Catheter insertion device and fluid delivery assembly

Abstract

A delivery device is provided with an insertion device having a retraction spring configuration for automatic insertion needle retraction. A button of the insertion device is used to insert the insertion needle and catheter, and once the insertion needle are fully inserted, a rotating engagement releases the needle hub where the springs automatically retract the insertion needle. A catheter assembly includes a catheter hub, a septum and a catheter. The catheter hub has a fluid passage separate from the insertion needle to supply a fluid to the catheter. The fluid passage can extend through a distal end of the septum, through a side portion of the catheter hub and septum, or through a side portion of the catheter hub directly to a fluid chamber formed between the septum and a distal end of the catheter hub.

Description

Catheter Insertion Device and Fluid Delivery AssemblyField of the Disc losure

[0001] The present disclosure relates generally to a medical infusion and delivery device for delivering a fluid, medication or drug to a patient. The delivery device includes catheter, an insertion needle, and an automatic insertion mechanism to position the catheter at a selected depth in the patient. The insertion mechanism includes a retraction spring configuration for automatic insertion needle retraction after insertion into a subject. A fluid supply is included to supply a fluid through the catheter with reduced pressure drop from the supply to the catheter.Background

[0002] Bolus injection and infusion therapy and treatment for various conditions is often used to deliver a drug, medication or other fluid to a patient or subject over a few minutes to an extended period of time. The infusion and delivery devices can be configured to prolonged use over several days to provide a continuous and controlled rate of delivery. One such delivery' device is for infusion pump therapy such as a pump. The pump assembly can provide continuous infusion of a medication to a patient at varying rates.

[0003] Bolus injection and infusion pump therapy require 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 a medication takes place. Needles are generally used for short time drug delivery or infusion while flexible catheter are preferred for longer treatment due to its better acceptance by patients. Bolus and infusion pump therapy offers the advantages of continuous infusion of drugs, precision dosing, and programmable delivery schedules.

[0004] Infusion pumps advantageously deliver a medication over time rather than in single injections, typically resulting in less variation of the medication over time. In addition, infusion pumps may reduce the number of needle injections that would otherwise be needed.

[0005] To facilitate infusion therapy, there are generally two types of pump mechanisms, namely, conventional pumps and patch pumps. Conventional pumps require the use of adisposable 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.

[0006] Another type of pump mechanism is a patch pump, also call a wearable drug delivery device. Unlike a conventional infusion 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 containing a drug adheres to the skin and delivers the drug over a period of time via an integrated subcutaneous cannula. Some patch pumps may wirelessly communicate with a separate controller device (as in one device sold by fnsulet 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 fluid reservoir is exhausted or complications may otherwise occur, such as restriction in the cannula or the infusion site.

[0007] As patch pumps are designed to be a self-contained unit that is worn by the patient, it is preferable its dimensions and weight are as small as possible, 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.

[0008] Drugs considered for such application are various and their fluidic properties, especially viscosity, can vary from IcP to 100 cP. When viscosity increases, pressure drop in the system increases but because these devices have to be small, pump pressure capabilitiesare generally limited. To solve this issue, the fluid path conducting the drug into the device have to be adapted to accept high viscosity drugs with limited pressure into the device so pump can transfer all types of fluids. Moreover, the drop pressure is linked to flow rate that can vary from 5 to 20 ml / min for bolus injection to O.lml / hr or below for infusion. Because the insertion mechanism is part of the fluid path it has to take this problem into account.

[0009] Wearable devices often include an automatic catheter insertion mechanism that can be deployed by the user. The catheter insertion mechanism includes an actuator that is actuated by the user to release a spring loaded insertion needle that is received in the lumen of the catheter. Hie actuation moves the insertion needle and catheter from a retracted position to an extended position where the insertion needle pierces the skin of the patient and positions the catheter in the patient. The insertion mechanism then automatically retracts leaving the catheter in the patient. In some devices, the insertion needle is hollow and is connected to a fluid supply to supply the fluid to the proximal inlet end of the catheter for delivering the fluid to the patient. The catheter hub usually includes a septum for the needle to form a seal between the needle and the catheter hub to reduce or prevent leakage of the fluid being supplied to the patient. The lumen of the needle is inherently smaller than the lumen of the catheter since the insertion needle must have a dimension to pass through the catheter during insertion. The small inner diameter of the lumen of the needle limits the flow of the medication and results in a pressure drop between the distal end of the insertion needle and the catheter.

[0010] Accordingly, a need exists for an improved insertion mechanism and catheter hub assembly that can supply the fluid to the catheter with reduced pressure drop and such a high pressure to deliver the fluid through the insertion needle at a desired rate.Summary

[0011] An object of the present device is to substantially address the above and other concerns, and provide advanced, improved, and novel components and elements of an insertion device that facilitates insertion of the in-dwelling or soft catheter and retract theinsertion needle, while reducing the number of components required for the construction and use of the insertion device.

[0012] .Another object of the present device is to provide an insertion device with automatic insertion needle retraction with a reduced number of parts to keep part production costs low and simplify device assembly. Automatic retraction also simplifies the user interface by minimizing the number of user steps for activation.

[0013] The catheter insertion device in one embodiment includes an insertion mechanism and needle retraction mechanism. A catheter hub that supports the catheter receives the fluid to be delivered to the patient through a fluid passage that is separate from the insertion needle. In one embodiment, the insertion needle can be solid without an internal passage or lumen. In other embodiments, the insertion needle can have a hollow core to provide a medication or fluid to a patient. The fluid supply is provided by a passage or conduit that is spaced from the location of the insertion needle.

[0014] A catheter assembly in one embodiment includes a catheter hub configured for moving within the housing of a delivery device between a retracted position and an extended position. The catheter hub supports the catheter that extends from a distal end of the catheter hub. A proximal end of the catheter hub receives a septum. An insertion needle passes through the septum and through the catheter during insertion and can be withdrawn from the catheter after the catheter is inserted into the patient. The end portion or tip of the insertion needle when withdrawn remains in septum to prevent leakage from the septum where the insertion needle passes through the septum. A fluid passage is provided in the catheter hub between the septum and the proximal end of the catheter to supply a fluid to be delivered to the patient. The catheter assembly in one embodiment has a catheter hub supporting a catheter and a septum receiving the insertion needle that passes through the catheter during insertion. The septum has a proximal side and distal side where the insertion needle passes through the proximal side to the distal side and to the catheter. A fluid supply passage is provided in the catheter hub that can extend through the septum to supply the fluid to the inlet of the catheter. The fluid supply can extend through a side opening in the hub where a supply tube extends transverse to the axis of the catheter. A conduit can be connected to the supply tube andextend transversely through the fluid passage in the catheter hub. In one embodiment, the conduit extends through the proximal side of the septum and into a fluid chamber in the septum and / or catheter hub to supply the fluid to the catheter. The conduit is spaced from the insertion needle through an opening in the septum that is separate from the opening that receives the insertion needle.

