Cam drive for managing disposable penetrating member actions with a single motor and motor and control system

This application claims the benefit of U.S. Ser. No. 61/148,767, filed Jan. 30, 2009 which application is fully incorporated herein by reference.

1. Field of the Invention

This invention relates to analyte measurement devices, and more specifically, to systems and methods that securely hold a cam disk without the use of more complex non-back drivable gears.

2. Description of the Related Art

Lancing devices are known in the medical health-care products industry for piercing the skin to produce blood for analysis. Typically, a drop of blood for this type of analysis is obtained by making a small incision in the fingertip, creating a small wound, which generates a small blood droplet on the surface of the skin.

Early methods of lancing included piercing or slicing the skin with a needle or razor. Current methods utilize lancing devices that contain a multitude of spring, cam and mass actuators to drive the lancet. These include cantilever springs, diaphragms, coil springs, as well as gravity plumbs used to drive the lancet. The device may be held against the skin and mechanically triggered to ballistically launch the lancet. Unfortunately, the pain associated with each lancing event using known technology discourages patients from testing. In addition to vibratory stimulation of the skin as the driver impacts the end of a launcher stop, known spring based devices have the possibility of firing lancets that harmonically oscillate against the patient tissue, causing multiple strikes due to recoil. This recoil and multiple strikes of the lancet is one major impediment to patient compliance with a structured glucose monitoring regime.

Success rate generally encompasses the probability of producing a blood sample with one lancing action, which is sufficient in volume to perform the desired analytical test. The blood may appear spontaneously at the surface of the skin, or may be “milked” from the wound. Milking generally involves pressing the side of the digit, or in proximity of the wound to express the blood to the surface. In traditional methods, the blood droplet produced by the lancing action must reach the surface of the skin to be viable for testing.

When using existing methods, blood often flows from the cut blood vessels but is then trapped below the surface of the skin, forming a hematoma. In other instances, a wound is created, but no blood flows from the wound. In either case, the lancing process cannot be combined with the sample acquisition and testing step. Spontaneous blood droplet generation with current mechanical launching system varies between launcher types but on average it is about 50% of lancet strikes, which would be spontaneous. Otherwise milking is required to yield blood. Mechanical launchers are unlikely to provide the means for integrated sample acquisition and testing if one out of every two strikes does not yield a spontaneous blood sample.

Many diabetic patients (insulin dependent) are required to self-test for blood glucose levels five to six times daily. The large number of steps required in traditional methods of glucose testing ranging from lancing, to milking of blood, applying blood to the test strip, and getting the measurements from the test strip discourages many diabetic patients from testing their blood glucose levels as often as recommended. Tight control of plasma glucose through frequent testing is therefore mandatory for disease management. The pain associated with each lancing event further discourages patients from testing. Additionally, the wound channel left on the patient by known systems may also be of a size that discourages those who are active with their hands or who are worried about healing of those wound channels from testing their glucose levels.

Another problem frequently encountered by patients who must use lancing equipment to obtain and analyze blood samples is the amount of manual dexterity and hand-eye coordination required to properly operate the lancing and sample testing equipment due to retinopathies and neuropathies particularly, severe in elderly diabetic patients. For those patients, operating existing lancet and sample testing equipment can be a challenge. Once a blood droplet is created, that droplet must then be guided into a receiving channel of a small test strip or the like. If the sample placement on the strip is unsuccessful, repetition of the entire procedure including re-lancing the skin to obtain a new blood droplet is necessary.

Early methods of using test strips required a relatively substantial volume of blood to obtain an accurate glucose measurement. This large blood requirement made the monitoring experience a painful one for the user since the user may need to lance deeper than comfortable to obtain sufficient blood generation. Alternatively, if insufficient blood is spontaneously generated, the user may need to “milk” the wound to squeeze enough blood to the skin surface. Neither method is desirable as they take additional user effort and may be painful. The discomfort and inconvenience associated with such lancing events may deter a user from testing their blood glucose levels in a rigorous manner sufficient to control their diabetes.

