HK40001863B - Gas canisters and methods for making them - Google Patents

Description

Gas tank and method for manufacturing the same

Data of related applications

This application is a continuation-in-part application of co-pending U.S. application serial No. 15/064,464 filed on 8/3/2016, the entire disclosure of which is expressly incorporated herein by reference.

Technical Field

The present disclosure relates generally to canisters for storing gas, and more particularly, to disposable gas canisters that may be loaded into a medical device or other tool to provide energy during use of the medical device or other tool, and methods for making such canisters.

Background

Various surgical procedures involve the use of medical devices that require an energy source, for example, to provide recharging power to components of the device. For example, intraocular lens inserter devices may be used to deliver a replacement lens in an eye with cataracts. Such IOL inserters may require an external power source to push the lens loaded into the inserter into the patient's eye.

Accordingly, an energy source for IOL inserters and other medical devices or tools would be useful.

Disclosure of Invention

The present disclosure relates to canisters for storing gas, and more particularly, to disposable gas canisters that may be loaded into a medical device or other tool to provide energy during use of the medical device or other tool, and methods for making such canisters.

According to an exemplary embodiment, a canister is provided comprising an elongated, e.g. cylindrical, body and a lid attached to the body to define a cavity filled with a gas, e.g. pressurized and/or at least partially liquefied carbon dioxide. In some embodiments, the body includes a cylindrical region defining a first diameter, a closed first end, and a neck region optionally defining a second diameter less than the first diameter and extending from the cylindrical region to an open second end defining an end wall, the body defining a central axis extending between the first and second ends. The cap may include an annular portion including a closed first end, an open second end, a penetrable or detachable septum formed at the first end, and an annular flange extending radially from the second end of the annular portion, thereby defining a lower surface defining a plane substantially perpendicular to the central axis, and an annular protrusion extending from the lower surface.

In an exemplary embodiment, the first end of the ring portion may be inserted into the open second end of the body of the canister such that the ring portion is spaced from the inner surface of the neck region, and the diaphragm is disposed within the neck region, and the tab may be welded to the end wall of the second end of the body, thereby closing the cavity.

According to another embodiment, a gas actuated tool is provided that includes a housing containing a functional portion and an actuator portion including a chamber; a canister within the chamber, the canister comprising an elongated body, the body comprising a closed first end and an open second end, the canister further comprising a lid welded to the open second end of the elongated body and including a diaphragm defining an internal cavity filled with a pressurized gas, the diaphragm comprising a central region and a relatively thin perimeter at least partially surrounding the central region; and a carriage movable within the housing from a first position, the carriage containing a pin disposed adjacent the septum, the pin including a blunt, beveled tip. An actuator on the actuator portion is coupled to the carrier such that initial activation of the actuator moves the carrier from the first position to the second position such that the beveled tip of the pin applies a localized force to the diaphragm to at least partially separate the diaphragm from the cover to release pressurized gas from the canister into the one or more channels within the housing.

According to another embodiment, a method is provided for manufacturing a can, the can comprising providing an elongate, e.g., cylindrical, body comprising a cylindrical region defining a first diameter, a closed first end, and a neck region defining a second diameter smaller than the first diameter and extending from the cylindrical region to an open second end defining an end wall, the body defining a central axis extending between the first and second ends; and providing a cap comprising an annular portion including a closed first end and an open second end, a penetrable or detachable septum formed at the first end and an annular flange extending radially from the second end of the annular portion thereby defining a lower surface defining a plane substantially perpendicular to the central axis, and an annular protrusion extending from the lower surface. The first end of the ring portion may be inserted into the open second end of the body of the canister such that the ring portion is spaced from the inner surface of the neck region and the diaphragm is disposed within the neck region. A gas (e.g., carbon dioxide, nitrogen, or hydrofluorocarbon) may be introduced into the interior of the body and the tab may be welded to the end wall of the second end of the body, thereby closing the cavity of the canister in which the gas is located.

Alternatively, the cap (including the detachable diaphragm) may include an outer flange that is larger than the open second end of the body. Instead of inserting the cap into the open second end, the flange may be positioned over the open second end and welded to the neck region.

According to yet another embodiment, there is provided a method for preparing a medical device or other tool for surgery, the method comprising providing a device comprising a housing including a chamber having a canister therein, an actuator, and a cradle within the housing in a first position, the canister comprising an elongate body comprising a closed first end and an open second end, the canister further comprising a cap welded to the open second end comprising a diaphragm, thereby defining an internal cavity filled with a pressurized and/or at least partially liquefied gas; and actuating the actuator to move the carrier from the first position to the second position such that the pins on the carrier open the diaphragm, thereby releasing pressurized gas from the canister into the one or more channels within the device. In one embodiment, the septum may be a relatively thin-walled panel that may be penetrated or pierced by a pin to open the lid. In another embodiment, the diaphragm may include a relatively thin perimeter surrounding a relatively thick central portion such that the pin tears at least a portion of the perimeter to otherwise separate, thereby opening the cover.

According to yet another embodiment, there is provided a method for preparing a medical device or other tool for surgery, the method comprising providing a canister comprising an elongate body comprising a closed first end and an open second end, the canister further comprising a cap welded to the open second end comprising a septum, thereby defining an internal cavity filled with a pressurized and/or at least partially liquefied gas; loading a canister into a housing of the device; and actuating the device to cause a pin in the housing to open a diaphragm to release pressurized gas from the canister into one or more channels within the device.

According to another embodiment, there is provided a method for performing a procedure, the method comprising providing a medical device comprising a housing including a chamber having a canister therein, an actuator and a cradle within the housing in a first position, the canister comprising an elongate body, the body comprising a closed first end and an open second end, the canister further comprising a cap welded to the open second end including a diaphragm thereby defining an internal cavity filled with a pressurized and/or at least partially liquefied gas; initially actuating an actuator to move a carriage from a first position to a second position, such that a pin on the carriage opens a diaphragm, thereby releasing pressurized gas from a canister into one or more channels within a medical device to pressurize an incompressible liquid within the housing; and subsequently actuating the actuator to cause the incompressible liquid to flow and deliver one of the medicament and the implant from the medical device into the patient.

