US20230181823A1 - Treatment system with automated cannula and sensor inserter, fluid delivery device, and drive mechanism for use therewith - Google Patents

Abstract

A method of inserting a cannula and a sensor into a user using a cannula and sensor insertion mechanism, the method includes holding the cannula in a first pre-insertion position with a trigger arm, releasing the trigger arm such that a cannula insertion spring moves the cannula from the first pre-insertion position to a second post-insertion position, inserting the introducer needle and the cannula into the user, and retracting the introducer needle from within the cannula with a needle retraction spring.

Description

BACKGROUND OF THEINVENTION1. Field of the Invention
• The present general inventive concept relates to a treatment system, and more particularly to devices, systems, and methods capable of monitoring body signals of particular conditions or diseases, including blood glucose levels and treating a user by selectively delivering an appropriate amount of one or more therapeutic agents, fluids, or drugs based on the monitored body signals.
2. Background of the Invention
• There currently exists several diseases and conditions which are monitored and/or treated by therapeutic agents and/or medicines. These diseases may be diagnosed and treated based upon the existence or non-existence of particular enzymes, proteins, glucose, and/or other chemicals within a patient's body.
• For instance, diabetes is a disease which can be characterized by the absence or improper utilization of insulin secreted by a patient's pancreas. Insulin is used by the body to facilitate the delivery of glucose into cells. Typically, in mammals, the body maintains a blood glucose level at a range between 64.8 and 104.4 mg/dL. Glucose is the main source of energy for body cells and is transported throughout the body through the bloodstream. Glucose requires the hormone insulin in order to be absorbed by the body cells. Many people having various types of diseases and conditions, including diabetes, may need to inject one or more therapeutic agents to more effectively treat and manage their disease or condition.
• As such, there is a need for devices, systems, and methods which may treat diseases and conditions by selectively administering one or more therapeutic agents including insulin and glucagon based on data received from one or more integrated sensors.
BRIEF SUMMARY OF THE INVENTION
• The present general inventive concept relates to devices, systems, and methods capable of monitoring body signals of particular conditions or diseases, including blood glucose levels and treating by selectively delivering an appropriate amount of one or more therapeutic agents, fluids, or drugs based on the monitored body signals.
• The present general inventive concept also relates to a drive system including a propellant enclosed in an expandable membrane which is heated by a heat source (e.g., light or other energy) to push/pull on a system of gears to pull a plunger disposed in a fluid reservoir.
• Features and/or utilities of the present general inventive concept may be achieved by providing a treatment system configured to treat a condition using a first fluid, the treatment system including a first reservoir configured to store a first fluid, a cannula insertion mechanism configured to insert a cannula into a user, the cannula in fluid communication with the first reservoir, a first rotatable shaft member configured to pull a first plunger disposed within the first reservoir and coupled to the first rotatable shaft member by a first flexible member, and a drive mechanism having a first expandable member configured to move from a first position to a second position to rotate the first rotatable shaft member to deliver the first fluid to the user through the cannula.
• The first fluid may include a first therapeutic agent.
• The cannula insertion mechanism may further include a cannula insertion spring configured to move the cannula from a first pre-insertion position to a second post-insertion position.
• The cannula insertion mechanism further includes a trigger arm configured to hold the cannula insertion spring such that the cannula is in the first pre-insertion position and configured to release the insertion spring such that the cannula moves to the second post-insertion position.
• The drive mechanism may further include a first gear member configured to rotate the first rotatable shaft member when the first expandable member is moved between the first position and the second position.
• The first gear member may include a first portion configured hold the trigger arm in a first position such that the cannula is in the first pre-insertion position and a second portion configured to release the trigger arm to a second position such that the cannula is allowed to move to the second post-insertion position.
