HK1117016B - Lancet protective cap - Google Patents

Description

Lancet protection cap

Technical Field

The present invention relates generally to a unique technique for maintaining the sterility and integrity of a lancet tip. The present invention relates more particularly, but not exclusively, to manufacturing techniques for quickly and easily producing a plurality of protective caps. In addition, a plurality of lancet tips with protective caps may be stored in a cartridge or cassette.

Background

Body fluid sampling devices have been developed to extract body fluid from the human body, such as blood or interstitial fluid, and to analyze any number of characteristics of the extracted body fluid, such as blood glucose levels for diabetes. To monitor the patient's condition, a medical practitioner or individual first creates an incision in the skin by lancing the subject's skin with a lancet. To avoid infection of the incision site and/or contamination of the collected fluid, the lancet is sterilized and packaged in a sterile manner prior to use. One form of packaging the lancet in a sterile environment is to place the entire lancet between two walls of layered material and heat seal portions of the layered material around the entire lancet. The inner layer of the wall is typically formed of a protective sterile filler and the outer layer of the wall is typically formed of a foil material. Between the inner and outer walls is an intermediate layer formed of an adhesive. Heat and pressure from a heat seal die or other mechanism is applied to the layered material around the entire lancet periphery to form a heat seal line. When heat and pressure are applied to the layered material, the adhesive in the intermediate layer seeps through the inner and outer walls along the heat seal line to secure the walls together. To use the lancet, the user must peel the two walls apart along the heat seal line to expose the lancet. One problem often associated with this packaging is that the user must separate the walls while maintaining the lancet within the sterile package until the lancet is ready for use. Another difficulty that may be associated with such packaging is that excess adhesive may seep through the inner and outer walls, making it more difficult for the user to separate the walls.

Another form of packaging the lancet within a sterile environment involves the use of a protective cap to cover the tip of the lancet. One form of applying the protective cap to the lancet tip is by injection molding. The material, typically plastic, is heated until it can flow and then the material is injected into a mold that includes the lancet. The mold is shaped to form a protective cover to cover the lancet. The material typically remains in the mold until cooled and solidified. The protective cover and lancet are removed from the mold.

A potential disadvantage of sealing the entire lancet between two walls of material or injection molding is the long cycle time to seal the lancet or form the cap. Typical cycle times for sealing an entire lancet between two walls of material include placing the entire lancet between two walls of layered material and heat sealing portions of the layered material around the entire lancet. Typical cycle times for injection molding include heating the material, injecting the heated material into a mold, cooling the material within the mold to form a protective cover, and removing the cover and lancet from the mold. Another potential difficulty with sealing the entire lancet between two walls of material or injection molding is that both forms tend to be more expensive to manufacture to protect the sterility of the lancet than other forms of maintaining the sterility of the lancet. Another obstacle often associated with lancets is the safe disposal of the lancet when it is used. For example, a user or medical practitioner using a lancet would not wish to accidentally prick others or herself with a contaminated lancet, thus potentially exposing them to disease. The two walls of the sealed package are often separated to expose the lancet, however the two walls typically cannot be resealed together by a medical practitioner or patient for safe disposal of the used lancet. Similarly, replacing the injection molded cap on the lancet tip may be difficult for people whose hand dexterity is limited.

Maintaining the sterility of the lancet while providing easy removal of the protective cover can be difficult, particularly when testing is performed on its own. Often, the subject is an elderly person or otherwise somewhat debilitated person who reduces the dexterity of their hand, which in turn makes removal of the cap difficult. One solution is to weaken the connection between the cover and the lancet, but by weakening this connection the protective cover is more prone to shifting during transport.

Accordingly, there is a need for further improvements in the art.

Disclosure of Invention

One aspect of the present invention relates to a method for covering a lancing tip. At least the lancing tip is sandwiched between a first web of material that is resistant to melting at a particular temperature and a second web of material that is meltable at the particular temperature. The method also includes melting the second web by heating the first web and the second web to a particular temperature to encapsulate at least the lancing tip within the sterile enclosure. Further, during melting, the first web is maintained in an unmelted state to form a band that protects the integrity of the lancing tip.

