin. That is, the base component is not subjected to a force perpendicular to the patient's skin, i.e., a force that pulls the base component away from the patient. In another example, prior to insertion, for example, the inserter 10 may be adhered to the delivery component 8 along the adjacent surface between the inserter 10 and the delivery component 8. These surfaces must be essentially perpendicular to the patient's skin in order to generate a tensile force in a direction parallel to the patient's skin when the inserter 10 is removed from the delivery component 8.

  6A-6D show the base part and the delivery part in the separated position from various angles. In FIG. 6A, these two parts are shown from below. This figure shows an opening 12B through which the penetrating member 7 can be inserted through the base part. A cannula 22 extends through the opening 12B. From this figure it can be seen how the reservoir 6 can be positioned on the delivery part 8 and how the two release handles 9 positioned on both sides are arranged on the edge of the delivery part 8. In addition, a longitudinal track corresponding to the raised longitudinal guide means 4 provided on the base part is visible.

  The two release handles 9 are formed as S-shaped bands. One end of the band is hingedly attached to the housing of the delivery part 8. While the S-shaped first curve extends slightly beyond the outer surface of the housing of the delivery part 8, the second curve is free. That is, it is not attached to the housing of the delivery part 8 and has a hook shape so that it can be hung on the part 15 protruding from the distal surface of the base part. When the delivery part 8 is locked to the base part, both release handles 9 are hooked on the protruding part 15. In order to remove the delivery part 8 from the base part, the hook-like part of the release handle 9 is released from the protruding part 15 of the base part by pushing the two release handles 9 provided on both sides together, The delivery part 8 is moved backwards, i.e. away from the cannula part 7 and is removed from the base part in this direction.

  In FIG. 6B, the two parts are shown from above. This figure shows that the delivery part 8 of this embodiment can be joined to the base part by pushing the delivery part 8 downward towards the guide means 4. The guide means 4 is in this case a raised longitudinal platform with a metal lining 5 attached to the upper surface. The delivery component 8 is provided with corresponding means, for example a track corresponding to the raised platform 4. Corresponding means of the delivery part 8 can slide longitudinally along the metal lining 5 of the raised platform 4. When the delivery part 8 reaches its operating position, the two release handles 9 engage with the two protruding parts 15 protruding from the upper surface of the surface plate 1 respectively. The delivery part 8 is locked in all horizontal directions by the release handle 9 when in its activated position. Due to the locking mechanism, the delivery device can be attached to and removed from the base part as many times as necessary. That is, a single use base part can be combined with a multiple use delivery part.

  In FIG. 6C, two parts are shown in a state before insertion of the penetrating member from the end opposite to the end to which the inserter 10 is attached. From this side, the inlet opening 13 of the connector part 3 can be seen. For example, a drug can enter from the reservoir 6 through the inlet opening 13 of the connector part 3. The inlet opening 13 is protected by a membrane so that contamination by microorganisms does not occur. According to one embodiment, the connector part 3 is provided with both a connector needle (not shown because it is arranged behind the bubble membrane) and a bubble self-closing membrane 17. The reservoir 6 may be provided with a bubble-like self-closing membrane. As a result, a flow path for transferring a medicine such as insulin or nutrients from the reservoir to the connector part 3 is formed. Since both parts are provided with self-closing membranes, these two units can be separated from each other and later recombined without contaminating the connector part 3 and thus the patient.

  FIG. 7 is a longitudinal sectional view of the assembly shown in FIGS. 4, 5, and 6. From this figure, it can be seen how the fastening parts 14 of the connector part 3 of the base part and the inserter 10 are joined together.

  FIG. 8 shows the inserter 10 removed from the rest of the assembly. From this side, the fastening means 14PR and 14PL of the inserter 10 can be seen.

