CN100560151C - Intubation equipment - Google Patents

Abstract

Cannula device suitable as an element for use in a base element of an infusion set. The cannula device comprising a housing and at least one membrane together defining at least one cavity adapted to receive the piercing member of the connector, the cannula device further comprising a cannula mounted in said housing and in fluid communication with said at least one cavity, wherein said device can receive the piercing member of the connector from more than one direction and the housing has a geometry such that the cannula can extend from the base element in more than one direction.

Description

Intubation equipment

technical field

The invention relates to a cannula device especially for infusion sets. Such devices can be used in various types of infusion sets.

Typically, infusion sets for intermittent or continuous administration of therapeutic substances such as insulin are in the form of two-part devices.

A conventional infusion set includes a base member having a cannula for insertion into a patient, said base member having means for receiving a connector cannula protruding from a connector, and engaging the connector cannula with the cannula of the base member. Means for forming fluid communication. Typically, the connector needle is in fluid communication with a drug delivery device, such as an insulin pump.

Background technique

Various types of infusion sets are described in WO 02/068014 A2, EP 0 956 879 A1, US 5 522 803, US 2003/0225373 A1 and WO 03/026728 A1.

US 2003/0176852 A1 discloses an infusion set in which a base element comprises a pivoting part comprising a cannula for insertion into a patient, and the pivoting part has a lumen with a receiving end adapted to receive an inserted A device needle or a connector cannula and two connection ends (3161 and 320) are used for further connection with the cannula of the base element. During insertion, the pivoting member is positioned perpendicular to the base element, and the introducer needle pierces the membrane in the receiving end so that the needle passes through the catheter and through the first connection end into the cannula, which can then be insert. After insertion, the needle is removed and the pivoting member is connected to the connector. The connector and the pivoting part are connected from the same direction as the connection between the pivoting part and the interposer. The pivoting member is then turned so that the second connection end is aligned with the cannula. This device has the disadvantage that it is sensitive to the movement of the pivoting parts, so that even a slight rotation will stop the delivery of the drug.

WO 02/094352 A2 discloses an infusion set which has such a configuration in the base element that it can receive an insertion needle from one direction and a connector needle from a second direction. This design does not allow the patient to choose in which direction he/she wants to attach the connector and base element.

In these prior art infusion sets, the configuration of the cannula and the means for providing fluid communication between the cannula and the cannula from the connector are unique to each set. Typically, each infusion set also uses specific guiding and/or locking means of the set, thus only allowing certain connectors to engage with the base element.

It would be highly desirable, both manufacturing and practical, if a common part was available, with a cannula and means adapted to receive the cannula from the connector, and suitable for most/all common infusion sets. The present invention is intended to cover an infusion set as described above and variations thereof when such generic components are used therein.

Typically, the connector and base element are connected in a plane substantially parallel to the surface of the wearer's skin or in a direction substantially perpendicular to the wearer's skin.

Furthermore, in prior art infusion sets, if the person carrying the base element wishes to change to a different base element for some reason, both the connector and the base element are replaced. It would be advantageous if different types of connectors could be used with the same base element and vice versa, and it would also be advantageous if connections from different angles were also possible.

Contents of the invention

It is therefore an object of the present invention to provide a cannula device which can be used as an integral part in most/all infusion sets and which is available for connection from more than one direction.

According to the present invention, there is provided a cannula device for an infusion set for mounting in a base element, comprising a housing and at least one membrane, both of which define at least one cavity adapted to receive a piercing member of a connector, the insertion The tube device further comprises a cannula mounted in the housing and in fluid communication with the at least one cavity, the device being receivable from a first receiving orientation to the piercing member of the connector, and furthermore being receivable from a different The piercing member of the connector is received in a second receiving orientation of the first orientation, providing fluid communication between the piercing member of the connector and at least one cavity. The device is characterized in that the intubation device has means for attaching the intubation device to corresponding means of the base element and that the housing has such a geometry that the cannula can exit the base in more than one direction Component sticks out.

An advantage of such an element is that it can be used as a critical component in an infusion set, viewed parallel and perpendicular to the connection between the connector and the base element with respect to the wearer's skin. In this way, this critical component can be mass-produced and used as a component in a range of desired designs of infusion sets. This results in lower manufacturing costs, more flexible production lines and more flexible products.

Suitable shapes which enable the cannula to protrude from the base element in more than one direction are eg a substantially cuboidal housing or a cuboidal housing having at least two sides. Such a cuboidal housing can be oriented with a cannula, pointing in multiple directions within the same hole. Another suitable geometric shape is a segment of a sphere bounded by two facets in a sphere, or a segment of an ellipsoid defined by two facets of an ellipsoid. Preferably, the angle between the tangent planes in the sphere and ellipsoid is between 60 and 120 degrees, with an angle of approximately 90 degrees being particularly preferred. Furthermore, a suitable housing may be cylindrical or in the shape of a box, which can be attached to the base in a manner that allows it to rotate.

It is to be emphasized that it is not mandatory that multiple orientations are available when attaching to the base element, but can also result from the possibility of multiple attachment directions.

In a preferred embodiment, the cannula device is releasably attached to the base element, thereby allowing its exchange. The exchanging can be carried out by removing the cannula device, for example by sliding the cannula device away from the base element guided by the integrated guide means. Another intubation device can then be equipped in the same base element by sliding the intubation device in through the same set of guides or using different guides if a different orientation of the soft cannula is desired. implemented at the appropriate location. This has the advantage that the base element can be reused several times by the patient, thereby saving medical costs. Furthermore, the option of using different cannula devices in the same base element is provided, for example having such devices with different cannula sizes, ie different lengths and/or diameters, thereby adapting the infusion set to patients using standard components.

The invention also relates to a base element having multiple sets of guide means to enable it to be connected to an intubation device of the above-mentioned type in such a way that the intubation device has more than one possible orientation of its main axis. In a preferred embodiment, the base element further has a stop which stops the cannula device at various heights and/or distances from the bottom position, thereby enabling the infusion set to be used with the same cannula device Instead, it has a variety of cannula exposure lengths (the part of the cannula that penetrates the patient).

In a preferred embodiment, the cannula device can be mounted in the base element at different levels, thereby providing the option of varying the cannula insertion depth. This gives the advantage that one cannula device and one base element can be used together for more than one insertion depth, thereby further adapting the infusion set to individual patients and furthermore as the infusion set can be used, for example, for children and adults .

Furthermore, different insertion angles can be used for the same base element. By changing from an intubation device having a first angle between the cannula and the housing to an intubation device having a second angle between the cannula and the housing, it is possible to obtain more than one angle of insertion using the same base element.

In a further preferred embodiment, the intubation device is provided with guide means for guiding the connection with the connector and/or for guiding the assembly with the base element. In a more preferred embodiment, the intubation device has more than one type of guiding and/or locking means. This allows the patient to use his or her preferred bonding orientation, for example some patients prefer bonding parallel to the skin while others prefer bonding perpendicular to the skin.

The guide means described above are used to guide the coupling, thereby fixing the needle and/or the cannula end in the correct position and position, or to guide the attachment of the cannula device to the base element.

In a preferred embodiment, the guide means guide both the assembly of the intubation device with the base element and the coupling with the connector and/or the inserter.

Preferably, the cannula device is adapted to be removably attachable to the base element of the infusion set.

Preferably, the piercing member of the connector is in the form of a cannula.

In a preferred embodiment locking means are used to releasably lock the connector and base element together.

Infusion sets with intubation devices of the above types offer unique options for patients. The cannula can now be inserted with a conventional inserter, perpendicular to the skin to give an entry of a predetermined penetration depth, and can be connected with the connector parallel to the skin surface, providing a lower profile infusion set.

In a preferred embodiment, the cannula device is a soft cannula, preferably the soft cannula is made of plastic material. The preferred plastic material for the soft cannula is one that is flexible enough to bend as the patient moves and rigid enough to avoid tangling and occluding the drug supply. Furthermore, the material must be compatible with medical use, ie must remain minimally irritating to the skin and be non-toxic, must not break down in the body, etc. Thermoplastic elastomers (TPE) are the type of material that meets these requirements. Examples of such useful elastomers are: polyester ethers, ECDEL, styrene-based TPEs, olefin-based TPEs, polyurethane-based TPEs, ester-based TPEs, amide-based TPEs, polyolefins and silicone rubbers. In a preferred embodiment, the material is selected from polypropylene, C-FLEX ^™ , C-FLEX ^™ and polypropylene, LUPOLEN ^™ 1840H, LUPOLEN ^™ 3020D, PELLETHANE ^™ 2363-75D, PELLETHANE ^™ 2363-55D, TECOTHANE ^™ and CARBOTHANE ^™ mixture.

