JP2011510774A - Assembly including an inserter, cannula part, and base part - Google Patents

Abstract

An insertion device (10) for inserting a penetration member (7) into a patient, a penetration member (7) attached to the insertion device (10) before use, and a penetration member (7) during use. An inserter (10) comprising a base part including a part configured to receive a penetrating member (7) that can be attached to the base part and fastening means (2) for attaching the base part to a patient. ) Includes inserter attachment means (14) for locking the inserter (10) to the base part before and during insertion of the penetrating member (7), the inserter attachment means being used for the insertion of the penetrating member (7). After insertion, the inserter can be unlocked so that it can be removed from the base part, the inserter attachment means comprising at least one protruding part and at least one corresponding opening. To provide.
Either at least one protruding part or at least one corresponding opening is positioned on the surface of the base part and the corresponding part, the protruding part or opening being on the surface of the inserter (10). It is positioned.
[Selection] Figure 1

Description

  The present invention relates to an assembly for continuously administering a substance such as insulin having a therapeutic action, or an assembly for continuously reading components. The assembly includes a base part to be attached to the patient's skin to which the insertion device and delivery means are attached. The delivery means typically includes a reservoir and, for example, a pump, and the insertion device includes means for inserting a penetrating member, for example in the form of a cannula or sensor.

  WO 2007/071258 describes a medical device for delivering a fluid comprising an injection part and a fluid delivery part, which can be separated and rejoined. The fluid delivery part includes a reservoir in which a fluid transport means, for example in the form of a pump, and a housing in which the working unit of the delivery part is placed. An injection component includes a base plate, a cannula component including a body with a through opening provided with a cannula extending through the proximal side of the base plate, and a mounting pad for securing the base plate to the user's skin, for example Means. The delivery part and the injection part are assembled by a connector including a flow path through which fluid passes from the reservoir to the through opening of the cannula part. The channel is provided with means for blocking access to the injection part when the connector is removed from the delivery part and / or the injection part. The embodiment illustrated in this document is very complex and not easy to manufacture.

  US 2007/0191772 discloses an infusion set assembly that includes an infusion device that is provided with a manual inserter, ie, that inserts the insertion needle by pushing the insertion needle into the patient's skin. The infusion set assembly is desirably provided to the user in a pre-assembled state and placed in a sterilization package, as shown in FIGS. The base part (15), called the cannula housing, includes a pair of pivot holes (26) formed to snap-fit and receive a pivot pin (25) located in the penetrating member (16), called the septum housing. . These pivot holes (26) are desirably through holes that are open both inward and outward, and the pivot pin (25) is a flexible arm (24) configured to flex inwardly. ). When the pivot pin (25) is placed in the pivot hole (26), the penetrating member (16) is held by the base plate (15) and can pivot between an upright position and a horizontal position. An insertion guide housing (68) guides the movement of the insertion needle assembly (38) including the insertion needle. The insertion guide housing (68) rests on the top surface of the base part (15) and is initially attached to the base part by a flexible barb (79) that engages the outer part of the pivot hole (26). It has been. When the pivot pin (25) engages the pivot hole (26), the pivot pin (25) extends through the pivot hole (26). This is so that the return guide (79) provided on the insertion guide housing (68) is pushed outward by the pivot pin (25) so that the insertion guide housing (68) is unlatched from the base part. To be done. According to this disclosure, the disengagement of the inserter (38, 68) is performed by movement and positioning of the penetrating member (16). This is undesirable because the risk of the penetrating member (16) being incorrectly positioned increases if the pivot pin, which is part of the penetrating member, terminates at the desired location within the pivot hole. If the assembly fails during positioning of the penetrating member, the infusion assembly must be removed from the patient's skin and tried again with a new assembly.

WO2007 / 071258 US2007 / 0191774

  It is an object of the present invention to have problems in positioning the penetrating member relative to the inserter, problems in positioning the inserter relative to the base component, and positioning the penetrating member relative to the patient. It is to provide an assembly that solves this problem. If these actions are not performed correctly, the penetrating member may be contaminated, the penetrating member may not be properly positioned, or the inserter may not be properly positioned, thus causing infection at the insertion site and improper penetration member. Proper placement issues arise.

  Furthermore, it is an object of the present invention to eliminate some of the problems of the injection assembly described in the prior art. For example, avoiding the penetration component in releasing the inserter. This is because the risk of failure increases when a penetrating part is involved in releasing the inserter.

The above-mentioned problem is solved by the device according to claim 1. This device
An inserter for inserting the penetrating member into the patient;
A penetrating member attached to the inserter prior to use, comprising a penetrating opening that forms a fluid connection between the delivery means and the patient upon insertion; and
A base part, including a portion configured to receive the penetrating member and fastening means for attaching the base part to a patient, the penetrating member being attachable to the base part during use;
The inserter includes inserter attachment means for locking the inserter to the base part before and during insertion of the penetrating member, the inserter attachment means removing the inserter from the base part after insertion of the penetrating member And the inserter attachment means relates to an assembly comprising at least one protruding part and at least one corresponding opening. Either at least one protruding component or at least one corresponding opening is positioned on the surface of the base component, and the protruding component or component corresponding to the opening is positioned on the surface of the inserter.

  When the inserter attachment means is positioned on the surface of the inserter and the surface of the base part, respectively, the movement of the penetrating part from the start position inside the inserter to the end position of the base part is associated with the engagement of the inserter. The impact of the release is not added.

  Usually, one or more corresponding pairs of protrusions and openings are provided, and all attachment means provided on each of the inserter and base part are oriented in the same direction. That is, if one or more corresponding pairs of projecting parts and openings are positioned on only one side of the base part, the entire part of the inserter is moved in one direction to move the inserter to the base part. Can be removed from the engaged state.

  According to one embodiment, during insertion, the inserter is moved into the base part by interaction between the moving part of the inserter guiding the insertion of the penetrating member from the first position to the final position and the stationary part of the base part. That is, the inserter attachment means disengages. The moving part of the inserter can move forward in a direction substantially perpendicular to the insertion direction of the penetrating member, ie 90 ° ± 45 °, usually 90 ° ± 15 °.

  According to one of the embodiments according to the invention, another problem solved by such an assembly is that when an inserter is removed from the base part, if an automatic release mechanism is provided, the penetration That is, the risk that the member is displaced, for example, part or all of the penetrating member is pulled out, is greatly reduced.

  The assembly according to claim 1 includes an inserter and a base part for inserting the penetrating member into the patient. The base part is provided with fastening means for attaching the base part to the patient, and the penetrating member has a through opening that forms a fluid connection between the delivery means and the patient when the penetrating member is inserted. Is provided. The device is characterized in that the inserter is provided with attachment means for locking the inserter to the base part before and during insertion of the penetrating member.

