Patent Publication Number: US-11045604-B2

Title: Medical device assembly

Description:
CROSS REFERENCE TO RELATED APPLICATION 
     This U.S. patent application claims priority U.S. Provisional Patent Application 62/373,574, filed on Aug. 11, 2016, which is hereby incorporated by reference in its entirety. 
    
    
     TECHNICAL FIELD 
     This disclosure relates to a medical device assembly. 
     BACKGROUND 
     Various medical devices for determining a pain threshold of a patient are known in the art, such as, for example, algometers; an algometer is used to measure the pressure and/or force eliciting a pressure-pain threshold. While known medical devices have proven to be acceptable for such applications, such conventional medical devices are nevertheless susceptible to improvements that may enhance their overall performance and cost. Therefore, a need exists to develop improved medical devices and methodologies for utilizing the same that advance the art. 
     SUMMARY 
     One aspect of the disclosure provides a medical device assembly. The medical device assembly includes a therapeusis delivery portion and an algometer portion. The therapeusis delivery portion includes a body having a proximal end and a distal end. The algometer portion includes a body having a proximal end and a distal end. The body of the therapeusis delivery portion defines a therapeusis-delivering passage and an algometer-receiving passage. The algometer-receiving passage may be sized to receive a portion of the algometer portion for connecting the algometer portion to the therapeusis delivery portion. 
     Implementations of the disclosure may include one or more of the following optional features. In some implementations, the algometer portion includes a handle portion and a wand portion. In some implementations, the algometer-receiving passage may be defined by one or more attachment clips. The one or more attachment clips includes a plurality of attachment clips. At least a first attachment clip of the plurality of attachment clips may be sized to connect to the handle portion of the algometer portion. At least a second attachment clip of the plurality of attachment clips may be sized to connect to the wand portion of the algometer portion. 
     In some instances, the body of the therapeusis delivery portion may be defined by a substantially tube shape. An inner surface of the body of the therapeusis delivery portion defines the therapeusis-delivering passage. 
     In some examples, the body of the therapeusis delivery portion includes a sheath. The sheath includes an inner surface and an outer surface. The inner surface of the sheath defines the algometer-receiving passage. 
     In some implementations, the sheath includes a proximal opening and an enclosed distal end. The proximal opening permits fluid communication with the algometer-receiving passage. 
     In some instances, the body of the therapeusis delivery portion may be defined by a substantially tube shape. An inner surface of the body of the therapeusis delivery portion defines the therapeusis-delivering passage. 
     In some examples, at least a portion of the enclosed distal end of the sheath includes an electrically-conductive material. In another example, all of a thickness of the enclosed distal end of the sheath may be formed from the electrically-conductive material. 
     In yet another example, a thickness of the enclosed distal end of the sheath may be formed from a first material and a second material. The first material may be a non-conductive material. The second material may be the electrically-conductive material. The electrically-conductive material may be impregnated within the non-conductive material. 
     In some implementations, a thickness of the enclosed distal end of the sheath may be bound by the inner surface of the sheath and the outer surface of the sheath. The conductive material may be disposed adjacent the outer surface of the sheath along the enclosed distal end of the sheath. 
     In some instances, the medical device further includes one or more sensors and a processor. The one or more sensors may be connected to the distal end of the algometer portion. The processor may be communicatively-coupled to the one or more sensors. The processor may be disposed within the body of the algometer portion. The one or more sensors may include a force application sensor. The one or more sensors may include an electromyography (EMG) sensor. 
     In some examples, the medical device further includes one or more visual indicators and one or more user input devices. The one or more visual indicators may be attached to the body of the algometer portion. The one or more visual indicators may include at least one of a light emitting diode and a liquid crystal display. The one or more user input devices may be attached to the body of the algometer portion. 
     Another aspect of the disclosure provides a portion of medical device assembly. The portion of medical device assembly includes a therapeusis delivery portion. The therapeusis delivery portion includes a body having a proximal end and a distal end. The body of the therapeusis delivery portion may define a therapeusis-delivering passage and an algometer-receiving passage that may be sized to receive a portion of an algometer portion of the medical device assembly, thereby connecting the algometer portion to the therapeusis delivery portion and forming the medical device assembly. The body of the therapeusis delivery portion includes a sheath. The sheath includes an inner surface and an outer surface. The inner surface of the sheath may define the algometer-receiving passage. 
     Implementations of the disclosure may include one or more of the following optional features. In some implementations, the sheath includes a proximal opening and an enclosed distal end. The proximal opening permits fluid communication with the algometer-receiving passage. 
     In some implementations, at least a portion of the enclosed distal end of the sheath may include an electrically-conductive material. In other implementations, all of a thickness of the enclosed distal end of the sheath may be formed from the electrically-conductive material. 
     In other implementations, a thickness of the enclosed distal end of the sheath may be formed from a first material and a second material. The first material may be a non-conductive material. The second material may be the electrically-conductive material. The electrically-conductive material may be impregnated within the non-conductive material. 
     In some instances, a thickness of the enclosed distal end of the sheath may be bound by the inner surface of the sheath and the outer surface of the sheath. The conductive material may be disposed adjacent the outer surface of the sheath along the enclosed distal end of the sheath. 
     In yet another aspect of the disclosure provides a method. The method includes disposing a force application sensor of an algometer portion of a medical device assembly adjacent a locus of a patient; determining a level of pain being experienced by the patient; and providing therapy to the locus of the patient by communicating therapeusis from a therapeusis container through a needle and to the locus. 
     Implementations of the disclosure may include one or more of the following optional features. In some implementations, prior to the disposing step, the method includes: assembling the medical device by connecting a therapeusis delivery portion to an algometer portion. The therapeusis delivery portion may include a body. The algometer portion may include a body having a proximal end and a distal end. The body of the therapeusis delivery portion may define a therapeusis-delivering passage. A portion of the algometer portion is disposed within the algometer-receiving passage for assembling the medical device. 
     In some implementations, the method further includes disposing one or more sensors connected to the distal end of the algometer portion adjacent the locus of the patient; and obtaining data from the one or more sensors. The method may further include obtaining an amount of force applied to the locus of the patient. The method may further include obtaining a measurement related to changes in nerve conduction or muscle spasms at or near the locus of the patient. 
     The details of one or more implementations of the disclosure are set forth in the accompanying drawings and the description below. Other aspects, features, and advantages will be apparent from the description and drawings, and from the claims. 
    
