Automatic catheter insertion device

Abstract

A catheter insertion device includes a housing with a base, a catheter, an insertion needle and an actuator. The device includes at least one spring that is actuated by the actuator to move the insertion needle and catheter to an extended position. In one embodiment, the spring can also retract the insertion needle automatically when the catheter is in the extended position. The spring can be operatively connect to a sleeve that rotates to move the insertion needle and catheter to the extended position and then retract the insertion needle. In another embodiment, the device includes a first spring to move the insertion needle and catheter to the extended position and a second spring to retract the insertion needle.

Description

AUTOMATIC CATHETER INSERTION DEVICEField of the Invention

[0001] The present disclosure relates to an automatic catheter insertion device and to a delivery device including the catheter insertion device. The catheter insertion device is primarily for use with an on body injection device or an infusion set for introducing a catheter or cannula into a patient and automatically retracting an insertion needle once the catheter or cannula is moved to an extended position with respect to the device. The catheter insertion device includes an actuator that is deployed to insert the catheter into the patient and then automatically retract the insertion needle with respect to the catheter to a position where a medication can be supplied through the catheter. The disclosure is further directed to a method of inserting a catheter using the catheter insertion device. The automatic insertion device does not require manual insertion by the user to provide fast and a force for proper insertion of catheter.Background of the Invention

[0002] Treatment methods for some conditions and diseases utilize a continuous delivery of a medication. One commonly used device is a delivery device that can be attached to the patient for delivering a continuous and controlled delivery of the medication to a patient.

[0003] A medication delivery pump can provide continuous infusion of the medication to a patient at varying rates in order to more closely match the intended treatment. Medication delivery pumps often include an infusion cannula, typically in the form of an infusion needle or a flexible catheter, that pierces the patient’s skin and through which, infusion of the medication takes place. The medication pump offers the advantages of continuous delivery of a medication, precision dosing, and programmable delivery schedules.

[0004] In infusion therapy, medication doses can be administered at a basal rate and in a bolus dose. The medication pump cay also be capable of programming the basal rate of a medication to vary according to the different times of the day and night. Medication pumps may be configured to enable the patient to program the volume of the bolus dose as needed.

[0005] Medication delivery pumps advantageously deliver a medication over time rather than in single injections, typically resulting in less variation. In addition, medication pumps may reduce the number of needle sticks and improve management.

[0006] To facilitate drug therapy, there are generally two types of pumps, namely, conventional pumps and patch pumps. Conventional pumps require the use of a disposable component, typically referred to as an infusion set, tubing set or pump set, which conveys the medication from a reservoir within the pump into the skin of the user. The infusion set consists of a pump connector, a length of tubing, and a hub or base from which a cannula, in the form of a hollow metal infusion needle or flexible plastic catheter extends. The base typically has an adhesive that retains the base on the skin surface during use. The cannula can be inserted onto the skin manually or with the aid of a manual or automatic insertion device. The insertion device may be a separate unit required by the user.

[0007] Another type of delivery device is a patch pump, also called a wearable drug delivery device. Unlike a conventional pump and infusion set combination, a patch pump is an integrated device that combines most or all of the fluidic components, including the fluid reservoir, pumping mechanism and mechanism for automatically inserting the cannula, in a single housing which is adhesively attached to an infusion site on the patient’s skin, and does not require the use of a separate infusion or tubing set. A patch pump adheres to the skin and delivers the medication over a period of time via an integrated subcutaneous cannula. Some patch pumps may wirelessly communicate with a separatecontroller device (as in one device sold by Insulet Corporation under the brand name OmniPod®), while others are completely self-contained. Such devices are replaced on a frequent basis, such as every three days, when the medication reservoir is exhausted or complications may otherwise occur, such as restriction in the cannula or the infusion site.

[0008] As patch pumps are designed to be a self-contained unit that is worn by the patient, it is preferable the dimensions and weight are as small as possible and comfortable to wear so that it does not interfere with the activities of the user. Thus, in order to minimize discomfort to the user, it would be preferable to minimize the overall thickness of the patch pump. However, in order to minimize the thickness of the patch pump, its constituent parts should be reduced as much as possible. One such part is the insertion mechanism for automatically inserting the cannula into the user’s skin.

[0009] In order to minimize the height of the insertion mechanism, some conventional insertion mechanisms are configured to insert the cannula at an acute angle from the surface of the skin, e.g. 30-45 degrees. However, it may be preferable to insert the cannula perpendicular or close to the perpendicular from the surface of the skin, since this would require the minimum length of cannula insertion. In other words, with the minimum length of cannula being inserted into the user’s skin, the user can experience greater comfort and fewer complications, such as premature kinking of the cannula. But one problem with configuring the insertion mechanism to insert the cannula perpendicular to the surface of the skin is that this may increase the overall height of the insertion mechanism, and therefore of the patch pump itself.

[0010] Accordingly, a need exists for an improved insertion mechanism for use in a limited space environment, such as in the patch pump, that can cost- effectively insert a cannula vertically or close to perpendicularly into the surface of a user’s skin, while minimizing or reducing its height, in order to reduce the overall height of the device the insertion mechanism is incorporated into, suchas a patch pump. There is also a need for improved automatic pricking and insertion of the needle and catheter where the pricking is not affected by the patient that can otherwise lead to improper insertion and discomfort to the patient.Summary

[0011] The present device is directed to an insertion device for use with delivery device, such as an infusion device, patch pump or other on body delivery device. The insertion device provides automatic pricking and insertion of a catheter or cannula without the manual insertion by the user. The insertion device provides rapid insertion at an appropriate insertion force to limit the pain to the user, thereby preventing inappropriate catheter insertion.

[0012] The insertion device is primarily for inserting or positioning a catheter, cannula or other fluid delivery mechanism into the skin of a subject. The catheter insertion device has an actuator that is actuated automatically to deploy the device and to introduce the catheter into the patient by the use of an insertion needle and to automatically retract the insertion needle with respect to the catheter when the catheter is deployed to a predetermined depth.

[0013] One embodiment of the device includes an on body delivery device, such as an infusion set having a self-contained catheter insertion or introducing device that deploys the catheter and insertion needle and retracts the insertion needle after insertion in a single operation by the user.

[0014] Another feature of the catheter insertion device includes a manually operated actuator that is separable, moved or actuated by the user to insert the catheter into the patient and where the actuator automatically releases the insertion needle when the catheter is moved to an extended position to retract the insertion needle into the housing of the device.

[0015] Another feature of the catheter insertion device where a catheter and an insertion needle are movable between a first retracted position and a secondextended position. A catheter hub receives the insertion needle during movement to the second position where the needle then retracts at least partially from the catheter and catheter hub. A spring is provided to automatically retract the needle with respect to the catheter and catheter hub when the catheter and insertion needle are deployed.

[0016] In one embodiment, a spring is initially in a loaded or compressed condition and is released by movement of the actuator to deploy the catheter and insertion needle. The spring can be coupled to a base or a housing of the device. In one embodiment, the actuator forms a spring retainer to retain the spring in the loaded condition. Movement of the actuator releases the spring to deploy the catheter and insertion needle and then retract the insertion needle from the proximal end of the catheter.

[0017] In another embodiment, the catheter insertion device includes a housing receiving a catheter and catheter hub, an insertion needle, and an actuator. The actuator is manually deployed to release a first spring that moves the catheter and insertion needle to extend from the housing and to position the catheter and insertion needle into a subject. A second spring is operatively connected to the insertion needle where the insertion needle is released when the needle and catheter are in the extended position to retract the insertion needle relative to the housing and the catheter. In one embodiment, the first spring can engage the housing and a catheter hub supporting the catheter to move the catheter and insertion needle to the extended position. The second spring can extend between the catheter hub and the needle or a needle hub supporting the needle to retract the needle relative to the catheter.

[0018] In another embodiment, the catheter insertion device includes a catheter, insertion needle, and actuator. A downward force applied to the actuator moves a member toward a distal end of a housing to engage a catheter hub and release the catheter hub from a locked position with respect to thehousing. A first spring then moves the catheter and needle to an extended position. When the catheter and needle are in the extended position, the catheter and needle disengage from each other where a second spring retracts the needle with respect to the catheter.

[0019] The catheter insertion device in one embodiment includes a housing receiving a catheter and catheter hub and an insertion needle and needle hub for axial movement in the housing. A sleeve surrounds the housing and is operatively connected to the catheter hub and needle hub where rotation of the sleeve with respect to the housing moves the catheter and needle to the extended position and then retracts the needle with respect to the catheter with the catheter remaining in the extended position. The sleeve can include a first surface, such as a cam surface or slot, which engages the needle hub and catheter hub to move the needle and catheter to the extended position. The sleeve can include second surface, such a cam surface or slot, so that rotation of the sleeve retracts the needle with respect to the catheter. A third surface on the sleeve is operatively connected to the catheter hub to retain the catheter in the extended position during rotation of the sleeve when retracting the needle.

