Patent Description:
A conventional insertion device disclosed in <CIT> is for inserting a biosensor into a host, and includes a plunger, and a piercing assembly to which a sensor assembly is mounted.

The piercing assembly is inserted into the host upon depression of the plunger, and is retracted from the host when the plunger is released. During the insertion and retraction operations, the piercing assembly may be obliquely inserted into the host, and may therefore be obliquely retracted from the host to cause discomfort of the host.

<CIT> relates to an insertion device including an applicator and sensor module disposed in the applicator. The applicator includes a plunger body and a needle extracting body connecting the plunger body to a needle part. During downward movement of the needle, the plunger body is spaced apart from a protruding surface of a hook guiding part, and a stopper protrusion of the plunger body serves to limit a travel distance of the plunger body.

<CIT> relates to an insertion device where a member moves a needle to cause the needle to move within an internal housing of the device and actuate the needle, thereby allowing the needle to be retracted into the internal housing after insertion.

Therefore, an object of the disclosure is to provide an insertion module that can alleviate at least one of the drawbacks of the prior art.

According to the disclosure, the insertion module is adapted to guide an insertion needle to move stably before inserting into a host, and includes a main body, an auxiliary insertion seat, an insertion needle assembly and a sensor assembly. The main body has an accommodating hole that extends along an axial line, and a plurality of slide grooves that are disposed on the accommodating hole around the axial line and communicate with the accommodating hole. The auxiliary insertion seat has a base portion, and a plurality of wing portions that are connected to the base portion. Each of the wing portions is reciprocated within a respective one of the slide grooves, and has a protruding portion. The insertion needle assembly includes a needle seat assembled with the base portion of the auxiliary insertion seat, and an insertion needle that is connected to the needle seat. A distance between a tip end of the insertion needle and a skin surface of the host is defined as an initial stroke distance. The sensor assembly includes a sensing seat, and a sensor that is held within the sensing seat. The sensing seat is assembled with the base portion of the auxiliary insertion seat. The insertion needle is inserted through the sensing seat to cover the sensor. Each of the slide grooves has a wall surface. The protruding portion of each of the wing portions resiliently abuts against the wall surface of a respective one of the slide grooves in point-contact such that the auxiliary insertion seat is fixed before inserting into the host through the interference between the protruding portions and the wall surfaces to provide a stable inserting and prevent the insertion needle from oblique in said initial stroke distance. The wall surface of each of said slide grooves is gradually widened along an insertion direction.

Another object of the disclosure is to provide an insertion device that can alleviate at least one of the drawbacks of the prior art.

According to the disclosure, the insertion device includes an actuation module and an insertion module. The actuation module includes a cover body, a main cover received in the cover body, an insertion seat connected to the main cover, a first elastic member abutting against the main cover and the insertion seat, a retraction seat disposed between the main cover and the insertion seat, and a second elastic member abutting against the retraction seat and the insertion seat. The insertion module is as described previously.

Other features and advantages of the disclosure will become apparent in the following detailed description of the embodiments with reference to the accompanying drawings, of which:.

Referring to <FIG>, the first embodiment of the insertion device according to the disclosure is able to guide an insertion needle to move stably before inserting into a host, and includes a limiting member <NUM>, an actuation unit <NUM> and an insertion module <NUM>.

The limiting member <NUM> includes an upper casing <NUM>, and a lower casing <NUM> that is able to be tightly coupled to the upper casing <NUM>.

The actuation module <NUM> includes a cover body <NUM> that is disposed in the upper casing <NUM>, a main cover <NUM> that is received in the cover body <NUM>, an insertion seat <NUM> that is connected to the main cover <NUM>, a first elastic member <NUM> abutted against the main cover <NUM> and the insertion seat <NUM>, a retraction seat <NUM> that is disposed between the main cover <NUM> and the insertion seat <NUM>, and a second elastic member <NUM> abutted against the retraction seat <NUM> and the insertion seat <NUM>. The cover body <NUM> has a pair of lining engaging structures <NUM> at a bottom portion thereof. The first elastic member <NUM> and the second elastic member <NUM> may be configured as pre-compressed springs. The cover body <NUM> has a pair of urging portions <NUM> on an inner surrounding surface thereof. The main cover <NUM> has a limiting member <NUM> that extends toward the insertion seat <NUM>. The insertion seat <NUM> has a pair of barb-shaped retraction positioning portions <NUM>, and a pair of buckle portions <NUM> that are able to be respectively pushed by the urging portions <NUM> of the cover body <NUM>.