[0015] In another embodiment, the catheter assembly includes a catheter hub, a catheter extending from a distal side of the catheter hub, a septum received in the catheter hub, and an insertion needle extending through the septum from a proximal side of the septum and to the catheter. The septum has a recess formed in a distal side facing the proximal end of the catheter to form a fluid chamber. A fluid passage is provided in a side portion of the catheter hub and a fluid passage is provided in a side portion of the septum that is aligned with the fluid passage in the catheter hub. The fluid passage is connected to a fluid supply to supply a fluid through the fluid passages and into the fluid chamber where the fluid can be directed to the catheter to supply the fluid to the patient. In one embodiment, a rigid conduit can be positioned in the fluid passages of the catheter hub and septum to direct the fluid to the fluid chamber.

[0016] In a further embodiment, the catheter assembly includes a catheter hub, a catheter extending from a distal side of the catheter hub, and a septum received in the catheter hub where the septum is positioned in a proximal end of the catheter hub and spaced from the distal end to form a fluid chamber between the septum and the distal end of the hub. An insertion needle extends through the septum from a proximal side of the septum to the catheter. A fluid supply conduit is coupled to the distal end of the catheter hub to supply a fluid to the fluid chamber for directing the fluid through the catheter. In this embodiment, the supply conduit can extend from a side portion of the catheter hub or from a distal side of the catheter hub.

[0017] These and other objects are substantially achieved by providing a fluid delivery device comprising a housing; an insertion needle, a catheter assembly, and an actuator to move the insertion needle and catheter assembly from a first position to a second position, and to move the insertion needle to the first position when the catheter assembly is in the second position.The catheter assembly comprises a catheter hub having an internal cavity and an outlet and a septum received in the cavity where the insertion needle is configured to extend through the septum and said catheter. The catheter assembly has a fluid passage configured for supplying a fluid to the catheter when the insertion needle is retracted from the catheter.

[0018] The features of the device are also provided by a catheter assembly comprising a catheter hub having a proximal end with a coupling configured for removably coupling with a needle hub for linear movement by a catheter insertion device. The catheter hub has a cavity, a proximal end with a proximal opening, and a distal end with a distal opening. A septum is received in the proximal end of said catheter hub and closes the proximal end of the catheter hub. The catheter assembly has a fluid chamber positioned between the septum and the distal opening of the catheter hub. The catheter hub assembly has a fluid passage for supplying fluid to the fluid chamber. A catheter is coupled to the distal opening of the catheter hub for receiving fluid from the fluid chamber.

[0019] Additional and / or other aspects and advantages of the present device will be set for in the description that follows, or will be apparent from the description, or may be learned by the practice of the invention. The present device may comprise a method or apparatus or system having one or more of the above aspects, and / or one or more of the features and combinations thereof. The present device may comprise one or more of the features and / or combinations of the above aspects as recited, for example, in the attached claims.Brief Description of the Drawings

[0020] Tire 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:

[0021] Fig. 1 is an isometric view of an exemplary delivery device in a pre-activation state in accordance with an embodiment of the delivery device;

[0022] Fig. 2 is another isometric view of the insertion device of Fig. 1 in the deployed state;

[0023] Fig. 3 is an exploded view of the delivery device and insertion device;

[0024] Fig. 4 is an exploded view of the insertion device of Fig. 1 in accordance with an embodiment of the delivery device;

[0025] Fig. 5 is a perspective view of the catheter hub, needle hub, and actuator button;

[0026] Fig. 6 is a cross sectional view of the delivery device showing the catheter and insertion needle in the initial state;

[0027] Fig. 7 is a perspective view of the housing of the insertion assembly mechanism;

[0028] Fig. 8 is a perspective view of the housing of the insertion assembly showing the detent sliding in the slot of the housing;

[0029] Fig. 9 is a perspective view of the housing of the insertion assembly showing the detent after retraction of the needle hub;

[0030] Fig. 10 is a cross sectional view of the delivery device after the insertion needle is retracted;

[0031] Fig. 11 is a perspective view of the catheter hub in one embodiment;

[0032] Fig. 12 is a perspective view of the catheter hub of Fig. 11;

[0033] Fig. 13 is a side view of the catheter hub of Fig. 11;

[0034] Fig. 14 is a cross sectional view of catheter hub of Fig. 11;

[0035] Fig. 15 is an exploded side view of the catheter hub of Fig. 11;

[0036] Fig. 16 is an exploded view in cross section of the catheter hub of Fig. 11;

[0037] Fig. 17 is a perspective view of another embodiment of the catheter hub;

[0038] Fig. 18 is a side view of the catheter hub of Fig. 17;

[0039] Fig. 19 is a cross sectional view of the catheter hub of Fig. 17;

[0040] Fig. 20 is an exploded side view of the catheter hub of Fig. 17;

[0041] Fig. 21 is an explode view in cross section of the catheter hub of Fig. 17;

[0042] Fig. 22 is an exploded view of an alternative embodiment of the catheter hub of Fig. 17;

[0043] Fig. 23 is a perspective view of the catheter hub in a further embodiment;

[0044] Fig. 24 is an exploded view of the catheter hub of Fig. 23;

[0045] Fig. 25 is a side view of the catheter hub of Fig. 23;

[0046] Fig. 26 is an explode view of the catheter hub of Fig. 23;

[0047] Fig. 27 is a cross sectional view of the catheter hub of Fig. 23;

[0048] Fig. 28 is an exploded view of the catheter hub of Fig. 23 in cross section;

[0049] Fig. 29 is an exploded view' of an alternative embodiment of the catheter of Fig. 23;

[0050] Fig. 30 is a perspective view of the catheter hub in another embodiment;

[0051] Fig. 31 is a side view of the catheter hub of Fig. 30;

[0052] Fig. 32 is an exploded view of the catheter hub of Fig 30;

[0053] Fig. 33 is cross sectional view of the catheter hub of Fig. 30;

[0054] Fig. 34 is an exploded view of the catheter hub of Fig. 30 in cross section;

[0055] Fig. 35 is a perspective view of a further embodiment of the catheter hub;

[0056] Fig. 36 is an exploded view of the catheter hub of Fig. 35;

[0057] Fig. 37 is an exploded view of the catheter hub of Fig. 35 in cross section;

[0058] Fig. 38 is a cross sectional side view of the catheter hub of Fig. 35;

[0059] Fig. 39 is a cross sectional view of the septum of the catheter hub of Fig. 35;

[0060] Fig. 40 is a cross sectional view of the septum and supply conduit of the catheter hub of Fig. 35;

[0061] Fig. 41 is a perspective view of the catheter hub in another embodiment;

[0062] Fig. 42 is cross sectional view of the catheter hub of Fig. 41;

[0063] Fig. 43 is an exploded view of the catheter hub of Fig. 41;

[0064] Fig. 44 is a cross sectional view of the catheter hub of Fig. 41; and

[0065] Fig. 45 is an explode view of the catheter hub in cross section.