[0020] In a further embodiment, the catheter insertion device includes a housing receiving a catheter and catheter hub and a needle and needle hub. A rotatable sleeve surround the housing and is operatively engaged with the catheter hub and needle hub to move the catheter and needle to an extended position and to retract the needle relative to the catheter. A spring engages the sleeve to rotate the sleeve. An actuator engages the sleeve to retain the sleeve in a first position with the spring under load. The actuator is manually operated to release the sleeve where the spring rotates the sleeve to move the catheter and needle to the extended position.

[0021] These and other aspects of the device are basically attained by providing a catheter insertion device having a housing with a base, a catheter movable between a first retracted position and a second extended position withrespect to the housing, an introducer needle within the catheter and movable between a first retracted position and a second extended position with respect to the base, and an actuator for actuating the device. A spring and spring retainer are disposed in the housing to retain the spring in an initial compressed condition. The catheter and needle are coupled to the actuator and are movable between a first position where the catheter and needle are retracted within the housing and a second position where the catheter and needle extend from the housing, and where the retainer releases the spring when the actuator is moved to the second position to automatically retract the needle into the actuator.The various aspects are also attained by a catheter insertion device comprising a body having an axial passage, a catheter movable between a first retracted position and a second extended position with respect to said body, and an insertion needle within said catheter and movable between a first retracted position and a second extended position with respect to said body. A first spring is configured for moving the catheter and insertion needle from the retracted position to the extended position where the catheter and insertion needle extend from a distal side of said body. An actuator is movable between a first retaining position to retain the first spring under load and a second position to release the first spring where the first spring moves the catheter to the extended position. A second spring extends between the catheter and insertion needle to retract the insertion needle with respect to the catheter when the catheter is in the extended position.

[0022] The catheter insertion device can comprise a body having an axial passage, a catheter movable between a first retracted position and a second extended position with respect to the body, an insertion needle within the catheter and movable between a first retracted position and a second extended position with respect to said body. A sleeve surrounds the body and is rotatable around the body. The sleeve has an inner surface with a camsurface. A spring is operatively coupled to the sleeve for rotating the sleeve relative to the body. An actuator is movable from a first position to retain the spring in a loaded condition to a second position to release the spring to rotate the sleeve to move the catheter and insertion needle to the extended position and to retract the insertion needle relative to the catheter when the catheter is moved to the extended position.

[0023] These and other features of the device will become apparent from the following detailed description of the invention which, taken in conjunction with the annexed drawings, show various embodiments of the invention.Brief Description of the Drawings

[0024] The various objects, advantages and novel features of the exemplary embodiments of the present invention will be more readily appreciated from the following detailed description when read in conjunction with the appended drawings, in which:

[0025] Fig. 1 is a perspective view of a patch pump incorporating a low- profile cannula insertion device, illustrated with a transparent cover for clarity;

[0026] Fig. 2 is an exploded view of the various components of the patch pump of Fig. 1, illustrated with a cover;

[0027] Fig. 3 is a perspective view of an alternative design for a patch pump having a flexible reservoir, illustrated without a cover;

[0028] Fig. 4 is a patch-pump fluidic architecture and metering sub-system diagram of the patch pump of Fig. 3;

[0029] Fig. 5 is a side view of the catheter insertion device in a first embodiment;

[0030] Fig. 6 is a front view of the device of Fig. 5;

[0031] Fig. 7 is an exploded perspective view of the device of Fig. 5;

[0032] Fig. 8 is an exploded side view of the device of Fig. 5;

[0033] Fig. 9 is a cross sectional side view of the device of Fig. 5 in the initial position;

[0034] Fig. 10 is a cross sectional side view of Fig. 5 with the actuator deployed;

[0035] Fig. 11 is a cross sectional side view of Fig. 9 showing the retracted insertion needle;

[0036] Fig. 12 is a cross sectional front view of the device of Fig. 5 in the initial position;

[0037] Figs. 13A and 13B are, respectively, a cross sectional front view, and a partial enlarged cross sectional view, of the device of Fig 5 showing the catheter deployed;

[0038] Fig. 14 is a cross sectional front view of the device of Fig. 5 showing the needle retracted;

[0039] Fig. 15 is a cross section view of the device in an alternative embodiment;

[0040] Fig. 16 is a perspective view of the housing of the device of Fig. 15;

[0041] Fig. 17 is a bottom perspective view of the cap of the device of Fig. 15;

[0042] Fig. 18 is a cross section view of the device of Fig. 15 showing the catheter in the original position;

[0043] Fig. 19 is a cross section view of the device of Fig. 15 showing the catheter in the deployed condition prior to retracting the needle;

[0044] Fig. 20 is a cross section view of the device after the needle is retracted;

[0045] Fig. 21 is perspective view of the catheter insertion device in another embodiment;

[0046] Fig. 22 is an exploded view of the device of Fig. 21 ;

[0047] Fig. 23 is a side view of the sleeve;

[0048] Fig. 24 is a cross sectional view of the device of Fig. 21 in the original position;

[0049] Fig. 25 is another cross sectional view of the device of Fig. 21;

[0050] Fig. 26 is a cross sectional view of the sleeve of Fig. 23;

[0051] Fig. 27 is cross sectional view of the housing of Fig. 21 ;

[0052] Fig. 28 is another cross sectional view of the housing of Fig.

[0053] Fig. 29 is a side view showing the tab received in the slot of the sleeve;

[0054] Fig. 30 is cross section view showing the catheter and needle in the deployed position;

[0055] Fig. 31 is cross sectional view showing the needle in the retracted position;

[0056] Fig. 32 is perspective view showing the tab engaging the cam surface to rotate the needle hub for retracting the needle;

[0057] Fig. 33 is another embodiment of the catheter insertion device;

[0058] Fig. 34 is an exploded view of the device of Fig. 33;

[0059] Fig. 35 a cross section side view of the device and needle shield of Fig- 32;

[0060] Fig. 36 is a cross section view of the device with the needle shield remover separated;

[0061] Fig. 37 is an exploded side view of the device;

[0062] Fig. 38 is an exploded view in cross section of the device;

[0063] Fig. 39 is a perspective view of the needle shield remover;

[0064] Fig. 40 is a perspective view of the needle hub and catheter hub;

[0065] Fig. 41 is a cross section view of the sleeve of the device of Fig. 33;

[0066] Fig. 42 is a perspective view of the device in the initial position;

[0067] Fig. 43 is a perspective view of the device with the needle shield removed;

[0068] Fig. 44 is a perspective view showing the rotation of the sleeve;

[0069] Fig. 45 is a perspective view showing the continued rotation of the sleeve;

[0070] Fig. 46 is perspective view showing the needle and catheter deployed;

[0071] Fig. 47 is a perspective view showing the needle hub before retracting;

[0072] Fig. 48 is perspective view showing the needle during the retracting movement;

[0073] Fig. 49 is a perspective view showing the needle hub in the retracted position;

[0074] Fig. 50 is a perspective view of a further embodiment of the catheter insertion device;

[0075] Fig. 51 is side view of the device of Fig. 50;

[0076] Fig. 52 is an exploded view of the device;

[0077] Fig. 53 is a cross sectional view of device;

[0078] Fig. 54 is an exploded view of the catheter hub and needle hub;

[0079] Fig. 55 is a cross sectional view of the housing;

[0080] Fig. 56 is a partial side view of the housing, catheter hub and needle hub in the initial position;

[0081] Fig. 57 is a partial side view showing the needle hub depressed;

[0082] Fig. 58 is a cross sectional view showing the catheter and needle deployed;

[0083] Fig. 59 is a side view of the needle hub disengaging from the catheter hub;

[0084] Fig. 60 is a side view showing the needle disengaged from the catheter hub; and

[0085] Fig. 61 is a cross sectional view of the deployed device.Detailed Description

[0086] It will be understood by one skilled in the art that this disclosure is not limited in its application to the specific details of construction and the arrangement of components set forth in the following description or illustrated in the drawings. The embodiments herein are capable of being practiced or carried out in various ways. Also, it will be understood that the phraseologyand terminology used herein is for the purpose of description and should not be regarded as limiting. The use of "including," "comprising,” or "having" and variations thereof herein is meant to encompass the items listed thereafter and equivalents thereof as well as additional items. Unless limited otherwise, the terms "connected," "coupled," and "mounted," and variations thereof herein are used broadly and encompass direct and indirect connections, couplings, and mountings. In addition, the terms "connected" and "coupled" and variations thereof are not restricted to physical or mechanical connections or couplings. Further, terms such as up, down, bottom, and top are relative, and are employed to aid illustration, but are not limiting. Any of the embodiments and / or elements and features of the disclosed embodiments may be combined with one another to form various additional embodiments not specifically disclosed, as long as they do not contradict or are not inconsistent with each other. Terms of degree, such as “substantially”, “about” and “approximately” are understood by those skilled in the art to refer to reasonable ranges around and including the given value and ranges outside the given value, for example, general tolerances associated with manufacturing, assembly, and use of the embodiments. The term “substantially” when referring to a structure or characteristic includes the characteristic that is mostly or entirely present. The terms needle, insertion needle and introducer needle can be used interchangeably. The term catheter refers to a device having lumen suitable for delivering a fluid substance to a subject. The term catheter and cannula can be used interchangeably and can be a flexible catheter or cannula as known in the art.