  9, 10 and 11 show a third embodiment of the inserter 10. 9 and 10, the inserter 10 is shown removed from the rest of the assembly. The inserter 10 includes an actuator handle 11 similar to the first and second embodiments of the inserter 10. The actuator handle 11 is shown in a state before insertion in FIG. 9, and is shown in a state after insertion in FIG. In the third embodiment of the inserter 10, a moving part 38 is provided as shown in FIG. The moving member 38 is provided with a protruding member 38A. The projecting member 38A is an integral part of the moving part 38. The moving part 38 is shown in two different FIGS. 12A and 12B. “Integral part” means that it moves simultaneously with the moving part 38 and is stationary with respect to the moving part 38. Typically, it is molded with the same material as the moving part, but may be made of a different material and attached to the moving part 38 after it is manufactured.

  The protruding part 38A of the moving part 38 is provided with an inclination. This inclination is an inclined surface disposed on the front side of the protruding part 38A so that the contour on the front side of the protruding part 38A forms the head of the arrow.

  The fastening means of this embodiment includes a hinge-like part 14. This hinge-like part 14 is attached to the housing of the inserter 10 in this embodiment. In another aspect, the hinge-like component may be attached to the internal component of the inserter 10, for example, to the same component to which the protruding components 14PR and 14PL are attached. In the illustrated embodiment, the hinged part 14 is formed by forming two notches over the entire height of the housing. The housing is typically made of a hard molded plastic material such as polypropylene and is very flexible because the hinge-like part 14 has a relatively long shape. That is, the hinge-like part 14 is very flexible, and it is easy to push the hinge-like part 14 outward from the relaxed position. Inward movement is blocked by the presence of guide means 33 for the penetrating member, which in this embodiment is the cannula part 7. Further, the hinge-like part 14 may be formed of a material different from the material of the housing of the inserter 10, for example, metal, and the metal-like hinge-like part 14 is rotatably attached to the housing.

  The lower or proximal end of the hinge-like part 14 is provided with two inward hooks ("inward" means that the hook is facing the inside of the housing). These two hooks lock the housing to the base part by catching the stationary protruding part 14B of the base part. Since these two hooks are inward, they are released from the locked position by being pushed outward, i.e. away from the center of the housing. The hinge-like component 14 is further provided with a contact member 14A having a round plate shape made of a rigid material. The contact member 14 </ b> A is arranged around the guide means 33 for the cannula part 7, inside the hinge-like part 14. When the moving part 38 moves from its starting position to its end position, the protruding member 38A disposed at the rear edge of the moving part 38 hits the contact member 14A having an inclined surface, and the contact member 14A and thus the hinge-like part 14 is moved. Pressed outward. This is because the contact member 14 </ b> A is firmly attached so as not to be detached from the hinge-like component 14.

  The housing of the inserter 10 further includes two protruding parts in the form of rounded hooks 14PL and 14PR provided on the inner surface of the wall facing the inward hooks of the hinged part 14. These protruding parts 14PL and 14PR are fitted in corresponding openings 14L and 14R provided in the base part near the connector part 3. The opening provided in the base part is shown in FIG. 16A. When fastening means in the form of openings 14L and 14R provided in the base part engage with corresponding fastening means in the form of round hooks provided in the inserter 10, the inserter 10 relates to the base part. The base part is prevented from moving in both the direction parallel to the length direction of the base part and the direction perpendicular to the surface plate 1. Movement in the direction parallel to the length direction of the base part is rounded off in the protruding part and is prevented to form a grip around the opening, movement in the direction perpendicular to the surface plate 1 is protruding. The part is blocked because it is inserted into the opening. After fully inserting the penetrating member (see FIG. 10), the inserter 10 can be removed from the base part.

  To remove the inserter 10 from the base part, the inserter 10 is pivoted about an axis along the top surfaces of the openings 14L and 14R. The upper surfaces (distal surfaces) of the openings 14L and 14R provide a contact surface for the rounded hooks 14PL and 14PR, along which the lower contact surfaces of the rounded hooks 14PL and 14PR slide. This allows it to be pushed out of the openings 14L and 14R when rotational movement is applied to the inserter housing 30. After insertion, the base part including the surface plate 1 and the inserted part 7 are completely stationary with respect to the surface on which the cannula or sensor is inserted, and rotational movement is applied only by the inserter 10.