    
     
       DESCRIPTION OF DRAWINGS 
         FIG. 1A  is an exploded side view of an exemplary medical device assembly. 
         FIG. 1B  is an assembled side view of the exemplary medical device assembly of  FIG. 1A . 
         FIG. 1C  is a side view of the medical device assembly of  FIG. 1B  disposed adjacent a patient. 
         FIG. 1D  is a side view of the medical device assembly of  FIG. 1C  showing therapeusis delivered to the patient by way of a needle extending through the medical device assembly that is interfaced with the patient. 
         FIG. 2A  is a cross-sectional view of the medical device assembly according to line  2 A- 2 A of  FIG. 1A . 
         FIG. 2B  is a partially assembled view of the medical device assembly according to  FIG. 2A . 
         FIG. 2C  is a partially assembled view of the medical device assembly according to  FIG. 2B  and line  2 C- 2 C of  FIG. 1B . 
         FIG. 3A  is an exploded side view of an exemplary medical device assembly. 
         FIG. 3B  is an assembled side view of the exemplary medical device assembly of  FIG. 3A . 
         FIG. 3C  is a side view of the medical device assembly of  FIG. 3B  disposed adjacent a patient. 
         FIG. 3D  is a side view of the medical device assembly of  FIG. 3C  showing therapeusis delivered to the patient by way of a needle extending through the medical device assembly that is interfaced with the patient. 
         FIG. 3D ′ is an exemplary enlarged view of  FIG. 3D  according to line  3 D. 
         FIG. 3D ″ is an exemplary enlarged view of  FIG. 3D  according to line  3 D. 
         FIG. 3D ′″ is an exemplary enlarged view of  FIG. 3D  according to line  3 D. 
         FIG. 4  is an end view of a portion of the medical device assembly according to arrow  4  of  FIG. 1A  or  FIG. 3A . 
         FIG. 5  is a block diagram of the medical device assembly of  FIGS. 1A-1D  or  FIGS. 3A-3D . 
     
    
    
