Vacuum assisted lancing system with elective vacuum release and method for blood extraction with minimal pain.

(54) Title: VACUUM ASSISTED PUNCTURE SYSTEM WITH SELECTIVE VACUUM RELEASE AND METHOD FOR EXTRACTION OF BLOOD WITH MINIMAL PAIN.

(54) Title: VACUUM ASSISTED LANCING SYSTEM WITH ELECTIVE VACUUM RELEASE AND METHOD FOR BLOOD EXTRACTION WITH MINIMAL PAIN.

(57) Summary

A vacuum assisted puncture system for blood collection may include a tubular body having a vacuum chamber, a puncture mechanism configured to be removably coupled with a lancet, a vacuum mechanism including a piston slidably coupled within the body, a release mechanism to selectively hold the vacuum mechanism in an energized state, and an opening to allow fluid communication between the vacuum chamber and an atmosphere surrounding the vacuum chamber; the system may include means to selectively start vacuum dissipation and a fixed or adjustable depth controller; A method of manipulating a surface for blood collection may include attaching the puncture system to the surface, blocking the opening, creating a vacuum, moving the lancet coupler from a first position distal to the surface to a second position proximal to the surface, maintain vacuum for a period, and begin dissipating the vacuum by unlocking the opening.

(57) Abstract

A vacuum assisted lancing system for blood extraction can inelude a tubular body having a vacuum chamber, a lancing mechanism configured to removably couple with a lance, a vacuum mechanism including a piston slideably coupled within the body, a release mechanism for selectively holding the vacuum mechanism in an energized State, and an opening for allowing fluid communication between the vacuum chamber and an atmosphere surrounding the vacuum chamber. The system can inelude means for selectively commencing dissipation of the vacuum and a fixed or adjustable depth controller. A method of manipulating a surface for blood extraction can inelude coupling the lancing system to the surface, blocking the opening, creating a vacuum, moving the lance coupler f rom a first position distal from the surface to a second position proximal to the surface, maintaining the vacuum for a period of time, and commencing dissipation of the vacuum by unblocking the opening.

Institute

Mexican Property

Industrial

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PATENT TITLE NO. 336397

Owner (s): CHRISTOPHER A. JACOBS

Address: 4011 Livingston St., Midland, Texas, 79707-3131, USA

Name: VACUUM ASSISTED PUNCTURE SYSTEM WITH SELECTIVE VACUUM RELEASE AND METHOD FOR EXTRACTION OF BLOOD WITH MINIMAL PAIN.

Classification: IC.8: A61B5 / 151

Inventor (s): CHRISTOPHER A. JACOBS

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from the '12 / 1997, llOS 1 ', 3' 12/14/1999,

II and 30 of the State 08/04/2004 and 09/13/21 Divisional rectors, Titulítemos of the Mexican Institute of the s and of the 15/1999, action V side the rganic 1 °, 3 ° is of the opledad ref my itutc

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Arenal No 550, Floor 1,

Col. Pueblo Santa María Tepepan, Xochimilco Delegation,

CP 16020. México, D. F Tel. (55) 53 34 07 00 www.tmpi.gob.mx

Issue Date: January 15, 2016

DIVISIONAL DIRECTOR OF PATENTS

NAHANNY CANAL REYES

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MX / 2016/5807

VACUUM ASSISTED PUNCTURE SYSTEM WITH RELEASE OF

SELECTIVE VACUUM AND METHOD FOR EXTRACTION OF BLOOD WITH

MINIMAL PAIN

STATEMENT WITH RESPECT TO INVESTIGATION OR DEVELOPMENT

SPONSORED BY THE FEDERAL GOVERNMENT

Not applicable.

REFERENCE TO THE APPENDIX

Not applicable

FIELD OF THE INVENTION

The invention described and taught herein generally relates to blood collection devices and methods. More specifically, the invention relates to vacuum assisted puncture devices and useful methods for drawing a quantity of blood for sampling or testing.

DESCRIPTION OF THE RELATED TECHNIQUE ^lrl '..... ““ ““ v. · -—. ·:.;. ü-L {$ ​​© ¡Sa tT@pa anclav.¿íí2i ;:

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There are many medical reasons where a small amount of blood needs to be drawn from a human. Determining blood glucose levels for diagnosis and treatment of diabetes is one of the most common applications where access to blood is required. Diabetes has become a significant health risk in the United States and other parts of the world. The increase in diabetes has caused alarm in the medical community. Major companies, research institutions, and the consuming public collectively spend significant resources for diabetes prevention, testing, and treatment. A person with diabetes is usually asked to test their blood several times a day for glucose levels and take corrective action if necessary. Failure to be tested and not to take corrective action when necessary can cause injury, long and short-term degradation of human body functions, and in some cases death.

Currently, the market provides a large number of skin puncture devices that produce a wound or other opening from which blood is drawn. However, most require testing on an area of ​​a user's skin that has a high concentration of blood vessels near the skin's surface, so the puncture can produce an acceptable amount of blood. The most common area for testing is the tip of the fingers, although the toes have also been used. However, these heavily vascularized areas of the human body fntíusírlai are usually highly sensitive, having a rich supply of nerve endings. As a result, blood-rich areas, such as the tips of the fingers, are often more sensitive to pain than other less vascularized areas. Therefore, the areas that are ideally suited for drawing blood for testing are the most sensitive to pain.

For those individuals who are asked to test themselves, frequent testing can have negative effects on their emotional health, physical health, and even personality. At the very least, in an effort to avoid pain, they are motivated not to get tested as often as their doctor requires. A loss of frequency and continuity in the test can lead to physical and emotional complications, or a significant loss of accuracy in determining appropriate dietary corrections and medication regimens. Health care personnel may also be asked to puncture a patient's skin to draw blood for testing, which is typically done on the fingers. In some situations, however, the fingers and toes may not be available for testing, such as when these areas of the patient's body are bandaged or injured, and an alternate test site may be required on the patient's body. patient.

Some blood collection devices simply puncture the skin and the patient manually presses the area to produce

<img file="MX336397B_D0005.tif" />

the required amount of blood. Other Industrial Afeilpiperopic Extraction Devices seek to use a vacuum to increase blood recovery from the puncture. However, in a market survey of such devices, the inventor has found that vacuum assisted devices are not portable with mechanized vacuum pumps, which can significantly decrease their value for mobile patients, or require unwanted maintenance, such as a replacement for batteries, which are not always available. Furthermore, many of these devices do not adequately produce a desirable amount of blood from portions of the skin other than the fingers and toes. Newer devices house multiple lancets on the same holder, and with each use a new lancet is automatically selected and used, so the patient never uses the same lancet twice. Many, if not all, of these devices, including those that apply a vacuum, have not been successful in reliably drawing sufficient amounts of blood from less painful areas of the skin than fingers and toes. Reducing or eliminating pain has been shown to significantly stimulate the patient to follow the test procedure prescribed by a physician.

Although each of these devices may have certain limited applications, there remains a need to provide a simplified and improved vacuum-assisted lancing device that can be routinely used at various locations on the skin and yet draw a sufficient amount of blood. for the required test.

BRIEF DESCRIPTION OF THE INVENTION uncle and -. -: 7..0:

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A vacuum assisted puncture system for blood collection may include a tubular body having a vacuum chamber, a puncture mechanism configured to be removably coupled with a lancet, a vacuum mechanism including a piston slidably coupled within the body, a release mechanism to selectively hold the vacuum mechanism in an energized state, and an opening to allow fluid communication between the vacuum chamber and an atmosphere surrounding the vacuum chamber. The system may include a means for selectively starting the dissipation of the vacuum. One method of manipulating a surface for blood collection may include attaching the puncture system to the surface, blocking the opening, creating a vacuum, moving the lancet coupler from a first position distal to the surface to a second position proximal to the surface, maintain vacuum for a period, and begin dissipating the vacuum by unlocking the opening.

A vacuum assisted puncture system for blood collection may include a body having a central longitudinal axis, a puncture end and a free end, a puncture mechanism coupled with the body and adapted to removably engage with a lancet, a mechanism of vacuum coupled with the body and which includes a slidingly coupled piston with the body whereby a vacuum chamber can form between the piston and the puncture end of the body, A release mechanism adapted to selectively hold the vacuum mechanism in an energized state, and an opening through the body that can allow fluid communication between the vacuum chamber and an atmosphere surrounding the vacuum chamber. The opening through the body can be adapted to be sealably hooked by a user so that the user can selectively lock and unlock the opening.

The release mechanism may include a release, and the opening may be provided in the trigger. The release may be in an activated position, and the opening may be adapted to be at least partially blocked when the trigger is in the activated position. The system may include a valve coupled to the opening, and may include a tubular lancet guide removably coupled to the body and adapted to sealably engage a surface to be punctured. The lancet guide may have a transparent viewing area to view the surface. The system may include a depth controller attached to the body and adapted to sealably engage a surface to be punctured. The depth controller can be fixed or adjustable and can include a spacer that has a variable thickness. The system may include a lancet attached to the puncture mechanism.

A vacuum assisted puncture system for blood collection may include a body having a first end adapted to sealably engage a surface to be punctured, a second longitudinally opposite end, and an en1fi vacuum chamber? c¿_v._w,_IlLthe first and second ends, a means for creating a vacuum in the vacuum chamber and acting on the surface, a means for arranging a lancet in contact with the surface while the vacuum is acting on the surface, and a means for starting selectively dissipating the vacuum after the vacuum has acted on the surface for a period. The means for selectively starting the dissipation of the vacuum may include an opening through the body to allow fluid communication between the vacuum chamber and an atmosphere surrounding the vacuum chamber. The means for creating a vacuum may include a release coupled to the body, and the opening through the body may be provided through the trigger. The system may include a means to simultaneously initiate the creation of the vacuum and at least partially block the opening. The system may include means for dissipating the vacuum at a controlled rate. The system may include a lancet coupled to the medium to dispose a lancet in contact with the surface.

One method of manipulating a blood collection surface may include attaching a puncture system to the surface, blocking an opening, activating the puncture system, thereby creating a vacuum, vacuuming the surface, and moving a lancet coupler from one first position distal of the surface to a second position proximal to the surface, maintain the vacuum for a period, and begin dissipation of the vacuum. The onset of vacuum dissipation may include unlocking the opening and allowing the surface to fluidly communicate with an atmosphere surrounding the puncture system while the puncture system is coupled to the surface.

The puncture system can include a release coupled with the opening, and the lock and trigger steps can be accomplished simultaneously by latching and holding the trigger. The onset of vacuum dissipation may include unhooking the trigger. Locking the opening may include sealably hooking the opening with a finger or other body, and unlocking the opening may include unhooking the opening and finger or other body. The puncture system may include a lancet removably coupled to a lancet coupler, and the method may include puncturing the surface. The method may include maintaining the vacuum for a period after a puncture has been made at the surface, and may include verifying that a quantity of blood has been drawn before beginning the dissipation of the vacuum.

BRIEF DESCRIPTION OF THE DRAWINGS

Figure 1 is a schematic isometric view of one of many modalities of a vacuum puncture system in accordance with the description.

Figure 2 is a schematic assembly isometric view of the

- ^ 7 ^ * ^ vacuum puncture system of figure 1. 1

Figure 3A is a schematic cross-sectional view of another of many embodiments of a vacuum puncture system having an indicator in accordance with the description.

Figure 3B is a schematic cross-sectional view of the indicator of Figure 3A in a display window.

Figure 4 is a schematic cross-sectional view of one of many modalities of a puncture mechanism in accordance with the description.

Figure 5A is an illustration of one of many modalities of a vacuum puncture system in a cocked position in accordance with the description.

Figures 5B, 5C and 5D are illustrations of the system of Figure 5A in three respective positions during puncture.

Figure 5E is an illustration of the system of Figure 5A in an uncocked position.

Figure 5F is an illustration of the system of Figure 5A manipulating a surface during puncture.

Figure 5G is an illustration of the system of Figure 5A by vibrating a surface during puncture.

Figure 5H is a graph illustrating an example of the magnitude of the vacuum versus the time during which puncture can occur during a vacuum cycle in accordance with the description.

Figure 6 isometric front schematic view of one of many modalities of a vacuum puncture system having depth controller in accordance with the description.

Figure 7A is a schematic cross-sectional view of the system of Figure 6.

Figure 7B is a schematic cross-sectional view of the system of Figure 6 with a base that contacts a spacer.

Figure 7C is a schematic cross-sectional view of the system of Figure 6 during blood collection.

Figure 8A is an illustration of one of many embodiments of a vacuum puncture system having a puncture tool in accordance with the description.

Figure 8B is an illustration of a lancet being inserted into a lancet coupler with a lancing tool of Figure 8A.

Figure 8C is an illustration of a lancet that is attached to the lancet coupler with the lancing tool of Figure 8A.

Figure 8D is an illustration of a lancet being removed from the lancet coupler with the lance tool of Figure 8A.