  According to one embodiment, the attachment means can be unlocked so that the inserter can be removed from the base part after insertion of the penetrating member.

  According to one embodiment, during insertion, the inserter can be released from the base part by interaction between the moving part of the inserter and the stationary part of the base part. The “stationary part” means a part that does not move in the same forward direction as the moving part, and the stationary part may move in a direction perpendicular to the forward direction of the moving part. It should be understood that an interaction is a physical contact that takes place at a specific time. During the forward movement of the moving part, it takes place between a part of the moving part and a part of the inserter housing, ie a stationary part with respect to the inserter housing.

  According to one embodiment, the penetrating member is attached to the base part by a connecting part before and during insertion. Usually, this connecting part permanently attaches the penetrating member to the base part. That is, after insertion, the penetrating member is also attached to the base part. The connecting part may be formed of a flexible material. This flexible material may be, for example, in the form of a tube that forms a flow path between the penetrating member and the base part. The term “flexible” can mean both an elastic material and a soft, bendable material.

  According to another embodiment, the inserter is released from the base part by applying a force to the inserter or part of the inserter in a direction different from the insertion direction of the penetrating member. The removal of the inserter does not occur before the penetrating member is fully inserted into the base part, according to some embodiments. That is, the penetrating member is positioned in a state in which a part thereof is inserted into the base part before insertion. The force may be applied in a direction substantially perpendicular to the insertion direction of the penetrating member, ie, 90 ° ± 45 °, usually 90 ° ± 15 °.

  According to the third embodiment, the release of the inserter from the base part is at least partly performed by releasing the force in a direction towards the base part. This force presses or presses the base part against the patient's skin to prevent the base part and the penetrating member from coming off the patient. The force can be provided by a spring unit that exerts a force on the proximal face of the inserter housing and the distal face of the base part. A surface on the proximal side means facing the patient after insertion of the penetrating member, and a surface on the distal side means facing away from the patient after insertion of the penetrating member. It means that

  The spring may be a leaf spring, with one end attached so that it does not come off part of the inserter and the other end in contact with the top surface of the base part before the inserter is released from the base part. ing.

  According to a fourth embodiment, the attachment means for insertion includes at least one protruding part corresponding to the opening of the base part. The fact that the projecting part corresponds to the opening means that the projecting part fits snugly into the opening, and the projecting part usually has either a circular or polygonal cross section. At least one protruding component may be inserted into the corresponding opening in a direction substantially parallel to the upper surface of the base component. The direction being substantially parallel means that the insertion direction of the protruding component may be shifted by 0 ° to 10 ° from the plane formed by the upper surface of the base component.

  According to a fifth embodiment, the attachment means comprises at least one hook formed by a part of the inserter housing. At least one hook may face inward, i.e. the hook is located on the inner surface of the housing of the inserter and towards the center of the housing. Furthermore, the at least one hook may face at least two projecting parts arranged on the surface of the housing facing the at least one hook. Furthermore, at least one hook may simultaneously face two protruding parts. At least one hook is disposed between the two protruding parts. If one or two hooks are arranged between the projecting parts positioned facing each other, the inserter is mounted with a very stable triangular position.

  According to one embodiment, the penetrating member is provided with attachment means for ensuring that the penetrating member is securely attached to the base part after insertion.

  According to one embodiment, a sealing means for forming a fluid tight connection between the base part and the penetrating member is provided in either the penetrating member or the base part or both, Furthermore, sealing means are provided for forming a fluid connection to the delivery means. Preferably, the penetrating member is provided with sealing means for forming a fluid tight connection with the base part.

  According to one embodiment, the penetrating member is provided with sealing means along the edge of the opening that forms the fluid connection with the base part. If the opening is circular, the seal has the form of an O-ring.

  According to the sixth embodiment, the base part is provided with the lengthwise opening extending from the upper surface of the connecting part of the base part to the lower surface of the connecting part of the base part, and this opening is at least of the penetrating member. Corresponds to the contour of the non-penetrating end. After insertion, the penetrating component of the penetrating member is inserted under the patient's skin. “Corresponding” usually means that the two parts fit snugly when the opening and the inserted member have the same shape. The outlet of the channel may be open to the wall of the opening, and when the penetrating member is inserted, the inlet of the penetrating member to the fluid corresponds to the outlet of the channel.

  According to one embodiment, at least a portion of the base component is formed of a hard material and an adhesive surface is provided on the proximal side of the device to allow the base component to adhere to the patient's skin. Proximal is the side of the device that is closer to the patient's skin, and the fact that the material is rigid means that the insertion needle cannot penetrate and such material cannot be compressed or expanded, It can be bent if its thickness allows. The hard material may be provided with an opening, and the penetrating member can be inserted through the opening. The hard material may be a molded plastic material such as polypropylene.

  According to one embodiment, one penetrating member includes a cannula part having a body made of hard material and is mounted so that a soft or cutting cannula does not come off the cannula part. The cannula is the part that forms the flow path through the patient's skin and is usually a hollow needle. If the cannula is soft, it must be inserted with a separate insertion needle, and if the cannula is a cutting cannula, it can itself cut through the patient's skin, and a separate insertion needle It is not necessary to insert with. Usually, the medication is transported through the flow path, or blood or other liquid is transported from the patient. Preferably, the body of the cannula component has an inner opening from which fluid is directed to the cannula, the inner opening including at least one inlet, through which the fluid or needle enters the inner opening. Can be put. The inner opening may have two inlets through which fluid or needles can enter the inner opening.

According to one embodiment, the at least one penetrating member includes a sensor component. The sensor component contacts through the patient's skin. It does not need to be sent physically. Typically, a signal is sent between the sensor end in contact with the patient's blood and the sensor end in contact with the reader that records the signal.
According to one embodiment, the assembly is delivered to the user in a sterilized condition with the penetrating member in the retracted position within the inserter and the inserter attached to the base component. A “sterilized state” is a protected, uncontaminated state in which the assembly can be stored for use at any time. When the user receives the assembly, the user only has to open the package, i.e. remove the assembly, e.g. first after cleaning the position on the patient's skin where the penetrating member is inserted To do.
Next, embodiments of the present invention will be described with reference to the accompanying drawings.

FIG. 1 is a side view of a first embodiment of an assembly according to the invention with a delivery part and an inserter connected to a base part. FIG. 2 is a view of the embodiment of FIG. 1 as viewed from above. FIG. 3 shows the embodiment of FIGS. 1 and 2 after the cannula part has been inserted and the inserter has been removed. FIG. 4 is a view of the embodiment of FIG. 1 as viewed from the end with the insertion device attached prior to insertion of the penetrating member. FIG. 5A is a view of the delivery part separated from the base part as seen from below. FIG. 5B is a top view of the delivery component separated from the base component. FIG. 6 is a diagram of a second embodiment of a base part that can be used in an assembly according to the invention. FIG. 7 is a longitudinal sectional view of the assembly shown in FIGS. 1 to 5 at the position of one fastening means for the inserter. FIG. 8 is a view of the inserter when not attached to the base part. 9A to 9F are views showing a second embodiment of the inserter and the base part. FIG. 10 is a view showing an example of a penetrating member that can be used with the assembly.

