NEEDLE ASSEMBLY WITH DIAGNOSTIC ANALYSIS PROVISIONS

Abstract

A needle assembly. The needle assembly enabling the analysis of fluid trapped in a flashback chamber after an insertion needle has been inserted into a patient's vein.

Claims

1-15. (canceled)

16. A safety needle assembly, comprising: an insertion needle having a sharpened distal tip, a proximal end and a shaft defining a lumen extending therebetween; a needle hub operably coupled to the proximal end of the insertion needle, the needle hub including a chamber comprising a wall defining an access port; and a sample vial coupleable to the access port of the needle hub and in fluid communication with the chamber, whereupon collection of a bodily fluid of a patient within the sample vial, the sample vial is removable from the access port to enable storage of the bodily fluid separate from the insertion needle and needle hub.

17. The safety needle assembly of claim 16, wherein the sample vial is tubular.

18. The safety needle assembly of claim 16, wherein the sample vial comprises a flash plug configured to enable air to escape as bodily fluid fills the sample vial.

19. The safety needle assembly of claim 16, wherein the sample vial is constructed of at least one of a transparent or translucent material to enable a clinician to visually see when bodily fluid enters the sample vial.

20. The safety needle assembly of claim 16, further comprising a needle housing slideably coupled to the needle hub between a first position wherein the sharpened distal tip of the needle extends from the needle housing and a second position wherein the sharpened distal tip of the needle is housed within the housing.

21. The safety needle assembly of claim 20, wherein the sample vial is positioned in proximity to at one of a distal end or proximal end of the needle housing.

22. The safety needle assembly of claim 20, wherein the sample vial extends outwardly from an exterior wall of the needle housing.

23. The safety needle assembly of claim 16, wherein a wall of the sample vial contains a color changing substance that changes color based on a characteristic of the bodily fluid contained within the cavity, thereby providing a visual indication of a condition of a patient.

24. The safety needle assembly of claim 23, wherein the patient condition is at least one of glucose level, pregnancy, pH balance, and hormone level.

25. The safety needle assembly of claim 23, wherein the color changing substance is deposited on the interior surface in a pattern.

26. A needle assembly for accessing fluid from a patient, comprising: an insertion needle having a sharpened distal tip, a proximal end and a shaft defining a lumen extending therebetween; a needle hub operably coupled to the proximal end of the insertion needle, the needle hub including a chamber comprising a wall defining an access port; a needle housing slideably coupled to the needle hub between a first position wherein the sharpened distal tip of the needle extends from the needle housing and a second position wherein the sharpened distal tip of the needle is housed within the housing; and a sample vial coupleable to the access port of the needle hub and in fluid communication with the chamber, whereupon collection of a bodily fluid of a patient within the sample vial, the sample vial is removable from the access port to enable storage of the bodily fluid separate from the insertion needle and needle hub.

27. The needle assembly of claim 26, wherein the sample vial is tubular.

28. The needle assembly of claim 26, wherein the sample vial comprises a flash plug configured to enable air to escape as bodily fluid fills the sample vial.

29. The needle assembly of claim 26, wherein the sample vial is constructed of at least one of a transparent or translucent material to enable a clinician to visually see when bodily fluid enters the sample vial.

30. The needle assembly of claim 26, wherein the sample vial is positioned in proximity to at one of a distal end or proximal end of the needle housing.

31. The needle assembly of claim 26, wherein the sample vial extends outwardly from an exterior wall of the needle housing.

32. The needle assembly of claim 26, wherein a wall of the sample vial contains a color changing substance that changes color based on a characteristic of the bodily fluid contained within the cavity, thereby providing a visual indication of a condition of a patient.

33. The needle assembly of claim 32, wherein the patient condition is at least one of glucose level, pregnancy, pH balance, and hormone level.

34. The needle assembly of claim 32, wherein the color changing substance is deposited on the interior surface in a pattern.

35. A method of accessing fluid from a patient, comprising: inserting an insertion needle having a sharpened distal tip into a body of a patient, the insertion needle operably coupled to a needle hub, the needle hub including a chamber comprising a wall defining an access port, and a sample vial coupleable to the access port of the needle hub and in fluid communication with the chamber; collecting a sample of bodily fluid of a patient within the sample vial; and removing the sample vial from the access port to enable storage of the bodily fluid separate from the insertion needle and needle hub.