• The drive mechanism may rotate the first gear member from the first portion to the second portion by moving the first expandable member between the first position and the second position to thereby release the trigger arm and insert the cannula into the user.
• The cannula insertion mechanism may be further configured to insert a sensor into the user.
• The sensor may include a continuous glucose sensor.
• The treatment system may further include a controller configured to activate the drive mechanism to deliver an amount of the first fluid based on data received from the sensor.
• Features and/or utilities of the present general inventive concept may also be achieved by providing a treatment system configured to treat a condition using a first therapeutic agent and a second therapeutic agent, the treatment system including a first reservoir configured to store a first fluid, a second reservoir configured to store a second fluid, a cannula insertion mechanism configured to insert a cannula into a user, the cannula in fluid communication with the first and second reservoirs, a first rotatable shaft member configured to pull a first plunger disposed within the first reservoir and coupled to by a first flexible member, a second rotatable shaft member configured to pull a second plunger disposed within the second reservoir and coupled to by a second flexible member, and a drive mechanism having a first expandable member and a second expandable member, each configured to move from a first position to a second position to rotate one shaft member to deliver a fluid.
• The first fluid may include a first therapeutic agent.
• The second fluid may include a second therapeutic agent.
• The cannula insertion mechanism may further include a cannula insertion spring configured to move the cannula from a first pre-insertion position to a second post-insertion position.
• The cannula insertion mechanism may further include a trigger arm configured to hold the cannula insertion spring such that the cannula is in the first pre-insertion position and configured to release the insertion spring such that the cannula moves to the second post-insertion position.
• The drive mechanism may further include a first gear member configured to rotate the first rotatable shaft member when the first expandable member is moved between the first position and the second position.
• The first gear member may include a first portion configured hold the trigger arm in a first position such that the cannula is in the first pre-insertion position and a second portion configured to release the trigger arm to a second position such that the cannula is allowed to move to the second post-insertion position.
• The drive mechanism may rotate the first gear member from the first portion to the second portion by moving the first expandable member between the first position and the second position to thereby release the trigger arm and insert the cannula into the user.
• The cannula insertion mechanism may be further configured to insert a sensor into the user.
• The sensor may include a continuous glucose sensor.
• The treatment system may further include a controller coupled with the circuit board an configured to activate the drive mechanism to deliver an amount of the first fluid based on data received from the sensor.
• Additional aspects of the present general inventive concept will be set forth in part in the description which follows and, in part, will be obvious from the description, or may be learned by practice of the general inventive concept.
BRIEF DESCRIPTIONS OF THE DRAWINGS
• These and/or other aspects of the present general inventive concept will become apparent and more readily appreciated from the following description of the embodiments, taken in conjunction with the accompanying drawings of which:
• FIG.1 is a top perspective view of a treatment system according to an exemplary embodiment of the present general inventive concept;
• FIG.2 is a top perspective view of the treatment system illustrated inFIG.1, with a top housing removed;
• FIG.3A is a bottom perspective view of the treatment system illustrated inFIG.1;
• FIG.3B is an enlarged detail view of item ‘A’ illustrated inFIG.3A;
• FIG.4 is a top perspective view of the treatment system illustrated inFIG.1, wherein the cannula and sensor insertion mechanism is in a mid-deployed state according to an example embodiment of the present general inventive concept;
• FIG.5A is a bottom perspective view of the treatment system illustrated inFIG.4;
• FIG.5B is an enlarged detail view of item ‘B’ illustrated inFIG.5A;
• FIG.6 is a top perspective view of the treatment system illustrated inFIG.1, wherein the cannula and sensor inserter are in a post-deployed state according to an example embodiment of the present general inventive concept;