FIG. 11 is a cross-sectional view of a second embodiment of a penetrating member that can be used with the assembly. FIG. 12 is a view of a third embodiment of an inserter to be used with an assembly, prior to insertion of a cannula component. 13 is a view of the embodiment of the inserter of FIG. 12 after insertion of the cannula component. 14A-14C illustrate a method of removing the inserter embodiment shown in FIGS. 12 and 13 from the base part of the assembly according to the present invention. 15A and 15B are diagrams showing an example of a moving part to be used in the assembly shown in FIGS. 12 to 14. 16A and 16B are views showing an embodiment of the base part. 17A and 17B show a fourth embodiment of the inserter to be used in the assembly, after insertion of the cannula part. 18A and 18B are views showing the internal components of the inserter housing of the fourth embodiment of the inserter. FIG. 19 is a diagram of one embodiment of a moving part to be used in the assembly shown in FIGS. 17 and 18. FIG. 20 is a schematic diagram illustrating one embodiment of an assembly according to the present invention.

  FIGS. 1-5 show an assembly according to the present invention including an inserter 10, a delivery piece 8, and a base piece. The base part includes a surface plate 1 attached to the contact surface. This surface plate 1 is usually made of a hard material and has an adhesive surface on the proximal side of the device. The surface plate 1 according to this embodiment is formed of a molded plastic material, which can be, for example, polypropylene, the contact surface being the proximal side of the mounting pad 2, which during the manufacture of the device It is attached so as not to be detached from the surface plate 1. The term “proximal” means the side or surface that is closer to the patient when the mounting pad is applied to the patient, and the term “distal” is the one that is farther from the patient when the device is in use. Means the edge or surface of

  FIG. 1 shows an embodiment of the assembly as seen from the side, and FIG. 2 shows the same embodiment as seen from above. FIG. 3 shows the same embodiment viewed from above, but in FIG. 3, the penetrating member is inserted and the inserter is removed from the assembly. 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 an opening that passes straight through the base part. The cannula part 7 is provided with a penetrating member in the form of a cannula 22. In this position, the cannula 22 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. Insertion is initiated by pushing the handle 11. FIG. 2 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 retracted inside the inserter 10 and the inserter 10 can be 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, there is no separate insertion needle and therefore there is no need to retract the insertion needle. The inserter 10 is attached close to one end of the surface plate 1. Thus, according to one embodiment, the inserter 10 can be pivoted to remove the inserter 10 from engagement with the base plate after insertion of the cannula 22. In practice, the inserter 10 normally projects on the patient's skin relative to the surface plate 1.
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 one outer cover of the connector part 3 are simply molded 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 a medicine reservoir 6 or a patient, for example. 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 or outlet opening that delivers fluid to the reservoir 6 or receives fluid from the reservoir 6, and the second opening 12 delivers fluid to the cannula 7 or fluid An inlet opening or an outlet opening received from the cannula 7 (see FIGS. 5C and 5D). The connector part 3 may be provided with another opening for injecting, for example, the second medicine or nutrient, or for bringing the fluid in the flow path into contact 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, an elastic seal 18 is provided around the outlet opening 12 of the connector part 3. When the cannula part 7 is inserted, the cannula part 7 is press fitted into the cannula opening 12 and the elastic seal 18 forms a complete fluid tight gasket around the corresponding openings 12 and 20 (see FIGS. 10 and 11). ). In order to improve the press fit and thereby improve the fluid tight connection between the cannula part 7 and the outlet of the flow path, the cross section of the cannula opening 12A is parallel to the cannula 22 and the flow path when inserted. May be reduced in a plane perpendicular to the positioned surface. The cross section of the cannula part 7 is correspondingly reduced.

  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 into which the cannula part 7 is fitted accurately. That is, the cannula opening 12A has the same shape or contour as the cannula part 7 and is large enough to fit the cannula part 7 therethrough. 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 the same height as the outer surface of the connector part 3 around the cannula opening 12A. Is below.

  After the cannula part 7 is fully inserted into the connector part 3, the opening on the side of the body of the cannula part 7 corresponds to the opening 12 in the flow path of the connector part 3 so that fluid can flow from one part to the other. Can flow.

  4 shows the same embodiment as FIG. 3 with the inserter 10 removed, but FIG. 4 shows the device from the end that was covered by the inserter 10 before the inserter 10 was removed. From this end, it is possible to see a part of the fastening means 14 that securely attaches the inserter 10 to the base part before insertion. According to this embodiment, the fastening means 14 includes two openings 14L and 14R provided in the connector part 3. These openings correspond to the two projecting parts 14PL and 14PR projecting from the side of the inserter housing (see FIGS. 7 and 8). These projecting parts project towards the base part and towards the connector part 3 having a corresponding opening. When the fastening means 14L and 14R provided on the base part are engaged with the 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. It will not move in the direction. After insertion of the penetrating member, the inserter 10 can be removed from the base part when the penetrating member is fully inserted into the base part as shown in FIG. When the inserter 10 is removed from the base part, the inserter 10 is moved horizontally relative to the patient's skin. That is, no force perpendicular to the patient's skin is applied to the base part, that is, no force is applied to pull the base part away from the patient.

  Those skilled in the art will readily appreciate other methods for attaching the inserter to the base component, both mechanical methods and using adhesive surfaces.

  5A to 5D are views showing the base part and the delivery part in a separated state from various angles.

  FIG. 5A shows two parts viewed from below. In this figure, an opening 12B is shown, through which the penetrating member 7 can be passed through the base part, and the cannula 22 extends through the opening 12B. From this figure it can be seen how the reservoir 6 is positioned on the delivery part and how the two release handles 9 positioned on both sides are arranged on the edge of the delivery part 8. Furthermore, a longitudinal track corresponding to the raised longitudinal guide means 4 provided on the base part is shown.

  The two release handles 9 are formed as s-shaped bands, one end of which is hingedly attached to the housing of the delivery part 8 and the s-shaped first curve extends slightly beyond the outer surface of the delivery part 8 housing. The second curve is free. That is, the second curve is not attached to the housing of the delivery part 8 and has a hook-like shape that can be hung around 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. When the delivery part 8 is to be removed 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 on both sides together, and the delivery part is moved backward. That is, away from the cannula part 7 and can be removed from the base part in this direction.