[0066] Throughout the drawings, like reference numerals will be understood to refer to like parts, components and structures.Detailed Description of the Exemplary Embodiments

[0067] The exemplary embodiments of the delivery device described below provide a novel mechanism of providing one or more infusion device elements that are configured to insert a catheter up to 8 mm into a skin surface, but embodiments are not limited thereto. The insertion device is configured to perform the insertion of the insertion needle and catheterwhich allows the insertion device to be smaller, simpler and cheaper than the prior insertion devices.

[0068] 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 tire 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 phraseology and 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 the given value or range, such as ± 2%, and including the given value and ranges, 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 and can include the specific structure or characteristic. 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. The term insertion device and catheter insertion device can be used interchangeably.

[0069] The delivery device 10 is configured for delivering a controlled dosage of a medication to patient over an extended period of time. One example of a medication is insulin although itis understood that the delivery device not limited to insulin delivery. The delivery device is able to deliver many different medications or drugs where extended delivery and extended treatment is needed.

[0070] The delivery device 10 as disclosed includes a catheter insertion mechanism, a pump mechanism, and a metering mechanism as known in the art such as those commonly used for drug delivery. The pump mechanism and metering mechanism are not shown for clarity as these components are known in the art. An example of medication delivery device is disclosed in U.S. Patent No 10,737,038, which is hereby incorporated by reference in its entirety. The catheter insertion mechanism can be an insertion mechanism as known in the art. The catheter insertion mechanism as disclosed herein is intended to be exemplary’ and not intended to limit the scope of the disclosure.

[0071] One feature of the present device provides a fluid delivery passage though the catheter hub to the catheter rather than through a hollow insertion needle to the catheter. Supplying the fluid directly to the catheter and / or catheter hub rather than through the lumen of the insertion needle provides certain advantages that cannot be or are difficult to attain by the prior devices that supply the fluid through the lumen of the insertion needle. The inner dimension and diameter of the insertion needle that is smaller than the inner dimension and diameter catheter requires a higher pressure and flow rate to provide the desired volume and rate of flow through the catheter compared to supplying the fluid directly to the catheter. The smaller diameter of the lumen of the needle results in a pressure drop as the fluid exits the needle and passes into the lumen of the catheter. By supplying the fluid to the catheter without passing through the lumen of the insertion needle minimizes fluid flow resistance during injection and delivery and avoids the pressure loss or pressure drop that occurs in a smaller diameter lumen of the insertion needle when delivered to the larger diameter of the catheter.

[0072] Exemplary embodiments of the device described below, utilize an insertion mechanism and insertion device and include a retraction spring configured for automatic insertion needle retraction after insertion. The catheter insertion device can be automatic or manually operated. The retraction spring configuration in the embodiment shown is implemented using a plurality of cylindrical or barrel-shaped guides. In an exemplary embodiment, one barrel guides abutton and catheter, and adjacent barrels that house retraction springs on each side of the button and catheter.

[0073] Fig. 1 shows the delivery device and insertion device before use and Fig. 2 shows the delivery' device 10 after deployment of the cannula. As shown in Figs. 1-3, the delivery device includes a top housing 12 and a base 14 forming an internal cavity for enclosing the catheter insertion device and fluid supply mechanism. The top housing 12 is shown having an opening through a top surface from which a user-accessible, and manual actuator, such as a button or cap. The top housing 12, button, and a mechanism housing can be manufactured from ABS, PA, PC, PE, PMMA, PP, PETG and the base 14 can be manufactured from PETG, PA, PC, PE, PMMA, PP, ABS, but embodiments are not limited thereto.

[0074] The delivery device 10 includes a fluid supply reservoir (not shown) that supplies a fluid to a catheter 16 for delivering the fluid to the patient. An insertion needle 18 is included that initially is positioned in the lumen of the catheter and extends from the distal end of the catheter for inserting into a patient and positioning the catheter in the patient. The insertion needle 18 is retracted after insertion in the patient as known in the art. The fluid then can be supplied to the patient though the catheter.

[0075] The delivery device includes a catheter insertion device 20 as shown in Figs. 3 and 4. The catheter insertion device 20 is assembled from a number of components that are enclosed within the delivery device. The components as discussed in greater detail below include a catheter assembly, an insertion needle assembly, and an actuator assembly. Other features and functions of the insertion device that are well-known to those skilled in the art are omitted from the figures and discussion for clarity. For example, the catheter insertion device and mechanism is understood by one skilled in the art so that some details of the insertion mechanism are omitted for clarity.

[0076] Figs. 3 and 4 are exploded views of a catheter insertion device and mechanism in one embodiment of the delivery device 10. The delivery device 10 is not intended to be limited to the disclosed insertion mechanism. The catheter insertion device 20 includes a catheter hub 24, an insertion needle hub 26, and an actuator 28, shown as a manually operated button.

[0077] The catheter 16 is coupled to the catheter hub 24 as shown in Fig. 4. The catheter hub 24 includes a body 30 with a proximal end 32 and a distal end 34 with an internal cavity extending between the proximal end and the distal end. A funnel shaped wedge 36 having an outlet tube receives the catheter 16 as known in the art. The wedge 36 is fitted within the body 30 to couple the catheter 16 to the body 30 of the catheter hub 24. The wedge 36 in the embodiment shown has a side wall forming a cavity in the wedge. A septum 38 is positioned in the wedge 36 and the assembly positioned in the catheter hub 24. The septum 38 is accessible through the proximal end of the catheter hub 24. The septum 38 can include an optional slit for receiving the insertion needle 18.

[0078] As shown in Fig. 4, the catheter hub 24 in the embodiment shown is configured for mating and operating with the needle hub 26 of the catheter insertion device 20. In the embodiment shown, the catheter hub has longitudinally oriented arms 40. As shown, two arms 40 are provided that extend from the proximal end 32 of the body 30. Each arm 40 has a transversely extending tab 42 that extends perpendicular to the longitudinal axis of the catheter hub 24 and the arms 40. As discussed below, the tabs 42 are configured to couple to the needle hub 26 during the insertion operation and can separate from the needle hub so that the needle hub and insertion needle can be retracted after the catheter is inserted into the patient. An outwardly extending detent 44 projects radially outward from at least one arm 40 and preferably both arms 40 for removably coupling with the needle hub.