• FIG.7A is a bottom perspective view of the treatment system illustrated inFIG.6;
• FIG.7B is an enlarged detail view of item ‘C’ illustrated inFIG.7A;
• FIG.8 is a back-perspective view of the treatment system illustrated inFIG.1, with a top and base housing removed;
• FIG.9 is a front perspective view of the treatment system illustrated inFIG.8;
• FIG.10 is a top perspective view of a treatment system according to another exemplary embodiment, with a top housing and a base housing removed;
• FIG.11 is a top perspective view of the treatment system illustrated inFIG.10, with the fluid reservoirs removed;
• FIG.12 is a top perspective view of the treatment system illustrated inFIG.11, with the manifold removed;
• FIG.13 is a top perspective view of the treatment system illustrated inFIG.12, with a drive mechanism cover removed;
• FIG.14 is a top perspective view of the treatment system illustrated inFIG.13, with a drive mechanism guide member removed;
• FIG.15 is a top view of the drive mechanism of the treatment system illustrated inFIG.14;
• FIG.16 is a top view of the drive mechanism of the treatment system illustrated inFIG.15, with a second rotatable shaft member removed;
• FIG.17 is a front perspective view of the cannula and sensor inserter of the treatment system illustrated inFIG.10;
• FIG.18 is a side perspective view of the cannula and sensor inserter of the treatment system illustrated inFIG.17; and
• FIG.19 is a bottom perspective view of the cannula and sensor inserter of the treatment system illustrated inFIG.17.
DETAILED DESCRIPTION
• Reference will now be made in detail to the exemplary embodiments of the present general inventive concept, examples of which are illustrated in the accompanying drawings, wherein like reference numerals refer to the like elements throughout. The exemplary embodiments are described below in order to explain the present general inventive concept by referring to the figures.
• FIG.1 is a top perspective view of atreatment system100 according to an exemplary embodiment of the present general inventive concept.FIG.2 is a top perspective view of thetreatment system100 illustrated inFIG.1, with atop housing104 removed.
• Referring toFIGS.1 and2, according to an exemplary embodiment of the present general inventive concept, thetreatment system100 is configured to treat auser10 having various conditions or diseases, such as diabetes and/or various other chronic diseases.
• In alternative exemplary embodiments, thetreatment system100 may be configured to treat a variety of diseases and/or conditions in humans and/or animals, wherein a first fluid110amay include a first therapeutic agent used for the treatment of such diseases or conditions. However, the present general inventive concept is not limited thereto.
• In the present exemplary embodiment, thetreatment system100 includes abase housing102 and atop housing104 configured to enclose and seal exemplary embodiments of afirst reservoir110 configured to receive and store a first fluid110a(e.g., a first therapeutic agent), a cannula andsensor insertion mechanism120 configured to insert acannula122 and asensor124 into auser10 thereby providing fluid communication between thefirst reservoir110 and theuser10 through thecannula122 and the ability to monitor particular body signals of theuser10 using thesensor124, a firstrotatable shaft member130 configured to wind-up or pull afirst plunger140 disposed within thefirst reservoir110 and coupled to the firstrotatable shaft member130 by a first flexible member132 (seeFIG.11), a manifold150 configured to provide fluid communication between the one ormore reservoirs110 and thecannula122, and adrive mechanism160 having one or moreexpandable members162,165 configured to move from a first position to a second position to rotate the firstrotatable shaft member130 and deliver the first fluid110astored within thefirst reservoir110 to theuser10 through thecannula122. However, the present general inventive concept is not limited thereto.
• In exemplary embodiments, thetreatment system100 may further include atop housing104 which is configured to be coupled and sealed to thebase housing102 such that an interior of thetreatment system100 is waterproof and/or water resistant from an exterior environment.
• In exemplary embodiments, thetreatment system100 may further include an additionalfirst reservoir110 also having afirst plunger140 to accommodate a desired volume of the first fluid110awhich is to be delivered to theuser10.
• In exemplary embodiments, theflexible member132 may be constructed from a stainless-steel material or various other non-toxic and human safe materials and compatible with various fluids which are stored within thefluid reservoirs110 and administered to theuser10.