  FIG. 5B shows two parts as seen from above. This figure shows a method of joining the delivery part 8 to the base part by pushing the delivery part 8 of this embodiment downwards toward the guide means 4. The guide means 4 is in this case a raised longitudinal platform with, for example, 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 is provided. The corresponding means of the delivery part 8 can slide longitudinally along the metal lining 5 of the raised platform 4 of the base part. When the delivery part 8 reaches its working position, the two release handles 9 engage with the two projecting parts 15 projecting from the upper surface of the surface plate 1, respectively. The delivery part 8 is locked in the horizontal direction by the release handle 9 when in its working 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.

  FIG. 5C shows the two parts before insertion of the penetrating member as seen from the end opposite the end where the inserter is attached. From this figure, it is possible to see the inlet opening 13 of the connector part 3, for example, from which the medicine can be placed from the reservoir 6. The inlet opening 13 is protected by a membrane to prevent contamination by microorganisms. 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 is formed for transferring a pharmaceutical product, such as insulin or nutrient, from the reservoir to the connector part 3. Since both parts are provided with self-closing membranes, the two units can be separated from each other and can later be recombined without the connector part 3 and thereby without contaminating the patient.

  FIG. 6 shows a second embodiment of the base part. This embodiment is provided with two guide means 4 in the form of two right-angled sections shaped as follows: these sections project from the surface plate 1 of the base part. The guide means 4 correspond to the means provided on the delivery part 8 or the cover to be attached to the base part. Such corresponding means are for example one or more with contours in the form of “and L”. It can be formed as the above hook.

  The flow path of the connector part 3 is very short compared to the embodiment shown in FIGS. 1 to 6, and the inlet of the connector part 3 is arranged in a central position with respect to the guide means 4, but the inserted cannula part 7 has the same contour as the cannula part 7 fitted in the embodiment of FIGS.

  FIG. 7 is a longitudinal sectional view of the assembly shown in FIGS. From this figure, it can be seen how the base part connector part 3 and the fastening means 14 of 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 are visible.

  9A to 9F show attachment means with an automatic release function. The insertion device 1 includes a housing 30, a base part 100, a moving part 38, a biasing part 40, and a penetrating member 50. The penetrating member 50 is the same as the penetrating member described in FIG. For illustrative purposes, the means such as moving part 38 are shown as being translucent.

  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 two positions. The housing 30 further includes guide means 14 for the penetrating member 50. By this guide means 14, the penetrating member 50 can be moved between two positions. The housing 30 further includes guide means 34 for the biasing component 40. By means of the guide means 34, the biasing component 40 can be moved between two positions. The housing 30 is attached to the base component 100. This attachment is releasable. In this embodiment, the attachment is performed by a connecting portion including the hinge 35 and the locking member 14. As a result, the housing 30 and the base component 100 are releasably connected. The hinge 35 includes at least a partially rounded surface of the wall of the housing 30 so that the housing can pivot with respect to the base part 100. The locking member 14 of the housing 30 interacts with the locking means 108 of the base part 100.

  The letter “b” in FIG. 9C indicates the height of the housing 30 of the insertion device 1. The height “b” is preferably 5 mm to 100 mm, usually 10 mm to 50 mm, and more specifically 20 mm to 30 mm. An exemplary embodiment is 25 mm.

  The housing 30 further includes holding means 31. The holding means 31 holds the moving part 38 in the starting position by engaging with the locking means 28 provided on the moving part 38. According to this embodiment, the holding means further provides a stop for stopping the movement of the biasing component 40.

  The guide means 13 for the moving part 38 controls the movement of the moving part 38 with respect to the housing 30. The guide means 13 is attached to or connected to the inner surface of the housing or is an integral part of the inner surface of the housing, and usually has a longitudinal track shape corresponding to the surface of the moving part 38. It has. In the illustrated embodiment, the moving part 38 can be moved parallel to the base part 100, that is, horizontally with respect to the base part 100, by guidance by the guide means 13. The movement is usually a sliding movement in a direction parallel to the surface of the base part 100. That is, the movement is a longitudinal movement or a linear movement.

  The guide means 33 for the penetrating member 50 is part of the housing 30 or connected to the housing or integral with the housing, the penetrating member 50 being clearly defined different from the direction of the moving member 38. Only move in the direction. 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 cylindrical hollow element, in which case the penetrating member 50 is at least between an advanced position and a retracted position along the longitudinal axis of the cylindrical element. In between, the piston can move so as to move in the cylinder. Such a movement is a sliding movement in which the inner surface of the cylindrical element and the outer surface of the penetrating member 50 are in continuous contact and provide guidance. In another aspect, 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 from the accompanying drawings, the guide means 33 for the penetrating member 50 may extend from the inner ceiling of the housing to the lower part 100 according to the present invention. The guide means 33 of the penetrating member 50 is not attached to the base part 100, but may extend down to and contact the base part 100, or may provide support to the base part 100, for example. Good.

  By the guide means 15 of the urging component 40, the urging component 40 performs a controlled movement with respect to the housing 30. The guide means 15 is attached to the housing 30 or is integral with the housing 30. In the illustrated embodiment, the biasing component 40 is guided by the guide means 15 and moves parallel to the base component 100, i.e. horizontally with respect to the base component 100. The guide means 15 is provided as part of the inner surface of the housing according to this embodiment. The guide means 15 may be formed as a longitudinal track that guides the biasing component 40 in a well-defined direction or may simply be the inner surface of the wall of the housing 30. Such movement is usually a sliding movement. This is because the guide means 15 and the biasing component 40 keep in contact when moving relative to each other. This movement is usually a linear movement. According to this embodiment, the moving direction of the biasing component 40 is the same as the moving direction of the moving component 38, and therefore the guide means 15 of the biasing component 40 is the same as the guide means 13 of the moving component 38. Alternatively, on the set of guide means 13, 15, a well-defined at least partly simultaneous movement of the moving part 38 and the biasing part 40 takes place.

  The moving part 38 includes conversion means 39 that converts the movement of the moving part 38, in this embodiment, the horizontal movement into the insertion direction movement of the penetrating member 50, and then converts the penetrating member 50 into at least the insertion needle retracting direction movement. Is provided. According to this embodiment, the conversion means is formed as an open V-shaped track of the moving part 38. This corresponds to the cylindrical protruding part 51 of the penetrating member 50. The V-shaped track 39 is sized to fit snugly into the protruding part 51 of the penetrating member 50 in order to provide a clearly defined 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 locking member 14 of the housing from the locking means 108 of the base part 100. The release is performed by the interaction between the release member 29 and a part of the housing 30. In this embodiment, a part of the housing 30 is the inner wall of the housing 30 opposite to the biasing means 40, and when the linear movement of the biasing means 40 continues to the inner wall of the housing 30, End with.