A further impediment to patient compliance is the amount of time that at lower volumes, it becomes even more important that blood or other fluid sample be directed to a measurement device without being wasted or spilled along the way. Known devices do not effectively handle the low sample volumes in an efficient manner. Accordingly, improved sensing devices are desired to increase user compliance and reduce the hurdles associated with analyte measurement.

A further concern is the use of blood glucose monitoring devices in a professional setting. For the professional health care market, single device multiple user is the norm. A sterility barrier between patients is required or a single use professional lancing device is used and then discarded after use. To interface an integrated point of care lancing, sampling and analyte detection device with a multiple user paradigm, each lancet analyte detecting member pair may be isolated from the previous and subsequent user.

There is a need for an analyte measurement device with an improved disk indexing and drive mechanism. There is a further need for an analyte measurement device that employs a cam drive with a motion profile that is variable in real time to vary force, distance, speed, acceleration, noise levels and isolates cam-follower functions. There is a further need for an analyte measurement device with a cam disk motion profile where all movements are provided by a single motor and control system in order to significantly reduce parts, power and complexity.

An object of the present invention is to provide an analyte measurement device that has an improved disk indexing and drive mechanism.

A further object of the present invention is to provide an analyte measurement device that has a cam drive with a motion profile that is variable in real time to vary force, distance, speed, acceleration, noise levels and isolates cam-follower functions.

Another object of the present invention is to provide an analyte measurement device with a cam disk motion profile where all movements are provided by a single motor and control system in order to significantly reduce parts, power and complexity.

These and other objects of the present invention are achieved in an analyte and detecting apparatus with a housing and a disposable positionable in the housing. A penetrating member driver is positioned in the housing. A plurality of penetrating members are positioned in the disposable. Each penetrating member is configured to be coupled to the penetrating member driver. A plurality of sampling chambers are provided with each one including an analyte sensor. A cam disk indexing and drive mechanism is included.

FIG. 1 illustrates one embodiment of an analyte measurement apparatus of the present invention with a cam disk indexing and drive mechanism.

FIG. 2 illustrates another embodiment of an analyte measurement apparatus of the present invention with a cam disk indexing and drive mechanism that includes a battery, plate upper, PCB assembly, cam disk, plate lower, bobbin ear and a lancing disk.

FIG. 3 illustrates an embodiment of an analyte measurement apparatus of the present invention with a cam disk indexing and drive mechanism that has features selected from at least one of, indexing in variable increments, punch follower, indexing in an opposite direction, gripping of the penetrating member as well as un-gripping, park and un-park which is retaining and releasing of the gripper shaft and multiple punching.

FIG. 4 is a flow chart illustrating in one embodiment of operation of a cam disk indexing and drive mechanism of the present invention.

FIG. 5 illustrates one embodiment of a ratchet modeling of the present invention with two cams.

FIG. 6 illustrates one embodiment of a flowchart showing how a cam disk indexing and drive mechanism of the present invention operates.

As shown in FIG. 7 illustrates the operation of the indexer. A ratchet pushes a post on the indexer in one direction. An adjustment of indexing can be achieved to a selected active chamber.

FIG. 8 illustrates one embodiment of the present invention showing timing and angles of a cam disk.

FIG. 9 illustrates a lancing device used in one embodiment of the present invention.

FIG. 10 illustrates a lancing device used in one embodiment of the present invention.

FIG. 11 illustrates analyte detecting members coupled to a cartridge in one embodiment of the present invention.

FIG. 12 illustrates a punch with a widened portion in one embodiment of the present invention.

FIG. 13 illustrates a narrow punch with winged portions in one embodiment of the present invention.