• In the present exemplary embodiment, thetreatment system100 includes a circuit board106 to control operations of thetreatment system100, aheat source107 to expand one ormore actuators163,164,166,167, and a re-chargeable power supply108 to provide power to the circuit board106 and theheat source107. The circuit board106 may further communicate with asensor124 to control an amount of fluid administered from the one or morefluid reservoirs110 by controlling the activation of the one ormore actuators163,164,166,167.
• In alternative exemplary embodiments, thetreatment system100 is configured to be partially re-usable, wherein the power supply108, the circuit board106 and/or theheat source107 may be detachably coupled to thebase housing102. However, the present general inventive concept is not limited thereto.
• In alternative exemplary embodiments, thetreatment system100 may be configured to include afirst reservoir110 used to store a first fluid (e.g., insulin) and asecond fluid reservoir112 used to store a second fluid (e.g., glucagon). In an exemplary embodiment, thetreatment system100 may be configured to receive data from thesensor124 regarding the user's glucose level and then calculate or otherwise determine an amount of the first fluid110a(e.g., insulin) that is to be delivered from thefirst reservoir110 and/or an amount of the second fluid112a(e.g., glucagon) that is to be delivered from thesecond reservoir112 based on the user's glucose level. However, the present general inventive concept is not limited thereto.
• That is, in alternative embodiments, thetreatment system100 may be configured to receive data from other various sensors, including a heart rate sensor to determine an amount of the first and/or second fluid to deliver to theuser10.
• FIG.3A is a bottom perspective view of the treatment system illustrated inFIG.1 andFIG.3B is an enlarged detail view of item ‘A’ illustrated inFIG.3A.FIG.4 is a top perspective view of the treatment system illustrated inFIG.1, wherein the cannula and sensor insertion mechanism is in a mid-deployed state according to an example embodiment of the present general inventive concept.FIG.5A is a bottom perspective view of the treatment system illustrated inFIG.4 andFIG.5B is an enlarged detail view of item ‘B’ illustrated inFIG.5A.FIG.6 is a top perspective view of the treatment system illustrated inFIG.1, wherein the cannula and sensor inserter are in a post-deployed state according to an example embodiment of the present general inventive concept.FIG.7A is a bottom perspective view of the treatment system illustrated inFIG.6 andFIG.7B is an enlarged detail view of item ‘C’ illustrated inFIG.7A.
• The cannula andsensor insertion mechanism120 is configured to insert acannula122 and asensor124 into auser10. However, in alternative embodiments, the cannula andsensor insertion mechanism120 may be configured to insert one ormore cannulas122 and/or one ormore sensors124 into theuser10.
• In the present exemplary embodiment, thecannula insertion mechanism120 may further include acannula insertion spring126 which is configured to move the cannula122 (e.g., a soft flexible cannula) from a firstpre-insertion position122a(seeFIG.3B) to a secondpost-insertion position122b(seeFIG.7B), anintroducer needle127 which is disposed in at least a portion of thecannula122 and is configured to insert thecannula122 into theuser10, aneedle retraction spring128 which is configured to remove or partially retract theintroducer needle127 from within thecannula122, after thecannula122 is inserted into the user10 (seeFIG.7B), and atrigger arm129 configured to hold thecannula insertion spring126 such that thecannula122 is in the firstpre-insertion position122aand configured to release theinsertion spring126 such that thecannula122 moves to the secondpost-insertion position122b.
• That is, in the present embodiment, thecannula insertion spring126 may be used to push theintroducer needle127 andcannula122 toward and into theuser10 such that theintroducer needle127 initially penetrates the skin to allow thecannula122 to be inserted into theuser10, and then theneedle retraction spring128 may be used to retract theintroducer needle127 from within thecannula122, thereby allowing thecannula122 to remain inserted into theuser10 while maintaining fluid communication with at least onereservoir110. However, the present general inventive concept is not limited thereto.
• Referring toFIG.3B, theintroducer needle127 is disposed within thecannula122 and remains flush a bottom surface of thebase housing102. Once thetrigger arm129 is released, thecannula122, theintroducer needle127, and thesensor124 move toward and into the user10 (seeFIG.5B), wherein thecannula122, theintroducer needle127, and thesensor124 extend beyond the bottom surface of thebase housing102. Once the retracttrigger180 contacts asurface109aof ainsertion guide member109, aneedle retraction spring128 is allowed to release in order to retract theintroducer needle127, thereby allowing thecannula122 and thesensor124 to remain inserted inside of the user10 (seeFIG.7B).
