Background

[0001] This patent is directed to drug transfer device, and, in particular, to a drug transfer device configured to transfer a drug from one or more ampules to a syringe.

[0002] As set forth in more detail below, the present disclosure sets forth a drug transfer device embodying advantageous alternatives to prior art devices.

Summary

[0003] In one aspect, a drug transfer device includes a table having a plurality of ampule holders arranged thereon, each ampule holder configured to receive an ampule having a body defining a cavity to receive drug therein and a top attached to the body to close the cavity. The device also includes a first station and a second station. The first station includes an ampule opener, the opener having a first position spaced from the ampule holder and a second position proximate to the ampule holder to separate the top of the ampule from the body to define an open ampule. The second station includes a syringe holder and a plunger actuator, at least one of (i) the ampule holder and (ii) the syringe holder being moveable between a first position wherein a tip of a syringe disposed in the syringe holder is spaced from the ampule holder and a second position wherein the tip is proximate to the ampule holder so that the tip is disposed within the cavity of an open ampule disposed in the ampule holder, and the plunger actuator moveable relative to the syringe holder in the second position to move a plunger disposed in the syringe relative to the syringe to draw drug from the open ampule. The table is movable to index at least one of the ampule holders between the first and second stations.

[0004] In another aspect, a drug transfer device includes a table having a plurality of ampule holders arranged thereon, each ampule holder configured to receive an ampule having a body defining a cavity to receive drug therein and a top attached to the body to close the cavity. The device also includes a first station and a second station. The first station includes an ampule opener, the opener having a first position spaced from the ampule holder and a second position proximate to the ampule holder to separate the top of the ampule from the body to define an open ampule. The second station includes a syringe with a plunger disposed within a bore between a first end with a tip and a second end, at least one of the ampule and the syringe being movable between a first position wherein the tip is spaced from the ampule holder and a second position wherein the tip is proximate to the ampule holder so that the tip is disposed within the cavity of the open ampule disposed in the ampule holder and wherein the plunger is moveable toward the second end to draw drug from the ampule into the bore. The table is movable to index at least one of the ampule holders between the first and second stations.

[0005] Additional aspects of the disclosure are defined by the claims of this patent.

Brief Description of the Drawings

[0006] It is believed that the disclosure will be more fully understood from the following description taken in conjunction with the accompanying drawings. Some of the figures may have been simplified by the omission of selected elements for the purpose of more clearly showing other elements. Such omissions of elements in some figures are not necessarily indicative of the presence or absence of particular elements in any of the exemplary embodiments, except as may be explicitly delineated in the corresponding written description. None of the drawings is necessarily to scale.

[0007] Fig. 1 is a perspective view of a drug transfer device according to the present disclosure;

[0008] Fig. 2 is a perspective view of the drug transfer device of Fig. 1 taken from the opposite side;

[0009] Fig. 3 is a plan view of the drug transfer device of Fig. 1;

[0010] Fig. 4 is a frontal view of the drug transfer device of Fig. 1;

[0011] Fig. 5 is a side view of the drug transfer device of Fig. 1;

[0012] Fig. 6 is a partial cross- sectional view of the drug transfer device of Fig.

1, illustrating an embodiment of first station including an ampule opener according to the present disclosure in a first position;

[0013] Fig. 7 is a partial cross- sectional view of the ampule opener of Fig. 6, with the opener contacting the ampule in a second position;

[0014] Fig. 8 is a partial cross- sectional view of the ampule opener of Fig. 6, with the top of the ampule passing along an incline into a sharps container; [0015] Fig. 9 is a partial cross- sectional view of the drug transfer device of Fig. 1, illustrating an embodiment of a second station including a fill mechanism for withdrawing drug from an open ampule in a first, spaced position;

[0016] Fig. 10 is a partial cross- sectional view of the fill mechanism of Fig. 9 in a second, proximate position;

[0017] Fig. 11 is a partial cross- sectional view of the fill mechanism of Fig. 9 returning to the first position from the second position; and

[0018] Fig. 12 is a schematic of the internal organization of the drug transfer device of Fig. 1 according to one embodiment.