     Like reference symbols in the various drawings indicate like elements. 
     DETAILED DESCRIPTION 
     Referring to  FIGS. 1A -ID, an exemplary medical device assembly is shown generally at  10 . The medical device assembly  10  includes a therapeusis delivery portion  12  (see also,  FIGS. 2A-2C ) and an algometer portion  14 . Each of the therapeusis delivery portion  12  and the algometer portion  14  includes a body  12   B ,  14   B  having a proximal end  12   P ,  14   P  and a distal end  12   D ,  14   D . 
     The body  12   B  of the therapeusis delivery portion  12  may form a tube-shaped body having a therapeusis-delivering passage  16  (see, e.g.,  FIGS. 2A-2C ) extending there-through. The tube-shaped body  12   B  of the therapeusis delivery portion  12  may include one or more attachment clips  18  integrally extending from or attached to an outer surface  12   O  of the tube-shaped body  12   B  of the therapeusis delivery portion  12 . An inner surface  121  (see, e.g.,  FIGS. 2A-2C ) of the tube-shaped body  12   B  defines the therapeusis-delivering passage  16 . 
     The body  14   B  of the algometer portion  14  includes a handle portion  14   B1  and a wand portion  14   B2 . The handle portion  14   B1  includes the proximal end  14   P  of the algometer portion  14  and the wand portion  14   B2  includes the distal end  14   D  of the algometer portion  14 . The handle portion  14   B1  and the wand portion  14   B2  may be respectively defined by a diameter D 14-1 , D 14-2 ; the diameter D 14-1  of the handle portion  14   B1  may be greater than the diameter D 14-2  of the wand portion  14   B2 . 
     As seen in  FIGS. 2A-2C , each attachment clip  18  of the one or more attachment clips  18  may be defined by a substantially C-shaped body having an inner surface  18   I  and an outer surface  18   O . The inner surface  18   I  of each attachment clip  18  defines an axial algometer-receiving passage  20 . The axial algometer-receiving passage  20  may be defined by a diameter D 20  (see, e.g.  FIG. 2A ). Access to the axial algometer-receiving passage  20  is permitting by a radial opening  22  defined by opposing ends  24  of each attachment clip  18 . 
     As seen in  FIG. 2A , a non-radially-outwardly flexed, at-rest distance X 24  extending between the opposing ends  24  of each attachment clip  18  is sized to be less than the diameter D 14-1 , D 14-2  of each of the handle portion  14   B1  and the wand portion  14   B2 . The non-radially-outwardly flexed, at-rest distance X 24  is less than the diameter D 14-2  for any attachment clip  18  associated with the wand portion  14   B2 , and, correspondingly, the non-radially-outwardly flexed, at-rest distance X 24  is less than the diameter D 14-1  for any attachment clip  18  associated with the handle portion  14   B1 . With reference to  FIG. 2B , as the one or more attachment clips  18  are brought into engagement with one or both of the handle portion  14   B1  and the wand portion  14   B2  of the body  14   B  of the algometer portion  14  for the purpose of joining the therapeusis delivery portion  12  to the algometer portion  14 , because the distance X 24  is sized to be less than the diameter D 14-1 , D 14-2  of each of the handle portion  14   B1  and the wand portion  14   B2 , the one or more attachment clips  18  are flexed radially outwardly (according to the direction of arrow Y) as the one or more attachment clips  18  are progressively joined (see, e.g., arrow J in  FIGS. 2A-2B ) to the body  14   B  of the algometer portion  14 . As seen in  FIGS. 1B and 2C , upon the opposing ends  24  of each attachment clip  18  being advanced in the direction of arrow J along one or more of the handle portion  14   B1  and the wand portion  14   B2 , the one or more attachment clips  18  are flexed radially inwardly (according to the direction of arrow Y′) such that the inner surface  18   I  of the one or more attachment clips  18  is disposed against and grips an outer surface  14   O  of the body  14   B  of the algometer portion  14  for joining the therapeusis delivery portion  12  to the algometer portion  14 . After arranging the one or more attachment clips  18  adjacent to the outer surface  14   O  of the body  14   B  of the algometer portion  14 , the tube-shaped body  12   B  of the therapeusis delivery portion  12  is connected to the body  14   B  algometer portion  14  for forming the medical device assembly  10 . 
     As seen in  FIGS. 1C-1D , the tube-shaped body  12   B  of the therapeusis delivery portion  12  may define a therapeusis delivery port for delivering therapeusis T to a patient P. In order to deliver therapeusis T to the patient P, a flexible needle N may be reciprocatingly-disposed within the therapeusis-delivering passage  16  extending through the body  12   B  of the therapeusis delivery portion  12 . The flexible needle N is interfaced with the patient P by: (1) inserting the flexible needle N through the a proximal opening  16   P  formed by the tube-shaped body  12   B  of the therapeusis delivery portion  12  that is in fluid communication with the therapeusis-delivering passage  16 , (2) extending the flexible needle N through the therapeusis-delivering passage  16  that extends along a length L 12  of the tube-shaped body  12   B  of the therapeusis delivery portion  12  and (3) extending the flexible needle N out of a distal opening  16   D  formed by the tube-shaped body  12   B  of the therapeusis delivery portion  12  that is in fluid communication with the therapeusis-delivering passage  16 . The flexible needle N may be connected to a therapeusis container C that contains the therapeusis T. 
     In some implementations, the flexible needle N and therapeusis container C may be a conventional syringe S. In an example, one or more of the flexible needle N and the therapeusis container C may be directly interfaced with the medical device assembly  10 . In other example, one or more of the flexible needled N and the therapeusis container C may not be directly interfaced (i.e., one or more of the flexible needle N and the therapeusis container may be ‘indirectly’ interfaced) with the medical device assembly  10  in, for example, a free-floating arrangement such that an operator holds, for example, one or both of the therapeusis delivery portion  12  and the algometer portion  14  with one hand and then the operator operates/holds flexible needle N and/or the therapeusis container C with his/her other hand. In an example, if the flexible needle N and the therapeusis container C form a syringe S, the syringe S may be interfaced with the therapeusis delivery portion  12  by way of, for example, a threaded connection (by way of, e.g., a Luer lock, not shown). 
     With reference to  FIG. 4 , in an example, one or more sensors  26  may be connected to the distal end  14   D  of the algometer portion  14 . A sensor  26   a  of the one or more sensors  26  may include a force application sensor for measuring an amount of force (according to the direction of arrow F as seen in, e.g.,  FIGS. 1C-1D ) imparted by an operator from the handle portion  14   B1  of the  14   B  to the distal end  14   D  of the algometer portion  14 . Another sensor  26   b  of the one or more sensors  26  may include a sensor that measures changes in nerve conduction or muscle spasms (e.g., an electromyography (EMG) sensor). 
     Prior to interfacing the flexible needle N with the medical device assembly  10  as seen in  FIG. 1D , an operator disposes the force application sensor  26   a  adjacent a locus (e.g., a trigger-point) P L  of a patient P (e.g., the levator ani muscles of the patient P) and applies an amount of force F thereto as seen in  FIG. 1C . During the course of applying the force application sensor  26   a  adjacent the locus P L  of the levator ani muscles of the patient P, the operator may ask the patient P to describe the level of pain being experienced (e.g., on a zero-to-ten threshold with zero being no pain being experienced and ten being an extreme amount of pain being experienced). With reference to  FIG. 1D , if, for example, the operator determines that the level of pain being described by the patient P is sufficient for providing the therapeusis T to the locus P L , the operator may then selectively interface the flexible needle N with the medical device assembly  10  as described above for communicating the therapeusis T: (1) from the therapeusis container C, (2) through the flexible needle N, and (3) to or near the site of the locus P L  where the patient P has described the level of pain being experienced. 
     With reference to  FIG. 1A , at least a first portion of the body  14   B  of the algometer portion  14  may axially extend along a first axis A 14 -A 14 , and, in some instances, the tube-shaped body  12   B  of the therapeusis delivery portion  12  may axially extend along a second axis A 12 -A 12 ; the first axis A 14 -A 14  and the second axis A 12 -A 12  may be parallel to one another. With reference to  FIG. 1B , after the therapeusis delivery portion  12  is attached to the algometer portion  14  as described above at  FIGS. 2A-2C , in some instances, the distal end  12   D  of the tube-shaped body  12   B  of the therapeusis delivery portion  12  may be aligned with the distal end  14   D  of the body  14   B  of the algometer portion  14 . Further, the proximal end  12   P  of the tube-shaped body  12   B  of the therapeusis delivery portion  12  may be arranged upstream of and extend beyond the proximal end  14   P  of the body  14   B  of the algometer portion  14  at a distance D +Δ . Alternatively, the proximal end  12   P  of the tube-shaped body  12   B  of the therapeusis delivery portion  12  may be arranged downstream of the proximal end  14   P  of the body  14   a  of the algometer portion  14  at a distance D −Δ  (see, e.g.,  FIG. 1B ). In some embodiments, the proximal end  12   P  is arranged downstream of the handle portion  14   B1  of the algometer portion  14   B2  (i.e., D −Δ  is equal to or shorter than the handle portion  14   B1 ). 
     As seen in  FIGS. 1A-1D , in some instances, both of the first axis A 14 -A 14  and the second axis A 12 -A 12  may define a non-linear axial component. For example, a second portion of the body  14   B  of the algometer portion  14  proximate the distal end  14   D  of the body  14   B  of the algometer portion  14  may axially deviate along an arcuate path to define a non-linear axial component of the first axis A 14 -A 14 ; as a result of the non-linearity of the first axis A 14 -A 14 , the body  14   B  of the algometer portion  14  may be defined to curve at a first angle θ 1 . Similarly, as seen in  FIGS. 1A-1D , the tube-shaped body  12   B  of the therapeusis delivery portion  12  proximate the distal end  12   D  may axially deviate along an arcuate path to define a non-linear axial component of the second axis A 12 -A 12 ; as a result of the non-linearity of the second axis A 12 -A 12 , the tube-shaped body  12   B  of the therapeusis delivery portion  12  may be defined to curve at a second angle θ 2 . Each of the first angle θ 1  and the second angle θ 2  may be approximately equal to an angle greater than about 0° and less than about 270°. In some instances, the first angle θ 1  may be equal to the second angle θ 2 . As will be explained in the following disclosure, the selected angular orientation defined by the first angle θ 1  and the second angle θ 2  will allow an operator of the medical device assembly  10  to access otherwise obstructed or potentially difficult regions to be analyzed for determining a pain threshold of the patient P (e.g., the lateral walls of a pelvis). 