• In alternative embodiments, thecannula122 may include a tri-lumen structure wherein afirst lumen122amay be in fluid communication with afirst reservoir110, asecond lumen122bmay be in fluid communication with asecond reservoir112, and athird lumen122cmay be used to house theintroducer needle127. As such, there exists a first fluid path between thecannula122 and thefirst reservoir110 through thefirst lumen122ato administer the first fluid or therapeutic agent and a second fluid path between thecannula122 and thesecond reservoir112 through thesecond lumen122bto administer the second fluid or therapeutic agent. However, the present general inventive concept is not limited thereto.
• In alternative exemplary embodiments, thecannula insertion spring126 may also be used to push asensor124 toward and into theuser10 such that theintroducer needle127 initially penetrates the skin to allow thecannula122 and/or thesensor124 to be inserted into theuser10, and then theneedle retraction spring128 may be used to retract theintroducer needle127 from within thecannula122, thereby allowing thecannula122 and thesensor124 to remain inserted into theuser10 while maintaining fluid communication with at least onereservoir110. However, the present general inventive concept is not limited thereto.
• In exemplary embodiments, thesensor124 may be configured for integrated continuous monitoring of the user's10 glucose levels, such as a continuous glucose monitor (CGM). Thesensor124 may be configured to be integrated with wireless or wired communication such that once inserted, thesensor124 may continuously transmit data or information of the user's glucose levels to the circuit board106.
• In the present exemplary embodiment, during a single uninterrupted action, when thetrigger arm129 is released, thecannula insertion spring126 pulls theslide insert125 which is coupled to theintroducer needle127 andcannula122 toward aninsertion guide member109. Once the retracttrigger180 protruding from theslide insert125 contacts asurface109aof theguide member109, theneedle retraction spring128 is allowed to release, thereby retracting theintroducer needle127 and allowing thecannula122 andsensor124 to remain inserted in theuser10.
• In exemplary embodiments, thecannula insertion mechanism120 is configured to automatically insert acannula122 into a user at a predetermined angle and depth and retract theintroducer needle127 based on a profile of theguide member109. However, the present general inventive concept is not limited thereto. In exemplary embodiments, thecannula122 may be inserted at an angle between 2 degrees and 95 degrees to a depth of 0.5 mm to 15 mm. However, the insertion angle and depth of thecannula122 may vary as needed.
• In exemplary embodiments, thetreatment system100 is used to subcutaneously and/or transcutaneously deliver a therapeutic agent (i.e., a first fluid) such as medicine, hormones, steroids, or various other fluids to a user. However, the present general inventive concept is not limited thereto. That is, in alternative exemplary embodiments, thetreatment system100 may also be used to deliver nano-particles, nano-medicines, insulin, glucagon, antibiotics, morphine, gene therapy medicines, AZT, chemotherapy medications, or the like. In addition, in alternative exemplary embodiments, thetreatment system100 may include one ormore reservoirs110 configured to deliver one or more fluids required for treating various types of conditions and/or diseases. Although not illustrated, the present general inventive concept may be embodied with asingle fluid reservoir110 and/or multiplefluid reservoirs110, as needed.
• In the present exemplary embodiment, thedrive mechanism160 includes a firstexpandable member162 having one or moreactuator members163,164. Eachactuator member163,164 consists of a propellant sealed within an expandable membrane or foil. As heat (e.g., from the heat source107) is applied to theactuator member163,164, the propellant disposed within the expandable membrane expands causing the expandable membranes of theactuator members163,164 to expand. As such, by disposing afirst actuator163 on a first side of afirst gear member168 and asecond actuator164 on a second side of thefirst gear member168, thegear168 may be forced to rotate by alternating the application of heat to thefirst actuator163 and thesecond actuator164. In addition, the first andsecond actuator members163 and164 may be coupled to a pivotally coupledgear pusher170, such that application of heat to thefirst actuator163 may push the first gear and application of heat to thesecond actuator164 may pull the first gear. As a result, the gear may be rotated in the same direction (e.g., clockwise) when either of the first andsecond actuators163,164 are exposed to heat.
