Patent Application
20080171971
The present invention relates to the mixing and dispensing of sensitive biological and bioactive materials, including, for example, preserved agents. More particularly, the invention concerns a device for the admixing of a powdered or otherwise preserved agent, such as a lyophilized drug, and a fluid through a specialized fluid channel in the piston of a syringe. This invention allows lyophilized agents such as Botox, Factor VIII, Immunoglobulin IgG, and many others to be delivered. Moreover these drugs can be stored and utilized without the need for syringes, complicated sterile technique, or professional training in the mixing of drugs in remote places such as on the battlefield or in rural areas.
State of the art information relevant to attempts to address the problem of resuspension of a preserved agent prior to its delivery can be found in U.S. Pat. Nos. 4,941,876; 5,330,426; 5,531,683; 5,637,087; 5,785,682; and 6,387,074, as well as U.S. Publication Nos. 2004/0138611 and 2005/0075602, each of which is expressly incorporated by reference as if fully set forth herein.
However, each of these references suffer from one or more of the following disadvantages: incomplete admixture of the fluid and the preserved agent, inaccurate dosage delivery of the resuspended agent, labor intensive devices, multiple sterile systems that increase the potential for compromises of sterile technique, and the inability to fully complete the admixing process in front of the patient. These various limitations make the present disclosure more desirable than the cited references, and are demonstrative of satisfaction of a longstanding need in the art addressed and overcome according to the teachings of the present disclosure.
The present disclosure serves as a simple solution to the myriad of formerly complicated solutions for the resuspension and delivery of preserved agents. The present system allows for simple loading and administration of preserved agents after resuspension in an appropriate fluid, which occurs completely within the device. This type of system is advantageous because it saves labor and reduces the probability of error inherent in multiple step processes involving systems with multiple needles, wipes for bottle tops, and other mistakes that potentially compromise sterility of the instrument and agent vehicle. Those skilled in the art will understand that any biological industrial product can be used with and is embraced by the instant disclosure.
According to a feature of the present disclosure, a piston fluid channel is used to admix a fluid with a preserved agent prior to delivery of the agent to a patient. A preserved agent ampoule in a first position holds the preserved agent. The ends of the preserved agent ampoule are pierceable septa. Fluid is loaded into a fluid chamber in the dispenser body prior to placing the piston into the dispenser body.
As force is applied to the piston via its plunger, a cannula on the end of the piston pierces the septum on the piston end of the preserved agent ampoule. The fluid is moved from a fluid chamber into a preserved agent ampoule chamber through a piston fluid channel and the piston cannula. A combination of at least one of compression force, a partial vacuum in the preserved agent ampoule chamber, or some combination of both causes the fluid to move through the piston fluid channel into the preserved agent ampoule chamber.
Once in the preserved agent ampoule chamber, the fluid and the preserved agent admix to form a resuspended agent ready for delivery to a patient. The person operating an embodiment of the present disclosure can, at this point, visually confirm that the preserved agent has been fully resuspended in the fluid prior to final delivery.
After resuspension of the preserved agent, additional force is applied to the piston by means of the plunger. This additional force moves the entire preserved agent ampoule into a second position, towards the interior end of the delivery cannula, which pierces the delivery end septum of the preserved agent ampoule and places the delivery cannula into the preserved agent ampoule chamber. In this position, the delivery cannula provides a channel to deliver the resuspended agent to the patient.
Additional force applied to the piston moves the piston end septum of the preserved agent ampoule through the preserved agent ampoule towards the delivery end septum. The compression force within the preserved agent ampoule chamber forces the resuspended agent into the delivery cannula and into the patient.
The above-mentioned features and objects of the present disclosure will become more apparent with reference to the following description taken in conjunction with the accompanying drawings wherein like reference numerals denote like elements and in which:
The present inventors discovered that certain biological, chemical, and pharmaceutical agents and compounds can be delivered via a novel piston fluid channel mechanism. According to embodiments of the present disclosure, piston fluid channel 121 allows for complete admixture of fluid 129 and preserved agent 107 within the container originally holding preserved agent 107. Once preserved agent 107 is admixed with fluid 129, resuspended agent 133 can then be delivered.