Figure 9 is a schematic cross-sectional view of one of many embodiments of a vacuum puncture system having an external vacuum indicator in accordance with the description.

Figure 10 is a schematic cross-sectional view of one of many embodiments of a vacuum puncture system having a

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external vacuum assembly in accordance with the description.

Figure 11 is a schematic isometric view of another industry 'many modalities of a vacuum puncture system in accordance with the description.

Figure 12 is a schematic assembly isometric view of the vacuum puncture system of Figure 11.

Figure 13A is a schematic cross-sectional view of the vacuum puncture system of Figure 11 in a cocked position.

Figure 13B is a schematic cross sectional view 10 of the vacuum puncture system of Figure 11 in an uncocked position.

Figure 14 is a schematic cross-sectional view of one of many embodiments of a puncture mechanism in accordance with the description.

FIG. 14A is a schematic cross-sectional view of the release mechanism of FIG. 14 coupled to the main arrow prior to activation.

Fig. 14B is a schematic cross-sectional view of the release mechanism of Fig. 14A decoupled from the main arrow after activation.

Figure 14C is a schematic view of another of many modalities of a release mechanism in a deactivated position in accordance with the description.

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Figure 14D is a schematic view of the release mechanism of Figure 14C in an activated position in accordance with the feskíslítoi description.

Figure 14E is a schematic view of another of many 5 modes of a release mechanism in a deactivated position in accordance with the description.

Figure 14F is a schematic view of the release mechanism of Figure 14E in an activated position in accordance with the description.

Figure 15A is an illustration of the vacuum puncture system of Figure 11 in a cocked position in accordance with the description.

Figure 15B is an illustration of the vacuum puncture system of Figure 15A in one of many activated positions where the first and second portions of the arrow coupler are coupled in accordance with the description.

Figure 15C is an illustration of the vacuum puncture system of Figure 15A in another of many activated positions where the first and second portions of the arrow coupler are decoupled in accordance with the description.

Figure 15D is an illustration of the vacuum puncture system of Figure 15A in another of many activated positions where the opening in the trigger is sealed in accordance with the description.

Figure 15E is an illustration of the vacuum puncture system of Figure 15A in another of many activated positions where the opening in the trigger is not sealed in accordance with the description. industrial

Figure 15F is an illustration of the system of Figure 15A in an uncocked position.

Figure 15G is a graph illustrating another example of vacuum magnitude versus a time over which puncture may occur during a vacuum cycle in accordance with the description.

Figure 16 is a schematic isometric view of another of many modalities of a vacuum puncture system in accordance with the description.

Figure 17 is an assembly isometric schematic view of the vacuum puncture system of Figure 16.

Figure 18 is a schematic view of one of many modalities of a vacuum puncture system having an adjustable depth controller in a first position in accordance with the description.

Figure 19 is a schematic view of the system of Figure 18 with the adjustable depth controller in a second position.

DETAILED DESCRIPTION OF THE INVENTION

The figures described above and the written description of the specific structures and functions shown below are not

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They present to limit the scope of what the applicant has invented or the scope of the appended claims. Rather, the figures and written description are provided to teach any person skilled in the art to make and use the invention for which protection is sought. Those skilled in the art will appreciate that not all of the features of a commercial embodiment of the invention are described or shown for clarity and understanding. Those skilled in this art will also appreciate that the development of a current commercial mode incorporates aspects of the present invention that require numerous implementation-specific decisions to achieve the developer's ultimate goal for the commercial mode. Such specific implementation decisions may include, and are probably not limited to, compliance with system-related, business-related, government-related and other restrictions, which may vary by specific implementation, location, and from time to time. other. Although a developer's efforts can be complex and time consuming in an absolute sense, however, such efforts can be a routine activity for those skilled in the art who have the benefit of this disclosure. It should be understood that the invention described and taught herein is susceptible to numerous and various modifications and alternative forms. Lastly, the use of a singular term, such as, but not limited to, "a", is not intended to limit the number of entities. Also, the use of relationship terms, such as, but not limited to, "up", "down", "Left", "right", "upper", "lower", "down", "up," lateral "And the like are used in the written description for clarity with specific reference to the figures and are not intended to be industrial in limiting the scope of the invention or the appended claims. When these elements are generally referred to, the number is used without the letter. Also, these designations do not limit the number of elements that can be used for that function. The terms "couple", "couple", "couple", "coupler" and the like are widely used herein and may include any method or device for securing, joining, linking, holding, fixing, joining, inserting therein, forming on or within it, communicate, or otherwise associate, for example, mechanically, magnetically, electrically, chemically, operably, directly or indirectly with intermediate elements, one or more member pieces to one another and further may include without limitation integrally forming one functional member with another in a unitary manner. Coupling may occur in any direction, including rotationally.

This description provides a vacuum assisted puncture system and method that can be easily used in a wide variety of places in a human or animal, even in places with less sensitivity, such as the stomach, sides, arms and legs. The system can be used with one hand and can be carried easily. The system can minimize pain due to its ability to operate in unconventional areas on a user, and in at least one mode minimizes pain due to vibration during puncture. The term "user" and similar terms are

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They widely use herein and include, without limitation, a person using the present invention on himself / herself, or on a Industrial Property person (or animal) who another person uses the present invention to puncture the person (or animal) . The vibration of the system can at least partially cover any pain of a patient during puncture. Furthermore, the lancet itself can easily be replaced from a position outside the system with simple insertion. As it does not require batteries, nor does it contain any form of motor, the system is virtually maintenance-free, other than after-use lancet replacement and occasional common cleaning. The system can be easily carried to be readily available when the user needs to take a blood sample. Integration of this system into a common mainstream method of blood glucose measurement can be significantly assisted because the system draws blood from the same body source as other devices. Therefore, special glucose measurement instruments and supplies may not be required, and blood measurement procedures may not have to be altered from those currently in practice.

Fig. 1 is a schematic isometric view of one of many modalities of vacuum puncture system 100 in accordance with the description. FIG. 2 is a schematic assembly isometric view of the vacuum puncture system of FIG. 1. FIG. 3A is a schematic cross-sectional view of another of many modalities of vacuum puncture system 100 having a compliance indicator 133.

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with the description. Fig. 3B is a schematic cross-sectional view of the indicator 133 of Fig. 3A in the viewing window fc (IU ti í

135. FIG. 4 is a schematic cross-sectional view of one of many modalities of lancing mechanism 118 in accordance with the description. Figures 1-4 will be described together. Vacuum puncture system 100 may include a device body 102, which may comprise, for example, a tubular vacuum body, to support one or more puncture components. The body of the device 102 may have a lower puncture end 104 and an upper free end 106, and may, but need not, be transparent, in whole or in part. The body of device 102 can be formed of any material, such as plastic, metal, or other material, separately or in combination, and can be of any size required by a particular application. System 100 may, but need not, include a handle 103, such as a foam, rubber, plastic, or other fastener, to hold the system. System 100 may, but need not, include a clip 131, such as a strap clip, bag clip, loop, or other clip, to support the system, for example, when not in use.

System 100 may include one or more puncture components (the components are collectively referred to herein as a puncture assembly), which may include one or more vacuum components, attached to the body of device 102. System 100 may include a guide for tab 112, such as a tube, attached to puncture end 104,

<img file="MX336397B_D0011.tif" />

such as to "direct" the system 100 or to contact a puncture surface, such as the skin, for puncture, directly or indirectly. The I - ,,

H'íC lancet guide 112 may be of any size required by a particular application, and may advantageously include a viewing area 114 for viewing the punctured surface. Display area 114 may be a "window" attached to lancet guide wall 112, or as another example, lancet guide 112 may be transparent, in whole or in part. Lancet guide 112 may, but need not, have a seal 116, such as an annular seal attached to its lower end to seal against a punctured surface or, as another example, at least to reduce discomfort to a user when system 100 is pressed against an area of ​​the user's body for puncture. Seal 116 may be, for example, a rounded or contoured edge, a smooth liner, such as a rubber liner, pad, gasket, or other seal, in whole or in part. As another example, in at least one embodiment, which is only one of many, seal 116 may be a suction cup (see, eg, figure 9). Seal 116 can, but need not, be flexible. For example, seal 116 can have an amount of flexibility, so puncture system 100 does not have to be held substantially perpendicular to a puncture surface to ensure sealing engagement with the surface. Seal 116 may, but need not, include or be formed of, in whole or in part, a material having holding properties, for example, whereby if the seal is moved or rotated while in contact with a surface, such as the skin, the surface concurrently dekse moves or rotates. ,

With additional reference to the figures. 1 and 2, system 100 may include a puncture mechanism 118 coupled to the puncture end

104, for example, to end cap 108, for supporting a lancet 120 (also known as a "lancet"). Lancet 120 may include a lancet base 120a to support a lancet needle 120b. The puncture mechanism 118 may include a puncture arrow 122 slidably coupled with the end cap 108, such as along the central longitudinal axis X, to communicate the lancet 120 with a surface during puncture. Lancet shaft 122 may include a lower lance engaging end 124 and an upper drive end 126, and may be of any length required by a particular application, as will be further described below. The puncture mechanism 118 may include a lancet coupler 128 coupled to the lancet mating end 124 to engage the lancet 120 with the shaft 122, removably or otherwise. For example, lancet coupler 128 may be tubular and may form an interference or friction fit with lancet base 120a. Lancet coupler 128 may, but need not, be adjustable, such as by having a slot or notch at least partially along its length, for example, to engage lancets of one or more sizes or shapes. As other examples, the lancet coupler 128 may include threads, screws, notches, or other fasteners to engage a lancet,

<img file="MX336397B_D0012.tif" />

as will be understood by one skilled in the art. The? Puncture mechanism 118 may include one or more diversion devices, such as the_i;puncture 130. Puncture spring 130 can be coupled to puncture arrow 122 to deflect arrow 122 in one or more directions, temporarily, momentarily, or otherwise, as will be described later. Puncture spring 130 may, but need not, comprise a plurality of springs, and may advantageously include two springs.

System 100 may include a vacuum mechanism 132 to create a vacuum and communicate with lancing mechanism 118 or other components of system 100. Vacuum mechanism 132 may include a main shaft 134 having a lower main drive end 136, an upper main free end 138, and at least one trigger coupler 140, such as, for example, a notch or indentation. The main shaft 134 can be slidably coupled with the upper end cap 110, for example, so that the main drive end 136 can be arranged inside the body of the device 102 and the main free end 138 can be arranged outside the body d I device 102. System 100 may, but need not, include a knob 146, such as a button cap attached to the main free end 138, to manipulate the main shaft 134 or other components. The system 100 may include a release mechanism 142, such as a trigger device, for communicating with the main arrow 134, for example, for releasably coupling with the trigger coupler 140, a series of couplers of

<img file="MX336397B_D0013.tif" />

release, or other portion of main arrow 134. The release mechanism

Pe

142 it can be any type of releasable coupler, adapted to cooperate with the main shaft 134, as will be understood by one skilled in the art. For example, the release mechanism 142 can be coupled with the main shaft 134 in one or more positions along its length, such as with the trigger coupler 140, a series thereof or, for example, a notch, groove or external surface, to releasably hold the main shaft 134 in a particular position until, for example, the trigger 144 is actuated, as will be described further below. Vacuum mechanism 132 may include a piston 148 coupled to main shaft 134 to communicate with one or more other components of system 100 to create a vacuum. Piston 148 may be adjustably, fixedly or otherwise coupled anywhere on main shaft 134 within the body of device 102, such as, for example, to main drive end 136. Piston 148 may, but need not, include one or more seals, such as one or more O-rings 150, and may sealably communicate with interior wall 152 of device body 102 which, for example, may form a chamber vacuum 154 within the body of device 102 between piston 148 and a surface to be punctured in communication with seal 116.

System 100 may include one or more openings 156, such as an air passage or orifice, for fluid communication between vacuum chamber 154 and an atmosphere surrounding the vacuum chamber. Opening 156 may be calibrated to allow air flow into vacuum chamber 1 54 at a predetermined rate of vacuum dissipation, such as, for example, a rate of vacuum dissipation less than a predetermined rate of vacuum generation at the vacuum chamber 154. The opening

156 it can be any suitable place to communicate with a vacuum in system 100, such as in the body of device 102 (see, e.g., figure 9), and advantageously it can, but need not, be in piston 148, separately or in combination. Each opening 156 may, but need not, be adjustable in size, which may include having an adjustable diameter or being Interchangeable, separately or in combination. One or more openings 156 can give any rate of vacuum dissipation required by a particular application, such as a linear speed, nonlinear speed, or other speed, in whole or in part, separately or in combination.

Vacuum mechanism 132 may Include a deflection device, such as a vacuum spring 158, coupled to piston 148 to deflect piston 148 in one or more directions, such as in the upward direction. Vacuum spring 158 may, but need not, include a compression spring disposed between lower end cap 108 and piston

148 that deflects the piston away from the lower end cap 108.