[0087] Fig. 1 is a perspective view of a patch pump 1. The patch pump 1 is illustrated with a see-through cover for clarity and illustrates various components that are assembled to form the patch pump 1. Fig. 2 is an exploded view of the various components of the patch pump of Fig. 1 , illustrated with a solid cover 2. The various components of the patch pump 1may include a reservoir 4 for storing the medication; a pump 3 for pumping the medication out of the reservoir 4; a power source 5 in the form of one or more batteries; an insertion mechanism 7 for an inserting and insertion needle with a catheter into a user’s skin; control electronics 8 in the form of a circuit board with optional communications capabilities to outside devices such as a remote controller and computer, including a smart phone; a dose button 6 on the cover 2 for actuating a medication dose, including a bolus dose; and a base 9 to which various components above may be attached via fasteners 91. The patch pump 1 also includes various fluid connector lines that transfer medication pumped out of the reservoir 4 to the infusion site.

[0088] It should be understood that inserter mechanisms come in various configurations. In some embodiments, the insertion mechanism inserts a soft catheter into the skin. In these embodiments, typically the soft catheter is supported on a rigid insertion needle. The insertion needle is inserted into the skin along with the soft catheter, and then retracted, leaving the soft catheter in the skin. In other embodiments, a soft catheter is not provided, and the insertion needle remains in the skin and forms a portion of the medication flow path to deliver medication until the delivery is finished. Insertion needles are typically hollow when they form part of the medication flow path. However, insertion needles that support a soft catheter and then retract may be solid or hollow. If the insertion needle deploys a soft catheter, and retracts but remains part of the flow path, then the insertion needle should be hollow. However, if the insertion needle deploys a soft catheter and then retracts but does not form part of the flow path, then the insertion needle may be solid or hollow. In either case, the insertion needle is preferably rigid enough to reliably penetrate the skin, but otherwise may be made flexible enough to provide comfort to the user.

[0089] Fig. 3 is a perspective view of an alternative design for a patch pump 1A having a flexible reservoir 4A, and illustrated without a cover. Such arrangement may further reduce the external dimensions of the patch pump 1A,with the flexible reservoir 4A filling voids within the patch pump 1A. The patch pump 1A is illustrated with a conventional cannula insertion device 7A that inserts the cannula, typically at an acute angle, less than 90 degrees, at the surface of a user’s skin. The patch pump 1A further includes a power source 5 A in the form of batteries; a metering sub-system 41 that monitors the volume of medication and includes a low volume detecting ability; control electronics 8A for controlling the components of the device; and a reservoir fill port 43 for receiving a refill syringe 45 to fill the reservoir 4A.

[0090] Fig. 4 is a patch-pump fluidic architecture and metering sub- system diagram of the patch pump 1A of Fig. 3. The power storage sub-system for the patch pump 1A includes batteries 5A. The control electronics 8A of the patch pump 1A may include a microcontroller 81, sensing electronics 82, pump and valve controller 83, sensing electronics 85, and deployment electronics 87 that control the actuation of the patch pump 1A. The patch pump 1A includes a fluidics sub-system that may include a reservoir 4A, volume sensor 47 for the reservoir 4A, a reservoir fill port 43 for receiving a refill syringe 45 to refill the reservoir 4A. The fluidics sub-system may include a metering system comprising a pump and valve actuator 411 and an integrated pump and valve mechanism 413. The fluidics sub-system may further include an occlusion sensor, a deploy actuator, as well as the cannula 47 for insertion into an infusion site on the user’s skin. The architecture for the patch pumps of Figs. 1 and 2 is the same or similar to that which is illustrated in Fig. 4.

[0091] The present catheter insertion device is for use with the medication delivery device, such as an on body delivery device, infusion set, or patch pump. The catheter insertion device has an actuator that is actuated to insert the catheter into the subject and automatically release a spring to retract the insertion needle at least partially from the catheter into the device so that the substance, such as a medication can be supplied through the catheter.

[0092] The delivery device is referred to as an on body delivery device, such as a patch pump or infusion device. The delivery device as disclosed includes an automatic catheter insertion mechanism for deploying the catheter and an insertion needle to introduce the catheter into a subject for delivering a substance, such as a medication. In one embodiment, the medication can be insulin although the delivery device is not limited to insulin delivery. Other fluids, drugs and pharmaceuticals can be delivered to the patient. The catheter insertion mechanism as described herein is an automatic insertion mechanism where the user deploys the device by activating an actuator. The insertion mechanism automatically introduces the catheter into the patient and then retracts the insertion needle. The catheter includes a fluid connection for delivering fluid through the catheter. The delivery device includes a suitable dispensing mechanism, storage container and metering devices for extended delivery of the substance, medication, drug or pharmaceutical to the subject or patient as known in the art.

[0093] In the following, various embodiments of the catheter insertion device are disclosed. The different embodiments of the insertion device can be used with the delivery device as shown in Figs. 1-4 or other delivery devices. In each embodiment, the catheter includes a fluid connection for connecting with the fluid source of a delivery device, such as the delivery device of Figs. 1-4, to deliver the substance, drug, or medication to the subject.

[0094] A first embodiment of the catheter insertion device is shown in Figs. 5-14 where the catheter insertion device 10 includes an actuator 12, a delivery device shown as a catheter 14, and an insertion needle 16. The catheter insertion device 10 can be incorporated into a delivery device, such as the device of Figs. 1-4. In other embodiments, the device can be a single deported needle set. The pump mechanism and related components are not shown in Figs. 5- 14 for clarity. In the embodiment as shown, the delivery device is a flexible catheter 14 as known in the art having a dimension and length suitablefor delivering a fluid substance, drug and / or pharmaceutical through the skin of a patient with minimal discomfort to the patient. Flexible catheters are generally preferred to reduce the discomfort to the patient. In other embodiments, the delivery device can be a rigid cannula or other delivery device having a lumen.

[0095] Catheter 14 has a first proximal end 18 and a second distal outer end 20. A fluid passage extends between the ends for delivering the fluid substance, drug, pharmaceutical or medication to the patient. First end 18 of catheter 14 is coupled to a catheter hub 22 as shown. Catheter hub 22 has a substantially cylindrical shape with a conical shaped lower end in the embodiment shown. Catheter hub 22 has an axial passage 24 extending between a proximal end and a distal end and has a dimension for receiving the proximal end of the catheter. The proximal end of the catheter 14 is fixed to the distal end of the catheter hub 22 and axial passage 24 by various attachment mechanisms. The proximal end of the catheter hub 22 and the axial passage 24 have a recessed portion receiving a septum 26 for closing the proximal end of the axial passage.

[0096] The catheter hub 22 includes a radially extending passage 28 that communicates with the axial passage 24 for supplying the fluid or medication to the axial passage and the catheter from the fluid source, such as the pump mechanism and related components of Figs. 1-4. In the embodiment shown, a conduit 44, such as a flexible tube, is connected to the catheter hub for supplying the medication.

[0097] The catheter hub 22 in the embodiment shown is coupled to a carrier 30 for sliding in a housing 32. In the embodiment shown in Fig. 8, the carrier 30 has a recess in a proximal end that receives and supports the catheter hub 22. The catheter hub 22 can have a radially projecting detent that is received in a complementing recess in the inner surface of the carrier 30 to couple the catheter hub 22 to the carrier 30. The carrier 30 and the catheter hub 22 forma catheter assembly 31 as discussed below. The connection between the carrier 30 and the catheter hub 22 form a fluid tight seal for supplying the fluid to the catheter.

