WO2018013493A1

WO2018013493A1 - Powered delivery device

Info

Publication number: WO2018013493A1
Application number: PCT/US2017/041406
Authority: WO
Inventors: Siddharth Desai
Original assignee: Heron Therapeutics LLC
Current assignee: Heron Therapeutics LLC
Priority date: 2016-07-11
Filing date: 2017-07-10
Publication date: 2018-01-18
Anticipated expiration: 2019-01-11

Abstract

A device (10) for delivery of a viscous or highly viscous material and uses thereof are described. The device (10) includes a housing (12), a power mechanism (14) and a delivery module (16). The power mechanism (14) is used to deliver the material from the delivery module (16).

Description

POWERED DELIVERY DEVICE

CROSS-REFERENCE TO RELATED APPLICATIONS

[0001] This application claims the benefit of U.S. Provisional Application No. 62/360,875, filed July 1 1 , 2016, incorporated herein by reference in its entirety.

TECHNICAL FIELD

[0002] The subject matter described herein relates to a device for powered delivery of an agent.

BACKGROUND

[0003] In the field of medicine, many types of liquid pharmaceutical preparations are injected into tissues or vessels in the human body. With increasing viscosity of the liquids to be injected, greater pressure is required in order to force the liquid through the thin injection cannula, e.g. hypodermic needle, with concomitant increases in the amount of force applied to the syringe plunger rod by the user. Typically, standard medical syringes and plunger rod configurations are operated by the user by holding the syringe barrel flange between the first two fingers and depressing the plunger with the thumb, in order to expel the liquid from the syringe through a cannula. For injecting highly viscous substances, typical syringe systems require the user to exert significant force on the enlarged proximal end of the plunger rod being depressed causing a reduction in control of the injection and prolonging the delivery, and potentially leading to failure of the plunger rod because of the high point load on the rod end.

[0004] It would, therefore, be an advantage in the art to provide a delivery device that includes an internal power source that provides enhanced control and ease of use when dispensing highly viscous materials. It would be a further advantage to provide a delivery device that allows the injection of high viscosity substances with only one hand. It would be a further advantage to provide delivery device which may be used with pre-filled syringe products. It would be yet a further advantage to provide a delivery device which may be used to deliver multiple doses of highly viscous materials.

BRIEF SUMMARY

[0005] The following aspects and embodiments thereof described and illustrated below are meant to be exemplary and illustrative, not limiting in scope.

[0006] In one aspect, a device for delivery of a viscous or highly viscous material is described. In embodiments, the device comprises (a) a housing having a proximal end and a distal end; (b) a power mechanism comprising a stored energy source being positioned within the housing; (c) a pressure regulator positioned within the housing proximal to the power mechanism; (d) a delivery module operatively coupled to the housing distal to the pressure regulator, and (e) an activation mechanism for operating the power mechanism such that the stored energy source acts on the plunger to deliver the viscous material through the needle. In embodiments, the delivery module comprises (i) an elongated chamber for holding the material and comprising an opening at a proximal end; (ii) a plunger positioned within the delivery module; and (iii) a needle operatively coupled to the opening.

[0007] In some embodiments, the stored energy source is a spring. In other embodiments, the stored energy source is a pneumatic cartridge. In embodiments, the pneumatic cartridge comprises at least one compressed gas or liquid. In embodiments, the stored energy source provides a force of about 50-200 Newtons. In embodiments, the power mechanism provides delivery of the material at a rate of about 0.05-0.1 mL/second.

[0008] In embodiments, the housing further comprises a connection mechanism for coupling the delivery module to the housing. In some embodiments, the connection mechanism is a releasable mechanism.

[0009] In some embodiments, the delivery module is at least partially positioned within the housing. In some embodiments, the device further includes a heating mechanism positioned at least partially within or contacting the housing.

[0010] In some embodiments, the device further comprises a holder coupled to the housing and configured to hold two or more delivery modules, wherein the holder comprises a rotating or sliding mechanism for sequentially moving each of the two or more delivery modules into alignment with the housing.

[0011] In embodiments, the viscous or highly viscous material is a pharmaceutical composition comprising at least one active agent and a pharmaceutically acceptable vehicle. In some embodiments, the vehicle comprises at least one polymer. In some embodiments, at least one of the at least one polymer is a polyorthoester. In embodiments, the polyorthoester is represented by the structure shown as Formula III,

III

where

A is R¹ or R³, R* is C1 -4 alkyl,

n ranges from 5 to 1000,

p and q are integers that vary from between about 1 to 20 and the average number of p or the average of the sum of p and q is between 1 and 7;

R³ and R⁶ are each independently:

x is an integer of 0-10;

R⁵ is H or methyl, and

the fraction of A units that are of formula R¹ is between 0 and 25 mole percent.