In a preferred embodiment the housing is made of plastic material, preferably polypropylene.

In a preferred embodiment, there is an angle between the first and second directions for receiving said needle and/or piercing member of at least 45°, more preferably said directions have an angle of at least 60°, even more preferably is that said directions have an angle of at least 75° between them, most preferably said directions have an angle of at least 85° between them.

In a more preferred embodiment, in addition to the above two directions, the intubation device can receive the piercing member from more directions, which preferably have an angle of 5°-175° with respect to the first direction, More preferred is an angle of 30°-150°.

In a preferred embodiment of the cannulation device there is a membrane in the cannulation device which can be pierced and seals the piercing member surrounding the connector so as to be in fluid communication with at least one lumen for each receiving direction.

In another preferred embodiment, there is a membrane through which the cannula and/or insertion needle of the connector can pierce regardless of the possible receiving angles.

In a preferred embodiment, the cannula device comprises a plurality of wells for receiving the piercing member of the connector. These dimples are in fluid communication with the cannula of the cannulation device.

In another preferred embodiment, the cannula device is rotated relative to the base element so that after turning the base element it can be inserted without moving the inserted cannula. Optionally, the base member is rotated to the desired angle relative to the cannula, and the cannula is then inserted, preferably using an inserter.

In a preferred embodiment, the intubation device is attached to the base element by a hinge.

In a preferred embodiment, the intubation device comprises a chamber which is in fluid communication with the piercing member of the connector when the connector is connected to the base element, and which chamber is also in fluid communication with the cannula of the intubation device . Having the chamber makes it easier to adjust the connection between the connector and the base element.

In another preferred embodiment, the piercing member of the connector is in direct fluid communication with the cannula of the cannulation device, ie without a lumen. This provides the advantage of having a smaller dead volume.

In a preferred embodiment, the membrane is made of silicone, more preferably self-sealing silicone.

In a preferred embodiment, the membrane intersects the axis of the cannula.

Another embodiment of the invention relates to an infusion set comprising a cannula device of the type described above. The intubation device may be attached to the base element by, for example, mechanical means, like a rim, groove or cock; by an adhesive such as glue, or by, for example, friction, the intubation device fitting in a hole in the base element, And the friction between the side walls of the hole and the cannulation device holds the cannulation device in place. In a preferred embodiment, the base element has a first set of locking means and the intubation device has a second set of locking means for securing the intubation device in the base element. Preferably, the locking device also has release means for releasing the intubation device from the base element.

In a preferred embodiment of the infusion set, the connector comprises a cannula which is breakable at a predetermined location. This makes it possible to use the connector as an inserter to insert the cannula of the intubation device. After insertion, the cannula of the connector is broken at the desired location and the connector is then used in a conventional manner.

A second aspect of the present invention relates to an infusion set comprising a base element comprising a cannula device of the type described above for penetration into a patient, and a connector for connecting the base element to a medical device via a catheter, The connector includes a piercing part of the connector in fluid communication with the tube; the base element optionally includes a first set of guide means and a first set of locking means for locking the connector to the base element; the connection The implement optionally includes a second set of guide means adapted to mate with the first set of guide means, and a second set of locking means adapted to releasably engage with the first set of lock means.

According to another aspect of the present invention, an infusion set is provided. The infusion set includes a base member and a cannula device removably connected to the base member. The cannula device includes a housing to which at least one membrane is secured, and a cannula mounted on the housing. The cannula device is adapted to receive the piercing member of the connector from a first receiving direction and from a second receiving direction different from the first direction, with fluid communication between the piercing member and the cannula of the cannula device.

Description of drawings

The intubation device will be described in further detail with reference to the accompanying drawings.

Figure 1 is a perspective view of an embodiment of an intubation device of the present invention;

Figure 2 is an enlarged view of the housing of the intubation device shown in Figure 1;

Figure 3 is a cross-sectional view of the intubation device shown in Figure 2;

Figure 4 is a perspective view of the intubation device connected to the inserter;

Figure 5 is a perspective view of the intubation device installed in the base element of the infusion set;

Figure 6 is an exploded perspective view of the intubation device installed in the base element;

Figure 7 is a top view of the intubation device installed in the base element and enclosed by the protective part;

Figure 8 is an exploded top perspective view showing the intubation device installed in the base member, wherein the cannula is substantially perpendicular to the main plane of the base member;

Figure 9 is a side view of the inserter connected to the embodiment shown in Figure 8;

Figure 10 is a perspective view showing the installation of the intubation device in the base element;

Figure 11 is an exploded side view showing another position of the intubation device installed in the base member;

Figure 12 is an exploded view showing the embodiment of Figure 11 from a different angle;

Figure 13 is an exploded view of the intubation device mounted in a second type of base element, including an inserter and a protective component;

Figure 14 is an exploded view of the intubation device installed in the base member shown in Figure 13, wherein the intubation device is installed in a vertical orientation;

Figure 15 is a top perspective view of the intubation device with a protective component in the base element;

Figure 16 is a sectional view of the embodiment shown in Figure 15;

Figure 17 is an exploded view of the embodiment shown in Figure 14 with different protective components;

Figure 18 is a perspective view of an embodiment of an intubation device, base element and inserter;

Figure 19 is a perspective view of the embodiment shown in Figure 18 with the interposer in a vertical orientation;

Figure 20 is a perspective view of the embodiment shown in Figure 18 with the inserter removed;

FIG. 21 is a top perspective view of the embodiment shown in FIG. 18 with the protective member engaged with the base member;

Figure 22A shows the intubation device of Figure 1;

22B-D illustrate the intubation device of FIG. 22A with various protective components;

Figures 23A-D show side views of the embodiment shown in Figures 22A-D;

Figures 24A-D show top views of the embodiment shown in Figures 22A-D;

Figure 25 is a perspective view of an embodiment of the invention having a protective component;

Figure 26 is a cross-sectional view of the embodiment shown in Figure 25;

Figure 27 is an exploded view of an embodiment of the present invention including an adhesive layer;

Figure 28 is an exploded bottom view of the embodiment shown in Figure 27;

Figure 29A is another embodiment of the inventive intubation device;

Figure 29B is a partial cross-sectional view of the embodiment shown in Figure 29A;

Figure 30A is a front perspective view of the intubation device and connector;

Figure 30B is a top perspective view of the embodiment shown in Figure 30A;

Figure 31A is an exploded top view of the cannulation device, base element and connector;

Figure 31B is a perspective view of the intubation device and base element of the embodiment shown in Figure 31A;

Figure 32A is a cross-sectional view of the embodiment shown in Figure 31A;

Figure 32B is a cross-sectional view of the embodiment shown in Figure 31B;

Figure 32C is a side view of the embodiment shown in Figure 31B;

Figure 32D is a top view of the embodiment shown in Figure 31B;

33A is a perspective view of the intubation device shown in FIG. 31B, with the intubation device in a vertical orientation;

Figure 33B is a perspective view of the intubation device shown in Figure 31A, with the intubation device in a vertical orientation;

Figures 33C and D show top views of the embodiment shown in Figures 33A and B, respectively;

Figure 34A is a front perspective view of an embodiment of an intubation device;

34B is a perspective view of an embodiment of a cannulation device, base element, and adhesive layer;

Figure 35 is a cross-sectional view of the embodiment shown in Figure 34B;

36A-E are top and perspective views of an embodiment of the present invention;

Figure 37A is a top perspective view of the cannula device and connector showing the cannula in a vertical orientation;

Figure 37B is a side perspective view of the embodiment shown in Figure 37A;

Figure 37C is a top view of the embodiment shown in Figure 37A;

Figure 38A is a side perspective view of the cannula device and connector showing the cannula in a parallel orientation;

Figure 38B is a top view of the embodiment shown in Figure 38A;

Figure 39 perspective view showing the inserter with the intubation device;

40A and B are perspective views showing the intubation device installed in the connector in different positions;

Figures 41A and B are cross-sectional views of the embodiment shown in Figures 40A and B, respectively;

Figures 42A and B are side views of the embodiment shown in Figures 41 A and B, respectively;