[0098] The housing 32 of the catheter insertion device 10 has a configuration for supporting the catheter assembly 31 and enabling the catheter assembly 31 to move axially in the housing between a first position where the catheter 22 is retracted and positioned within the housing 32 and an extended second position where the distal end of the catheter extends from the housing 32. The housing 32 as shown in this embodiment has a substantially cylindrical shape with an axial passage having an open proximal end 34 and a bottom wall 36 at a distal end. As shown in Fig. 8, the bottom wall 36 includes an opening 38 for the catheter to extend from the housing 32. The housing 32 has an inner wall 40 forming an axial chamber 48 with a shape and configuration for receiving the carrier 30 so that the carrier can slide or move axially within the chamber 48. The inner wall 40 has a longitudinally extending slot 42 for a conduit 44 that is connected to the radial passage 28 of the catheter hub 22 for supplying the fluid to the catheter 14. The housing 32 also has an outer wall 46 concentric with the inner wall 40 and has a longitudinal slot 47 aligned with the slot 42. The inner wall 40 and outer wall 46 are spaced apart to define an annular space 50.

[0099] The carrier 30 for the catheter hub 22 as shown in Figs. 7 and 8 has a body configured to be received in the axial chamber 48 of the housing 32 for axial movement relative to the housing. The carrier 30 in the embodiment shown has a substantially cylindrical shaped body 52 with a distal end having an opening for the catheter 14. The cylindrical shaped body 52 complements in the inner shape and dimension of the axial chamber 48 of the housing 32 to enable the carrier to slide within the axial chamber 48. A radial passage 54 extends through the carrier body 52 for receiving the conduit 44 as shown. A proximal end of the carrier body 52 has a radially extending flange 56 thatprojects radially outward into the annular space 50. The flange 56 includes an arcuate shaped opening 57 shown in Fig. 7. The arcuate shaped sections of the inner wall 40 extend through the openings 57 so that the needle carrier 31 can slide within the annular space 50 between the inner wall 40 and the outer wall 46. In the embodiment shown, the housing 32 includes two slots 42 in the inner wall 40 on opposite sides forming the wall portions that extend through the openings 57 in the flange 56. The flange 56 of the carrier body 52 has two connecting portions 59 that extend through a respective slot 42 into the annular space 50 of the housing shown in Fig. 8. The connecting portions 59 are oriented to prevent rotation of the carrier 30 relative to the housing 32 while enabling sliding axially with respect to the housing.

[0100] The flange 56 of the carrier 52 has a distal face with distally extending locking members shown as locking projections 58 and a proximal face with proximally extending coupling members shown as arms 60. The locking projections 58 include a flexible leg 62 with a hook member 64 formed by an inclined or angled end 66 facing outwardly and distally. A proximally facing ledge 68 extending outward forms a hook member. The proximally extending arms 60 are flexible to bend relative to the body 52. As shown, the arms 60 have an inwardly facing inclined surface 70 to bend the flexible arms 60 when the inclined surface 70 engages a surface. A distal end of the arms 60 have a lip 72 with a distally facing surface that extends radially inward.

[0101] The proximal end of the insertion needle 26 is coupled to a needle hub or needle carrier 74. The needle hub 74 has a cylindrical shaped body 76 and an outwardly extending flange 78. In the embodiment shown, the body 76 has a dimension the same as or substantially the same as the dimension of the catheter hub 22. Insertion needle 16 is received in the passage of catheter 14 and has a length to extend past the distal end of catheter 14 as shown. Insertion needle 16 in the embodiment shown is a needle that can be solid or hollow. When the needle is hollow, the needle is formed with a tight connectionwith the needle carrier to prevent fluid leakage around the needle. A hollow needle can be used for delivering a second drug or medication. The needle is typically made of stainless steel as known in the art. In another embodiment, the insertion needle can be a cannula with an internal passage or lumen for delivering a fluid, such as a medication or other pharmaceutical agent to the catheter and to the patient. Insertion needle 16 has a sharp and / or pointed distal end with a sharp tip for penetrating the skin of the patient to assist in inserting flexible catheter 14 into the skin of the patient as shown. Insertion needle 16 passes through septum 26 to provide a fluid tight seal between insertion needle 16 and catheter 14 as known in the art.

[0102] A cap 80 is coupled to the open top end of the housing 32 to enclose the needle carrier 30 within the housing. As shown, the inner surface of the cap 80 has an outer annular ledge 82 and an inner annular ledge 84.

[0103] The catheter insertion device 10 includes a biasing member in the form of a first spring 86 and a second spring 88. In the embodiment shown, the springs 86 and 88 are coil or torsion springs. The first spring 86 is positioned in the housing 32 surrounding the proximal arms 60 and extends between the proximal face of the tabs 56 and a proximal face of the outer ledge 82 of the cap 80. The second spring 88 surrounds body 76 of the needle hub 74 and extends between the distal face of the flange 78 and the distal face of the carrier 30 as shown in Figs. 9-14.

[0104] The housing 32 includes an opening in the side wall shown as a slot 90. The actuator 12 in this embodiment is a rigid key that can be a strip or puller. The actuator 12 extends through the slot 90 to contact the distal surface of the flange 56 to retain the catheter hub 22 and needle hub 74 is a first retracted position as shown in Figs. 9 and 12 and to retain the spring in a loaded state. The actuator 12 has a U-shaped end portion 92 that extends though the slot 90 to engage the tabs 56. A proximal end portion 94 of the actuator extends in a direction opposite from the end portion 92 and has adimension for gripping by the user so that the actuator 12 is separable from the device.

[0105] In the initial loaded state, the actuator 12 retains the catheter hub 22 and needle hub 74 in a retracted position with the springs 86 and 88 under load or a compression state as shown in Figs. 9 and 12. In the first position, the distal ends of the catheter 14 and insertion needle 16 are positioned within the housing 32. During use, the user removes the actuator 12 so that the first spring 86 is released to bias and move the catheter hub 22 and needle hub 74 distally to extend through the opening in the bottom wall of the housing 32 as shown in Figs. 10 and 13A- 13B. The insertion needle 16 extends from the distal end of the catheter 14 so that the needle can prick the tissue and to insert the catheter into the tissue. The distal movement of the catheter hub 22 causes the distal projections 58 to extend through openings 98 where the ledge 68 of the locking projections 58 hook to the housing 32. The inclined surface 66 of the distal projections engage the edge of the openings 98 to bend the locking projections 58 outward as they pass through the openings. Once clear of the openings, the locking projections spring back inwardly to the original position to lock the catheter hub 32 in the extended, deployed position.

[0106] The distal movement of the catheter hub 22 relative the housing 32 brings the inclined surface 70 of proximal arms 60 into contact with inclined surfaces 96 to deflect the proximal arms 60 radially outward and away from the needle hub 74 indicated by the arrows in Figs. 13A-13B to release the needle hub 74. Once released, the spring 88 biases and moves the needle hub 74 and the insertion needle 16 proximally to withdraw the needle at least partially from the catheter. In the embodiment shown, the needle 16 is retracted from the proximal end of the catheter 14 while at least the tip remains in the septum 26 to prevent leakage of fluid from the septum. In other embodiments, the septum can be made from a material that seals when the needle is removed completely. Fluid can then be supplied through the conduit44 through the carrier 30 and catheter hub 22 and though the catheter to deliver the fluid through the catheter. In one embodiment shown in Figs. 13A- 13B, the lip 72 of the arms 60 can include a hook portion to hook to the inner surface of the inner wall after separating from and releasing the needle hub 74 to assist in preventing the needle carrier from reconnecting with the carrier 30.

[0107] The catheter insertion device 100 in the embodiment of Figs. 15-20 is substantially the same as in Figs. 5-14 with the exception of the actuator 102 forming a trigger. In Figs. 15-20, identical members and parts are indicated by the same reference numbers for clarity. The actuator 102 of the embodiment of Figs. 15-20 is formed as part of the cap 104 and extends in a distal direction from the edge of the cap. As shown in Fig. 15 and Fig. 17, the actuator 102 is a projection extending from the outer perimeter and includes a tab 106 projecting radially inward. The tab 106 has a dimension and orientation to engage the distal face of the flange of the carrier 30 to capture the flange and retain the carrier 30 in the initial position before use. The cap 104 in the embodiment shown is able to rotate relative to the housing 32. The housing 32 in the embodiment shown has an open slot 108 with a dimension complementing the dimension of the tab 106. The tab 106 as shown in Fig. 17 projects radially inward relative to the cap and housing. The tab 106 as shown has an inclined leading edge 110, an inclined trailing edge 112, and a curved concave surface 1 14 between the leading edge and the trailing edge. The slot 108 as shown in Fig. 16 has an inclined leading edge 1 16 and an inclined trailing edge 118 complementing the leading edge and trailing edge of the tab.