  The rotational movement can take place at the lower or proximal face of the inserter housing, which is inclined with respect to the upper face 1 of the base part and thus leaves a space for displacing the housing 30. The sloped lower surface (proximal surface) usually rests on the patient's skin at the end of the rotational movement.

  FIG. 11A shows the inserter in a pre-insertion position. In this state, the inclined lower surface is lifted from the patient's skin. The inward hook of the hinge-like part 14 is locked to the protruding part 14B of the base part.

  FIG. 11B shows the inserter after inserting the cannula part. In this state, the inclined lower surface is parallel to the patient's skin and the inward hook of the hinge-like part 14 is released from the locked position.

  FIG. 11C shows the inserter after removal from the base part.

  12A and 12B show the moving part 38 of the third embodiment of the inserter shown in FIGS. 9, 10 and 11. FIG. FIG. 12A shows the “rear side”, that is, the side opposite to the side where the penetrating member is provided, and FIG. 12B shows the “front side”, ie, the side where the penetrating member is provided. These figures show a protruding part 38A arranged at the rear edge of the moving part 38 with inclined sides, ie with the inclined part facing forward in the direction of movement. These figures show the conversion means 39 in the shape of a longitudinal opening formed in a V shape. Here, the start position is at the upper end of the V-shaped first line, and the end position for the penetrating member is at the upper end of the V-shaped second line.

  13 and 14 show a fourth embodiment of the inserter. This embodiment is different from the third embodiment in the fastening means 14 for fixing the inserter to the base part. The inserter 10 is shown in FIG. 13 and FIG. 14 in a state after insertion with the inserter 10 removed from the base part. The fourth embodiment has means for releasing a set of functionally independent fastening means that support each other.

  Similar to the third embodiment, the fourth embodiment of the inserter is provided with a moving part 38 provided with a protruding member 38A as an integral part (see FIGS. 15A and 15B). The moving part 38 of the fourth embodiment is further provided with a second integral part called positioning means 27. These positioning means 27 are attached to the lower rear edge of the moving part 38.

  The fastening means of this embodiment includes a hinge-like part 14 attached to the housing of the inserter 10, similar to the third embodiment of the inserter. This hinge-like component 14 moves in the same way as described for the third embodiment of FIGS. Two inward hooks are further provided at the lower or proximal end of the hinge-like part 14 of the fourth embodiment. These two hooks lock the housing to the base part by capturing a stationary protruding part 14B of the base part having a lower or proximal contact surface. Since these two hooks are inward, they are released by being pushed outward, i.e. away from the inside of the housing.

  The hinge-like part 14 is further provided with a plate-shaped contact member 14A arranged in the direction toward the center of the inserter around the guide means 33 of the cannula part 7, ie, “inward” from the hinge-like part 14. It has been. When the moving part 38 moves from its starting position to its end position, the protruding member 38A disposed at the rear edge of the moving part 38 hits the contact member 14A, and the inclined surface of the protruding member 38A and the contact member 14A are pressed outward. As a result, the hinge-like component 14 is pressed outward. This is because the contact member 14 </ b> A is securely attached so as not to be detached from the hinge-like component 14.

  According to the fourth embodiment, the protruding members 14PL and 14PR are positioned on the flexible member 114. These projecting members 14PL and 14PR have a rectangular outline according to this embodiment, but may have a circular or triangular outline, for example. The projecting members 14PL and 14PR are fitted into the openings 14P and 14L of the base part close to the connector part 3. These openings correspond to the rectangular projecting members 14PL and 14PR. When fastening means in the form of openings 14L and 14R provided in the base part engage with corresponding fastening means in the form of projecting members 14PL and 14PR provided in the inserter 10, the inserter 10 In this case, the movement is prevented from moving in both directions perpendicular to the surface plate 1 and in any direction parallel to the surface plate 1.