Likewise disclosed is a novel enhanced syringe-style device wherein the instant disclosure describes a novel method for mixing and dispensing preserved agent 107.
Dispenser body 101 is an open-ended container with a delivery end and a piston end according to an embodiment of the present disclosure. Delivery end of dispenser body 101 narrows to an articulation point where delivery cannula 103 connects for delivery of resuspended agent 131. Delivery cannula 103 can be a hypodermic needle or any other suitable dispensing structure as commonly known in the art. The interior end of delivery cannula 103 is either a part of cannula itself or a secondary structure, such as a spike, in fluid communication with delivery cannula 103 and providing a sealed channel in which resuspended agent 131 can be delivered. The interior end of delivery cannula 103 protrudes into the cavity of dispenser body 101 and pierces delivery end septum 109 of preserved agent ampoule 105 preparatory to delivery of resuspended agent 131.
According further to the illustrative example, preserved agent ampoule 105 is a hollow container with a delivery end and a piston end. Preserved agent ampoule 105 contains preserved agent 107. The delivery end is sealed with delivery end septum 109, which is made of a flexible material suitable to piercing by delivery cannula 103 as commonly known in the art. Delivery end septum 109 is fixed with respect to its position in preserved agent ampoule 105.
Preserved agent ampoule 105 contains preserved agent 107 and is inserted into dispenser body 101 through the opening in the piston end of dispenser body 101. According to one version of the instant teachings, once inserted into dispenser body 101, preserved agent ampoule 105 abuts a positioning protuberance, which are common in the art, contained within the inside surface of the delivery end of dispenser body 101. The protuberance holds preserved agent ampoule 105 in a first position for the piercing of piston end septum 111 with piston cannula 119.
A sufficient force moves preserved agent ampoule 105 past the positioning protuberance and into a second position. Thus, the positioning protuberance gives sufficient friction to prevent movement of preserved agent ampoule 105 during piercing of piston end septum 111, but not so much friction that additional force cannot move preserved agent ampoule 105. The positioning protuberance can be made of any suitable material capable of holding preserved agent ampoule 105 in place when a weaker but sufficient force is exerted on preserved agent ampoule 105 allowing piston cannula 119 to pierce piston end septum 111, but also permitting preserved agent ampoule 105 to move into a second position when a stronger force is exerted on it. The protuberance, in an exemplary embodiment, is a bearing-like member as commonly known in the art. Another embodiment is a positioning member, which holds preserved agent ampoule 105 in the first position. Positioning member extends from the inside to the outside of dispenser body 101. After piston cannula 119 pierces piston end septum 111 and fluid 129 is moved into preserved agent ampoule chamber 113, positioning member is removed and additional force exerted on preserved agent ampoule 105 moves it into the second position.
According to exemplary embodiments, piston end septum 111 is made of a material suitable to form a tight seal with the inner walls of preserved agent ampoule 105, but is also moveable within preserved agent ampoule 105 while maintaining the seal. The material is also suitable for piercing by piston cannula 119 as commonly known in the art. Piston end septum 111 should be made of a flexible material, such as rubber, so that the volume of fluid chamber 123 will not change during the piercing process. Alternately, a small pocket of air in fluid chamber 123 accomplishes the same objective.
In an embodiment, piston end septum 111 is a two piece system comprised of a support piece that moves through preserved agent ampoule chamber 113 and a pierceable region, similar to bottle tops commonly known in the art. The support piece can be made of metal, plastic, or other materials suitable for being pushed through preserved agent ampoule chamber 113. The support piece either forms a seal with the inner wall or walls of preserved agent ampoule 105 or has a separate sealing member connected. The pierceable region is made as previously described for piston end septum 111. Moreover, the region must be large enough for piston cannula 119 to reliably pierce it.
Piston end septum 111 forms a seal with preserved agent ampoule 105 via friction between piston end septum 111 and inner wall or walls of preserved agent ampoule 105. Unlike delivery end septum 109, piston end septum 111 is movable with respect to preserved agent ampoule 105. Applied force to piston end septum 111 will move it through preserved agent ampoule chamber 113 towards delivery end septum 109 in the delivery process of resuspended agent 131.