[0079] The needle hub 26 has a configuration for cooperating with the insertion device and mechanism for use in inserting the catheter in the patient and retracting from the catheter to a position where a fluid can be supplied to the catheter through the catheter hub. In the embodiment shown, the needle hub is configured for use with two operating springs 46 to retract the needle from the catheter after insertion into the patient. It is understood that the needle hub can be configured for use with other needle insertion mechanisms and spring configurations.

[0080] As shown in Figs. 3 and 4, the needle hub 26 has a body 48 with an elongated configuration relative to the axial dimension of the insertion needle and catheter hub 24. The outer end portions of the body 48 include a barrel 50 for cooperating with springs 46 that arereceived in the housing mechanism 22. The needle hub 26 is configured to slide within the housing mechanism 22 in a linear manner between an initial retracted position and a deployed extended position for introducing the catheter into the patient. The proximal face 52 of the body 48 is configured for cooperating with the tabs 42 of the catheter hub 24 where the catheter hub is coupled to the needle hub during insertion of the catheter and insertion needle into the patient. The proximal face 52 can be provided with a recess or notch with a dimension to receive a respective tab 42. As shown in Fig. 4, the insertion needle 18 extends from a distal side of the body 48.

[0081] The actuator 28 is shown as a button that slides to a deployed position. As shown in Figs. 3 and 4, the actuator includes a body 56 with two axially extending arms 58 that are spaced apart a distance to allow the needle hub 26 to slide axially in a slot formed between the arms 58. The distal ends of the arms 58 have an inwardly extending tab 60 for hooking onto the distal face of the catheter hub 24 to couple the catheter hub 24 and the actuator 28 together with the needle hub 26 positioned between the arms 58 and captured by the catheter hub 24.

[0082] As shown in Fig. 5 and Fig. 6, the catheter hub 24, needle hub 26 and actuator 28 are assembled as a single unit. Figs. 5 and 6 show the assembly in the initial configuration before actuating the insertion mechanism. The assembled delivery device and insertion mechanism is shown in Fig. 6 where the springs 46 bias the assembly of the catheter hub 24, needle hub 26, and actuator 28 in a proximal direction. The catheter hub 24 being removably coupled to the body 48 of the needle hub 26 by the tabs 42 retain the catheter hub and catheter in a retracted position where the catheter is held within the housing of the delivery' device. The housing 22 as shown in Figs. 6-9 has a spiral recess 62 that forms a groove on an inner surface that receives the detents 44 of the catheter hub 24. The spiral recess 62 forms a cam surface and the detents 44 form a cam follower for rotating the catheter hub 24 by axial or linear motion of the catheter hub 24 within the housing 22.

[0083] The insertion mechanism is operated by the user manually pressing the actuator 28 distally where the catheter hub 24 and needle hub 26 slide in a linear distal direction with respect to the housing. The downward movement of the actuator 28 forces the insertion needle 18 and catheter into the patient. As shown in Figs. 6-8, the detent 44 is received in thespiral recess 62 of the housing 22 so that the downward linear movement of the catheter hub 24 causes the catheter hub 24 to rotate relative the needle hub 26 while the needle hub does not rotate. The downward linear movement of the needle hub 26 is rotationally fixed relative the housing 22 by the body 48 sliding in axially oriented slots 64 in the housing 22. As shown in Fig. 9 when the detent 44 on the catheter hub reaches the distal end of the spiral recess, the rotation of the catheter hub 24 relative the needle hub 26 disengages the tabs 42 on the arms from the body 48 of the needle hub 26 where the spring 46 biases the needle hub and insertion needle in a proximal direction to retract the insertion needle from the catheter. The catheter hub 26 is retained in the deployed position by a coupling mechanism to prevent the catheter and catheter hub from movement in the proximal direction after being deployed. In one embodiment, the insertion needle 18 is retracted where the distal tip of the insertion needle is positioned in the septum to prevent leakage of fluid through the septum. A fluid, such as a medication, can then be supplied to the catheter for delivery’ to the patient.

[0084] Figs. 11-16 show one embodiment of catheter assembly including a catheter hub 70 for use with the delivery device and insertion mechanism as previously described and shown in Figs. 1-10. Tire catheter hub 70 can be used with other suitable insertion mechanisms as understood by one skilled in the art. The details of the insertion mechanism are not shown for clarity but are understood as being suitable for use in the insertion device described in connection with Figs. 1-10.

[0085] Referring to Figs. 11 and 12, the catheter hub 70 has a body 72 configured for moving from a first retracted position to a second extended position. The catheter hub has an inlet and outlet for supplying the fluid or medication. In the embodiment shown, the body 72 rotates relative to the actuator 28 and needle hub 26 by the linear movement of the actuator 28. In the embodiment shown, the body 72 has a substantially cylindrical shape with a proximal end 74 and a distal end 76. Hie body 72 is formed with a side wall 78 with an open proximal end and a distal wall 80 with an opening 82 for the catheter 84 to extend from the body of the catheter hub 70.

[0086] The proximal end 74 of the catheter hub body 72 is provided with proximally extending arms 86 oriented on opposite sides of the body 72. A tab 88 extends transverselyfrom the respective arm 86 for coupling with the proximal face of the needle hub 26 as described in connection with the previous embodiment of Figs. 1-10. A support member 90 extends radially outward from the proximal end of the body 72 as shown in Figs. 13 and 14. The support member 90 has an open U-shape for receiving and supporting a supply tube 92 and a conduit 94 for supplying a fluid to the catheter hub. Detents 95 extend radially outward from the body 72 for engaging the spiral recess 62 of the insertion device and mechanism as in the previous embodiment.

[0087] As shown in Figs. 15 and 16, a septum 96 is positioned in a sleeve 98 mounted within the internal cavity of the catheter hub body 72. The septum 96 has a substantially cylindrical shape with a distal face 100 and a proximal face 102. In one embodiment, the septum 96 can have an optional slit 104 or other small opening extending between the distal face 100 and proximal face 102 for receiving the insertion needle 18. The septum allows the insertion needle to slide in a linear direction through the catheter hub and catheter and form a seal between the septum and the insertion needle to prevent leakage of fluid around the insertion needle.

[0088] Tire septum 96 in the embodiment shown has an open portion at the distal face 100 forming a fluid chamber 106. A cavity and a fluid chamber 106 is formed as a recess in the distal face of the septum. A top wall 108 of the septum 96 closes the proximal side of the septum. In one embodiment, the top wall 108 of the septum 96 is pierced by the insertion needle. The conduit 94 as shown in Fig. 14 extends through the septum in a location spaced from the location of the insertion needle when the insertion needle pierces the septum. Alternatively, an opening can be provided to receive the conduit 94. The septum 96 can be made of a suitable flexible material, such as a silicone rubber, LSR, TPE, or PU to provide the sealing property while allowing the insertion needle to pass through.