The insertion module <NUM> is able to guide the insertion needle to move stably before the insertion needle is inserted into the host, and includes a main body <NUM>, an auxiliary insertion seat <NUM>, an insertion needle assembly <NUM>, a base <NUM> and a sensor assembly <NUM>.

The main body <NUM> has a pair of body engaging structures <NUM> that are able to respectively engage with the lining engaging structures <NUM> of the cover body <NUM>, an accommodating hole <NUM> that extends along an axial line (L), a plurality of slide grooves <NUM> disposed on the accommodating hole <NUM> around the axial line (L) and communicating with the accommodating hole <NUM>, and a pair of stopping portion <NUM>. The buckle portions <NUM> of the insertion seat <NUM> respectively and separably abut against the stopping portions <NUM> of the main body <NUM> so as to form an insertion limiting structure (A) (see <FIG>). The slide grooves <NUM> are equally spaced apart from each other around the axial line (L). In this embodiment, the number of the slide grooves <NUM> is three. Each of the slide grooves <NUM> has a wall surface <NUM> (see <FIG>) that is gradually widened along an insertion direction (F). The the wall surface <NUM> of each of the slide grooves <NUM> includes an included angle between the axial line (L) from <NUM> degree to <NUM> degrees.

The auxiliary insertion seat <NUM> has a base portion <NUM>, a plurality of wing portions <NUM> that are connected to the base portion <NUM>, and a plurality of coupling protrusions <NUM> that protrude from a bottom surface of the base portion <NUM>. The base portion <NUM> is movable along the accommodating hole <NUM>. Each of the wing portions <NUM> is movable along a respective one of the slide grooves <NUM>. Each of the wing portions <NUM> has a protruding portion <NUM> that resiliently abutted against the wall surface <NUM> of the respective one of the slide grooves <NUM> in point-contact. Each of the wing portions <NUM> has two notches <NUM> and is H-shaped. The notches <NUM> of each wing portion <NUM> are respectively formed at top and bottom portions of the wing portion <NUM>, such that each wing portion <NUM> provides a restoring force in a radially outward direction after being compressed in a radial direction of the auxiliary insertion seat <NUM> perpendicular to the axial line (L). The wing portions <NUM> of the auxiliary insertion seat <NUM> are equally spaced apart from each other around the axial line (L). In a modification, the number of the wing portion <NUM> may be two, and the wing portions <NUM> are equally spaced apart from each other by <NUM> degrees.

The insertion needle assembly <NUM> includes a needle seat <NUM> that is mounted between the retraction seat <NUM> and the base portion <NUM> of the auxiliary insertion seat <NUM>, and an insertion needle <NUM> that is connected to the needle seat <NUM>. The needle seat <NUM> and the retraction seat <NUM> are able to be separated from each other so as to prevent misalignment therebetween due to manufacturing tolerance. Referring to <FIG>, the distance between a tip end <NUM> of the insertion needle <NUM> and the skin surface of the host is defined as an initial stroke distance (H). In this embodiment, the initial stroke distance (H) is no greater than <NUM> millimeter.

The base <NUM> is separably positioned at a bottom portion of the main body <NUM>, and is able to be adhered to the skin surface via an adhesive pad.

The sensor assembly <NUM> includes a sensing seat <NUM>, and a sensor <NUM> held within the sensing seat <NUM>. The sensing seat <NUM> has a plurality of coupling recesses <NUM> that permit the coupling protrusions <NUM> of the auxiliary insertion seat <NUM> to engage therewith. The insertion needle <NUM> is inserted through the sensing seat <NUM> to cover the sensor <NUM>.

