Infusion module for electrosurgical instrument

By designing a medical equipment with transparent fluid storage and multi -color plunges, the existing electronic control fluid pump systems are complex and tedious, and the stability and availability of the fluid infusion are realized.

CN119365145APending Publication Date: 2025-01-24STRYKER CORP
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Patent Information

Application Number
CN202380047009.5
Authority / Receiving Office
CN · China
Patent Type
Applications(China)
Current Assignee / Owner
Priority Date
2022-06-16
Filing Date
2023-06-16
Publication Date
2025-01-24

AI Technical Summary

Technical Problem

Existing electronically controlled fluid pump systems are complex in structure and cumbersome in providing cooling or flushing fluids, making it difficult to improve their robustness and usability.

Method used

Designed a medical device, including the shell of a limited window, a transparent fluid storage, and a mobile plunger. The plunger has the first and second colors of different colors. Electric Surgery Equipment. The device allows users to view the different parts of the plunger through the window to monitor the volume of the fluid.

Benefits of technology

By simplifying the design of the fluid infusion module, the stability and availability of the equipment are improved, making the fluid's infusion more consistent and controllable, and reducing relevant risks.

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Abstract

A medical device for delivering a liquid to an electrosurgical instrument. A plunger is movably disposed within the fluid reservoir and biased. The plunger includes a first colored portion and a second colored portion. When the fluid reservoir contains the first volume, the first colored portion may be seen through the window, and movement of the plunger is configured to expose the second colored portion when the fluid reservoir discharges liquid. A housing of the device may include a first housing including a female buckle and a second housing including a male buckle. The female snap includes a female annular projection, a female snap tab, and a central locking feature. A central locking feature is received within the male annular protrusion to extend from the first housing to an axial position closer to a distal end of the female annular protrusion than the female snap tab.
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Description

[0001] Priority claim

[0002] This application claims priority to and all benefits of U.S. Provisional Patent Application No. 63 / 352,686, filed on June 16, 2022, the entire contents of which are incorporated herein by reference. Background Art

[0003] Radiofrequency (RF) energy is commonly used to ablate diseased tissue to treat pain or conditions. The tissue may be a sensory nerve, an intraosseous nerve, or an intraosseous tumor, among other anatomical structures. Traditionally, electrodes are connected to an electrosurgical console, and the RF energy is conducted from the electrode to the tissue through the electrode-tissue interface to produce a lesion at the treatment site. For intraosseous tumors, the RF energy typically heats the tissue to at least 90°C (194°F) to destroy tumor cells. Due to the higher temperature at the treatment site, infusing a fluid such as saline into the treatment location can limit burning by increasing the conductivity of the electrode-tissue interface. Therefore, continuous and consistent infusion of fluids into the treatment site can improve the efficacy of ablation procedures while reducing the risks associated with such procedures.

[0004] It is known to utilize electronically controlled fluid pump systems to provide cooling or irrigation fluids, which can be complex in structure and cumbersome to operate. One solution is an infusion module disclosed in co-owned International Publication No. 2020 / 198150 published on October 1, 2020, in which a spring is biased within the housing to deliver fluid consistently to the treatment site. There is still opportunity for further improvement of the infusion module to increase its robustness and usability. Summary of the invention

[0005] According to a first aspect of the present disclosure, a medical device for delivering liquid to an electrosurgical instrument includes: a housing defining a window. A fluid reservoir is disposed within the housing and configured to receive liquid. At least a portion of the fluid reservoir is transparent. A plunger is movably disposed within the fluid reservoir and includes a first colored portion and a second colored portion having a different color from the first colored portion. A spring is disposed within the housing and configured to bias the plunger to discharge an infusion fluid to the electrosurgical instrument. The medical device is configured to be viewable by a user such that the first colored portion of the plunger is visible through the window when the fluid reservoir contains a first volume of liquid, and the plunger is configured to expose the second colored portion of the plunger within the window when the fluid reservoir discharges at least a portion of the liquid to contain a second volume of liquid less than the first volume.

[0006] According to a second aspect of the present disclosure, a medical device for delivering a liquid to an electrosurgical instrument includes a housing defining a window. A fluid reservoir is located within the housing and is configured to receive a liquid. At least a portion of the fluid reservoir is transparent. A plunger is movably disposed within the fluid reservoir and includes a first colored portion and a second colored portion having a different color from the first colored portion. A spring is disposed within the housing and is configured to bias the plunger to discharge an infusion fluid to the electrosurgical instrument. The medical device is configured to be viewable by a user so that the second colored portion of the plunger can be seen through the window to indicate that the volume of the infusion fluid is small, wherein less than about 20% of the liquid-filled volume remains within the fluid reservoir.

[0007] According to a third aspect of the present disclosure, a method for monitoring liquid delivery during an ablation procedure using a medical device is provided. A sealing head of a plunger is visible through a window when a fluid reservoir contains a first volume of liquid. The medical device is operated to discharge a portion of the liquid from the fluid reservoir. A first colored portion of the plunger is visible through the window when the fluid reservoir contains a second volume of liquid that is less than the first volume. The medical device can also be operated to discharge another portion of the liquid from the fluid reservoir. A second colored portion of the plunger is visible through the window when the fluid reservoir contains a third volume of liquid that is less than the first volume and the second volume.

[0008] According to a fourth aspect of the present invention, a medical device housing is provided, wherein the first housing includes a female snap and the second housing includes a male snap. The female snap includes a female annular protrusion extending from the first housing to the distal end, a female snap boss extending inwardly from the female annular protrusion, and a central locking feature located in the female annular protrusion. The male snap includes a male annular protrusion extending from the second housing to the distal end and received in the female annular protrusion. The central locking feature is received in the male annular protrusion. The male snap boss extends outwardly from the male annular protrusion and engages the female snap boss. In addition, the central locking feature extends from the first housing to an axial position closer to the distal end of the female annular protrusion than the female snap boss.

[0009] According to a fifth aspect of the present invention, a medical device housing is provided, wherein the first housing includes a female snap and the second housing includes a male snap. The female snap includes a female protrusion extending from the first housing to a first distance and defining a first gap. The female snap protrusion extends into the first gap and is located at a second distance from the first housing. The central locking feature is located in the first gap. The male snap includes a male protrusion extending from the second housing and defining a second gap. The male protrusion is received in the first gap, and the central locking feature is received in the second gap. The male snap protrusion extends away from the second gap. The male snap protrusion extends outward from the male protrusion and engages the female snap protrusion. In addition, the central locking feature extends from the first housing to a third distance greater than the second distance.

[0010] According to a sixth aspect of the present invention, a medical device housing is provided, wherein the first housing includes a female snap and the second housing includes a male snap. The female snap includes a female protrusion extending from the first housing and defining a first gap and at least one groove. The female snap protrusion extends inward from the female protrusion. The central locking feature is arranged in the first gap of the female protrusion. The male snap includes a male protrusion extending from the second housing and defining a second gap and at least one groove. The male protrusion is received in the first gap, and the central locking feature is received in the second gap. The male snap protrusion extends outward from the male protrusion and engages the female snap protrusion. In addition, the grooves are configured to allow at least one of the female protrusion and the male protrusion to deflect so that the female snap is matched with the male snap. The central locking feature extends from the first housing to an axial position, which is configured to limit or prevent the male protrusion from deflecting inward when the first snap is matched with the second snap.

[0011] Any of the above aspects may be combined in whole or in part with any other aspect. Any of the above aspects, whether a partial or complete combination, may be further combined in whole or in part with any of the following embodiments.

[0012] In certain embodiments, the second colored portion is not visible through the port when the fluid reservoir contains a first volume of liquid. The liquid may be visible through the window when the fluid reservoir contains a first volume of liquid. The first colored portion and the second colored portion may span the length of the window, and this indicates that the fluid reservoir is substantially empty.