[0089] The sleeve 98 as shown has a shape and configuration to support the septum 96 within the body 72 of the catheter hub 70. As shown in Fig. 16, the sleeve 98 has a substantially cylindrical side wall 112 with a dimension to receive the septum 98 and fit within the cavity of the body 72. A bottom wall 114 at the distal end of the side wall includes a tubular extension 116. As shown, the catheter 84 is fitted onto the tubular extension 116. The septum 96 ispositioned in the open proximal end of the sleeve 98 with the recess of the septum facing the bottom wall 114 to form the fluid chamber 106. An inwardly extending lip 118 at the proximal end of the body 72 captures and retains the septum 96 and sleeve 98 within the body 72 of the catheter hub 70. The lip 118 can be made of molded plastic or a separate member that can be force fit or bonded to the body 72. The fluid chamber 106 has an inner dimension greater than an inner dimension of the outlet of the fluid chamber 106 and the inner diameter of the catheter and greater than an outer diameter of the insertion needle.

[0090] The supply tube 92 can be a flexible tube and has a first end connected to the fluid supply and pump mechanism of the delivery’ device 10. The supply tube 92 is sufficiently flexible to move with the catheter hub during the activation and deployment of the insertion mechanism. A second end of the supply tube 92 is coupled to the conduit 94. In the embodiment shown, the conduit 94 has an outlet end positioned in the cavity and fluid chamber 106 of the septum 96. The supply tube and conduit have an internal dimension to provide a sufficient fluid flow to the catheter with limited pressure drop between the conduit and the fluid chamber of the septum. In the embodiment shown, the conduit has a bend or elbow to extend through the top wall of the septum. The conduit 94 can be rigid and made of metal or plastic material. The outlet end of the conduit has a section parallel to the insertion needle. In the embodiment shown, the supply tube 92 is received in the U-shaped support 90 and extends transversely relative to the longitudinal dimension of the catheter hub, catheter, and insertion needle. The conduit 94 is shaped to pass through the second opening 110 to supply a fluid, such as a medication, to the fluid chamber 106 and to the catheter 84.

[0091] The catheter hub 70 operates in a manner as in the previous embodiment by the tabs 88 coupling to the needle hub 26 so that the insertion needle 18 extends through the catheter 16 for positioning the catheter in the patient. The actuator 28 is deployed to move the needle hub and catheter hub in a linear direction to extend from the bottom of the delivery device and position the catheter in the patient. The detents engage the spiral recess of the housing 22 to rotate the catheter hub 70 to disengage the tabs 88 from the needle hub where the springs 46 retract the needle hub from the catheter 70 with the catheter 16 remaining in the patient. In this embodiment, the insertion needle is retracted so that the tip of the insertion needle ispositioned in the top wall of the septum 96. Alternatively, the distal end or tip of the insertion needle can be positioned in the fluid chamber 106. The position of the insertion needle is such that the insertion needle does not interfere with the supply of the fluid through the conduit 94 so that the fluid can be directed to and through the fluid chamber 106 and through the catheter to the patient. The supply tube 92 and the conduit 98 can have an internal dimension to provide a desired rate of flow of the fluid through the catheter and to minimize a pressure drop when the fluid exits the conduit and fills the fluid chamber. In this embodiment, the insertion needle can be a solid needle. In other embodiments, the insertion needle can be open with one end sealed or blocked.

[0092] Figs. 17-22 show another embodiment of the catheter assembly including a catheter hub 120 that can be used with the delivery device 10 and insertion mechanism as in the previous embodiment of Figs. 1-10. In a manner similar to the previous embodiments, the catheter hub 120 includes a catheter hub body 122 with an inlet and outlet, a septum 124 and a sleeve 126 for receiving and supporting the septum 124.

[0093] The catheter hub body 122 has an open proximal end 127, a distal end closed by a distal wall 128, and a side wall 130. The distal wall 128 has an opening 132 for the catheter 160 and the sleeve 126. The side wall 130 has an opening 134 for receiving a fluid supply. An inwardly extending lip 136 is provided at the proximal end of the catheter body to form an opening 138 and an internal cavity 140. The lip 136 can be molded with the body 122 or formed as a separate member attached to the body by a suitable mechanism. A detent 141 extends radially outward from the side wall 130 for engaging the spiral recess in the housing 22 to rotate the catheter assembly relative to the actuator and needle hub during linear movement of the catheter hub and needle hub with respect to the delivery’ device 10.

[0094] The septum 124 is similar to the previous embodiment and has a substantially cylindrical shaped side wall 142, a proximal top face 144, and distal face 146. A recess is formed in the distal face 146 to form a fluid chamber 148. The side wall 142 includes an opening 150 for receiving the fluid and conveying the fluid into the fluid chamber 148. The fluid chamber has an inner diameter greater than an outer diameter of the insertion needle and greater than an inner diameter of the outlet of the fluid chamber and catheter.

[0095] The sleeve 126 has a side wall 152 with an open proximal end 154, and a distal wall 156 with an opening. As in the previous embodiment, a tubular extension 158 extends from the opening in the distal wall 156. A catheter 160 is coupled to the tubular extension 158. The side wall 152 of the sleeve 126 has an opening 162. In an alternative embodiment shown in Fig. 22, the sleeve has a U-shaped opening 164 in the side wall 152.

[0096] The septum 124 is fitted in the cavity’ of the sleeve 126 with the side 150 opening aligned with the opening 134 in the body 122 of the catheter hub 120. As in the previous embodiments, the septum forms a fluid tight seal between the septum and the body. A supply conduit 166 extends through the respective openings in the catheter side wall and septum. An inlet end of the supply conduit 166 is connected to a fluid supply 168 that is connected to the delivery' device 10 and an outlet end is positioned in the fluid chamber of the septum 124. The catheter and catheter hub are deployed as in the previous embodiment by the insertion mechanism to position the catheter in the patient. A fluid is supplied by conduit 166 to the fluid chamber 148 and to the inlet end of the catheter 160 to deliver the fluid to the patient.

[0097] Figs. 23-29 show a further embodiment of the catheter assembly including a catheter hub 172 that is configured for cooperating with the delivery’ device 10 and the insertion mechanism as in the previous embodiments. The catheter hub 172 is configured for mating with a catheter insertion device and insertion needle hub for positioning the catheter in the patient and for withdrawing the insertion needle after deployment. The catheter insertion device can be as described in the previous embodiment. The catheter hub can include appropriate mechanism components for operating with the catheter insertion device. The catheter hub can include the coupling tabs shown in phantom lines in Fig. 23 for mating with the needle hub and to enable separation from the needle hub in the manner of Figs. 1-10 by rotation of the catheter hub by the distal movement and the spiral recess in the housing of the delivery device.