Description

BRIEF DESCRIPTION OF THE DRAWINGS

[0025] The disclosure can be more completely understood in consideration of the following detailed description of various embodiments of the disclosure, in connection with the accompanying drawings, in which:

[0026] FIG. 1 is a perspective view depicting a peripheral intravenous catheter of the prior art in a first position.

[0027] FIG. 2 is a perspective view depicting the peripheral intravenous catheter of FIG. 1 in a second position.

[0028] FIG. 3 is a perspective view depicting a first embodiment of a safety needle assembly in a first position in accordance with the disclosure.

[0029] FIG. 4 is a perspective view depicting the safety needle assembly of FIG. 3 in a second position.

[0030] FIG. 5 is cross sectional view depicting the safety needle assembly of FIG. 3.

[0031] FIGS. 6A-C depict views of a needle hub in accordance with embodiments of the disclosure.

[0032] FIG. 7 is a perspective view depicting the interaction between a needle hub and a needle housing in accordance with embodiments of the disclosure in a first position.

[0033] FIG. 8 is a perspective view depicting the interaction between the needle hub and the needle housing of FIG. 7 in a second position.

[0034] FIG. 9 is a perspective view depicting a second embodiment of a safety needle assembly in a first position in accordance with the disclosure.

[0035] FIG. 10 is a perspective view depicting the safety needle assembly of FIG. 9 in a second position.

[0036] FIG. 11 is a perspective view depicting a third embodiment of a safety needle assembly in accordance with the disclosure.

[0037] FIG. 12 is a perspective view depicting a fourth embodiment of a safety needle assembly in accordance with the disclosure.

[0038] FIGS. 13A-B are cross sectional views depicting a fifth embodiment of a safety needle assembly in accordance with the disclosure.

[0039] FIGS. 14A-B are cross sectional views depicting a sixth embodiment of a safety needle assembly in accordance with the disclosure.

[0040] FIG. 15 is a cross sectional view depicting a seventh embodiment of a safety needle assembly in accordance with the disclosure.

[0041] FIG. 16 is a perspective view depicting an eighth embodiment of a safety needle assembly in accordance with the disclosure.

[0042] FIGS. 17-18 depict the safety needle assembly of FIG. 16 with the end cap in an open position.

[0043] FIG. 19 is a perspective view depicting a ninth embodiment of a safety needle assembly in accordance with the disclosure.

[0044] FIG. 20 is a perspective view depicting a tenth embodiment of a safety needle assembly in accordance with the disclosure.

[0045] FIGS. 21A-B depict a flash chamber having a circumferential groove and ring in accordance with the disclosure.

[0046] FIG. 22 depicts a flash chamber with a tapered nose flash plug in accordance with the disclosure.

[0047] FIG. 23 depicts a flash chamber with a stepped nose flash plug in accordance with the disclosure.

[0048] FIGS. 24-27 depict a flash chamber having patterns of one or more color changing substances applied to the interior of the flash chamber cavity defining wall in accordance with the disclosure.

[0049] While embodiments of the disclosure are amenable to various modifications and alternative forms, specifics thereof are shown by way of example in the drawings and will be described in detail. It should be understood, however, that the intention is not to limit the disclosure to the particular embodiments described. On the contrary, the intention is to cover all modifications, equivalents, and alternatives falling within the spirit and scope of the disclosure as defined by the appended claims.

DETAILED DESCRIPTION

[0050] Referring to FIGS. 1 and 2, a safety needle assembly 20 according to the prior art is depicted. Details of the safety needle assembly 20 are described in the Background section above.

A. First Embodiment

[0051] Referring to FIGS. 3-8, a safety needle assembly 100 according to a first embodiment of the disclosure is depicted. Safety needle assembly 100 can include an insertion needle 102, a needle hub 104, and a needle housing 106, Insertion needle 102 can have a sharpened distal tip 108, a proximal end 110 and a shaft 112 defining a lumen 114 extending therebetween.

[0052] Needle hub 104 can be operably coupled to the proximal end 110 of the insertion needle 102. As depicted in FIGS. 5 and 6A-C, the needle hub 104 can include a flash chamber 116 comprising a wall 118 defining a cavity 120. In one version, the cavity defining wall 118 can be constructed of a transparent or translucent material to enable a clinician to visually see when fluid enters the cavity 120.