[0013] In some embodiments, the plunger also includes a sealing head having a color different from the first colored portion and the second colored portion, and the sealing head is visible through the window when the fluid reservoir contains a third volume of liquid greater than the first volume. The third volume can indicate that the fluid reservoir is substantially full of liquid. The plunger can include a support member coaxially disposed within the spring and engaging an internal support of the housing. The plunger can be formed of a material of the same color as the first colored portion, and wherein the second colored portion is coupled to the plunger. The window can be oblong, and the length of the window can correspond to approximately six milliliters of liquid visible within the fluid reservoir. The fluid reservoir can be free of volume markings.

[0014] In certain embodiments, the device includes a port assembly defining a first inlet, a second inlet, and an outlet, and a valve. The valve can be configured to guide a liquid injected from an external source into a fluid reservoir through the first inlet, and further guide the liquid discharged from the fluid reservoir through the second inlet and the outlet. The port assembly can engage a second internal barrier of the housing to resist movement of the fluid reservoir due to the force of the spring biasing plunger. The outlet can be oriented to be orthogonal to each of the first inlet and the second inlet. The device may also include a collar coupled to the valve and coupled to the fluid reservoir via a Luer connector. The collar may be configured to be adjusted during assembly of the housing to rotatably orient the second inlet so that it is aligned with the orifice.

[0015] In some embodiments, the female snap-fit ​​protrusion includes a distal inclined surface and a proximal inclined surface that directly engages with a complementary proximal inclined surface of the male snap-fit ​​protrusion. In some embodiments, the axial position of the central locking feature is closer to the distal end of the female annular protrusion than the transition between the distal inclined surface and the proximal inclined surface. In some embodiments, the female snap-fit ​​protrusion also includes a transition surface between the distal inclined surface and the proximal inclined surface.

[0016] In some embodiments, at least one of the female annular protrusion and the male annular protrusion defines at least one groove, which is configured to allow at least one of the female annular protrusion and the male annular protrusion to deflect so that the female buckle is matched with the male buckle. Each of the female and male protrusions can have an annular shape, and the female buckle protrusion and / or the male buckle protrusion can be annular. The central locking feature is configured to limit or prevent the male annular protrusion from deflecting inward when the first buckle is matched with the second buckle. The central locking feature can be coaxially arranged in the female annular protrusion. The central locking feature can extend from the first housing in a tapered manner. The at least one groove can be two grooves extending longitudinally from the distal end of each of the female annular protrusion and the male annular protrusion. The two grooves can be arranged opposite to each other in the diameter direction. The parts of the female buckle protrusion and the parts of the male buckle protrusion can be arranged on each side of the two grooves of the corresponding one of the female annular protrusion and the male annular protrusion. BRIEF DESCRIPTION OF THE DRAWINGS

[0017] Figure 1 is a perspective view of an electrosurgical system.

[0018] Figure 2 is a perspective view of the infusion module.

[0019] Figure 3 is an exploded view of the infusion module.

[0020] Figure 4 is an exploded view of the housing of the infusion module including the female and male snaps.

[0021] Figure 5A yes Figure 4 A cross-sectional view of a female snap and a male snap in a mating configuration.

[0022] Figure 5B yes Figure 4 A cross-sectional view of the female and male snaps in a non-mated configuration.

[0023] Fig. 6A is a cross-sectional view of an alternative snap fit in a mated configuration.

[0024] Figure 6B is a cross-sectional view of an alternative snap fit in a non-mated configuration.

[0025] Figures 7A-7D is a partial view of the infusion module including the window.

[0026] Figures 8A-8B are various perspective views of the packaging structure of the infusion module. DETAILED DESCRIPTION

[0027] During a radiofrequency (RF) ablation procedure, delivering an electrically conductive fluid to a treatment site generally helps to improve the efficacy of the ablation while reducing the likelihood of charring tissue at the treatment site. Accordingly, an electrosurgical system including an infusion module is provided. Figure 1 , the electrosurgical system 100 includes an electrosurgical console 110, an electrosurgical instrument 120, and an optional cable accessory 112. The cable accessory 112 is configured to be detachably coupled to the electrosurgical console 110, and the electrosurgical instrument 120 is configured to be detachably coupled to the electrosurgical console 110 and / or the cable accessory 112. The electrosurgical instrument 120 can be a bipolar electrode, for example, a self-grounding bipolar electrode, in which a proximal electrode 122 and a distal electrode 124 provide a current path through the tissue to be ablated. In short, the electrosurgical instrument 120 can be an ablation probe. The ablation probe can include a thermocouple to provide a temperature measurement of the tissue near the electrodes 122, 124. Additional thermocouples can be used to monitor soft tissue at points of interest, such as the spinal canal, to inform the user whether ablation heat is transferred to an undesirable location. In addition, the electrosurgical system 100 includes an infusion module 200. The infusion module 200 can guide a fluid (e.g., a liquid) through the electrosurgical instrument 120 and discharge it near the proximal and distal electrodes 122, 124. A suitable embodiment of the electrosurgical instrument 120 is disclosed in the aforementioned International Publication No. WO2020 / 198150.

[0028] The electrosurgical system 100 is configured to treat tissue, namely by RF ablation. The electrosurgical console 110 generates controlled radio frequency electrical energy and transmits the energy through the electrosurgical instruments 120A, 120B and the tissue, thereby heating the tissue to a temperature sufficient to destroy tissue cells. Ablation can be performed by a self-grounded bipolar configuration, as described in the co-owned International Publication No. WO2018 / 200254 published on November 1, 2018, the entire contents of which are incorporated herein by reference. In some embodiments, the electrosurgical system 100 is used to ablate nerves for pain management. In other embodiments, the electrosurgical system 100 is used to ablate lesions, particularly intrabone tumors. An exemplary procedure of particular interest is the ablation of tumors within a vertebral body. The introducer assembly is deployed through the pedicles of the vertebral body to facilitate access to the vertebral body, and the electrosurgical console 110 applies temperature-controlled RF energy to the tumor. Nerves associated with or around the tumor can also be ablated to provide pain relief. It should be appreciated that the electrosurgical system 100 of the present disclosure may be used to treat intraosseous tumors in the long bones, skull, mandible, ileum, and the like.

[0029] like Figure 1 As shown, the electrosurgical console 110 includes a display 114 configured to display a graphical user interface (GUI) 116 to enable a user to select operating parameters provided by the software on the electrosurgical console 110, as well as other operations. In one example, the display 114 is a touch screen, so that a digital mark displayed on the display 114 can be selected using a touch position that can be capacitively sensed on the touch screen. The electrosurgical console 110 generally includes a controller, one or more processors, and a memory. Computer executable instructions can be stored on the memory, such as in a database in the memory. These instructions can be accessed by the processor and can be executed by the processor to implement various functions of the electrosurgical console 110. An exemplary electrosurgical console 110 can be disclosed in the above-mentioned International Publication No. WO2018 / 200254.

[0030] refer to Figure 2, showing the infusion module 200 in more detail. The infusion module 200 can be releasably connected to the electrosurgical instrument 120A via a fluid connector 202 (e.g., a Luer lock connector). When connected to the electrosurgical instrument 120A, the infusion module 200 is configured to be in fluid communication with the electrosurgical instrument 120A. Although the infusion module 200 is shown as having a single fluid connector 202, it is also envisioned that the fluid connector 202 is connected to a shunt line to supply fluid to multiple electrosurgical instruments 120A. Regardless of how many instruments 120A are used, the infusion module 200 includes the fluid connector 202 and a flexible infusion line 204, a blocking clamp 206, a filter and vent assembly 208, and a flow restrictor 210. The infusion module 200 also includes a housing 270, which is configured to accommodate other elements of the infusion module 200. The housing is generally comprised of a first shell 272 and a second shell 274 , wherein at least one of the first shell 272 and the second shell 274 defines a window 280 through which a user may determine the amount of fluid remaining in the infusion module 200 .