In one embodiment of the present invention, an improved cam disk indexing and drive mechanism is provided. The present invention is particularly suitable with the analyte measurement and detecting systems disclosed in W.O. 2005/120365, incorporated herein by reference. In one embodiment, the cam disk manages all disposable penetrating member actions with a single motor drive, including but not limited to indexing, punching of one or more seals, and gripping of the penetrating member.

In one embodiment, a parking lever is provided that can include an over-molded rod, that can be made of a variety of materials including but not limited to carbon and the like. The over-molded rod is securely, safely and reliably constrained during inactivity of a penetrating member by a simple and single rotating cam feature contained within the single cam disk which is held securely without the use of more complex non-back drivable gears. In one embodiment, a pre-described cam disk motion profile is variable in real time to vary force, distance, speed, acceleration, noise levels and isolate cam-follower functions. All movements can be provided by a single motor and control system significantly reducing parts, power, complexity. A low precision low resolution cam disk can be provided that drives a high precision, high resolution penetrating member disposable and provides significant force, reliability, simplicity and accuracy benefits.

In various embodiments of the present invention, (i) rapid penetrating member cartridge foil detection mapping is achieved with multiple foil detection sensors in parallel or serial use, bi-directional ratcheted indexing movement, (ii) progressive real time foil detection of the in-use chamber ensures a foiled chamber is tested immediately prior to use, increasing safety and reliability, (iii) the cam disk enables seal (foil) detection without additional obligations of punching(s), gripping, or shield insertion which significantly reduces foil and penetrating member loss, (iv) cam disk ratchets and bi-directional drive enable isolate cam-follower functions out of sequence(s) such as independent penetrating member cartridge rotation without progressing sequential or previous cam disk followers, (v) the cam drive significantly simplifies complex and reliable mechanical movements in the handling and preparation of disposable objects, and (vi) an improved hub provides simple positive tactile insertion in any penetrating member cartridge chamber rotational orientation.

In FIG. 1 , the cam drive 10 and cam drive followers are illustrated. It includes the cam drive 10 and the disposable 14 that contains the penetrating members and glucose sensors. A gear box 16 and motor 18 are provided, which are the drive train for the cam disk 20 . The cam includes a plurality of followers. The present invention provides a great deal of precision. Because there is a gear box, the driving system does not require accuracy. Repeatability is achieved because of the cam disk which has multiple operations and features on it. This activates a plurality of functions in the device. This provides a great economy of scale. Everything can be amplified to the disposable without much power. Large forces and speeds can be attained. Very rapid detection of the seals (foils) can be obtained with the present invention.

In this embodiment, the indexing and drive mechanism includes an actuator 21 , disk cam module 22 , lower/upper plate 24 , parking lever 26 , disk cam 28 , punching lever 30 , slide cam 32 , outset mold 34 , bobbin gear 36 , indexing gear 38 and a center guide 50 .

Additional elements of the FIG. 1 embodiment are illustrated in FIG. 2 . As shown in FIG. 2 , the indexing and drive mechanism includes a battery 42 , plate upper 44 , PCB assembly 46 , cam disk 48 , plate lower 50 , bobbin ear 52 and a lancing disk 54 . FIG. 2 shows a rigid chassis for the elements of the cam drive. A rigid structure is created by two plates and four posts.

FIG. 3 illustrates a cam drive with different features including but not limited to, indexing in variable increments, punch follower, indexing in an opposite direction, gripping of the penetrating member as well as un-gripping, park and un-park which is retaining and releasing of the gripper shaft, multiple punching, and the like.

FIG. 4 is a flow chart illustrating how the cam disk operates. By way of illustrating, indexing can proceed in two directions, and nested loops can be achieved. This programs a great number of sub-routines that can be performed.

FIG. 5 shows one embodiment of ratchet modeling of the present invention with two cams 56 and 58 that can be used with the present invention, index cam-1 and an index cam-2. These are then coupled to followers. The followers provide for indexing, punching, parking and gripping. All of these functions can occur at the same time. Additionally, with the present invention, a very repeatable process can be achieved.