[0108] The actuator 102 is operated by the user by rotating the cap 104 relative to the housing where the inclined leading edge of the tab 106 engages the inclined leading edge of the slot 108. The actuator 102 and tab 106 are sufficiently flexible that the actuator deflects outward by the inclined surfaces contacting one another thereby releasing the flange and enabling the carrier 30 and needle hub to slide to the deployed position shown in Fig. 16. The carrier30 and associated locking member and coupling member, and housing 32 are otherwise constructed the same as or substantially the same as in Figs. 5-14. In Figs. 15-20, the locking member and coupling tabs are not shown in detail but are understood to be included as in the embodiment of Figs. 1-14. In this manner the carrier moves to the deployed position by the spring 86 to couple to the housing by the projections and release the needle hub to retract the needle hub and needle to the retracted and deployed position shown in Fig. 17.

[0109] Fig. 21-32 show another embodiment of the catheter insertion device 120. The device 120 includes a housing 122, a catheter 124, a catheter hub and carrier 126, a movable sleeve 128, and an actuator 130. The housing 122 has a substantially cylindrical shape with a distal end having a base 132 for placing against the surface of the subject. As shown in Figs. 22 and 25, the base extends radially outward and includes a central opening 134 to enable the catheter 124 to extend through the base when deployed. The housing 122 has a proximal end closed by a cap 136 to enclose the center cavity 138 of the housing. At the proximal end of the side wall 140 of the housing 122, two opposing slots 142 are provided for receiving the actuator 130. The side wall 140 also includes two openings 144 oriented distally of the slots 142. A longitudinally extending slot 146 is formed in the side wall 140 to allow the supply conduit 150 connected to the catheter to slide axially during deployment of the device.

[0110] The side wall 140 has an inner surface extending between the proximal end and the distal end of the housing 122. A cam member 152 is formed on the inner surface of the side wall as shown in Fig. 28. The cam member 152 has an inclined cam surface 154 facing in the proximal direction relative to the device.

[0111] The catheter 124 is a flexible member with a proximal end coupled to the catheter hub 126 as in the previous embodiments. The catheter hub 124 has a cylindrical body 156 with an outwardly extending flange 158. Thecatheter hub 126 is configured and dimensioned to slide within the sleeve as discussed below. As shown in Fig. 22, the catheter hub 126 has an axial passage 160 for receiving the catheter and a radially extending passage 162 for receiving the supply conduit 150 for directing fluid to the catheter 122 from a suitable supply. A septum 164 is provided in the proximal end of the axial passage 160 to close the proximal end of the axial passage.

[0112] An insertion needle 166 is received in the catheter for inserting the catheter into the subject as in the previous embodiments. The insertion needle 166 is coupled to a needle hub or carrier 168 for axial movement within the housing and the catheter. The needle hub 168 in the embodiment shown has a cylindrical or substantially cylindrical shaped body 170 with two guide tabs 172 projecting radially outward from opposite sides of the body 170. As shown in Fig. 22, a post 174 extends in a distal direction with respect to the device. A spring 176 surrounds the post 174 and is oriented between the body 170 and the catheter hub 126 and the septum 164.

[0113] The sleeve 128 has a cylindrical shape for axial movement within the housing 122 between an initial position and a deployed condition. Referring to Fig. 23 and Fig. 26, the sleeve 128 has a cylindrical side wall 178 defining an axial passage 180 extending between a top proximal end 182 and a bottom distal end 184. The outer surface of the side wall 178 has an upper first flange 186 and a second flange 188 spaced distally from the first flange 186.

[0114] As shown, at least one and typically two outwardly extending tabs 190 project outwardly from the side wall 178 and are oriented between the distal end and the proximal end of the sleeve 128. The tabs 190 have a flexible leg 192 extending at an incline in the proximal direction and outwardly relative to the side wall. The flexible legs 192 have an inclined distal surface 194 for sliding into locking engagement with the housing 122 and a proximal face 196 for retaining the legs 192 and the sleeve 128 in the locked position.

[0115] The side wall of the sleeve 128 includes a slot 198 having an axially extending section 200 that extends from the proximal end toward the distal end of the sleeve 128. An inclined section 202 extends from the distal end of the slot 198 toward the distal end of the sleeve. A lateral transverse section 204 extends from the inclined section 202. As shown in Fig. 25, an actuator spring 206 is positioned around the sleeve 128 and extends between the flange 188 and the cap 136 of the housing 122.

[0116] The sleeve 128 includes an inner transverse wall 208 positioned toward the distal end of the sleeve as shown in Fig. 26. Inner wall 208 has a recess 210 to receive the end of the spring 176 to bias the needle hub 168 and the insertion needle away from the catheter hub 136. A central hole 212 is provided for the insertion needle 166 to pass through.

[0117] The actuator 130 in the embodiment shown is received in the slot 142 in the housing for capturing the sleeve 128 in the loaded condition. The actuator 130 as shown has a flat configuration with a pair of flat prongs 214 with a dimension to be received in the slots 142 and to engage the flange 188 of the sleeve.

[0118] Figs. 21, 24 and 25 show the insertion device 120 in the loaded condition ready for use. In the loaded condition, the sleeve 128 is in the proximal end of the housing 122 and retained by the prongs 214 of the actuator 130. The spring 206 is captured between the flange 188 and the end cap 136 of the housing and is under load in a compressed condition. The sleeve extends from the opening in the cap 136 and is captured by the flange 186 engaging the cap. The needle hub 168 is coupled to the sleeve in the initial position so that the needle hub is able to move with the movement of the sleeve. In the embodiment shown, the proximal end of the catheter hub 126 is received in the open end of the sleeve 128 and can be retained by a friction fit. The tabs 172 of the needle hub 168 are received in the transverse section 204 of the slot 198 as shown in Fig. 29 so that the needle hub 168 and needle 166move with the sleeve in the initial condition. The needle is enclosed in the housing 122 in the initial condition as shown in Figs. 24 and 25.

[0119] During use, the device 120 is position against the target area of the subject. The actuator 130 is manually removed from the housing 122 to separate from the flange 188 of the sleeve 128. Once separated, the spring 206 moves the sleeve 128, needle hub 168 and catheter hub 126 to the extended position where the needle and catheter are inserted into the subject as depicted in Fig. 30. The locking tabs 190 of the sleeve slide downward along the inner surface of the housing where the tabs 190 spring outward into engagement with the openings 144 in the housing to prevent proximal movement of the sleeve and catheter hub. The downward movement of the sleeve 128 with the needle hub 168 brings the tabs 172 of the needle hub 168 into contact with the inclined surface 154 of the cam member 152 on the inner surface of the housing as shown in Fig. 32. The inclined cam surface 154 contacts the tabs 172 causing the needle hub 168 to rotate relative to the sleeve 128 and to guide the tabs 172 into the inclined section 202 and the axially extending section 200 of the slot. The needle hub 168 then travels in the proximal direction by the spring 176 to retract the needle from the catheter 124.

[0120] In the embodiment shown in Fig. 31 , the needle 166 is retracted from the catheter 124 and needle tip is retained in the septum 164 to prevent leakage of fluid through the septum. In other embodiments, the needle can be removed completely. The supply conduit 150 coupled to the catheter hub 126 slides within the slot 146 in the housing 122 with the movement of the sleeve 128 and the catheter hub 126. In the deployed condition shown in Fig. 31, a fluid can be supplied through the supply conduit 150 to the catheter from a suitable source.

[0121] A further embodiment is shown Figs. 33-49 where the catheter insertion device 220 includes a housing 222, a catheter 224 coupled to acatheter hub 226, an insertion needle 228 coupled to a needle hub 230, and an actuator 234.

[0122] As shown in Fig. 35 a needle shield 238 is coupled to the catheter hub 226 prior to use. A needle shield remover 236 is coupled to the housing 222 for coupling to the needle shield 238 by a friction fit. A post 240 projects from the needle shield remover 238 forming a stop member to block the movement of the actuator 234 and prevent premature activation.