Alternatively, or collectively, for example, vacuum spring 158 may include a tension spring that deflects piston 148 toward upper end cap 110, such as a tension spring disposed between I piston k *! ·· Η 'ρ

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148 and the top end cap 110, as will be understood by one skilled in the art of IP having the benefits of this disclosure. Vacuum spring T58^c^^iS“^orIndusfriQí can, but does not need, include a plurality of springs.

System 100 may include a vacuum indicator 133 to indicate whether or to what extent a vacuum exists within vacuum chamber 154. For example, indicator 133 may indicate when a vacuum having at least a predetermined magnitude is present in the system or, as another example, when a vacuum below the predetermined magnitude may be present, including when a vacuum is not present. In at least one embodiment, which is only one of many, pointer 133 may be a visual pointer, such as a tab, mark, color medium, notch, or other visible pointer, coupled to the main arrow 134, piston 148, or other component, whereby indicator 133 may visually indicate, such as by being visible, when no vacuum or a vacuum below a predetermined magnitude is present in the system. Indicator 133 may be visible, for example, through a slot, window, body portion of device 102, or other transparent means, which may be of any size or shape. As shown in the figures. 3A and 3B, for example, indicator 133 may not be visible, such as being within the body of device 102, while a vacuum having a predetermined magnitude may be present in the system, and may become visible, such as by passing through a free end portion 106 and into an indicator window 135 when no vacuum or vacuum below a predetermined magnitude is present in the system. As another example, the Cf © ÍCS l indicator 133 can be visible through at least a body portion of device 102, through an elongated window arranged longitudinally along the body of device 102, or through a combination of the same. Alternatively, indicator 133 need not be visible through the body of device 102 and may be visible only when it is outside of the body of device 102, in whole or in part (see, eg, Figures 5A-5E). For example, and without limitation, indicator 133 may be a mark on arrow 34 that is only visible outside the body of device 102 (e.g., above release mechanism 142) when arrow 134 has a free end sufficiently out 106, to indicate that the vacuum has dropped below a predetermined value. In at least one of many alternative embodiments, indicator 133 may be an audible indicator, digital indicator, electrical indicator, electronic indicator or, as other examples, a pressure sensitive indicator or mechanical indicator, separately or in combination. Indicator 133 may, but need not, indicate to a user when a vacuum in system 100 during puncture is sufficiently dissipated (i.e., is of sufficiently low magnitude) that system 100 can be removed from a surface to which it is has to puncture. For example, in an application where the skin is being punctured for blood collection purposes, indicator 133 may indicate when system 100 can be removed from the skin so that the blood drawn does not splash, as it might happen due to an atmospheric air flow, eg, if seal 116 were to be lifted from the skin with a vacuum - 7; relatively high in the vacuum chamber 154. Industry;

System 100 may include an arrow coupler 160 to releasably couple one or more components of system 100, such as spike arrow 122 and main arrow 134. Arrow coupler 160 may include two or more portions that optionally mate with the other. For example, the arrow coupler 160 may include a first portion 160a coupled to the puncture arrow 122, such as the drive end 126, and a second portion 160b coupled to the main arrow.

134, such as the main drive end 136. The first portion

160a and second portion 160b can be adapted to releasably couple to each other when they are brought at least close to each other and to disengage under a predetermined event, for example, when sufficient force is applied to the arrow coupler 160. In at least one embodiment, which is only one of many, one of the portions 160a, 160b may be a magnet and the other portion may be magnetic material, which may allow, for example, the puncture arrow 122 and the Main shaft 134 remains engaged until a separating force, such as a tension force, is applied enough to overcome the coupling force between the first portion 160a and the second portion 160b. Alternatively, or collectively, any portion 160a, 160b may be a portion of one of arrows 122,134, such as one of drive ends 126, 136 or, as another example, second portion 160b may

UÜ ¡,,, ...

be coupled to, Including integrally formed with, piston 148. In so Fl © lG Pi less one other embodiment, which is just one of many, the first and second Industrial 160 arrow coupler portions may include hook and loop material, fasteners mechanical, ball and socket joints, tacky material, or other couplers, as required by a particular application. In at least one embodiment, which is only one of many, a sufficient separation force can be any force less than a force generated by the vacuum spring 158 (see, eg, Figure 2).

Referring to Figure 4, lancing mechanism 118 may, but need not, include lower end cap 108. Alternatively, piercing mechanism 118 may be separately coupled to lower end cap 108 or other piercing end portion 104 of the device body 102. Puncture spring 130 may include a plurality of springs, such as upper spring 130a and lower spring 130b (collectively referred to herein as puncture spring 130). Puncture mechanism 118 may include a stop 129, such as a tab or block, to support puncture spring 130 or define puncture arrow stroke 122, in whole or in part. In at least one embodiment, such as the embodiment shown in Figure 4, which is only one of many, the stop 129 may be disposed between the mating end of the lancet 124 and the drive end 126 of the deflection arrow. Puncture 122. The upper spring 130a can be coupled between the stop 129 and the drive end 126, and the lower spring 130b can be coupled between the stop

OF

129 and the mating end of the lancet 124. Each puncture spring cf © lo Fsv, '.

130a, 130b may be loosely arranged around the shaft 122 or may have one or more ends fixedly attached to the shaft 122 or stop 129, separately or in combination. Each puncture spring

130a, 130b can be any type of spring, or other deflection device, and can have any K value or length required by a particular application. The lancet shaft 122 can have a state of rest, which can be at least partially defined by communication between the springs 130a, 130b and stop 129, separately or in combination with one or more other components of system 100. For example, when shaft 122 is at rest, one or more of springs 130a, 130b may, but need not, be in its natural state (ie, neither compressed nor extended). Alternatively, one or more springs may be under tension or compression when the puncture arrow 122 is at rest or, as another example, while the puncture arrow 122 is in motion, such as during puncture, as required by a particular application. and how one skilled in the art will understand it. When the puncture arrow 122 is in the resting position, the lancet needle 120b may, but need not, be distal of a punctured surface 168, such as the skin (see, eg, figure 5F). The lancet shaft 122 can be of any length required by a particular application and can be slidably coupled with the stop 129 whereby the puncture spring 130 can deflect the shaft 122, such as in the upward or downward direction, as

<img file="MX336397B_D0014.tif" />

will be described further below. ¡

I've

Figure 5A is an illustration of one of many modalities ^^^ g ^^ of a vacuum puncture system 100 in a cocked position in accordance with the description. Figures 5B, 5C and 5D are illustrations of the system 100 of Figure 5A in three respective positions during puncture.

Figure 5E is an illustration of the system 100 of Figure 5A in an uncocked position. FIG. 5F is an illustration of the system 100 of FIG. 5A manipulating a surface during puncture. Figure 5G is an illustration of the system 100 of Figure 5A vibrating a surface during puncture. At least one of many methods of using the system 100 embodiment shown in Figures 5A-5G can be described.

Figure 5H is a graph illustrating the magnitude of vacuum versus the time during which puncture can occur during a vacuum cycle. Figures 5A-5H will be described together.

A lancet 120 can be attached to the puncture mechanism

118, such as using one of the methods described herein, for example, before or after system 100 is in a "cocked" position (see, eg, Figure 5A). System 100 can be cocked, for example, by pressing knob 146 downward until at least one main shaft portion 134, such as trigger coupler 140, engages with release mechanism 142, which can releasably hold main shaft 134 and piston 148 down toward puncture end 104, such as against the force of vacuum spring 158. The second portion of the

<img file="MX336397B_D0015.tif" />

arrow coupler 160b at the main drive end 136 Me can it couple to the first portion 160a of the arrow coupler 160 in fttdusdrive drive end 126 of the puncture arrow 122. The drive end 126 can, but need not, move down during cocking, temporarily or otherwise. Upper spring 130a and Lower spring 130b may, but need not, be in their natural states. System 100 can hook a surface to be punctured (not shown), such as an area of ​​skin on a person's body, which can be any area. For example, seal 116 on lancet guide 112 can engage the surface such that at least a partially watertight seal is formed between seal 116 and the surface.

System 100 can be activated, or triggered, for example, by actuating trigger 144, which can at least partially disengage main shaft 134 and, for example, release coupler 140, from release mechanism 142, which can allow the main arrow 134 slidably communicates with the upper end cap 110. Release 144 can be pressed directly, such as with a user's finger, or indirectly actuated, for example, using a magnet, electrical or mechanical actuator, or other method, as required by a particular application.

Vacuum spring 158 can at least partially decompress (or lose tension if a tension spring, as mentioned above and as described below) and piston 148, main shaft 134 and shaft coupler 160 can be moved in the direction ascends to the settlement of the

13,-- :

surface to which the puncture is made. The 148 piston, which can, but rft?_c If Proposed needs to include one or more seals, such as O-rings 150, they may be in sliding seal engagement with the inner wall 152 of the device body 102, thereby at least partially forming a vacuum in the vacuum chamber. 154 as piston 148 moves away from the punctured surface. One or more components of lancing mechanism 118, such as drive end 126 and piercing shaft 122, may be moved upward with the main shaft 134, for example, due to the coupling force of the shaft coupler

160 and the force of the expansion vacuum spring 158. The upper spring

130a can expand and Bottom spring 130b can contract, which can, for example, individually or in combination, exert a greater force on its first portion 160a of arrow coupler 160 in the opposite direction (eg, downward) of the force exerted on the second portion 160b by the vacuum spring 158 (eg, upward) as the vacuum spring 158 expands (Figure 5B). The lancet shaft 122 may have a shorter stroke than the main shaft 134. For example, the stop 129 may limit the stroke of the lancing shaft 122, for example, preventing at least a portion of the shaft 122 from traveling. upwards beyond the top or, as another example, the puncture spring 130 (collectively referred to as springs 130a and 130b) can be arranged to limit the puncture arrow stroke 122, separately or in combination with the stop 129. In at least one embodiment, which is only one of many, the puncture spring 130

<img file="MX336397B_D0016.tif" />

it can have, for example, a length or value K that can give a puncture spring force greater than the coupling force of the shaft ^ ^^ ^ ^ arrow coupler 160 when the puncture arrow 122 is at a posfc &lt;9 $^us^^Qi particular, which can be any position required by a particular application.

Arrow coupler 160 can be decoupled and second portion 160b can continue to move in the upward direction (Figure 5C). Piston 148 can continue to move upward during and after surface penetration, continuously or in segments, such as by using two or more release couplers 140 that successively engage release mechanism 142, which can increase the vacuum to which the surface can be exposed. The upper spring 130a can contract and the lower spring 130b can expand, individually or in combination, which can, for example, cause the first portion 160a to move in the opposite (i.e. down) direction of the second portion 160b of the arrow coupler 160. The lancet arrow 122 can be retracted from the surface and the coupling force between the portions 160a and 160b can be overcome. The puncture mechanism 118 can move into a rest position, such as due to the force of one or more springs 130. The puncture arrow 122 can move downward, such as until at least a portion of lancet 120 makes contact with the surface (figure 5D). In at least one mode, which is just one of many, the puncture arrow 122 can, but does not need,

<img file="MX336397B_D0017.tif" />

move down enough that the upper spring 130 is at least partially compressed and the lower spring 130b expands so that it? rí§rF &lt;^ P ^^ c partially as the lancet 120 punctures the surface .

As one skilled in the art will understand, inertia can cause the puncture arrow 122 to move beyond its rest position (e.g., down), for example, so that the lancet needle 120b can pierce the surface, before returning to its resting position. After at least partially penetrating the surface, each of the springs 130a, 130b and the puncture arrow 122 can return to a state of rest (FIG. 5E), and the lancet 120 can be disposed up and distally from the surface .

The surface can be subjected to a vacuum before, during or after puncture, separately or in combination. Air can enter vacuum chamber 154 (selectively, automatically, or otherwise), such as through opening 156, which can dissipate vacuum at any rate required by a particular application. Indicator 133, such as a tab, slot, or mark, can be made visible, such as by passing outside the body of device 102, which may indicate dissipation of the vacuum, in whole or in part. System 100 can be disengaged from the surface, which can leave an amount of blood on the surface for collection.