Another aspect relates to a device for maintaining the sterility and protecting the integrity of a lancet tip. The device includes a lancet with a lancet tip for forming an incision in the skin. Further, the first web of multi-layer material is in contact with the lancet tip. A second web of the multi-layer material is in contact with the first web and sandwiches the lancet tip between the first web and the second web to protect the sterility of the lancet tip. The structure that maintains the integrity of the lancet tip is formed by thermally fusing the first web and the second web together. Further, the structure is cut to form a protective cap covering the lancet tip.

Drawings

Further forms, objects, features, aspects, benefits, advantages, and embodiments of the present invention will become apparent from the detailed description and figures provided herewith.

FIG. 1 is a front view of a protective cap covering a lancet according to one embodiment of the present invention.

Fig. 2 is a perspective view of a plurality of lancets sandwiched between two webs according to the embodiment shown in fig. 1.

Fig. 3 is a partial cross-sectional view of the web of fig. 2 taken along line 3-3 of fig. 2.

Fig. 4 is a perspective view of a plurality of lancets on top of a web during one stage of the manufacturing process.

FIG. 5 is a front view of a plurality of protective caps covering a plurality of lancet tips of lancets, each cap having a rectangular shape with a tapered end with concave shaped edges.

FIG. 6 is a front view of a plurality of protective caps covering a plurality of lancet tips of lancets, each cap having a rectangular shape with a tapered end with a convex shaped edge.

FIG. 7 is a front view of a plurality of protective caps covering a plurality of lancet tips of an integrated lancing test strip, each cap having a rectangular shape with a tapered end with a convex shaped edge.

FIG. 8 is a front view of a plurality of protective caps covering a plurality of lancet tips of lancets, each cap having a rectangular shape with a tapered end with triangular shaped edges.

FIG. 9 is a front view of a plurality of protective caps covering a plurality of lancet tips of an integrated lancing test strip, each cap having a rectangular shape with a tapered end with triangular shaped edges.

Detailed Description

For the purposes of promoting an understanding of the principles of the invention, reference will now be made to the embodiments illustrated in the drawings and specific language will be used to describe the same. It will nevertheless be understood that no limitation of the scope of the invention is thereby intended. Any alterations and further modifications in the described embodiments, and any further applications of the principles of the invention as described herein are contemplated as would normally occur to one skilled in the art to which the invention relates. One embodiment of the invention is shown in great detail, but one of ordinary skill in the relevant art will recognize that some features not relevant to the present invention may not be shown for the sake of clarity.

The present invention relates generally to a protective cap that protects the integrity and sterility of a lancet tip and/or an integrated lancing test strip for a lancet. It is contemplated that other devices may be protected with a protective cover. One technique for quickly manufacturing the protective cap is to sandwich the lancet tip between two webs of multi-layer material to protect the sterility of the lancet tip, heat seal the webs together to form a structure that protects the integrity of the lancet tip, and cut the structure to form a protective cap that covers the lancet tip. In another technique, a plurality of lancet tips are sandwiched between two webs of multi-layer material and a plurality of protective caps are formed from the structure. The layers of material used for the web are selected based on the application and desired characteristics or features of the layers to protect the integrity and sterility of the lancet tip. The layer of material in contact with the lancet tip has a low melting point, which enables the layer to melt rapidly and encapsulate the lancet tip when thermal energy is applied to the web. The sterility of the lancet tip is protected by the encapsulation of the lancet tip. Further, the high melting point of the web layer forming the outer portion of the cover is such that it does not melt when thermal energy is applied to the multi-layer material. These outer web layers behave like shells or molds when heat energy is applied to the web during the manufacturing process. Because these outer layers do not melt, thermal energy may be applied to the outer and inner layers, thus melting the inner layer and encapsulating the lancet tip. The strong adhesive layer of the web positioned to form the outer surface of the cap also provides a rigid protective outer layer or shell to protect the integrity of the lancet tip.

Selected features from the various embodiments of the present invention will be described with reference to a bare lancet or an integrated lancing test strip of the type illustrated in the drawings, but it should be appreciated that these features can be incorporated into other types of designs. By way of non-limiting example, while the integrated lancing test strip is illustrated with the lancet fixed relative to the remainder of the test strip, it should be appreciated that the lancet or other portion of the test strip may move relative to the remainder of the test strip. It is contemplated that multiple lancets with protective covers or multiple integrated lancing test strips with protective covers can be stored or combined together within a container to form a cartridge or cassette.