[0012] In embodiments, the composition further comprises one or more aprotic solvents selected from at least one of dimethyl sulfoxide, dimethyl acetamide, N-methyl pyrrolidone.

[0013] In another aspect, a method of delivering a viscous or highly viscous material is described. In embodiments, the method comprises operatively connecting a delivery module containing the material to a proximal end of a delivery device housing, the delivery module comprising an opening and a plunger; and activating a power mechanism comprising a stored energy source within the delivery device to thereby move the plunger within the delivery module to deliver the material through the delivery module opening. In some embodiments, the material has a viscosity of at least about 500 centipoise.

[0014] In embodiments, the power module is activated by a trigger mechanism. In some embodiments, the trigger mechanism controls the release of energy from the stored energy source.

[0015] In embodiments, the delivery module is at least partially inserted into a proximal end of the housing. In embodiments, the delivery device comprises one or more compartments comprising the material. In embodiments, the material is delivered from the delivery module opening at a rate of between about 0.05-0.1 mL/second. In embodiments, the fluid is delivered from the delivery module at a continuous rate. In embodiments, the stored energy source provides force of at least about 50-200 Newtons on the plunger.

[0016] In embodiments, the method includes heating the material before, during and/or after delivering the material. [0017] In embodiments, the viscous or highly viscous material is a pharmaceutical composition comprising at least one active agent and a pharmaceutically acceptable vehicle. In some embodiments, the vehicle comprises at least one polymer. In some embodiments, at least one of the at least one polymer is a polyorthoester. In embodiments, the polyorthoester is represented by the structure shown as Formula III,

III

where

A is R¹ or R³,

R* is C1 -4 alkyl,

n ranges from 5 to 1000,

R³ and R⁶ are each independently:

x is an integer of 0-10;

R⁵ is H or methyl, and

the fraction of A units that are of formula te R¹ is between 0 and 25 mole percent.

[0018] In embodiments, the composition further comprises one or more aprotic solvents selected from at least one of dimethyl sulfoxide, dimethyl acetamide, N-methyl pyrrolidone.

[0019] In addition to the exemplary aspects and embodiments described above, further aspects and embodiments will become apparent by reference to the drawings and by study of the following descriptions.

[0020] Additional embodiments of the present device and methods will be apparent from the following description, drawings, examples, and claims. As can be appreciated from the foregoing and following description, each and every feature described herein, and each and every combination of two or more of such features, is included within the scope of the present disclosure provided that the features included in such a combination are not mutually inconsistent. In addition, any feature or combination of features may be specifically excluded from any embodiment of the present invention. Additional aspects and advantages of the present invention are set forth in the following description and claims, particularly when considered in conjunction with the accompanying examples and drawings.

BRIEF DESCRIPTION OF THE DRAWINGS

[0021] FIG. 1 is an illustration of a delivery device in one embodiment.

[0022] FIG. 2 is an illustration of a delivery device in one embodiment.

[0023] FIGS. 3A-3C are illustrations of modules of the delivery device in some embodiments.

[0024] FIGS. 4A-4B are illustrations of embodiments of housing configurations in some embodiments.

[0025] FIG. 5 is an illustration of a delivery device in one embodiment.

DETAILED DESCRIPTION

I. Definitions

[0026] Various aspects now will be described more fully hereinafter. Such aspects may, however, be embodied in many different forms and should not be construed as limited to the embodiments set forth herein; rather, these embodiments are provided so that this disclosure will be thorough and complete, and will fully convey its scope to those skilled in the art.

[0027] Where a range of values is provided, it is intended that each intervening value between the upper and lower limit of that range and any other stated or intervening value in that stated range is encompassed within the disclosure. For example, if a range of 1 μιη to 8 μιη is stated, it is intended that 2 μιη, 3 μιη, 4 μιη, 5 μιη, 6 μιη, and 7 μιη are also explicitly disclosed, as well as the range of values greater than or equal to 1 μιη and the range of values less than or equal to 8 μιη.

[0028] Where a range of values is provided, it is intended that each intervening value between the upper and lower limit of that range and any other stated or intervening value in that stated range is encompassed within the disclosure. For example, if a range of 10 to 500 centipoise (cp) is stated, it is intended that 1 1 , 12, 13, 14, 15 cp, etc. are also explicitly disclosed, as well as the range of values greater than or equal to 10 cp up to about 500 cp and the range of values less than or equal to 500 cp down to about 10 cp.