[0031] The infusion module 200 supplies fluid to the electrosurgical instrument 120A through a flexible infusion line 204. In order to ensure that only fluid is supplied to the instrument 120A, the filter and vent assembly 208 include a gas-permeable, liquid-impermeable vent to allow gas to escape before reaching the fluid coupler 202. In order to control the amount of fluid supplied, a blocking clamp 206 and a flow restrictor 210 are provided on the infusion line 204. The blocking clamp 206 can completely stop the flow of fluid (e.g., in a clamped configuration), and the flow restrictor 210 can control the amount of fluid supplied when the blocking clamp 206 is configured to allow fluid flow (e.g., in an unclamped configuration). The flow restrictor 210 can be configured to limit the fluid flow to a rate between about 0.5 and about 15 milliliters per hour (mL / hour). It should be understood that the flow rate of the fluid output of the infusion module 200 can be modified by using a specific example of the flow restrictor 210 to produce a desired flow rate. Various flow restrictors or flow restriction devices known to those skilled in the art may be used, and for purposes of this disclosure, they may be described as any component that is shaped to restrict the flow of a fluid to a set flow rate. Some non-limiting examples of such flow restrictors are capillaries (e.g., pipes with a predetermined cross-sectional restriction to control the flow rate through them), while other such flow restrictors use single-stage or multi-stage orifice plates to handle high and low flow rates. In many examples, the flow restrictor 210 limits the fluid output to a rate of about 0.5 to about 15 mL / hour or about 1 to about 12 mL / hour.

[0032] refer to Figure 3, an infusion module 200 is shown in exploded view. To couple the infusion module 200 to the infusion line 204, the infusion module 200 includes a port assembly 220 and a fluid reservoir 230 coupled to the infusion line 204. The port assembly 220 includes a port coupler 222, a fill port 224, a port body 225, and a collar assembly 226. Generally speaking, the port coupler 222 defines an outlet through which fluid can flow out of the port assembly 220 from the fluid reservoir 230, while the fill port 224 and the collar assembly 226 each include an inlet through which fluid can flow into the port assembly 220. More specifically, fluid can be introduced through the inlet defined by the fill port 224 to fill the fluid reservoir 230. During use, the same fluid from the fluid reservoir 230 can flow through the inlet defined by the collar assembly 226, so that the fluid leaves the port assembly 220 through the outlet defined by the port coupler 222 and enters the infusion line 204. The port assembly 220 is partially housed within the housing 270 of the infusion module 200 and is located distal to the fluid reservoir 230. Figure 2 As best shown, the port coupler 222 extends through the housing 270 of the infusion module 200 and connects or releasably connects to the flexible infusion line 204. Figure 2 As shown, the fill port 224 extends through the second housing 274 of the housing 270 of the infusion module 200. Advantageously, the port assembly 220 allows the infusion module 200 to be loaded through the inlet defined by the fill port 224 when the infusion module 200 is coupled to the electrosurgical instrument 120A. In addition, if the fluid is exhausted, the infusion module 200 can be reloaded during use. Nevertheless, the port assembly 220 also allows the infusion module 200 to be loaded when the infusion module 200 is not coupled to the instrument 120A.

[0033] Infusion module 200 is configured to be releasably connected to a filling source, such as a syringe filled with a fluid such as saline. Some non-limiting examples of suitable filling sources are 5, 6, 7, 8, 9 or 10 mL syringes with a Luer lock end connection device. The filling source can be filled with a fluid previously extracted from a fluid supply source (such as an intravenous injection (IV) fluid bag, a sterile fluid bottle, etc.). The total volume fluid capacity of the infusion module 200 of this example can be from about 1 to about 20 mL, or more specifically from about 2 to about 10 mL, or even more specifically from about 2 to about 8 mL. In some examples, the capacity of fluid reservoir 230 is 6 mL. In this example, port assembly 220 includes a filling port 224 (such as a Luer lock coupling, a sliding end coupling, an eccentric end coupling, a catheter end coupling, etc.) releasably connected to a corresponding connector on the filling source, and a port coupling 222 that is connected to or releasably connected to a flexible infusion line 204 in some examples. To provide a secure connection between the fluid reservoir 230 and the infusion line 204, the collar assembly 226 may include a positioning and / or length adjustment device. Figure 3 As can be seen, the collar assembly 226 can include at least one adjustment member 228 configured to be coupled to the port assembly 220 and the fluid reservoir 230 (e.g., via a Luer lock fitting) such that the adjustment member 228 completes the fluid connection between the fluid reservoir 230 and the port assembly 220. In the illustrated embodiment, the collar assembly 226 includes two adjustment members 228, each of which can be rotated relative to the remainder of the port assembly 220 to change the length of the collar assembly 226. In addition, the adjustment members 228 allow the port assembly 220 to rotate relative to the fluid reservoir 230 to ensure that the fill port 224 can be removed from the outer surface of the infusion module 200 when assembled.

[0034] The fluid reservoir 230 is configured to hold the fluid within the void defined by the fluid reservoir 230. It should be understood that the fluid used herein refers to a liquid, but may present another suitable phase. As described in more detail below, the fluid reservoir 230 may be made of a transparent plastic (e.g., polypropylene) so that a user can view the fluid reservoir 230 through one of the windows 280 and determine the amount of fluid contained in the void defined by the fluid reservoir 230. In order to provide the pressure required to deliver the fluid from the fluid reservoir 230 to the electrosurgical instrument 120A, the infusion module 200 also includes a plunger 240, which is configured to be pushed into the void of the fluid reservoir 230 by a biasing element 250. The plunger 240 may be at least partially hollow to accommodate the biasing element 250. In the illustrated embodiment, the biasing element 250 is a spring configured to store potential energy when compressed. A support member 260 may be disposed within the biasing element to prevent the biasing element from bending. For example, when the biasing element 250 is a spring, the support member 260 may be disposed within the spring to prevent the spring from bending when compressed. In such an embodiment, the biasing element 250 is at least partially disposed within the plunger 240 and surrounds the support member 260. The first housing 272 of the housing 270 may include a bracket 290 configured to abut the biasing element 250 and the support member 260. The bracket 290 provides support for the biasing element 250 when the biasing element 250 pushes the plunger 240 toward the fluid reservoir 230 and / or into the void of the fluid reservoir 230. Alternatively, the support member 260 may abut the bracket 290, and the biasing element 250 may abut the support member 260. In either case, the bracket 290 provides a fixed surface on which the biasing element 250 can apply force. It is also envisioned that the second housing 274 of the housing may include the bracket 290 instead of the first housing 272 or in addition to the first housing 272.

[0035] The plunger 240 generally includes a sealing head 242, a first colored portion 244, and a second colored portion 246. When the fluid reservoir 230 is made of a transparent plastic, the plunger 240 can be seen through the transparent plastic when the plunger 240 is located within the void defined by the fluid reservoir 230. By extension, the sealing head 242, the first colored portion 244, and the second colored portion 246 can also be visible through the transparent plastic of the fluid reservoir 230, depending on how far the plunger 240 is pushed into the void of the fluid reservoir 230. For example, as described below, a user can view the fluid reservoir 230 through the window 280 of the infusion module 200 to determine the fluid content of the fluid reservoir 230 based on the visibility of at least one of the sealing head 242, the first colored portion 244, and the second colored portion 246 through the window 280. The plunger 240 can be formed of a colored material so that the plunger 240 itself is colored to include at least one of the colored portions 244, 246. Alternatively, a piece of material (e.g., colored tape) can be secured to the exterior of the plunger 240 to define at least one of the colored portions 244, 246. For example, the plunger 240 can be formed from a first colored material (e.g., colored plastic) to define the first colored portion 244, while the second colored portion 246 is created by securing a piece of colored material to the exterior of the plunger 240.