  The flexible member 114 is attached to the housing or is a stationary part with respect to the housing 30, the flexible member being in a first position where the inserter is locked to the base part, and the inserter from the base part. It is possible to move between two positions of the released second position. 17A and 17B, the flexible member 114 is shown in the relaxed locking position, and the arrow in FIG. 17B indicates the direction in which the flexible member 114 moves to assume the second release position. . According to the illustrated embodiment, the flexible member 114 is formed as an integral part of the guide means 32 for the moving part 38. That is, the flexible member 114 forms part of the surface or wall on which the moving part 38 slides. A contact member 115 is provided on the flexible member 114. According to this embodiment, the contact piece 115 has a triangular outline with a pointed edge facing forward in the direction of movement during insertion. The contact component 115 is formed with an inclined surface that is pointed in the direction opposite to the moving direction of the moving component 38 during insertion.

  In order to move the flexible member 14 from the first relaxed-locked position to the second released position, a force large enough to move the flexible member 114 to the second position must be applied to the flexible member 114. Don't be.

  14A and 14B show an integral part of the inserter housing 30 that provides a guide part for the moving part. These parts are not visible when the surrounding housing is in place. 14A and 14B are cross-sectional views of the inner housing part at the same location, but in FIG. 14A the moving part 38 has been removed so that the contact part 115 of the inner part can be seen. The contact part 115 is provided with a protruding inclined surface, which contacts the positioning means 27 of the moving part 38 when the moving part 38 is in its final or final position.

  15A and 15B show the moving part 38 of the fourth embodiment of the inserter shown in FIGS. FIG. 15A shows the “rear side”, that is, the side opposite to the side where the penetrating member is provided, and FIG. 15B shows the “front side”, ie, the side where the penetrating member is provided. These figures show a protruding part 38A arranged at the rear edge of the moving part 38 with inclined sides, ie with the inclined part facing forward in the direction of movement. These figures show the conversion means 39 in the shape of a longitudinal opening formed in a V shape. Here, the start position is at the upper end of the V-shaped first line, and the end position for the penetrating member is at the upper end of the V-shaped second line. The end position is arranged below the start position. The lower edge of the moving part 38 is provided with positioning means 27 for positioning the moving part 38 relative to the inserter housing when sliding along the guide part 32 provided by the peripheral parts of the inserter housing. However, its primary function is to “push” the housing flexible member 114 “backward” as the moving part 38 and the integral positioning means 27 pass.

  When the positioning means 27 of the moving part 38 comes into contact with the flexible member 114, the flexible member 114 is pushed away from the connector part 3 of the base part, and the fastening means in the form of protruding parts 14PL and 14PR are used as the base part. From the corresponding openings 14L and 14R. When the moving part 38 is in its final position, the integral parts 38A and 27 are in a position where both the hinge-like part 14 and the flexible member 114 are withdrawn from their relaxed-locked positions. This means that the inserter can be removed from the base part when the moving part 38 is in its final position.

  FIG. 16 is an enlarged view of the cannula part 7 used in the embodiment of FIGS. This embodiment includes a body 24 provided with a cannula 22 and a protruding front 25. The protruding front portion 25 has a flat surface provided with the opening 20. The protruding front part 25 of the cannula part 7 does not necessarily have to be flat and in fact may have any desired shape as long as a corresponding surface facing the cannula part 7 can be formed on the connector part 3. . In one embodiment, the anterior portion 25 is such that the cross section at the top or distal end of the cannula component 7 is larger than the cross section at the proximal end of the anterior portion, ie, the end closer to the patient after insertion. It is inclined. The opening 20 of the protruding front 25 is an inlet or outlet through which liquid can enter or exit the cannula part 7. The main body 24 is further provided with an upper opening 21. This opening may be covered with a self-closing membrane. The opening 21 requires some kind of entrance protection. This is because it faces the outer surface that contacts the surroundings. The upper opening 21 is mainly used when inserting the cannula part 7 when the cannula 22 is a soft cannula. The softness of the cannula 22 means that it is made of a relatively soft material that alone cannot penetrate the patient's skin. In this case, when inserting the cannula, it is necessary to use a pointed insertion needle made of a relatively hard material. This pointed needle passes through the top opening 21, through the interior hollow portion of the body 24 of the cannula part, through the entire length of the cannula 22, and the pointed end of the insertion needle pierces the open end of the hollow cannula 22. Can be inserted. After insertion, i.e., after the cannula 22 has been placed subcutaneously or percutaneously in the patient, the insertion needle is withdrawn, leaving the cannula in the patient's body. The cannula part 7 is further provided with fastening means 23. The fastening means 23 in this embodiment has the form of a series of outward hooks 23 that are flexible to the body 24 so that they can pivot inwardly towards the center of the cannula part 7. It is attached in a sex. When the cannula part 7 is pressed against the base part, the hook 23 passes through the edge. This edge pushes these hooks toward the center as the hooks pass, and when the hooks pass the edges, the hooks return to their original position and the top surface of one or more hooks is The cannula part 7 is locked against the edge.