  The housing includes a resilient member 36 that initiates removal of the housing 30 from the base component 100 upon release of the locking member 14 of the housing. According to the embodiment shown in FIG. 9, 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 attached so that one end thereof is not detached from the housing 30, and the opposite end is pressed against the base part 100. The flexibility of the elastic member 36 is determined by its forming material and the physical dimensions of the material. According to the present embodiment, the elastic member 36 is formed of the same material as the housing, that is, a hard plastic, and is usually formed during molding of the housing 30, but is made of metal and is formed after the housing is molded. It may be attached so as not to come off.

  Insertion of the penetrating member 50 using the insertion device 1 according to the present invention is performed by biasing the biasing component 40. The biasing component 40 is biased by pushing the component toward the housing 30. The biasing component 40 includes interaction means 41. The interaction means 41 interacts with the holding means 31 of the housing 30 to restrain the biasing component 40 from moving forward. As can be seen in FIG. 9A, the biasing component 40 protrudes from the housing 30 in the illustrated non-actuated state. The letter “a” indicates the protruding length of the biasing component 40 with respect to the housing 30. The protruding length of the biasing component 40 before operation is usually 1 mm to 100 mm, or 5 mm to 50 mm, or 10 mm to 25 mm, or 15 mm to 20 mm. In the illustrated embodiment, the protruding length is 17 mm. In another embodiment of the present invention, the biasing component 40 does not protrude from the housing 30 or protrudes slightly from the housing 30.

The insertion device 1 is normally in an inactive state prior to use, such as during transportation or storage.
According to this embodiment, the spring 45 is provided between the moving part 38 and the biasing part 40. Normally, the spring 45 is in a relaxed state during storage. This normally extends the product storage time without any loss of functionality. If the spring 45 is in a pressed state during storage, there is a risk that the performance of the product will rapidly decline. As shown in FIGS. 9A to 9F, the spring 45 may be a coil spring having two ends. The first end 46 of the spring 45 is attached to the moving part 38, i.e., connected, and the second end 47 is attached to the biasing part 40, i.e., connected. Yes. The spring 45 is positioned along the moving direction of the biasing component 40 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 of the device must provide the energy directly. The user pushes the biasing component 40 toward the housing 30, thereby moving the moving component 38 in the horizontal direction, thereby moving the biasing component 40 in the horizontal direction.

  The spring 45 in the illustrated embodiment stores energy when the spring 45 is pressed by the operating movement of the biasing component 40. During operation of the biasing component 40, the moving component 38 is stationary. When the interaction means 41 of the biasing part 40 comes into contact with the locking means 28, the moving part 38 is released from the stationary position and moves in the direction defined by the guide means 32. The forward movement of the biasing means 40 stops when the interaction means 41 comes into contact with the holding means 31 of the housing 30. According to the embodiment of FIG. 9, the direction of the moving part 38 is the same as the forward direction of the biasing means 40. When the moving part 38 pressed by the spring 45 hits the inner surface of the housing 30, the spring 45 releases the releasable connection between the locking member 14 of the housing 30 and the locking means of the base part 100. It is in a sufficiently pressed state to provide the energy of This is done by making the wall of the housing 30 or at least a portion of this wall sufficiently flexible so that the wall curves outward and the locking member 14 can be released from the base part 100. 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 have to pull the insertion device 1 away from the base part 100.

As shown in FIGS. 9A to 9F, the insertion device 1 takes a first position to a sixth position described below. That is,
(I) In the first position (see FIG. 9A), in this position, the penetrating member 50 is fully retracted, does not protrude from the insertion device 1, and the biasing component 40 protrudes from the housing 30. / Not activated, the base part 100 is positioned on the patient's skin and the penetrating member 50 is sterilized in this position and can be inserted at any time.
(II) Second position (see FIG. 9B) In this position, the biasing part 40 is actuated, i.e. pushed towards the housing 30 and the locking means 28 of the moving part 38 is released, Although the interaction means 41 is in contact with the holding means 31, the penetrating member 50 and the moving part 38 have not yet moved.
(III) Third position (see FIG. 9C) In this position, parts of the penetrating member 50 to be inserted under the patient's skin, such as the cannula 54 and / or the insertion needle 53, pass through the opening 101 of the base part 100. Projecting from the housing 30. The main body 55 of the penetrating member 50 is attached to the base part 100 by holding means in the form of a mechanical hook that holds the edge of the base part 100.
(IV) Fourth position (see FIG. 9D) In this position, the moving part 38 moves to its final position and hits the inner wall of the housing 30, and the holding means of the penetrating member 50 causes the cannula and cannula body of the penetrating member 50 to move. Holding in place, the insertion needle 53 is retracted to a completely free degree and is not in contact with any part of the penetrating member 50 remaining in the insertion position. 14 remains connected.
(V) Fifth position (see FIG. 9E) In this position, the spring 45 is pressed against the inner wall of the housing 30 to release the locking member 14, and the elastic member 36 pushes the housing 30 away from the base part 100. Therefore, the housing 30 pivots around the hinge 35.
(VI) Sixth position (see FIG. 9F) In this position, the housing 30 has been completely removed from the base part 100, leaving the base part 100 attached to the surface of the patient's skin 200 and the cannula 54 being Inserted into patient tissue 210.

  FIG. 10 is an enlarged view of the cannula part 7 shown in FIG. This embodiment has a body 24 that includes a cannula 22 and a protruding front portion 25 with a flat surface provided with an opening 20. The protruding front part 25 of the cannula part 7 does not necessarily have to be flat and may actually have any shape as long as it can form a surface corresponding to the connector part 3 facing the cannula part 7. In one embodiment, the anterior portion 25 is inclined such that the cross-section at the top or distal end of the cannula component 7 is greater than the cross-section at the proximal end of the anterior portion or the end closer to the patient after insertion. ing. The opening 20 of the protruding front 25 is an inlet through which liquid can enter the cannula part 7 or an outlet through which liquid can exit the cannula part. The body 24 is further provided with a top opening 21 that can be covered with a self-closing membrane. Since the opening 21 faces the outer surface in contact with the surroundings, it requires some kind of entrance protection. The top 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 itself 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 penetrates the open end of the hollow cannula 22 through the top opening 21, through the interior hollow portion of the body 24 of the cannula component, and through the entire length of the cannula 22. You can insert as you exit. After insertion, i.e., the cannula 22 is placed percutaneously under the patient's skin, the insertion needle is retracted, leaving the cannula 22 in the patient. The cannula part 7 is further provided with fastening means 23. The fastening means 23 has the form of a series of outward hooks 23 in this embodiment. These hooks 23 are attached to the body 24 so that they can pivot inwardly toward the center of the cannula part 7. When the cannula part 7 is pressed against the base part, the hook 23 passes the edge, and when the hook 23 passes the edge, the edge presses the hook 23 toward the center, and the hook 23 When passed, it returns to its original state and the upper surface of one or more hooks contacts the lower surface of the edge and is locked so that the cannula part 7 does not come off the edge.