• In exemplary embodiments, thedrive mechanism160 includes a plurality of gears which translates a linear motion of the firstexpandable member162 into rotation of the firstrotatable shaft member130 to thereby wind up thefirst plunger140 disposed within thefirst reservoir110 and deliver the first fluid110ato theuser10 through thecannula122. In the present embodiment, thedrive mechanism160 includes afirst gear member168 configured to rotate the firstrotatable shaft member130 when theactuators163,164 of the firstexpandable member162 is moved between the first position and the second position.
• In exemplary embodiments, thefirst gear member168 includes afirst portion168aconfigured hold thetrigger arm129 in a first position129asuch that thecannula122 is in the firstpre-insertion position122aand asecond portion168bconfigured to release thetrigger arm129 to a second position129bsuch that thecannula122 is allowed to move to the secondpost-insertion position122b. Thedrive mechanism160 rotates thefirst gear member168 from thefirst portion168ato thesecond portion168bby moving theactuators163,164 of the firstexpandable member162 between the first position and the second position to thereby release thetrigger arm129 and insert thecannula122 into theuser10.
• In the present exemplary embodiment, thetreatment system100 includes asingle fluid reservoir110, acannula insertion mechanism120, a firstrotatable shaft member130, a manifold150, adrive mechanism160, and a first expandable member160aincluding first andsecond actuator members162,163. Auser10 may insert a syringe into afill port152 of the manifold150 in order to fill thefluid reservoir110 with a first fluid110aor therapeutic agent. As the fluid enters thefill port152, the fluid passes into thereservoir110 through the manifold150 thereby pushing theplunger140 disposed within thefluid reservoir110 away from themanifold150. The firstrotatable shaft member130 is allowed to rotate to allow theflexible member132 coupled to theplunger140 to unwind and allow theplunger140 to move away from themanifold150.
• Theactuators163,164 of the firstexpandable members162 are heated in alternating fashion in order to rotate the firstrotatable shaft member130 which, in turn, winds up the firstflexible member132 around theshaft member130 and forces the first fluid110astored within thefluid reservoir110 through the manifold150 into thefirst lumen122aof thecannula122 and into theuser10. However, the present general inventive concept is not limited thereto.
• In alternative exemplary embodiments, thedrive mechanism160 includes a secondexpandable member165 having one or moreactuator members166,167. Eachactuator member166,167 consists of a propellant sealed within an expandable membrane or foil. As heat (e.g., from the heat source107) is applied to theactuator member166,167, the propellant disposed within the expandable membrane expands causing the expandable membranes of theactuator members166,167 to expand. As such, by disposing athird actuator166 on a first side of asecond gear member169 and afourth actuator167 on a second side of thesecond gear member169, thegear169 may be forced to rotate by alternating the application of heat to thethird actuator166 and thefourth actuator167. In addition, the third andfourth actuator members166 and167 may be coupled to a pivotally coupledgear pusher170, such that application of heat to thethird actuator166 may push the second gear and application of heat to thesecond actuator167 may pull the second gear. As a result, thesecond gear169 may be rotated in the same direction (e.g., counter-clockwise) when either of the third andfourth actuators166,167 are exposed to heat.
• In exemplary embodiments, thedrive mechanism160 includes a plurality of gears which translates a linear motion of the secondexpandable member165 into rotation of the secondrotatable shaft member135 to thereby wind up thesecond plunger142 disposed within thesecond reservoir112 and deliver the second fluid112ato theuser10 through thecannula122. In the present embodiment, thedrive mechanism160 includes asecond gear member169 configured to rotate the secondrotatable shaft member135 when theactuators166,167 of the secondexpandable member165 is moved between the first position and the second position.
• In the present exemplary embodiment, thetreatment system100 includes afirst fluid reservoir110, asecond fluid reservoir112, acannula insertion mechanism120, a firstrotatable shaft member130, a secondrotatable shaft member135, a manifold150, adrive mechanism160, a firstexpandable member162 including first andsecond actuator members163,164, and a secondexpandable member165 including third andfourth actuator members166,167.