According to yet another embodiment, a medical device is provided that includes a housing containing a treatment portion and an actuator portion including a chamber; a canister within the chamber, the canister comprising an elongated body, the body comprising a closed first end and an open second end, the canister further comprising a lid welded to the open second end and including a penetrable or detachable septum, thereby defining an internal cavity filled with a pressurized gas; a carriage movable within the housing from a first position, the carriage including a pin disposed adjacent the diaphragm; and an actuator on the actuator portion coupled to the carriage such that initial activation of the actuator moves the carriage from a first position to a second position causing the pin to open the diaphragm thereby releasing pressurized gas from the canister into the one or more channels within the medical device.

According to yet another embodiment, there is provided a gas powered tool comprising a housing containing a functional portion and an actuator portion comprising a chamber; a canister within the chamber comprising an elongate body comprising a closed first end and an open second end, the canister further comprising a lid welded to the open second end and comprising a penetrable or detachable septum defining an internal cavity filled with a pressurized and/or at least partially liquefied gas; a carriage movable within the housing from a first position, the carriage including a pin disposed adjacent the diaphragm; and an actuator on the actuator portion coupled to the carriage such that initial activation of the actuator moves the carriage from a first position to a second position causing the pin to open the diaphragm thereby releasing pressurized gas from the canister into the one or more channels within the tool.

In an exemplary embodiment, the pin may include a blunt, e.g., beveled, tip that may be sized to open the septum. For example, the beveled tip may apply a more localized force to the septum, which may reduce the overall force required to open the septum. The pins may have a smaller diameter or other cross-section than the diaphragm, for example, allowing gas to flow freely and/or quickly around the pins once the diaphragm is opened.

Other aspects and features, including the need for and use of the present disclosure, will become apparent from consideration of the following description taken in conjunction with the accompanying drawings.

Drawings

It should be understood that the exemplary devices and components thereof shown in the figures are not necessarily drawn to scale, emphasis instead being placed upon illustrating various aspects and features of the embodiments shown. The accompanying drawings illustrate exemplary embodiments, and in which:

FIG. 1A is a cross-sectional view of an exemplary embodiment of an intraocular lens inserter including a disposable gas canister loaded therein.

FIG. 1B is a cross-sectional view of the lens inserter of FIG. 1A with the actuator activated such that the pin pierces the septum of the gas canister to deliver gas therefrom to provide a source of energy for the lens inserter.

Fig. 1C is a detail showing an exemplary embodiment of a pin on an actuator, as shown in fig. 1A and 1B, which may be used to pierce a septum of a gas canister.

Fig. 2 is a cross-sectional view of an exemplary embodiment of a gas canister including a lid welded to a body.

Figure 3 is a cross-sectional detail of the body of the canister of figure 2.

Fig. 4A and 4B are perspective and cross-sectional views of a lid of the can of fig. 2.

Fig. 5A and 5B are perspective and cross-sectional views of another embodiment of a cover.

Fig. 6 is a cross-sectional detail showing the cap of fig. 5A and 5B attached to the neck of a body (such as the body of fig. 3).

Detailed Description

Turning to the drawings, FIGS. 1A and 1B illustrate an exemplary embodiment of an intraocular lens (IOL) inserter 10, which inserter 10 includes a lens delivery portion 20, an actuator 30, and an energy device, such as a canister 40. Intraocular lens inserter 10 can include a body portion 12, body portion 12 including various cavities, recesses, and conduits, for example, for providing communication between canister 40 and lens delivery portion 20, for example, for delivering a lens (not shown) from a lens compartment 22 loaded into or onto lens delivery portion 20, secured to lens delivery portion 20, or otherwise forming part of lens delivery portion 20, for example, as described in U.S. publication No. 2015/0282928, the entire disclosure of which is expressly incorporated herein by reference. Alternatively, the actuator 30 and energy device (e.g., canister 40) may be disposed in other medical devices or tools that may be actuated by releasing pressurized gas from the canister 40 to actuate functional portions of the tool, similar to the methods described elsewhere herein. For example, the actuator 30 and canister 40 may be provided in a shunt inserter for glaucoma surgery, a syringe plunger pusher for liquid injection, or other tool (not shown).

For example, in the exemplary embodiment shown in FIGS. 1A and 1B, IOL inserter 10 may be provided with a canister 40 already disposed within housing 12, i.e., secured within chamber 16. Alternatively, the housing 12 may include a removable cover 14, allowing the canister 40 to be removed and replaced with a new canister if desired. In the embodiment shown, IOL inserter 10 includes a bracket 32 coupled to actuator 30 and carrying a pin 34. When the canister 40 is loaded into the chamber 16 (e.g., during manufacture or prior to use, e.g., at some time prior to use, the canister 40 may be loaded into the housing 12 through the lid 14), the pin 34 may be disposed adjacent a membrane 67 of the canister 40, as shown in fig. 1A. Additionally, IOL inserter 10 may include an O-ring or other seal 36 disposed within chamber 16 adjacent pin 34 that may slidably engage neck 58 of canister 40, e.g., to provide a substantially fluid tight seal between neck 58 and the fluid passageway within IOL inserter 10.

Optionally, the carrier 32 may be slidably disposed within the body portion 12, e.g., such that activation of the actuator 30, as shown in fig. 1B, causes the carrier 32 and pin 34 to move axially, e.g., from a home or distal position, shown proximally in fig. 1A toward the canister 40, to a proximal position, shown in fig. 1B, thereby piercing the septum 67 with the pin 34 and allowing gas to escape from the canister 40. Optionally, a spring or other biasing mechanism 38 may be disposed within the body portion 12, for example, within the chamber 16 adjacent the O-ring 36 and/or around the neck 58 of the canister 40, for biasing the carriage 32 distally toward the distal position. Thus, when the actuator 30 is released, the carriage 32 may automatically return to the distal position and the pin 34 may be withdrawn from the septum 67, as shown in fig. 1A.

For example, FIG. 1C illustrates an exemplary embodiment of a pin 34 that may be carried by the actuator 30 (not shown in FIG. 1C). In this embodiment, the pin 34 includes a blunt, e.g., beveled, tip 34a that may be sized to open the can 40. For example, the beveled tip 34a may apply a more localized force to the septum 167 of the canister 40 (e.g., the septum 167 shown in fig. 5A and 5B and described further elsewhere herein), which may reduce the overall force required to open the septum 167, as described further elsewhere herein. The pin 34 may have a smaller diameter or other cross-section than the diaphragm 167, for example, to allow gas to flow freely and/or quickly around the pin 34 once the diaphragm 167 is opened, as described elsewhere herein.