     In other examples, the first and second axes A 14 -A 14 , A 12 -A 12  extending through each of the body  14   B  of the algometer portion  14  and the tube-shaped body  12   B  of the therapeusis delivery portion  12  may not axially deviate along their respective axes A 14 -A 14 , A 12 -A 12 . Because each of the body  14   B  of the algometer portion  14  and the tube-shaped body  12   B  of the therapeusis delivery portion  12  may not axially deviate along their respective axes A 14 -A 14 , A 12 -A 12  (i.e., each of the first and second axes A 14 -A 14 , A 12 -A 12  may remain substantially linear), the body  14   B  of the algometer portion  14  and the tube-shaped body  12   a  of the therapeusis delivery portion  12  may remain parallel to one another. 
     The design of the algometer portion  14  and the therapeusis delivery portion  12  to include an angular deviation (if any) along their respective axes A 14 -A 14 , A 12 -A 12  as described above may depend on the application of the medical device assembly  10 . For example, if the medical device assembly  10  is to be utilized for determining pain and/or treating pain in a vaginal region of a patient P, the first angle θ 1  and the second angle θ 2  may be approximately equal to about 70°. In another example, if the medical device assembly  10  is utilized for endoscopically determining pain and/or treating pain of a patient P (by, e.g., disposing the force application sensor  26   a  against the patient&#39;s skin), the first angle θ 1  and the second angle θ 2  may be approximately equal to about 0°. In yet another example, if the medical device assembly  10  is utilized for superficially determining pain and/or treating pain of a patient P (by, e.g., disposing the force application sensor  26   a  against the patient&#39;s skin), the first angle θ 1  and the second angle θ 2  may be approximately equal to about 0°. In some instances, if the medical device assembly  10  is utilized in an ear-nose-throat (ENT) application for determining pain and/or treating pain of a patient P (by, e.g., disposing the force application sensor  26   a  against the larynx), the first angle θ 1  and the second angle θ 2  may be between approximately equal to about 0° and 45°. In another implementation, if the medical device assembly  10  is utilized in dental application for determining pain and/or treating pain of a patient P (e.g., by disposing the force application sensor  26   a  adjacent a patient&#39;s gums), the first angle θ 1  and the second angle θ 2  may be between approximately equal to about 0° and 270°. 
     Referring to  FIG. 4 , the force application sensor  26   a  may be disposed upon the distal end  14   D  of the body  14   B  of the algometer portion  14 . With reference to  FIG. 5 , the force application sensor  26   a  may be hard-wired or wirelessly connected to electronics (e.g., a processor  34 ) disposed within, for example, the body  14   B  of the algometer portion  14 . 
     The force application sensor  26   a  may comprise a strain gauge or other component for measuring the application of force F in a small amount (e.g., 0.1 to 100 grams) that measures forces F directed to a surface of the patient P as a result of an operator of the medical device assembly  10 : (1) gripping the handle portion  14   B1  of the body  14   B  of the algometer portion  14  and (2) pushing the force application sensor  26   a  toward the surface of the patient P. In some instances, the strain gauge may comprise a Ni—Cu Metal foil construction. In some implementations, the strain gauge may determine a range of input forces F between about 0N to 1N, 0N to 5N, or 0N to 10N. In some examples, the strain gauge may include the following dimensions: 720.639 mm in length, 10 microns in width and 0.05 microns in thickness. In some instances, the stain gauge may be defined by a resistance equal to approximately about 706.226 kΩ. In other examples, an exemplary strain gauge may be commercially available from Strain Measurement Devices under the name S 256 . 
     As seen in  FIG. 5 , the amount of force F applied to the surface of the patient P by the operator may be determined by the electronics (e.g., the processor  34 ) subsequently transmitted to for example, a computer workstation W such that the data may be visually represented upon, for example, a display or monitor of the computer workstation W for clinical analysis by the operator or another clinician. The force data may be transmitted from the processor  34  to the computer workstation W over a wired connection (by way of, e.g., a hardwire data port  36 ) or a wireless connection. In some implementations, a wired connection directly connects the processor  34  to the computer workstation W or a wireless connection (e.g., a Bluetooth connection) indirectly connects the electronics to the computer workstation W by way of, for example an antenna  28  disposed within the body  14   B  of the algometer portion  14 . The antenna  28  is connected to the processor  34 . 
     The processor  34  may also be connected to an accelerometer (not shown) disposed within the body  14   B  of the algometer portion  14  to allow for the storage of spatial coordinate positions of the medial device assembly  10  for allowing clinicians to determine the success or failure of previously-applied therapy to a previously-examined surface area of the patient P over a period of time. The force data could be recorded and saved in data collection software (e.g., MICROSOFT EXCEL®) of the computer workstation W. In some instances, any portion of the medical device assembly  10  may include, for example, indicia, lines, markings or the like in order to spatially assist the operator in determining, for example, depth of insertion of the medical device assembly  10  within a body cavity of the patient P. 
     The processor  34  may be connected to other components that may or may not be associated with the medical device assembly  10 . In some instances, other components may include, for example: a battery, one or more light emitting diodes (LEDs)  30 , a liquid crystal display (LCD), buttons  32  or the like. In an example, the LCD may display force values measured from the force application sensor  26   a  in order to permit, for example, a clinician to immediately visually determine an amount of force F being applied to a patient P by the algometer portion  14 . In some instances, the one or more LEDs  30  may be illuminated when the medical device assembly  10  is powered on. In other examples, the one or more LEDs  30  may be illuminated when the processor  34  is paired with the computer workstation W for communicating force data thereto. In other examples, the one or more other components may also include the EMG sensor  26   b  that measures changes in nerve conduction or muscle spasms. 
     Other components connected to the electronics may include a battery disposed within the body  14   B  of the algometer portion  14 . The specifications of the battery may be dependent upon an overall power consumption of the medical device assembly  10 . In some examples, power consumption considerations of the medical device assembly  10  may include: strain gauge bias voltage of the force application sensor  26   a , Wheatstone bridge input voltage, the supply voltage of the one or more LEDs  30  and the like. The bias and input voltage of the sensor strain gauge and Wheatstone bridge may require approximately 3V to 5V. The electronics may be at different potentials, which may require voltage steps (up/down) that may be addressed by a voltage regulator circuit connected to, for example, a single AAA battery with a 1.5V rating. 
     Upon the operator of the medical device assembly  10  pushing the force application sensor  26   a  toward the surface of the patient P and locating a specific spatial area of discomfort of the patient, the operator may (1) guide the flexible needle N through the tube-shaped body  12   B  of the therapeusis delivery portion  12  and (2) optionally arrange the flexible needle N for contact with the area of discomfort of the patient P. Then, the operator may actuate the syringe S for delivering therapeusis: (1) from the therapeusis container C, (2) through the flexible needle N and (3) into to the area of discomfort of the patient P for providing therapy to the patient P. The therapeusis contained by the therapeusis container C that is ultimately delivered to the area of discomfort of the patient P may include, for example, a pharmaceutical, anesthetic or the like. Although an exemplary embodiment described above is directed to an externally-located therapeusis container C containing the therapeusis, other implementations may include a therapeusis container C stowed within, for example, the algometer portion  14  such that a user may actuate, for example, a button  32  for causing therapeusis to be delivered from the therapeusis container C from the algometer portion  14  to the area of discomfort of the patient P. Furthermore, the therapeusis may be delivered without using a flexible needle N (e.g., the therapeusis may be pumped through the tube-shaped body  12   B  of the therapeusis delivery portion  12  for topical delivery to the area of discomfort of the patient P. 
     An exemplary amplification of the Wheatstone Bridge Output Voltage is now discussed. Micro-electro-mechanical-systems (MEMS) devices may have a supply voltage of up to 100V but only output a voltage on the order of microns (Froehlich, n.d.). Due to this low output, it may have a gain amplifier that will amplify the measurable quantity that the sensor outputs. The output voltage for the Wheatstone bridge in the pressure-sensing device should be amplified in order for the interface circuits to be able to properly measure the voltage. Typical microcontroller inputs operate with an input of 0-3.3 volts (Froehlich, n.d.). An applicable device that was chosen to amplify the bridge output voltage is an operational amplifier (op-amp). The configuration of the operational amplifier will be in the form of a non-inverting op-amp. The image below shows a non-inverting operational amplifier. 
     The fabrication of operational amplifiers makes it so that there is a very large input impendence on the input terminals of the device. As a result, the current going into these terminals are so small that their amounts are negligible. The input of this amplifier will be the output voltage of the bridge circuit of the pressure sensor. Below is the equation for the output of the non-inverting op-amp, in relation to the input voltage: 
     