Figure 43 is a cross-sectional view of an embodiment of the intubation device of the present invention showing the connector in communication with the cannula;

Figure 44 is a top perspective view of the intubation device, base element and connector showing the locking mechanism;

Figure 45 is a top view of an embodiment of the present invention;

Figure 46 is a top perspective view of the intubation device, base element and inserter;

Figure 47 is a perspective view of the intubation device and inserter mounted on the base member in a vertical orientation;

Figure 48 shows an inserter mountable on an intubation device;

Figure 49 is a perspective view of an embodiment of the present invention showing an angled base element;

Figure 50 is a top view of the intubation device mounted in an angled base element;

Figure 51 is a cross-sectional view of the embodiment shown in Figure 50;

Figure 52 is a front perspective view of the embodiment shown in Figure 50;

Figure 53 is a top perspective view of the embodiment shown in Figure 50;

Figure 54 is a perspective view of the embodiment shown in Figure 50;

Figure 55 is a perspective view of the embodiment shown in Figure 50;

Figure 56 is a perspective view of the embodiment shown in Figure 50;

Figure 57 is a front perspective view of the embodiment shown in Figure 50;

Figure 58 is an exploded perspective view of another embodiment of the present invention;

Figure 59 is an exploded perspective view of the intubation device and base element shown in Figure 58;

Figure 60 is a perspective view of the embodiment shown in Figure 59 with the intubation device in a vertical orientation;

Figure 61 is a perspective view of the embodiment shown in Figure 60 with the intubation device in a parallel orientation;

Figure 62 is an exploded perspective view of the embodiment shown in Figure 61;

Figure 63 is an exploded perspective view of the embodiment shown in Figure 61; and

64 is a cross-sectional view of the intubation device shown in FIG. 58 .

Figure 65 shows a section of a sphere defined by two cutting planes.

Detailed ways

Fig. 1 shows a first embodiment of the invention. In this embodiment, the intubation device 1 comprises a housing 2 and a membrane 3 which together define a cavity 6 adapted to receive a piercing member protruding from the connector. Cannula 4 is mounted in housing 2 and is in fluid communication with lumen 6 . The membrane 3 may have an oval or elongated shape covering at least a part of the two sides 8 , 10 of the intubation device 1 . The membrane 3 can also be configured in alternative shapes such as, but not limited to, circular, rectangular, triangular, and other shapes. This opens up the possibility for the connector to connect from more than one angle. Membrane 3 is shown as a single membrane which is bent around cavity 6 . Alternatively, more than one membrane may be provided for the inlet of the piercing member in different receiving directions, as described below.

In the embodiment shown in FIG. 1 , guide means 5 are provided on the housing 2 to guide connection with a device such as a connector, interposer or both. This helps ensure proper alignment of the cannula from the connector, connector needle, or both, as described below. As shown in Figures 1 and 2, and as described below, the guide means 5 can guide the connection from at least two substantially mutually perpendicular angles.

FIG. 2 shows the cavity 6 defined by the housing 2 and the membrane 3 . Lumen 6 may be in fluid communication with cannula 4 . As shown, pairs of guide means 5 extend from the housing 2 opposite each other on sides 9 , 11 of the housing 2 . Each guide means 5 may comprise a pair of elongate track members 12 adapted for sliding engagement with a device such as a connector or interposer, as described below. Each track member 12 may further include a slot 14 defined in the track member 12 for removably engaging additional or the same equipment. It will be clear to a person skilled in the art that further guide means 5 may be used for removable engagement with devices, like connectors, eg forming infusion sets, or inserters.

The sectional view of the intubation device 1 shown in FIG. 3 shows the lumen 6 in further detail. The lumen 6 defines a chamber 16 which is in fluid communication with the cannula 4 . The piercing member (such piercing member 580 , 680 described below) can penetrate the membrane 3 at any position on the membrane 3 to communicate with the chamber 16 . Thus, a piercing member such as a piercing member can be in fluid communication with the cannula 4 of the device 1, thus making it possible for the connector to be connected to the cannula device 1 from different angles. As shown in FIG. 3 , the cannula device 1 may further comprise access channels 17 and 19 for the cannula 4 . Each channel 17 and 19 may be in fluid communication with chamber 16 through the piercing member for receipt of a therapeutic substance. Alternatively, access channels 17 and 19 may receive piercing members directly for delivery of a therapeutic substance, as described below.

As shown in FIG. 4 , the intubation device 1 is connected to an inserter 50 . A needle 51 extends from the inserter 50 , penetrates the membrane 3 in a first position and protrudes through the cannula 4 . The cannula 4 of the device 1 is placed subcutaneously in the patient using the inserter 50 . After insertion, the inserter 50 is removed and the cannula 4 is left in the patient for delivery of the therapeutic substance and withdrawn later, for example, when the base member (shown in FIG. 5 ), the cannula device 1, or both are removed. when removed. FIG. 4 shows that the inserter 50 can be connected to the cannula device 1 from a first insertion direction 18 which is substantially parallel to or aligned with the axis 103 of the cannula 4 . A portion of the membrane 3 remains accessible such that it is possible to connect to the connector from a second direction 20 different from the first direction 18 . As shown, the angle between the two directions 18, 20 is approximately 90°. The first direction 18 and the second direction 20 may be predetermined by the positioning of the access chambers 17 and 19 to guide receipt of the piercing member. Alternatively, any receiving orientation may be used for the chamber 16 to allow fluid communication between the piercing member and the cannula 4 of the cannula device for delivery of the therapeutic substance. By way of example, further angles between the first direction 18 and the second direction 20 are possible. Preferably, the angle between the first direction 18 and the second direction 20 ranges from about 5° to about 175°, more preferably from about 30° to about 150°. Preferably, the angle between the first direction 18 and the second direction 20 is at least about 45°, more preferably about 60°, 75°, 85°, most preferably about 90°. Those skilled in the art will appreciate that other connection orientations are possible and from many different angles.

As shown in FIG. 5 , the cannula device 1 is assembled in the base element 100 of the infusion set 90 . In this embodiment, the base element 100 comprises a base guide 101 which cooperates with the guide 5 mounted on the housing 2 of the intubation device 1 . The guide 5 on the intubation device 1 can be used to guide and align the intubation device 1 in the base guide 101 of the base element 100 and guide the connection to the connector. The opening 102 in the part of the base guide 101 of the base element 100 can be used for the guide 5 of the intubation device 1 or the connection of a device like a connector or an inserter from a second direction other than the first direction 18. The direction 20 , the first direction 18 is parallel to the axis 103 of the cannula 4 . The guide means 5 may be an elongated rectangular track, as shown in this embodiment, or a pin, or other type of known alignment mechanism.

The protective components 104, 105 are shown in FIG. 5 . The protective parts 104 , 105 protect and at least partially enclose and cover the intubation device 1 on several sides. The protective part 105 includes a guide arm 106 and a locking arm 107, similar to guide and locking arms that may be provided on a connector. Exemplary engagement of a locking arm of a connector with an infusion set is disclosed in detail in U.S. 5,522,803, which is hereby incorporated by reference in its entirety. Guide arm 106 is adapted to mate with a mating opening 110 formed in inserter 50 as shown in FIGS. 5 and 6 .

FIG. 6 shows a perspective view of an alternative embodiment shown in FIG. 5 . Optionally, the guide arm 106 may mate with the guide 101 of the base 100, as shown in Figure 8, which shows the inserter 50 removed. The locking arm 107 releasably engages an opening 114 formed in the base 100 . The detachable engagement of the intubation device 1 with the base element 100 allows for exchanging the base element 100 and the intubation device 1 . For example, without limitation, the intubation device 1 may be removed from the base element 100 by sliding the intubation device 1 out of the base element 100 . Another intubation device 1 can be slid into the same base element 100 using the same guide arm 106 of the base element 100 . An advantage of the invention is that the same base element can be reused several times by the patient, thus saving medical costs. In addition, interchangeable cannula devices and base elements allow for the use of different cannula devices in the same base element, for example, but not limited to, cannula devices having cannulas 4 of different sizes, i.e. cannula 4 length or diameter. Such exchange allows the infusion set to be kitted out to suit the patient's needs by using these components in standard sizes.

FIG. 7 shows that the intubation device 1 is detachably mounted on the base element 100 , and the intubation device 1 and the base 100 are covered by the protective parts 104 and 105 .