[0123] The housing 222 as shown in Fig. 34 includes a base 242 for placing against the surface of the subject for delivering a fluid or medication. An adhesive can be provided on the bottom face of the base 242 for attaching the housing to the subject during use. An opening 244 is provided to receive the post 240 of the needle shield remover 236. The housing 222 in the embodiment shown has a cylindrical or substantially cylindrical shape having an axial passage 246 for receiving the catheter hub 226 and needle hub 230. The housing 222 has two longitudinally extending slots 248 that extend from a top proximal end to a bottom distal end at the base 242. The slots 248 are positioned on opposite sides of the cylindrical housing 222.

[0124] The catheter 224 is coupled to the catheter hub 226 for axial movement within the axial passage 246 of the housing 222. As shown in Figs. 34 and 40, the catheter hub 226 is configured for connecting to a supply conduit 250 to supply a fluid through the catheter hub to the catheter 224 for delivering the fluid or medication to the subject. The catheter hub 226 has a cylindrical shaped body 252 with a shape and dimension for sliding axially in the passage 246 of the housing 222. The body 252 has an internal cavity or passage for receiving fluid from the conduit 252 and directing the fluid through the catheter 224. The body 252 has an open top end receiving a septum 254 to close the open top end of the catheter hub 226. As in the previous embodiment, the septum 254 is oriented to seal the open top end of the catheter hub 226 and prevent leakage when the insertion needle is retracted.

[0125] The body 252 includes a collar 255 at the distal end of the body and at least one and typically two lugs 256 projecting radially outward from opposite sides of the collar. The lugs 256 have a radial width complementing the width of the slots 248 to enable the catheter hub 226 to slide axially relative to the housing 22 with limited rotational movement of the catheter hub with respect to the housing. Each lug 256 includes a tab 258 forming a cam follower that projects radially outward from the respective lug and the catheter hub 226.

[0126] The needle hub 230 has a shape and outer dimension complementing the shape and outer dimension of the catheter hub 226. The needle hub 230 includes a cylindrical shaped body 260 with a distal face 262 that has a recess 264 as shown in Fig. 38 complementing the dimension of the body 252 of the catheter hub so that the needle hub 230 is able to mate with the needle hub. The body 252 of the catheter hub 230 can have a dimension to couple to the recess of the needle hub by a friction fit.

[0127] The outer face of the needle hub 230 includes two lugs 266 projecting radially outward as shown in Fig. 40. The lugs 266 have a shape and dimension complementing the lugs 256 of the catheter hub 226. The lugs 266 have width to slide axially in the slot 248 in a manner similar to the sliding movement of the lugs 256. The catheter hub 226 and the needle hub 30 can mate with each other with the respective lugs aligned for sliding together with the slot 248 or sliding independently within the slot 248. The radial face of the lugs 266 include a radially extending tab 267 forming a cam follower as discussed below.

[0128] The sleeve 232 is configured for coupling the housing 222 and rotating relative to the housing. The sleeve 232 has a substantially cylindrical shape with an outer surface 268 and an inner surface 270. The sleeve 232 can be made as one piece unit or as two cylindrical sections coupled together. The sleeve 232 has an open distal end 272 to fit over the housing 222 and an openproximal end 274. The sleeve 232 slides over the housing and is retained by an outwardly projecting lip 276 on the proximal end of the housing as shown in Fig. 34 to allow the sleeve to rotate with respect to the housing 222.

[0129] The inner surface 270 of the sleeve 232 includes a cam surface shown as a cam groove 278 for the tabs 258 that form cam followers of the needle hub and catheter hub. As shown in Fig. 41 , the cam groove 278 has a proximal section 280 at the proximal end 274 with a flat surface 282 facing in the proximal direction. The proximal section 280 is open to the proximal end of the sleeve and has a longitudinal dimension to receive the tabs 258 and 267 when the tabs are oriented along the longitudinal axis. A first inclined section 282 extends from the proximal section 280 in a spiral manner toward the distal end of the sleeve 232 as shown in Fig. 41. The first inclined section 282 terminates at an intersection between a second inclined section 284 and a transverse lateral section 286. As shown in Fig. 38, the second inclined section 284 extends toward the proximal end of the sleeve and the lateral section 286 extends transversely around the perimeter of the sleeve on the inner surface. The lateral section 286 has length corresponding to the spiral length of the second inclined section 284 so that the ends of lateral section 286 and the second inclined section 284 are axially aligned as shown in Fig. 38.

[0130] The sleeve 232 is coupled to the housing 222 for rotational movement relative to the housing. A torsion spring 288 is positioned around the sleeve 232 to rotate the sleeve. The torsion spring 288 has a first end 290 that engages a lug 292 projecting from the base 242 and a second end 294 that engages a lug 296 that projects radially outward from the sleeve. The torsion spring 288 is configured to be retained in a loaded condition or configuration and to rotate the sleeve when the sleeve and / or spring are released.

[0131] The actuator 234 is configured for sliding between a locking position shown in Fig. 42 and a deployed, unlocking position shown in Fig. 44. The actuator 234 includes a locking tab 300 formed by a leg 302 extending fromthe bottom side of the actuator and a projection 304 that extends parallel to the plane of the actuator toward the housing 222. A stop member 306 projects from the bottom side of the actuator on a side opposite the locking tab 300. The upper surface of the actuator 234 has a recessed portion 308 for sliding the actuator by the user, such as by applying a force from a thumb or finger of the user.

[0132] In the initial assembly of the catheter insertion device 220 as shown in Fig. 42, the needle shield 238 and the needle shield remover 236 are coupled to the base 242 of the housing 222. The post 240 extends through the opening in the base and is oriented to contact the stop member 306 to prevent movement of the actuator 234 before use. The needle shield remover 236 also includes two arcuate shaped projections 310 that are inserted through the distal end of the housing 22 into the slots 248 to prevent axial movement of the needle hub and catheter hub. In the initial position before use, the projection 304 of the actuator 234 is received in an aperture 312 in the outer surface of the sleeve 232 to prevent rotation of the sleeve with respect to the housing. The spring 288 is coupled to the base of the housing and the sleeve as discussed above and initially wound in a loaded or tensioned condition. The locking tab 300 that is received in the aperture 312 retains the sleeve 232 under tension by the spring.

[0133] The catheter insertion device 220 in the embodiment shown is part of delivery device as shown in Figs. 1-4 and as described in the previous embodiments. During use, the needle shield remover 236 is separated from the base of the housing 232 which removes the needle shield 238 from the catheter and catheter hub. In the position shown in Fig. 43, the catheter insertion device 220 is in the ready position for use. The device is positioned on the target site of the subject and the actuator 234 is manually moved to slide to the position shown in Fig. 44 in the direction of the arrow in Fig. 44. The sliding movement separates the locking tab 300 from the aperture 312 in thesleeve 232 where the spring rotates the sleeve to deploy the device and insert the catheter into the patient.

[0134] In the ready position shown in Fig. 43, the tabs 258 of the catheter hub 226 are aligned with the horizontal / lateral surface 282 of the proximal section 280 of the cam groove 278 to prevent axial movement of the catheter hub 226 and the needle hub 230. The torsion spring 288 rotates the sleeve 232 while the catheter hub 226 and needle hub 230 are restricted from rotation by the respective lugs being received in the slots 248. The torsion spring 288 rotates the sleeve to the position shown in Fig. 44 where the tab 267 of the needle hub 230 contacts the vertical longitudinal surface of the proximal section of the cam groove 278. The tab 267 engages the vertical longitudinal surface to prevent further rotation of the sleeve. The actuator is then depressed manually in the direction to the downward arrow of Fig. 45 to move the needle hub and catheter hub in the distal direction. The downward movement of the needle hub and catheter hub by the actuator then aligns the tabs 258 and 267 with the second inclined section of the cam groove.

[0135] The rotation of the sleeve 232 as shown in Fig. 45 and Fig. 46 moves the catheter hub and the needle hub along the second inclined surface 284 of the cam groove 278 to a distal position shown in Fig. 46 and Fig. 47 where the catheter and insertion needle extend from the device to insert the catheter into the subject. When the catheter hub and needle hub are in the distal position shown in Fig. 47, the tabs 258 on the catheter hub align with the lateral section 286 of the cam groove 278 and the tabs 267 on the needle hub align with the second inclined section 284. Continued rotation of the sleeve by the spring slides the tabs 258 along the lateral section 286 while the tabs 267 slide along the second inclined section of the cam groove to retract the needle hub and needle into the housing relative to the catheter until the tabs 267 reach the proximal end of the cam groove. The tabs 267 in the deployed position contact a transverse lateral surface at the proximal end of the cam groove toresist further axial movement of the needle hub. The tabs 258 of the catheter hub are captured in the lateral section 286 of the cam groove 278 to retain the catheter in the extended position. After the device is deployed, the fluid is supplied through the supply connection to the catheter hub and catheter for delivering the fluid to the subject.