[0029] As used in this specification the singular forms "a," "an," and "the" include plural referents unless the context clearly dictates otherwise. [0030] Optional" or "optionally" means that the subsequently described circumstance may or may not occur, so that the description includes instances where the circumstance occurs and instances where it does not.

[0031] The term "substantially" in reference to a certain feature or entity means to a significant degree or nearly completely (i.e. to a degree of 85% or greater) in reference to the feature or entity.

[0032] The term "about," particularly in reference to a given quantity, is meant to encompass deviations of plus or minus 5%.

II. Device

[0033] A device for delivering a therapeutic agent such as a viscous or highly viscous material is best understood by reference to Figs. 1 -5. The device is described and exemplified with regard to delivery of a viscous or highly viscous material. It will be understood, of course, that the same disclosure and principles apply to the delivery of various other substances, material, fluids and the like. Reference to the material hereafter is made to a viscous material; however, it will be understood that the disclosure hereafter applies to a highly viscous material.

[0034] As an overview, the device is useful for to improve delivery of viscous and/or highly viscous materials, substances or fluids by powered means. The device includes a power mechanism that makes it easily possible to apply a much higher pressure to the viscous material. In embodiments, the device dispenses the viscous material with increased control of the dispensing process including the delivery rate and amount of material that may be delivered.

[0035] With initial reference to Figs. 1 -3, a powered delivery device 10 comprises a housing 12, one or more power mechanisms 14, and one or more delivery modules 16. The delivery module is operatively coupled to the housing using any suitable means as known in the art. In some embodiments, the housing distal end includes a connector that is threaded to match a connector on the delivery module. In other embodiments, the delivery module may be inserted at least partially into the housing to form a tight seal with a portion of the housing such that the housing holds the delivery module. In other embodiments, the housing includes a quick connect/disconnect connector 30 as known in the art. In one embodiment, the quick connect/disconnect connector is a screw type connector where the connector includes a collar that is rotated to tighten against the housing in order to narrow the opening or tighten against the delivery module. In this embodiment, the collar may be rotated the opposite direction to loosen and allow the delivery module to be disconnected from the housing. [0036] The delivery module 16 includes an elongate chamber 70 for holding the viscous material. The elongate chamber includes an open distal end 72 and an opening 24 at the distal end. In some embodiments, the delivery module is preloaded with the viscous material. The elongate chamber may be of any suitable size for holding the desired amount of viscous material and/or for connecting to the housing. The elongate chamber may be formed of any suitable material, including but not limited to, plastics, glass, ceramics, and polymers including polycarbonate. In some embodiments, the chamber is formed of a shatter-proof material. In some embodiments, the elongate chamber is formed of a transparent, semi-transparent material to allow a user to visually inspect the viscous material and/or operation of the device. In embodiments, the chamber includes graduations or markings to indicate the volume of material in the chamber and/or volume of material dispensed.

[0037] The elongate chamber may be any suitable size (width and/or length) to hold the desired volume of a material to be dispensed. In some embodiments, the elongate chamber is sized to contain at least about 0.5-10 ml_ of a material to be delivered. In some embodiments, the chamber is sized to contain at least about 1 -10 ml_, 1 -5 ml_ or 1 -3 ml_.

[0038] In some embodiments, the elongate chamber contains or is configured to contain a pharmaceutical composition. In certain embodiments, the composition is a viscous liquid with a viscosity, e.g., from about 10 to about 250,000 centipoise (cp). In some embodiments, the composition is a viscous liquid with a viscosity from about 10 cp to about 100,000 cp. In other embodiments, the composition is a viscous liquid with a viscosity from about 10-500 cp, about 10-3000 cp, about 10-5000 cp, about 10-12,000, about 10-24,000 cp, about 10-80,000 cp, about 10-130,000, about 3000-5000 cp, about 3000-12,000, about 3000-24,000 cp, about 3000-80,000 cp, about 3000-130,000, about 5000-12,000, about 5000-24,000 cp, about 5000-80,000 cp, about 5000-130,000, about 12,000-24,000 cp, about 12,000-80,000 cp, about 12,000-130,000, about 24,000-80,000 cp, about 24,000-130,000, or about 80,000-130,000 cp. In some specific, but not limiting embodiments, the viscous liquid has a viscosity of at least about or from about 10 cp, about 500 cp, about 3000 cp, about 5000 cp, about 12,000 cp, about 24,000 cp, about 80,000 cp, or about 130,000 cp. In embodiments, the composition is comprised of an active agent and a vehicle. In some embodiments, the composition has a viscosity of at least about 500 cp. In some embodiments, the viscosity is measured at 37 °C or 25 °C. In some embodiments, the viscosity is measured using a cone and plate viscometer.