  FIG. 17 is an enlarged view of a second embodiment of the cannula part 7. This embodiment also includes a body 24 provided with a cannula 22 and a protruding front 25. The protruding front portion 25 has a flat surface provided with the opening 20. However, according to this embodiment, the projecting front 25 is inclined to reduce the force required to insert the cannula part and to reduce deformation of the seal 18. The inclination of the front 25 is defined by the angle d between the center line c of the cannula 2 and a line parallel to the surface surrounding the opening 20. The angle d is greater than 0 ° and smaller than 90 °. Usually, dε [0 °, 30 °] or [60 °, 90 °] depending on the diameter of the seal 18. The distance d1 between the distal end of the surface of the projection front 25, ie the end of the cannula part 7 remote from the patient after insertion, and the center line c of the cannula part 7 is the proximal end of the surface of the projection front 25 That is, it is larger than the distance d2 between the end portion closer to the patient after insertion and the center line c of the cannula part 7. Usually, the distance d2 is very small so that the proximal end of the protruding front part 25 does not contact the seal 18 of the connector part 3 during insertion.

  In one embodiment (not shown), the angle d is approximately 90 °, ie d = 90 °. Such an embodiment has the appearance that the connector part 3 is provided with an upward opening 12 in the figure corresponding to FIG. 11 and the downward opening 20 of the cannula part 7 is combined therewith. This means that the force pushing the cannula part 7 towards the seal 18 acts in a substantially vertical direction on the contact surface of the seal 18, so that the cannula part 7 slides along the seal 18 during insertion of the cannula part 7. This means that the seal 18 is not deformed. In another embodiment (see FIG. 16), d = 0 °. This means that the protruding front part 25 and the center line c are parallel. According to this embodiment, the cannula part 7 is in sliding contact with the protruding seal 18, thereby deforming the seal.

  According to the embodiment of FIG. 16, the protruding front part 25 of the cannula part 7 does not necessarily have to be flat, in fact, as long as a corresponding surface facing the cannula part 7 can be formed on the connector part 3. It may have a desired shape. Furthermore, the opening 20 of the protruding front portion 25 may be an inlet or an outlet depending on the purpose of the cannula part 7. The cross-sectional view of FIG. 17 shows a method of covering the upper opening 21 of the main body 24 with a self-closing membrane 21A. As in the embodiment of FIG. 10, the upper opening 21 is used primarily when inserting the cannula part 7 when the cannula 22 is a soft cannula, but the patient receives via the opening 20. It can also be used to inject drugs or nutrients other than the main drug, such as insulin.

  Fastening means 23 is also provided in this embodiment of the cannula part 7, in which the fastening means 23 has the form of a protruding part 23 provided on the cannula part 7. This corresponds to the flexible part 23A provided on the stationary base part. As the protruding part 23 of the cannula part 7 passes through the flexible part 23A during insertion of the cannula part 7, the flexible part 23A can be pushed outward as indicated by the arrow in FIG. After insertion, the upper surface of the protruding part 23 of the cannula part 7 is locked with the lower surface of the flexible part 23A of the base part, preventing the cannula part 7 from being detached from the base part.