Figure 8 shows the intubation device 1 mounted in the base element 100 in the alternative position shown in Figures 5-7. In particular, the cannula device 1 is mounted in a second orientation 20 , wherein the cannula 4 is mounted on the base element 100 substantially perpendicular to the main plane 118 of the base element 100 . The base element 100 comprises a plurality of guide means 105 and openings 102 to enable removable connection of the intubation device 1 in at least these plurality of orientations. As shown in FIG. 8 , the guide means 5 of the housing 2 is detachably engaged with the opening 102 on the base element 100 . Changing the orientation of the guide 5 of the housing 2 with respect to the guide 101 and the opening 102 on the base element 100 can change the angle between the cannula 4 and the base element 100 , which may be desirable in certain circumstances. The protective parts 104 , 105 are also engageable with the base element 100 when the guide means 5 of the housing 2 is slidably received in the opening 102 of the base element 100 .

As shown in FIG. 9, in conjunction with FIG. 8, when the cannula device 1 is slidably received in the opening 102 in the base member 100, an inserter 50 comprising a needle 51 extending through the cannula 4 is connected to the cannula device1. The protective parts 104 , 105 are also engaged with the base element 100 . Optionally, a connector (eg, connectors 450, 550, 650 described below) may engage the base element 100 and connect to the cannula in the position where the inserter 50 is shown or in the position where the protective member 105 is shown on device 1. As shown in FIG. 9 , the intubation device 1 and inserter 50 engage the base element 100 in a vertical orientation (compared to the parallel orientation shown in FIG. 7 ).

In FIG. 10 , the cannula device 1 is mounted in the base element 100 in a first orientation 18 , in which case the cannula 4 is substantially parallel to the main plane 118 of the base element 100 . The intubation device 1 is slidably retained in the base element 100 by means of friction between the guide means 5 of the intubation device 1 and the guide means 101 of the base element 100 . The guide arm 106 of the protective member 105 is slidably engaged in the opening 122 formed in the base 100 when the intubation device 1 is engaged with the base 100 . There are also several ways for a person skilled in the art to engage the cannulation device 1 with the base element 100 . For example, but not limited to, mechanical means, such as rims, grooves, or cocks; utilizing adhesives such as adhesives, or utilizing, for example, friction, the cannula device 1 is mated to the opening 102 in the base member 100 and passed through the cannula The device 1 is held there by friction between the sides of the guide means 5 and the sides of the opening 102 . The base element 100 may further comprise locking means which removably secure the intubation device 1 in the base element 100 . In addition, the intubation device 1 may have locking means, like the engaging notches 14 shown in FIG. 2 , for securing the intubation device 1 in the base element 100 . The locking device may further comprise disengaging means for releasing the locking device.

11 and 12 show how the locking arm of the protective part 105 or alternatively a connector having a similar locking arm (as shown in FIGS. 52-57 ) can engage within the opening 107 in the base element 100 . The cannula 4 is shown extending in a parallel direction, similar to FIG. 7 .

Preferably, the cannulation device 1 of the present invention is made of the following materials, but is not limited to the materials described here. Those skilled in the art will recognize that other materials are possible and within the scope of the present invention.

The housing 2 of the intubation device 1 of the present invention is preferably made of plastic material, more preferably polypropylene. The films of the present invention are preferably made of silicone, more preferably self-sealing silicone. The membrane is preferably adapted to be pierced by the piercing member and sealingly surrounds the piercing member so as to be in fluid communication with the cannula of the cannulation device or with at least one lumen in each receiving direction.

As shown, the cannula 4 of the cannulation device 1 is preferably a soft cannula. Preferably, the cannula 4 is made of plastic material. The preferred plastic material for the soft cannula 4 is also a material that is flexible enough to bend when the patient moves and rigid enough to avoid kinks and seal off the drug supply. Further, the material should be medically acceptable, ie minimal skin irritation, non-toxic, non-decomposable in vivo, and the like. Thermoplastic elastomers (TPE) are the type of material that meet these requirements. Examples of such elastomers include, but are not limited to: polyester ethers, ECDEL, styrene-based TPEs, olefin-based TPEs, polyurethane-based TPEs, amide-based TPEs, polyolefins, and silicone rubbers. In a preferred embodiment, the material is selected from the group consisting of polypropylene, C-FLEX™, C-FLEX™ and polypropylene, LUPOLEN™ 1840H, LUPOLEN™ 3020D, PELLETHANE™ 2363-75D, PELLETHANE™ 2363-55D, TECOTHANE™ and CARBOTHANE™ mixture.

An alternative embodiment of the invention is shown in FIGS. 13-25 illustrating the same intubation device 1 mounted in a different type of base element 200 . Figures 13-25 show how the cannulation device of Figures 1-12 can be installed in different types of infusion sets, illustrating the advantages of the cannulation device of the present invention.

As shown in FIG. 13 , the cannula device 1 is engaged with the base element 200 in the first direction 18 , in which case the cannula 4 is substantially parallel to the main plane 218 of the base element 200 . FIG. 13 also shows that the inserter 50 is connected to the cannula device 1 with a needle 51 extending through the cannula 4 . The protrusion 22 extends from the inserter 50 and slidably engages the guide 5 of the intubation device 1 .

In this embodiment, the base element 200 comprises guide means 201 which cooperate with the guide means 5 on the intubation device 1 as described above. The cannula 4 extends through an opening 203 in the base element 200 , the opening 203 being dimensioned to receive a cannula ring 210 of the cannula device 1 . The base element 200 further comprises upstanding guide means 206 , 207 adapted to slidingly receive guide means 208 , 209 of the corresponding protective part 204 when the inserter 50 is removed from the intubation device 1 . The protective part 204 may cover the cannula device 1 when the cannula 4 is fixed in the patient's skin and can deliver a therapeutic substance to the patient through the cannula 4 . The guides 208, 209 can be seen most clearly in Fig. 16, where the guides 206, 207 of the base element 200 and the guides 208, 209 of the protective part 204 are adapted to rotatably mate together so that the The protective part 204 is removably secured to the base element 200 . Preferably, the guide means 207, 208 may further comprise barbed protrusions 211 for engagement. The guides 206 , 209 may also include barbed protrusions 111 . As shown in FIG. 13 , the base element 200 preferably includes two upstanding guides 206 , 207 on opposite sides of the base element 200 . Alternatively, any number of guides 206, 207 or only guide 207 may be used to engage corresponding guides 208, 209 or guides 208, respectively, and guides 206, 207 and 208, 209 may be sufficient to protect the Part 204 is removably secured to any size of base element 200 . Other alignment, locking and/or guiding mechanisms may be provided.

The protective component 204 may include an opening 212, which is best seen in FIG. 15 . A tubing (not shown) for delivering a therapeutic substance to the cannula device 201 can be inserted through the opening 212 so that the therapeutic substance can be delivered to the patient through the cannula 4 while the cover is on the base element 200 . The protective member 204 may further include elongated openings 214 on opposite sides of the protective member 204 . Preferably, the opening 214 extends inwardly from the outer perimeter 216 of the component 204 and generally follows the contour of the outer perimeter 216 . Guard member side 218 adjacent opening 214 provides a partially flexible surface for gripping and turning guard member 204 to engage or release base member 200 . However, those skilled in the art will recognize that alternative engagement and release can be accomplished by any mechanism generally known to those skilled in the art.

FIG. 14 shows the cannula device 1 engaged with the base element 200 in a second direction 20 , in which case the cannula 4 is substantially perpendicular to the main plane of the base element 200 . FIG. 14 also shows an introducer 50 with a needle 51 connected to the cannula device 1 and extending through the cannula 4 . Interposer 50 and protective member 204 are engaged as described above with respect to FIG. 13 . Once the inserter 50 has been removed from the intubation device 1 and the base element 200 , the protective part 204 can engage with the guide means 206 , 207 of the base element 200 as shown in FIG. 15 . In some embodiments, the protective member is engageable with the base element while the inserter is also engaged with the base element, as described below. In the embodiment shown in FIG. 15 , the cannula 4 extends from the bottom of the base 200 . As mentioned above, the tubing can extend from the opening 212 .

Figure 16 shows a cross-sectional view of the device shown in Figure 15, where the protective member 204 is engaged with the base element 200, and the intubation device 1 is positioned within the base element 200, from which the cannula 4 protrudes vertically. on the main plane 218 of the base element 200 . The protective member 204 is sized and shaped to mate with the base member 200 .