Referring to <FIG> and <FIG>, after the first embodiment of the insertion device is assembled, the upper portion <NUM> and the lower portion <NUM> of the main body assembly <NUM> are interconnected, a top portion of the cover body <NUM> and a top portion of the main cover <NUM> are spaced apart from each other by a distance (D) (see <FIG>), the buckle portions <NUM> of the insertion seat <NUM> respectively abut against the stopping portions <NUM> of the main body <NUM> so as to position the insertion seat <NUM> at a pre-insertion position, the first elastic member <NUM> is pre-compressed between the insertion seat <NUM> and the main cover <NUM> to generate a restoring force, the second elastic member <NUM> is pre-compressed between the retraction seat <NUM> and the insertion seat <NUM> to generate a restoring force, the retraction positioning portion <NUM> of the insertion seat <NUM> is limited by the limiting member <NUM> of the main cover <NUM> so that the retraction seat <NUM> is at a pre-insertion position, the coupling protrusions <NUM> of the auxiliary insertion seat <NUM> is fitted into the coupling recesses <NUM> of the sensing seat <NUM> so that the sensing seat <NUM> and the auxiliary insertion seat <NUM> are interconnected, the auxiliary insertion seat <NUM> is connected to the needle seat <NUM> of the insertion needle assembly <NUM> so that the insertion needle assembly <NUM> is retained in the main body <NUM> and is shielded by the base <NUM>, and the base <NUM> is positioned relative to the main body <NUM>. The retraction positioning portions <NUM> of the insertion seat <NUM> is removably limited by the limiting member <NUM> of the main cover, so as to form a retraction limiting structure (B) (see <FIG>) that positions the retraction seat <NUM> relative to the insertion seat <NUM>.

Referring to <FIG> and <FIG>, the base <NUM> is firstly positioned at a to-be-inserted portion of the skin surface of the host. When the upper casing <NUM> is not depressed, the insertion limiting structure (A) that is formed between the buckle portions <NUM> of the insertion seat <NUM> and the stopping portions <NUM> of the main body <NUM> maintains the insertion seat <NUM> at the pre-insertion position. Referring to <FIG> and <FIG>, when the upper casing <NUM> is depressed toward the skin surface, the buckle portions <NUM> of the insertion seat <NUM> are respectively pushed by the urging portions <NUM> of the upper casing <NUM> to be deformed inwardly and to be respectively separated from the stopping portions <NUM> of the main body <NUM>, so that the insertion limiting structure (A) is collapsed. At the same time, the body engaging structures <NUM> of the main body <NUM> respectively engage the lining engaging structure <NUM> of the cover body <NUM>, so that the upper casing <NUM> is positioned relative to the main body <NUM>.

Referring to <FIG> and <FIG>, after the insertion limiting structure (A) is collapsed, the restoring force of the first elastic member <NUM> is permitted to be released, and moves the insertion seat <NUM> to an insertion position to implement automatic-insertion, such that the sensor assembly <NUM> is moved by the insertion seat <NUM> to a post-insertion position, that a portion of the sensor <NUM> is inserted underneath the skin surface, and that the sensing seat <NUM> is positioned onto the mounting portion <NUM> of the base <NUM>. After the sensor <NUM> is inserted underneath the skin surface, the limiting member <NUM> of the main cover <NUM> is separated from the retraction positioning portions <NUM> of the insertion seat <NUM>, so that the retraction positioning portions <NUM> are permitted to be deformed outwardly to collapse the retraction limiting structure (B). As such, the restoring force of the second elastic member <NUM> is permitted to be released, and drives the retraction seat <NUM> to move in a retraction direction (R) past the retraction positioning portions <NUM> of the insertion seat <NUM> away from the skin surface, such that the insertion needle assembly <NUM> is separated from the auxiliary insertion seat <NUM> and is retracted into the insertion seat <NUM> to hide the insertion needle <NUM> thereof and to implement automatic-retraction (see <FIG> and <FIG>). The coupling protrusions <NUM> of the auxiliary insertion seat <NUM> remains fitted into the coupling recesses <NUM> of the sensing seat <NUM> so that the auxiliary insertion seat <NUM> is connected to the sensing seat <NUM> of the sensor assembly <NUM>. The sensor assembly <NUM> is positioned into the base <NUM> during the insertion operation, and the base <NUM> is adhered to the skin surface by virtue of an adhesive pad <NUM> thereof (referring to <FIG> and <FIG>, the base <NUM> having been separated from the bottom portion of the main body <NUM>).

Referring to <FIG> and <FIG>, after the insertion operation is accomplished, the separated lower casing <NUM> can be re-coupled to the upper casing <NUM>, such that the used insertion device can be disposed in compliance with standard of discard of medical waste.