  FIG. 18 a shows another embodiment of the moving part 38. This moving part 38 has a large tolerance for deviation from the standard insertion depth. FIG. 18a shows the “rear side”, i.e. the side opposite the side where the penetrating member is provided, and when placed in the inserter, the moving part moves from right to left, where the penetrating member of the inserter is It stays in a stationary horizontal position, where it moves first down and then up. FIG. 18a shows a projecting part 38A arranged at the trailing edge of the moving part 38 and a guide means 39 for the converting means arranged within the boundary of the moving part. According to this embodiment, the guide means 39 is formed by a notch having a contour surrounding an open space in which the converting means 51 of the penetrating member can move inside. The guide means 39 further includes a pivotable part 39A. This part can pivot about a stem that attaches the part to the body of the moving part 38. The pivotable part 39A forms an upper limit that can be deflected when the moving part 38 moves from right to left in FIG. 18a. That is, the pivotable component 39A swings upward when the conversion means passes. When the pivotable component 39A passes through the penetrating member conversion means 51, the component 39A swings back to its rest position.

  The conversion means 51 has a starting position at position A with respect to the moving part 38. When the moving part 38 moves to the left, the penetrating member conversion means 51 reaches position B by sliding along the upper surface of the guide means 39, at which position the penetrating member insertion needle 53 is moved to the patient. Contact with the skin.

  At position C, the cannula 22 joined to or surrounding the insertion needle 53 contacts the patient's skin.

  At position D, sealing begins. That is, contact occurs between the cannula part 7 and the surface plate 1. The user can hear a clicking click as one piece of information indicating that the cannula 22 is in the correct position and the stationary base part holding means 23 has locked the cannula part 7 to the base part.

  When the penetrating member conversion means 51 passes from position A to position D, it slides along the lower contact surface of pivotable component 39A. The penetrating member is driven downward by this contact surface. Therefore, it is important that the surface is smooth and the frictional resistance is as small as possible.

  In position E, the penetrating member must be fully inserted. Since the pivotable part 39A can be bent, the change in the insertion depth can be reduced, i.e. within the range of ± 0.5 mm.

  In position G, the insertion needle 53 exits the self-closing membrane 21A covering the upper opening 21 of the cannula part 7. In position H, the insertion needle 53 is in a safe position. That is, the insertion needle 53 is retracted with respect to the housing of the inserter. Usually, it is retracted at least 1 mm relative to the housing.

  When the penetrating member converting means 51 moves from the position E to the position H, it slides along the upper contact surface of the track forming the guide means 39 of the moving part 38. This contact surface drives the penetrating member backward, i.e. upward. This contact surface must be smooth and have as low a frictional resistance as possible.

  FIG. 18 b is a side view of the moving part 38. The arrow with reference symbol A displays the side shown in FIG. 18a.

  19A, 19B, and 19C illustrate one embodiment of a flat spring that can be used to drive the moving part 38 forward in any exemplary embodiment of the inserter. According to this embodiment, the spring 45 is provided between the moving part 38 and the actuating part 11. Normally, the spring 45 is in a relaxed state during storage. This is because this usually increases the time during which the product can be stored while maintaining full functionality. If the spring 45 is pressed during storage, there is a risk that the performance of the product will rapidly deteriorate. In this embodiment, the spring 45 is a flat spring made of a plastic material, for example, and has two ends. The first end 46 is attached to or connected to the moving part 38, and the second end 47 is attached to the actuating part 11 or connected to the moving part 38. The second end 47 of the spring 45 rests on the block 47a.

The spring 45 in the illustrated embodiment stores energy generated by the operation of the operating component 11 when the spring 45 is pressed by the first movement. The characteristic of a flat spring is that it curves and curves when the spring is pressed. Due to the presence of the block 47a and the form of the block, ie the length of the block 47a, the spring 45 can only bend in one direction when pressed. The inserter housing (not shown) includes holding means 31. The holding means 31 may have a form of a pivot arm that holds the moving part 38 in the starting position by engaging with a locking means 28 provided on the moving part 38. The locking means 28 according to the embodiment shown in FIGS. 19A, 19B and 19C have the form of protruding parts, for example with a triangular or circular contour.
The deformation of the spring 45 by pressing can be used to release the moving part 38 from the locked-start position.

  FIG. 19A shows an example at the starting position. The spring is in a relaxed state, i.e. not pressed, and the holding means 31 of the housing is in the locked position. In order to start the insertion, the user O is required to push the actuator 11. By doing this, the spring is pressed. During operation of the actuating part 11, the moving part 38 is in a stationary state.