In FIG. 6 , illustrates a flowchart of how the cam disk can be operated. In this embodiment, the user starts with a test. The disposable seal is then taken into consideration. Indexing occurs at the punching station and then it is moved over to a gripping position. Right before the penetrating member is launched, it is parked. It is also parked after launch.

As shown in FIG. 7 the operation of the indexer is illustrated. A ratchet pushes a post on the indexer in one direction. An adjustment of indexing can be achieved to a selected active chamber.

FIG. 8 illustrates timing and angles of the cam disk. The cam disk can be moved in both x-y, and y-z directions. This provides for movement in three orthogonal directions. In FIG. 8 , the first column lists follower functions, the second column lists motions, the third column lists the angle that the motion occurs in, the fourth column lists the number of gear teeth and the fifth column lists the time required.

Expected variations or differences in the results are contemplated in accordance with the objects and practices of the present invention. It is intended, therefore, that the invention be defined by the scope of the claims which follow and that such claims be interpreted as broadly as is reasonable.

FIG. 9 illustrates an embodiment of a tissue penetration device, more specifically, a lancing device 80 that includes a controllable driver 179 coupled to a tissue penetration element. The lancing device 80 has a proximal end 81 and a distal end 82 . At the distal end 82 is the tissue penetration element in the form of a penetrating member 83 , which is coupled to an elongate coupler shaft 84 by a drive coupler 85 . The elongate coupler shaft 84 has a proximal end 86 and a distal end 87 . A driver coil pack 88 is disposed about the elongate coupler shaft 84 proximal of the penetrating member 83 . A position sensor 91 is disposed about a proximal portion 92 of the elongate coupler shaft 84 and an electrical conductor 94 electrically couples a processor 93 to the position sensor 91 . The elongate coupler shaft 84 driven by the driver coil pack 88 controlled by the position sensor 91 and processor 93 form the controllable driver, specifically, a controllable electromagnetic driver.

Referring to FIG. 10 , the lancing device 80 can be seen in more detail, in partial longitudinal section. The penetrating member 83 has a proximal end 95 and a distal end 96 with a shaφpened point at the distal end 96 of the penetrating member 83 and a drive head 98 disposed at the proximal end 95 of the penetrating member 83 . A penetrating member shaft 201 is disposed between the drive head 98 and the sharpened point 97 . The penetrating member shaft 201 may be comprised of stainless steel, or any other suitable material or alloy and have a transverse dimension of about 0.1 to about 0.4 mm. The penetrating member shaft may have a length of about 3 mm to about 50 mm, specifically, about 15 mm to about 20 mm. The drive head 98 of the penetrating member 83 is an enlarged portion having a transverse dimension greater than a transverse dimension of the penetrating member shaft 201 distal of the drive head 98 . This configuration allows the drive head 98 to be mechanically captured by the drive coupler 85 . The drive head 98 may have a transverse dimension of about 0.5 to about 2 mm.

A magnetic member 102 is secured to the elongate coupler shaft 84 proximal of the drive coupler 85 on a distal portion 203 of the elongate coupler shaft 84 . The magnetic member 102 is a substantially cylindrical piece of magnetic material having an axial lumen 204 extending the length of the magnetic member 102 . The magnetic member 102 has an outer transverse dimension that allows the magnetic member 102 to slide easily within an axial lumen 105 of a low friction, possibly lubricious, polymer guide tube 105 ′ disposed within the driver coil pack 88 . The magnetic member 102 may have an outer transverse dimension of about 1.0 to about 5.0 mm, specifically, about 2.3 to about 2.5 mm. The magnetic member 102 may have a length of about 3.0 to about 5.0 mm, specifically, about 4.7 to about 4.9 mm. The magnetic member 102 can be made from a variety of magnetic materials including ferrous metals such as ferrous steel, iron, ferrite, or the like. The magnetic member 102 may be secured to the distal portion 203 of the elongate coupler shaft 84 by a variety of methods including adhesive or epoxy bonding, welding, crimping or any other suitable method.