[0036] In order to hold the fluid reservoir 230 in place, the reservoir 230 may include a collar 232 shaped to abut a portion of the housing 270. For example, the first housing 272 may include a reservoir guide 292 shaped to receive the fluid reservoir 230. The reservoir guide 292 may include a support surface 294 shaped to abut the collar 232 of the fluid reservoir 230, so that the support surface 294 resists displacement of the fluid reservoir 230 due to the force applied by the biasing element 250 and the plunger 240. Instead, the collar 232 will be pushed against the support surface 294, and the fluid reservoir 230 will remain in place. In addition, the first housing 272 and / or the second housing 274 may include an internal barrier for resisting the forces to which the port assembly is subjected. For example, the internal barrier may include a port support 296 arranged to support the port assembly 220. The port support 296 is generally shaped to receive the port assembly 220 and may include a wing 298 extending from one of the first and second housings 272, 274 to the other of the first and second housings 272, 274. In the illustrated embodiment, the wing 298 extends from both the first and second housings 272, 274 and is shaped to abut the port body 225. When the biasing element 250 applies a force to the plunger 240, the plunger 240 applies a force to the fluid reservoir 230, and the fluid reservoir 230 applies a force to the port assembly 220. The port support 296 and the wing 298 support are arranged to resist this force on the port assembly 220 and maintain the port assembly 220 in the same position relative to the housing 270.

[0037] As described above, the first shell 272 of the housing includes a bracket 290 to provide a fixed surface against which the biasing element 250 stores the potential energy required to push the plunger 240 into the void of the fluid reservoir 230. In order to ensure that the infusion module 200 provides a consistent volume of fluid through the infusion line 204 over time, the biasing element 250 is configured to store a large amount of potential energy. Thus, when the biasing element 250 is compressed between the bracket 290 and the plunger 240, the bracket 290 and the housing 270 itself are subjected to a considerable force from the biasing element 250. In order to ensure that the first shell 272 is not separated from the second shell 274 due to this force, the first shell 272 can be fixed to the second shell 274 by means of a snap that can resist this force.

[0038] refer to Figure 4, shows the housing 270 of the infusion module 200, wherein the first housing 272 is separated from the second housing 274. The first housing 272 includes a female snap 300, and the second housing 274 includes a male snap 350. The female snap 300 is configured to receive the male snap 350 to fasten the first housing 272 to the second housing 274. As can be seen from the figure, each housing 272, 274 may include more than one pair of snaps 300, 350 (e.g., four pairs of snaps) to provide a stronger fastening relationship between the first housing 272 and the second housing 274. If the first housing 272 includes four female snaps 300 and / or the second housing 274 includes four male snaps 350, each male snap 350 is substantially the same as the other male snaps 350, and each female snap 300 is substantially the same as the other female snaps 300. It is also contemplated that one of the female snaps 300 is different from the remaining female snaps 300, and one of the male snaps 350 is different from the remaining male snaps 350. For example, one pair of snaps 300, 350 may be configured to provide a stronger fastening relationship than the remaining snaps 300, 350.

[0039] The female snap 300 includes a female annular protrusion 310, a female snap boss 320, and a central locking feature 330. The female annular protrusion 310 extends from the first housing 272 to a distal end 312. In the illustrated embodiment, the female annular protrusion 310 defines a slot 314 that is configured to allow the female annular protrusion 310 to deflect and better allow the female snap 300 to receive the male snap 350. More specifically, the female annular protrusion 310 can define a pair of diametrically opposed slots 314, each slot 314 extending longitudinally from the distal end 312 of the female annular protrusion 310, so that the protrusion 310 is split into two "sides". The female annular protrusion 310 also includes a female snap boss 320 extending inwardly from the female annular protrusion 310, so that the female snap 300 can better retain the male snap 350, as described below. The female snap boss 320 may be located anywhere between the first housing 272 and the distal end 312 of the female annular protrusion 310 .

[0040] Similar to the female snap 300, the male snap 350 includes a male annular protrusion 360 and a male snap boss 370. The male annular protrusion 360 extends from the second housing 274 to a distal end 362. In the illustrated embodiment, the male annular protrusion 360 defines a slot 364 that is configured to allow the male annular protrusion 360 to deflect and better allow the male snap 350 to be received by the female snap 300. More specifically, the male annular protrusion 360 may define a pair of diametrically opposed slots 364, each slot 364 extending longitudinally from the distal end 362 of the male annular protrusion 360, so that the protrusion 360 is split into two "sides". The male annular protrusion 360 also includes a male snap boss 370, which extends outwardly from the male annular protrusion 360 and is located at the distal end 362 of the male annular protrusion 360. The male snap tab 370 is configured to engage the female snap tab 320 when the snaps 300 , 350 mate with each other.

[0041] The female buckle 300 also includes a central locking feature 330 coaxially disposed within the female annular protrusion 310. As described in more detail below, the central locking feature 330 is configured to be received by the male annular protrusion 360 when the buckles 300, 350 are mated with each other and resist inward deformation of the male annular protrusion 360. The central locking feature 330 extends from the first housing 272 to an axial position closer to the distal end 312 of the female annular protrusion 310 than the female buckle protrusion 320. In other words, the central locking feature 330 generally terminates at an axial position between the distal end 312 of the female annular protrusion 310 and the buckle protrusion 320. It is also contemplated that the central locking feature 330 is at least as long as the female annular protrusion 310 and terminates at an axial position that is approximately equal to or greater than the distal end 312 of the female annular protrusion 310. Regardless of the relative length of the central locking feature 330, the male annular protrusion 360 is configured to receive the central locking feature 330, so the protrusion 360 must be long enough to accommodate the central locking feature 330 while not hindering the mating ability of the buckles 300, 350. In the illustrated embodiment, the central locking feature 330 includes a tapered distal end 332 to help position the male buckle 350 when it is pushed toward the female buckle 300.

[0042] See also Figure 5A and 5B , Figure 5A The matching configuration of the buckles 300 and 350 is shown in FIG. Figure 5B 300, 350 is shown in the non-matching configuration. As can be seen from the figure, the female annular protrusion 310 includes a female buckle protrusion 320, which is configured to be when the buckles 300, 350 are in Figure 5A370 when in a mating configuration. To this end, the female snap protrusion 320 may include a proximal inclined surface 322, a distal inclined surface 324, and a transition surface 326 extending between the proximal and distal inclined surfaces 322, 324 of the female snap protrusion 320. Similarly, the male snap protrusion 370 may include a proximal inclined surface 372, a distal inclined surface 374, and a transition surface 376 extending between the proximal and distal inclined surfaces 372, 374 of the male snap protrusion 370. In this way, the shape of the snap protrusions 320, 370 is generally trapezoidal. Although the illustrated embodiment shows transition surfaces 326, 376 extending between the respective inclined surfaces 322, 324 and 372, 374, the transition surfaces 326, 376 may not exist at all. Instead, the proximal inclined surfaces 322, 372 can directly meet the corresponding distal inclined surfaces 324, 374, so that the snap protrusions 320, 370 are generally triangular. Regardless of the configuration, the snap protrusions 320, 370 generally extend radially from the annular protrusions 310, 360, so that the snap protrusions 320, 370 are ring-shaped.

[0043] When the female annular protrusion 310 is pushed toward the male annular protrusion 360 and enters a mating configuration with the male annular protrusion 360, the distal inclined surface 374 of the male snap boss 370 abuts against at least one of the distal inclined surface 324 of the female snap boss 320 and / or the inclined distal end 332 of the central locking feature 330. The two inclined surfaces 324, 374 form a V-shaped receiving channel toward the distal end 312 of the female annular protrusion 310. When the male snap 350 is pushed toward the female snap 300, the V-shaped receiving channel helps to position the male annular protrusion 360 into the female annular protrusion 310.

[0044] Once the buckles 300, 350 are in Figure 5A 370. When the male and female annular projections 310 are moved away from each other to return the male and female annular projections 310 to the mating configuration, the proximal inclined surface 322 of the female snap projection 320 will abut the proximal inclined surface 372 of the male snap projection 370. Thereafter, if the snaps 300 and 350 are forced away from each other in an attempt to return the snaps 300 and 350 to the non-mating configuration, the contact between the female snap projection 320 and the male snap projection 370 causes the female annular projection 310 to substantially prevent the male annular projection 360 from being removed from the female annular projection 310. Therefore, in order to remove the male annular projection 360 from the female annular projection 310, at least one of the annular projections 310 and 360 must be deflected outwardly or inwardly, respectively. For example, if the male annular projection 360 is deflected inwardly, the male snap projection 370 may no longer abut the female snap projection 320, and the male annular projection 360 may be removed from the female annular projection 310. Alternatively, if the female annular projection 310 is deflected outwardly, a similar result may occur.