[0053] The cavity 120 can be in fluid communication with the lumen 114 of the insertion needle 102. For example, in one version, the distal end 124 of the flash chamber 116 can include an aperture 126 sized to accommodate the proximal end 110 of the insertion needle 102. The cavity 120 can be sealed by a gas permeable flash plug 122. For example, in one version, the proximal end 128 of cavity 120 can be plugged with a microporous flash plug 122. Flash plug 122 can be comprised of a material that enables air to vent from the cavity 120 as fluid fills the cavity 120, while inhibiting the fluid from passing through the flash plug 122 and out of the cavity 120.

[0054] In one version, the flash chamber 116 can include a diagnostic sampling port 130. Diagnostic sampling port 130 can be configured to selectively provide a clinician access to fluid trapped in the cavity 120. In one version, the diagnostic sampling port 130 can be positioned on the wall 118 between the needle 102 and the flash plug 122. Because the internal diameter of the cavity 120 is generally smaller than the length of the cavity 120, locating diagnostic sampling port 130 generally orthogonal to the lumen 114 of the insertion needle 102 provides the advantage of enabling greater access to cavity 120. For example, an access port 150 positioned along the wall 118 can be sized to accommodate a standard sized blood glucose test strip, whereas such a standard sized blood glucose test strip may not fit within the internal diameter of cavity 120 if the diagnostic sampling port 130 is positioned on the proximal end 128 of cavity 120, or if it is included as part of the flash plug 122. Additionally, positioning diagnostic sampling port 130 along wall 118 does not cause any interference with the proper venting of flash plug 122.

[0055] In one version, diagnostic sampling port 130 can comprise a self-sealing member 133. Self-sealing member 133 can be, for example, constructed of silicone rubber. In some versions, for the purpose of preserving the integrity of the fluid trapped within cavity 120, the interior of flash chamber 116 can be coated with fluid integrity preserving substance, such as heparin.

[0056] Needle housing 106 has a distal end 132 and a proximal end 134. Distal end 132 of needle housing 106 can be configured with a tapered blunt tip sized to create a friction fit with a portion of a catheter hub 30. Distal end 132 can further define an aperture 140 through which insertion needle 102 can pass. In some versions, safety needle assembly 100 can include a catheter hub coupling and release mechanism configured to couple to the catheter hub in the first position, and release from the catheter hub 30 in the second position. Various catheter hub coupling and release mechanisms are disclosed in a concurrently filed application entitled “Releaseable Catheter Hub Retainer,” Attorney Docket No. 4176.180US02, which is incorporated by reference herein. Needle housing 106 can be slideably coupled to the needle hub 104. For example, in one version, needle hub 104 can have “C” shaped cross section 142 conformed to fit around the outer surface of the needle housing 106 in a manner that inhibits the needle hub 104 from readily separating from the needle housing 106, yet enables the needle hub 104 to slide along the longitudinal axis of the needle housing 106 with minimal resistance. In a further version, the needle housing 106 can include structure defining a groove 144, and the needle hub 104 can be configured to slide along the groove 144, thereby inhibiting the needle hub 104 from rotating about the longitudinal axis of the needle housing 106. In one version, the needle hub 104 can include a lug 146 configured to fit within the groove 144 of the needle housing 106, thereby enabling linear movement of the needle hub 104 substantially parallel to the longitudinal axis of the needle housing 106, but restricting rotational movement of the needle hub 104 relative to the needle housing 106.

[0057] Needle housing 106 can be moveable between a first position (as depicted in FIGS. 3 and 7), wherein the sharpened distal tip 108 extends from the needle housing 106, and a second position (as depicted in FIGS. 4 and 8), wherein the sharpened distal tip 108 is housed within the needle housing 106. In the first position, when a catheter 22 is operably coupled to needle housing 106, a portion of insertion needle 102 can extend through aperture 140, and catheter 22, such that the sharpened distal tip 108 of insertion needle 102 protrudes slightly from catheter 22. In the second position, insertion needle 102 is withdrawn from catheter 22 and sharpened distal tip 108 is housed by needle housing 106 in a manner intended to reduce or eliminate the likelihood of an inadvertent needle stick.