       
         
           
             
               
                 
                   
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                     2 
                   
                   ) 
                 
               
             
           
         
       
     
     Looking at the above equation (Eq. 2), the gain of the amplifier, K, is 
             1   +         R   2       R   1       .           
The gain is dependent on the values of resistors R 1  and R 2 . These resistors will be chosen such that the output voltage of the operational amplifier will be in an adequate range to be read by other electronics. This gain will be selected after the device is actually fabricated and the output voltage can actually be tested.
 
     In order for the users to know how much force F is being applied to the force application sensor  26   a , it may create a function that depends on the force F being applied. This function may be related to the applied force F of the amplified output voltage from the Wheatstone bridge. This will be done in the laboratory. A machine will apply many increments of known forces F to the force application sensor  26   a  and the corresponding output voltages from the bridge will be recorded. These data points will be plotted with output voltage on the y-axis and applied force F on the x-axis. After all of the data points have been collected software, such as MATLAB, will be used to realize the equation of the line from the data points. 
     Calibration of the force application sensor  26   a  may be done in order to ensure accurate voltage-to-force conversions. For example, if the Wheatstone bridge has an output voltage of 1 volt at equilibrium (when no force F is being applied), rather than zero, this 1 volt may correlate to no force F being applied to the force application sensor  26   a.    
     In some implementations, the electronics may include Texas Instrument (TI) CP3SP33 Connectivity Processor with Cache, Digital Signal Processor (DSP), Bluetooth, USB and a dual Controller Area Network (CAN) Interface to provide the processing power of the interface. The TI DSP could be able to pair with its corresponding USB hub device. This will enable the transmitting and receiving functionality of the DSP. The chip could contain an analog to digital converter to take the diaphragm voltage signal from the sensor and convert it to force F. The force F could then be transmitted to the computer workstation (e.g., a paired laptop) and stored in a data file (TI, 2014). 
     Referring to  FIGS. 3A-3D , an exemplary medical device assembly is shown generally at  100 . The medical device assembly  100  includes a therapeusis delivery portion  112  (see also,  FIGS. 3D ′,  3 D″,  3 D′″) and an algometer portion  114 . Each of the therapeusis delivery portion  112  and the algometer portion  114  includes a body  112   B ,  114   B  having a proximal end  112   P ,  114   P  and a distal end  112   D ,  114   D . 
     The body  112   B  of the therapeusis delivery portion  112  is similar to the body  12   B  of the therapeusis delivery portion  12  described above at  FIGS. 1A-1D  with the exception that the body  112   B  of the therapeusis delivery portion  112  is not attached to the algometer portion  114  with the one or more attachment clips  18 . Rather, the body  112   B  of the therapeusis delivery portion  112  includes a sheath  118  that is sleeved-over a portion (e.g., the wand portion  114   B2 ) L 114-2  of a length L 114  of the body  114   B  of the algometer portion  114  that extends away from the distal end  114   D  of the body  114   B  of the algometer portion  114  as seen in  FIGS. 3A-3B  (i.e., the sheath  118  connects the body  112   B  of the therapeusis delivery portion  112  to the algometer portion  114 ). A remainder portion (e.g., the handle portion  114   B1 ) L 114-1  of the length L 114  of the body  114   B  of the algometer portion  114  may not be covered by the sheath  118 . 
     The sheath  118  may be made substantially similar to a condom or prophylactic that promotes cleanliness or mitigates bacterial contamination of the portion L 114-2  of the length L 114  of the body  114   B  of the algometer portion  114 . The sheath  118  may be made from any desirable material such as silicone, latex, plastic, any prophylactic material or the like. Although the sheath  118  may be made from one material (such as, e.g., a non-electrically-conductive material), the sheath  118  may include two or more materials. Exemplary examples of the sheath  118  including more than one material (e.g., a first, non-electrically-conductive material M 1  and a second, electrically-conductive material M 2 ) will be described in the following disclosure at  FIGS. 3D ′,  3 D″,  3 D′″ whereby at least a portion of an enclosed distal end  118   D  of the sheath  118  may optionally include the second, electrically-conductive material M 2 , e.g., a conductive thermoplastic polyurethane (such as Pre-Elect TPU 1511). 
     The sheath  118  generally includes a tube-shaped body  118   B  having a proximal opening  118   P  and an enclosed distal end  118   D . The tube-shaped body  118   B  includes an inner surface  118   I  (see, e.g.,  FIGS. 3D ′,  3 D″,  3 D′″) and an outer surface  118   O . The inner surface  118   I  and the enclosed distal end  118   D  define an axial algometer-receiving passage  120  (see, e.g.,  FIGS. 3D ′,  3 D″,  3 D′″) extending through the tube-shaped body  118   B . Access to the axial algometer-receiving passage  120  is permitted by way of an axial opening formed by the proximal opening  118   P  of the sheath  118 . 
     As seen in  FIGS. 3A-3B , the proximal opening  118   P  of the sheath  118  is sized for receiving the distal end  114   D  of the algometer portion  114  such that the wand portion  114   B2  of the algometer portion  114  may be subsequently-disposed within the axial algometer-receiving passage  120  of the sheath  118  for forming the medical device assembly  100 . Once the wand portion  114   B2  of the algometer portion  114  is disposed within the axial algometer-receiving passage  120  of the sheath  118  as seen in  FIG. 3B , the inner surface  118   I  of sheath  118  defined by the enclosed distal end  118   D  of the sheath  118  extends over and may be disposed adjacent the distal end  114   D  of the body  114   B  algometer portion  14  thereby creating a barrier (as seen in  FIGS. 3D ′,  3 D″,  3 D′″) between the distal end  114   D  of the body  114   B  algometer portion  114  and the patient P. 
     With reference to  FIGS. 3D ′,  3 D″,  3 D′″, in order to permit electrical communication between, for example, the patient P and an EMG sensor  126   b  located at the distal end  114   D  of the algometer portion  114 , at least a portion of the sheath  118  extending over the distal end  114   D  of the body  114   B  algometer portion  114  may include a second, electrically-conductive material M 2  that is different from a first, non-electrically-conductive material M 1 ; the second, electrically-conductive material M 2  is shown generally at  150 . Referring to  FIG. 3D ′, a thickness T 118  of the portion of the sheath  118  extending over the distal end  114   D  of the body  114   B  algometer portion  114  may be impregnated with an electrically-conductive material  150  (such as, e.g., a conductive thermoplastic polyurethane) that permits communication of an electrical signal E from the patient P and through the thickness T 118  of the portion of the sheath  118  to the EMG sensor  126   b . In another example, referring to  FIG. 3D ″, the electrically-conductive material  150  (such as, e.g., a conductive thermoplastic polyurethane) may define an entirety of the thickness T 118  of the portion of the sheath  118  extending over the distal end  114   D  of the body  114   B  algometer portion  114  that permits communication of the electrical signal E from the patient P and through the thickness T 118  of the portion of the sheath  118  to the EMG sensor  126   b . In yet another example, with reference to  FIGS. 3D ′″, the outer surface  118   O  of the portion of the sheath  118  extending over the distal end  114   D  of the body  114   B  algometer portion  114  may include a layer of electrically-conductive material  150  (such as, e.g., a conductive thermoplastic polyurethane) that is directly disposed adjacent the patient P and acts as a transmitter that communicates the electrical signal E through the thickness T 118  of the portion of the sheath  118  to a receiver, such as the EMG sensor  126   b.    
     Referring to  FIGS. 3A-3D , in addition to the sheath  118 , the body  112   a  of the therapeusis delivery portion  112  may form a tube-shaped body having a therapeusis-delivering passage  116  (see, e.g.,  FIGS. 3D ′,  3 D″,  3 D′″) extending there-through. An inner surface  112   I  (see, e.g.,  FIGS. 3D ′,  3 D″,  3 D′″) of the tube-shaped body  112   B  defines the therapeusis-delivering passage  116 . 