Detailed Description of Various Embodiments

[0019] Fig. 1 illustrates a drug transfer device 100 according to the present disclosure. The drug transfer device 100 includes a base 102 on which is mounted a moveable table 104. In particular, the table 104 has a plurality of ampule holders 106 arranged thereon in which a plurality of ampules 108 is disposed. Further, the drug transfer device 100 includes a housing 110 in which is disposed a first station 112 (see Figs. 1 and 6-8) and a second station 114 (see Figs. 1 and 9-11). An actuator 116 is provided on the right hand side of the device 100, movement of the actuator 116 causing motion of the ampules 108 in the holders 106 between the first and second stations 112, 114. More particularly, the actuator 116 causes the table 104 to index at least one of the holders 106 between the first and second stations 112, 114.

[0020] Each ampule 108 has a body 120 joined to a top or head 122 by a neck 124 of tapered profile with a reduced diameter relative to the body 120 and the top 122. The body 120 defines a cavity 126 (see Fig. 10) capable of receiving a drug therein. The top 122 is attached to the body 120 (as one piece or integrally as illustrated) to close the cavity 126. At the first station 112, the top 122 is separated from the body 120 to open the ampule 108. At the second station 114, the drug in the cavity 126 is drawn into a syringe 130. The syringe 130 is removably secured to the second station 114, such that the syringe 130 may be detached from the device 100 and subsequently used, for example, to inject the contents of the syringe 130 into the contents of a bag for intravenous administration to a patient.

[0021] Having discussed the drug transfer device in general terms, the specific details of the illustrated embodiment(s) are now discussed. [0022] As mentioned above, the table 104 includes a plurality of ampule holders 106. As illustrated, each ampule holder 106 is configured to receive at least a portion of the body 120 of an ampule 108, leaving the top 122 and the neck 124 exposed. More specifically, each ampule holder 106 comprises a receptacle disposed or formed within a surface 140 of the table 104, the receptacle receiving at least a portion of the ampule body 120.

[0023] As illustrated and best seen in Figs. 1-3, the table 104 is circular, with the plurality of ampule holders 106 disposed about the periphery (see, e.g., Fig. 3). Thus, the table 104 rotates about an axis 142 (see Fig. 3) to index the ampule holders 106 between the first and second stations 112, 114. That is, a given holder 106 moves an angular distance between the first and second stations 112, 114 as the holder 106 indexes between station 112 and station 114.

[0024] It will be recognized that according to alternative embodiments, the table may be linear instead, and the holders may index between the first and second stations 112, 114 with the translation of the table axially along a line of motion. Moreover, while the holders 106 have been illustrated as integral with the table (i.e., formed as one piece), the holders 106 could be individual and separate from each other and from the table, each holder 106 being secured separately to the table to define the complete subassembly. While a particular number of holders 106 has been illustrated in the drawings, other embodiments may have a greater or a lesser number of holders 106. According to the number of holders 106 and the angular distance between the first and second stations 112, 114, the ampule 108 may not index directly from the first station 112 to the second station 114, but may index through a holding pattern between the first and second stations 112, 114.

[0025] As illustrated in Figs. 6-8, first station 112 includes an ampule opener 150. According to the illustrated embodiment, the opener 150 has a first position (Fig. 6) spaced from the ampule holder 106 and the ampule 108 disposed therein. The opener 150 also has a second position (Fig. 7) proximate to the ampule holder 106 and the ampule 108 disposed there. In the second position, the opener 150 contacts or abuts the ampule 108 to separate the top 122 of the ampule 108 from the body 120 to define an open ampule and expose the cavity 126.

[0026] As illustrated, the opener 150 may be in the form of a cam 152. The cam 152 has a curved surface 154 that is rotatable about an axis 156. Because the curved surface 154 is oblong or elongated, as the curved surface 154 rotates between a first position (Fig. 6) and a second position (Fig. 7), the surface 154 is initially spaced from the ampule holder 106 and the ampule 108, and then brought proximate to the ampule holder 106 and in contact with the ampule 108 so as to contact and break off the ampule top 122.

[0027] The device 100 may be provided with a sharps container 160, and the first station 112 may include an incline or ramp 162 (see Fig. 8). The ramp 162 has a first end 164 proximate to the first station 112 and a second end 166 proximate to the sharps container 160 to transfer the ampule top 122 from the first station 112 to the sharps container 160 (Fig. 8).