[0098] Referring to Fig. 23-26, the catheter hub 172 includes a body 174, a sleeve 176, a septum 178 and a catheter 180 coupled to the sleeve in a manner similar to the previous embodiments. The body 174 of the catheter hub 172 has a substantially cylindrical side wall 182 with a flat side portion 184. The flat side portion 184 has an opening 186 forming an inletand a tubular collar 188 extending from the flat side portion 184 with a dimension for receiving and coupling with a supply tube 190.

[0099] As shown in Fig. 27 and Fig. 28, the body 174 has a distal end wall 192 with an opening 194 for the catheter 180. A top wall 196 is provided at the proximal end of the body 174 and is provided with an opening 198 to expose a portion of the septum 178 for the insertion needle to access the septum. The top wall 196 and the distal end wall 192 define an internal cavity 200 with a dimension for receiving the septum and sleeve as shown in Fig. 28. In the embodiment shown, the body is illustrated as a one-piece member although it is understood that the body can be made from two or more pieces for assembly and positioning the sleeve and septum within the cavity 200. For example, the top wall can be separate from the side wall and assembled after positioning the septum in the cavity of the body by welding, friction fit or an adhesive.

[0100] The sleeve 176 is similar to the previous embodiment and is configured to support the septum 178 and convey the fluid to the catheter 180. Tire sleeve 176 has a cylindrical side wall 202 with a flat surface 204 complementing the internal dimensions of the catheter hub. The sleeve 176 has a distal bottom wall with an opening and tubular extension 206 forming an outlet and for coupling with the catheter 180 as shown in Fig. 26. As shown in Fig. 24, the flat side surface 204 has an opening 208 that aligns with the passage of the collar 188 for conveying fluid from the supply tube 190. The sleeve 176 has an open proximal end 210 for receiving and supporting the septum 178.

[0101] The septum 178 has a shape and dimension to fit within the cavity of the sleeve 176. As shown in Fig. 24, the septum 178 has a cylindrical side wall 212 with a flat surface 214, and a proximal top wall 216. The top wall 216 can include an opening or slit for receiving the insertion needle as in the previous embodiments. In one embodiment, the septum can be formed without a slit where the insertion needle pierces the septum. The septum 178 in the embodiment shown, has an open distal end 218 forming an internal cavity and fluid chamber 220. The flat surface 214 of the septum 178 has an opening 222 that aligns with the opening 208 of the sleeve 176 and the opening 186 in the body of the catheter hub. In an alternative embodiment shown in Fig. 29, the opening 208 in the sleeve 176 has asubstantially U-shape. The fluid chamber 220 has an inner diameter greater than an inner diameter of an open distal end of the sleeve and greater than the inner diameter of the catheter.

[0102] The catheter hub 172 is configured for use with the delivery device and insertion mechanism of Figs. 1-10. The catheter hub 176 is positioned in the patient with the aid of the insertion needle where the insertion needle is retracted after insertion of the catheter. The insertion needle is retracted where the distal end or tip of the insertion needle is captured in the top wall of the septum to prevent leakage of fluid around the insertion needle. The fluid is supplied from the reservoir and pump mechanism of the delivery device through the supply tube 190 to the fluid chamber 220. The fluid is then conveyed through the catheter as in the previous embodiment. In an embodiment of the device, the supply tube and openings in the body, sleeve and septum have a dimension to reduce restricted flow and avoid a pressure drop when the fluid enters the fluid chamber and the catheter. In one embodiment, the supply tube and openings in the body have an internal dimension greater than the inner dimension of a standard hollow insertion needle.

[0103] Figs 30-34 shown a further embodiment of a catheter assembly. As in the previous embodiments, the catheter assembly 230 includes a catheter hub 234 with an inlet and an outlet, a body forming a proximal cap 232, a septum 236 and a catheter 238. The catheter assembly 230 can be used in the delivery device of Figs. 1-10 as in the previous embodiments. The proximal cap 232 in this embodiment has a substantially cylindrical side wall 240 with an open distal end 242, and a proximal top wall 244 with a central opening 246 as shown in Fig. 34. The top wall 244 in combination with the open distal end 242 from an internal cavity 248. As in the previous embodiment, the cap can include coupling members for mating with the needle hub where the body can separate from the needle hub when the catheter hub is deployed.

[0104] The catheter hub 234 in the embodiment shown is configured for coupling to a fluid supply and to the cap 232. The catheter hub 234 has a cylindrical side wall 250 with an open proximal end 252 and has a dimension to fit within the cavity 248 of the cap 232. A distal bottom wall 253 extends inwardly from the side wall 250 to a conical shaped portion 254 that extends distally from the bottom wall to form a funnel shape having an inner fluidchamber 256. An outlet at the apex of the funnel, conical shaped portion includes a tubular extension 258 forming an outlet and for coupling with the catheter 238.

[0105] A fluid coupling 260 forming an inlet extends from the inclined wall of the conical shaped portion 254. The coupling 260 is configured for connecting to a tubular supply 262 to supply the fluid to the fluid chamber 256 and to the catheter. In the embodiment shown, the fluid coupling 260 extends at an incline relative to the longitudinal dimension of the catheter hub 234. In other embodiments, the fluid coupling 260 can extend substantially perpendicular to the longitudinal axis of the catheter hub.

[0106] The septum 236 in this embodiment has a substantially cylindrical shape with a circular side surface 264, a proximal surface 266, and a distal surface 268. An optional slit or opening extends between the proximal surface and distal surface to allow the insertion needle to pass through. As shown in Fig. 33, the septum 236 is received in the cavity of the catheter hub 234 and against the inwardly extending bottom wall 253 to enclose the fluid chamber 256 of the catheter hub 234. The side wall 250 of the catheter hub and the septum 236 are received in the cavity of the cap 232. Tire fluid chamber 256 has an inner diameter greater than an inner diameter of the distal opening of the fluid chamber and greater than an inner diameter of the catheter.

[0107] The catheter hub 234 is coupled to the insertion mechanism of the delivery device as in the previous embodiments. The catheter 238 is positioned in the patient and the insertion needle is retracted as in the previous embodiments. The fluid to be delivered to the patient is supplied through supply tube 262 into the fluid chamber 256. The fluid is then directed through the tubular extension 258 and through the catheter to the patient. The supply tube and fluid chamber have an inner diameter to avoid or minimize the pressure drop between the supply tube and the fluid chamber.