     The body  114   B  of the algometer portion  114  includes the handle portion  114   B1  and the wand portion  114   B2 . The handle portion  114   B1  includes the proximal end  114   P  of the algometer portion  114  and the wand portion  114   B2  includes the distal end  114   D  of the algometer portion  114 . The handle portion  114   B1  and the wand portion  114   B2  may be respectively defined by a diameter D 114-1 , D 114-2 ; the diameter D 114-1  of the handle portion  114   B1  may be greater than the diameter D 114-2  of the wand portion  114   B2 . 
     As seen in  FIGS. 3C-3D , the tube-shaped body  112   B  of the therapeusis delivery portion  112  may define a therapeusis delivery port for delivering therapeusis T to a patient P. In order to deliver therapeusis to the patient P, a flexible needle N may be reciprocatingly-disposed within the therapeusis-delivering passage  116  extending through the body  112   B  of the therapeusis delivery portion  112 . The flexible needle N is interfaced with the patient P by: (1) inserting the flexible needle N through the a proximal opening  116   P  (see, e.g.,  FIGS. 3B-3D ) formed by the tube-shaped body  112   B  of the therapeusis delivery portion  112  that is in fluid communication with the therapeusis-delivering passage  116 , (2) extending the flexible needle N through the therapeusis-delivering passage  116  that extends along a length L 112  (see, e.g.,  FIG. 3B ) of the tube-shaped body  112   B  of the therapeusis delivery portion  112  and (3) extending the flexible needle N out of a distal opening  116   D  formed by the tube-shaped body  112   B  of the therapeusis delivery portion  112  that is in fluid communication with the therapeusis-delivering passage  116 . The flexible needle N may be connected to a therapeusis container C that contains therapeusis. 
     In some implementations, the flexible needle N and therapeusis container C may be a conventional syringe S. In an example, one or more of the flexible needle N and the therapeusis container C may be directly interfaced with the medical device assembly  100 . In other example, one or more of the flexible needled N and the therapeusis container C may not be directly interfaced (i.e., one or more of the flexible needle N and the therapeusis container may be ‘indirectly’ interfaced) with the medical device assembly  100  in, for example, a free-floating arrangement such that an operator holds, for example, one or both of the therapeusis delivery portion  112  and the algometer portion  114  with one hand and then the operator operates/holds flexible needle N and/or the therapeusis container C with his/her other hand. In an example, if the flexible needle N and the therapeusis container C form a syringe S, the syringe S may be interfaced with the therapeusis delivery portion  112  by way of, for example, a threaded connection (by way of, e.g., a Luer lock, not shown). 
     With reference to  FIG. 4 , in an example, one or more sensors  126  may be connected to the distal end  114   D  of the algometer portion  114 . A sensor  126   a  of the one or more sensors  126  may include a force application sensor for measuring an amount of force (according to the direction of arrow F as seen in, e.g.,  FIGS. 3C-3D ) imparted by an operator from the handle portion  114   B1  of the body  114   B  of the algometer portion  114  to the distal end  114   D  of the algometer portion  114 . Another sensor  126   b  of the one or more sensors  126  may include a sensor that measures changes in nerve conduction or muscle spasms (e.g., an electro-myography (EMG) sensor). 
     Referring to  FIGS. 3B-3C , in an example, prior to interfacing the flexible needle N with the medical device assembly  100 , an operator disposes the force application sensor  126   a  adjacent a locus (e.g., a trigger-point) P L  of a patient P (e.g., the levator ani muscles of the patient P) and applies an amount of force F thereto. During the course of applying the force application sensor  126   a  adjacent the locus P L  of the levator ani muscles of the patient P, the operator may ask the patient P to describe the level of pain being experienced (e.g., on a zero-to-ten threshold with zero being no pain being experienced and ten being an extreme amount of pain being experienced). With reference to  FIG. 3D , if, for example, the operator determines that the level of pain being described by the patient P is sufficient for providing therapeusis T to the locus P L , the operator may then selectively interface the flexible needle N with the medical device assembly  100  as described above for communicating therapeusis T: (1) from the therapeusis container C, (2) through the flexible needle N, and (3) to or near the site of the locus P L  where the patient P has described the level of pain being experienced. 
     At least a first portion of the body  114   B  of the algometer portion  114  may axially extend along a first axis A 114 -A 114 , and, in some instances as seen in  FIG. 3A , the tube-shaped body  112 E of the therapeusis delivery portion  112  may axially extend along a second axis A 112 -A 112 ; the first axis A 114 -A 114  and the second axis A 112 -A 112  may be parallel to one another. After the therapeusis delivery portion  112  is attached to the algometer portion  114  as described above at  FIGS. 3A-3B , in some instances, the distal end  112   D  of the tube-shaped body  112   B  of the therapeusis delivery portion  112  may be aligned with the distal end  114   D  of the body  114   B  of the algometer portion  114 . Further, the proximal end  112   P  of the tube-shaped body  112   a  of the therapeusis delivery portion  112  may be arranged upstream of and extend beyond the proximal end  114   P  of the body  1148  of the algometer portion  114  at a distance D+a. Alternatively, the proximal end  112   P  of the tube-shaped body  112   B  of the therapeusis delivery portion  112  may be arranged downstream of the proximal end  114   P  of the body  114   B  of the algometer portion  114  at a distance D-o (see, e.g.,  FIG. 3B ). 
     As seen in  FIGS. 3A-3D , in some instances, both of the first axis A 114 -A 114  and the second axis A 112 -A 112  may define a non-linear axial component. For example, a second portion of the body  114   B  of the algometer portion  114  proximate the distal end  114   D  of the body  114   B  of the algometer portion  114  may axially deviate along an arcuate path to define a non-linear axial component of the first axis A 114 -A 114 ; as a result of the non-linearity of the first axis A 114 -A 114 , the body  114   B  of the algometer portion  114  may be defined to curve at a first angle θ 1 . Similarly, as seen in  FIGS. 3A-3D , the tube-shaped body  112   B  of the therapeusis delivery portion  112  proximate the distal end  112   D  may axially deviate along an arcuate path to define a non-linear axial component of the second axis A 112 -A 112 ; as a result of the non-linearity of the second axis A 112 -A 112 , the tube-shaped body  112   B  of the therapeusis delivery portion  112  may be defined to curve at a second angle θ 2 . Each of the first angle θ 1  and the second angle θ 2  may be approximately equal to an angle greater than about 0° and less than about 270°. In some instances, the first angle θ 1  may be equal to the second angle θ 2 . As will be explained in the following disclosure, the selected angular orientation defined by the first angle θ 1  and the second angle θ 2  will allow an operator of the medical device assembly  100  to access otherwise obstructed or potentially difficult regions to be analyzed for determining a pain threshold of the patient P (e.g., the lateral walls of a pelvis). 
     In other examples, the first and second axes A 114 -A 114 , A 112 -A 112  extending through each of the body  114   B  of the algometer portion  114  and the tube-shaped body  112   B  of the therapeusis delivery portion  112  may not axially deviate along their respective axes A 114 -A 114 , A 112 -A 112 . Because each of the body  114   B  of the algometer portion  114  and the tube-shaped body  112   B  of the therapeusis delivery portion  112  may not axially deviate along their respective axes A 114 -A 114 , A 112 -A 112  (i.e., each of the first and second axes A 114 -A 114 , A 112 -A 112  may remain substantially linear), the body  114   B  of the algometer portion  114  and the tube-shaped body  112   B  of the therapeusis delivery portion  112  may remain parallel to one another. 