[0136] Figs. 50-61 show another embodiment of the catheter insertion device 320. Various aspects of the device are the same or substantially the same as in the previous embodiments and are not described in detail. In the embodiment shown, the device 320 includes a housing 322 for supporting a catheter 324 coupled to a catheter hub 326, an insertion needle 328 coupled to a needle hub 330, and an actuator 332. A needle shield and needle shield remover 236 are shown in phantom lines in Fig. 51. The needle shield remover and needle shield are the same or substantially the same as in the previous embodiment, and therefore are not discussed here in detail.

[0137] The housing 322 includes a base 334 for placing against the surface of the subject during the insertion of the catheter 324 and delivery of the medication. The base 334 includes openings 336 for the needle shield remover as in the previous embodiment. The housing 334 has a side wall 338 projecting from the base 334 forming an axial passage 340. The side wall 338 as shown in Fig. 55 has an open proximal top end with a retaining collar 342 to capture the needle hub 330 within the housing as discussed below. The collar 342 can be integrally formed with the side wall or can be separate member that is coupled to the side wall by a suitable mechanism, such as an adhesive.

[0138] As shown in Fig. 55, the side wall 338 has an inner surface with a dimension and configuration to enable the catheter hub 326 and needle hub 330 to move and / or slide axially within the axial passage 340. The side wall 338 includes an opening forming a slot 344 extending between the proximal top end and the distal bottom end of the side wall 338. In the embodimentshown, three slots 344 are provided in the side wall 338. The number of slots 344 are determined by the configuration of the catheter hub 326.

[0139] The slots 344 as shown have a shape to define at least one proximal top ledge 346 oriented at the proximal end of the respective slot. In the embodiment shown, the slots have a ledge 346 on opposite sides of the slot. The ledge 346 is oriented in a transverse, lateral direction relative to the center axis of the axial passage 340. The slot 344 includes a substantially vertical surface 348 and an opposing inclined surface 350 for guiding the catheter hub and needle hub to an extended and deployed position. The side wall 388 includes an inwardly extending ledge 352 formed at the lower distal end of the side wall 338 and the slot 344 as shown in Fig. 55. The ledge 352 has a protrusion 354 extending toward the proximal end of the housing 322 and has an inclined proximally facing surface 356.

[0140] The catheter hub 326 as shown in Fig. 54 has a body 358 with a circular shape, a top proximal end 360, and a bottom distal end 362. The catheter 324 extends from the distal end 362. The catheter hub 326 has an internal cavity receiving a fluid from a supply conduit 364 for supplying fluid through the catheter. The top end of the catheter hub 326 has a recess receiving a septum 366.

[0141] The catheter hub 326 as shown in Fig. 54 includes one or more arms 368 extending radially outward from the body 358. The three arms 368 in the embodiment shown provide a guide mechanism for the axial movement of the catheter hub in the housing. In other embodiments, more or fewer than three arms can be provided. The arms 368 have a length to extend outward to be received in a respective slot 344 of the housing 322 for sliding in the slot. The arms 368 have a projection 370 with a first face 372 oriented in the axial plane and extending radially outward. The projection 370 has an undercut defined by a distal face 374 facing axially toward the distal end of the housing 322. The arms 368 have a second face 376 spaced laterally from the first face 372.As shown in Figs. 56 and 57, the distal face of the arms 368 have an inclined cam surface 378.

[0142] The needle hub 330 has a body 380 with a substantially cylindrical shape configured to rotate within the body of the housing 222 and relative to the catheter hub 326. As shown in Fig. 54, the body 380 has a top proximal end 382 and a distal end with a distally extending post 384 supporting the needle 328. A side wall 386 extends between the proximal end and the distal end and has a substantially cylindrical shape.

[0143] As shown in Fig. 54, the side wall 386 has longitudinal recess 388 extending between the proximal end and the distal end of the body 380. Adjacent the recess 388 is a cutout 390 at the proximal end lateral surface 392 facing in the proximal direction and forming a ledge. Adjacent the recess 388 on a side opposite the cutout 390 is a leg 394 extending longitudinally toward the distal end of the needle hub. The leg 394 projects from the side wall 386 in the distal direction. The leg 394 has a substantially L-shape formed with a lateral projection 396 having a proximal surface 398, a distal surface 400, and an end surface 402 extending in the longitudinal direction.

[0144] The actuator 332 is similar to the actuator in the previous embodiment and is configured to slide in a transverse direction with respect to the longitudinal, axial dimension of the housing, catheter, and needle. The actuator is also configured to move in an axial direction relative to the housing during the actuation of the device. In the embodiment shown, the actuator has a projection 404 extending from the leading end of the actuator. The catheter insertion device includes a latching member 406 oriented for mating with the projection 404 of the actuator. As shown in Fig. 52, the latching member 406 has at least one and typically two arms 408 spaced apart a distance to receive the projection 404 when the actuator is moved to the deployed position. The arms 408 have a recess 410 configured to receive a respective detent 412 on the projection.

[0145] A spring 414 is oriented in the device and extends between the distal face of the needle hub 330 and the proximal face of the arms 368 of the catheter hub 326 to bias the needle hub in a proximal direction relative to the proximal end of the device. A second spring 416 surrounds the spring 414 and extends between the arms 368 of the catheter hub 326 and the inner surface of the collar 342 to bias the catheter hub in the distal direction for positioning the catheter distally of the housing. In one embodiment, two separate springs can be used to bias the catheter hub to the extended position as necessary to provide sufficient biasing force to insert the needle and catheter into the subject. A single spring can also be used where the spring can provide a sufficient insertion force.

[0146] The catheter insertion device 320 in the initial configuration is shown in Fig. 50. The housing of the deliveiy device is not shown in Fig. 52 for clarity although it is understood that the insertion device is used in conjunction with a suitable fluid delivery device, such as the housing and fluid delivery device of Figs. 1-4. During use, the needle shield remover and needle shield are separated from the catheter insertion device. The catheter insertion device is positioned on the surface of the subject at the selected target site where the needle and catheter are in a retracted position within the housing. The actuator is moved by sliding to the position shown in Fig. 53 where the actuator couples with the latching member.

[0147] In the initial position prior to deployment, the needle hub 330 and the catheter hub 326 are in the retracted proximal position shown in Fig. 56. As shown, the end face 402 of the leg of the needle hub is aligned with and engages the face 376 of the projection 370 to prevent rotation of the catheter hub 326. The cam 378 of the catheter hub contacts the inclined surface 356 of the housing to prevent axial movement of the catheter hub 326 and the needle hub 330 as shown in Fig. 56. A downward distal force is applied to the actuator 332 to move the needle hub 330 in the distal direction to disengagethe L-shaped leg 394 from the face of the projection 370. The biasing force applied by the spring 412 causes the cam surface 378 that engages the ledge 346 of the slot 344 in the housing to rotate the catheter hub to a position where the projection 370 couples with the leg 394 to capture the needle hub with the catheter hub with the spring 414 in a loaded compressed state. The spring 416 then is able to bias the catheter hub and needle hub distally where the needle and catheter project from the distal end of the housing and position the catheter and needle in the subject. When the catheter hub is deployed and reaches the bottom end of the slot in the housing, the inclined surface 356 of the protrusion 354 engages the inclined surface of the leg 394 causing the needle hub to rotate relative to the catheter hub and disengage from the catheter hub. The spring 414 then biases the needle hub and needle to the proximal end of the housing to retract the needle from the catheter where a fluid can be delivered through the catheter.

[0148] In one embodiment, the needle is retracted relative to the catheter while remaining in the septum to prevent leakage from the septum. Fluid is then delivered through the supply conduit to the cavity of the catheter hub and to the catheter to delivery fluid to the subject.

[0149] Although only a few exemplary embodiments of the present invention have been described in detail above, those skilled in the art will readily appreciate that many modifications are possible in the exemplary embodiments without materially departing from the novel teachings and advantages of this invention. Any of the embodiments and / or elements disclosed herein may be combined with one another to form various additional embodiments not specifically disclosed, as long as they do not contradict each other. It is particularly noted that those skilled in the art can readily combine the various technical aspects of the various elements of the various exemplary embodiments that have been described above in numerous other ways, all ofwhich are considered to be within the scope of the invention, which is defined by the appended claims and their equivalents.