A punctured surface 168 can, but need not, be manipulated during the puncture, which may include twisting,

<img file="MX336397B_D0018.tif" />

pumping, up and down pressure, or any movement, separately or in combination (see, eg, figure 5F). By exercising where the surface 168 is skin, one or more components at the puncture end 104 of the body of the device 102, such as the lancet guide 112 or seal 116, can be used to rub, massage or otherwise manipulate the skin at any time during the puncture process, for example, before, during or after puncturing the skin, which may result in a larger volume of blood 176 being drawn and / or faster blood draw. As an example of this manipulation, the seal 116 can be placed against the skin and twisted in one or more directions, such as from back to front, clockwise, then counterclockwise (or vice versa), for example, whereby the skin is twisted, such as due to friction between the skin and the seal 116, which can increase blood flow to the area where the puncture is made or outside of an opening in the skin made by lancet 120. The surface of seal 116 can be made of or coated with a fastener-like substance, such as for assist torsion of the surface when seal 116 is being twisted. Another example of this manipulation, which can speed up the blood draw, may include increasing and decreasing the inward pressure of the seal 116 on the surface in a pulse-like action. Each of these types of manipulation, such as squeezing a finger that is pricked, can speed up blood flow through a lancet-generated hole. This may be especially true in the presence of

<img file="MX336397B_D0019.tif" />

a vacuum on the surface as described in the present description. The degree of manipulation, if any, of the skin can vary from one surface to another in user areas, and from one user to another, as will be understood by one skilled in the art having the benefits of this disclosure.

With continued reference to Figures 5A-5G, and further reference to Figure 5H, the time and magnitude of vacuum and puncture creation may include one or more variables, as will be understood by one skilled in the art, each of which may have any value required by a particular application. The magnitude of the vacuum and the speed at which the vacuum can be created, the puncture time, such as when the arrow coupler 160 disengages, the speed at which the lancet 120 can travel, and the force with which the lancet 120 hits a surface, or other factors can, but need not, be optimized for a particular application. Also, vacuum creation can occur in a single stage, or in multiple stages. For example, one or more of these factors can be correlated with the travel and time of the piston 148 along a length of the body of the device 102. As will be understood by one skilled in the art, the additional piston 148 travels within the body of the device 102 (eg, away from a punctured surface), as high as a vacuum chamber vacuum 154 can be. Furthermore, the force with which the lancet 120 makes contact with a surface, such as the skin, may be at least sufficient to prick or penetrate the surface, and advantageously may drive at least a portion of the needle 120b through the surface and

<img file="MX336397B_D0020.tif" />

inside the subcutaneous tissue below the surface from which sgj ^ uedé take the blood. One or more variables can be defined by the length yAS ^ - '* K value of a spring, such as puncture spring 130 or vacuum spring 158, the volume of the vacuum chamber 154 or, as another example, by the weight, stroke, or length of an arrow, such as puncture arrow 122 or main arrow 134.

In at least one embodiment, such as the embodiment shown in Figures 5A-5G, which is only one of many, the stroke of the spike arrow 122 can determine when the arrow coupler 160 can be disengaged during puncture and when the lancet 120 can contact or penetrate the punctured surface, such as during a period in which a vacuum can be applied to the surface. For example, when released from a cocked position, piston 148 can travel upward from a lower position (see, e.g., Figure 5A) where there is no vacuum within vacuum chamber 154 at a higher position. (see, eg, Figure 5E), thereby creating a maximum vacuum within vacuum chamber 154, which can be any amount of vacuum, such as up to 76.6 cm of mercury, required by a particular application.

As shown for illustrative purposes in Figure 5H, puncture of a surface can occur at any time before, during, or after a vacuum cycle, as appropriate for a particular application. For example, surface puncture may occur before a vacuum is created, as indicated by reference A. Alternatively, the

<img file="MX336397B_D0021.tif" />

surface puncture can occur while the vacuum is increasing ^ ftr'X, ^L :

of the Own in the body of the device, as indicated by reference B, such as Igfllustrt ©! 1/2 of peak vacuum P. As will be understood by one skilled in the art having the benefits of this disclosure, reference B illustrates one of many puncture times during vacuum creation, and puncture may alternatively occur at any point a along a line between references A and C. Puncture can also occur when the vacuum is at a peak vacuum P, illustrated by reference C. In one or more other modalities, puncture can occur after the peak vacuum and before the vacuum has completely dissipated, such as as at a point in time illustrated by reference D, which can be, for example, 1 / 3P, or any point in time along a line between references C and E. As another example, puncture may occur after a vacuum has dissipated, such as at the point in time illustrated by reference E.

As described above, puncture can occur at any time during a vacuum cycle, including before, during, or after a vacuum has been created, and can advantageously occur when at least a partial vacuum is created, such as between 30 % and 70%, or any increase between them, of the maximum vacuum for a particular application. In at least one embodiment, which is only one of many, the puncture may advantageously occur between 40% and 60% of creation, vacuum, or any increase between them, such as 50% of creation of vacuum. For example, the maximum vacuum can be -50.8 cmHg, since the surface can be

<img file="MX336397B_D0022.tif" />

puncture when the vacuum in vacuum chamber 154 is, for example, -25.4 cmHg. However, this is not necessarily the case '^ and the

Incited examples described herein are for illustrative purposes. The puncture time can, but need not, be adjustable. For example, in at least one embodiment, such as a commercial embodiment, which is only one of many, system 100 may include a plurality of interchangeable puncture arrows, each of which may have a different length, which may determine when puncture occurs during a vacuum cycle, as described above.

The speed at which the vacuum is created, which can be at least partially determined by the speed at which the piston 148 travels upward, may, but need not, be adjustable. For example, in at least one embodiment, system 100 may include an impact damper, piston, or other device (not shown), to control the speed at which piston 148 rises during puncture. The vacuum can be dissipated, or released, such as through opening 156, or movement of piston 148, separately or in combination, at any speed and at any time required by a particular application. For example, where the surface to which a puncture is made is the skin, the vacuum can be advantageously released at a speed and time that can allow an adequate amount of blood for collection to be drawn from the surface or, as another example , at a speed that can at least partially minimize blood spatter when the system is removed from the

JjJ; L-skin.

d © lQ PfSpiiGiíüG

With continued reference to Figures 5A-5G, the Iflfttóstel system can, but need not, be adapted to vibrate during puncture. The term "vibrate" and conjugations thereof are widely used herein and specifically include, without limitation, any stirring, shuddering, pulsing, or other movement applied by the puncture system 100 to a surface to which a puncture is made. One or more vibrations may occur at a predetermined time in proximity (eg, in time and space) for the lancet to penetrate a surface, which may conceal the user's penetrating sensation. Vibration in system 100 can at least partially conceal the pain associated with the puncture, if at all, such as where the surface on which the puncture is made is the skin. Vibration can be controlled by adjusting the properties of one or more of the components, such as dynamic components, of a particular embodiment of system 100, and can be of any magnitude or duration required by a particular application. The magnitude of a vibration can depend on, or be predetermined by, for example, the mass of one or more components in the system, the K value of one or more springs, the blow of one or more arrows, the momentum of one or more components, or other factors, as will be understood by one of skill in the art having the benefits of this disclosure. One or more vibrations may occur individually, consecutively, concurrently, supplementally or otherwise, and may occur n, or transfer to, one

<img file="MX336397B_D0023.tif" />

or more components of system 100. Advantageously, one or more Ffor vibrators may be present at puncture end 104, for example, whereby vibrations can be transferred at least partially to surface 168 during puncture (see, eg, figure 5G), which in this way can help cover puncture pain. Vibration can be caused by any of the components, such as dynamic components, of a particular embodiment of system 100, and can be of any magnitude or duration required by a particular application. The magnitude of a vibration can depend on, or be predetermined by, for example, the mass of one or more components in the system, the K value of one or more springs, the blow of one or more arrows, the momentum of one or more components, or other factors, as will be understood by one of skill in the art having the benefits of this disclosure. In at least one embodiment, which is only one of many, a vibration can begin before penetration of a surface and, at least partially, can continue during penetration of the surface. The vibration can advantageously, but need not, continue after a puncture has been made to the surface. As other examples, one or more components of the puncture mechanism 118, such as puncture spring 130 or puncture arrow 122, can cause vibration in system 100, separately or in combination with other components in the system.

In at least one embodiment, which is only one of many, one or more portions of the puncture assembly, such as the puncture arrow

<img file="MX336397B_D0024.tif" />

122, lancet coupler 128, or main arrow 134, can be moved in one a. ·. l:

first direction, such as towards the free end 106 of the body.

£ Γί £ s Lí üí i.¹one device 102, for example, at a first distance. One or more of the portions, such as the first portion 160a of the arrow coupler 160, may be stopped from moving further in the first direction, such as beyond the first distance, for example, by the stop 129, which may causing a vibration in one or more parts of system 100. Advantageously, the vibration continues to occur for an amount of time at least long enough for the surface to be penetrated. One or more components can move in a second direction, such as in a direction opposite to the first direction, for example, towards the puncture end 104 of the body of the device 102. One or more components, such as the puncture shaft 122 or the first portion 160a of the shaft coupler 160, may be stopped from moving further in the second direction, for example, beyond a second distance, which may cause one or more vibrations in system 100.

FIG. 6 is a schematic front isometric view of one of many embodiments of the vacuum puncture system 100 having a depth controller 162 in accordance with the description. Figure 7A is a schematic cross-sectional view of the system 100 of Figure 6. Figure 7B is a schematic cross-sectional view of the system 100 of Figure 6 with a base contacting a spacer.

Figure 7C is a schematic cross-sectional view of system 100

<img file="MX336397B_D0025.tif" />

of figure 6 during blood collection. Figures 6-7C are d ^ gr ^ i ^^. ^ Next to each other. Vacuum puncture system 100 may include depth controller 162 to control the depth at which a puncture is made on a surface during puncture. The depth controller 162 may include a calibrated spacer 164 and a spacer coupler 166 to couple the spacer 164 to the puncture end 104 of the body of the device 102. Depth controller 162 can be formed of any material, such as plastic or metal, and can be replaceably and interchangeably coupled to the body of device 10 102 in a way, such as being threaded into it, forming interference or friction fit with one or more other system 100 components, or fastened with fasteners, such as screws, clamps, adhesive, or other fasteners, removably, permanently, or otherwise, and another method of fixing. Alternatively, depth controller 162 may be fixedly coupled to device body 102, integrally or otherwise, or any portion thereof. Depth controller 162 may, but need not, be transparent, in whole or in part. The spacer coupler 166 can be tubular and can be coupled, for example, to the lancet guide 112 (see, e.g., Figure 20 1) or, as another example, instead of the lancet guide 112, according to is required by a particular application. Spacer 164 can be coupled to spacer coupler 166, including being integrally formed therewith, between lancet 120 and a surface 168 to which i is to be made i

<img file="MX336397B_D0026.tif" />

a puncture. As another example, depth controller 162 can

L.

be adjustable, such as by means of one or more variadtetg Propicdet Industries components, a spacer 164 of variable length or thickness, as will be further described below (see, e.g., Figure 18).

Spacer 164 may include a central opening, such as a hole 170, to allow at least a portion of lancet 120 to pass through it, and may have a calibrated thickness "t", which may be any thickness required by a particular application, and which may be the same or different from the thickness of one or more portions of the spacer coupler 166. Spacer 164 may, but need not, be adjustable, which may include being interchangeable, individually or simultaneously with spacer coupler 166, for example, to allow spacers of different thicknesses. Hole 170 (having dimension "d" in FIG. 7A) can have any shape or cross-sectional area required by a particular application, and advantageously can have a larger cross-sectional area than that of needle 120b and more smaller than that of base 120a (having a dimension "D" in FIG. 7A) whereby needle 120b can pass through hole 170 and base 120a cannot, ie,

D&gt; d (see, e.g., figure 7B). Base 120a can contact the upper surface 172 of spacer 164 during puncture, which can limit the depth to which needle 120b can penetrate surface 168, such as the difference between length T of needle 120b and thickness Y of separator 164. This may be advantageous, for example, because the depth

The penetration rate of needle 120b at surface 168 can be controlled ^ X ^ ® regardless of the force with which the lancet 120 travels ^ er? downward direction during puncture, which can be any force. For example, where surface 168 is skin, the force required to support lancet 120 on skin may vary from application to application and from user to user, such as between relatively smooth and thin skin and relatively rough skin and thick, such as callused skin.

Depth controller 162 can allow, for example, a relatively large force, such as a force large enough to prick callused skin, to also be used on softer areas of the skin, for example, by stopping the travel distance of needle 120b, so that regardless of its roughness, the skin can be punctured to a depth of T minus "t" when the bottom surface 174 of the separator 164 is adjacent to the skin, i.e. a depth equal to the difference between the length "Γ of the lancet needle 120b and the thickness" t "of the spacer 164. As another advantageous example, where the surface 168 that is punctured is the skin, an obtuse force can be produced or vibration, such as from an impact between upper surface 172 and base 120a, which can, but does not need, covers the pain that may result from the puncture. In at least one embodiment, which is only one of many, and is described herein for illustrative purposes only, lancet 120, which may, but need not, be a commercially available sideboard lancet, may have a base 120a having a dimension "D" (which can, but need not, be a

<img file="MX336397B_D0027.tif" />

diameter) of .635 cm and a 120b lancet needle that has a length T of .317 cm. Spacer 164 may have a thickness "t" of 0.226 ^^ nrj ^ un, hole 170 having a dimension "d" of 1,290 cm. As will be understood by a person skilled in the art having the benefits of this description, this illustrative embodiment, for example, can penetrate the surface 168 that is punctured at 0.228 cm, which is the difference between the illustrative length T of the needle 120a and the thickness " t "illustrative of the separator 164. As another example, the surface 168 can be penetrated up to .165 cm where the separator 164 has a thickness of .152 cm and the needle 120b has a length of .317 cm.