• Auser10 may insert a syringe into afill port152 of the manifold150 in order to fill thefirst fluid reservoir110 with a first fluid110aor therapeutic agent and into a fill port (not illustrated) in order to fill thesecond fluid reservoir112 with a second fluid112aor therapeutic agent. As the fluids enters the fill ports, the fluids respectively pass into thereservoir110 or thereservoir112 through the manifold150 thereby pushing theplunger140 disposed within thefirst fluid reservoir110 and theplunger142 disposed within thesecond fluid reservoir112 away from themanifold150. The firstrotatable shaft member130 is allowed to rotate to allow theflexible member132 coupled to theplunger140 to unwind and allow theplunger140 to move away from themanifold150. Similarly, the secondrotatable shaft member135 is allowed to rotate to allow theflexible member136 coupled to theplunger142 to unwind and allow theplunger142 to move away from themanifold150.
• Theactuators163,164 of the firstexpandable members162 are heated in alternating fashion in order to rotate the firstrotatable shaft member130 which, in turn, winds up the firstflexible member132 around theshaft member130 and forces the first fluid110astored within thefluid reservoir110 through the manifold150 into thefirst lumen122aof thecannula122 and into theuser10.
• Similarly, theactuators166,167 of the secondexpandable members165 are heated in alternating fashion in order to rotate the secondrotatable shaft member135 which, in turn, winds up the secondflexible member136 around theshaft member135 and forces the first fluid112astored within thefluid reservoir112 through the manifold150 into thesecond lumen122bof thecannula122 and into theuser10.
• FIG.10 is a top perspective view of atreatment system200 according to another exemplary embodiment, with the top housing and base housing removed.FIG.11 is a top perspective view of the treatment system illustrated inFIG.10, with the fluid reservoirs removed.FIG.12 is a top perspective view of the treatment system illustrated inFIG.11, with the manifold removed.FIG.13 is a top perspective view of the treatment system illustrated inFIG.12, with a drive mechanism cover removed.FIG.14 is a top perspective view of the treatment system illustrated inFIG.13, with a drive mechanism guide member removed.
• That is, in alternative exemplary embodiments, thetreatment system200 is configured to treat a condition using a first therapeutic agent and a second therapeutic agent, thetreatment system200 includes afirst reservoir110 configured to store a first fluid, asecond reservoir112 configured to store a second fluid, acannula insertion mechanism120 configured to insert acannula122 into auser10, thecannula122 in fluid communication with the first andsecond reservoirs110,112, a firstrotatable shaft member130 configured to pull afirst plunger140 disposed within thefirst reservoir110 and coupled to by a firstflexible member132, a secondrotatable shaft member135 configured to pull asecond plunger142 disposed within thesecond reservoir112 and coupled to by a secondflexible member136, and adrive mechanism160 having a firstexpandable member162 and a secondexpandable member165, each configured to move from a first position to a second position to rotate one shaft member to deliver a fluid.
• In exemplary embodiments, the first fluid includes a first therapeutic agent and the second fluid includes a second therapeutic agent.
• In exemplary embodiments, the cannula insertion mechanism further includes a cannula insertion spring configured to move the cannula from a first pre-insertion position to a second post-insertion position.
• The cannula insertion mechanism further includes a trigger arm configured to hold the cannula insertion spring such that the cannula is in the first pre-insertion position and configured to release the insertion spring such that the cannula moves to the second post-insertion position.
• The drive mechanism further includes a first gear member configured to rotate the first rotatable shaft member when the first expandable member is moved between the first position and the second position and a second gear member configured to rotate the second rotatable shaft member when the second expandable member is moved between a first position and a second position.
• The first gear member may include a first portion configured hold the trigger arm in a first position such that the cannula is in the first pre-insertion position and a second portion configured to release the trigger arm to a second position such that the cannula is allowed to move to the second post-insertion position.
• Although a few exemplary embodiments of the present general inventive concept have been illustrated and described, it will be appreciated by those skilled in the art that changes may be made in these exemplary embodiments without departing from the principles and spirit of the general inventive concept, the scope of which is defined in the appended claims and their equivalents.