[0058] In one version, the insertion needle 102 can be locked in position relative to needle housing 106. Several different types of locking mechanisms can be used for this purpose. For example, in one version, the structure of the needle housing 106 defining the groove 144 can further define a bottleneck 148, wherein the bottleneck 148 generally has a narrower width than the groove 144. Lug 146 of the needle hub 104 can be triangular or wedge-like in shape where the apex of the wedge faces the bottleneck 148 when in the first position. When an external force is applied to the needle hub 104 in an effort to slide it into the second position, the apex of the wedge of lug 146 will come into contact with the bottleneck 148. Bottleneck 148, which can have a width narrower than that of the lug 146 will initially resist movement of the lug 146 through the bottleneck 148. However, with sufficient force the wedge-shape lug 146 will cause the bottleneck 148 to temporarily deform, thereby enabling the lug 146 to pass through the bottleneck 148. Thereafter the lug 146 will be unable to pass back through the bottleneck 148 in the opposite direction, and the insertion needle 102 will be locked in position relative to the needle housing 106.

[0059] The needle housing 106 can include structure defining an access port 150. Access port 150 can be sized to accommodate a standard sized blood glucose test strip. In some embodiments, the access port 150 is positioned in proximity to the proximal end 134 of the needle housing 106 to align with the diagnostic sampling port 130 when the needle housing 106 is in the second position. Positioning the access port 150 in this location enables a clinician to access fluid trapped within the cavity 120 of flash chamber 116 when the insertion needle 102 is safely secured in the second position, thereby reducing the risk of an inadvertent needle stick.

B. Second Embodiment

[0060] Referring to FIGS. 9 and 10, a safety needle assembly 200 according to a second embodiment of the disclosure is depicted. In this embodiment, the access port 250 can be positioned in proximity to the distal end 232 of needle housing 206 to align with the diagnostic sampling port 230 when the needle housing 206 is in the first position. Positioning access port 250 in this location enables diagnostic sampling port 230 to be housed within the needle housing 206 in the second position; thereby reducing the likelihood that fluid will spill from the cavity 220 of flash chamber 216 should diagnostic sampling port 230 leak or fail.

C. Third and Fourth Embodiments

[0061] Referring to FIGS. 11 and 12, safety needle assemblies 300 and 400 according to a third and fourth embodiment of the disclosure are depicted. Safety needle assemblies 300 and 400 can include removable sample vials 352, 452. In one version, the sample vial 352, 452 can be comprised of a tubular member 354, 454 that selectively couples to access port 350, 450. Tubular member 354, 454 can include a sample vial flash plug 356 to enable air to escape as sample vial 352, 452 fills with fluid. In some versions, the sample vial flash plug 356 can be used in place of or as a replacement for a flash plug positioned within the flash chamber.

[0062] In some versions, safety needle assemblies 300 and 400 can include at least one of a protective needle housing 380, 480, a self-contained antiseptic swab, and a tourniquet for treatment and/or preparation of a biological site of a patient. Various catheter insertion devices having protective needle housings, a self-contained antiseptic swabs, and/or tourniquets are disclosed in a concurrently filed application entitled “Antiseptic Sheath with Site Preparation Provisions,” Attorney Docket No. 4176.1791.7502, which is incorporated by reference herein.

D. Fifth and Sixth Embodiments

[0063] Referring to FIGS. 13A-B and 14A-B, safety needle assemblies 500 and 600 according to a fifth and sixth embodiment of the disclosure are depicted. Safety needle assemblies 500 and 600 can include fluid sampling strips 558, 658, such as a blood glucose monitoring test strip or other similar test strip, device or mechanism, which can be pre-inserted into access port 550, 650 and/or diagnostic sampling port 530, 630. In one embodiment, fluid sampling strip 558, 658 includes a portion 560, 660 that is designed to collect fluid through capillary action, and another portion with electrical contacts (as depicted in FIG. 15) for connection with one or more fluid analyzers. In other embodiments, fluid sampling strip 558, 658 can begin as one color, such as white, and change color based on a chemical reaction with the fluid sample. In some embodiments, the fluid sampling strip 558, 658 is never removed from the safety needle assembly 500 or 600.