The thickness "t" of spacer 164 can be any thickness required by a particular application, where the greater the thickness "t, the smaller the lancet penetration depth, and vice versa, for a particular T of a required needle 120a for a particular application. The thickness "t" of a particular separator 164 may advantageously allow at least a portion of needle 120b to penetrate surface 168, such as skin or other puncture surface, so that blood 176 can leave surface 168. Illustrative thicknesses of spacer 164 may include .254 cm, .203 cm, .152 cm, .102 cm, and .051 cm, as well as thicknesses greater than, less than, or between such values. Spacer 164 can be calibrated for any surface, such as for one or more areas of a user's skin. For example, separator 164 may be relatively thin for some surfaces, such as where blood vessels are scarce or more distant from the surface of the skin, or separator 164 may be relatively thick for other superficial ones. example, where blood can be closer to the skin, which can vary from one application to another, or from one user to another. The bottom surface 174 of spacer 164 may, but need not, be in direct contact with a puncture surface, for example, to allow hole 170 to sealably latch to the surface. In at least one embodiment, for example, depth controller 162 may include an annular flange (not shown), which may comprise a seal, coupled to bottom surface 174 and extending downward to engage a puncture surface, individually or in combination with the bottom surface 174.

Depth controller 162 may include interchangeable or modular units, which may include interchangeable spacers 164 for a particular depth controller 162 or, as another example, interchangeable depth controllers 162 for a particular system 100, wherein one or more depth controllers 162 may, but need not, have separators 164 of different calibrated thickness. Each exchange unit can be graded and, for example, can vary in Increments from one unit to another. In at least one embodiment, which is just one of many, system 100 may include a plurality of depth controllers 162, such as an assembly or kit, which may include a plurality of different depth controllers or stops that may be installed. selectively changed or moved by a user as required by a particular application. At least in one of.

In one mode, which is just one of many, a set of depth controllers 162 can be stored, or storable, in a container, such as a bag or case, such as when not in use. A user may choose to use any one or more depth controllers 162 required by a particular application, which may include choosing to use a depth controller already attached to the body of device 102 or, as another example, may include choosing a depth controller separate from the body. device 102 and attaching the chosen depth controller to the body of device 102.

FIG. 8A is an illustration of one of many modalities of a vacuum puncture system having a lancet tool 200 in accordance with the description. FIG. 8B is an illustration of a lancet 120 that is inserted into a lancet coupler 128 with the puncture tool 200. FIG. 8C is an illustration of a lancet 120 that is coupled to the lancet coupler 128 with the lancing tool 200 . FIG. 8D is an illustration of a lancet 120 being removed from lancet coupler 128 with lancing tool 200.

Figures 8A-8D will be described next to each other. The vacuum puncture system 100 may include a lancet tool 200 for coupling and decoupling a lancet 120 with the lancet coupler end 124 of the puncture shaft 122, such as the lancet coupler 128, securely and conveniently. The lancet tool 200 may include a lancet tool body 202 and one or more couplers, such as, ppr'íelGFíCit .. /, example, lancet insert coupler 204 and removal coupler d &amp; K &amp; sfe .; lancet 206, which can, but does not need, to be tubular. For example, insert coupler 204 and removal coupler 206 may, but need not, have annular cross sections and / or one or more longitudinal grooves to allow lancet 120 to be inserted therein, as one skilled in the art will understand. technique.

To install lancet 120 in system 100, for example, lancet 120 can be inserted into insert coupler 204 "needle end first" so that lancet needle 120b 120 is within insert coupler 204 and so that lancet base 120a engage with insert coupler 204 and at least one base portion 120a projects from insert coupler 204 (see, eg, Figure 8B). In at least one embodiment, which is just one of many, base 120a and insert coupler 204 may form a slack fit or, as another example, an interference fit less than an interference fit between lancet coupler 128 and base 120a. Insertion coupler 204 and lancet 120 can be moved toward puncture end 104, as indicated by the arrows in Figure 8B, and arranged such that base portion 120a projecting from insertion coupler 204 engages with the lancet mating end 124 of the puncture arrow 122, such as the lancet coupler 128 (see, e.g., Figure 8C). For example, as mentioned before, lancet base 120a can form an interference fit with lancet coupler 128 whereby lancet 120 disengages from insert coupler 204 and remains seated in lancet coupler 128 to make a puncture when the puncture tool 200 is removed from the lancet guide 112, as indicated by the arrow in Figure 8C.

To remove lancet 120 from lancet coupler 128, for example, lancet removal coupler 206 can be inserted into lancet guide 112 until removal coupler 206 passes over needle 120b and engages a base 120a of lancet 120. For example, removal coupler 206 and base 120a can form an interference fit, such as an interference fit that has a greater interference (i.e., a tighter fit) than the interference fit formed between base 120a and lancet coupler 128. Lancet tool 200 and lancet 120 can be moved away from lancet coupler 128, as indicated by the arrows in Figure 8D, and lancet 120 can be disengaged from lancet coupler 128 and remain coupled to removal coupler 206, which can remove lancet 120 from lancet coupling end 124. Although lancet insert coupler 204 and lancet removal coupler 206 from puncture tool

200 have been described here to communicate with lancet 120 using one or more "settings", such as an interference or slack fit, this is not necessarily the case and alternatively each coupler 204,206 can be mated to lancet 120 by any way required by a

<img file="MX336397B_D0028.tif" />

particular application, as will be understood by one skilled in the art. As a R7 deiap_IQÍ-_tl For example, which is just one of many, lancet 120 may be threadably attached IncTisphthata to lancet coupler 128, and one or more of couplers 204, 206 of lancing tool 200 may include a notch, groove, or other structure to communicate with lancet 120, such as in a complementary manner, separately or in combination with a particular setting, for example, to screw lancet 120 or unscrew lancet 120 from lancet coupler 128.

In at least one embodiment of the lancing system 100, which is only one of many, the lancing tool 200 can be attached to the body of the lancet device 102, such as to the outside along its length, when it is not In use. For example, the body of the lancet device 102 or lancing tool 200 may, but need not, have at least one bracket 208, such as complementary couplers, mounted thereon, such as, for example, magnets, hook material and loops, snap fits or other fasteners. As other examples, the body of the device 102 may have a hook, clamp, handle, or other fastener attached thereto and adapted to hold the puncture tool 200, such as by the body of the tool 202, or the body of the device 102 may have a stem or bracket adapted to engage insertion coupler 204 or removal coupler 206. Lancet tool 200 can be formed of any material required by a particular application, such as plastic, metal or other material, and can be of any shape or size,

<img file="MX336397B_D0029.tif" />

This is as understood by one of skill in the art having the benefits of description.

FIG. 9 is a schematic cross-sectional view of one of many embodiments of a vacuum puncture system 300 having an external vacuum gauge 302 in accordance with the description. For purposes of clarity, the same reference numbers as those previously used here will be used in some cases, while new reference numbers will be used to reference components that may not have been previously described. It should be understood that although the same reference number can be used to reference a component in two or more figures, the component may, but need not, be exactly the same in practice, which is required by a particular embodiment or mode.

Lancing system 300 can generally operate similarly to one or more of the other modalities described herein, and can include an external vacuum gauge 302 coupled to the body of device 102 to indicate whether a vacuum is present in the system. Indicator 302 may include indicator body 304 coupled in fluid communication with vacuum chamber 154, such as indicator air tube 306, which may be any type of conduit. Indicator 302 may include marker 310 sealably coupled within indicator body 304 and an indicator spring 308 coupled between marker 310 and vacuum chamber 154. Indicator 302 may include a display window 312 for viewing marker 310, such as, for example, when there is no vacuum in the system. Window 312 can be attached anywhere to indicator body 304, eg, top or side, and can be any size. For example, window 312 may, but need not, be at least a portion of the body of Indicator 304, and may be at least partially transparent, such as a thin transparent strip along the length of the body of Indicator 304. Alternatively, for example, the body of the indicator 304 may be completely transparent.

Indicator 302 can be attached to the body of device 10 102 anywhere between a punctured surface and piston 148.

Indicator 302 may be an "L-type Indicator (as shown in FIG. 9), for example, whereby indicator body 304 is parallel to device body 102, an" L-type "indicator, for example whereby the body of the indicator 304 is perpendicular to the body of the device 102 or, as another example, the indicator 302 can be arranged at another angle, which can be any angle, in relation to the central longitudinal axis X of the system.

As a vacuum is created in system 300 during puncture, marker 310, such as a disc or other indicator, can travel to tube 306 and, for example, spring 308 can be compressed. Marker 310 may, but need not, be invisible. As the vacuum is released during puncture, marker 310 can move along tube 306 and spring 308 can expand, which can move at least

Ίί a portion of marker 310 on display, such as being vtsit ^ kp ^ gi through window 312. Although Indicator 308 spring may¹^¹¹⁸^⁰* show that it is a compression spring in Figure 9 for illustrative purposes, it need not be, and alternatively it may be a tension spring, or both, separately or in combination, as will be understood by one skilled in the art.

With further reference to FIG. 9, system 300 may include at least one opening between vacuum chamber 154 and an atmosphere surrounding the vacuum chamber, as described above (see, e.g., FIG.

5A). For example, and without limitation, the embodiment of Figure 9, which is only one of many, may include three openings 156A, 156B, and 156C (collectively "opening 156"), but this is not necessarily the case and, alternatively, the System 300 can include any number of openings 156, such as one, two or more, or none, as required by a particular application. Each opening 156, such as one or more of the openings 156A-C, may be in the piston 148, device body 102, or another portion of system 300, separately or in combination. Similar to the embodiment of Figure 9, any embodiment of the present invention, such as one or more of the other embodiments shown or described herein, may include any number of openings 156 arranged anywhere required by a particular application, separately or in combination, as will be understood by one skilled in the art having the benefits of the present disclosure. Although one or more hard drives 156 n a particular modality can give a speed d

<img file="MX336397B_D0030.tif" />

L Linear vacuum dissipation (see, e.g., figure 5H), this is not necessarymeqtp ctelePív;. · ;.

The case and, alternatively, a vacuum dissipation rate can be non-linear, as required by a particular application.

FIG. 10 is a schematic cross-sectional view of one of many embodiments of a vacuum puncture system 400 having an external vacuum assembly 402 in accordance with the description.

System 400 can include a puncture assembly 404 to puncture a surface, which can be any puncture assembly required by a particular application. Puncture assembly 404 may, but need not, include a vacuum mechanism coupled to the body of main device 408, such as, for example, one or more of the modalities described herein, partially, separately, or in combination. System 400 may include a lancet 120, such as a commercially available lancet, and a vacuum chamber 406, which may, but need not, extend at least partially within the body of main device 408. System 400 may include an assembly external vacuum 402 to create at least partially a vacuum in vacuum chamber 406. Vacuum assembly 402 may, but need not, be a second source, additional source, or supplemental vacuum source in system 400, and may operate separately or in combination with one or more other components, such as vacuum components, components puncture, or other components of the 400 system.

Vacuum assembly 402 can include a vacuum body 410

I '' and · '';

to support one or more system components. Vacuum body 410 may be tubular and may have a vacuum end 412 and a longitudinally opposite exlroiWF'¡c 414. Vacuum body 410 may, but need not, be rigidly, removably coupled to main device body 408 or otherwise. Vacuum assembly 402 can include an arrow 416, which can be slidably coupled to end 414. Vacuum assembly 402 may include a release mechanism 418 coupled, for example, to end 414 of vacuum body 410, which can cooperate with arrow 416 to removably hold arrow 416 or one or more other components in one or more positions. The vacuum assembly

402 may include a piston 420, which may be in sealing engagement with the vacuum body 410, such as with an internal surface 422, for example, to create, increase the level of, or dissipate a vacuum within the vacuum chamber 406 Piston 420 may, but does not need, include an opening (see,

eg, Figure 5E) therein to allow fluid communication between vacuum chamber 406 and an atmosphere surrounding vacuum chamber 406. Vacuum assembly 402 may include one or more springs, such as spring 424, to deflect piston 420 in one or more directions, for example, towards end 414 of vacuum body 410. Vacuum assembly 402 can be fluidly coupled to vacuum chamber 406, for example, through conduit 426, which can be any conduit, such as a pipe, tube, or other conduit, to direct fluid. Therefore, vacuum chamber 406 may include conduit 426 and at least a portion of the vacuum body.

410.