The guide means 207 of the base element 200 and the guide means 208 of the protective part 204, on which the inner pair of guide means 207, 208 footprint barbed protrusions 211, are shown rotatably fixed together. As noted above and shown in FIG. 16, the outer pair of guides 207, 208 do not include barbed projections 211, however those skilled in the art will recognize that each of the guides 207, 208 may Barbed projections 211 are included. The access channels 17 and 19 of the cannulation device 1 are located under the membrane 3 and are protected by the protective member 204 .

Figure 17 shows the same intubation device 1 engaged with the same base element 200 by the guide 5 of the intubation device 1 being inserted into the base guide 201, where the cannula 4 is in a first direction 18 extends substantially parallel to the main plane 218 of the base element 200 . FIG. 17 shows a pair of protective parts 250 , 252 which are engageable with the base element 200 to cover the intubation device 1 and the base element 200 . The guard members 250 , 252 are sized and shaped to mate with the base member 200 to cover the base member 200 . As mentioned above, alternative shapes for the base element 200 and the protective components 250, 252 are also possible. Other configurations for mating these various elements together may also be used.

The protective part 250 comprises a pair of guide means 254 which may be adapted to engage the guide means 207 of the base element 200 . As mentioned above, base element 200 may include guide means 206 . The guide 206 is slidable with the protrusion 256 on the outer periphery 258 of the protective part 250 . The protective member 250 may further include a notch 260 for engaging an edge 270 of the base element 200 . The protective part 250 covers a part of the membrane 3 of the cannula device 1 and can also engage the protective part when the base element 200 is attached to the patient's skin and the cannula 4 is positioned percutaneously for therapeutic substance delivery. 252 thus covering the base element 200 . As shown in FIG. 17, the protective part may comprise a portion 264 for covering the membrane 3 of the intubation device 1, and this part 264 may be pierced by a needle different from the rest of the protective part, such as the needle 51 of the inserter 50. made of materials. For example, portion 264 may be integrally molded to protective member 250 and formed from an elastomer. The protective member 252 is slidably engaged with the protective member 250 .

FIG. 18 shows the protective member 250 engaged with the base element 200 as described above in FIG. 17 . The protective member 252 can be removed from the protective member 250 and the base member 200 when the protective member 250 is engaged with the base member 200 . The needle 51 of the inserter 50 can be inserted into the membrane 3 of the cannula device 1 and extends through the cannula 4 in the first direction 18 . The inserter 50 can be removed and replaced with the protective member 252, or alternatively with a connector, like the connectors 450, 550, 650 described below, for delivery of the therapeutic substance.

Fig. 19 shows the cannula device 1 (under the protective parts 250, 252), which is engaged with the base element 200 in the second direction 20, and the inserter 50 inserts the needle 51 into the cannula device 1 in the second direction Pass through cannula 4. FIG. 19 shows that the needle 51 pierces the portion 264 of the protective member 250 . When the cannula device 1 is engaged with the base element 200 in the second direction 20, the protective members 250, 252 may remain engaged with the base element 200, thereby protecting the base element when the needle 51 of the introducer 50 extends through the cannula 4 200 and intubation equipment 1 .

FIG. 20 shows the embodiment of FIG. 17 described above, showing the guard member 250 engaged with the base member 200 and the guard member 252 not yet engaged. As shown, the guard member 252 is engageable in a direction parallel to the direction in which the cannula 4 protrudes from the base element 200 . FIG. 21 shows the compact dimensions of the device when the protective part 252 is engaged with the protective part 250 and the base element 200 . In this form, more sensitive components of the device are covered and protected, while the components themselves are easily transported and packaged. As described above, the protective member 252 can be removed and a connector can be inserted in place of the protective member 252 , with similar compact dimensions.

FIG. 22 shows a perspective view of the intubation device 1 and includes several assembly configurations, including base elements 100 , 200 and protective parts 104 , 105 , 204 , 250 , 252 . Fig. 22A shows the intubation device 1 itself. FIG. 22B The intubation device 1 is inserted into the base element 100 . The protective parts 104, 105 cover the base element 100 and the cannulation device 1, while at least part of the membrane 3 can be inserted by an inserter or connector needle for delivery of a therapeutic substance.

FIG. 22C shows the intubation device 1 engaged with the base element 200 . The protective part 204 is shown covering the intubation device 1 and the base element 200, already mentioned above.

FIG. 22D shows the intubation device 1 engaged with the base element 200 and the protective parts 250 , 252 covering the intubation device 1 and the base element 200 .

Figures 23A-D show side views of an intubation device 1 engaged with a corresponding embodiment different from that shown in Figures 22B-D.

Figures 24A-D show top views of the embodiment shown in Figures 22B-D, respectively.

Figure 25 shows another embodiment of the present invention. As shown, the base element 300 engages the protective components 350, 352 to form a compact device. Attached to the base element 300 is shown an adhesive layer 310 for adhering the base element 300 to the patient's skin.

FIG. 26 shows a cross-sectional view of the embodiment shown in FIG. 25 . The base member 300 includes a plurality of protrusions 320 having bottom surfaces 322 which together form a bottom surface 324 of the base member 300 as shown in FIGS. 26 and 28 . An access port 328 may be formed in the base member 300 , wherein the access port 328 is connected to a passageway 330 that is in fluid connection with the cannula 304 extending from the base member 300 . The protective member 352 can be removed and a connector, such as the connectors 450, 550, 650 described below, can be inserted in the same location for delivery of the therapeutic substance. Adhesive layer 310 is adhered to bottom surface 322 of base member 300 and is formed of a material that is pierceable by a needle of an introducer (not shown), extending through cannula 304 . Optionally, adhesive layer 310 may include an opening through which cannula 304 may protrude.

FIG. 27 shows an exploded view of the embodiment shown in FIG. 25 . As shown, the guard member 352 includes a guide arm 306 and a locking arm 307 for engagement of the guard member 352 with the base member 300 . The locking arms 307 are engageable with the base member 300 through corresponding openings 314 in the base member 200 as described above in FIGS. 5 and 6 .

FIG. 28 shows an exploded bottom view of the embodiment shown in FIG. 25 . A protrusion 320 is shown having a bottom surface 322 on the base member 300 . The base element 300 further comprises a peripheral surface 332 extending around the periphery of the base element 300 , to which the adhesive layer 310 can be bonded in addition to the surface 322 . As shown in Figures 25-28, the general shape of the embodiment is cylindrical, with an adhesive layer 310, base member 300 and protective members 350, 352 shaped to fit together to form a compact device. Those skilled in the art will recognize that alternative shapes are possible, including but not limited to oval, rectangular, and square, and that it is preferred that the components of the embodiments form a compact device.

An alternative embodiment of an intubation device 401 is shown in FIGS. 29A and 29B . The intubation device 401 comprises a housing 402 , a membrane 403 and openings 405 , 407 . Preferably, housing 402 is generally cylindrical, although other shapes are possible. In this embodiment, the cylindrical shape includes radially extending protrusions 413 (or flanges) that define openings 405 and 407 and that when positioned in a base member such as base member 400 shown in FIG. 30A , which can be used as a guide. As shown in the cross-sectional view of Figure 29B, the membrane 403 together with the housing 402 defines a cavity 406 in the housing 402, and the cavity 406 is located in the housing 402 for receiving a piercing member from a connector (described below) . Cannula 404 protrudes from housing 402 below lumen 406, as shown in Figure 29B. In this embodiment, the housing 402 is rotatably attached to the base member 400, as shown in FIG. Rotation, without moving cannula 404, thereby minimizing pain for the patient. Alternatively, base member 400 may be rotated relative to cannula 404 to a desired angle, and cannula 404 then inserted using an inserter such as inserter 50 shown in FIG. 4 . As shown in FIG. 29A , end portion 412 may be generally circular in order to provide rotation within base member 400 . However, end portion 412 may be of any size and shape capable of moving within base member 400 as will be apparent to those skilled in the art.

In FIGS. 30A and B it can be seen that the cannula 404 of the cannula device 401 is connected to the base member 400 and the inserter 450 . In this embodiment, the base element 400 includes a connection member 446 adapted to receive the end portion 412 of the housing 402 . Connection member 446 and end portion 412 may be shaped and sized to facilitate rotation of housing 402 relative to base member 400 . The device 401 further comprises an adhesive layer 410 for adhering the base element 400 to the patient's skin. The adhesive layer 410 is shown attached to the base member 400, and the adhesive layer 410 may include a cut-out portion 448, which is when the end portion 412 of the housing 402 is rotated in the connecting part 446 of the base member 400 to change the position of the cannula 404. The angle relative to the skin is used for the cannula 404 .