[0039] In some embodiments, the chamber is prefilled with the composition. [0040] Any active agent can be used in order to treat any disease or condition. In certain embodiments, the active agent is an anti-emetic such as a 5-HT3 receptor antagonist including but not limited to ondansetron, palonosetron, tropisetron, lehsetron, alosetron, granisetron, dolasetron, bernesetron, ramosetron, azasetron, itasetron, zacopride, cilansetron or pharmaceutically acceptable salts thereof. In preferred embodiments, the active agent is granisetron and the disease or condition is chemotherapy induced nausea and vomiting (e.g., acute or delayed onset). Additional active agents include, but are not limited to local anesthetic pain management medication such as a ropivacaine, bupivacaine, lidocaine and levobuipvacaine.

[0041] The vehicle can be any suitable polymer that can be utilized to deliver an active agent by either immediate or controlled release. A controlled release composition of the present invention can deliver an active agent e.g., from about 1 to about 7 days. In certain embodiments, the vehicle is a polymer such as a polyorthoester. Some exemplary polyorthoesters are described in U.S. Publication No. 2014-0275145, the disclosure of which is incorporated by reference herein. In certain embodiments, the vehicle is a polymer such as a polyorthoester. In some embodiments, the composition comprises (i) a polyorthoester represented by the structure shown as Formula III,

III

where

A is R¹ or R³,

R* is C1 -4 alkyl,

n ranges from 5 to 1000,

R³ and R⁶ are each independently:

x is an integer of 0-10; R⁵ is H or methyl, and

the fraction of A units that are of formula te R¹ is between 0 and 25 mole percent;

(ii) a solvent consisting essentially of one or more aprotic solvents, wherein at least one of the one or more aprotic solvents is an aprotic solvent such as dimethyl sulfoxide, dimethyl acetamide, N-methyl pyrrolidone, and combinations thereof in which the polyorthoester is miscible to form a liquid single phase; and

(iii) about 1 -20 weight percent of a local anesthetic selected from the group consisting of bupivacaine, levobupivacaine, dibucaine, mepivacaine, procaine, lidocaine, tetracaine, and ropivacaine, and their pharmaceutically acceptable salts, dispersed or solubilized in the single phase. In embodiments, the anesthetic is released from the composition over a period of between approximately 1 day and approximately 8 weeks when measured by an in vitro dissolution test at 37 °C in phosphate buffered saline. In some embodiments, A is R¹ in 0 to

10% of the monomeric units of the polyorthoester. In embodiments, the polyorthoester has a molecular weight between about 1 ,000 and 10,000 Daltons.

[0042] In some embodiments, the polyorthoester includes one or more subunits selected from

where

x is an integer from 1 -4,

the total amount of p is an integer from 1 -20, and

s is an integer from 1 -4.

[0043] In some embodiments, the composition comprises one or more aprotic solvents present in an amount between 10-60 percent by weight of the composition. In embodiments, the active agent, such as a local anesthetic, is present in the composition in an amount between 2 and 5 percent by weight of the delivery system. In embodiments, the rate of solvent release from the system correlates with the rate of release of the active agent. [0044] The delivery module 16 includes a plunger assembly 18 at least partly positioned within the elongate chamber 70. Preferably, the plunger assembly is slidably positioned within the chamber for sliding movement along at least a portion of the chamber. The plunger assembly is positioned within the chamber between the composition at the proximal end and a power mechanism. As will be described further below, when the power mechanism is activated, a stored energy source acts on the plunger to move the plunger within the chamber toward the chamber proximal end thereby pushing the composition out of the chamber for delivery.

[0045] In some embodiments, the plunger assembly 18 includes a head 48 and a distal push section 52 connected by a shaft 50. In use, forward (toward the distal end) movement of the plunger forces the composition toward the opening. The head comprises a top side 74 and a bottom side 76. The plunger shaft 50 extends from the bottom side of the plunger head between the plunger head and the distal push section 52. The top side of the plunger head may have any shape as suitable for pushing the composition through the chamber. In some embodiments, the top side of the plunger head has a flat or convex shape. The plunger head has a width or diameter such that the plunger head makes a liquid and/or airtight seal with the inner wall of the elongate chamber in order to push the composition through the chamber. The head, shaft and/ or distal push section may be formed as a single piece and/or as separate pieces.