  FIG. 19B shows the embodiment in the applied position. The spring 45 is fully pressed, and in this fully pressed state, the spring 45 is curved so as to come into contact with the holding means 31 of the housing. The spring releases the moving part 38 from the housing by pushing the holding means 31 away from the locking means 28 of the moving part 38.

  FIG. 19C shows the embodiment with the moving part 38 moved to its final position. The actuator handle 11 is in the same position as in FIG. 19B when the load is fully applied, and the holding means 31 of the housing is in the unlocked position. In this state, the penetrating member to be inserted is inserted subcutaneously. The next step performed by the user is to remove the inserter housing from the insertion location.

DESCRIPTION OF SYMBOLS 1 Insertion device 22 Cannula 23 Holding means 24 Main body 30 Housing 32, 33 Guide means 38 Moving part 50 Penetrating member 51 Conversion means 52 Holding means 53 Insertion needle 100 Base part 101 Opening part 102 Interaction means 121 Seal

Claims (30)

The penetrating member (50) connected to the converting means (52);
-A guide means (39) for restricting the movement of the converting means (52) and guiding the penetrating member (50) from a first position to a second position in a first or insertion direction towards the injection site Moving parts (38);
An insertion device comprising a stationary housing (30) comprising guide means (32) for restricting movement of said moving part (38);
The insertion device characterized in that the guide means (32) guides the moving part (38) linearly in the first direction, that is, in a second direction different from the insertion direction. The insertion device according to claim 1.
Insertion device comprising guide means (33) for limiting the movement of the penetrating member (50) to linear movement in the first direction. The insertion device according to claim 2,
The insertion device, wherein the first direction makes an angle β with respect to the surface into which the penetrating member (50) is to be inserted, where 30 ° ≦ β ≦ 90 °. The insertion device according to claim 1, 2, or 3,
The insertion device, wherein the direction of the moving part (38) during insertion is essentially parallel to the surface to which the moving part (38) is attached. The insertion device according to any one of claims 1 to 4,
The insertion device (1) is attached to a base part (100) before insertion of the penetrating member (50), which base part (100) is attached to the surface into which the penetrating member (50) is to be inserted. An insertion device wherein the penetrating member (50) is in contact with or passes through the base part during insertion. The insertion device according to any one of claims 1 to 5,
The penetrating member (50) is attached to a body (24) that holds a cannula (22), the body (24) holding means (for securing the body (24) and the cannula (22) to an insertion surface ( 23). The insertion device according to claim 5,
The penetrating member (50) is attached to a body (24) that holds a cannula (22), the body (24) holding means (for securing the body (24) and the cannula (22) to an insertion surface ( 23), and the holding means (23) interacts with the interaction means (102) provided in the base part (100) when inserted, and the body (24) of the penetrating member (50) is Insertion device held in the base part (100). The insertion device according to any one of claims 1 to 7,
The insertion device, wherein the guide means (39) of the moving part (38) includes a groove in which the converting means (52) of the penetrating member (50) can slide. The insertion device according to claim 8,
The groove is essentially V-shaped or U-shaped, and has a start point (22a), an intermediate point (22b), and an end point (at least part of the penetrating member (50) or the penetrating member (50)). 22c) insertion device. The insertion device according to any one of claims 1 to 9,
Insertion device, wherein the energy storage means (45) provides the energy required to move the moving part (38) to a starting position or a stopping position. The insertion device according to any one of claims 1 to 10,
The housing (30) includes holding means (31) for holding the moving part (38) in a starting position, and the moving part (38) interacts with the holding means (31) in the starting position. Insertion device comprising stop means (28), wherein said actuating part (11) comprises interaction means (41) that interact with said locking means (28) when actuated. The insertion device according to claim 11,
Insertion device, wherein the locking means (28) are released from a locked position by the interaction of the actuating part (11) with the interaction means (41). The insertion device according to claim 12,
The locking means (28) has the form of a hook provided with an inclined surface inclined in the direction opposite to the forward movement direction of the operating part (11), and the holding means (31) is separated from the housing. Insertion device which is a protruding part and can be captured by a hook formed by said locking means (28). The insertion device according to claim 11, 12, or 13,