Claims (11)

What is claimed is:

1. A cannula and sensor insertion mechanism for inserting a cannula and a sensor into a user, the mechanism comprising:

a cannula insertion spring configured to move a cannula from a first pre-insertion position to a second post-insertion position;

an introducer needle disposed in at least a portion of the cannula and configured to insert the cannula into a user;

a needle retraction spring configured to remove or partially retract the introducer needle from within the cannula after the cannula is inserted into the user; and

a trigger arm configured to hold the cannula insertion spring such that the cannula is in the first pre-insertion position and configured to release the insertion spring such that the cannula moves to the second post-insertion position.

2. The cannula and sensor insertion mechanism ofclaim 1, further comprising a tri-lumen structure, wherein a first lumen is in fluid communication with a first reservoir to administer a first fluid, a second lumen is in fluid communication with a second reservoir to administer a second fluid, and a third lumen is used to house the introducer needle.

3. The cannula and sensor insertion mechanism ofclaim 1, wherein the cannula insertion spring is used to push a sensor toward and into the user.

4. The cannula and sensor insertion mechanism ofclaim 1, wherein the introducer needle is disposed within the cannula and remains flush with a bottom surface of a base housing.

5. The cannula and sensor insertion mechanism ofclaim 1, wherein the trigger arm is released such that the cannula, the introducer needle, and the sensor move toward and into the user.

6. The cannula and sensor insertion mechanism ofclaim 5, wherein the cannula, the introducer needle, and the sensor extend beyond the bottom surface of the base housing.

7. The cannula and sensor insertion mechanism ofclaim 1, wherein a retract trigger contacts a surface of an insertion guide member and a needle retraction spring is allowed to release to retract the introducer needle, thereby allowing the cannula and the sensor to remain inserted inside of the user.

8. The cannula and sensor insertion mechanism ofclaim 1, wherein the introducer needle initially penetrates the skin to allow the cannula and/or the sensor to be inserted into the user.

9. A method of inserting a cannula and a sensor into a user using a cannula and sensor insertion mechanism, the method comprising:

holding a cannula in a first pre-insertion position with a trigger arm;

releasing the trigger arm such that a cannula insertion spring moves the cannula from the first pre-insertion position to a second post-insertion position;

inserting an introducer needle and the cannula into the user; and

retracting the introducer needle from within the cannula with a needle retraction spring.

10. The method ofclaim 9, further comprising the step of using the cannula insertion spring to push a sensor toward and into the user.

11. A cannula and sensor insertion mechanism configured to insert a cannula and a sensor into a user, the mechanism comprising a spring-loaded mechanism that pushes a cannula and a sensor into the user and a retraction mechanism that removes a needle from within the cannula after insertion.

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