[0046] The plunger, or one or more pieces thereof, may be formed of any suitable material. In embodiments, at least a portion of the plunger is formed of a plastic, glass, ceramic, metal, silicon, rubber, or composites thereof. In one embodiment, at least a portion of the plunger is formed of a thermoplastic material. In one embodiment, at least a portion of the plunger is formed of a polydimethyl thermoset material.

[0047] An optional needle assembly 22 is attached to the distal end of the delivery module, in some embodiments. The needle can be any gauge but preferably has a gauge of between about 31 gauge to about 12 gauge. In some embodiments, the needle has a gauge of between about 23 to 18 gauge or about 26 to 18 gauge. In some embodiments, the needle has a length of about 1 -4 inches in length. In some embodiments, the needle acts as a damper by way of the needle's exit size. It will be appreciated that the opening in the chamber may also act as a damper. In some embodiments, the device includes a damper mechanism as known in the art in or around the delivery module or within the housing.

[0048] A power mechanism 14 is positioned at least partially within the housing. The power mechanism comprises one or more stored energy sources that act on the plunger distal push section 52. The power mechanism and one or more stored energy sources must provide sufficient force on the plunger to dispense the viscous material. In some embodiments, the power mechanism and one or more stored energy sources provide a force of about 50-200 Newtons. In embodiments, the power mechanism and one or more stored energy sources provide a flow rate of the viscous material of about 10-15 mL/second. In some embodiments, the power mechanism and one or more stored energy sources provide sufficient force to delivery about 3 ml_ of the viscous material in about 35-40 seconds. In some embodiments, the power mechanism produces pressure of less than about 40 psi. Excessive pressure during delivery can cause backpressure and/or damage.

[0049] In some embodiments, the stored energy source is activated by an activation mechanism 26 such as a trigger or lever coupled to the housing and the stored energy source. The trigger or lever may be an on/off type switch or a trigger/lever that provides differential force from the power mechanism. In some embodiments, the activation mechanism provides continuous delivery of the viscous material when activated (e.g. pressed). In some embodiments, the activation mechanism may activate the energy source to provide continuous delivery of the material or a fixed bolus volume of the material.

[0050] In some embodiments, the device includes a flow indicator 64 to indicate flow of the viscous material from the device. In some embodiments, the device includes one or more flow sensors as known in the art. In one embodiment, the device includes at least two pressure sensors to measure pressure within the device at two or more separated positions. The pressure differential between the measurements is used to determine the flow, which is shown by the flow indicator.

[0051] The housing preferably has a shape allowing the device to fit comfortably in one hand. In some embodiments, the housing has an ergonomic shape. Figs. 4A-4B show two exemplary configurations for the housing. Fig. 4A illustrates a pen style configuration. In this embodiment, the proximal end of the housing 12 is an elongate cylinder 60. This embodiment may be held in one hand similar to holding a pen with one finger able to operate the activation mechanism. The embodiment of Fig. 4B includes an ergonomic grip 62 at the distal end of the housing. In some embodiments, the housing includes a hand or finger rest 58 to facilitate comfort and/or ability to use the device with one hand. In some embodiments, the housing proximal end includes an opening that may be used to insert the power mechanism. The opening may sealed or plugged during delivery of the viscous material.

[0052] In one embodiment, the stored energy source is a pneumatic energy source. In some embodiments, the stored energy source is a compressed gas or liquid module or cartridge. Any suitable compressed gas or liquid may be used. In some embodiments, the gas is an inert gas. In some embodiments the gas is selected from carbon dioxide, nitrogen, air or other compressible gases. In some embodiments, stored energy source comprises a liquid form of nitrogen, carbon dioxide or a liquid form of other known compressible gases. In some embodiments, the pneumatic energy source may be replaced within the housing so that at least a portion of the device is reusable. In some embodiments, the pneumatic energy source may be useful for delivery of a viscous material from one or more delivery modules. In some embodiments, the device includes a valve such as a poppet valve connected to the pneumatic energy source and the activation mechanism to stop flow of the gas/liquid from the energy source when the activation mechanism is no longer activated (e.g. pressed). In some embodiments, the device includes an indicator to show when the energy source is empty or needs replacement.