Proximal of the magnetic member 102 , an optical encoder flag is secured to the elongate coupler shaft 84 . The optical encoder flag is configured to move within a slot 107 in the position sensor 91 . The slot 107 of the position sensor 91 is formed between a first body portion and a second body portion of the position sensor 91 . The slot 107 may have separation width of about 1.5 to about 2.0 mm. The optical encoder flag can have a length of about 14 to about 18 mm, a width of about 3 to about 5 mm and a thickness of about 0.04 to about 0.06 mm.

The optical encoder flag interacts with various optical beams generated by LEDs disposed on or in the position sensor body portions and in a predetermined manner. The interaction of the optical beams generated by the LEDs of the position sensor 91 generates a signal that indicates the longitudinal position of the optical flag relative to the position sensor 91 with a substantially high degree of resolution. The resolution of the position sensor 91 may be about 200 to about 400 cycles per inch, specifically, about 350 to about 370 cycles per inch. The position sensor 91 may have a speed response time (position/time resolution) of 0 to about 120,000 Hz, where one dark and light stripe of the flag constitutes one Hertz, or cycle per second. The position of the optical encoder flag relative to the magnetic member 102 , driver coil pack 88 and position sensor 91 is such that the optical encoder 91 can provide precise positional information about the penetrating member 83 over the entire length of the penetrating member's power stroke.

An optical encoder that is suitable for the position sensor 91 is a linear optical incremental encoder, model HEDS 9200, manufactured by Agilent Technologies. The model HEDS 9200 may have a length of about 20 to about 30 mm, a width of about 8 to about 12 mm, and a height of about 9 to about 11 mm. Although the position sensor 91 illustrated is a linear optical incremental encoder, other suitable position sensor embodiments could be used, provided they posses the requisite positional resolution and time response. The HEDS 9200 is a two channel device where the channels are 90 degrees out of phase with each other. This results in a resolution of four times the basic cycle of the flag. These quadrature outputs make it possible for the processor to determine the direction of penetrating member travel. Other suitable position sensors include capacitive encoders, analog reflective sensors, such as the reflective position sensor discussed above, and the like.

A coupler shaft guide 111 is disposed towards the proximal end 81 of the lancing device 80 . The guide 111 has a guide lumen 112 disposed in the guide 111 to slidingly accept the proximal portion 92 of the elongate coupler shaft 84 . The guide 111 keeps the elongate coupler shaft 84 centered horizontally and vertically in the slot 102 of the optical encoder 91 .

members via seals, foils, covers, polymeric, or similar materials used to seal the cavities and provide enclosed areas for the penetrating members to rest in. In the present embodiment, a foil or seal layer 320 is applied to one surface of the cartridge 300 . The seal layer 320 may be made of a variety of materials such as a metallic foil or other seal materials and may be of a tensile strength and other quality that may provide a sealed, sterile environment until the seal layer 320 is penetrate by a suitable or penetrating device providing a preselected or selected amount of force to open the sealed, Referring now to FIG. 11 , a still further embodiment of a cartridge according to the present invention will be described. FIG. 11 shows one embodiment of a cartridge 300 which may be removably inserted into an apparatus for driving penetrating members to pierce skin or tissue. The cartridge 300 has a plurality of penetrating members 302 that may be individually or otherwise selectively actuated so that the penetrating members 302 may extend outward from the cartridge, as indicated by arrow 304 , to penetrate tissue. In the present embodiment, the cartridge 300 may be based on a flat disc with a number of penetrating members such as, but in no way limited to, (25, 50, 75, 100, . . . ) arranged radially on the disc or cartridge 300 . It should be understood that although the cartridge 300 is shown as a disc or a disc-shaped housing, other shapes or configurations of the cartridge may also work without departing from the spirit of the present invention of placing a plurality of penetrating members to be engaged, singly or in some combination, by a penetrating member driver.