Referring to <FIG> and <FIG>, during the insertion, an initial speed of the insertion needle assembly <NUM> is insufficient to ensure that the insertion needle <NUM> is parallel to the insertion direction (F). At this time, the contact among the protruding portions <NUM> of the wing portions <NUM> and the wall surfaces <NUM> of the slide grooves <NUM> serves to position the insertion needle <NUM> such that the insertion needle <NUM> is parallel to the insertion direction (F). After the the insertion needle assembly <NUM> is accelerated to provide the insertion straightness , and prevent the insertion needle <NUM> from being oblique to the insertion direction (F), the protruding portions <NUM> of the wing portions <NUM> are separated from portions of the wall surfaces <NUM> of the slide grooves <NUM> that gradually widened along an insertion direction (F). Accordingly, the insertion needle <NUM> can be guided stably in the initial stroke distance (H), and then is supported by the skin surface when the insertion needle <NUM> contacts the skin surface after the initial stroke distance (H) so as to be steadily and rapidly inserted underneath the skin surface. By virtue of the notches <NUM> of each wing portion <NUM>, each wing portion <NUM> is compressible in the radial direction of the auxiliary insertion seat <NUM>, and generates a restoring force in the radially outward direction after being compressed. In addition, the protruding portions <NUM> of the wing portions <NUM> abuts against the wall surfaces <NUM> of the slide grooves <NUM> to position the insertion needle assembly <NUM>, such that the insertion needle <NUM> is prevented from being oblique to the insertion direction (F), and that the insertion needle <NUM> can be steadily inserted into the host to reduce discomfort of the host.

Referring to <FIG>, a second embodiment of the insertion device according to the disclosure is different form the first embodiment in that: each of the wing portions <NUM>' of the auxiliary insertion seat <NUM>' has a notch <NUM>' that opens upwardly. The notch <NUM>' of each wing portion <NUM>' is indented downwardly from a top portion of the wing portion <NUM>', such that each wing portion <NUM>' is compressible in the radial direction of the auxiliary insertion seat <NUM>' perpendicular to the axial line (L), and generates a restoring force in a radially outward direction after being compressed.

Referring to <FIG>, a third embodiment of the insertion device according to the disclosure is different form the first embodiment in that: each of the wing portions <NUM>" of the auxiliary insertion seat <NUM>" has a notch <NUM>" that opens downwardly. The notch <NUM>" of each wing portion <NUM>" is indented upwardly from a bottom portion of the wing portion <NUM>", such that each wing portion <NUM>" is compressible in the radial direction of the auxiliary insertion seat <NUM>" perpendicular to the axial line (L), and generates a restoring force in a radially outward direction after being compressed.

Claim 1:
An insertion module (<NUM>) adapted to guide an insertion needle to move stably before inserting into a host, characterized by:
a main body (<NUM>) having an accommodating hole (<NUM>) extending along an axial line (L), and a plurality of slide grooves (<NUM>) disposed on said accommodating hole (<NUM>) around the axial line (L) and communicating with said accommodating hole (<NUM>);
an auxiliary insertion seat (<NUM>) having a base portion (<NUM>), and a plurality of wing portions (<NUM>) connected to said base portion (<NUM>), wherein each of said wing portions (<NUM>) is reciprocated within a respective one of said slide grooves (<NUM>), and has a protruding portion (<NUM>);
an insertion needle assembly (<NUM>) including a needle seat (<NUM>) assembled with said base portion (<NUM>) of said auxiliary insertion seat (<NUM>), and an insertion needle (<NUM>) connected to said needle seat (<NUM>), wherein a distance between a tip end (<NUM>) of said insertion needle (<NUM>) and a skin surface of the host is defined as an initial stroke distance (H); and
a sensor assembly (<NUM>) including a sensing seat (<NUM>), and a sensor (<NUM>) held within said sensing seat (<NUM>), wherein said sensing seat (<NUM>) is assembled with said base portion (<NUM>) of said auxiliary insertion seat (<NUM>), and said insertion needle (<NUM>) is inserted through said sensing seat (<NUM>) to cover said sensor (<NUM>);
wherein each of said slide grooves (<NUM>) has a wall surface (<NUM>), and said protruding portion (<NUM>) of each of said wing portions (<NUM>) resiliently abuts against said wall surface (<NUM>) of a respective one of said slide grooves (<NUM>) in point-contact such that said auxiliary insertion seat (<NUM>) is fixed before inserting into the host through the interference between said protruding portions (<NUM>) and said wall surfaces (<NUM>) to provide a stable inserting and prevent said insertion needle (<NUM>) from oblique in said initial stroke distance; and
characterized in that
said wall surface (<NUM>) of each of said slide grooves (<NUM>) is gradually widened along an insertion direction (F).