Insertion device, wherein the forward movement of the actuating part (11) is stopped by contact between the interaction means (41) of the actuating part and the holding means (31) of the moving part (38). The insertion device according to any one of claims 1 to 14,
The base part (100) is attached to the mounting surface, and the insertion device (10) attaches the insertion device (10) to the base part (100) before insertion and inserts the cannula (22). Insertion device, sometimes comprising means (14, 29, 35, 36) for removing the insertion device (10) from the base part (100). The insertion device according to claim 15,
The means for attaching and detaching the insertion device (10) and the base part (100) comprises:
Fastening means (14, 14A, 14PL, 14PR) for releasably locking the housing (30) of the insertion device to the base part (100);
An insertion device comprising release means (29, 36, 27, 38A) for releasing the housing (30) from the base part (100) after insertion of the penetrating member (50). The insertion device according to claim 16,
The release means includes an elastic member (36) in a pressed or deformed state, and the elastic member causes the housing (30) of the insertion device to move to the base part (100) when the fastening means (14) is released. ) Insertion device that pushes away. The insertion device according to claim 17,
The elastic member (36) has the form of a leaf spring and is positioned between the base part (100) and the insertion device (10), the leaf spring (36) An insertion device that is deformed when 10) is locked to the base part (100). The insertion device according to claim 16, 17 or 18,
The fastening means (14) for releasably locking the housing (30) to the base part (100) has the form of a hook (14, 14A) made of a hard material, and is integrated with the housing (30). An insertion device that captures corresponding parts (108, 14B) of the base part (100). The insertion device according to any one of claims 16 to 19,
The fastening means (14) has the form of one or more projecting parts (14PR, 14PL), which project into the corresponding openings (14R, 14L) of the base part (100). Insertion device to be fitted. The insertion device according to claim 20,
The one or more protruding parts (14PR, 14PL) can be removed from the corresponding openings (14R, 14L) of the base part (100) by rotational movement, and the insertion device (10) Insertion device attached to the base part at a predetermined distance allowing rotational movement of the insertion device (10) from the surface on which a penetrating member (50) is inserted. The insertion device according to claim 21,
The distance from the surface through which the penetrating member (50) is inserted is obtained by forming an inclined proximal surface on the insertion device (10), the proximal surface being driven by the rotational movement. An insertion device that is parallel to the surface into which the member is inserted. The insertion device according to any one of claims 16 to 22,
An insertion device, wherein the fastening means (14, 14A, 14PL, 14PR) are connected to the stationary housing (30) so that they can bend. The insertion device according to claim 23.
The moving part (38) is provided with one or more protruding parts (38A, 27) so that these parts can be bent when the moving part (38) is moved. An insertion device that contacts and fastens fastening means (14, 14A, 14PL, 14PR) coupled to the base, thereby releasing the insertion device (10) from the base part (100). The insertion device according to any one of claims 1 to 24,
The insertion device performs the following operations when the operating component (11) is operated:
(E) applying a load to the spring (45);
(F) moving the moving part (38) from a start position to a stop position;
(G) An insertion device for performing the retracting movement of the holding means (52) of the penetrating member (50) after converting the movement of the moving part (38) into the movement of the penetrating member (50). The insertion device according to claim 25, further comprising:
(H) An insertion device comprising means capable of releasing the housing (30) from the base plate (100) upon insertion of the penetrating member (50). The insertion device according to claim 25 or 26,
The insertion device, wherein the housing (30) is connected to the base plate (100) via connecting means (35, 14). 28. The insertion device according to claim 27.
The insertion device, wherein the coupling means comprises at least one hinge (35) and at least one locking member (14). The insertion device according to claim 26, 27 or 28,
An insertion device wherein the housing (30) is released from the base plate (100) by the interaction of a release member (29) and a portion of the side wall of the housing (30). 30. The insertion device of claim 29.
An insertion device wherein the portion of the housing is flexible and can be twisted / pivoted with respect to the remainder of the housing.

Images