[0045] Considering the above, it is apparent that the fastening strength of the buckles 300, 350 depends on the amount of force required to deflect at least one of the female and / or male annular protrusions 310, 360 outwardly and / or inwardly, respectively. Therefore, the fastening strength of the buckles 300, 350 may be affected by the material from which the buckles 300, 350 are made, the shape of the annular protrusions 310, 360 (e.g., the length of the grooves 314, 364), the shape of the protrusions 320, 370, and / or the locking element that limits the deflection of at least one of the annular protrusions 310, 360. Figure 3-5B In the illustrated embodiment, the locking element is a central locking feature 330 configured to limit inward deflection of the male annular protrusion 360. Therefore, since the male annular protrusion 360 is limited from deflecting inward, the female annular protrusion 310 must deflect outward to allow the buckle 300, 350 to move from the mating configuration to the non-mating configuration.

[0046] In order for the central locking feature 330 to limit the inward deflection of the male annular protrusion 360, the male snap protrusion 370 must be pushed against the central locking feature 330 and the female snap protrusion 320 at the same time. More specifically, when the male snap 350 is forced away from the female snap 300, the central locking feature 330 must resist the inward deflection of the male annular protrusion 360 before the proximal inclined surface 372 of the male snap protrusion 370 moves out of contact with the proximal inclined surface 322 of the female snap protrusion 320. Therefore, the central locking feature 330 generally extends from the first housing 272 to an axial height at least as high as (or higher than) the female snap protrusion 320. In this way, the male snap protrusion 370 contacts the central locking feature 330 before the proximal inclined surface 372 of the male snap protrusion 370 moves out of contact with the proximal inclined surface 322 of the female snap protrusion 320. In addition, the central locking feature 330 must have a sufficient radius so that the male annular protrusion 360 cannot deflect inward to such a point / degree that the proximal inclined surface 372 of the male snap protrusion 370 moves out of contact with the proximal inclined surface 322 of the female snap protrusion 320 before the male annular protrusion 360 contacts the central locking feature 330.

[0047] Another way to illustrate the relationship between the buckles 300, 350 is to use a range of heights relative to the first housing 272, such as Figure 5AAs shown. For example, the first height H1 may represent the length of the female annular protrusion 310 from the first housing, the second height H2 may represent the distance between the first housing 272 and the female buckle protrusion 320, the third height H3 may represent the distance between the first housing 272 and the distal end 332 of the central locking feature 330, and the fourth height H4 may represent the distance between the first housing 272 and the male buckle protrusion 370 when the male buckle 350 is mated with the female buckle 300. In the figure, the second height H2 is aligned with the transition surface 326 of the female buckle protrusion 320, and the fourth height H4 is aligned with the transition surface 376 of the male buckle protrusion 370. Alternatively, if the proximal inclined surface 322 and the distal inclined surface 324 of the female buckle protrusion 320 are combined together without the transition surface 326 therebetween, the second height H2 may be aligned with the transition portion between the proximal inclined surface 322 and the distal inclined surface 324. Similarly, if the proximal inclined surface 372 and the distal inclined surface 374 of the male buckle protrusion 370 are combined without a transition surface 376 therebetween, the fourth height H4 may be aligned with the transition portion between the proximal inclined surface 372 and the distal inclined surface 374. Generally speaking, the first height H1 is the largest, followed by the third height H3, and then the second height H2, and the fourth height H4 is the smallest among the heights H1, H2, H3, and H4. However, the first height H1 may be substantially equal to the third height H3.

[0048] refer to Fig. 6A and 6B , an alternative buckle embodiment is shown, which includes a female buckle 400 and a male buckle 450. These alternative buckles 400, 450 are substantially similar to the buckles 300, 350, however, the central locking feature 330 has been replaced with an outer locking feature 430. As such, most of the elements of the previously discussed buckles 300, 350 are present in the alternative buckles 400, 450, and similar elements are indicated by the last two digits being the same but the first digit being changed from 3 to 4 (e.g., 300 to 400 and 350 to 450). Fig. 6A An alternative buckle 400, 450 mating configuration is shown, and Figure 6B A non-mating configuration of the alternative snaps 400 , 450 is shown.

[0049] Similar to the female buckle 300, the female buckle 400 includes a female annular protrusion 410 and a female buckle protrusion 420. The female annular protrusion 410 extends from the first housing 272 to a distal end 412. Although not shown in the figure, the female annular protrusion 410 defines a groove 414, which is configured to allow the female annular protrusion 410 to deflect and better allow the female buckle 400 to receive the male buckle 450. More specifically, the female annular protrusion 410 can define a pair of grooves 414 arranged opposite in the diametric direction, each groove 414 extending longitudinally from the distal end 412 of the female annular protrusion 410. The female annular protrusion 410 also includes a female buckle protrusion 420 extending inwardly from the female annular protrusion 410, so that the female buckle 400 can better retain the male buckle 450. The female buckle protrusion 420 can be located at any position between the first housing 272 and the distal end 412 of the female annular protrusion 410.

[0050] Similar to the male snap 350, the male snap 450 includes a male annular protrusion 460 and a male snap boss 470. The male annular protrusion 460 extends from the second housing 274 to a distal end 462. Although not shown in the figures, the male annular protrusion 460 defines a slot 464 that is configured to allow the male annular protrusion 460 to deflect and better allow the male snap 450 to be received by the female snap 400. More specifically, the male annular protrusion 460 may define a pair of diametrically opposed slots 464, each slot 464 extending longitudinally from the distal end 462 of the male annular protrusion 460. The male annular protrusion 460 also includes a male snap boss 470 that extends outwardly from the male annular protrusion 460 and is located at the distal end 462 of the male annular protrusion 460. The male snap boss 470 is configured to engage the female snap boss 420 when the snaps 400, 450 are mated with each other.

[0051] As Figure 5A and 5B An alternative to the central locking feature 330 of the buckles 300, 350 shown in FIG. Fig. 6A and 6B The male buckle 450 in the embodiment also includes an outer locking feature 430. As described in more detail below, the outer locking feature 430 is configured to cooperate with the male annular protrusion 460 to receive the female annular protrusion 410 when the buckles 400, 450 are mated with each other, and resist outward deformation of the female annular protrusion 410. The outer locking feature 430 extends from the second housing 274 to an axial position at least substantially equal to the distal end 462 of the male annular protrusion 460. In the illustrated embodiment, the outer locking feature 430 includes a tapered distal end 432 to help position the female buckle 400 when the female buckle 400 is pushed toward the male buckle 450.

[0052] Similar to the previous buckles 300, 350, the female annular protrusion 410 includes a female buckle protrusion 420, which is configured to Fig. 6A424 and 432. The female snap protrusion 420 may be provided with a proximal bevel surface 422, a distal bevel surface 424, and a transition surface 426 extending between the proximal and distal bevel surfaces 422, 424 of the female snap protrusion 420. Similarly, the male snap protrusion 470 may be provided with a proximal bevel surface 472, a distal bevel surface 474, and a transition surface 476 extending between the proximal and distal bevel surfaces 472, 474 of the male snap protrusion 470. When the female annular protrusion 410 is pushed toward the male annular protrusion 460 and into a mating configuration with the male annular protrusion 460, the distal bevel surface 424 of the female snap protrusion 420 abuts against at least one of the distal bevel surface 474 of the male snap protrusion 470 and / or the sloped distal end 432 of the outer locking feature 430. The two inclined surfaces 424, 474 form a V-shaped receiving channel toward the distal end 412 of the male annular protrusion 460. When the male buckle 400 is pushed toward the female buckle 450, the V-shaped receiving channel helps to position the male annular protrusion 460 into the female annular protrusion 410.