A protective cap 20 according to one embodiment of the present invention will now be described with reference to fig. 1, 2 and 3. The cap 20 includes a first web 22 and a second web 24. The lancet 26 is sandwiched between the first web 22 and the second web 24. As illustrated in fig. 3, the first web 22 and the second web 24 are formed from a multi-layer material 28. In the embodiment illustrated in fig. 3, the multi-layer material 28 is formed from a first layer 30 and a second layer 32. In other embodiments, the multi-layer material 28 may have additional layers different from the first layer 30 and the second layer 32, or may have only a single layer. In yet another embodiment, portions of first web 22 and/or second web 24 melt at a particular temperature to encapsulate at least the lancet tip of lancet 26. In this embodiment, another portion of first web 22 and/or second web 24 does not melt at the same particular temperature, however this portion forms a rigid outer layer of protective cap 20 to protect the integrity of the lancet tip. By way of non-limiting example, the first web 22 and the second web 24 may be made of polystyrene and polyethylene.

In the illustrated embodiment, the lancet 26 has a generally flat shape. Lancets 26 with flat shapes are easily and quickly manufactured, and a plurality of lancets 26 having flat shapes can be easily stacked or stored in a magazine or magazine. As should be appreciated, the lancet 26 may be of a variety of geometries. For example, the lancet 26 may be circular. The lancet 26 may be formed from a variety of materials, such as metal, plastic, ceramic, or a combination of metals, such as metal and plastic, and the like.

As shown in fig. 4, the lancet 26 has a lancet tip 34. The lancet tip 34 is generally triangular, however it should be appreciated that the lancet tip 34 may be of a variety of geometries. The lancet tip 34 is configured to cut an incision in skin or other types of tissue.

As shown in fig. 2, the protective cap 20 is formed from a first web 22 and a second web 24. The first web 22 and the second web 24 are shown as rectangular pieces of multi-layer material 28, however in other embodiments the first web 22 and the second web 24 may be shaped differently. It will be appreciated that the first web 22 and/or the second web 24, which are shaped as rectangular pieces, tend to roll onto the shaft evenly compared to other shapes. It is contemplated that the axes of first web 22 and the axes of second web 24 may be used to form protective caps 20 to increase the speed of manufacturing of protective caps 20, as will be discussed below. For illustration purposes, in fig. 2, the width of the first web 22 is greater than the width of the second web 24. In other forms, the width of the first web 22 may be substantially equal to or less than the width of the second web 24. Further, for illustration purposes, the length of the first web 22 is greater than the length of the second web 24 in fig. 2. As should be appreciated, in other forms, the length of the first web 22 may be substantially equal to or less than the length of the second web 24.

The multilayer material 28 as shown in fig. 3 includes a first layer 30 and a second layer 32. In one embodiment, multilayer material 28 may be formed by co-extruding first layer 30 and second layer 32 from a device onto a surface configured to receive first layer 30 and second layer 32. It is contemplated that the surface is shaped to receive first layer 30 and/or second layer 32 to form multi-layer material 28, however multi-layer material 28 may be removed from the surface. In another form, the first layer 30 may be extruded from the apparatus onto a surface, and the second layer 32 may be extruded onto the first layer 30 to form the multi-layer material 28. It should be appreciated that the multi-layer material 28 may be formed by other techniques. It is contemplated that the multi-layer material 28 may be bent or rolled onto a reel for storage and/or use during manufacture of the protective cap 20.