Γ

<img file="MX336397B_D0031.tif" />

Many can generally operate or function similarly to one or more of the other modalities described herein, such as to create or release a vacuum, in whole or in part, in vacuum chamber 406. For example, the vacuum assembly 402 can create at least a portion of a vacuum in vacuum chamber 406, and puncture assembly 404 can puncture a surface before, during, or after a vacuum exists. Vacuum assembly 402 can, but does not need, create or dissipate a vacuum in portions, such as segments or stages, for example, by movement of piston 420 in one or more directions. Vacuum assembly 402 may cooperate with puncture assembly 404 to form a vacuum, in whole or in part, for example, in one embodiment, which is only one of many, where puncture assembly 404 includes a vacuum or otherwise may be capable of creating at least a portion of a vacuum independent of vacuum assembly 402. Penetration of a surface can occur at any time during puncture, such as at a predetermined time during vacuum creation, as required by a particular application.

With one or more illustrative embodiments of the present invention having been described above, another of many embodiments will now be described. For clarity purposes, the same reference numbers as those used earlier here will be used in some t

<img file="MX336397B_D0032.tif" />

cases, while new reference numbers will be used to rerttar &lt;®p ^

Industrial components that may, but do not necessarily, differ from those described above, in whole or in part. It should be understood that although the same reference number can be used to reference a component in two or more figures, the component may, but need not, be exactly the same in practice, which is required by a particular modality or application, and the Reference numbers used here are arbitrarily chosen for ease of explanation. One or more of the components and principles described above are also applicable to the following embodiments, and vice versa, regardless of whether similar reference numbers are used, as will be readily understood by one skilled in the art. Certain details may not be repeated for the sake of brevity and to avoid unnecessary repetition, although such details may be uniformly applied to all embodiments of the present invention.

Figure 11 is a schematic isometric view of another of many embodiments of a vacuum puncture system in accordance with the description. Figure 12 is a schematic isometric assembly view of the vacuum puncture system of Figure 11. Figure 13A is a schematic cross-sectional view of the vacuum puncture system of Figure 11 in a cocked position. Figure 13B is a schematic cross-sectional view of the vacuum puncture system of Figure 11 in an uncocked position. Fig. 14 is a schematic cross sectional view of one of many modalities of a puncture mechanism ¡$ e_cof ία ​​in accordance with the description. Figure 14A is a schematic cross-sectional view of the release mechanism of Figure 14 coupled to the main arrow prior to activation. Fig. 14B is a schematic cross-sectional view of the release mechanism of Fig. 14A decoupled from the main arrow after activation. Figure 14C is a schematic view of another of many modalities of a release mechanism in a deactivated position in accordance with the description. Figure 14D is a schematic view of the release mechanism of Figure 14C in an activated position in accordance with the description. Figure 14E is a schematic view of another of many modalities of a release mechanism in a deactivated position in accordance with the description. Figure 14F is a schematic view of the release mechanism of Figure 14E in an activated position in accordance with the description. Figures 11-14F will be described together.

Vacuum puncture system 500 may include a body of device 102, which may include one or more end caps 108, 110, coupled to or integrally formed therewith, in whole or in part. A puncture mechanism 518 can be coupled to body 102, such as a puncture end 104, to support a lancet 120 (also known as a "lancet"). Puncture mechanism 518 may include a puncture arrow 122 slidably coupled with end cap 108, such as along the central longitudinal axis X, to communicate lancet 120 with a surface during puncture. The arrow of puncture delsFre ,.

122 may include a lower lancet coupling end 124 and upper actuation end 126. Lancing mechanism 518 may include a lancet coupler 128 coupled to the lancet coupling end 124 to engage lancet 120 with arrow 122, removably or de another way. Puncture mechanism 518 may include one or more diverting devices, such as puncture spring 130. Puncture spring 130 may be coupled to puncture arrow 122 to deflect arrow 122 in one or more directions, temporarily, momentarily, or otherwise, as will be described later. Puncture spring 130 may, but need not, comprise a plurality of springs, and may advantageously include two springs.

System 500 may include a release mechanism 542, such as a trigger assembly, which may include a release 144, one or more release couplers, and one or more components coupled therebetween, as will be further described below. Release mechanism 542 may include a structure to cooperate with other components of system 500, such as puncture mechanism 518, vacuum mechanism 532, or other elements of the system, separately in combination. Release mechanism 542 can be any type of puncture releasable coupling system, and can be adapted to cooperate with main shaft 134, such as by optionally coupling with firing coupler 140, piston 148, and / or other

IH

I

Μ

Pi

<img file="MX336397B_D0033.tif" />

system components coupled to arrow 134, releasably hold main arrow 134 in one or more positions. By

<img file="MX336397B_D0034.tif" />

In one embodiment, trigger 144 may sealably engage one or more portions of the system, such as body 102 or end cap 108, which may, but need not include, one or more seals 153, such as an O-ring, gasket, or other device for at least partially limiting the entry or escape of fluid, such as into or out of the body 102 or vacuum chamber 154. At least three possible release mechanism modalities 542, which are just three of many, will now be described with reference to Figures 14-14F for illustrative purposes.

As an example, in the embodiment of Figures 14-14B, which is just one of many, release mechanism 542 may include a second trigger coupler 141, such as a retainer or hook, to releasably engage coupler 140, such as as a notch or groove (or vice versa) in any way required by a particular application. The system may, but need not, include one or more retainers 143, such as a ring, washer, gasket, disc, or other structure or fastener, to at least partially hold the coupler holding 141 in place. Release mechanism 542 may include one or more deflection devices, such as a spring 147, to deflect at least a portion of the mechanism, such as trigger 144 or coupler 141, in one or more directions, and may include one or more couplers or fasteners, such as pin 149, for ✓

coupling one or more components of the mechanism together. For example, him

<img file="MX336397B_D0035.tif" />

Pin 149 can engage trigger 144 and coupler 141 to translate movement between them. Pin 149 may pass through each opening 151 in stop 129, such as a slot, hole, or other opening. Spring 147 may bias trigger 144 to a deactivated position, for example, radially outward, and may bias coupler 141, such as by biasing pin 149, to a position to engage with main shaft 134, such as with the coupler 140. In a cocked position (eg, Figure 14A), couplers 140, 141 can be coupled and can hold piston 148 and main shaft 134 in a downward or other energetic position. For example, retainer 141a may be arranged adjacent wall 140a to retain piston 148 and main shaft 134, such as in a pre-trigger position 158a of vacuum spring 158.

Referring to Figure 14B, release mechanism 542 can be activated by moving trigger 144 to an activated position to allow couplers 140, 141 to decouple from each other. For example, by pressing the trigger 144 radially inward (as illustrated by the vertical arrow in Figure 14B), such as by sliding with a user's fingers, or otherwise, electronically including, the retainer 141a can be moved from a cocked position adjacent wall 140a to an activated out-of-way position of coupler 140, which may allow couplers 140, 141 to disengage. For example, the retainer 141a can be moved from a pr-firing position so that the piston kc 148 and the main shaft 134 are no longer held against the force flftj ,;

Indusfri vacuum spring 158, which can allow piston 148 and main arrow 134 to move to a non-cocked or de-energized position (e.g., clockwise as illustrated by the horizontal arrow in Figure 14B) as vacuum spring 158 is compressed or de-energized.

Switching to Figures 14C, 14D, as a second example, trigger 144 and coupler 141 may alternatively be integrally formed as a single component and pin 149 (Figure 14A) may, but need not, be absent. In such an embodiment, which is only one of many, trigger 144 and coupler 141 may be made at least partially of elastic material, such as one or more elastomers (e.g., rubber) or shape memory metals, separately or in combination, and spring 147 (Figure 14A) may, but need not, be absent, as one skilled in the art will understand. For example, trigger 144 may be mushroom shaped with its hat 144a adjacent to the exterior of end cap 108, body 102, or a coupler 702 coupled thereto, such as a washer, gasket, or seal, and its stem 144b extending radially. inward toward trigger coupler 141. The elasticity of the material from which trigger 144, or one or more other system components, can be at least partially formed can allow a user to at least temporarily or otherwise deform trigger 144 to activate system 500. (e.g., figure 14D), and you can return one or more pressed components, such as the

<img file="MX336397B_D0036.tif" />

trigger 144 or other components, to a default position and can you?

a © la Propase · return coupler 141 to a rest position (eg, figure 14C) in an indirect spring-type manner. For example, as shown for exemplary purposes in FIG. 14C, trigger 144 may bias trigger coupler 141 in the upward direction (as illustrated) by causing at least a portion of coupler 141, such as retainer. 141a, interferes or otherwise engages with coupler 140, such as with wall 140a, to cocking the system. A user can apply a deformation or activation force or pressure (such as applying a finger) to trigger 144, and the elastic resistance of trigger 144, which can be of any magnitude required by a particular application, can be at least partially overcome . Trigger 144 can force or push detent 141a some distance Ad, which can be any distance required by a particular application. Retainer 141a may come out of a position of interference with wall 140a, which may allow piston 148 to move to the right (as illustrated) during firing of the system (Figure 14D). Therefore, as one skilled in the art having the benefits of the present disclosure will readily understand, the embodiment of Figures 14C, 14D operates similarly to that of Figures 14A, 14B, although the mechanics of one or more of the elastic components in the former may replace that of one or more springs 147 in the latter, in whole or in part, separately or in combination.

A third example of a release mechanism, which is only

<img file="MX336397B_D0037.tif" />

<img file="MX336397B_D0038.tif" />

542 it may include a wishbone or wedge type mechanism to selectively hold piston 148 and main shaft 134 in a cocked position. For example, release mechanism 542 may include a U-shaped or C-coupler 601, such as a C-ring, circular clamp, jump ring, or other coupler, and at least one wedge 602 to define a trajectory of movement of at least a portion of coupler 601, such as ends 601a, 601b. Wedge 602 can include any structure (or structures) that can cooperate with coupler 601 as described herein, such as one or more blocks or spindles. Coupler 601 may include one or more tabs 603, such as projections or other retainers, for mating with one or more other system components, such as main shaft 134, piston 148, or trigger coupler 140. The coupler

601 it can expand and contract against wedge 602, which respectively can increase and decrease a distance between tabs 603 to allow tabs 603 to releasably engage and disengage with arrow 134, such as selectively retaining trigger coupler 140. In a cocked position (e.g., Figure 14E), the tabs 603 can be engaged with the coupler 140, such as by being adjacent thereto, and can hold the piston 148 and main shaft 134 in a downward or otherwise energized, such as against the force 158a of vacuum spring 158. Release mechanism 542 may be activated by

<img file="MX336397B_D0039.tif" />

If · you;:, \ &lt;

Arrange coupler 601 in an activated position (e.g., Figure 14F), for example, by pressing trigger 144 radially inward (as ftftfusffiei 'shown by the arrow in Figure 14F for illustrative purposes), which may allow the ends 601a, 601b slide and disperse against the wedge 602, thus at least partially separating the tabs 603. The tabs 603 can be disengaged from the coupler 140, such as by moving radially outward from the piston 148 or coupler 140, which can allow the piston 148 and the main shaft 134 to move to an uncocked or de-energized position. Other types of release mechanisms may be coupled to System 500, separately or in combination with one or more of those specifically described herein, in whole or in part, as will be readily understood by one skilled in the art having the benefits of present description. For example, although coupler 601 is shown in Figures 14E-14F for illustrative purposes to expand and contract against a wedge 602, coupler 601 could alternatively expand and contract between two or more wedges or opposing surfaces (not shown) to engage or decoupling with a corresponding trigger coupler 140, as will be readily understood by one skilled in the art having the benefits of this disclosure.

System 500 may include a vacuum mechanism 532 to create a vacuum and cooperate with lancing mechanism 518 or other system components during puncture. Vacuum mechanism 532 may include a main shaft 134 with a lower main drive end 136 and an upper main free end 138, and at least.

a trigger coupler 140, which can, but does not need, be coupler ^ KJÍPÍl · · /.

Piston 148. The system 500 may, but need not, include a knob 146, such as a button or cap attached to the main free end 138. Vacuum mechanism 532 may include one or more pistons, such as the piston 148, coupled to main shaft 134 to cooperate with one or more of other components of system 500 to create a vacuum. The piston 148 can be coupled, adjustable, fixedly or otherwise, anywhere on the main shaft 134 within the body of the device 102, such as, for example, to the main drive end 136, and can form at least partially a vacuum chamber 154 within the body of device 102. System 500 may include one or more openings 556, such as an air passage or orifice, for fluid communication between vacuum chamber 154 and an atmosphere surrounding the vacuum chamber. System 500 may include one or more openings between other portions of body interior 102 and the atmosphere, such as opening 557, for example, to allow fluid (eg, air) to flow into or out of body 102 as piston 148 moves along the length of the body. Opening 557 can be arranged anywhere in the system, such as at the free end

106 of the body, cover 110, or another place. Aperture 556 can be calibrated to allow air to flow into vacuum chamber 154 at a predetermined rate of vacuum dissipation, which can be any speed required by a particular application. Opening 556 can be any

<img file="MX336397B_D0040.tif" />

i and suitable location for fluid communication with a vacuum in the 5QQ system, such as in the body of the device 102, and may advantageously, not necessarily, be in the trigger 144. One or more openings 556 may give any rate of vacuum dissipation required by a particular application, such as a linear speed, nonlinear speed, or other speed, in whole or in part, separately or in combination.