[0108] Figs. 35-40 show another embodiment of the catheter assembly including a catheter hub 272 with an inlet and outlet that is configured for cooperating with the delivery device 10 and the insertion mechanism as in the previous embodiments. The features of the delivery device and catheter insertion mechanism are not shown for clarity. The catheter hub is configured for mating with a catheter insertion device and insertion needle hub forpositioning the catheter in the patient and for withdrawing the insertion needle after deployment. The catheter insertion mechanism can be as described in the previous embodiments. The catheter hub can include appropriate mechanism components for operating with the catheter insertion device. The catheter hub can include the coupling tabs shown in phantom lines in Fig. 35 for mating with the needle hub and to able to separate from the needle hub in the manner of Figs. 1-10 by rotation of the catheter hub by the distal movement and the spiral recess in the housing of the delivery device.

[0109] Referring to Figs. 35 and 36, the catheter hub 270 includes a body 272, a sleeve 274, a septum 276, and a catheter 278 coupled to the sleeve 274 in a manner similar to the previous embodiments. The body 272 of the catheter hub 270 has a cylindrical or substantially cylindrical side wall 290 with an opening 292 forming an inlet with a dimension for receiving coupling with a supply tube 302.

[0110] As shown in Fig. 37 and Fig. 38, the body 272 has a distal end wall 280 with an opening 286 forming an outlet for the catheter 278. A top wall 284 is provided at the proximal end of the body 272 and is provided with an opening 286 to expose a portion of the septum 276 for the insertion needle to access the septum. The top wall 284 and the distal end wall 280 define an internal cavity 288 shown in Fig. 37 with a dimension for receiving the septum 276 and sleeve 274. Tire body 272 has a cylindrical or substantially cylindrical side wall 290 with an opening 292 for the supply tube 302.

[0111] In the embodiment shown, the body is illustrated as a one-piece member although it is understood that the body can be made from two or more pieces for assembly and positioning the sleeve and septum within the cavity 288. For example, the top wall can be separate from the side wall and assembled after positioning the septum in the cavity of the body by overmolding, welding, friction fit or an adhesive. The sleeve 274 is similar to the previous embodiment and is configured to support the septum 276 and directing the fluid to the catheter 278. The sleeve 274 has a cylindrical side wall 294 with an outer surface complementing the internal dimensions of the body 272 of the catheter hub. The sleeve 274 has a distal bottom wall 296 with an opening and extension tube 298 forming an outlet and for coupling with the catheter 278.

[0112] As shown in Fig. 37, the side surface of the side wall 294 has an opening 300 that aligns with the opening 292 in the body 272 for conveying and directing fluid from the supply tube 302. The sleeve 274 has an open proximal end 304 coupled to the extension tube 298. The septum 276 has a shape and dimension to fit within the cavity of the sleeve 274. As shown, the septum 276 has a cylindrical shaped side surface with a proximal top face 312 and a distal end face 314. The septum 276 can include an opening or slit for receiving the insertion needle as in the previous embodiments. In one embodiment, the septum can be formed without a slit where the insertion needle pierces the septum.

[0113] The septum 276 in the embodiment shown is a two-part assembly having a flexible member 308 and a rigid member 310. The flexible member 308 and the rigid member 310 can be separate members or coupled together to form a unitary assembly. The flexible member 308 and rigid member 310 can be attached by an adhesive, heat stamped, overmolding or other suitable attachment mechanisms. The flexible member 308 has a cylindrical shape with the top proximal face 312 and the bottom distal face 314. The flexible member 308 is a soft, resilient polymeric material that can be pierced by the insertion needle for introducing the catheter into the patient and forms a seal around the needle to prevent leakage. The flexible member 308 can be made of silicone, TPE or other suitable materials. The rigid member 310 in the embodiment shown has a cylindrical, annular side wall 316 substantially the same size as the flexible member 308.

[0114] The side wall 316 of the rigid member 310 has an opening 318 with a dimension for receiving and / or cooperating with the supply tube 302. As shown in Fig. 37 the supply tube 302 is connected to a rigid tube 321 that extends through the opening in the side wall of the body 272, the sleeve 274 and the septum 276 to direct the fluid to the fluid cavity 320. In other embodiments, the supply tube 302 can be coupled directly to the side wall of the body 272 and / or positioned in the opening 318. The annular sidewall 316 defines 320 internal fluid cavity 320 for receiving the fluid from the supply tube 302 for directing the fluid to the catheter 278.

[0115] The catheter hub 270 is configured for use with the delivery' device and insertion mechanism of Figs. 1-10. The catheter hub 270 is positioned in the patient with theaid of the insertion needle where the insertion needle is retracted after insertion of the catheter. The insertion needle is retracted where the distal end or tip of the insertion needle is captured in the top wall of the septum to prevent leakage of fluid around the insertion needle. The fluid is supplied from the reservoir and pump mechanism of the delivery device through the supply tube 302 to the fluid chamber 320. The fluid is then conveyed through the catheter as in the previous embodiment. In an embodiment of the device, the supply tube and openings in the body, sleeve and septum have a dimension to reduce restricted flow and avoid a pressure drop when the fluid enters the fluid chamber and the catheter. In one embodiment, the supply tube and openings in the body have an internal dimension greater than the inner dimension of a standard hollow catheter and insertion needle.

[0116] Figs. 41-45 show another embodiment of the catheter hub assembly 322 that is configured for operating with the delivery' device of Figs. 1-10 and the insertion mechanism as described in the previous embodiments. The catheter hub 322 is configured for operating with a catheter insertion mechanism and insertion needle for positioning the catheter in the patient and for withdrawing the insertion needle after deployment and described in the previous embodiments.

[0117] Referring to Figs. 41-45, the catheter hub 322 includes a body 324 and a septum 326. The body 324 has a side wall 328 for cooperating with the insertion mechanism as in the previous embodiments. As shown in Fig. 43, the body 324 has a pair of latching arms 330 for coupling with the needle hub as in the previous embodiments. The needle hub is not shown for clarity.

[0118] The body 324 has a proximal end 342 with an opening 344 for receiving the septum 326 and a distal end 346 with an opening 348 for a catheter 350. The catheter 350 is coupled to a funnel-shaped wedge 352 fitted in the opening of the body to couple the catheter to the body 324 as shown in Fig. 45. The wedge 352 has an internal passage forming a fluid outlet. The body 324 is formed with an internal cavity defining a fluid chamber 354. The fluid chamber 354 as shown Fig. 42 is open with the opening 344 at the proximal end 342. An internal ledge 356 forming a shelf is provided between the open end 342 and the fluid chamber 354 with a shape and configuration for supporting the septum 326.