The materials used for the first layer 30 and the second layer 32 are selected based on the desired characteristics or properties of the protective cover 20. One desirable feature is the high melting point of the first layer 30. The first layer 30 of the first web 22 and the first layer 30 of the second web 24 form the outer surface of the protective cap 20 as shown in fig. 1, 2 and 3. The high melting point of the first layer 30 prevents the first layer 30 from melting when thermal energy is applied to the web 22 and/or the web 24 to heat the web to a particular temperature. When heat energy is applied to web 22 and/or web 24, first layer 30 behaves like a shell or mold for second layer 32 during the manufacturing process. Another desirable feature is the low melting point of second layer 32. For example, second layer 32 of first web 22 and second layer 32 of second web 24 contact lancet tip 34 in the embodiment shown in fig. 1, 2, and 3. The low melting point of second layer 32 enables second layer 32 to rapidly melt and encapsulate lancet tip 34 with a small amount of thermal energy applied to it to heat second layer 32 to a particular temperature. Thermal energy may be applied to the first layer 30 and the second layer 32 in contact with the lancet tip 34, thus melting the second layer 32 and encapsulating the lancet tip 34. Encapsulating the lancet tip 34 with the second layer 32 protects the sterility of the lancet tip 34. The low melting point reduces the amount of time required to heat the second layer 32. Another desirable characteristic is the tackiness of the first layer 30 and/or the second layer 32. In the embodiment shown in fig. 1, 2, and 3, first layer 30 of first web 22 and first layer 30 of second web 32 each form an outer surface of protective cap 20. The strongly adhesive first layer 30 of first web 22 and first layer 30 of second web 24 provide a rigid protective outer layer or shell to protect the integrity of lancet tip 34. An additional desirable characteristic or feature is the adhesion of first layer 30 to second layer 32. The adhesion of the first layer 30 to the second layer 32 allows the layers to be adhered together to form the multi-layer material 28. It should be appreciated that an adhesive intermediate layer may be placed between first layer 30 and second layer 32 to hold the layers together. Other characteristics as desired may be selected to determine the type of material used for first layer 30 and/or second layer 32.

In one form in which thermal energy is applied to web 24 from a laser, first layer 30 and/or second layer 32 of web 22 may be dark colored to absorb thermal energy from the laser. In this form, energy from the laser is applied to the first layer 30 of the web 24. The first layer 30 and the second layer 32 of the web 24 are colorless such that the dark colored web 22 absorbs thermal energy from the laser. It should be appreciated that other forms of applying thermal energy to web 22 and/or web 24 will be discussed below. It is contemplated that if heat energy is applied to the web 24 in a form other than a laser, the web 22 and the first layer 30 and/or the second layer 32 of the web 24 may be any color desired by the user.

In one form, the first layer 30 and/or the second layer 32 may have a smooth surface to receive the lancet tip 34 and/or a user or device, respectively. In another form, second layer 32 has ridges or texture on its surface that contacts lancet tip 34. Further, when thermal energy is applied to webs 22 and/or 24, the ridges cause second layer 32 to rapidly melt and encapsulate lancet tip 34.

First layer 30 and second layer 32 may be formed from a variety of materials. In one embodiment, first layer 30 is formed of polystyrene and second layer 32 is formed of polyethylene. By way of non-limiting example, the first layer 30 is approximately 0.3 millimeters and the second layer 32 is approximately 0.1 millimeters. It should be appreciated in this embodiment that first layer 30 of first web 22 is positioned away from lancet tip 34 and forms the rigid outer layer of protective cap 20. It should also be appreciated in this embodiment that heating the second layer 32 positioned adjacent the lancet tip 34 encapsulates the lancet tip 34 within the second layer 32. In other embodiments, the first layer 30 may be formed of a material such as metal, plastic, or polyester, or a composite material such as metal and plastic, or any other material in which the first layer 30 is a heat resistant material and also forms a protective outer layer of the cover 20. The second layer 32 may be formed of a material such as a thermoplastic, polymer, plastic, or any other material that may melt to encapsulate the lancet tip 34 and may be removed from the lancet tip 34 for use of the lancet 26.