Vacuum mechanism 532 may include a deflection device, such as vacuum spring 158, coupled to piston 148 to deflect piston 148 in one or more directions, such as in the upward direction toward free end 106. For example, vacuum spring 158 may include a tension spring, as shown in the embodiment of FIG. 12, which is only one of many, whereby a rest position for trigger coupler 140 may be toward the top end cap 110.

System 500 may, but need not, include a vacuum gauge (such as one or more of the vacuum gauges described above; see, e.g., Figure 2) to indicate whether or to what degree a vacuum exists within the vacuum chamber 154. For example, in an application where the skin is being pricked for blood drawing purposes, it could sometimes be detrimental for the user to pull the skin system 500 when there is still a vacuum in chamber 154 because the air flowing inside could disperse or otherwise alter the blood collection on the surface. For this reason, it may be advantageous for the user to know the vacuum level in chamber 154. A vacuum gauge can be calibrated to indicate when the

<img file="MX336397B_D0041.tif" />

System 500 can be removed from the skin to at least minimize any potential that the blood drawn could splatter.

With additional reference to the figures. 12-14, system 500 may include an arrow coupler 160 to ulcerably couple one or more system components, such as lancing arrow 122 and main arrow 134. For example, arrow coupler 160 may include a first portion 160a coupled to puncture arrow 122, such as to drive end 126, and a second portion 160b coupled to main arrow 134, either directly or indirectly, such as with piston 148. The puncture mechanism 518 may include a stop 129, such as a tongue, block, disk or other structure, to support the puncture spring 130 and define a puncture arrow stroke 122, in whole on part. For example, the upper spring 130a can be coupled between the stop 129 and the actuating end 126, and the lower spring 130b can be coupled between the stop 129 and the coupling end of lancet 124. The stop 129 may be coupled with the body 102, such as with the end cap 108, in any way required by a particular application, which may, but need not, include the use of one or more fasteners 145, such as screws, pins , adhesives, or other fastening devices, separately or in combination. Alternatively, fasteners 145 need not be used, and stop 129 may be coupled to body 102 in another manner, such as by force or friction adjustment, or may be integrally formed with cover 108, in whole or in part.

<img file="MX336397B_D0042.tif" />

Figure 15A is an illustration of the vacuum puncture system of Figure 11 in a cocked position in accordance with the description ^ &amp; f / j Figure 15B is an illustration of the vacuum puncture system of Figure 15A in one of many positions activated wherein the first and second 5 portions of the arrow coupler are coupled in accordance with the description. Figure 15C is an illustration of the vacuum puncture system of Figure 15A in another of many activated positions where the first and second portions of the arrow coupler are decoupled in accordance with the description. Figure 15D is an illustration of the vacuum puncture system 10 of Figure 15A in another of many activated positions where the opening in the trigger is sealed in accordance with the description. Figure 15E is an illustration of the vacuum puncture system of Figure 15A in another of many activated positions where the opening in the trigger is not sealed in accordance with the description. Fig. 15 15F is an illustration of the system of Fig. 15A in an uncocked position. At least one of many methods of using the system 500 embodiment shown in Figures 15A-15F can be described. Figure 15G is a graph illustrating another example of vacuum magnitude versus a time over which puncture may occur during a vacuum cycle of 20 in accordance with the description. Figures 15A-15G will be described together.

A lancet 120 may be attached to the puncture mechanism 518, such as using one of the methods described herein, for example, before or

<img file="MX336397B_D0043.tif" />

after system 500 is in a "cocked" position (see, SíKh * ··

e.g., figure 15A). A lancet guide, such as the depth controller⁰ Industrié Property

162, can be coupled to puncture end 104, such as with end cap 108. System 500 can be cocked, for example, by pressing knob 146 down until trigger coupler 140 engages with release mechanism 142 , such as by releasably engaging coupler 141. The first and second portions 160a, 160b of arrow coupler 160 may be coupled together to releasably engage the drive ends of arrows 122, 134. Actuating end 126 may, but need not, move down during cocking, temporarily or otherwise. The upper spring 130a and the lower spring 130b may, but need not, be in their natural states. System 500 can contact a surface to be punctured (not shown), such as an area of ​​skin on a person's body, which can be any area, and can advantageously form at least a partially watertight seal between the depth controller 162, or a portion thereof, such as seal 116, and the surface. Seal 116 can be integrally formed with depth controller 162 (as shown for illustrative purposes) or it can be a separate structure attached to depth controller 162, separately or in combination.

A user may place his finger on the trigger 144 in preparation for firing the system and the opening 556 may advantageously be at least temporarily closed, for example, to seal at least substantially the vacuum chamber 154 between the body 102, the piston 148 and the Surface to be punctured. As shown in the moéátidád

In Figures 15A-15F, which is just one of many, opening 556 may be advantageously arranged through trigger 144, for example, so that a user can simultaneously block, plug or otherwise obstruct the opening 556 by hooking trigger 144 with a finger or other actuator (such as a glove or other object). However, this is not necessarily the case and, alternatively or collectively, opening 556 may be located elsewhere, such as through body 102 or cover.

108, and a user can close the opening (s) in another way, such as using another finger. As another example, system 500 may include a valve (not shown), such as a ball valve, needle valve, or other device for regulating or directing the flow of fluid, to selectively start, stop, or otherwise control the flow through one or more openings, such as opening 556.

As indicated by the arrows in Figures 15B-15C, system 500 can be activated by actuating (eg, pressing inward) trigger 144, which can allow coupler 140 and coupler 141 to disengage or disengage from another way. Vacuum spring 158 s can at least partially contract and piston 148, main shaft 134, and shaft coupler 160 can move upwards away from the surface to be punctured. Piston 148 can at least partially form a vacuum in vacuum chamber 154 at ϊ υ [/

X- -V ·. i. Ii25¿. '. R' h as piston 148 moves away from the punctured surface, and opening 556 may remain closed, for example, to hold the chamber sealed. One or more components of lancing mechanism 118, such as drive end 126 and piercing shaft 122 may be moved upward with main shaft 134, for example, due to the mating force of shaft coupler 160 and the contraction force of vacuum spring 158. The upper spring 130a can be expanded and the lower spring 130b can be contracted, which, for example, individually or in combination, can exert an increasing force on the first portion 160a of the arrow coupler 160 in an opposite direction (see. gr., down) from a force exerted on a second portion 160b by vacuum spring 158 (eg, upward) as vacuum spring 158 contracts (Fig. 15B). Lance arrow 122 may contact stop 129, which can limit a puncture arrow hit 122.

Arrow coupler 160 may be disengaged and second portion 160b may continue to move in an upward direction (as illustrated in the figures for illustrative purposes) while first portion 160a and puncture arrow 122 may be reversed and moved in one direction. opposite direction (eg, down) towards the surface to be punctured (figure 15C). Lancet 120 can penetrate the surface and lancing mechanism 518 can return to a resting state. Piston 148 may continue to move upward at least partially toward free end 106. As piston 148 moves toward © I d © ks Γλν free end 106, such as under spring force 158, an empty magnitude formed in vacuum chamber 154 can gradually increase and opening 556 can remain closed (Figure 15D). The vacuum can generate a force acting on the piston 148 in a direction opposite to a spring force 158 (eg, downward), and the magnitude of the vacuum force can finally become greater than or equal to that of the spring force, for example, so that the piston 148 can come to rest at least partially between its cocked and uncocked positions (Figure 15E) along the length of the body 102, which can occur anywhere along the length of the body or arrow strike 134 as required by a particular application.

At this point, in the illustrative vacuum assisted puncture process, the magnitude of the vacuum may, but need not, be at least substantially constant, and the vacuum may act on the punctured surface, which may advantageously result in suction than by at least partially draws, or helps draw, blood from the surface. The user can maintain the vacuum state in the vacuum chamber 154 by keeping the opening 556 closed, for example, by keeping his finger sealed against it, which may, but need not, include holding the trigger 144 at less partially in a powered position (eg, inward, as indicated by the arrow in Figure 15E). The user can see the area in which the surface has been punctured, such as

<img file="MX336397B_D0044.tif" />

Id L ...

Through display area 114, which may, but need not, be porf ^ r of 5th Property minus a portion of a lancet guide (see, e.g., figure 1) oi | ftdustriGi depth controller 162, and advantageously you can check whether or when a desired amount of blood, such as enough blood for testing, has risen from the surface. Although the applicant expects that a required or desired amount of blood will often be recognized by a user through experience in puncturing and drawing blood, this is not necessarily the case, and a volume of blood drawn can be quantified by other measurements. . For example, in at least one embodiment of the system, hole 170 may be dimensioned or calibrated, such as through one or more dimensions, to contain a minimum volume of blood drawn required by a particular application.

In these ways, it will be apparent that a user can advantageously maintain the vacuum on the surface until a desired amount of blood is drawn, and, for example, can subsequently selectively begin dissipating the vacuum by opening or unlocking one or more openings 556 , such as removing your finger from trigger 144 and opening 556 (eg, as indicated by the vertical arrow in Figure 15F). Unlocking opening 556 can allow air to flow into vacuum chamber 154, and piston 148 can resume travel (eg, as indicated by the horizontal arrow in Figure 15F) to free end 106 until that, for example, the vacuum mechanism 532 comes to rest in an unlocked position (FIG. 15F). The vacuum can be dissipated at any speed required by a particular application, and advantageously it can be dissipated at a relatively fast rate by unlocking the industrial opening as the user observes or verifies that a sufficient amount of blood, such as a suitable amount for testing, has been withdrawn. Such an advantage can at least partially minimize the amount of time the system makes contact with the skin while at the same time providing the user with an easily obtainable indication that the elapsed time and amount of vacuum have been sufficient. to draw a required amount of blood for the purpose of a particular application. At the user's option, as can be determined from the user's visual feedback, System 500 can be disengaged from the surface, which can leave a quantity of blood in a puddle on the surface for collection.

As explained above with reference to one or more of other embodiments of the present invention, the surface can be vacuumized before, during, or after puncture, separately or in combination. Air can enter or leave vacuum chamber 154 and body 102 at any speed required by a particular application. A punctured surface can, but does not need, to be manipulated during puncture, which may include twisting, pumping, up and down pressure, or any movement, separately or in combination (see, e.g., figure 5F) . With continued reference to Figures 15A-15F, and further reference to Figure 15G, the time and magnitude of vacuum and puncture creation

<img file="MX336397B_D0045.tif" />

it can include one or more variables, as one skilled in the art will understand, each of which can have any value required by a particular application. For example, the magnitude of the vacuum, the speed at which the vacuum can be created, the puncture time, such as when the arrow coupler 160 disengages, the speed at which the lancet 120 can travel, and the force with which lancet 120 hits a surface, or other factors, can be optimized for a particular application. Vacuum creation can occur in a single stage, or in multiple stages.

As shown for illustrative purposes in Figure 15G, puncture of a surface can occur at any time before, during, or after a vacuum cycle, which may be suitable for a particular application. For example, surface puncture can occur before a vacuum is created, as indicated by reference A. Alternatively, puncture can occur while the vacuum is increasing in the body of the device, as indicated by reference B. As one skilled in the art will have the benefits of this disclosure, reference B illustrates one of many puncture times during vacuum creation, and puncture may alternatively occur at any point along a line between references. A and C. As another example, puncture can occur when the vacuum is at peak vacuum P, illustrated by reference C. In at least one embodiment of the present invention, such as, for example, the embodiment shown and described in Figures 15A-15F, the magnitude of vacuum, such as peak vacuum P, can be maintained for a period of time mpo containment vacuum after puncture has occurred, as indicated by the CD line, from iWiecteei te

A containment time can be any period required by a particular application industry or otherwise chosen by a user, such as a sufficient amount of time to allow a desired amount of blood to rise from the surface. A user may allow the vacuum to dissipate, in whole or in part, or may begin dissipating the vacuum, at a time of her choosing, for example, through aperture manipulation 556. Vacuum dissipation can occur at any rate required by a particular application, as indicated for illustrative purposes by the slope of the DE line, such as until the vacuum has completely dissipated, as illustrated by reference E in Figure 15G.