Each penetrating member 302 may be contained in a cavity 306 in the cartridge 300 with the penetrating member's sharpened end facing radially outward and may be in the same plane as that of the cartridge. The cavity 306 may be molded, pressed, forged, or otherwise formed in the cartridge. Although not limited in this manner, the ends of the cavities 306 may be divided into individual fingers (such as one for each cavity) on the outer periphery of the disc. The particular shape of each cavity 306 may be designed to suit the size or shape of the penetrating member therein or the amount of space desired for placement of the analyte detecting members 308 . For example and not limitation, the cavity 306 may have a V-shaped cross-section, a U-shaped cross-section, C-shaped cross-section, a multi-level cross section or the other cross-sections. The opening 310 through which a penetrating member 302 may exit to penetrate tissue may also have a variety of shapes, such as but not limited to, a circular opening, a square or rectangular opening, a U-shaped opening, a narrow opening that only allows the penetrating member to pass, an opening with more clearance on the sides, a slit, a configuration as shown in FIG. 11 , or the other shapes.

In this embodiment, after actuation, the penetrating member 302 is returned into the cartridge and may be held within the cartridge 300 in a manner so that it is not able to be used again. By way of example and not limitation, a used penetrating member may be returned into the cartridge and held by the launcher in position until the next lancing event. At the time of the next lancing, the launcher may disengage the used penetrating member with the cartridge 300 turned or indexed to the next clean penetrating member such that the cavity holding the used penetrating member is position so that it is not accessible to the user (i.e. turn away from a penetrating member exit opening). In some embodiments, the tip of a used penetrating member may be driven into a protective stop that hold the penetrating member in place after use. The cartridge 300 is replaceable with a new cartridge 300 once all the penetrating members have been used or at such other time or condition as deemed desirable by the user.

Referring still to the embodiment in 11 , the cartridge 300 may provide sterile environments for penetrating sterile environment. Each cavity 306 may be individually sealed with a layer 320 in a manner such that the opening of one cavity does not interfere with the sterility in an adjacent or other cavity in the cartridge 300 . As seen in the embodiment of FIG. 11 , the seal layer 320 may be a planar material that is adhered to a top surface of the cartridge 300 .

Depending on the orientation of the cartridge 300 in the penetrating member driver apparatus, the seal layer 320 may be on the top surface, side surface, bottom surface, or other positioned surface. For ease of illustration and discussion of the embodiment of FIG. 11 , the layer 320 is placed on a top surface of the cartridge 300 . The cavities 306 holding the penetrating members 302 are sealed on by the foil layer 320 and thus create the sterile environments for the penetrating members. The foil layer 320 may seal a plurality of cavities 306 or only a select number of cavities as desired.