Lancet tip 34 is sandwiched between first web 22 and second web 24. As shown in fig. 2, a plurality of lancets 26 may be sandwiched between first web 22 and second web 24. In this form, the first web 22, lancets 26 and second web 24 are assembled in a layered fashion such that a plurality of protective caps 20 can be easily assembled and manufactured in a continuous fashion. In one manufacturing process, as shown in FIG. 4, a continuous web 22 is positioned such that a plurality of lancet tips 34 are placed in a side-by-side fashion atop the web 22. The continuous web 24 is then placed over the lancet tip 34, thus sandwiching the lancet tip 34 between the first web 22 and the second web 24, as shown in fig. 2. As will be discussed below, heat energy is applied to web 22 and/or web 24. It is contemplated that a variety of techniques may be used to sandwich lancet tip 34 between first web 22 and second web 24 and increase the speed of manufacture of protective cap 20. By way of non-limiting example, the first web 22 may be rolled onto a first shaft and the second web 24 may be rolled onto a second shaft to increase manufacturing speed. Further, when the first web 22 and the second web 24 are unfolded, a plurality of lancet tips 34 are positioned in a side-by-side manner between the first web 22 and the second web 24. In this form, the hot plate can apply thermal energy to the second web 24 as the second web 24 is unwound from the shaft. The heated web 24 is placed atop the first web 22, wherein the second layer 32 of the web 22 and the second layer 32 of the web 24 melt to encapsulate the lancet tip 34.

The first web 22 and the second web 24 are heat fused together to create a structure or a single piece of tape 36 as shown in fig. 5. Thermal energy is applied to first web 22 and/or second web 24 to bond the webs together to form structure 36 to protect the integrity of lancet tip 34. Lancet tip 34 remains sandwiched between the webs as heat energy is applied to first web 22 and/or second web 24. The lancet tip 34 is embedded in the structure 36 when the second layer 32 of the first web 22 and/or the second layer 32 of the second web 24 melts and encapsulates the lancet tip 34. One source of thermal energy is the application of electromagnetic radiation to the first web 22 and/or the second web 24 by a laser. To apply thermal energy to second web 24 by a laser, it is advantageous to have a dark colored first web 22 and a colorless second web 24 because the laser emits radiation to the colorless second web 24. The dark colored first web 22 absorbs more heat and energy from the laser, thereby heating and melting the second layer 32 of the first web and the second layer 32 of the second web 24. In one embodiment, a laser with electromagnetic radiation that produces a wavelength of about 790 to 830 nanometers may be used as a source of thermal energy. Another example of thermal energy may be infrared radiation applied to first web 22 and/or second web 24 to form structure 36. A hot plate or hot rollers may also be applied to first web 22 and/or second web 24 to form structure 36. One thermal range for hot plates or hot rollers may be approximately 95 to 130 degrees celsius. In one form, the structure 36 is cooled to a desired temperature to form the protective cap 20 to cover the lancet tip 34.

The one-piece structure 36 may be cut to a desired shape to form the pull-off tab or protective cap 20. Some shapes for the protective cap 20 are rectangular, circular, or triangular. Whether protective cap 20 covers lancet 26 or is an integrated lancing test strip 38, its shape can vary. Further, whether protective cap 20 is used with a device for personal use or with a cartridge or cassette that stores a plurality of lancets 26 or integrated lancing test strips 38, its shape can vary, as described below. In another form, the one-piece structure 36 is not cut, but rather maintains a continuous strip. In this embodiment, the structure 36 forms a continuous strip that can be received within a cartridge or bin. A variety of techniques may be used for cutting structure 36. One form of cutting the structure 36 to form the block-out cover 20 is die cutting. Another technique for cutting the structure 36 is to punch the structure 36 with a machine that forms the shape of each protective cap 20. Yet another technique for cutting the structure 36 to form the protective cap 20 is rotary shearing.

The protective cap 20 protects the integrity and sterility of the lancet tip 34. It should be appreciated that protective cap 20 may also protect the integrity and sterility of an integrated lancing test strip 38 as shown in FIGS. 8 and 9. It should also be appreciated that the integrated lancing test strip 38 includes a lancet and a test strip or other test device to analyze bodily fluids. The test strip may analyze the body fluid by electrochemical means such as electrodes and reagents, optical, and/or magnetic analysis, among others. In one embodiment, the lancet is sterilized prior to attachment to the test strip to form an integrated lancing test strip 38. In another embodiment, the lancet is attached to the test strip to form an integrated lancing test strip 38, and the lancet is then sterilized. In this embodiment, the test strip is calibrated.