In an illustrative embodiment, preserved agent ampoule 105 is sealed under vacuum conditions. The vacuum is intended to move fluid 129 from fluid chamber 123 to preserved agent ampoule chamber 113, through piston fluid channel 121 and piston cannula 119, in the absence of compression force. However, vacuum conditions are not necessary; fluid 129 can be moved from fluid chamber 123 into preserved agent ampoule 105 via compression of fluid chamber 123 by movement of piston 115 toward the delivery end of dispenser body 101, which raises the internal pressure of fluid chamber 123, consequently forcing fluid 129 through piston fluid channel 121 and piston cannula 119, and into preserved agent ampoule chamber 113 as previously described.
In an embodiment, dispenser body 101 and preserved agent ampoule 105 are made of a transparent material suitable to visual inspection of the mixing process. The person administering the agent can visually verify resuspension of preserved agent 107 into fluid 129, ensuring that the complete dosage of preserved agent 107 resuspends into fluid 129. Additionally, the entire process can be performed in front of the patient.
Referring still to an illustrative embodiment in
When inserted into dispenser body 101, at least one sealing member 133 of piston 115 articulates with the inner wall or walls of dispenser body 101 to form a seal. Each sealing member 133 is made of a suitable material, such as rubber, plastic, polymers, ePTFE, and the like, allowing for a tight seal between sealing member 133 and the inner wall or walls of dispenser body 101. Each sealing member 133 also allows for movement of piston 115 when axial force is applied to piston 115. Such movement does not break the seal between each sealing member 133 and the inner wall or walls of dispenser body 101.
Piston 115 also contains piston fluid channel 121. Piston fluid channel opening 125 and piston cannula opening 127 are the end points of piston fluid channel 121. Piston fluid channel 121 forms a sealed and continuous conduit between fluid chamber 123 and preserved agent ampoule chamber 113. Thus, piston fluid channel 121 allows fluid 129 to flow from fluid chamber 123 to preserved agent ampoule chamber 113 when vacuum force or compressive force is applied to fluid chamber 123. In an embodiment, piston fluid channel opening 125 is placed in a location where the entire volume of fluid 129 may be removed from fluid chamber 123 and moved into preserved agent ampoule chamber 113.
Piston cannula 119 extends from piston 115 and is used to pierce piston end septum 111. In an embodiment, the delivery end of piston cannula 119 is a trocar suitable for piercing piston end septum 111. Piston cannula 119 can be made from any suitable material commonly known in the art to be used for piercing, such as hypodermic needles or spikes. Piston cannula 119 also serves to move fluid 129 from fluid chamber 123 to preserved agent ampoule chamber 113. Thus, it can be considered an integral part of the fluid transport system of the present disclosure. In an embodiment, piston cannula 119 and the interior end of delivery cannula 103 are off-axis of each other, which prevents piston cannula 119 from abutting into delivery cannula 103 in the process of delivering resuspended agent 131.
According still to an illustrative embodiment of
Referring again to
Delivery of resuspended agent 131 by compression force within preserved agent ampoule chamber 113 allows a precise and accurate delivery of a predetermined dosage of resuspended drug 131 to the patient. Moreover, if the factory preloads the system, the entire apparatus can be opened and operated in the presence of the patient, which allays patient concerns about safety and contamination stemming from improper sterile technique or reuse of hypodermic needles.
In another embodiment, the system is flexible. Dispenser body 101 and piston 115 are reusable after being properly cleaned and sterilized. Additionally, doctors can choose from various available fluids when fluid 129 is loaded on-site. Reuseable core components provide a mixing and dispensing apparatus that is both cost effective and simple to load and operate. Additionally, it also gives doctors greater flexibility in the way preserved agent 107 is mixed, in addition to the concentration of the dose administered. These features make embodiments of the present disclosure superior to other devices on the market today.