     The design of the algometer portion  114  and the therapeusis delivery portion  112  to include an angular deviation (if any) along their respective axes A 114 -A 114 , A 112 -A 112  as described above may depend on the application of the medical device assembly  100 . For example, if the medical device assembly  100  is to be utilized for determining pain and/or treating pain in a vaginal region of a patient P, the first angle θ 1  and the second angle θ 2  may be approximately equal to about 70°. In another example, if the medical device assembly  100  is utilized for endoscopically determining pain and/or treating pain of a patient P (by, e.g., disposing the force application sensor  126   a  against the patient&#39;s skin), the first angle θ 1  and the second angle θ 2  may be approximately equal to about 0°. In yet another example, if the medical device assembly  100  is utilized for superficially determining pain and/or treating pain of a patient P (by, e.g., disposing the force application sensor  126   a  against the patient&#39;s skin), the first angle θ 1  and the second angle θ 2  may be approximately equal to about 00. In some instances, if the medical device assembly  100  is utilized in an ear-nose-throat (ENT) application for determining pain and/or treating pain of a patient P (by, e.g., disposing the force application sensor  126   a  against the larynx), the first angle θ 1  and the second angle θ 2  may be between approximately equal to about 0° and 45°. In another implementation, if the medical device assembly  100  is utilized in dental application for determining pain and/or treating pain of a patient P (e.g., by disposing the force application sensor  126   a  adjacent a patient&#39;s gums), the first angle θ 1  and the second angle θ 2  may be between approximately equal to about 0° and 270°. 
     Referring to  FIG. 4 , the force application sensor  126   a  may be disposed upon the distal end  114   D  of the body  114   B  of the algometer portion  114 . With reference to  FIG. 5 , the force application sensor  126   a  may be hard-wired or wirelessly connected to electronics (e.g., a processor  134 ) disposed within, for example, the body  114   B  of the algometer portion  114 . 
     The force application sensor  126   a  may comprise a strain gauge or other component for measuring the application of force F in a small amount (e.g., 0.1 to 100 grams) that measures forces F directed to a surface of the patient P as a result of an operator of the medical device assembly  100 : (1) gripping the handle portion  114   B1  of the body  114   B  of the algometer portion  114  and (2) pushing the force application sensor  126   a  toward the surface of the patient P. In some instances, the strain gauge may comprise a Ni—Cu Metal foil construction. In some implementations, the strain gauge may determine a range of input forces F between about 0N to 1N, 0N to 5N, or 0N to 10N. In some examples, the strain gauge may include the following dimensions: 720.639 mm in length, 10 microns in width and 0.05 microns in thickness. In some instances, the stain gauge may be defined by a resistance equal to approximately about 706.226 kΩ. In other examples, an exemplary strain gauge may be commercially available from Strain Measurement Devices under the name S 256 . 
     With reference to  FIG. 5 , the amount of force F applied to the surface of the patient P by the operator may be determined by the electronics (e.g., the processor  134 ) subsequently transmitted to for example, a computer workstation W such that the data may be visually represented upon, for example, a display or monitor of the computer workstation W for clinical analysis by the operator or another clinician. The force data may be transmitted from the processor  134  to the computer workstation W over a wired connection (by way of, e.g., a hardwire data port  136 ) or a wireless connection. In some implementations, a wired connection directly connects the processor  134  to the computer workstation W or a wireless connection (e.g., a Bluetooth connection) indirectly connects the electronics to the computer workstation W by way of, for example an antenna  128  disposed within the body  114   B  of the algometer portion  114 . The antenna  128  is connected to the processor  134 . 
     The processor  134  may also be connected to an accelerometer (not shown) disposed within the body  114   B  of the algometer portion  114  to allow for the storage of spatial coordinate positions of the medial device assembly  100  for allowing clinicians to determine the success or failure of previously-applied therapy to a previously-examined surface area of the patient P over a period of time. The force data could be recorded and saved in data collection software (e.g., MICROSOFT EXCEL®) of the computer workstation W. In some instances, any portion of the medical device assembly  100  may include, for example, indicia, lines, markings or the like in order to spatially assist the operator in determining, for example, depth of insertion of the medical device assembly  10  within a body cavity of the patient P. 
     The processor  134  may be connected to other components that may or may not be associated with the medical device assembly  100 . In some instances, other components may include, for example: a battery, one or more light emitting diodes (LEDs)  130 , a liquid crystal display (LCD), buttons  132  or the like. In an example, the LCD may display force values measured from the force application sensor  126   a  in order to permit, for example, a clinician to immediately visually determine an amount of force F being applied to a patient P by the algometer portion  114 . In some instances, the one or more LEDs  130  may be illuminated when the medical device assembly  100  is powered on. In other examples, the one or more LEDs  130  may be illuminated when the processor  134  is paired with the computer workstation W for communicating force data thereto. In other examples, the one or more other components may also include the EMG sensor  126   b  that measures changes in nerve conduction or muscle spasms. 
     Other components connected to the electronics may include a battery disposed within the body  114   B  of the algometer portion  114 . The specifications of the battery may be dependent upon an overall power consumption of the medical device assembly  100 . In some examples, power consumption considerations of the medical device assembly  100  may include: strain gauge bias voltage of the force application sensor  126   a , Wheatstone bridge input voltage, the supply voltage of the one or more LEDs  130  and the like. The bias and input voltage of the sensor strain gauge and Wheatstone bridge may require approximately 3V to 5V. The electronics may be at different potentials, which may require voltage steps (up/down) that may be addressed by a voltage regulator circuit connected to, for example, a single AAA battery with a 1.5V rating. 
     Upon the operator of the medical device assembly  100  pushing the force application sensor  126   a  toward the surface of the patient P and locating a specific spatial area of discomfort of the patient, the operator may (1) guide the flexible needle N through the tube-shaped body  112   B  of the therapeusis delivery portion  112  and (2) optionally arrange the flexible needle N for contact with the area of discomfort of the patient P. Then, the operator may actuate the syringe S for delivering therapeusis: (1) from the therapeusis container C, (2) through the flexible needle N and (3) into to the area of discomfort of the patient P for providing therapy to the patient P. The therapeusis contained by the therapeusis container C that is ultimately delivered to the area of discomfort of the patient P may include, for example, a pharmaceutical, anesthetic or the like. Although an exemplary embodiment described above is directed to an externally-located therapeusis container C containing the therapeusis, other implementations may include a therapeusis container C stowed within, for example, the algometer portion  114  such that a user may actuate, for example, a button  132  for causing therapeusis to be delivered from the therapeusis container C from the algometer portion  114  to the area of discomfort of the patient P. Furthermore, the therapeusis may be delivered without using a flexible needle N (e.g., the therapeusis may be pumped through the tube-shaped body  112   B  of the therapeusis delivery portion  112  for topical delivery to the area of discomfort of the patient P. 
     An exemplary amplification of the Wheatstone Bridge Output Voltage is now discussed. Micro-electro-mechanical-systems (MEMS) devices may have a supply voltage of up to 100V but only output a voltage on the order of microns (Froehlich, n.d.). Due to this low output, it may have a gain amplifier that will amplify the measurable quantity that the sensor outputs. The output voltage for the Wheatstone bridge in the pressure-sensing device should be amplified in order for the interface circuits to be able to properly measure the voltage. Typical microcontroller inputs operate with an input of 0-3.3 volts (Froehlich, n.d.). An applicable device that was chosen to amplify the bridge output voltage is an operational amplifier (op-amp). The configuration of the operational amplifier will be in the form of a non-inverting op-amp. The image below shows a non-inverting operational amplifier. 
     The fabrication of operational amplifiers makes it so that there is a very large input impendence on the input terminals of the device. As a result, the current going into these terminals are so small that their amounts are negligible. The input of this amplifier will be the output voltage of the bridge circuit of the pressure sensor. Below is the equation for the output of the non-inverting op-amp, in relation to the input voltage: 
     