Connector 450 connects to intubation device housing 402 through openings 405, 407 in housing 402 (also shown and described below with reference to FIG. 31A). Connector 450 may further include tubing 452 for delivering a therapeutic substance to cannula 404 for delivery to the patient. The connector 450 may include a button 454 for releasing the connector 450 from the housing 402 . Alternatively, any method of releasing the connector 450 from the housing 402 can be used, including, but not limited to, pressing the external portion 456 on each side of the connector 450 to release the grip arm 458 ( shown in Figure 31A).

FIG. 31A shows connector 450 prior to connection with housing 402 . The connector 450 may include locking arms 458 and guides 470 similar to those of the protective component used with the intubation device 1 described above. Locking arm 458 enables connector 450 to be inserted into opening 405 in housing 402 and removably locked in place for delivery of a therapeutic substance. Connector 450 may also include a piercing member 480 that connects connector 450 to cannula 404 . Piercing member 480 may be inserted through membrane 403 and into cannula 404 or into lumen 406 to be in flow communication with cannula 404 . The piercing member 480 is adapted to break at a predetermined location. This allows the connector 450 to be used as an inserter for inserting the cannula 404 of the cannulation device 401 . The piercing member 480 can then be broken at the desired location, thereby using the connector 450 in a conventional manner. The piercing member 480 extends through the membrane and can pierce the membrane, but does not have to puncture the membrane. For example, the piercing member may be inserted through a pre-formed hole in the membrane. The term piercing member as used herein may include a cannula, including a rigid cannula or needle, a semi-rigid cannula, or a soft cannula or any member suitable for piercing a membrane.

As shown in FIGS. 31A and B, the base member 400 of this embodiment may be flexible or hinged to facilitate rotation of the housing 402 within the base member 401 . Figure 3 IB shows the cannula 404 turned towards the skin and the base member 400 flexed to rotate. The base element 401 may further include a hinge 472 connected to the connection part 446 . Hinge 472 may be used to rotate cannula 404 from a parallel to the skin to an angle towards the skin. Rotation of housing 402 may also cause cannula 404 to be inserted into the skin, accompanied by a syringe needle, such as needle 51 shown in cannulation device 1 . The connector 450 can be connected at any angle and the insertion device 480 can be inserted into the membrane 403 from multiple directions.

FIG. 32A forms a cavity 406 in the housing 402 and a cannula 404 protruding from the cavity 406 . FIG. 32B shows a portion of housing 402 cut away from base member 400 . The connection member 446 is shown to be of circular configuration having a raised perimeter 474 and a central recess 476 adapted to receive the end portion 412 of the housing 402 . A portion of the base member 400 is shown protruding from the connection member 446 . Figure 32C shows the cannula 404 rotated from a parallel to the skin direction. FIG. 32D shows a top view of the intubation device 401 .

Figures 33A-D show a cannulation device 401 with a cannula 404 extending in a different direction than previously shown in Figures 30-32. Cannula 404 is shown extending substantially perpendicular to cannula 404 shown in FIGS. 31-32 . FIG. 33B shows the cannula device 401 in a state where the cannula 404 extends perpendicularly from the base member 400 . Connector 450 is shown removably connected to housing 402 in openings 405 , 407 of housing 402 . Opening 482 in adhesive layer 410 is shown in FIG. 33B to allow cannula 404 to extend through and into the patient's skin. Figures 33C and D show top views of the intubation device 401 shown in Figures 33A and B, respectively.

FIG. 34 shows housing 402 with openings 405 , 407 . Membrane 403 is shown in the center of housing 402 for receiving an insertion device for flow delivery of a therapeutic substance through cannula 404 . The end portion 412 is shown having a generally rectangular shape for mating with a similarly shaped connection member 446 of the base member 400 shown in Figure 34B. As mentioned above, the housing 402 is rotatable within the base element 400 .

FIG. 35 shows cavity 406 formed inside housing 402 . Membrane 403 may cover a portion of cavity 406 . The top portion 484 of the cannula 404 connects with the cavity 406 within the housing 402 . Lumen 406 allows insertion of the piercing member of the connector into membrane 403 from any receiving orientation, and puts cannula 404 in fluid communication with the connector for delivery of a therapeutic substance. In this embodiment, the cannula 404 is shown extending perpendicularly from the housing 402 with respect to the plane 418 of the base member 400 . A pair of openings 486 are shown on the housing 402 for receiving a connector or protective component in two different orientations. The base element 400 also includes a substantially square-shaped connection member 446 for receiving the end portion 412 of the housing 402 . Adhesive layer 410 may be adhered to the patient's skin.

36A-E show intubation device 401 from different angles. FIG. 36A shows a top view of intubation device 401 with connector 450 attached to housing 402 . Cannula 404 is shown extending in a direction substantially parallel to base member 400 . Tubing 452 extends from connector 450 for connection to a medical device (not shown) for delivery of a therapeutic substance. Figure 36B shows the intubation device 401 from Figure 36A with the connector 450 removed. Figure 36C shows a perspective view of the intubation device 401 of Figure 36A. FIG. 36D shows a rear perspective view of intubation device 401 with connector 450 attached to housing 402 .

37A-C illustrate a cannulation device 401 in which the cannula 404 extends in a direction substantially perpendicular to the plane 418 of the base member 400 . FIG. 37A shows the connector 450 being connected within a set of openings 484 in the housing 402 , where the connection is parallel to the plane of the base member 400 . A second set of the pair of openings 488 is shown open in a second direction in which the connector 450 may be inserted, wherein the connection is substantially perpendicular to the plane 418 of the base member 400 . FIG. 37B shows a side perspective view of the cannula device 401 with the cannula 404 extending below the base element 400 . Figure 37C shows a top view of the device shown in Figure 37A.

FIG. 38A shows the cannula device of FIG. 37A with the housing 402 repositioned in the base element 400 so that the cannula 404 extends substantially parallel to the plane 418 of the base element 400 . The connector 450 is shown connected to the housing 402 in a direction parallel to the plane 418 of the base member 400 . 38B is a top view of the intubation device 401 shown in FIG. 38A , where it can be seen that the guide arm 470 and the locking arm 458 from the connector 450 are connected to the housing 402 to form a removable connection.

FIG. 39 shows the intubation device 501 connected to the inserter 550 . The intubation device 501 is shown removed from the base element to reveal the connection of the inserter 560 to the guide 505 of the intubation device 501 .

As shown in Figures 40A and B, the cannula device 501 can be connected to the connector 550 at different heights and distances from the patient's skin so that the cannula 504 can penetrate to different depths into the patient's skin. Positioning member 507 is shown in FIGS. 40A and 41A , positioned below intubation device 501 . A positioning member 507 may be positioned between the base member 500 (shown in FIG. 43 ) and the cannula device 501 for varying the height and distance at which the cannula device 501 is inserted into the skin. The positioning feature 507 allows the cannulation device 501 to be positioned higher in the connector 550 in FIG. 40A when compared to the position of the cannulation device in the connector 550 in FIG. 41A and 41B). The use of multiple guides can also position the cannula device at multiple heights relative to the base element. The multiple heights of the cannula device relative to the base element enable one cannula device and one base element together to be used for more than one insertion depth, adapting the infusion set to individual patients and thus also making the infusion set usable for children and aldult. Cannula device 501 also includes a membrane 503 adapted to receive a piercing member 580, such as a cannula, from connector 550, thereby fluidly connecting connector 550 to cannula 504 for delivery of a therapeutic substance. Those skilled in the art will appreciate that the cannula may be rigid, such as but not limited to a needle, semi-rigid or flexible.