An embodiment of the present disclosure also includes a backflow restrictor built into piston cannula 119 or piston fluid channel 121, as is commonly known in the art. The backflow restrictor allows fluid 129 to flow unidirectionally from piston fluid channel opening 125 towards piston cannula opening 127. One such embodiment comprises a one-way valve, as commonly known to artisans. In its closed state, the one-way valve is positioned such that the edges form a tight seal within piston fluid channel 121 or piston cannula 119. When fluid 129 flows in the proper direction from piston fluid channel opening 125 towards piston cannula opening 127, the one-way valve is forced into an open position by the flow of the fluid. However, fluid flowing from piston cannula opening 127 to piston fluid channel opening 125 forces the one-way valve to close, which seals piston fluid channel 121 to back flow.
Consequently, as piston end septum 111 moves through preserved agent ampoule chamber 113 toward delivery end septum 109, the pressure in preserved agent ampoule chamber 113 increases, which seals piston fluid channel 121 and forces resuspended agent 131 to flow into delivery cannula 103, rather than back through piston cannula 119 and fluid channel 121 into fluid chamber 123.
Another embodiment includes, in addition to that already disclosed, a lever that, when activated, advances preserved agent ampoule 105 into a second position as shown in
An embodiment of the present disclosure as illustrated in
Spike ports are well known in the art and easy to manufacture. Spike port 135 can be integrated into piston 115 in a single molding process. Thereafter, at least one opening is created forming piston fluid channel opening 125, which is created so as to be in fluid communication with piston cannula opening 127. Thus, piston fluid channel opening 125, piston fluid channel 121, and piston cannula opening 127 form a sealed, continuous channel by which fluid chamber 123 is put into fluid communication with preserved agent ampoule chamber 113. Spike port 135 can be made of materials that are well known in the art.
In an illustrative embodiment as shown in
An illustrative example of similar adjustment mechanism 141 comprises a screw-like mechanism allowing the axial length of cannula assembly 149 to be adjusted. As seen in greater detail in an illustrative example in
Cannula assembly 149 contains at least one cannula assembly positioning member 155 to ensure that piston 115 and cannula assembly 149 remain correctly aligned relative to each other. Within the piston, at least one cannula assembly receiver 143 receives cannula assembly positioning member 155 as shown in
In a similar embodiment, the cannula assembly 149 adjustment mechanism comprises a notched positioning mechanism allowing the axial length of cannula assembly 149 to be adjusted. Fluid adjustment actuator 153 is connected to the cannula assembly. The cannula assembly contains a protuberance that articulates with notches in piston 121. In a first position, the protuberance fits into one of a plurality of notches, fixing the position of the protuberance with respect to the notch. Rotating the cannula assembly 149 moves it into a second position where cannula assembly 149 is not positioned in a notch and may move axially. The plurality of notches allows for a plurality of fixed positions for cannula assembly 149 with respect to piston 115. Thus, variations in the volume of fluid 129 moved into preserved agent ampoule chamber 113 is accomplished.
Referring to an illustrative method, preserved agent ampoule 105 is loaded into dispenser body 101 as shown in
According to an embodiment of an illustrative method, sealing of preserved agent ampoule 105 may occur under vacuum conditions sufficient to move fluid 129 from fluid chamber 123 into preserved agent ampoule 105 when piston end septum 111 is pierced. The vacuum pressure should not be so great as to prematurely dislodge piston end septum 111 towards delivery end septum 109. The process of loading preserved agent 107 into preserved agent ampoule chamber 113 should be conducted under sterile conditions.
Referring now to an embodiment represented in
According still to
According to an embodiment demonstrated in
An embodiment of a method of delivering a specified volume of fluid 129 into preserved agent ampoule chamber 113 is demonstrated in
While the apparatus and method have been described in terms of what are presently considered to be the most practical and preferred embodiments, it is to be understood that the disclosure need not be limited to the disclosed embodiments. It is intended to cover various modifications and similar arrangements included within the spirit and scope of the claims, the scope of which should be accorded the broadest interpretation so as to encompass all such modifications and similar structures. The present disclosure includes any and all embodiments of the following claims.