As described above, puncture can occur at any time during a vacuum cycle, including before, during, or after a vacuum has been created, and can advantageously occur when at least a partial vacuum is created, such as between 30% and 70%, or any Increase between them, of the maximum vacuum for a particular application. In at least one embodiment, which is only one of many, the puncture may advantageously occur between 40% and 60% of creation, vacuum, or any increase between them, such as 50% of creation of vacuum. For example, the maximum vacuum can be -50.8 cmHg, and a puncture can be made at the surface when the vacuum in vacuum chamber 154 is, for example, -25.4 cmHg. However, this is not necessarily the case, and the examples described herein are for illustrative purposes. Time

<img file="MX336397B_D0046.tif" />

puncture can, but does not need, be adjustable. For example, in por láJ;

d © IS Piémenos in a modality, such as a commercial modality, which is just one of many, the system 500 may include a plurality of interchangeable puncture arrows, each of which may have a different length, which can determine when it occurs puncture during a vacuum cycle, as described above.

FIG. 16 is a schematic isometric view of another of many embodiments of a vacuum puncture system 500 in accordance with the description. Figure 17 is a schematic assembly isometric view of the vacuum puncture system 500 of Figure 16. Figures 16-17 will be described in conjunction with one another. Figures 16-17 illustrate another of many embodiments of system 500, which may include a puncture mechanism 518, vacuum mechanism 532, and release mechanism 542, such as one or more of those described herein, separately or in combination, in in whole or in part. This embodiment may generally function similarly to one or more of the other system embodiments described herein, as will be understood by one skilled in the art having the benefits of the present disclosure, and similar features and methods may not be described here again for avoid repetition.

As with one or more of the other embodiments shown and described in the present disclosure, the vacuum puncture system 500 of Figures 16-17 may include a device body 102, which may include one or more end caps 108, 110 , attached to it or formed

<img file="MX336397B_D0047.tif" />

integrally with it, in whole or in part. Body 102 can, but does not need, be at least partially curved or contoured, tebusfrici as on its exterior, to provide a comfortable, ergonomic, or user-friendly handle as required by a particular application. A puncture mechanism 518 can be coupled to body 102, such as a puncture end 104, to support a lancet 120 (also known as a "lancet"). Puncture mechanism 518 may include a puncture arrow 122 slidably coupled with end cap 108, such as along the central longitudinal axis X, to communicate lancet 120 with a surface during puncture. Puncture shaft 122 may include a lower lancet engagement end 124 and an upper drive end 126. Lancing mechanism 518 may include a lancet coupler 128 coupled to the lancet mating end 124 to engage lancet 120 with arrow 122, removably or otherwise. Puncture mechanism 518 may include one or more diverting devices, such as puncture springs 130a, 130b (collectively referred to as puncture spring 130). Puncture spring 130 may be coupled to puncture arrow 122 to deflect arrow 122 in one or more directions, temporarily, momentarily, or otherwise, as described above.

System 500 may include release mechanism 542, such as a trigger assembly, which may include trigger 144, one or more trigger couplers, and one or more components coupled therebetween. As shown for illustrative purposes in Figures 16 tict L ·

17, system 500 may advantageously include the release mechanism embodiment 542 shown in Figures 14C, 14D and described above, separately or in combination with one or more of the other illustrative release mechanisms described herein, in whole or in part. . Release mechanism 542 may include a structure to cooperate with other components of system 500, such as puncture mechanism 518, vacuum mechanism 532, or other elements of the system, separately or in combination. For example, release mechanism 542 may be adapted to cooperate with main shaft 134, such as by including one or more trigger couplers 141, for example, to optionally mate with trigger coupler 140, piston 148, and / or other system components coupled to arrow 134, to releasably contain main arrow 134 in one or more positions. In at least one embodiment, trigger 144 may sealably engage one or more portions of the system, such as body 102 or end caps 108, which may, but need not include, one or more couplers 702, such as an O-ring, gasket, washer, seal, or other device to at least partially limit the entry or escape of fluid, such as into or out of body 102 or vacuum chamber 154. System 500 may include one or more arrow couplers, which may include one or more portions, such as first portion 160a and second portion 160b, for at least temporarily coupling puncture flap 122 and fl cha main 134. Arrow coupler 160, or a portion thereof, may be coupled to another component of the system, such as a single SYPl ^ i ^ cc; © arrows, 122, 134, in any way required by a particular application, which may, but it need not include the use of one or more fasteners 704, such as a pin, screw, bolt, arrow, adhesive, or other fastener, separately or in combination. System 500 may include a knob 146 for cocking the system, which may, but need not, include two or more portions coupled to each other, such as first portion 146a, second portion 146b, and upper end cap 110 (collectively referred to as knob 146 ). As also shown and described above (see, e.g., Figures 11-14D), vacuum mechanism 532 may include one or more components to create a vacuum in chamber 154, such as one or more vacuum springs. 158 and 148 pistons, which may, but need not, include one or more 150 O-rings.

With continued reference to Figures 16-17, system 500 may include one or more depth controllers 162, which may advantageously be at least partially formed of transparent material, for example, to include a display area 114, in its entirety. or in part. Depth controller 162 can include interchangeable or modular units, which can include interchangeable spacers 164 for a particular depth controller 162. As another example, system 500 may include a plurality of interchangeable depth controllers, such as, for example, depth controller 162 and one, two, three, or more alternate depth controllers 162. In; In any case, each interchangeable spacer 164 can, but does not need, Industrial to have a different calibrated length, such as lengths L1, L2, and L3, which can include any length required by a particular application.

As another example, depth controller 162 may be adjustable, such as by means of one or more variable components, for example, a spacer 164 of variable length or thickness, as will be further described below. Typically, but not necessarily, the length of each spacer 164 may be less than the length of a particular lancet needle 120b to be used with the spacer. Each exchange unit can be graded and, for example, can vary in increments from one unit to another. In at least one embodiment, such as a commercial embodiment, system 500 may include and will be sold with a plurality of depth controllers as a set or kit. A user may choose to use any one or more depth controllers 162 required by a particular application, which may include choosing to use a depth controller already attached to the body of device 102 or, as another example, may include choosing a depth controller separate from the body. device 102 and attaching the chosen depth controller to the body of device 102. Similarly, system 500, or any assembly or kit including one or more components of system 500, may include a plurality of interchangeable deflection devices, such as one or more interchangeable puncture springs.

<img file="MX336397B_D0048.tif" />

130a, 130b or 158 vacuum springs to alter one or more dq characteristics?^{nsí&gt; ;? ÍJÍÍ}puncture of the system. For example, each deviation device. Interchangeable can have one or more unique characteristics, such as dimension, material, or elasticity characteristics (eg, spring constant). A particular deflection device, or combination of deflection devices, can be chosen and implemented as required by a particular application based on one or more specific application factors, such as the material or surface to be punctured, the depth of puncture, required puncture or vacuum forces, or other factors, as will be readily understood by one skilled in the art having the benefits of the Applicant's disclosure.

FIG. 18 is a schematic view of one of many embodiments of a vacuum puncture system 500 having an adjustable depth controller 162 in a first position in accordance with the description. FIG. 19 is a schematic view of the system 500 of FIG. 18 with the adjustable depth controller 162 in a second position. Figures 18 and 19 will be described together. As described above, the vacuum puncture system 500 can include one or more depth controllers 162 for controlling the puncture depth, which can include one or more spacers 164 that can be interchanged, such as individually or by means of controllers. Interchangeable depth 162 (see, e.g., figure 17). The general structure and function of one or more depth controllers 162 in accordance with

Lawai.i:

The present invention has been described above, for example, with respect to -iM in Figures 6-7C, and need not be repeated in its entirety. Turning to many other depth controller 162 modalities, the system 500 may include an adjustable depth controller 162 for controlling the lancet penetration depth, which may, but need not, take the place of one or more of a plurality of depth controllers or separators, and that alternatively can be used together with them, in whole or in part. As shown in the figures. 18-19, depth controller 162 can include adjustable structure, which can be any structure required by a particular application, to vary the thickness "t" of the separator 164 in a range of values, such as between a thickness for minimum penetration of the surface 168 by lancet needle 120b, not including penetration, and a thickness for maximum penetration of surface 168. As described above, base 120a can contact an upper surface of spacer 164 during puncture, which can limit the depth to which needle 120b can penetrate surface 168, such as for the difference in length T of needle 120b. and the thickness "t" of the separator 164. As will be understood by one skilled in the art having the benefits of the Applicant's description, the thickness value "t" can be maximized in order to minimize, or even prevent, the depth of penetration of the lancet, and the thickness value “t” can be minimized to maximize the depth of penetration of the lancet. For example, depth controller 162 may have a "security" setting where the thickness value "t" may be _v Proslecíac ef greater than or equal to the length value T of needle 120b, thus preventing needle 120b from projecting beyond separator 164 when not intended, such as during storage, travel, or periods of non-use.

With continued reference to Figures 18-19, one of many embodiments of an adjustable depth controller 162 may include an adjustable spacer 164 for variable thickness "t". For example, spacer 164 may include one or more blocks 180a, 180b (collectively referred to herein as blocks 180), such as shims, wedges, discs, or other structure, to define at least temporarily the adjustable thickness "t" of spacer 164 . For example, at least one of the blocks, such as the uppermost block 180a, may be movable, for example by rotation, sliding or other movement, separately or in combination, to change the relative positions of the blocks, increasing or thereby decreasing the overall thickness "t" of spacer 164, such as by changing the distance between surfaces 181, 183 of the blocks. Alternatively, both blocks 180 may, but need not, be movable. Blocks 180 can, but need not, be coupled to each other, and a movable block can cooperate with depth controller 162 in any way required by a particular application, for example, when traveling along a slot or other path. , by adjusting friction by rotation around or along a guide structure, separately or in combination. At least in a modality of a puncture system that

<img file="MX336397B_D0049.tif" />

it has a 162 adjustable depth controller which is just one of _Lmany, one or more blocks 180 can have a coupler 182 partaehssírta 'manipulate one or more blocks to adjust the thickness of the spacer 164. The coupler 182 can be any type of coupler required by a particular application, such as an opening, a projection, a threaded, slotted, notched or otherwise adapted (partial or complete) hole, or other structure. Alternatively, coupler 182 may be absent. Coupler 182 may, but need not, be adapted to couple or otherwise cooperate with one or more actuators 184 to move one or more blocks 180 between one or more positions to define at least temporarily or "set" the thickness of the spacer 164. Actuator 184 can be any type of actuator required by a particular application, such as a bar, lever, or other structure, and can be coupled to coupler 182 temporarily, permanently, or otherwise, including being integrally formed therewith, in in whole or in part. As another example, actuator 184 may be a user-supplied actuator, such as a user's fingerprint or other device for moving a block 180, for example, a pin, toothpick, the head of a pen or pencil, or other device. As will be understood by one of skill in the art having the benefits of Applicant's description, the adjustable depth controller 162 or spacer 164 can be adjustable in any one or more of many conventional ways of adjustment, alone or in combination, and the components adjustable d I system

<img file="MX336397B_D0050.tif" />

500 shown in Figures 18-19 are just a few of many.

<img file="MX336397B_D0051.tif" />

possibilities. For example, the depth controller was adjustable 16 ^^andp? ec ^^ have a fixed dimension spacer, and the distance between the spacer and the body of the system can be adjustable, such as by means of sliding, coiling or otherwise movable features.

As one skilled in the art will also understand, although the 162 adjustable depth controller is described herein with reference to system 500 for illustrative purposes, the features and components of these elements apply equally to all other puncture systems described here, separately or in combination, specifically including, without limitation, systems 100, 300, and 400 described with reference to Figures 1-10.

Other and additional embodiments using one or more aspects of the invention described above can be contemplated without departing from the essence of the applicant's invention. Furthermore, the various methods and modalities of the puncture system can be included in combination with each other to produce variations of the described methods and modalities. For example, unless the context requires otherwise, all elements and methods described with reference to the modalities of Figures 1-10 apply equally to the modalities of Figures 11-19, and vice versa. The discussion of elements in the singular can include elements in the plural and vice versa. References to at least one element followed by a reference to the element can include one or more elements. Also, various aspects of the modalities could be used together to meet the goals outlined in the description. Unless the context requires Jo „contrary, the word comprise or variations as comprehending '^^^ JJ understanding, shall be understood as implying the inclusion of at least the established element or the step or group of elements or steps or equivalents thereof, and not the exclusion of a larger numerical quantity or any other element or step, or group of elements or steps or equivalents thereof. The device or system can be used in a number of directions and orientations. The order of the steps can occur in a variety of sequences unless otherwise specifically limited. The different steps described herein can be combined with other steps, intermixed with the established steps, and / or can be divided into multiple steps. Elements were also described functionally and can be represented as separate components, or can be combined into components that have multiple functions.

The invention was described in the context of preferred and other embodiments and each embodiment of the invention was not described. Obvious modifications and alterations to the disclosed modalities are available to those skilled in the art. The described and non-described modalities are not intended to limit or restrict the scope or field of application of the invention devised by the applicant, but rather, in accordance with patent laws, the applicant seeks to fully protect all such modifications and improvements. fall within the scope or equivalent scope of the following claims.

d © the Property

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