[0053] Once the buckles 400, 450 are in Fig. 6A In the mating configuration, the proximal inclined surface 422 of the female snap protrusion 420 will abut the proximal inclined surface 472 of the male snap protrusion 470. Then, if the snaps 400, 450 are forced away from each other in an attempt to return the snaps 400, 450 to the non-mating configuration, the contact between the female snap protrusion 420 and the male snap protrusion 470 causes the female annular protrusion 410 to substantially prevent the male annular protrusion 460 from being removed from the female annular protrusion 310. Therefore, the only way to remove the male annular protrusion 460 from the female annular protrusion 410 is to deflect at least one of the annular protrusions 410, 460 outwardly or inwardly, respectively. For example, if the male annular protrusion 460 is deflected inwardly, the male snap protrusion 470 may no longer abut the female snap protrusion 420, and the male annular protrusion 460 may be removed from the female annular protrusion 410. Alternatively, if the female annular protrusion 410 is deflected outwardly, a similar result will occur.

[0054] In order for the outer locking feature 430 to limit the outward deflection of the female annular protrusion 410, the female snap protrusion 420 must be pushed against both the outer locking feature 430 and the male snap protrusion 470. More specifically, when the male snap 450 is forced away from the female snap 400, the outer locking feature 430 must resist the outward deflection of the female annular protrusion 410 before the proximal inclined surface 472 of the female snap protrusion 420 moves out of contact with the proximal inclined surface 472 of the male snap protrusion 470. Therefore, the outer locking feature 430 generally extends from the second housing 272 to an axial height at least as high as (or higher than) the male snap protrusion 420. In this way, the female snap protrusion 420 contacts the outer locking feature 430 before the proximal inclined surface 422 of the female snap protrusion 420 moves out of contact with the proximal inclined surface 472 of the male snap protrusion 470. In addition, the external locking feature 430 must be close enough to the male annular protrusion 460 so that the female annular protrusion 410 cannot deflect outward to such a point / degree / position that the proximal inclined surface 422 of the female snap protrusion 420 moves out of contact with the proximal inclined surface 472 of the male snap protrusion 470 before the female annular protrusion 410 contacts the external locking feature 430.

[0055] The housing 270 and the buckles 300, 350, 400, 450 can be formed by various molding techniques, such as injection molding. By extension, the housing 270 and the buckles 300, 350, 400, 450 can be formed by plastic materials compatible with the selected molding process. Two types of materials that can be used are thermoplastics and thermosetting plastics. It is also envisioned that the buckles 300, 350, 400, 450 are formed with a material different from the rest of the housing 270, or even the female buckles 300, 400 are formed with a material different from the male buckles 350, 450. For example, since the locking features 330, 430 prevent the male annular protrusions 360 from deflecting inwardly and the female annular protrusions 410 from deflecting outwardly, these protrusions 360, 410 may not need to be formed by plastics that are as strong as the complementary protrusions 310, 460.

[0056] refer to Figures 7A-7D, showing a partial view of the infusion module 200 including the window 280. These views focus on the elements of the infusion module 200 that can be seen through the window 280 when the fluid reservoir 230 is filled with different volumes of fluid - these visible elements are the sealing head 242, the first colored portion 244 and the second colored portion 246. In practice, this allows the user to view the fluid reservoir 230 through the window 280 of the infusion module 200 and determine the fluid content of the fluid reservoir 230 based on the visibility of at least one of the sealing head 242, the first colored portion 244 and the second colored portion 246 through the window 280. In addition, since the fluid reservoir 230 is substantially transparent as described above, the fluid contained therein can also be seen through the window 280. Although the fluid reservoir 230 is substantially transparent, the reservoir 230 can also include incremental hash marks to indicate the amount of fluid remaining. For example, the fluid reservoir 230 can include 6 larger hash marks representing 1 mL increments and 4 smaller hash marks representing 1 / 5 mL increments.

[0057] refer to Fig. 7A , the infusion module 200 displays that the fluid reservoir 230 has been filled to substantially maximum capacity (e.g., 6 mL of fluid has been filled, and the total capacity is 6 mL). In this state, the sealing head 242 can be seen through the window 280, but the first and second colored portions 244, 246 cannot be seen through the window 280. In one example, the infusion module 200 can reach this state after the user fills the fluid reservoir 230 to maximum capacity but before using the infusion module 200 to provide fluid to the treatment site.

[0058] Figure 7B The infusion module 200 is shown with the fluid reservoir 230 filled to a level equal to or greater than one-third of the maximum capacity but less than the maximum capacity (e.g., filled with 2-5.9 mL of fluid for a total capacity of 6 mL). In this state, the sealing head 242 and the first colored portion 244 are both visible through the window 280, while the second colored portion 246 is not visible through the window 280. In one example, the infusion module 200 can reach this state after the infusion module 200 has provided between 0.1 and 3 mL of fluid to the treatment site.

[0059] refer to Figure 7C, the infusion module 200 shows that the fluid reservoir 230 is filled to less than one-third of the maximum capacity (e.g., the total capacity is 6 mL, but it is filled with equal to or less than 2 mL of fluid). In this state, the sealing head 242 and the first and second colored portions 244, 246 are visible through the window 280. In addition, only a small amount of the second colored portion 246 is visible through the window 280. In one example, the infusion module 200 can reach this state after the infusion module 200 provides at least 4 mL but less than 6 mL of fluid to the treatment site.

[0060] at last, Fig.7D The infusion module 200 is shown with the fluid reservoir 230 substantially empty (e.g., having a total capacity of 6 mL and filled with approximately 0 mL of fluid). In this state, both the first and second colored portions 244, 246 are visible through the window 280. When the fluid reservoir 230 is empty, a greater amount of the second colored portion 246 is visible through the window 280 than when the fluid reservoir 230 is filled to less than one-third of its maximum capacity. Fig.7D 280, the sealing head 242 is no longer visible through the window, but it is contemplated that the sealing head 242 may be visible (or invisible) when the fluid reservoir 230 is substantially empty. In one example, the infusion module 200 may reach this state after the infusion module 200 has provided 6 mL of fluid to the treatment site. In addition, as described below, the infusion module 200 may be shipped with the fluid reservoir 230 empty, and the first and second colored portions 244, 246 may be visible through the window 280 before the infusion module 200 is used.

[0061] refer to Fig. 8A and 8B , a packing assembly 500 of an infusion module 200 is shown. The packing assembly 500 is configured to allow the manufacturer to transport the infusion module 200 and other associated elements in a safe and orderly manner. For this reason, the packing assembly 500 generally comprises an attachment surface 510 configured to be detachably coupled to the infusion module 200 and other associated elements of the packing assembly 500, and an information surface 520 that is optionally coupled to the attachment surface 510 and is configured to present information to the user. The packing assembly 500 can be made of flexible paper and / or plastic material and can be made up of single or multiple pieces. In the illustrated embodiment, the packing assembly 500 is a single material piece, and wherein the attachment surface 510 is substantially plane and is connected to the information surface 520 by the bending in the material.

[0062] Specific reference Fig. 8A, information surface 520 is shown as a folded piece of packaging assembly 500 and is formed from the same piece of material as attachment surface 510. Thus, the manufacturer need not separately include a supplemental information leaflet or packet as is typically done when shipping a product with informational material. Additionally, information surface 520 is accessible to the user in a sterile field, in contrast to typical instructions for use that are non-sterile and not readily accessible to the user. Fig. 8A , the information surface 520 is shown as being folded over a portion of the attachment surface 510 such that a portion of the attachment surface 510 is hidden behind the information surface 520. In this way, before removing an element (e.g., an infusion module 200) attached to the attachment surface 510, the user's attention is directed to the information contained on the information surface 520. The information surface 520 generally includes operating instructions for guiding the user in using the infusion module 200 and its associated elements. For example, in the figure, the instructions include: (1) filling the infusion module 200 with fluid through the fill port 224, (2) connecting the infusion module 200 to the electrosurgical instrument 120A through the fluid connector 202, and (3) priming the infusion module 200 by waiting a certain length of time for fluid to begin flowing from the electrosurgical instrument 120A. It is also contemplated that additional / different instructions for use and / or additional / different information may be included on the information surface 520. The information surface 520 may also include instructions / information on the other side of the material so that the user can see more information when the information surface 520 is unfolded relative to the attachment surface 510. As an example, one side of the information surface 520 may contain instructions on how to read the information presented through the window 280 of the infusion module 200, as described above with reference to Figures 7A-7D Other examples are also contemplated.