To use the lancet 26, the cap 20 must be removed from the lancet tip 34. To remove the cap 20 and expose the lancet tip 34 for personal use of the device, the user pulls the cap 20 in a direction opposite the lancet 26. The cover 20 acts as a pull-off tab wherein the user removes the cover 20 by pulling it in a direction away from the lancet 26. To assist the user in removing the lid 20, an indicator or symbol 40 may be placed on the lid 20, as shown in FIG. 5. As shown, the symbol 40 assists the user in removing the cap from the lancet tip 34 by giving an indication or showing the direction in which the cap 20 is pulled. In other forms, the symbol 40 may be a manufacturer's logo, trademark, or any other text or graphic. To manually remove the cap 20, a user grasps the cap 20 in the area indicated by arrow 41 shown in fig. 1. The user begins to pull the cap 20 in a direction away from the lancet 26 as indicated by symbol 40 in fig. 5. As the user applies force on the cap 20, the molded cap 20 is sheared away from the lancet tip 34. As the user continues to pull the cap 20 away from the lancet 26, the seal of the cap 20 with the lancet tip 34 eventually breaks, and the cap 20 is completely removed from the lancet 26 to expose the lancet tip 34.

In some forms, the cap 20 and lancet tip 34 are stored within a cartridge or canister, and to remove the cap 20 from the lancet tip 34, a tool within the integrated testing device will engage with the cap 20 and remove it to expose the lancet tip 34. It should be appreciated that there are a variety of techniques for automatically removing the cover 20 from the lancet 26 or integrated lancing test strip 38 housed within the cassette. These techniques are known in the art and are not important to an appreciation of the present invention, and therefore will not be discussed in detail below.

As illustrated in fig. 5, 6, 7, 8, and 9 and described below, structure 36 may be cut to form a plurality of protective caps 20 having a variety of shapes. It should be appreciated that the shaped protective cap 20 illustrated in fig. 5, 6 and 7 is configured for use with a personal use testing device in which a user will manually remove the cap 20 from the lancet tip 34. It should also be appreciated that the shaped protective cap 20 illustrated in fig. 8 and 9 is configured for use with an integrated test device that stores a plurality of protective caps 20 and lancets 26 (or integrated lancing test strips 38) within a cartridge.

As illustrated in fig. 5, the structure 36 may be cut to form an ergonomically shaped protective cap 20. The protective cap 20 has a tapered end 42. The protective cap 20 is generally rectangular in shape. It should be appreciated that the tapered end 42 may be shaped to assist a user in grasping and removing the protective cap 20. The tapered end 42 has an edge 44, the edge 44 being semi-circular in shape. In addition, the edge 44 has a concave shape.

According to fig. 6, the protective cap 20a includes a tapered end 42 a. It should be appreciated that protective cap 20a is similar to protective cap 20. The tapered end 42a includes a rounded shaped edge 44a, however the edge 44a forms a convex shape.

Referring to FIG. 7, protective cap 20b has a tapered end 42b with an edge 44 b. Protective cover 20b is similar to cover 20 a.

Referring to fig. 8, the protective cap 20c is generally rectangular in shape with a tapered end 42c, the tapered end 42c having a triangular shaped edge 44c in the form of an isosceles triangle. In other forms, the shaped edge 44c may be angled differently. For example, the shaped edge 44c may form a right triangle, or a scalene triangle, or the like. Protective cap 20c also has a notch 46 c. The notch 46c is semi-circular in shape. In other forms, the notches 46c may be shaped differently. It should be appreciated that the shaped edge 44c and/or indentation 46c assist a mechanical or electrical device in grasping and removing the protective cap 20 c.

A protective cap 20d according to another form is illustrated in fig. 9. As shown, the protective cap 20d has a tapered end 42 d. The tapered end 42d includes a triangular shaped edge 44d in the form of an isosceles triangle. It should be appreciated that protective cap 20d is similar to protective cap 20 c.

While the invention has been illustrated and described in detail in the drawings and foregoing description, the same is to be considered as illustrative and not restrictive in character, it being understood that only the preferred embodiment has been shown and described and that all changes and modifications that come within the spirit of the invention are desired to be protected.