In a still further feature of FIG. 11 , the cartridge 300 may optionally include a plurality of analyte detecting members 308 on a substrate 322 which may be attached to a bottom surface of the cartridge 300 . The substrate may be made of a material such as, but not limited to, a polymer, a foil, or other material suitable for attaching to a cartridge and holding the analyte detecting members 308 . As seen in FIG. 11 , the substrate 322 may hold a plurality of analyte detecting members, such as but not limited to, about 10-50, 50-100, or other combinations of analyte detecting members. This facilitates the assembly and integration of analyte detecting members 308 with cartridge 300 . These analyte detecting members 308 may enable an integrated body fluid sampling system where the penetrating members 302 create a wound tract in a target tissue, which expresses body fluid that flows into the cartridge for analyte detection by at least one of the analyte detecting members 308 . The substrate 322 may contain any number of analyte detecting members 308 suitable for detecting analytes in cartridge having a plurality of cavities 306 . In one embodiment, many analyte detecting members 308 may be printed onto a single substrate 322 which is then adhered to the cartridge to facilitate manufacturing and simplify assembly. The analyte detecting members 308 may be electrochemical in nature. The analyte detecting members 308 may further contain enzymes, dyes, or other detectors which react when exposed to the desired analyte. Additionally, the analyte detecting members 308 may comprise of clear optical windows that allow light to pass into the body fluid for analyte analysis. The number, location, and type of analyte detecting member 308 may be varied as desired, based in part on the design of the cartridge, number of analytes to be measured, the need for analyte detecting member calibration, and the sensitivity of the analyte detecting members. If the cartridge 300 uses an analyte detecting member arrangement where the analyte detecting members are on a substrate attached to the bottom of the cartridge, there may be through holes (as shown in FIG. 11 ), wicking elements, capillary tube or other devices on the cartridge 300 to allow body fluid to flow from the cartridge to the analyte detecting members 308 for analysis. In other configurations, the analyte detecting members 308 may be printed, formed, or otherwise located directly in the cavities housing the penetrating members 302 or areas on the cartridge surface that receive blood after lancing.

The use of the seal layer 320 and substrate or analyte detecting member layer 322 may facilitate the manufacture of these cartridges 10 . For example, a single seal layer 320 may be adhered, attached, or otherwise coupled to the cartridge 300 as indicated by arrows 324 to seal many of the cavities 306 at one time. A sheet 322 of analyte detecting members may also be adhered, attached, or otherwise coupled to the cartridge 300 as indicated by arrows 325 to provide many analyte detecting members on the cartridge at one time. During manufacturing of one embodiment of the present invention, the cartridge 300 may be loaded with penetrating members 302 , sealed with layer 320 and a temporary layer (not shown) on the bottom where substrate 322 would later go, to provide a sealed environment for the penetrating members. This assembly with the temporary bottom layer is then taken to be sterilized. After sterilization, the assembly is taken to a clean room (or it may already be in a clear room or equivalent environment) where the temporary bottom layer is removed and the substrate 322 with analyte detecting members is coupled to the cartridge as shown in FIG. 11 . This process allows for the sterile assembly of the cartridge with the penetrating members 302 using processes and/or temperatures that may degrade the accuracy or functionality of the analyte detecting members on substrate 322 . As a nonlimiting example, the entire cartridge 300 may then be placed in a further sealed container such as a pouch, bag, plastic molded container, etc . . . to facilitate contact, improve ruggedness, and/or allow for easier handling.

In some embodiments, more than one seal layer 320 may be used to seal the cavities 306 . As examples of some embodiments, multiple layers may be placed over each cavity 306 , half or some selected portion of the cavities may be sealed with one layer with the other half or selected portion of the cavities sealed with another sheet or layer, different shaped cavities may use different seal layer, or the like. The seal layer 320 may have different physical properties, such as those covering the penetrating members 302 near the end of the cartridge may have a different color such as red to indicate to the user (if visually inspectable) that the user is down to say 10, 5, or other number of penetrating members before the cartridge should be changed out.

Referring now to FIGS. 12 and 13 , various embodiments of the present invention will now be described in further detail. Improvements have been made to the punch device 400 . The present invention addresses issues with the punch moving the cut foil to the sides of the chamber, so that the foil springs back and you get some end effects where the punch angles the foil into the corner, resulting in tearing rather than a clean cut to open the sterility barrier. The gripper has to bend the foil out of the way, as it runs along the channel and this results in the half Newton range or force required.

FIG. 12 shows an embodiment of the punch 400 with a widened portion 402 that tightly fits against the opening of the cavity. Some embodiments may also have a flash portion 406 that interferes with the punch 400 during punching. The helps push the flaps of the foil to the side and does not interfere with the gripper during travel.

FIG. 13 shows yet another embodiment with a narrow punch 410 with winged portions 412 . The wings 412 are of sufficient size and stiffness to push the foil pieces against the side of the cavities.