[0063] Specific reference Figure 8B, the attachment surface 510 is shown in more detail, and the information surface 520 is unfolded so that the attachment surface 510 is no longer hidden behind the information surface 520. As shown, the attachment surface 510 includes features configured to removably couple at least the infusion module 200, the infusion line 204, the fluid coupler 202, and the filling source 530 to the attachment surface 510. These features may include cutouts in the attachment surface 510 to form positioning features 512, fastening features 514, and wrapping features 516 including protrusions 518. The features 512, 514, 516 may be formed by cutting the material of the attachment surface 510 with a sharp object and then folding the material to form the features 512, 514, 516. In the exemplary embodiment shown in the drawings, the infusion module 200 may be removably coupled to the attachment surface 510 via the wrapping features 516. The wrapping feature 516 is formed of material cut from the attachment surface 510 (although still connected to the attachment surface 510 and at least a portion of the cutout portion) and is configured to wrap around the infusion module 200. The wrapping feature 516 includes a protrusion 518 and a receiving cutout 519. When the wrapping feature 516 is wrapped around the infusion module 200, the protrusion 518 is guided into the receiving cutout 519. Once the protrusion 518 is received by the receiving cutout 519, the wrapping feature 516 is securely held on the infusion module 200. Once desired, the wrapping feature 516 can be pulled away from the infusion module 200 to remove the protrusion 518 from the receiving cutout 519, so that the infusion module 200 can be removed from the attachment surface 510. The infusion line 204 is detachably coupled to the attachment surface 510 by the locating feature 512, which is formed as a cutout portion of the attachment surface 510. The infusion line 204 is wrapped around the locating feature 512, and the fluid coupler 202 is then removably secured to the attachment surface by the securing feature 514. Similar to the other features 512, 516, the securing feature 514 is also a piece of material cut out of the attachment surface 510, but is still connected to the attachment surface 510 by at least some material. The filling source 530 is also removably secured to the attachment surface 510 by the securing feature 514. It is also contemplated that the elements 200, 202, 204, 530 may be secured to the attachment surface 510 by other means. In addition, the filling source 530 may be an external filling source as described above.

[0064] In order to reduce the strain on the various components of the infusion module 200, in many examples, the infusion module 200 is assembled with minimal compression on the biasing element 250 and minimal or even zero volumetric fluid capacity in the fluid reservoir 230. In this way, the infusion module 200 is not packed with fluid that may leak from the fluid reservoir 230 and / or the biasing element 250 does not cause unnecessary strain on the bracket 290. After the user removes the infusion module 200 from the packaging, the information surface 520 will guide the user on how to use the infusion module 200. For example, to load the infusion module 200, the filling source 530 is connected to the filling port 224 via a Luer lock or similar connection mechanism, and the fluid is injected into the infusion module 200. During the injection, the fluid reservoir 230 is filled with fluid, and the biasing element 250 is further compressed when the volumetric fluid capacity of the fluid reservoir 230 increases to accommodate the injected fluid. As the volumetric fluid capacity of the fluid reservoir 230 increases, the plunger 240 is moved out of the fluid reservoir 230 and moves toward the bracket 290. Additionally, as the volumetric fluid capacity of the fluid reservoir 230 increases, the biasing element 250 is further compressed. In short, loading the infusion module 200 simultaneously fills the fluid reservoir 230 and stores potential energy in the biasing element 250.

[0065] Once the irrigation module 200 is loaded and connected to the electrosurgical instrument 120A via the fluid coupler 202, the fluid reservoir 230 is in fluid communication with the irrigation line 204 and the fluid coupler 202, and the biasing element 250 is configured to release potential energy and actuate the plunger 240 to expel fluid from the fluid reservoir 230 into the irrigation line 204, through the fluid coupler 202, into the electrosurgical instrument 120A, and ultimately to the treatment site.

[0066] Several embodiments have been discussed in the foregoing description. However, the embodiments discussed herein are not intended to be exhaustive or to limit the invention to any particular form. The terms used are intended to have the nature of descriptive terms rather than restrictive terms. In light of the above teachings, many modifications and variations may be made, and the invention may be practiced in a manner different from that specifically described. Certain inventive aspects are disclosed according to the following exemplary clauses.

[0067] Item 1 - A method for monitoring fluid delivery during an ablation procedure using a medical device, the medical device comprising a housing defining a window, a fluid reservoir located within the housing, and a plunger biased within the fluid reservoir to expel fluid, the method comprising: observing a sealing head of the plunger through the window when the fluid reservoir contains a first volume of liquid; operating the medical device to expel a portion of the liquid from the fluid reservoir; observing a first colored portion of the plunger through the window when the fluid reservoir contains a second volume of liquid less than the first volume; further operating the medical device to expel another portion of the liquid from the fluid reservoir; and observing a second colored portion of the plunger through the window when the fluid reservoir contains a third volume of liquid less than the first volume and the second volume.

[0068] Clause 2 - The method of clause 1, further comprising observing the liquid through the window and through the fluid reservoir while the fluid reservoir contains the first volume of liquid.

[0069] Clause 2 - The method of clause 1 or 2, further comprising viewing only the sealing head through the window to indicate that the fluid reservoir is substantially full of liquid.

[0070] Clause 3 - The method of clause 1 or 2, further comprising visualizing each of the sealing head, the first colored portion, and the second colored portion, indicating a small volume of liquid, wherein less than about 35% of the liquid fill volume remains within the fluid reservoir.

[0071] Clause 4 - The method of clause 1 or 2, further comprising: viewing only the first colored portion and the second colored portion indicates that the fluid reservoir is substantially empty.

[0072] Clause 5 - The method of any of clauses 1-4, wherein the fluid reservoir is packaged empty, the method further comprising filling the medical device by directing liquid from a fill source through the fill port and into the fluid reservoir.

[0073] Clause 6 - The method of clause 5, further comprising priming the medical device by operating the device for a predetermined period of time prior to initiating the ablation procedure.

[0074] Clause 7—The method of clause 6, wherein the steps of filling and preparing the medical device are printed on packaging to which the device and the external source are coupled.

Claims

1. A medical device for delivering a fluid to an electrosurgical instrument, the device comprising: a housing defining a window; a fluid reservoir disposed within the housing and configured to receive a liquid, wherein at least a portion of the fluid reservoir is transparent; a plunger movably disposed within the fluid reservoir and comprising a first colored portion and a second colored portion having a different color than the first colored portion; and a spring disposed within the housing and configured to bias the plunger to expel fluid into the electrosurgical instrument, wherein a first colored portion of the plunger is visible through the window when the fluid reservoir contains a first volume of liquid, and wherein movement of the plunger is configured to expose a second colored portion of the plunger within the window when the fluid reservoir discharges at least a portion of the liquid to contain a second volume of liquid less than the first volume.

2. The medical device according to claim 1, wherein: The second colored portion is not visible through the window when the fluid reservoir contains the first volume of liquid.

3. The medical device according to claim 1 or 2, wherein: When the fluid reservoir contains a first volume of liquid, the liquid is visible through the window.

4. The medical device according to any one of claims 1 to 3, wherein: The plunger also includes a sealing head having another color different from the first colored portion and the second colored portion, wherein the sealing head is visible through the window when the fluid reservoir contains a third volume of liquid greater than the first volume, and optionally, wherein the third volume indicates that the fluid reservoir is substantially full of liquid.

5. The medical device according to any one of claims 1 to 4, wherein: The plunger also includes a support member coaxially disposed within the spring and engaging an internal bracket of the housing.

6. A medical device for delivering a fluid to an electrosurgical instrument, the device comprising: a housing defining a window; a fluid reservoir disposed within the housing and configured to receive a liquid, wherein at least a portion of the fluid reservoir is transparent; a plunger movably disposed within the fluid reservoir and comprising a first colored portion and a second colored portion having a different color than the first colored portion; and a spring disposed within the housing and configured to bias the plunger to expel fluid into the electrosurgical instrument, Therein, the second colored portion of the plunger can be seen through the window to indicate that the volume of liquid is low, when less than about 35% of the full volume of liquid remains in the fluid reservoir.