In some cases, the lens compartment 22 may be a lens cartridge that may be loaded into the lens delivery portion 20. In other cases, lens compartment 22 may be fixedly attached to IOL inserter 10 or form an integral part of IOL inserter 10. IOL inserter 10 may be used to deliver a lens contained within lens compartment 22 into a patient's eye. For example, actuator 30 may be activated to deliver gas from canister 40 through one or more channels of body portion 12, e.g., to pressurize an incompressible fluid to deliver a lens from lens delivery portion 20 during cataract surgery.

Turning to fig. 2, an exemplary embodiment of a canister 40 is shown. In some cases, canister 40 may provide a disposable energy source for a medical device or other tool, such as IOL inserter 10 of FIGS. 1A and 1B. Generally, the canister 40 includes a body 50 and a lid 60 welded to the body 50 to provide an enclosed cavity 42 filled with a fluid (e.g., carbon dioxide). The fluid contained within enclosed cavity 42 may be used to provide the desired potential energy or recharging power to IOL inserter 10, such as to advance a lens from lens delivery portion 20. In alternative embodiments, canister 40 may be filled with other two-phase gases, such as hydrofluorocarbons (e.g., HFC-134a), or single-phase gases, such as nitrogen. As used herein, "pressurized gas" may include a single-phase gas or a two-phase gas, for example, where the gas is at least partially liquefied, and thus may include a gaseous or mixed liquid-gaseous fluid. The volume of cavity 42 may be sufficient to provide energy to the medical device, for example, the recharging power of IOL inserter 10 may be substantially constant and/or controlled when actuator 30 is actuated. In exemplary embodiments, the cavity 42 may have an internal volume of no greater than about 1.8 milliliters (1.8mL), or no greater than about 1 milliliter (1mL), for example, between about 0.5-1.8mL, or between about 0.68-0.75 mL. However, in other embodiments, the internal volume of the cavity 42 may be any desired volume. For example, in some cases, the internal volume of the cavity 42 may be greater than 1.8mL or less than 0.5 mL.

In some embodiments, the body 50 and the cover 60 are formed of stainless steel or other corrosion resistant, desirable or suitable metals or other materials. In some embodiments, one or more of the body 50 and the cover 60 may be formed by one or more of drawing, stamping, machining, casting, molding, and the like. For example, referring to fig. 3, body 50 may be deep drawn from a metal sheet (e.g., a round sheet metal blank of type 305 stainless steel) using one or more dies and punches (not shown), for example, to form a main cylindrical region 52 and a closed base or first end 54 of body 50. Additional processing may be used to form a tapered shoulder region 56 and an open neck region or second end 58 that defines an opening or channel 59 in communication with the interior 51 of the body 50. For example, the shoulder and neck regions 56, 58 may be formed by necking or the like such that the neck region 58 has a substantially uniform diameter that is less than the diameter of the main cylindrical region 52. Alternatively, the neck region 58 may have a similar diameter as the main cylindrical region 52, i.e., the shoulder region 56 is omitted. The area of the body 50 may be substantially radially symmetric about the central axis 44 of the canister 40. Neck region 58 may terminate in a substantially flat end wall 58a that defines a plane substantially perpendicular to axis 44.

In an exemplary embodiment, the body 50 may have a length between the first end 54 and the end wall 58a of the neck region 58 of less than about thirty millimeters (30mm), the outer diameter of the barrel region 52 may be no greater than about ten millimeters (10mm) or no greater than about eight millimeters (8mm), and the outer diameter of the neck region 58 may be no greater than about five millimeters (5mm), or no greater than about four millimeters (4 mm). Neck region 58 may have a substantially uniform diametrical length of between about three to eight millimeters (3-8mm) or between about four to six millimeters (4-6mm), for example, of sufficient length to accommodate the O-ring 36 and carrier 32 sliding along neck region 58 during actuation of IOL inserter 10, as described elsewhere herein. However, the dimensions and shapes provided are merely examples. Accordingly, the various dimensions of the various aspects of the canister 40 may be selected to be any desired dimensions. Further, the shape of the various aspects of the canister may be any desired shape. For example, one or more shapes of one or more aspects of the canister may be radially asymmetric with respect to the central axis 44 of the canister 40.

Similarly, as best seen in fig. 4A and 4B, the cover 60 may be stamped, cast, drawn, and/or otherwise processed from another blank, for example, to define an annular body 62 having a relatively thin closed or first end 64 and an open second end 66 that is also symmetrical about the axis 44. The annular body 62 may have an outer diameter that is smaller than the neck region 58 of the body 50 such that the annular body 62 may be inserted into the opening 59 while providing the required clearance between the annular body 62 and the neck region 58, which facilitates welding the cap 60 protrusion to the body 50, as described elsewhere herein.

The closed end 64 is formed to include a penetrable wall or membrane 67 having a desired diameter and/or thickness for accessing the gas within the cavity 42 once the canister 40 is loaded into the medical device, as described elsewhere herein. In an exemplary embodiment, the diaphragm 67 may have a substantially uniform thickness. For example, in some embodiments, the diaphragm 67 may have a wall thickness of about 0.10-0.25 mm. In other embodiments, the diaphragm 67 may have a wall thickness of no greater than about 0.16 mm. In some embodiments, the septum 67 may have a diameter of between about 0.80-1.20 mm. In other embodiments, the septum 67 may have a diameter of no greater than about 1.0 mm. Although some exemplary dimensions are provided, the scope of the present disclosure is not so limited. In fact, the size and shape of the various aspects of the cover 60 may be any desired shape or size. For example, various sizes and shapes of the lid 60 may be selected based on the application of the lid 60 and/or the jar 40.