[0119] As shown in Fig. 42, the side wall 328 of the body 324 includes a collar 358 extending transversely relative to the longitudinal axis of the body 324. A fluid passage 360 extends through the collar 358 and the side wall 328 forming an inlet to provide fluid communication with the fluid chamber 354. A supply tube 362 is connected to the collar 356 for supplying fluid to the catheter hub.

[0120] In the embodiment shown, the septum 326 has a shape complementing the shape and dimension of the opening 344 and is made of a suitable soft material to that can be pierced by the insertion needle during use. The septum 326 as shown has a substantially flat top proximal face 364 and a substantially flat bottom distal face 366 as shown in Figs. 42 and 43. The ledge 356 is spaced from the open proximal end 342 a distance corresponding to the axial dimension of the septum 326 so that the septum fits within the opening 344. In the embodiment shown, a locking ring 368 snaps into a complementing groove or lip 379 in the open proximal end 342 of the body 324 to retain the septum 326 in the opening 344. In alternative embodiments, the locking ring 368 can be attached to the body 324 by an adhesive, welding or other mechanism. The septum 326 fits within the opening 344 to form a seal to prevent leakage around the septum.

[0121] The fluid passage 360 and the supply tube 362 have an internal diameter to provide a sufficient flow of the fluid to the fluid chamber 354 with little or no pressure drop as the fluid enters the fluid chamber. The fluid passage 360 has an internal diameter to allow reduced fluid pressure relative to prior devices so that there is minimal restriction of fluid flow to the catheter. The septum 326 have a substantially flat, disc shape for simplified manufacturing and assembly of the septum into the catheter hub 322.

[0122] The catheter hub 322 is configured for use with the delivery7device and insertion mechanism of Figs. 1-10. The catheter hub 322 is positioned in the patient with the aid of the insertion needle where the insertion needle is retracted after insertion of the catheter. The insertion needle is retracted where the distal end or tip of the insertion needle is captured in the top wall of the septum to prevent leakage of fluid around the insertion needle. The fluid is supplied from the reservoir and pump mechanism of the delivery device through the supply tube 362 to the fluid chamber 354. The fluid is then directed through the catheter as in theprevious embodiment. In an embodiment of the device, the supply tube and openings in the body, sleeve and septum have a dimension to reduce restricted flow and avoid a pressure drop when the fluid enters the fluid chamber and the catheter. In one embodiment, the supply tube and openings in the body have an internal dimension greater than the inner dimension of a standard hollow catheter.

[0123] As noted above, it should be understood that insertion mechanisms are available in various configurations. In some embodiments, the inserter 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 from the skin, 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 flow path to deliver the medication until the infusion is finished. Insertion needles are typically hollow, and need to be hollow if they form part of the 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.

[0124] 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. Accordingly, all such modifications are intended to be included within the scope of the appended claims and their equivalents. 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 havebeen described above in numerous other ways, all of which are considered to be within the scope of the invention, which is defined by the appended claims and their equivalents.

Claims

Claims:1 . A fluid delivery device comprising: a housing; an insertion needle; a catheter assembly; an actuator and catheter insertion device to move the insertion needle and catheter assembly from a first position to a second position, and to move the insertion needle to the first position when the catheter assembly is in the second position; said catheter assembly comprising; a catheter hub having an internal cavity, an inlet, and an outlet; a septum received in said internal cavity where said insertion needle is configured to extend through said septum and said catheter; and where said catheter assembly has a fluid passage configured for supplying a fluid to said catheter when said insertion needle is retracted from said catheter.

2. The delivery device of claim 1, wherein said insertion needle is solid.

3. The delivery device of claim 1, wherein said fluid passage of said catheter assembly is spaced from and parallel to said insertion needle when said insertion needle is positioned in said septum.

4. The delivery device of claim 1, wherein said septum has an internal fluid chamber in fluid communication with said catheter and said fluid passage in said catheter assembly for supplying fluid to said catheter.

5. The delivery device of claim 4, wherein said fluid passage extends axially through a proximal end of said septum.

6. The delivery device of claim 4, wherein said fluid passage comprises a conduit having a first end connected to a fluid supply and a second end in communication with said fluid chamber.

7. The delivery device of claim 4, wherein said septum has an open recess in a distal side of said septum forming said fluid chamber, and where said fluid passage extends through a side of said septum into said fluid chamber and through a side of said catheter hub.

8. The delivery device of claim 7, wherein said catheter hub has an opening in a side wall connected to a fluid supply, and said septum has an opening aligned with said opening in said side wall of said catheter hub.

9. The delivery device of claim 8, further comprising a conduit extending through said opening in said side wall of said catheter hub and through said opening said septum, said conduit having a first end open to said fluid chamber in said septum and a second end connected to the fluid supply.

10. The delivery device of claim 1, wherein catheter assembly has a fluid chamber between said catheter hub and said septum, and where said fluid passage extends through said catheter hub to said fluid chamber at a location between said septum and an outlet of said catheter hub.

11. The delivery device of claim 10, wherein said fluid chamber of said catheter hub is oriented distally of said septum, and where said fluid passage of said catheter hub extends directly to said cavity distally of said septum.

12. A catheter assembly comprising: a catheter hub having a proximal end with a coupling configured for removably coupling with a needle hub and insertion needle for linear movement by a catheter insertion device, said catheter hub having a cavity, a proximal end with a proximal opening, and a distal end with a distal opening;a septum received in said proximal end of said catheter hub and closing said proximal end of said catheter hub, said catheter assembly has a fluid chamber positioned between said septum and said distal opening of said catheter hub, said fluid chamber having a dimension greater than an outer dimension of the insertion needle, said catheter hub assembly having a fluid passage for supplying fluid to said fluid chamber; and a catheter coupled to said distal opening of said catheter hub for receiving fluid from said fluid chamber.

13. The catheter assembly of claim 12, wherein said catheter hub has a side wall and a distal wall forming a fluid chamber between said septum and said distal wall, wherein said fluid chamber has an inner dimension greater than a dimension of said distal opening.

14. The catheter assembly of claim 12, wherein said septum has a first opening in a proximal face for receiving an insertion needle of the catheter insertion device, and where said fluid passage extends through said septum at a location spaced from said first opening.

15. The catheter assembly of claim 12, wherein said septum has a distal surface with a recess forming said fluid chamber.

16. The catheter assembly of claim 15, wherein said fluid passage extends into said recess of said septum.

17. The catheter assembly of claim 16, wherein said fluid passage extends through a distal side of said septum into said recess of said septum.

18. The catheter assembly of claim 16, wherein said fluid passage extends through a side wall of said catheter hub and a side portion of said septum into said recess of said septum.

19. The catheter assembly of claim 12, wherein said fluid passage extends through said catheter hub to said fluid chamber at a location between said septum and said distal wall.

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