FIG. 11 is an enlarged view of a second embodiment of the cannula part 7. This embodiment also includes a body 24 that includes a projecting front 25 with a flat surface with a cannula 22 and an opening 20, but according to this embodiment, the projecting front 25 is used for insertion of a cannula part. It is tilted to reduce the required force and to reduce the deformation of the seal 18. The inclination of the front portion 25 is determined by an angle d between the center line c of the cannula 22 and a line parallel to the surface around the opening 20. The angle d is greater than 0 ° and less than 90 °, usually dε [0 °, 30 °] or [60 °, 90 °] depending on the diameter of the seal 18. The distance d1 between the surface of the protruding part 25 at the distal end, ie the end of the cannula part 7 remote from the patient after insertion, and the center c of the cannula part 7 is close to the patient after the proximal end, ie insertion. Greater than the distance d2 between the surface of the protruding part 25 at the end and the center c of the cannula part 7. Usually, the distance d2 is so small that the proximal end of the protruding front 25 does not contact the seal 18 of the connector part 3 during insertion.
In one embodiment (not shown), the angle d is close to 90 °, i.e. d = 90 °, and such an embodiment shows that in the view corresponding to FIG. It appears to fit into the lower opening 20 of the cannula part 7. This means that the force pushing the cannula part 7 towards the seal 18 is close to perpendicular to the contact surface of the seal 18, so that the cannula part 7 moves along the seal 18 during insertion of the cannula part 7. The seal is prevented from being deformed by sliding.

  In another embodiment (see FIG. 10), d = 0 ° and 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. 10, the protruding front part 25 of the cannula part 7 does not necessarily have to be flat, but in practice any one can be used as long as it can form a surface corresponding to the connector part 3 facing the cannula part 7. It may be a 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. FIG. 11, which is a sectional view, shows a method of covering the top opening 21 of the main body 24 with a self-closing membrane 21 </ b> A. According to the embodiment of FIG. 10, the top opening 21 is mainly used when inserting the cannula part 7 when the cannula 22 is a soft cannula, whereas the top opening 21 is used by the patient in the opening 20. Can also be used to inject drugs or nutrients other than the main drug, which can be, for example, insulin.

  Fastening means 23 are also provided in this embodiment of the cannula part 7. In this embodiment, 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. The flexible part 23A can be pushed outward as shown by the arrow in FIG. 11 when the protruding part 23 of the cannula part 7 passes during insertion of the cannula part 7. After insertion, the upper surface of the protruding part 23 of the cannula part 7 engages the lower surface of the flexible part 23A of the base part, preventing the cannula part 7 from being removed from the base part.

12 to 14 show a third embodiment of the inserter. 12 and 13 show the inserter removed from the rest of the assembly. The inserter 10 includes an actuator handle 11 as in the first and second embodiments of the inserter. The actuator handle 11 is shown in a state before insertion in FIG. 12, and is shown in a state after insertion in FIG. The third embodiment of the inserter is provided with a moving part 38 as in the embodiment of FIG. The moving part 38 is provided with a protruding member 38A that is an integral part of the moving part 38. The moving part 38 is shown in two different views, namely FIGS. 15A and 15B. That is, the term “integrated part” means that the moving part moves simultaneously with the moving part and is positioned stationary with respect to the moving part. Usually, it is formed of the same material as the moving part together with the moving part, but may be formed of a different material and attached to the moving part 38 after the moving part 38 is manufactured.
The protruding part 38A provided on the moving part 38 is provided with an inclination. This inclination is an inclined surface arranged on the front side of the protruding part 38A so that the outline of the front part of the protruding part 38A forms an arrowhead shape.

  The fastening means of this embodiment includes a hinge part 14 attached to the housing of the inserter 10. In the illustrated embodiment, the hinge part 14 is actually formed as part of the housing, and the hinge part 14 is formed by two cuts extending over the entire height of the housing. The housing is typically made of a hard molded plastic such as polypropylene, and the hinge component 14 has a relatively long shape and is therefore very flexible. That is, the hinge part 14 is very flexible and easy to push outward from the relaxed state, and the inward movement is due to the presence of the guide means 33 for the penetrating member, which in this embodiment is the cannula part 7. Blocked. The hinge part 14 may be made of a material different from the material of the housing of the inserter, for example a metal, in which case it is rotatably attached to the housing.

  The lower or proximal end of the hinge part 14 is provided with two inward hooks ("inward" means that the hooks are pointed toward 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 the two hooks are inward, they are removed from the locked position by being pushed outward, i.e. away from the center of the housing. The hinge part 14 is further provided with a contact member 14A in the form of a circular plate made of rigid material. The contact member 14 </ b> A is arranged inside the hinge part 14 and around the guide means 33 for the cannula part 7. When the moving part 38 moves from its starting position to its end position, the inclined surface of the projecting member 38A disposed at the rear edge of the moving part 38 hits the contact member 14A, and the contact member 14A is pressed outward, so that the hinge The member 14 is pressed outward. This is because the contact member 14 </ b> A is firmly attached so as not to be detached from the hinge member 14.

  The inserter housing further comprises two protruding parts in the form of rounded hooks 14PL and 14PR on the inner surface of the wall facing the inward hook of the hinge member 14. These protruding parts 14PL and 14PR are fitted in corresponding openings 14L and 14R of the base part near the connector part 3. The opening of the base part is shown in FIG. 16A. When the 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 14PL and 14PR provided in the inserter 10, the inserter 10 The base component is prevented from moving in both directions parallel to the length direction of the base component and in a direction perpendicular to the surface plate 1. In a direction parallel to the length direction of the base part, the protruding part is rounded and forms a grip around the opening, so that it does not move with respect to the base part, and in a direction perpendicular to the surface plate 1, Since the protruding part is inserted into the opening, it is prevented from moving with respect to the base part. After fully inserting the penetrating member (see FIG. 13), 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 the axis provided by the top surfaces of the openings 14L and 14R. The upper surfaces (distal surfaces) of the openings 14L and 14R provide contact surfaces for the rounded hooks 14PL and 14PR. Along the contact surface, the lower contact surface of the hooks 14PL and 14PR having roundness can be slid, so that when the rotational movement is applied to the inserter housing 10, it can come out of the openings 14L and 14R. .

  Since the lower or proximal surface of the housing of the inserter 10 is inclined with respect to the upper surface 1 of the base part and thus there is room for displacing the housing 10, a rotational movement can take place. At the end of the rotational movement, the inclined lower (proximal) surface of the inserter housing typically rests on the patient's skin.

  FIG. 14A shows the inserter in place before insertion. In this state, the inclined lower surface is lifted from the patient's skin. The inward hook of the hinge part 14 is locked around a protruding part 14B provided on the base part.

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

  FIG. 14C shows the inserter after removal from the base part.