[0053] In some embodiments, the device includes a safety mechanism whereby the pneumatic/liquid energy source will only release gas/liquid when the device is integrated as a unit.

[0054] In some embodiments, the stored energy source is a spring 34. In one embodiment, the spring is a compression spring. The spring is retained in the housing in a compressed or restrained position until use. Activation of the activation mechanism at least partially releases the spring to travel to an extended position where the spring acts on the plunger to deliver the composition. In some embodiments, the activation mechanism releases the spring from a restrained position to a partial or fully elongate position. In other embodiments, the activation mechanism provides incremental release of the spring by adjusting the compression of the spring. In some embodiments, the device includes one or more restraining members that hold the spring in a constrained position until activated. In some embodiments, the restraining members are a safety feature to prevent premature expansion of the spring that can be negated or removed prior to delivery of the viscous material. It will be appreciated that the force applied by a spring is determined at least in part by the length of the spring, material used, wire diameter, and pitch of the spring. The spring may be configured to provide the desired force according to methods known in the art. In some embodiments, the spring energy source may be reset by compressing the spring after release. In some embodiments, the spring energy source may be useful for delivery of a viscous material from one or more delivery modules. In some embodiments, the power mechanism is modular and may be replaced within the housing. In this manner, at least a portion of the device is reusable. In some embodiments, a spring energy source may be selected based on the viscosity of the material and/or the volume of material to be delivered. In this manner, a spring providing greater force may be selected and included in the housing for delivery of larger volumes and/or more viscous materials. The spring may be formed of any suitable material including, but not limited to, a metal and a polymer/copolymer. In one embodiment, the spring is formed of a stainless steel, e.g. 304 ss.

[0055] In some embodiments, the device includes a pressure regulator. The pressure regulator may regulate release of the gas/liquid for pneumatically powered devices or moderate compression of a spring. By regulating operation of the stored energy source, the pressure regulator regulates pressure applied to the plunger.

[0056] The housing may be formed of any suitable material as known in the art that provides the required rigidity to hold the power mechanism and/or the delivery module. It will be appreciated that the housing may be formed of one or more materials. In some non- limiting embodiments, the housing is at least partially formed of a plastic, one or more polymers or copolymers, a ceramic, silicon, and a metal. In some embodiments the polymer is selected from polycarbonate (including reinforced polycarbonate) and Acrylonitrile Butadiene Styrene (ABS).

[0057] In some embodiments, the device includes a heater for raising the temperature of the viscous material. Heating the material can reduce the force required to deliver the material from the device. When the material is heated, the viscosity of the material is reduced and the overall force required to move the material through the device and delivery it is reduced. The force required to delivery the material is based on the Hagen Poisuelle equation:

F=128Q l_LA/nD⁴

F=syringe stopper (plunger) force

Q=volumetric flow rate

μ=dynamic viscosity

L=needle length

D=needle bore diameter

A=syringe plunger area

The force required to delivery the material is directly proportional to the viscosity of the material. Therefore, reducing the viscosity of the material by heating reduces the force necessary for delivery from the device.

[0058] In some embodiments, the device is configured to hold two or more delivery modules where the device is configured to alternatively dispense material from one or more of the deliver modules. With reference to Fig. 5, the device may include a holder 66 for fixedly holding two or more delivery modules. The holder is coupled to the housing. The holder aligns one of the delivery modules with the distal end of the housing to allow the power mechanism positioned within the housing to act on the plunger in the delivery module as described above. Once the desired amount of material is dispensed, the next delivery module 68 is moved into position for delivery. In some embodiments, the holder is a rotating holder and each module is rotated into position for delivery of the viscous material. In other embodiments, the holder includes a sliding mechanism and each delivery module is slid into delivery position.

[0059] Embodiments:

1 . A device for delivery of a viscous or highly viscous material, comprising:

(a) a housing having a proximal end and a distal end;

(b) a power mechanism comprising a stored energy source being positioned within the housing;

(c) a pressure regulator positioned within the housing proximal to the power mechanism;

(d) a delivery module operatively coupled to the housing distal to the pressure regulator comprising:

(i) an elongated chamber for holding the material and comprising an opening at a proximal end;

(ii) a plunger positioned within the delivery module;

(iii) a needle operatively coupled to the opening; and

(e) an activation mechanism for operating the power mechanism such that the stored energy source acts on the plunger to deliver the viscous material through the needle.

2. The device of embodiment 1 , wherein the stored energy source is a spring.

3. The device of the combined or separate embodiments 1 -2, wherein the stored energy source is a pneumatic cartridge.

4. The device of the combined or separate embodiments 1 -3, wherein the pneumatic cartridge comprises at least one compressed gas or liquid.