The septum 67 may be surrounded by a thicker shoulder 68 to support the septum 67 while allowing the septum 67 to be penetrated during operation of the medical device. For example, in some embodiments, the septum 67 may be penetrated during loading of the canister 40 into a medical device. In other embodiments, the septum 67 may be penetrated some time after the canister 40 is installed in the medical device, for example, during actuation of the medical device. For example, septum 67 may be sized to engage pin 34 of IOL inserter 10 shown in FIG. 1B when canister 40 is loaded into chamber 16 of IOL inserter 10 such that pin 34 readily pierces septum 67 with the maximum penetration force required when actuator 30 is first activated. In some embodiments, the force required to pierce septum 67 may be no greater than about one hundred newtons (100N). In some embodiments, the force required to pierce septum 67 may be no greater than about eighty newtons (80N). However, the force required to pierce the septum 67 may be selected to be any force required. Thus, in some embodiments, the piercing force may be greater than eighty newtons (80N) or greater than one hundred newtons (100N). Upon piercing septum 67, the gas within canister 40 is controllably released during use of IOL inserter 10, as described elsewhere herein.

Alternatively, as shown in fig. 1C, the diaphragm 167 may be a generally circular disk or panel defining a first thickness surrounded by a relatively thin-walled perimeter 167B extending to a shoulder 168, e.g., similar to the diaphragm 167 shown in fig. 5A and 5B described elsewhere herein. The thickness of the perimeter 167b can be selected to at least partially separate the septum 167 from the shoulder 168 when a predetermined piercing force is applied to the septum 167, e.g., no greater than about eighty newtons (80N) or otherwise similar to other embodiments described elsewhere herein.

The second end 66 of the cap 60 includes an annular flange 69 extending radially outward relative to the annular body 62, e.g., substantially perpendicular to the axis 44, thereby defining a lower surface 69a adjacent the annular body 62 and an upper surface 69b opposite the lower surface 69 a. The lower surface 69a may be substantially flat and may include an annular protrusion 70 spaced from the annular body 62 and the outer edge 69c of the annular flange 69. In some embodiments, the protrusion 70 may extend completely around the annular body 62 along the lower surface 69 a. In some embodiments, the protrusion 70 may be continuous. In other embodiments, the protrusion 70 may be discontinuous. In an exemplary embodiment, the projections 70 may taper from the lower surface 69a and terminate at a substantially flat end surface 70a, e.g., having a height of between about 0.2-0.3mm, e.g., about 0.25 mm. Alternatively, as shown in fig. 6, the tab 70 may be omitted and the lower surface 169a of the annular flange 160 may be positioned immediately adjacent the end wall 58a of the neck region 58, as described elsewhere herein.

Once formed, the body 50 and cover 60 may be further processed, such as deburring, breaking sharp edges, etc., to provide the required surface finish to the assembly prior to assembly.

The cover 60 may be substantially permanently attached to the body 50, such as by tab welding. For example, in an exemplary process, the body 50 and the cap 60 may be placed in a filling chamber (not shown), and the filling chamber may be filled with carbon dioxide (or other gas) to a desired pressure to fill the interior 51 of the body 50 with CO 2. The filling chamber may be controlled to a desired temperature such that it is below the saturation temperature of the gas at the filling pressure to condense the gas in the tank 40 to fill the tank 40 with liquefied gas.

Once filled, the cap 60 may be welded to the neck region 58 to close the interior 51 and seal the resulting liquid CO2 within the tank 40. For example, the first end 64 of the annular body 62 may be inserted into the passage 59 in the neck region 58 such that the wall of the annular body 62 is spaced apart from the inner surface of the neck region 58, e.g., until the end surface 70a of the protrusion 70 contacts the end wall 58a of the neck region 58. In this manner, when the cap 60 is welded to the body 50, a resulting weld may be formed between the tab 70 and the end wall 58a of the neck region 58. For example, in an exemplary tab welding process, the body 50 may be coupled to ground (or one electrode) within the fill chamber, and the opposing electrode may be placed against the upper surface 69b of the annular flange 69 on the cap 60, thereby retaining the tab 70 against the end wall 58a of the neck region 58. Once the body 50 and cap 60 are engaged, electrical energy may be applied to the electrodes to form a weld to connect the cap 60 and seal the resulting cavity 42 of the canister 40 with the desired volume of liquid CO2 therein.

In another alternative, instead of the annular body 62, the diaphragm may be formed in the same plane as the annular flange 69, which may have an outer diameter greater than the neck region 58 of the body 50, and an outer lip or flange may be provided (not shown) around the annular flange 69 sized to be received over the neck region 58. In this alternative, instead of inserting the annular body of the cap into the open second end, an outer lip or flange may be positioned over the open second end and welded to the neck region 58, e.g., similar to a bottle cap, except including a separable septum, e.g., any of the embodiments described herein.

When the canister 40 is removed from the filling chamber, the CO2 may return to its gaseous or mixed liquid-gaseous state, thereby providing the required pressure within the cavity 42. In an exemplary embodiment, the mass of CO2 provided within tank 40 after filling may be about six hundred milligrams (600mg) or less, or about five hundred milligrams (500mg) or less and/or have a resulting density of between about 0.50-1.0kg/L or between about 0.50-0.75 kg/L. In other embodiments, the mass and/or density of the fluid (e.g., CO2) within the tank 40 may be selected to be any desired mass or density. Further, it should be appreciated that, if desired, a gas or fluid other than CO2 may be used to fill tank 40, which provides the required pressure and/or recharging power during use.

Turning to fig. 5A and 5B, another embodiment of a cover 160 is shown that may be formed using similar materials and methods as the cover 60, for example, by pulling from a blank to define an annular body 162 having a relatively thin closed or first end 164 and an open second end 166. The annular body 162 may have an outer diameter that is smaller than the neck region 58 of the body 50 such that the annular body 162 may be inserted into the opening 59 while providing the required clearance between the annular body 162 and the neck region 58, which facilitates welding the cap 160 protrusion to the body 50, as described elsewhere herein.