Figures 41A and B show partial views of the embodiment shown in Figures 40A and B. Figure 41A shows an embodiment that allows connection of cannula device 501 and connector 550 from two different orientations. As shown, membrane 503 is a single membrane mounted on housing 502 . Multiple films 503 are also possible, as described below. A piercing member 580, shown as a cannula, can extend from the connector 550 and pierce the membrane 503 and depending on the orientation in which the piercing member 580 is received into the cannula device 501, the piercing member 580 can be within one of the two lumens 512 Finally, the two cavities 512 are formed in the intubation device 501 . The two lumens 512 may be in fluid communication with each other through a passageway 514 formed in the cannulation device 501 . Preferably, passageway 514 is provided inside housing 502 . This embodiment allows piercing member 580 to be in fluid communication with cannula 504 regardless of the direction in which the insertion device is inserted through membrane 503 . As shown in FIG. 41A , the piercing member 580 is substantially perpendicular to the cannula 504 of the intubation device 501 , and the cavity 512 into which the piercing member 580 is inserted and terminates, the flow communication passage 514 and the cannula 504 are connected. The chamber 516. Those skilled in the art will appreciate that the piercing member 580 may also be inserted into the membrane 503 from the top of the cannula device 501 in a direction substantially parallel to the cannula 504 . Piercing member 580 may also be inserted through membrane 503 and piercing member 580 may terminate within cannula 504 such that piercing member 580 is in direct flow communication with cannula 504 rather than through lumen 512 or passageway 514 .

Figure 41B shows an intubation device 501 that is connectable to a piercing member 580 from two directions, and wherein the piercing member 580 is connected to a single lumen 522 through the membrane 503 from either direction. The insertion device can enter the chamber 522 from the hole 524 in the wall 523 of the chamber 522 when the piercing member 580 is inserted through the membrane 503 in a direction perpendicular to the direction of the cannula 504 . Figures 41A and B also show that cannula device 501 is connected in connector 550 at different heights.

42A and B show side views of an intubation device 501 connected in a connector 550 at different heights.

FIG. 43 shows a connector 550 which is connected to the intubation device 501 and which can be mounted in the base element 500 . As shown, the connector 550 connects in a direction parallel to the main plane of the base element 500 . Connector 550 includes piercing member 580 shown connected directly to cannula 504 through membrane 503 .

FIG. 44 shows intubation device 501 connected to connector 550 and mounted in base element 500 . The cannula 504 extends in a direction parallel to the plane 518 of the base member 500, perpendicular to the direction shown in Figures 42A and B. The connector 550 includes a guide arm 506 and a locking arm 507 . As mentioned above, the guide arms assist in positioning the intubation device 501 in the base member 500 and the locking arms 507 removably lock the connector 550 and the base member 500 together. The locking arm 507 is shown extending into and locking a portion of the base member 500 and into an opening 511 on the base member 500 . Side 513 of locking arm 507 includes ridges 517 to help the patient grip locking arm 507 and slide connector 550 and base member 500 together to removably lock connector 550 and base member 500 . The gripping arm 507 may also be flexible so that the patient can push inward on the locking arm 507 to release the locking arm from the base element 500 . The membrane 503 remains exposed on top of the cannulation device 501 .

FIG. 45 shows intubation device 501 together with connector 550 and tubing 552 and base element 500 . Adhesive layer 510 is also shown with a cut-out 515 for cannula 504 .

FIG. 46 shows a cannula device 501 mounted on a base element 500 with a cannula 504 extending in a direction parallel to the main plane of the base element 500 . Inserter 560 is connectable to base element 500 and cannulation device 501 . A needle 561 protrudes from the introducer 560 through the membrane 503 of the cannula device and through the cannula 504 . FIG. 47 shows that the intubation device 501 shown in FIG. 46 is rotatable in a direction perpendicular to that shown in FIG. 46 and is mounted on the same base element 500 as shown in FIG. 46 . Cannula 504 extends downwardly from base member 500 . Inserter 560 is also shown connected to base member 500 and cannulation device 501 in a direction perpendicular to the direction shown in FIG. 46 .

FIG. 48 shows inserter 560 . Needle 561 extends from inserter 560, and guide arms 563 may extend on both sides of needle 561 for slidingly connecting guides of the cannula device (as described and shown above) to guide inserter 560 into the cannula The location in device 501.

FIG. 49 shows an embodiment similar to that shown in FIG. 45 with an angled base element 600 . The angled base member 600 can be seen more clearly in the side view shown in Figure 51, which shows the connector 650 inserted into the base member 600 at an angle relative to the base member's main plane 618. Cannulation device 601 may be mounted in base element 600 in several orientations including that shown in FIG. Connector 650 may be connected to base element 600 and cannulation device 601 . Connector 650 may include piercing member 680 that is inserted through membrane 603 of cannula device 601 to establish fluid communication between tubing 652 to cannula 604 for delivery of a therapeutic substance to the patient's skin. The connector 650 may also include a locking arm 607 that extends through an opening 611 in the connector 650 to removably lock the connector 650 to the base member 600 . Also shown is an adhesive layer 610 which is attached to the base element 600 and which may include a cut-out 615 for the cannula 604 . FIG. 50 shows a top view of the embodiment shown in FIG. 49 .

FIG. 52 shows a pipe planting device 601 with an angled base element 600 . As mentioned above, the connector 650 can be connected to the base element 600 . Connector 650 further includes guide arms to assist positioning of intubation device 601 within base member 600 (not shown, as described above in the embodiment of FIG. 6 ). The locking arm 607 removably engages with the base member 600 through an opening 611 in the base member 600 . Locking arm 607 is shown extending into and removably locking a portion of base member 600 into opening 611 in base member 600 . Side 613 of locking arm 607 may include ridges 617 to assist the patient in gripping the locking arm and removably locking connector 650 and base member 600 . The gripping arm 607 may also be flexible so the patient can push inwardly on the locking arm 507 to release the locking arm 607 from the base member 600 . 53-57 show perspective views of the intubation device 601 shown in FIG. 52 .

Figures 58-65 illustrate another preferred embodiment of the present invention. In FIGS. 58 and 59 , the cannulation device 701 is shaped as a cuboid and positioned in the base element 700 such that the cannula 704 of the cannulation device 701 is substantially perpendicular to the main surface 705 of the base element 700 . As noted above, other shapes of cannula device 701 are possible. Cannula device 701 may receive an insertion needle of an introducer (eg, as previously described and shown in FIG. 4 ) and connector 750 with cannula 751 from a direction substantially parallel to cannula 704 . The cannulation device 701 may comprise at least one membrane 703 through which an insertion needle or piercing member 751 is inserted. Figures 58 and 59 show a cannulation device 701 with two membranes 703, however, it will be appreciated by those skilled in the art that more membranes 703 are possible. A protective member or inserter may also be used for the cannula device 701 and base element 700 instead of the connector 750, as described above.

In addition, FIGS. 58 and 59 show that the connector 750 can be connected to the base member 700 from a direction substantially perpendicular to the cannula 704, and the piercing member 751 can pierce the membrane from a direction perpendicular to the connector 750 shown in FIG. 703. Cannula device 701 is configured in such a way that when cannula 704 is received regardless of the direction in which piercing member 751 is received, cannula 704 is in fluid communication with piercing member 751 . In the embodiment shown in Figures 58 and 59, the intubation device comprises a lumen 706, which is similar to the lumen 6 of the intubation device 1 described above. Alternatively, cannulation device 701 may not include lumen 706, with piercing member 751 in flow communication with cannula 704, similar to receiving a piercing member without lumen 706, similar to the device described above in FIG. 41B.

58 and 59 also illustrate an alternative mechanism for the removable locking connector 750 and base member 700 . The connector 750 includes a locking arm 707 for removably locking the base element 700 to the connector 750 . The locking arm 707 further includes a notched protrusion 720 for engaging the angled protrusion 722 on the base member 700 . The notched projection 720 of the connector 750 is slidably engaged with the angled projection 722 of the base member 700 . Projection 720 snaps together with projection 722 and projection 720 fits in the gap of base member 700 to releasably lock base member 700 to connector 750 . The base member 700 can be released from the connector 750 by pressing on the protrusion 720 . The connector 750 may also include a guide arm 706 to slidably engage the guide 705 of the intubation device 701 . Of course, alternative locking means may be used to releasably engage base member 700 and connector 751 .

58-60 illustrate cannula 704 extending substantially perpendicular to major surface 705 of base member 700 such that cannula 704 penetrates the patient's skin substantially perpendicular to major surface 705 of base member 700 . The base element 700 includes an opening 709 through which the cannula 704 of the cannulation device 701 can extend.

FIG. 61 shows cannula 704 extending in base member 700 through opening 709 substantially parallel to major surface 705 of base member 700 . 62 and 63 show the cannula device 701 prior to connection with the base element 700 , where the cannula 704 is to extend through the opening 709 , substantially parallel to the main surface 705 of the base element 700 .