5. The device of the combined or separate embodiments 1 -4, wherein the stored energy source provides a force of about 50-200 Newtons.

6. The device of the combined or separate embodiments 1 -5, wherein the power mechanism provides delivery of the material at a rate of about 0.05-0.1 mL/second.

7. The device of the combined or separate embodiments 1 -6, the housing further comprising a connection mechanism for coupling the delivery module to the housing.

8. The device of the combined or separate embodiments 1 -7, wherein the connection mechanism is a releasable mechanism.

9. The device of the combined or separate embodiments 1 -8, the delivery module being at least partially positioned within the housing. 10. The device of the combined or separate embodiments 1 -9, further comprising a heating mechanism positioned within the housing.

1 1 . The device of the combined or separate embodiments 1 -10, further comprising a holder coupled to the housing and configured to hold two or more delivery modules,

wherein the holder comprises a rotating or sliding mechanism for sequentially moving each of the two or more delivery modules into alignment with the housing.

12. The device of the combined or separate embodiments 1 -1 1 , wherein the viscous or highly viscous material is a pharmaceutical composition comprising at least one active agent and a pharmaceutically acceptable vehicle.

13. The device of the combined or separate embodiments 1 -12, wherein the vehicle comprises at least one polymer.

14. The device of the combined or separate embodiments 1 -13, wherein at least one of the at least one polymer is a polyorthoester.

15. The device of the combined or separate embodiments 1 -14, wherein the polyorthoester is represented by the structure shown as Formula III,

III

where

A is R¹ or R³,

R* is C1 -4 alkyl,

n ranges from 5 to 1000,

R³ and R⁶ are each independently:

x is an integer of 0-10;

R⁵ is H or methyl, and

the fraction of A units that are of formula R¹ is between 0 and 25 mole percent. 16. The device of the combined or separate embodiments 1 -15, wherein the composition further comprises one or more aprotic solvents selected from at least one of dimethyl sulfoxide, dimethyl acetamide, N-methyl pyrrolidone.

17. A method of delivering a viscous or highly viscous material, comprising:

operatively connecting a delivery module containing the material to a proximal end of a delivery device housing, the delivery module comprising an opening and a plunger;

activating a power mechanism comprising a stored energy source within the delivery device to thereby move the plunger within the delivery module to deliver the material through the delivery module opening.

18. The method of the combined or separate embodiments 17-, wherein the power module is activated by a trigger mechanism.

19. The method of the combined or separate embodiments 17-18, wherein the trigger mechanism controls the release of energy from the stored energy source.

20. The method of the combined or separate embodiments 17-19, wherein the delivery module is at least partially inserted into a proximal end of the housing.

21 . The method of the combined or separate embodiments 17-20, wherein the delivery device comprises one or more compartments comprising the material.

22. The method of the combined or separate embodiments 17-21 , wherein the material is delivered from the delivery module opening at a rate of between about 0.05-0.1 mL/second.

23. The method of the combined or separate embodiments 17-22, wherein the fluid is delivered from the delivery module at a continuous rate.

24. The method of the combined or separate embodiments 17-23, wherein the stored energy source provides force of at least about 50-200 Newtons on the plunger.

25. The method of the combined or separate embodiments 17-24, wherein the material has a viscosity of at least about 500 centipoise.

26. The method of the combined or separate embodiments 17-25, further comprising heating the material before, during and/or after delivering the material.

27. The method of the combined or separate embodiments 17-26, wherein the viscous or highly viscous material is a pharmaceutical composition comprising at least one active agent and a pharmaceutically acceptable vehicle.

28. The method of the combined or separate embodiments 17-27, wherein the vehicle comprises at least one polymer.

29. The method of the combined or separate embodiments 17-28, wherein at least one of the at least one polymer is a polyorthoester. 30. The method of the combined or separate embodiments 17-29, wherein the polyorthoester is represented by the structure shown as Formula II I,

III

where

A is R¹ or R³,

R* is C1 -4 alkyl,

n ranges from 5 to 1000,

R³ and R⁶ are each independently:

x is an integer of 0-10;

R⁵ is H or methyl, and

31 . The method of the combined or separate embodiments 17-30, wherein the composition further comprises one or more aprotic solvents selected from at least one of dimethyl sulfoxide, dimethyl acetamide, N-methyl pyrrolidone.