Closed end 164 is formed to include a separable wall or membrane 167 having a desired diameter and/or thickness for accessing the gas within cavity 42 once canister 40 is loaded into a medical device (not shown), as further described elsewhere herein. For example, as shown in fig. 5A and 5B, the diaphragm 167 can include a relatively thick central region 167a at least partially surrounded by a relatively thin peripheral edge 167B. Optionally, the perimeter 167b can completely surround the central region 167a or can extend only partially around the central region 167a, e.g., to provide a preferential hinge, as explained further elsewhere herein. Optionally, the central region 167a may have a rounded shape, e.g., as best seen in fig. 5B or may have a substantially uniform thickness that is substantially thicker than the perimeter 167B. Alternatively, the cover 160 may include a relatively thin-walled diaphragm 167' similar to the cover 60, for example, as shown in fig. 6, or the cover 60 shown in fig. 4A and 4B may include a thin perimeter (not shown) around a thicker central region.

The diaphragm 167 may be surrounded by a relatively thick shoulder 168 to support the diaphragm 167 while allowing the diaphragm 167 to at least partially separate from the shoulder 168 during operation of the medical device. For example, in some embodiments, the membrane 167 may be pressed inward such that the peripheral edge 167b tears or otherwise separates at least partially between the central region 167a and the shoulder during or after loading the canister 40 into a medical device, as described elsewhere herein. For example, as shown in FIG. 1C, a pin 34 may be provided that includes a beveled tip 34a that may exert a localized force against one side of the septum 167, which may enhance at least partial separation of the septum 167 from the shoulder 168. The pin 34 may have a diameter that is smaller than the outer perimeter of the diaphragm 167, for example, to facilitate gas flow freely from the canister 60 around the pin 34 once the diaphragm 167 is at least partially separated from the shoulder 168.

The second end 166 of the cap 160 includes an annular flange 169 that extends radially outward relative to the annular body 162, e.g., substantially perpendicular to the axis 44, thereby defining a lower surface 169a adjacent the annular body 162 and an upper surface 169b opposite the lower surface 169 a. The lower surface 169a may be substantially planar and may include an annular chamfer 170 that transitions from the lower surface 169a of the annular body 162 to the second end 166, e.g., to provide a welding interface for attaching the cover 160 to the body 50, as further described elsewhere herein.

Optionally, the annular body 162 may include one or more radial projections 172, such as a plurality of projections 172 spaced about the circumference of the second end 166. The projections 172 may be sized to contact the inner surface of the neck region 58 proximate the end wall 58a (as shown in fig. 6) to hold the cap 160 stationary and/or centered on the neck region 58 during connection. Additionally or alternatively, the annular body 162 may include one or more grooves or channels 174 in an outer surface of the annular body 162, e.g., a plurality of channels 174 extending between the first end 164 and the second end 166, which may facilitate gas entry into the interior of the canister 40 during filling.

For example, with additional reference to fig. 6, the first end 164 of the cap 160 may be inserted into the channel 59 in the neck region 58 of the body 50 until the flange 169 contacts the end wall 58a of the neck region 58. The tabs 172 (not shown in fig. 6) may hold the cover 160 in place and/or center the cover 160 within the channel 59.

Similar to other methods herein, in an exemplary method, the body 50 and the lid 160 may be placed in a filling chamber (not shown), and the filling chamber may be filled with carbon dioxide (or other gas) to a desired pressure to fill the interior 51 of the body 50 with CO 2. The channels 174 may facilitate the passage of gas through the lid 160 into the interior 51.

Once filled, the lid 160 may be welded to the neck region 58 to close the interior 51 and seal the resulting liquid CO2 within the tank 40. For example, first end 164 of annular body 162 may be inserted into passage 59 in neck region 58 such that the wall of annular body 162 is spaced apart from the inner surface of neck region 58, e.g., until lower surface 169a of flange 169 contacts end wall 58a of neck region 58. Once the body 50 and the lid 160 are engaged, electrical energy may be applied to electrodes (not shown) coupled to the lid 160 and the body 50 to form a weld to connect the lid 160 and seal the resulting cavity 42 of the tank 40 with the desired volume of liquid CO2 therein. When the cap 160 is welded to the body 50, the chamfer 170 may position the resulting weld to the inner periphery of the neck region 58, provide line contact to position the welding current to achieve a consistent weld, may center the cap 160 in the neck region 58, and/or reduce the flare of the outer neck diameter. Optionally, it should be appreciated that other features may be provided on the cap 160 to generate a concentrated current at desired locations of the cap 160 and/or the neck 58 to enhance resistance welding of the cap 160 to the neck 58.

Optionally, after the canister 40 is removed from the filling chamber, the canister 40 may be weighed to confirm that the required amount of gas has been loaded into the canister 40. For example, the mass and pressure of the gas may be determined by comparing the filled mass to the original mass of the body 50 and the cap 60, e.g., to confirm that the mass and pressure are within the required tolerances. For example, it may be desirable to confirm that the pressure within the canister 40 does not exceed a desired maximum density (e.g., 0.75mg/mL), or else the canister 40 may be caused to exceed regulatory standards and/or safe pressures. Likewise, the density and/or mass of the fluid contained within the tank 40 may be any desired density or mass.

During subsequent storage of the canister 40 (e.g., during normal storage periods prior to its loading into and use with a medical device), it may be necessary to confirm that gas has not leaked from the canister 40 during its intended storage period. For example, the canister 40 may be weighed again, for example, at one or more desired intervals to ensure that gas does not leak from the canister 40. Alternatively, other methods may be used to confirm that gas remains within canister 40, such as mass spectrometry, and the like. For example, although the cap 60 is welded to the body 50, gas may still leak from the canister 40, and thus, the canister 40 may be weighed to ensure that a sufficient gas fill remains to ensure a sufficient stroke of gas through the medical device loaded with the canister 40. One method is to weigh the tank 40 after filling; exposing the canister 40 to elevated temperatures to raise the internal pressure to accelerate any leaks that may be present; re-weighing the canister 40 to determine if there is a loss of mass indicating a leak; the leak rate over the shelf life is then inferred to ensure that sufficient gas remains in the canister 40 over the shelf life of the product.

Forming the body 50 and lid 60 from stainless steel may provide corrosion protection to the resulting can 40 for its intended shelf life. Galvanized steel has been used in conventional gas tanks to provide corrosion protection, but may not be suitable for the tank 40. In particular, metal plating, such as zinc, cannot be applied prior to welding the cover 60 to the body 50, as plating can be lost during welding, thereby compromising corrosion protection. If additional plating is applied to the weld, the plating may not be of uniform thickness (both on each can and between different cans). However, it should be appreciated that any suitable and/or desired material, such as metal, plastic, and/or composite material, may be used in place of stainless steel or galvanized steel.