7. The medical device according to claim 6, wherein: When the fluid reservoir is substantially full of liquid, the second colored portion is not visible through the window.

8. The medical device according to claim 6 or 7, wherein: When the fluid reservoir is substantially full of liquid the liquid is visible through the window.

9. The medical device according to any one of claims 1 to 8, wherein: The length of the window spanned by the first colored portion and the second colored portion indicates that the fluid reservoir is substantially empty.

10. The medical device according to any one of claims 1 to 9, wherein: The window is oblong.

11. The medical device according to any one of claims 1 to 16, wherein: The length of the window corresponds to approximately six milliliters of fluid visible within the fluid reservoir.

12. The medical device according to any one of claims 1 to 11, wherein: The fluid reservoir has no volume markings.

13. The medical device according to any one of claims 1 to 12, wherein: The plunger is formed of a material of the same color as the first colored portion, and wherein the second colored portion is coupled to the plunger.

14. The medical device of any one of claims 1-13, further comprising a port assembly defining a first inlet, a second inlet, and an outlet, wherein the valve is configured to direct liquid injected from an external source into the fluid reservoir through the first inlet, and also to direct liquid discharged from the fluid reservoir through the second inlet and through the outlet.

15. The medical device according to claim 14, wherein: The port assembly engages a second interior barrier of the housing to resist movement of the fluid reservoir due to the force of the spring biasing the plunger.

16. The medical device according to claim 14 or 15, wherein: The outlet is oriented orthogonal to each of the first inlet and the second inlet, the device also including a collar coupled to the valve and to the fluid reservoir via a Luer connector, wherein the collar is configured to be adjustable to rotatably orient the second inlet to align with the orifice during assembly of the housing.

17. A medical device housing, comprising: A first housing including a female buckle, wherein the female buckle includes: a female annular protrusion extending from the first housing to the distal end; a female buckle protrusion extending inwardly from the female annular protrusion; a central locking feature disposed within the female annular protrusion; A second housing including a male buckle, wherein the male buckle includes: a male annular projection extending from the second housing to a distal end and received within the female annular projection, wherein the central locking feature is received within the male annular projection; and a male snap tab extending outwardly from the male annular protrusion and engaging the female snap tab, Therein, the central locking feature extends from the first housing to an axial position closer to the distal end of the female annular protrusion than the female snap-fit ​​boss.

18. The medical device housing of claim 17, wherein: The female snap boss includes a distal ramped surface and a proximal ramped surface that directly engages a complementary proximal ramped surface of the male snap boss, and wherein the central locking feature is axially positioned closer to the distal end of the female annular protrusion than a transition between the distal ramped surface and the proximal ramped surface.

19. The medical device housing of claim 18, wherein: The female snap-fit ​​boss further includes a transition surface between the distal ramped surface and the proximal ramped surface, and wherein the central locking feature is axially located closer to the distal end of the female annular protrusion than a transition portion between the distal ramped surface and the transition surface.

20. The medical device housing according to any one of claims 17 to 19, wherein: At least one of the female annular protrusion and the male annular protrusion defines at least one groove, which is configured to allow at least one of the female annular protrusion and the male annular protrusion to deflect so that the female buckle is engaged with the male buckle, and wherein the central locking feature is configured to limit or prevent the male annular protrusion from deflecting inward when the first buckle is engaged with the second buckle.

21. The medical device housing of claim 20, wherein: The at least one groove is two grooves extending longitudinally from the distal end of each of the female annular protrusion and the male annular protrusion.

22. The medical device housing of claim 21, wherein: The two grooves are arranged opposite to each other in the diametrical direction.

23. The medical device housing according to claim 21 or 22, wherein: Portions of the female snap-fit ​​protrusion and portions of the male snap-fit ​​protrusion are respectively disposed on each side of the two grooves of a corresponding one of the female annular protrusion and the male annular protrusion.

24. The medical device housing according to any one of claims 17 to 23, wherein: A central locking feature is coaxially disposed within the female annular protrusion.

25. A medical device housing, comprising: A first housing including a female buckle, wherein the female buckle includes: a female protrusion extending from the first housing to a first distance and defining a first gap; a female buckle protrusion extending into the first gap and located at a second distance from the first housing; a central locking feature disposed within the first void; A second housing including a male buckle, wherein the male buckle includes: a male protrusion extending from the second housing and defining a second void, wherein the male protrusion is received within the first void and the central locking feature is received within the second void; a male snap projection extending away from the second void, the male snap projection extending outwardly from the male protrusion and engaging the female snap projection, Wherein, the central locking feature extends from the first housing to a third distance greater than the second distance.

26. The medical device housing of claim 25, wherein: The first distance is greater than the third distance.

27. The medical device housing according to claim 25 or 26, wherein: The male buckle protrusion is located at a fourth distance from the first housing, and the fourth distance is smaller than the third distance.

28. The medical device housing according to any one of claims 25-27, wherein: The female snap tab includes a distal ramped surface and a proximal ramped surface that directly engages a complementary proximal ramped surface of the male snap tab, and wherein the second distance is defined by a transition between the distal ramped surface and the proximal ramped surface.

29. The medical device housing of claim 28, wherein: The female snap tab also includes a transition surface between the distal angled surface and the proximal angled surface, and wherein the second distance is defined by a transition portion between the distal angled surface and the transition surface.

30. The medical device housing according to any one of claims 25 to 29, wherein: At least one of the female protrusion and the male protrusion defines at least one slot configured to allow at least one of the female protrusion and the male protrusion to deflect to enable the female buckle to mate with the male buckle, and wherein the central locking feature is configured to limit or prevent the male protrusion from deflecting inwardly when the first buckle mates with the second buckle.

31. A medical device housing, comprising: A first housing including a female buckle, wherein the female buckle includes: a female protrusion extending from the first housing and defining a first void and at least one slot; a female buckle protrusion extending inwardly from the female protrusion; a central locking feature disposed within the first void of the female protrusion; A second housing including a male buckle, wherein the male buckle includes: a male protrusion extending from the second housing and defining a second void and at least one slot, wherein the male protrusion is received within the first void and the central locking feature is received within the second void; and A male snap tab extending outwardly from the male protrusion and engaging the female snap tab, wherein the slot is configured to allow at least one of the female protrusion and the male protrusion to deflect to enable the female snap to engage with the male snap, and wherein the central locking feature extends from the first housing to an axial position configured to limit or prevent inward deflection of the male protrusion when the first snap engages with the second snap.

32. The medical device housing of claim 31, wherein: The at least one groove is two grooves extending longitudinally from the distal ends of the female protrusion and the male protrusion.

33. The medical device housing of claim 32, wherein: The two grooves are arranged opposite to each other in the diametrical direction.

34. The medical device housing according to claim 32 or 33, wherein: Portions of the female snap-fit ​​protrusion and portions of the male snap-fit ​​protrusion are respectively disposed on each side of the two grooves of a corresponding one of the female and male protrusions.

35. The medical device housing according to any one of claims 31-34, wherein: A central locking feature is coaxially disposed within the female protrusion.

36. The medical device housing according to any one of claims 31-35, wherein: Each of the female protrusion and the male protrusion has a ring shape.

37. The medical device housing according to any one of claims 31-36, wherein: The female snap-on protrusion and / or the male snap-on protrusion are annular.

38. The medical device housing according to any one of claims 31-37, wherein: The shape of the longitudinal section of the female buckle protrusion and / or the male buckle protrusion is substantially trapezoidal.

39. The medical device housing according to any one of claims 31-38, wherein: The central locking feature tapers away from the first housing.

40. The medical device housing according to any one of claims 17-39, wherein: At least one of the first housing, the second housing, the female buckle, and the male buckle is formed by injection molding.

41. An infusion device for ablation, comprising a medical device according to any one of claims 1-16, the medical device having a medical device housing according to any one of claims 17-40.

Citation Information

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