[0060] While a number of exemplary aspects and embodiments have been discussed above, those of skill in the art will recognize certain modifications, permutations, additions and sub-combinations thereof. It is therefore intended that the following appended claims and claims hereafter introduced are interpreted to include all such modifications, permutations, additions and sub-combinations as are within their true spirit and scope.

Claims

IT IS CLAIMED:

1 . A device for delivery of a viscous or highly viscous material, comprising:

(a) a housing having a proximal end and a distal end;

(ii) a plunger positioned within the delivery module;

(iii) a needle operatively coupled to the opening; and

2. The device of claim 1 , wherein the stored energy source is a spring.

3. The device of claim 1 , wherein the stored energy source is a pneumatic cartridge.

4. The device of claim 3, wherein the pneumatic cartridge comprises at least one

compressed gas or liquid.

5. The device of any previous claim, wherein the stored energy source provides a force of about 50-200 Newtons.

6. The device of any previous claim, wherein the power mechanism provides delivery of the material at a rate of about 0.05-0.1 mL/second.

7. The device of any previous claim, the housing further comprising a connection mechanism for coupling the delivery module to the housing.

8. The device of claim 7, wherein the connection mechanism is a releasable mechanism.

9. The device of any previous claim, the delivery module being at least partially positioned within the housing.

10. The device of any previous claim, further comprising a heating mechanism positioned within the housing.

1 1 . The device of any previous claim, further comprising a holder coupled to the housing and configured to hold two or more delivery modules,

12. The device of any previous claim, wherein the viscous or highly viscous material is a pharmaceutical composition comprising at least one active agent and a pharmaceutically acceptable vehicle.

13. The device of claim 12, wherein the vehicle comprises at least one polymer.

14. The device of claim 13, wherein at least one of the at least one polymer is a

polyorthoester.

15. The device of claim 14, wherein the polyorthoester is represented by the structure shown

III

where

A is R¹ or R³,

R* is C1 -4 alkyl,

n ranges from 5 to 1000,

R³ and R⁶ are each independently:

x is an integer of 0-10;

R⁵ is H or methyl, and

16. The device of claim 12, wherein the composition further comprises one or more aprotic solvents selected from at least one of dimethyl sulfoxide, dimethyl acetamide, N-methyl pyrrolidone.

17. A method of delivering a viscous or highly viscous material, comprising:

operatively connecting a delivery module containing the material to a proximal end of a delivery device housing, the delivery module comprising an opening and a plunger; activating a power mechanism comprising a stored energy source within the delivery device to thereby move the plunger within the delivery module to deliver the material through the delivery module opening.

18. The method of claim 17, wherein the power module is activated by a trigger mechanism.

19. The method of claim 18, wherein the trigger mechanism controls the release of energy from the stored energy source.

20. The method of any one of claims 17-19, wherein the delivery module is at least partially inserted into a proximal end of the housing.

21 . The method of any one of claims 17-20, wherein the delivery device comprises one or more compartments comprising the material.

22. The method of any one of claims 17-21 , wherein the material is delivered from the delivery module opening at a rate of between about 0.05-0.1 mL/second.

23. The method of any one of claims 17-22, wherein the fluid is delivered from the delivery module at a continuous rate.

24. The method of any one of claims 17-23, wherein the stored energy source provides force of at least about 50-200 Newtons on the plunger.

25. The method of any one of claims 17-24, wherein the material has a viscosity of at least about 500 centipoise.

26. The method of any one of claims 17-25, further comprising heating the material before, during and/or after delivering the material.

27. The method of any one of claims 17-26, wherein the viscous or highly viscous material is a pharmaceutical composition comprising at least one active agent and a pharmaceutically acceptable vehicle.

28. The method of claim 27, wherein the vehicle comprises at least one polymer.

29. The method of claim 28, wherein at least one of the at least one polymer is a

polyorthoester.

30. The method of claim 29, wherein the polyorthoester is represented by the structure shown

III

where

A is R¹ or R³, R* is C1 -4 alkyl,

n rang

R' is:

R³ and R⁶ are each independently:

x is an integer of 0-10;

R⁵ is H or methyl, and

31 . The method of any one of claims 27-30, wherein the composition further comprises one or more aprotic solvents selected from at least one of dimethyl sulfoxide, dimethyl acetamide, N-methyl pyrrolidone.

32. The method of any one of claims 17-31 , wherein the active agent is delivered in a region of tissue near a nerve, into an epidural space, as an intrathecal injection, around the periphery of a surgical site or wound or dispensing directly into a surgical site or wound.