E. Seventh Embodiment

[0064] Referring to FIG. 15, a safety needle assembly 700 according to a seventh embodiment of the disclosure is depicted. In this embodiment, fluid sampling strip 758 can pass through flash plug 722 at the proximal end 728 of cavity 720. In this embodiment, fluid sampling strip 758 is rolled or sized to fit within the internal diameter of cavity 720. Electrical contacts 762 of the fluid sampling strip 758 can protrude from the proximal end 734 of needle housing 706 for connection with a fluid analyzer. In one embodiment, safety needle assembly 700 can include an end cap 764 that operably couples to needle housing 706 or needle hub 704 to selectively restrict access to electrical contacts 762. In one embodiment, the fluid sampling strip 758 can be fixedly coupled to the end cap 764 so that after the end cap 764 is removed from needle housing 706, the electrical contacts 762 can be connected with a fluid analyzer while safety needle assembly 700 can be safely disposed of.

F. Eighth Embodiment

[0065] Referring to FIG. 16-18, a safety needle assembly 800 according to an eighth embodiment of the disclosure is depicted. In this embodiment, an end cap 864 can be hingedly coupled to needle hub 804. For example, end cap 864 can be coupled to needle hub 804 via a pivotal coupling 866, such as a pivot, hinge or living hinge. In other embodiments, end cap 864 selectively couples to needle hub 804 though a friction or snap fitting. In some embodiments, end cap 864 further includes a latch 868 configured to secure one or both sides of end cap 864 to needle hub 804.

[0066] Where the end cap 864 is hingedly coupled to the needle hub 804, it can be moveable between a closed position (as depicted in FIG. 16), wherein the end cap 864 covers the cavity sealing flash plug 822, and an open position (as depicted in FIGS. 17 and 18), wherein the end cap 864 pivots to enable removal of the flash plug 822 from the cavity 820. Hingedly connecting end cap 864 to needle hub 804 offers the advantage of limiting the number of loose components to be discarded after use.

[0067] When the safety needle assembly 800 is in the first position, such that the sharpened distal tip of the insertion needle extends from the needle housing 806 (as depicted in FIG. 16), the needle housing 806 at least partially secures the end cap 864 in the closed position by inhibiting the end cap 864 from pivoting. For example, in some embodiments, the proximal end 834 of the needle housing 806 can extend within end cap 864 when in the first position, thereby inhibiting end cap 864 from pivoting. Securing end cap 864 in place when in the first position ensures that the insertion needle 802 is safely housed in the needle housing 806 before access to the fluid trapped in the flash chamber 816 is enabled, thereby reducing the chance of an inadvertent needle stick, while also inhibiting accidental fluid spillage by a premature release of the flash plug 822.

[0068] In one embodiment, the flash plug 822 can include a gripping surface 870 to aid in the removal of the flash plug 822 from the cavity 820. For example, gripping surface 870 can be a portion of flash plug 822 that extends beyond cavity 820. In one embodiment, gripping surface can include a lip or a loop for grasping. In one embodiment, flash plug 822 and end cap 864 are operably coupled to one another, such that removal of the end cap 864 causes the flash plug 822 to be removed from the cavity 820, thereby enabling access to the fluid trapped within the flash chamber 816.

C. Ninth and Tenth Embodiments

[0069] Referring to FIGS. 19-27, a needle assembly 900 and a safety needle assembly 1000 according to a ninth and tenth embodiment of the disclosure are depicted. These embodiments can include one or more color changing substances 972, 1072 that change color based on one or more characteristics of a fluid contained within cavity 920, 1020, thereby providing a visual indication of the state or condition of the patient. For example, in one embodiment, the color changing substance 972, 1072 changes color based on the presence or amount of one or more constituents, such as glucose, cardiac enzymes, red cells, hormone level, or the level of one or more than one parameter, such as pH. For these embodiments, needle assembly 900 or safety needle assembly 1000 can comprise a variety of needle assemblies, needle housing or otherwise, provided that the needle assembly includes a flash chamber 916, 1016.

[0070] The color changing substance 972, 1072 can be bonded to the interior surface of the cavity 920, 1020. Referring to FIGS. 21A-B, in other embodiments, the color changing substance 972 is adhered to one or more layers of fluid wicking material 974. For increased visibility of the color changing substance 972 in opaque fluids, the fluid wicking material 974 can be in close proximity to the cavity defining wall 918 to reduce the amount of fluid between the color changing substance 972 and the inner surface of the cavity defining wall 918.

[0071] In one embodiment, the cavity defining wall 918 further defines a circumferential groove 976 positioned between the distal end and the proximal end of the cavity 920. A circumferential ring 978 including a color changing substance 972 can be positioned within the circumferential groove 976. In one embodiment, circumferential ring 978 can be comprised of a fluid wicking material 974 that wicks fluid toward the color changing substance 972 positioned in close proximity to the cavity defining wall 918. In another embodiment, circumferential ring 978 can be an o-ring coated with a color changing substance 972.