FIG. 64 shows an example of the inner portion 713 of the intubation device 701 . In this embodiment, piercing member 751 is to be inserted directly into channel 715 without a lumen for fluidly connecting piercing member 751 and cannula 704 as described above. Cannula connector 751 can pierce membrane 703 from either direction shown and directly into channel 715 to be in flow communication with cannula 704 .

Although the present invention has been described in conjunction with the preferred embodiments of the present invention, those skilled in the art will appreciate that additional additions, modifications, substitutions and deletions not specifically described can be made without departing from the appended The spirit and scope of the present invention are defined by the appended claims. The foregoing detailed description is therefore to be considered as illustrative rather than limiting, and it is to be understood that the following claims, including all equivalents, are intended to define the spirit and scope of this invention.

Figure 65 shows a segment of a sphere defined by two planes that cut the sphere into different segments, where the two planes have a line of intersection within the sphere. The shape of this section is useful as the shape of the cannula device housing. As an alternative to a segment of a sphere, a segment of an ellipsoid defined in the same way can be used, i.e. a segment of an ellipsoid defined by two planes that cut the ellipsoid into different segments, where the The two planes have intersecting lines within the ellipsoid.

Claims (25)

1. catheterization equipment (1,201,401 that is used for infusion set, 501,601,701), be used to be installed in seat element (100,200,300,400,500,600,700) in, described catheterization equipment comprises housing (2,402,502) and at least one thin film (3,403,503,603,703), described housing and described at least one thin film limit at least one together and are suitable for receiving connector (450,550,650,750) lancet and means (580,680) cavity (6,406,706), described catheterization equipment (1,201,401,501,601,701) further comprise intubate (4,304,404,504,604,704), this intubate is installed in described housing (2,402,502) in and with described at least one cavity (6,406,706) fluid is communicated with, and wherein said catheterization equipment can be from the described lancet and means (580,680) of first receive direction (18) receiving connector, and in addition can be from being different from second receive direction (20) receiving connector (450,550,650 of described first receive direction (18), 750) described lancet and means (580,680), thereby at the lancet and means (580 of adapter, 680) and described at least one cavity (6,402,502) provide fluid to be communicated with between, described catheterization equipment has and is used for catheterization equipment (1,201,401,501,601,701) be attached to the related device (101 of seat element, 210) device on (5), and described catheterization equipment is characterised in that described housing (2,402,502) geometry that has makes intubate (4,304,404,504,604,704) can along more than one direction (18,20) from seat element (100,200,300,400,500,600,700) stretch out.

2. catheterization equipment as claimed in claim 1 is characterized in that described catheterization equipment (1,201,401,501,601,701) comprises the thin film (3,403,503,603,703) that is used for each receive direction (18,20).

3. catheterization equipment as claimed in claim 1 or 2 is characterized in that described catheterization equipment comprises two thin film (3,403,503,603,703).

4. catheterization equipment as claimed in claim 1 is characterized in that the angle between first receive direction (18) and second receive direction (20) is at least 45 °.

5. catheterization equipment as claimed in claim 1 is characterized in that catheterization equipment (1,201,401,501,601,701) is suitable for receiving intubate (4,304,404,504,604,704) from other direction.

6. catheterization equipment as claimed in claim 5 is characterized in that the angle between described first receive direction (18) and described other direction (20) is 5 °-175 °.

7. catheterization equipment as claimed in claim 1 is characterized in that described thin film (3,403,503,603,703) is self-packing.

8. catheterization equipment as claimed in claim 7 is characterized in that described thin film (3,403,503,603,703) made by silicones.

9. catheterization equipment as claimed in claim 1 is characterized in that the housing (2,402,502) of described catheterization equipment (1,201,401,501,601,701) comprises guiding device (5,505).

10. catheterization equipment as claimed in claim 1 is characterized in that the housing (2,402,502) of described catheterization equipment (1,201,401,501,601,701) comprises locking device (14).

11. catheterization equipment as claimed in claim 10 is characterized in that the locking device (4) of described catheterization equipment (1,201,401,501,601,701) further comprises releasing device, is used to throw off locking device (14).

12. catheterization equipment as claimed in claim 9 is characterized in that guiding device (5,505) guide cannula equipment (1,201,401,501,601,701) with seat element (100,200,300,400,500,600,700) assembling, guide cannula equipment (1,201,401,501,601,701) with adapter (450,550,650,750) combination, and/or guide cannula equipment (1,201,401,501,601,701) with the combination of inserter (50,560).

13. catheterization equipment as claimed in claim 1 is characterized in that the housing (2,402,502) of described catheterization equipment (1,201,401,501,601,701) comprises a plurality of pits.

14. catheterization equipment as claimed in claim 1 is characterized in that described catheterization equipment (1,201,401,501,601,701) has drum.

15. catheterization equipment as claimed in claim 1 is characterized in that described catheterization equipment (1,201,401,501,601,701) comprises a cavity (6), this cavity is by membrane sealed.

16. seat element (100,200,300,400,500,600,700) catheterization equipment (1,201 that, is used for infusion set, 401,501,601,701) be installed in the described seat element, described catheterization equipment comprises housing (2,402,502) and at least one thin film (3,403,503,603,703), described housing and described at least one thin film limit at least one together and are suitable for receiving connector (450,550,650,750) lancet and means (580,680) cavity (6,406,706), described catheterization equipment (1,201,401,501,601,701) further comprise intubate (4,304,404,504,604,704), this intubate is installed in described housing (2,402,502) in and with described at least one cavity (6,406,706) fluid is communicated with, and wherein said catheterization equipment can be from the described lancet and means (580,680) of first receive direction (18) receiving connector, and in addition can be from being different from second receive direction (20) receiving connector (450,550,650 of described first receive direction (18), 750) described lancet and means (580,680), thereby at the lancet and means (580 of adapter, 680) and described at least one cavity (6,402,502) provide fluid to be communicated with between, described catheterization equipment has and is used for catheterization equipment (1,201,401,501,601,701) be attached to the related device (101 of seat element, 210) device on (5), and described catheterization equipment is characterised in that described housing (2,402,502) geometry that has makes intubate (4,304,404,504,604,704) can along more than one direction (18,20) from seat element (100,200,300,400,500,600,700) stretch out.

17. seat element as claimed in claim 16 is characterized in that described catheterization equipment (1,201,401,501,601,701) can be attached on the seat element (100,200,300,400,500,600,700) with differentiated levels.

18. seat element as claimed in claim 16 is characterized in that seat element (100,200,300,400,500,600,700) have catheterization equipment (1,201,401,501,601,701) on more than one direction, be attached to seat element (100,200,300,400,500,600,700) device on, described catheterization equipment has catheterization equipment (1,201,401,501,601,701) central axis.

19. as each the described seat element among the claim 16-18, it is characterized in that described seat element comprises guiding device (101,201), described guiding device is suitable for engaging with the guiding device (5) of catheterization equipment (1,201,401,501,601,701).

20., it is characterized in that described seat element comprises locking device as each the described seat element among the claim 16-18.

21. seat element as claimed in claim 20 is characterized in that described locking device is used for catheterization equipment (1,201,401,501,601,701) is locked onto on the seat element (100,200,300,400,500,600,700).

22. seat element as claimed in claim 20 is characterized in that described locking device is used for a connector is locked onto on the seat element (100,200,300,400,500,600,700).

23., it is characterized in that described catheterization equipment (1,201,401,501,601,701) can be with respect to the remainder rotation of seat element (100,200,300,400,500,600,700) as each the described seat element among the claim 16-18.

24. seat element as claimed in claim 23 is characterized in that described catheterization equipment (1,201,401,501,601,701) is attached on the seat element (100,200,300,400,500,600,700) by hinge (472).

25. one kind includes seat element (100,200,300,400,500,600,700) and adapter (450,550,650,750) infusion set, this seat element comprise as each describedly is used to insert the intravital catheterization equipment (1,201 of patient among the claim 1-15,401,501,601,701), described adapter (450,550,650,750) by conduit with seat element (100,200,300,400,500,600,700) link together described adapter (450 with armarium, 550,650,750) comprise adapter (450,550,650,750) lancet and means (580,680,751), this lancet and means is communicated with described catheter fluid; Seat element (100,200,300,400,500,600,700) comprises the first cover guiding device and the first cover locking device, is used for adapter is locked onto on the seat element (100,200,300,400,500,600,700); Described adapter (450,550,650,750) but comprise is suitable for the second cover guiding device that connects with the first cover guiding device and is suitable for locking device with second cover of delivery mode and the first cover locking means for engaging.

Images