       
         
           
             
               
                 
                   
                     V 
                     out 
                   
                   = 
                   
                     
                       ( 
                       
                         1 
                         + 
                         
                           
                             R 
                             2 
                           
                           
                             R 
                             1 
                           
                         
                       
                       ) 
                     
                     ⁢ 
                     
                       
                         V 
                         
                           i 
                           ⁢ 
                           
                               
                           
                           ⁢ 
                           n 
                         
                       
                       . 
                     
                   
                 
               
               
                 
                   ( 
                   
                     Eq 
                     . 
                     
                         
                     
                     ⁢ 
                     2 
                   
                   ) 
                 
               
             
           
         
       
     
     Looking at the above equation (Eq. 2), the gain of the amplifier, K, is 
             1   +         R   2       R   1       .           
The gain is dependent on the values of resistors R 1  and R 2 . These resistors will be chosen such that the output voltage of the operational amplifier will be in an adequate range to be read by other electronics. This gain will be selected after the device is actually fabricated and the output voltage can actually be tested.
 
     In order for the users to know how much force F is being applied to the force application sensor  126   a , it may create a function that depends on the force F being applied. This function may be related to the applied force F of the amplified output voltage from the Wheatstone bridge. This will be done in the laboratory. A machine will apply many increments of known forces F to the force application sensor  126   a  and the corresponding output voltages from the bridge will be recorded. These data points will be plotted with output voltage on the y-axis and applied force F on the x-axis. After all of the data points have been collected software, such as MATLAB, will be used to realize the equation of the line from the data points. 
     Calibration of the force application sensor  126   a  may be done in order to ensure accurate voltage-to-force conversions. For example, if the Wheatstone bridge has an output voltage of 1 volt at equilibrium (when no force F is being applied), rather than zero, this 1 volt may correlate to no force F being applied to the force application sensor  126   a.    
     In some implementations, the electronics may include Texas Instrument (TI) CP3SP33 Connectivity Processor with Cache, Digital Signal Processor (DSP), Bluetooth, USB and a dual Controller Area Network (CAN) Interface to provide the processing power of the interface. The TI DSP could be able to pair with its corresponding USB hub device. This will enable the transmitting and receiving functionality of the DSP. The chip could contain an analog to digital converter to take the diaphragm voltage signal from the sensor and convert it to force F. The force F could then be transmitted to the computer workstation (e.g., a paired laptop) and stored in a data file (TI, 2014). 
     A number of implementations have been described. Nevertheless, it will be understood that various modifications may be made without departing from the spirit and scope of the disclosure. Accordingly, other implementations are within the scope of the following claims. For example, the actions recited in the claims can be performed in a different order and still achieve desirable results.