[0028] Again, it will be recognized that other embodiments of the opener 150 are possible. For example, if the neck 124 of the ampule 120 is not scored, it may be necessary to provide mechanism to score the ampule 120 as well as separate the top 122 from the body 120 to expose the cavity 126. Further, while the illustrated opener 150 has a moveable surface that is initially spaced from the ampule 108 and then brought into contact with the ampule 108, it is also possible to provide a static or fixed surface that has a first position further away from the ampule 108 in a radial direction, for example, and a second position abutting the top 122, such that as the ampule 108 moves with the table 104 past the static surface between the first and second points, the motion of the ampule 108 with the moving table 104 in the direction of the second station 114 relative to the fixed or static surface causes the top 122 of the ampule 108 to separate gradually. For example, the fixed surface may be defined by a wall, edge or rim tangential to the table 104 or a wall, edge or rim that has a slightly larger radius relative to the table 104.

[0029] Returning to Fig. 1, the second station 114 includes a syringe 130. The syringe includes a plunger 170 disposed within a bore 172 between a first end 174 with a tip 176 and a second end 178. The tip 176 may be in the form of a luer tip as illustrated, or may have a needle or cannula embedded in a hub disposed at the first end 174. The syringe 130 may also include a plunger arm 180 that is attached at a first end 182 to the plunger 170 and has a thumb rest 184 disposed at a second end 186 (see, e.g., Fig. 9). The syringe 130 may also include a finger grip or flange 188 (see also Fig. 9). [0030] The syringe 130 is movable between a first position (Figs. 9, 11) wherein the tip 176 is spaced from the ampule holder 106 and ampule 108, and a second position (Fig. 10) wherein the tip 176 is proximate to the ampule holder 106 so that the tip 176 is disposed within the cavity 126 of the open ampule 108 disposed in the ampule holder 106. In certain embodiments, the tip 176 may depend into the cavity 126 to the bottom of the ampule 108. In this second position (Fig. 10), the plunger 170 is moved toward the second end 178 to draw drug from the ampule 108 into the bore 172. In this regard, compare S (Fig. 9) to S ₂ (Fig. 10), wherein S < S ₂ .

[0031] As merely one example, the second station 114 may include a carrier 200 movable between first and second positions so as to move the syringe 130 between first and second positions. The syringe 130 may be attached to the carrier 200 by securing the finger flange 188 in an appropriate syringe holder or clip 202 (see Fig. 1). The carrier 200 may also include a plunger actuator 204 having seat 206 for the thumb rest 184. While the syringe holder 202 is fixed relative to the carrier 200, the plunger actuator 204 is moveable relative to the carrier 200 between first and second positions (compare Figs. 9 and 10) to move the plunger 170 toward the second end 178.

[0032] Stated slightly differently, the syringe holder 202 and the plunger arm actuator 204 may be moveable together (i.e., as a unit) from a first position spaced from the ampule holder 106 and an ampule 108 to a second position proximate to the ampule holder and the ampule 108. In addition, the plunger actuator 204 is moveable relative to the syringe holder 202 between a first position and a second position to draw drug from the ampule 108 into a syringe 130 attached to the syringe holder 202. That is, the plunger actuator 204 is moveable between first and second positions to move the plunger 170 toward the second end 178 of the syringe 130.

[0033] In the alternative, the ampule holder 106 or the ampule 108 may move relative to the syringe holder 202 or the syringe 130. That is, at least one of the ampule holder 106 and the syringe holder 202 is moveable between a first position wherein a tip 176 of a syringe 130 disposed in the syringe holder 202 is spaced from the ampule holder 106 and a second position wherein the tip 176 is proximate to the ampule holder 106 so that the tip 176 is disposed within the cavity 126 of an open ampule 108 disposed in the ampule holder 106. Similarly, at least one of the ampule 108 and the syringe 130 may be movable between a first position wherein the tip 176 is spaced from the ampule holder 106 and a second position wherein the tip 176 is proximate to the ampule holder 106 so that the tip 176 is disposed within the cavity 126 of the open ampule 108 disposed in the ampule holder 106.