  15A and 15B show the moving part 38 of the third 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. FIG. 15B shows the “front side”, ie the side on which the penetrating member is provided. These figures show a protruding part 38A arranged at the trailing edge of the moving part 38. This protruding part 38A has inclined side portions, that is, inclined portions facing forward in the moving direction. These figures further show the conversion means 39 in the shape of the 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.

  16A and 16B show base components that can be used in the third embodiment of the inserter. FIG. 16A shows openings 14L and 14R according to this embodiment. These openings are rounded at an angle of 90 ° and open towards the proximal surface of the base part, ie the surface that is placed against the patient's skin.

  FIG. 16B shows the base part as viewed from above. From this angle, the cannula opening 12A can be looked down. According to this embodiment, the cannula opening is provided with guide means 26 for the cannula part 7. This guide means 26 includes opposed longitudinal tracks, which ensure correct placement of the cannula part 7.

  17 and 18 show a fourth embodiment of the inserter. This embodiment differs from the third embodiment in the fastening means 14 for fixing the inserter to the base part. In FIG. 17 and FIG. 18, the inserter 10 is shown in a state after insertion, 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 having a protruding member 38A which is an integral part of the moving part 38 (see FIGS. 19A and 19B). Further, the moving part 38 of the fourth embodiment is 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 part 14 attached to the housing of the inserter 10, similar to the third embodiment of the inserter. This hinge part 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 component 14 of the fourth embodiment. These two hooks lock the housing to the base part by capturing the base part's stationary protruding part 14B having a bottom or proximal contact surface. Since the two hooks are inward, they are released by being pushed outward, i.e. away from the inside of the housing.

  Also on the hinge part 14 is a contact member 14A in the form of a plate arranged in the direction towards the center of the inserter, ie “inward” from the hinge part 14 around the guide means 33 for the cannula part 7. Is provided. When the moving part 38 moves from its starting position to its end position, the inclined surface of the protruding part 38A arranged at the rear edge of the moving part 38 hits the contact member 14A, and the contact member 14A and thus the hinge member 14 moves outward. Pressed. This is because the contact member 14 </ b> A is firmly attached so as not to be detached from the hinge member 14.

  According to the fourth embodiment, the protruding members 14PL and 14PR are positioned on the flexible member 114. According to this embodiment, these protruding members 14PL and 14PR have a rectangular outline, but may have a circular or triangular outline, for example. The protruding members 14PL and 14PR are fitted into the openings 14P and 14L of the base part near the connector part 3. These openings correspond to the rectangular projecting members 14PL and 14PR. When the fastening means in the form of openings 14L and 14R provided in the base part are engaged with corresponding fastening means in the form of projecting members 14PL and 14PR provided in the inserter 10, the inserter 10 relates to the base part. , So as not to move both in the direction perpendicular to the surface plate 1 and in any direction parallel to the surface plate 1.

  The flexible member 114 can move between a housing or a second position so that the inserter 10 can move between a first position where the inserter 10 is locked relative to the base part and a second position where the inserter 10 is removed from the base part. Attached to a stationary part with respect to the housing 10. 17A and 17B show the flexible member 114 in the relaxed locked position. The arrow in FIG. 17B indicates the movement direction for taking 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, and a pointed edge is directed forward in the movement direction during insertion. The contact component 115 is formed with a ramp-shaped surface facing in the direction opposite to the moving direction of the moving component 38 being inserted.

  In order to move the flexible member 114 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. I must.

  18A and 18B show the internal parts of the inserter housing 10 that provide a guide part for the moving part 38. These internal parts are not visible when the surrounding housing is in place. 18A and 18B are the same cross-sections through these internal housing parts, but in FIG. 18A the moving part 38 has been removed so that the contact part 115 of the internal parts can be seen. The contact component 115 includes a protruding ramp-like surface that contacts the positioning component 27 of the moving component 38 when the moving component 38 is in its final or final position.

  19A and 19B show the moving part 38 of the fourth embodiment of the inserter shown in FIGS. FIG. 19A shows the “rear side”, that is, the side opposite to the side where the penetrating member is provided, and FIG. 19B shows the “front side”, ie, the side where the penetrating member is provided. These figures show a protruding part 38A arranged at the trailing edge of the moving part 38. The projecting part 38A includes ramps that face inclined sides or forwards in the direction of movement, and 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. Positioning means 27 is provided at the lower edge of the moving part 38, so that when the positioning means 27 slides along the guide means 32 provided by the peripheral parts of the inserter housing, the moving part with respect to the housing of the inserter. The main function is to press 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 projecting parts 14PL and 14PR are used as the base. It is pulled out from the corresponding openings 14L and 14R of the part. When the moving part 38 is in its final position, the integral parts 38A and 27 are in a position where both the hinge part 14 and the flexible member are pushed away from their relaxed-locked position. This means that the inserter can be removed from the base part when the moving part 38 is in its final position.

  FIG. 20 shows a portion of one embodiment of an assembly according to the present invention. This figure shows the surface plate 1 and the penetrating member in the form of a cannula part 7. The cannula part 7 includes a body 24, a cannula 22 and a self-closing membrane 21A that protects the upper access of the body 24. The cannula part 7 further has an access opening 20 connected to the connector part 3 via a tubular connection part 16. The tubular connecting part 16 forms a permanent flow path between the cannula part 7 and the connector part 3. However, the cannula part 7 is not arranged in the use position. Furthermore, the reservoir 6 for storing the medicine is shown in a position before being joined to the connector part 3 via the connector needle 19. The connector needle 19 forms a flow path with the cannula part 7.

  The flexible connection 16 must be sufficiently long and flexible to connect between the cannula part 7 and the connector part 3 in both the retracted position and the advanced position. Alternatively, the flexible connection 16 must be elastic and can be extended to place the cannula part in the retracted position. If the cannula component is placed inside the inserter (not shown) when in the retracted position, it may be of the type shown in any of the drawings referred to above, Or the completely different insertion device which can hold | maintain a penetration member in an insertion state may be sufficient.

  The flexible connecting portion 16 is attached so that the penetrating member is not detached from the surface plate 1.