Claims (21)

1. A method for covering a lancing tip, comprising:

sandwiching at least the lancing tip between a first web of material that is resistant to melting at a particular temperature and a second web of material that is meltable at the particular temperature; and

melting the second web by heating the first web and the second web to at least the specified temperature to encapsulate at least the lancing tip in a sterile enclosure;

wherein during melting, the first web remains in an unmelted state to form a band that protects the integrity of at least the lancing tip.

2. The method of claim 1, further comprising:

the second web is cooled to form a removable cover covering at least the lancing tip.

3. The method of claim 1, further comprising:

the first and second webs are cut to a desired shape to form pull-off tabs.

4. The method of claim 1, wherein:

the first web is a multi-layer material further comprising a material meltable at the specific temperature, the meltable material of the first web melting during melting; and

said melting the second web comprises melting the meltable material of the first web such that the anti-melt material of the first web remains unmelted.

5. The method of claim 1, wherein:

the second web is a multi-layer material further comprising a material resistant to melting at the specific temperature, the anti-melting material of the second web remaining in an unmelted state during melting; and

said melting the second web comprises melting the meltable material of the second web such that the anti-melt material of the second web remains unmelted.

6. The method of claim 1, wherein sandwiching at least the lancing tips between the first web and the second web comprises sandwiching a plurality of lancing tips between the first web and the second web.

7. The method of claim 1, further comprising:

wherein said sandwiching at least the lancing tips includes sandwiching a plurality of the lancing tips between a first web and a second web;

wherein the tape protects the integrity of at least the plurality of lancing tips; and

storing the plurality of lancing tips and the tape within a cartridge.

8. The method of claim 1, further comprising:

the lancing tip is attached to a test strip configured to analyze bodily fluids to form an integrated lancing test strip.

9. The method of claim 8, further comprising:

the lancing tip is sterilized prior to attaching the lancing tip to the test strip to form an integrated lancing test strip.

10. The method of claim 8, further comprising:

sterilizing the lancing tip after attaching the lancing tip to the test strip to form an integrated lancing test strip; and

calibrating the integrated lancing test strip, wherein the test strip is configured to analyze a bodily fluid sample.

11. The method of claim 1, further comprising:

an indicator is provided on the tape to show the direction in which the tape is removed to expose the lancing tip.

12. An apparatus, comprising:

a lancet having a lancet tip configured to form an incision in skin;

a first web of a multi-layer material, wherein the multi-layer material has a first layer that is heat resistant and a second layer that is heat sensitive; and

a second web having the multi-layer material, the second layer of the second web being in contact with the second layer of the first web and sandwiching the lancet tip between the first web and the second web to protect the sterility of the lancet tip;

wherein the second layer of the first web and the second layer of the second web are fused together to form a structure that encapsulates the lancet tip.

13. The apparatus of claim 12, wherein:

the first layer comprises polystyrene; and

the second layer comprises polyethylene.

14. The apparatus of claim 12, further comprising:

a plurality of lancet tips sandwiched between the first web and the second web.

15. The apparatus of claim 12, further comprising:

a plurality of lancet tips sandwiched between the first web and the second web;

a plurality of structures configured to encapsulate the plurality of lancet tips; and

a cartridge for storing the plurality of structures and the plurality of lancet tips.

16. The device of claim 12, wherein the structure is separable to form a protective cap to cover the lancet tip.

17. The apparatus of claim 12, wherein the first layer is rigid to form a protective outer surface of the structure.

18. The apparatus of claim 12, further comprising:

a test strip attached to the lancet and adapted to analyze body fluid from the incision.

19. An apparatus, comprising:

a lancet;

means for enclosing said lancets in a sterile environment, the means for enclosing comprising a first web, the first web comprising a plurality of layers, and portions of the first web being meltable at a temperature; and

means for stiffening said means for encapsulating comprising a second web comprising a plurality of layers, with portions of the second web being resistant to melting at the temperature, wherein said means for stiffening protects the integrity of said lancet, with the lancet sandwiched between the first web and the second web.

20. The apparatus of claim 19, further comprising:

a device for analyzing a body fluid from a lancet.

21. The apparatus of claim 19, wherein:

said means for encapsulating comprising a first web of a multi-layer material and a second web of said multi-layer material, wherein said multi-layer material has a first layer that is heat resistant and a second layer that is heat sensitive; and

the means for stiffening comprises the first layer being rigid.