Claims

CLAIMS1 . A catheter insertion device comprising: a housing having an axial passage; a catheter hub having a catheter and being movable between a retracted position and an extended position with respect to said housing; a needle hub having an insertion needle within said catheter and movable between a first retracted position and a second extended position with respect to said housing; a first spring configured for moving said needle hub and insertion needle and catheter hub and catheter from the retracted position to the extended position where said catheter extends from a distal end of said housing, a second spring configured for moving said insertion needle from the extended position to the retracted position with respect to said catheter and housing when said catheter is in the extended position; and an actuator for releasing said first spring to move said catheter and insertion needle to the extended position.

2. The catheter insertion device of claim 1 , wherein said actuator extends through an opening in said housing to contact said catheter hub, said actuator being separable from said housing where said first spring moves said catheter hub to the extended position.

3. The catheter insertion device of claim 1, wherein said first spring extends between a proximal end of said housing and said catheter hub to movesaid catheter hub, and said second spring extends between said catheter hub and said needle hub to move said needle hub to the retracted position.

4. The catheter insertion device of claim 3, wherein said catheter hub is coupled to a carrier having a locking projection that engages said housing when said catheter hub is in the extended position.

5. The catheter insertion device of claim 4, wherein said carrier has a coupling member extending proximally for coupling with said needle hub, and where said coupling member releases said needle hub when said catheter hub is in the extended position where said second spring retracts said needle relative to said catheter.

6. The catheter insertion device of claim 5, wherein said housing has an inclined surface, and said coupling member has a flexible arm to engage said inclined surface to bend said flexible arm to release said needle hub.

7. The catheter insertion device of claim 1 , further comprising a rotatable cap for rotating relative to said housing, and where said actuator is coupled to said rotatable cap where rotation of said rotatable cap releases said catheter hub.

8. The catheter insertion device of claim 7, wherein said housing has a side opening and said actuator includes a tab extending through said opening to engage said catheter, and where rotation of said cap relative to said housing deflects said tab to release said catheter hub.

9. The catheter insertion device of claim 4, wherein said carrier has a body with a radially extending flange, a coupling member extending from aproximal side of said flange for coupling with said needle hub, and where said projection extends from a distal side of said flange.

10. The catheter insertion device of claim 9, wherein said housing has an inner wall and an outer wall spaced radially outward from said inner wall, and said flange of said carrier has an opening receiving said inner wall where said carrier can slide axially relative to said inner wall and outer wall.1 1. The catheter insertion device of claim 10, wherein said inner wall has a proximally facing surface configured for contacting said coupling member to disengage said coupling member from said needle hub.

12. The catheter insertion device of claim 11, wherein said first spring is oriented within said inner wall and extends between a proximal end of said carrier and said needle hub, and said second spring is oriented between said inner wall and said outer wall and extends between a proximal side of said flange and a proximal end of said housing.

13. A catheter insertion device comprising: a housing having an axial passage; a catheter hub having a catheter movable between a first retracted position and a second extended position with respect to said housing; an insertion needle within said catheter and movable between a first retracted position and a second extended position with respect to said body; a first spring configured for moving said catheter and insertion needle from the retracted position to the extended position where said catheter and insertion needle extend from a distal side of said housing;an actuator movable between a first position where said first spring is under load and a second position to release said first spring where said first spring moves said catheter hub to the extended position; and a second spring extending between said catheter hub and said needle hub to retract said insertion needle with respect to said catheter when said catheter is in the extended position.

14. The catheter insertion device of claim 13, further comprising a sleeve movable axially within said housing between a retracted position and an extended position, and where said needle hub is movable axially within said sleeve between a first position and a retracted second position.

15. The catheter insertion device of claim 14, wherein said sleeve is biased distally relative to said housing by said first spring16. The catheter insertion device of claim 15, wherein said first spring is oriented between said sleeve and said housing and said second spring is oriented within said sleeve between said needle hub and said sleeve.

17. The catheter insertion device of claim 16, wherein said sleeve has a transverse inner wall defining an open distal end receiving said catheter hub, and where said needle hub is oriented within said sleeve between said transverse inner wall and a proximal end of said sleeve.

18. The catheter insertion device of claim 14, wherein said sleeve has a flange extending radially outward, and where said actuator contacts a distal surface of said flange to retain said sleeve in a proximal position relative to said housing, and where said actuator is separable from said housing to releasesaid sleeve where said first spring biases said sleeve, needle hub and catheter hub to the extended position.

19. The catheter insertion device of claim 18, said sleeve further comprising a locking tab, and where said housing has an opening configured to receive said locking tab when said sleeve is in the extended position.

20. The catheter insertion device of claim 14, wherein said needle hub has a guide tab received in a guide slot in said sleeve, said guide slot having a longitudinal section, and a transverse section at a distal end of said longitudinal section, said guide tab oriented in said transverse section when said needle hub is in the extended position.

21. The catheter insertion device of claim 20, wherein said guide tab translates from said transverse section to said longitudinal section when said sleeve moves to the extended position whereby said needle hub is biased to the retracted position by said second spring.

22. The catheter insertion device of claim 21 , wherein said housing includes a cam member configured to contact said guide tab and translate said guide tab from said transverse section to said longitudinal section of said guide groove.

23. The catheter insertion device of claim 13, wherein said actuator is movable laterally from a first position to a second position, and axially from said second position to a third position to actuate said device.

24. The catheter insertion device of claim 23, wherein said actuator engages said needle hub and moves said needle hub axially toward a distal end of said housing.

25. The catheter insertion device of claim 13, wherein said housing has a longitudinal slot configured for guiding said needle hub and said catheter hub from the retracted position to the extended position, said longitudinal slot having a ledge at a proximal end of said housing, said ledge configured for retaining said catheter hub in the retracted position.

26. The catheter insertion device of claim 25, wherein said catheter hub has a tab extending radially outward for contacting said ledge, and where said needle hub has a tab configured for contacting said tab on said catheter hub to retain said tab of said catheter hub on said ledge to prevent axial movement of said catheter hub.

27. The catheter insertion device of claim 26, wherein said catheter hub is movable from a first axial position to retain said tab of said catheter hub on said ledge to a second axial position where said tab of said catheter hub couples with said tab of said needle hub and said first spring moves said catheter hub and needle hub to the extended position.

28. The catheter insertion device of claim 27, wherein said tab of said needle hub separates from said tab of said catheter hub when said catheter hub is in the extended position whereby said second spring moves said needle hub and needle to a retracted position relative to said catheter.

29. A catheter insertion device comprising: a housing having an axial passage;a catheter hub having a catheter movable between a retracted position and an extended position with respect to said housing; a needle hub having an insertion needle within said catheter and movable between a retracted position and an extended position with respect to said housing; a sleeve surrounding said housing and being rotatable around said housing; a spring operatively coupled to said sleeve for rotating said sleeve relative to said housing; and an actuator movable from a first position to retain said spring in a loaded condition to a second position to release said spring to rotate said sleeve to move the catheter and insertion needle from the respective retracted position to the extended position, and to retract said insertion needle relative to said catheter when said catheter is moved to the extended position.

30. The catheter insertion device of claim 29, wherein said housing has a longitudinally extending guide slot, said catheter hub having an outwardly extending lug received in said guide slot, wherein said spring is in a loaded state when said sleeve in a first position.

31. The catheter insertion device of claim 30, wherein said spring is a coil spring surrounding said sleeve and having a first fixed end and a second end coupled to said sleeve, wherein said spring is in a loaded state when said sleeve is in a first position.

32. The catheter insertion device of claim 31 , wherein said actuator retains said sleeve in the first position and said spring is in a loaded state and releases said sleeve whereby said sleeve rotates relative to said housing.

33. The catheter insertion device of claim 30, wherein said sleeve has an inner surface with a cam groove, said needle hub having a tab received in said cam groove, and said catheter hub has a tab received in said cam groove, said cam groove configured to move said needle hub and catheter hub from the retracted position to the extended position by rotation of said sleeve relative to said housing.

34. The catheter insertion device of claim 33, wherein said sleeve is rotatable in a first direction from a first position where said needle hub and catheter hub are in the retracted position and a second position where said needle hub and catheter hub are in the extended position.

35. The catheter insertion device of claim 34, where said sleeve is rotatable in said first direction to a third position to retain said catheter hub in the extended position and to move said needle hub to a second retracted position.

36. The catheter insertion device of claim 35, wherein said cam groove has a first inclined section extending between a proximal end of said sleeve and a distal end of said sleeve to move said catheter hub and needle hub from the retracted position to the extended position, and a second inclined section extending between a distal end of said first inclined section toward the proximal end of said sleeve to move said needle hub from the extended positon to a second retracted position, and a lateral section extending laterally from said distal end said first inclined section to retain said catheter hub in the extended position.

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