[0072] Referring to FIGS. 22-23, in some embodiments, the flash plug 922 is coated with a color changing substance 972. To ensure proper fluid contact on the color changing substance 972, while ensuring visibility of the color changing substance 972, flash plug 922 can have a distal tapered nose 982 or a reduced diameter or stepped nose 984 to which the color changing substance 972 is adhered or deposited. In some embodiments, the length of the flash plug 922 can be increased to provide additional surface area for positioning of the color changing substance 972. In some embodiments, different regions on the surface of the flash plug (e.g., different steps, different circumferential areas, etc.) can be coated with different color changing substances 972A and 972B.

[0073] Referring to FIGS. 24-27, in some embodiments, the color changing substance 972, 1072 can be deposited on the interior surface of the cavity defining wall 918, 1018 in one or more patterns. For example, color changing substance 972, 1072 can be configured as one or more stripes, semi-spheres, ovals, rhombuses, or any other pattern including a company logo or trademark. In one embodiment, two or more color changing substances 972A and 972B change color based on different fluid characteristics. In one embodiment, the interior surface of the cavity 920, 1020 is further coated with a reference color 980, 1080 to which one or more color changing substances 972, 1072 can be compared. The interior surface of the cavity 920, 1020, or the exterior surface of flash plug 922, 1022, can further be coated with a range of reference colors 1080A-I along a color spectrum to which one or more color changing substances 1072 can be compared.

H. Operation

[0074] In operation, placement of the catheters described herein generally includes preparation of the biological site of the patient. Often a tourniquet is applied proximal to the biological site and a variety of techniques can be used to dilate the patient's vein. While wearing disposable gloves, the clinician cleanses the biological site and a vein is retracted or anchored by placing a thumb over the vein about 50 mm to 75 mm distal to the site. The needle and catheter are introduced into the vein by inserting the bevel of the sharpened distal tip into the vein at about a 20-30 degree angle with the bevel facing up in order to pierce one wall of the vein. If successful, blood from the vein will flow through the lumen of the needle and into the flash chamber, thereby indicating that the vein has been entered. A clinician can proceed to access the blood within the flash chamber for testing in accordance with the above described embodiments at this time or anytime thereafter.

[0075] To finish placement, the safety catheter assembly is lowered towards the skin to decrease the entry angle, and the catheter is advanced slightly into the vein. The needle is loosened and the catheter is gently advanced farther up into the vein until the catheter hub of the catheter is against the biological site. The tourniquet is loosened and the needle is withdrawn from the catheter, as the needle hub is moved from the first position to the second position, so that needle is safely locked within needle housing. Infusion tubing can be secured to the catheter hub of the catheter. The catheter is secured to the biological site by gauze and adhesive tape.

[0076] Persons of ordinary skill in the relevant arts will recognize that embodiments may comprise fewer features than illustrated in any individual embodiment described above. The embodiments described herein are not meant to be an exhaustive presentation of the ways in which the various features may be combined. Accordingly, the embodiments are not mutually exclusive combinations of features; rather, embodiments can comprise a combination of different individual features selected from different individual embodiments, as understood by persons of ordinary skill in the art. Moreover, elements described with respect to one embodiment can be implemented in other embodiments even when not described in such embodiments unless otherwise noted. Although a dependent claim may refer in the claims to a specific combination with one or more other claims, other embodiments can also include a combination of the dependent claim with the subject matter of each other dependent claim or a combination of one or more features with other dependent or independent claims. Such combinations are proposed herein unless it is stated that a specific combination is not intended. Furthermore, it is intended also to include features of a claim in any other independent claim even if this claim is not directly made dependent to the independent claim.

[0077] Any incorporation by reference of documents above is limited such that no subject matter is incorporated that is contrary to the explicit disclosure herein. Any incorporation by reference of documents above is further limited such that no claims included in the documents are incorporated by reference herein. Any incorporation by reference of documents above is yet further limited such that any definitions provided in the documents are not incorporated by reference herein unless expressly included herein.

[0078] For purposes of interpreting the claims, it is expressly intended that the provisions of Section 112, sixth paragraph of 35 U.S.C. are not to be invoked unless the specific terms “means for” or “step for” are recited in a claim.