DESCRIPTION OF SYMBOLS 1 Surface plate 2 Mounting pad 3 Connector part 4 Guide means 5 Magnet 6 Reservoir 7 Cannula part 8 Delivery part 9 Release part release handle 10 Inserter 11 Actuator handle for inserter 12 Outlet or second opening 12A Cannula opening 12B Cannula part Surface plate opening 13 inlet or first opening 14 fastener / hinge component fastening means 14A projecting member provided on locking means (see FIGS. 12-14)
14B Parts provided on the base part corresponding to the fastening means for the inserter 14R Fastening means for the inserter (right side)
Fastening means for 14L inserter (left side)
Fastening means with protruding 14PR inserter (right side)
Fastening means with protruding 14PL inserter (left side)
15 Base part protruding part 16 Flexible connection between cannula part and base part 17 Bubble membrane 18 Seal around outlet or second opening 19 Connector needle 20 Opening into cannula part 21 Top of cannula part Opening 21A Self-closing membrane 22 Cannula 23 Fastening means 24 Body of cannula part 25 Protruding front part 26 Guide means for cannula part provided in cannula opening 12A 27 Positioning means 28 Locking means 29 Release member 30 Housing 31 Holding means 32 Guide means for moving parts 33 Guide means for penetrating members 34 Guide means for biasing parts 35 Hinge 36 Elastic member 37 −
38 moving parts 38A protruding parts provided on the moving parts (see FIGS. 12 to 14)
39 Conversion means 40
41 interaction means 45 spring 46 first end of spring associated with moving part 47 second end of spring associated with biasing part 50 penetrating member 51 converting means 52 holding means for retaining penetrating member 53 insertion needle 100 base part 114 Flexible member of inserter housing 115 Contact member of flexible member 200 Skin surface 210 Tissue

Claims (24)

An inserter (10) for inserting the penetrating member (7) into the patient;
A penetrating member (7) attached to the inserter (10) prior to use, comprising a penetrating opening that forms a fluid connection between the delivery means (8) and the patient when inserted (7) and
A portion configured to receive the penetrating member (7) capable of attaching the penetrating member (7) to the base part during use; and fastening means (2) for attaching the base part to a patient; Including base parts, including
The inserter (10) includes inserter attachment means (14) for locking the inserter (10) to the base part before and during insertion of the penetrating member (7), the inserter attachment means (14) can be unlocked so that the inserter can be removed from the base part after insertion of the penetrating member (7), and the inserter attachment means (14, 14A, 14B, 14PR / R, 14PL / L) in an assembly comprising at least one protruding part and at least one corresponding opening,
Either the at least one protruding component or the at least one corresponding opening is positioned on the surface of the base component and the corresponding component, and the protruding component or opening is on the surface of the inserter (10). An assembly characterized by being positioned. The assembly of claim 1, wherein
A moving part (38) of the inserter (10) for guiding the insertion of the penetrating member (7) from a first position to a final position during insertion, and a stationary part (29, 225, 14A) of the base part; The assembly according to claim 1, characterized in that the inserter (10) is released from the base part by the interaction between the inserter attachment means (14). The assembly of claim 2, wherein
The moving part (38) of the inserter (10) is forwardly oriented in a direction substantially perpendicular to the insertion direction of the penetrating member (7), ie 90 ° ± 45 °, usually 90 ° ± 15 °. An assembly characterized by moving in a direction. The assembly according to claim 1, 2, or 3,
The assembly characterized in that the penetrating member (7) is attached to the base part by a tubular connecting part (16) before and during insertion. The assembly of claim 4, wherein
The assembly characterized in that the connecting part (16) is made of a flexible material. The assembly according to any one of claims 1 to 5,
The inserter (10) is released from the base part by applying a force to the inserter (10) or a part of the inserter (10) in a direction different from the insertion direction of the penetrating member (7). An assembly characterized by that. The assembly of claim 5, wherein
The assembly is characterized in that the force is applied in a direction substantially perpendicular to the insertion direction of the penetrating member (7), ie in the direction of 90 ° ± 45 °, usually 90 ° ± 15 °. The assembly according to any one of claims 1 to 7,
Assembly according to claim 1, characterized in that the release of the inserter (10) from the base part is at least partly performed by releasing a force in a direction towards the base part. 9. The assembly of claim 8,
The assembly is characterized in that the released force is a force provided by a spring unit (45) exerting a force on the proximal face of the inserter housing and the distal face of the base part (1). The assembly of claim 9, wherein
The spring (36) is a leaf spring, one end of which is attached to a part of the inserter, and the other end of the base part before the inserter is released from the base part. An assembly, wherein the assembly is in contact with the upper surface of the assembly. The assembly according to any one of claims 1 to 10,
The assembly (14) of the insertion (10) comprises at least one protruding part (14PR, 14PL) corresponding to the opening (14R, 14L) of the base part. The assembly of claim 11, wherein
The assembly characterized in that the at least one protruding part (14PR, 14PL) is inserted into the corresponding opening (14R, 14L) in a direction substantially parallel to the top surface of the base part. The assembly according to any one of claims 1 to 12,
The assembly characterized in that the attachment means (14) comprises at least one hook attached to a hinge part (14) formed by a part of the housing of the inserter (10). The assembly of claim 13, wherein
The assembly characterized in that the at least one hook faces inward, i.e. the hook is located on the inner surface of the housing of the inserter and towards the center of the housing. The assembly of claim 14, wherein
The assembly characterized in that the at least one hook faces at least two protruding parts (14PR, 14PL) arranged on the surface of the housing facing the at least one hook. The assembly of claim 15, wherein
The assembly, wherein the at least one hook is disposed between two projecting parts. The assembly according to any one of claims 1 to 16,
The penetrating member (7) is provided with attachment means (23) for securely attaching the penetrating member (7) so as not to be detached from the base part after insertion. Assembly. 18. An assembly according to any one of claims 1 to 17,
Seal means (18) for forming a fluid tight connection between the base part and the penetrating member (7) is provided on either the penetrating member (7), the base part or both. The base part is further provided with sealing means (17) for forming a fluid connection to the delivery means (8). The assembly according to any one of claims 1 to 18,
The portion formed to receive the penetrating member (7) has a longitudinal opening extending from the upper surface of the connecting component (3) of the base component to the lower surface of the connecting component (3) of the base component. 12A), and the opening (12A) corresponds at least to the contour of the non-penetrating end of the penetrating member (7). The assembly of claim 19, wherein
The outlet of the channel (12) is open to the wall of the opening (12A), and when the penetrating member (7) is inserted, the inlet of the penetrating member (7) to the channel of the channel is Assembly corresponding to the outlet (12). 21. The assembly according to any one of claims 1 to 20,
One penetrating member (7) comprises a cannula part having a body made of a hard material and is mounted such that a soft or cutting cannula (22) is not detached from said cannula part. The assembly of claim 21, wherein
The body (24) of the cannula component has an inner opening from which fluid is directed to the cannula (22), the inner opening including at least one inlet (20, 21). An assembly, characterized in that a fluid or needle can be introduced into the inner opening through the inlet. 23. The assembly according to any one of claims 1 to 22,
The assembly characterized in that the at least one penetrating member (7) comprises a sensor component. 24. The assembly according to any one of claims 1 to 23, wherein:
The assembly is delivered to a user in a sterilized condition in which the penetrating member (7) is in a retracted position in the inserter (10) and the inserter (10) is attached to the base part. Feature assembly.

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