[0034] As mentioned previously, movement of the actuator 116 causes movement (indexing) of the ampules 108 between the first and second stations 112, 114. According to the present disclosure, the movement of the actuator 116 also causes the motion of the opener 150 and the syringe holder 200/plunger actuator 204 (fill mechanism). To this end, the device 100 may be provided with a sequencer 210 (see Fig. 12), which sequencer 210 may be in the form of a mechanical, electrical, or electro-mechanical assembly. For instance, the sequencer 210 may be a set of linkages that convert the motion of the actuator 116 about axis 220 (see Fig. 2) into the motion of the cam 152 about the axis 156 and the translation of the carrier 200 relative to the housing 110 and the plunger actuator 204 relative to the carrier 200 (and thus relative to the syringe holder 202). Alternatively, the movement of the actuator 116 may send a signal to an electronic controller (comprising a processor and memory), which controller actuates, for example, one motor to move the cam 152 about the axis 156 and one or more motors to move the carrier 200 relative to the housing 110 and the actuator 204 relative to the carrier 200 (for example, by way of a rack and pinion transmission). According to such an embodiment, the illustrated arm- type actuator 116 may be replaced with a simple push button, for example.

[0035] According to an embodiment wherein the sequencer 210 is a controller, the controller may be programmed to index the table 104 to align one of the ampule holders 106 and the ampule 108 therein with the opener 150 at the first station 112, and to move the opener 150 (cam 152) between the first and second positions to separate the top 122 of the ampule from the body 120 to open access to the cavity 126. The controller may also be programmed to index the table 104 from the first station 112 to the second station 114 (which may not occur in a single motion), to move the syringe 130 (e.g., move the carrier 200 or otherwise move the holder 202/actuator 204 as a unit) from the first position to the second position, and to move the plunger actuator 204 to draw the contents of the ampule 108 into the syringe 130. The controller may further be programmed to move the syringe 130 (again, e.g., move the carrier 200 or otherwise move the holder 202/actuator 204 as a unit) from the second position to the first position, and index the table 104 to move the ampule holder 106 and used ampule 108 past the second station 114. Such programming would mirror the different actions that would be required of a mechanical sequencer, and would incorporate programming of subassemblies or subsystems (such as motors or solenoids) to achieve the steps outlined above.

[0036] It will also be noted that the device 100 includes a moveable (or removable), transparent cover 230 attached to the housing 110. The housing 110 and the cover 230 define a space in which the second station 114 (and particular the syringe 130) is disposed. According to other embodiments, the cover 230 may be solid (non-transparent), or the cover 230 may be omitted altogether.

[0037] Further, the device 100 may include an indicator 240. The indicator 240 may provide numeric information regarding the number of ampules 108 loaded into the table 104 initially, and the number of ampules 108 that still need to be processed once the operation of the device 100 has begun. For example, the user may manually set the indicator 240 by twisting a knob 242 to display the number of holders 106 occupied by ampules 108 in a window 244. As the actuator 116 is manipulated, the indicator 240 may decrease the number displayed in the window 244 by one each time an ampule is processed through the second station 114. The actuator 116 may be reset through the use of knob 242 as well.

[0038] According to alternative embodiments, each holder 106 may have a sensor therein that passes a signal to a controller which automatically counts the number of holders 106 occupied by ampules 108. Further, the indicator may be in the form of an electronic display (e.g., light emitting diode (LED) display) that is set by the controller according to the signals received from the sensors. The controller may then monitor the movement of the table 104, and decrease the count displayed on the indicator by one each time an ampule is processed through the second station 114.

[0039] Although the preceding text sets forth a detailed description of different embodiments of the invention, it should be understood that the legal scope of the invention is defined by the words of the claims set forth at the end of this patent. The detailed description is to be construed as exemplary only and does not describe every possible embodiment of the invention since describing every possible embodiment would be impractical, if not impossible. Numerous alternative embodiments could be implemented, using either current technology or technology developed after the filing date of this patent, which would still fall within the scope of the claims defining the invention.

[0040] It should also be understood that, unless a term is expressly defined in this patent using the sentence "As used herein, the term ' ' is hereby defined to mean..." or a similar sentence, there is no intent to limit the meaning of that term, either expressly or by implication, beyond its plain or ordinary meaning, and such term should not be interpreted to be limited in scope based on any statement made in any section of this patent (other than the language of the claims). To the extent that any term recited in the claims at the end of this patent is referred to in this patent in a manner consistent with a single meaning, that is done for sake of clarity only so as to not confuse the reader, and it is not intended that such claim term be limited, by implication or otherwise, to that single meaning. Finally, unless a claim element is defined by reciting the word "means" and a function without the recital of any structure, it is not intended that the scope of any claim element be interpreted based on the application of 35 U.S.C. § 112, sixth paragraph.