This variation in plating (before or after welding) may not meet the required tolerances to ensure that the quality and/or pressure of the gas within the finished cylinder is within the required range. Stainless steel can be formed to higher tolerances because such plating is not required, thereby ensuring that the properties of the gas are accurately determined after filling and/or during the shelf life of the can.

Subsequently, during manufacture, the canister 40 may be loaded into the medical device to provide an energy source that may be controllably released to provide the needed recharging power to operate the medical device. As explained above, in some embodiments, the energy source may be pressurized CO 2. For example, in some embodiments, IOL inserter 10 may be provided to a user with canister 40 preloaded in chamber 16 of housing 12. Thus, in some cases, the medical device pre-loaded with the canister 40 may be a disposable, single-use device. In some embodiments, the lid 14 may be substantially permanently coupled to the housing 12, such as by using adhesive bonding, sonic welding, an interference fit, one or more connectors, or the like (not shown) to prevent the lid 14 and the canister 40 from being removed by a user.

Alternatively, IOL inserter 10 may be a reusable device, for example, wherein a user may load one or more canisters 40 into housing 12 in succession as desired. For example, in the case of IOL inserter 10 shown in FIGS. 1A and 1B, the user may remove cap 14 and load canister 40 into chamber 16 of main body portion 12 of IOL inserter 10, e.g., such that septum 67 of cap 60 is disposed adjacent pin 34, as shown in FIG. 1A. The lid 14 may then be reattached to the body portion 12 to secure the canister 40 within the housing 12.

At any time, actuator 30 may be activated to guide carriage 32 proximally to the proximal position shown in fig. 1B, causing pin 34 to pass through septum 67, thereby delivering CO2 from canister 40 into one or more channels of IOL inserter 10. Alternatively, in the embodiment shown in fig. 5A and 5B, the perimeter 167B of the diaphragm 167 may tear or otherwise separate at least partially around the central region 167a to deliver CO2 from the canister 140. The released CO2 may be used to pressurize an incompressible liquid, such as silicone oil, within housing 12. Pressurized incompressible liquid may be used to deliver the lens from the lens compartment 22. O-ring seal 36 may slide along neck region 58 and prevent CO2 from leaking into chamber 16 or elsewhere than through the intended passageway in IOL inserter 10. The actuator 30 can then be released, allowing the carriage 32 to return to the distal position shown in fig. 1A.

In embodiments where the lens compartment 22 defines a separate lens cartridge, the lens compartment 22 may be loaded into the lens delivery section 20 (or may already be loaded). However, as explained above, the lens compartment 22 may be fixedly attached to or form an integral part of the body portion 12. Actuator 30 of IOL inserter 10 may be activated at any time to controllably deliver an incompressible fluid (e.g., silicone oil) under constant pressure from CO2 to deliver the lens from lens compartment 22. For example, actuator 30 may be selectively actuated such that the flow rate of the incompressible liquid is proportional to the degree to which actuator 30 is activated, e.g., to advance the lens from lens compartment 22 at a controlled rate, e.g., as described in the applications incorporated by reference herein.

After surgery, the entire IOL inserter 10 may be discarded, or when reusable, the canister 40 may be removed and the medical device may be cleaned and/or otherwise prepared for another procedure, at which time another canister may be loaded into the medical device.

Although a gas canister for an IOL inserter has been described herein, it should be understood that the gas canister may be used with other medical devices. For example, the gas canister may be used within an injector device, such as disclosed in U.S. patent application publication No. 2013/0317478, the entire disclosure of which is expressly incorporated herein by reference. For example, the injector device may include a needle or other cannula that may be used to deliver a viscous or other fluid contained within the device into the eye, wherein the gas canister provides a recharging power that may be controlled by an actuator of the injector device to controllably deliver the fluid into the eye. In another embodiment, a gas canister may be used to deliver a tubular shunt or other implant (not shown) into the eye or other area of the patient's body.

It is fully contemplated that the features, components, and/or steps described with reference to one or more embodiments, methods, or figures may be combined with the features, components, and/or steps described with reference to other embodiments, methods, or figures of the present disclosure.

While the various examples described herein are susceptible to various modifications and alternative forms, specific examples thereof have been shown in the drawings and are herein described in detail. It should be understood that the scope of the disclosure is not to be limited to the particular forms or methods disclosed, but on the contrary, the scope of the disclosure is to cover all modifications, equivalents, and alternatives falling within the scope of the appended claims.

Claims (50)

1. A can, comprising:

an elongated body comprising a cylindrical region defining a first diameter, a closed first end, and a neck region extending from the cylindrical region to an open second end defining an end wall, the elongated body defining a central axis extending between the first end and the second end; and

a cap comprising an annular portion including a closed first end and an open second end opposite the first end, a separable membrane formed at the first end of the cap and an annular flange extending radially from the second end of the annular portion of the cap thereby defining a lower surface defining a plane substantially perpendicular to the central axis, the membrane comprising a central region, a relatively thin periphery at least partially surrounding the central region, and an annular shoulder surrounding the peripheral region and extending inwardly from the annular portion, the peripheral region having a thickness thinner than the thickness of the central region and the annular shoulder for preferentially tearing the periphery to at least partially separate the central region from the annular shoulder,

the first end of the annular portion of the cap is inserted into the open second end of the elongated body such that the annular portion is spaced from an inner surface of the neck region and the diaphragm is disposed within the neck region, the annular flange is secured to the end wall of the second end of the elongated body thereby enclosing a cavity,

the cavity is filled with a pressurized and/or at least partially liquefied gas.

2. A can, comprising:

an elongated body comprising a cylindrical region defining a first diameter, a closed first end, and a neck region extending from the cylindrical region to an open second end defining an end wall, the elongated body defining a central axis extending between the first end and the second end; and

a cap comprising an annular portion including a closed first end and an open second end, a separable membrane formed at the first end of the cap, the membrane comprising a central region, a relatively thin periphery at least partially surrounding the central region, and an annular shoulder surrounding the peripheral region and extending inwardly from the annular portion, the peripheral region having a thickness that is less than the thickness of the central region and the annular shoulder for preferentially tearing the periphery to at least partially separate the central region from the annular shoulder,

said cap being secured to said end wall of said second end of said elongated body, thereby enclosing a cavity,

the cavity is filled with a pressurized and/or at least partially liquefied gas.

3. The can of claim 2, wherein the lid further comprises an annular flange extending radially from the second end of the annular portion of the lid, and wherein the annular flange is secured to the end wall, thereby closing the cavity.

4. A can, comprising:

an elongated body drawn from stainless steel comprising a cylindrical region defining a first diameter, a closed first end, and a neck region extending from the cylindrical region to an open second end defining an end wall, the elongated body defining a central axis extending between the first end and the second end; and

a cap drawn from stainless steel comprising an annular portion including a closed first end and an open second end opposite the first end, a separable diaphragm formed at the first end of the cap and an annular flange extending radially from the second end of the annular portion of the cap thereby defining a lower surface defining a plane substantially perpendicular to the central axis, the diaphragm comprising a dome-shaped central region, a relatively thin periphery at least partially surrounding the central region, and an annular shoulder surrounding the peripheral region and extending inwardly from the annular portion, the peripheral region having a thickness that is less than the thickness of the central region and the annular shoulder for preferentially tearing the periphery to at least partially separate the central region from the annular shoulder,

said first end of said annular portion of said cap being inserted into said open second end of said elongated body such that said annular portion is spaced from an inner surface of said neck region and said diaphragm is disposed within said neck region, said annular flange being secured to said end wall of said second end of said elongated body thereby enclosing a cavity, said dome-shaped central region extending from said first end of said cap into said cavity,

the cavity is filled with a pressurized and/or at least partially liquefied gas.

5. The canister according to any of claims 1-4, wherein the second end of the annular portion of the lid comprises a plurality of radial projections for supporting the lid within the neck region.

6. The canister of any of claims 1-4, wherein the annular portion further comprises one or more channels in an outer surface extending between the first end and the second end to provide a path for gas to enter the interior during filling.

7. The canister of any of claims 1-4, wherein the periphery completely surrounds the central region.

8. The canister of any of claims 1-4, wherein the perimeter extends partially around the central region to define a preferential hinge.

9. A canister according to any one of claims 1-3, wherein the central area has a rounded shape.

10. The canister of any of claims 1-3, wherein the elongated body and the lid are formed of stainless steel.

11. The canister according to any of claims 1-4, wherein the membrane has a thickness between 0.10-0.25 mm.

12. A canister according to any of claims 1-4, wherein the membrane has a diameter of between 0.80-1.20 mm.

13. The canister of any of claims 1-4, wherein the membrane has a diameter of no more than 1.0 mm.

14. The canister of any of claims 1-4, wherein the elongated body has a length between the end walls of the first and second ends of less than thirty millimeters (30 mm).

15. The canister of any one of claims 1-4, wherein the first diameter of the cylindrical region is no greater than ten millimeters (10 mm).

16. The canister of claim 15, wherein the neck region has a second diameter that is less than the first diameter, and wherein the second diameter of the neck region is no greater than five millimeters (5 mm).

17. The canister according to claim 16, wherein the second diameter of the neck region is no greater than four millimeters (4 mm).

18. A method for manufacturing a can, comprising:

providing an elongated body comprising a cylindrical region defining a first diameter, a closed first end, and a neck region extending from the cylindrical region to an open second end defining an end wall, the elongated body defining a central axis extending between the first end and the second end;

providing a cap comprising an annular portion including a closed first end and an open second end, a detachable septum formed at the first end of the cap and an annular flange extending radially from the second end of the annular portion of the cap, thereby defining a lower surface defining a plane substantially perpendicular to the central axis, and an annular protrusion extending from the lower surface, the diaphragm comprising a central region, a relatively thin periphery at least partially surrounding the central region, and an annular shoulder, the annular shoulder surrounding a peripheral region and extending inwardly from the annular portion, the peripheral region having a thickness that is thinner than the thickness of the central region and the annular shoulder for preferential tearing to at least partially separate the central region from the annular shoulder;

inserting the first end of the annular portion of the cap into the open second end of the elongated body such that the annular portion of the cap is spaced apart from an inner surface of the neck region of the elongated body and the septum is disposed within the neck region of the elongated body;

introducing a pressurized gas into the interior of the elongated body; and

welding the tab to the end wall of the second end of the elongated body thereby enclosing a cavity of the canister having the pressurized gas therein.

19. The method of claim 18, wherein the cavity of the canister has a volume of no greater than 1.8 milliliters (1.8 mL).

20. The method of claim 18, wherein introducing a pressurized gas into the interior of the elongated body comprises:

providing a cylindrical body and the cap within a fill chamber;

introducing a gas into the fill chamber;

controlling the filling chamber temperature at a temperature below a saturation temperature of the gas at a filling pressure to condense the gas within the interior of the elongated body.

21. The method of claim 19, wherein introducing a pressurized gas into the interior of the elongated body comprises:

providing a cylindrical body and the cap within a fill chamber;

introducing a gas into the fill chamber;

controlling the filling chamber temperature at a temperature below a saturation temperature of the gas at a filling pressure to condense the gas within the interior of the elongated body.

22. The method of claim 20, wherein welding the tab to the end wall includes:

coupling the elongated body to a first electrode; and

coupling a second electrode to the cover with the tab in contact with the end wall; and

passing an electrical current between the electrodes to weld the projection to the end wall.

23. The method of claim 21, wherein welding the tab to the end wall includes:

coupling the elongated body to a first electrode; and

coupling a second electrode to the cover with the tab in contact with the end wall; and

passing an electrical current between the electrodes to weld the projection to the end wall.

24. The method of any one of claims 18 to 23, wherein the elongate body is formed by:

deep drawing a stainless steel round blank to form the cylindrical region, the first end and an extension opposite the first end of the elongated body; and

necking the extension to define the neck region.

25. The method of any one of claims 18 to 23, wherein the cover is formed by drawing a stainless steel round blank.

26. The method of any one of claims 18 to 23, wherein the lid is formed by drawing a stainless steel round blank to form the first end of the lid and the annular flange.

27. A method according to any one of claims 18 to 23, wherein the membrane has a diameter of between 0.80-1.20 mm.

28. The method of any one of claims 18 to 23, further comprising weighing the canister to determine at least one of a mass and a density of the pressurized gas enclosed within the cavity.

29. The method of claim 28, further comprising weighing the canister to confirm that a minimum amount of pressurized gas remains enclosed within the cavity during a shelf life of the canister.

30. A method for preparing a gas actuated device for surgery, comprising:

providing a canister according to any of claims 1-17;

loading the canister into a housing of the device; and

actuating the device to cause a pin in the housing to open the diaphragm, thereby releasing pressurized gas from the canister into one or more channels within the device.

31. A method for preparing a medical device for surgery, comprising:

providing a canister according to any of claims 1-17;

loading the canister into a housing of a medical device; and

actuating the medical device to cause a pin in the housing to open the septum, the pin including a blunt, beveled tip that applies a localized force to one side of the septum to facilitate at least partial separation of the central region from the shoulder to release pressurized gas from the canister into one or more channels within the medical device.

32. The method of claim 30, wherein the pin has a blunt tip that applies a localized force to the septum to facilitate tearing of the septum perimeter.

33. The method of claim 30 or 31, wherein actuating the device includes moving a carriage carrying the pin within the housing from a first position in which the pin is adjacent the diaphragm to a second position in which the pin tears a perimeter of the diaphragm.

34. The method of claim 30 or 31, wherein actuating the device includes moving a carriage carrying the pin within the housing from a first position in which the pin is adjacent the diaphragm to a second position in which the pin is pressed against a central region of the diaphragm to at least partially separate a periphery of the diaphragm from the cover.

35. The method of claim 33, wherein the bracket is biased to the first position such that the pin is removed from the diaphragm when the device is no longer actuated.

36. The method of claim 34, wherein the bracket is biased to the first position such that the pin is removed from the diaphragm when the device is no longer actuated.

37. A method for preparing a medical device for surgery, comprising:

providing a medical device comprising a housing including a chamber having a canister according to any of claims 1-17, an actuator, and a cradle in a first position within the housing; and

actuating the actuator to move the carriage from the first position to a second position such that a pin on the carriage at least partially tears a perimeter of the septum releasing pressurized gas from the canister into one or more channels within the medical device, the pin including a blunt, beveled tip that applies a localized force to one side of the septum to facilitate at least partial separation of the central region from the shoulder.

38. The method of claim 37, wherein the bracket is biased to the first position such that the pin is removed from the open diaphragm when the actuator is released.

39. The method of claim 37, wherein the carrier includes a seal that slidably engages the neck region when the carrier is moved between the first position and the second position.

40. The method of claim 35, wherein the carrier includes a seal that slidably engages the neck region when the carrier is moved between the first position and the second position.

41. The method of claim 36, wherein the carrier includes a seal that slidably engages the neck region when the carrier is moved between the first position and the second position.

42. A medical device, comprising:

a housing containing a treatment portion and an actuator portion including a chamber;

the canister of any of claims 1-17, the canister being within the chamber;

a carriage movable within the housing from a first position, the carriage including a pin disposed adjacent the septum, the pin including a blunt, beveled tip that applies a localized force to one side of the septum to facilitate at least partial separation of the central region from the shoulder; and

an actuator on the actuator portion coupled to the carriage such that initial activation of the actuator moves the carriage from the first position to a second position causing the pin to at least partially tear the perimeter of the septum, thereby releasing pressurized gas from the canister into one or more channels within the medical device.

43. The medical device of claim 42, wherein the actuator portion further comprises an incompressible fluid pressurized by the pressurized gas when the pin opens the diaphragm to release the pressurized gas from the canister, and wherein the actuator is subsequently actuatable to flow the incompressible fluid and deliver one of an agent and an implant from the treatment portion.

44. The medical device of claim 42 or 43, wherein the bracket is biased to the first position such that the pin is removed from the diaphragm when the actuator is released.

45. The medical device of claim 42, wherein the treatment portion comprises a region including a pharmaceutical agent and a cannula in communication with the region, and wherein the pharmaceutical agent is delivered from the region through the cannula when the actuator is subsequently activated.

46. The medical device of claim 42, wherein the treatment portion includes a plunger adjacent to an intraocular lens, and wherein when the actuator is subsequently activated, the plunger is advanced to deliver the intraocular lens from the treatment portion.

47. The medical device of claim 42, wherein the treatment portion includes a plunger for a liquid injector, and wherein when the actuator is subsequently activated, the plunger is advanced to deliver liquid from the treatment portion.

48. The medical device of claim 42, wherein the treatment portion comprises a plunger for a shunt inserter, and wherein when the actuator is subsequently activated, the plunger is advanced to deliver a shunt from the treatment portion.

49. A gas actuated tool, comprising:

a housing containing a functional portion and an actuator portion including a chamber;

the canister of any of claims 1-17, the canister being within the chamber;

a carriage movable within the housing from a first position, the carriage including a pin disposed adjacent the septum, the pin including a blunt, beveled tip that applies a localized force to one side of the septum to facilitate at least partial separation of the central region from the shoulder; and

an actuator on the actuator portion coupled to the carriage such that initial activation of the actuator moves the carriage from the first position to a second position such that the beveled tip of the pin applies a localized force to the diaphragm to at least partially tear the periphery of the diaphragm from the lid to release pressurized gas from the canister into the one or more channels within the housing.

50. A gas actuated tool, comprising:

a housing containing a functional portion and an actuator portion including a chamber;

the canister of any of claims 1-17, the canister being within the chamber;

a carrier movable within the housing from a first position, the carrier including a pin disposed adjacent the septum, the pin including a blunt tip that applies a localized force to the septum to facilitate tearing of a periphery of the septum and to facilitate at least partial separation of the central region from the shoulder; and

an actuator on the actuator portion coupled to the carriage such that initial activation of the actuator moves the carriage from the first position to a second position such that the beveled tip of the pin applies a localized force to the diaphragm to at least partially tear the periphery of the diaphragm from the lid to release pressurized gas from the canister into the one or more channels within the housing,

the pin has a blunt tip that applies a localized force to the septum to facilitate tearing of the septum perimeter.