Contact detection and guidance system

Abstract

A contact detection device equipped with a base is provided. [Solution] A contact detection device 100 is provided, comprising a base 110, the base comprising a carriage 130 having a scanning track 145 and alignment guides configured to slide along the scanning track, a scanning head 125 mounted on the carriage, and a sensor array attached to the scanning head, comprising one or more pressure sensors, each pressure sensor configured to output a voltage signal in response to a change in pressure. Furthermore, the contact detection device further comprises a needle guide configured to be reversibly attached to the carriage.

Description

Technical Field

[0001] (Cross - reference to Related Applications) This application claims the benefit of U.S. Provisional Application No. 63 / 132,960, filed on December 31, 2020, and U.S. Provisional Application No. 62 / 980,085, filed on February 21, 2020, and these U.S. Provisional Applications are hereby incorporated by reference herein. (Statement Regarding Federally Sponsored Research) This invention was made with government support under Grant No. 1834481 awarded by the National Science Foundation. The government has certain rights in this invention.

Summary of the Invention

[0002] Embodiments of a contact detection device are provided herein. The contact detection device includes a base, the base includes a scanning track, a carriage configured to slide along the scanning track, a scanning head mounted on the carriage, and a sensor array attached to the scanning head, the sensor array including one or more pressure sensors, each pressure sensor being configured to output a voltage signal in response to a change in pressure.

[0003] In some embodiments, the carriage includes an alignment guide. In some embodiments, the contact detection device further includes a needle guide configured to be reversibly attached to the carriage. In some embodiments, the needle guide further includes a removal tab. In some embodiments, the contact detection device further includes a needle release gate configured to be reversibly attached to the carriage. In some embodiments, the needle release gate is configured to reversibly secure the needle to the carriage concentrically with the needle guide. In some embodiments, the scanning head further includes a scanning knob on its proximal side. In some embodiments, the base includes at least one limiter guide configured to limit the insertion depth of the injection needle. In some embodiments, the scanning knob includes at least one limiter guide. In some embodiments, the scanning knob includes two or more limiter guides configured to limit the insertion depth of the injection needle, and the scanning knob rotates to align one of the two or more limiter guides with the alignment guide.

[0004] In some embodiments, the contact detection device further comprises a bottom pad that forms the distal surface of the contact detection device. In some embodiments, the bottom pad is configured to be on the surface of the patient's skin. In some embodiments, the bottom pad has a concave curve with a radius of approximately 1 m. In some embodiments, the bottom pad has a hardness of approximately 20 Shore A to 30 Shore A.

[0005] In some embodiments, the scanning head is movable relative to the carriage. In some embodiments, the scanning head is biased toward the proximal side of the device. In some embodiments, the scanning head is biased by a spring. In some embodiments, the carriage includes a spring guide. In some embodiments, the scanning knob includes a spring projection, the carriage includes a spring guide, and the spring guide and the spring projection are configured to center the spring relative to the scanning head and the carriage.

[0006] In some embodiments, the sensor array is a matrix array. In some embodiments, the sensor array is a flexible sensor array. In some embodiments, the sensor array is mounted in a sensor array mounting area. In some embodiments, the sensor array is attached to the distal surface of the contact detection device.

[0007] In some embodiments, the base further comprises a handle. In some embodiments, the handle comprises a grip portion. In some embodiments, the needle guide further comprises a connector plate. In some embodiments, the device further comprises a connector coupled to the depth limiter, the connector being detachably attached to the connector plate of the needle guide so that the depth limiter is positioned in a first position aligned with the needle guide and a second position not aligned with the needle guide. In some embodiments, the connector is coupled to the depth limiter so that the depth limiter is positioned in an upper position away from the needle guide or in a lower position close to the needle guide. In some embodiments, the upper position is configured for arranging a 5-inch needle. In some embodiments, the upper position limits the depth of a 5-inch needle to about 0.5 cm to about 5 cm. In some embodiments, the lower position is configured for arranging a 3.5-inch needle. In some embodiments, the upper position limits the depth of a 3.5-inch needle to about 1 cm to about 3.5 cm. In some embodiments, the device further comprises a needle release gate configured to be reversibly attached to the carriage.

[0008] In the contact detection device according to claim 14, the needle release gate is configured to reversibly fix the needle to the carriage in a position concentric with the needle guide.

[0009] In some embodiments, the contact detection device further includes a locking mechanism that prevents the carriage from sliding along the scan track when the scan head is pressed against it. In some embodiments, the locking mechanism includes one or more locking tabs having pointed projections that engage with an elastic strip when the scan head is pressed against it. In some embodiments, the base further includes a position sensor.

[0010] In some embodiments, the contact detection device further comprises a monitoring device, the monitoring device comprising: a display screen operably coupled to the sensor array, configured to display a pressure map representing the location of an individual's target tissue based on the voltage signals output by the one or more pressure sensors; and a computing device comprising a processor operably coupled to the sensor unit and the monitoring device, and a non-temporary computer-readable storage medium having a computer program that includes instructions executable by the processor to i) convert the voltage signals from the sensor array into the pressure map and display the pressure map on the display screen, and ii) output the location of the alignment guide on the display screen.

[0011] In some embodiments, the base further comprises an interface configured to receive the monitoring device. In some embodiments, when the monitoring device is received by the interface, the interface comprises an electrical coupling such that the sensor array is electrically connected to the monitoring device. In some embodiments, the sensor array is electrically coupled to the interface by a flexible printed circuit board. In some embodiments, the monitoring device is coupled to the sensor array via a flexible printed circuit board. In some embodiments, the monitoring device comprises a printed circuit board.

[0012] In some embodiments, the contact detection device further comprises a sleeve configured to receive the monitoring device. In some embodiments, the contact detection device comprises a power supply. In some embodiments, the power supply is a battery in the monitoring device. In some embodiments, the sensor unit and the monitoring device are reversibly connected.

[0013] In some embodiments, the contact detection device includes a wireless transmitter operably connected to the sensor array for remotely transmitting the voltage signals output by the plurality of sensors. In some embodiments, the processor comprises commands for displaying the location of the target tissue and the location of the alignment guide on the display screen in real time. In some embodiments, the processor comprises commands for displaying the force applied to the target tissue in real time.

[0014] In some embodiments, the base further includes a midline indicator. In some embodiments, the distance between the distal surface of the base and the distal surface of the scanning head is approximately 0.1 cm to 5 cm. In some embodiments, the distance between the distal surface of the base and the distal surface of the scanning head is approximately 0.2 cm. In some embodiments, the active area of ​​the sensor array is approximately 350 mm. 2 In some embodiments, the distal surface of the scanning head is curved. In some embodiments, the radius of curvature of the scanning head is approximately 37.5 cm.

[0015] In some embodiments, the device further includes a depth lock for locking the position of the scanning head relative to the carriage at a certain depth. In some embodiments, the device further includes a button for releasing the scanning head from the locked position relative to the carriage. In some embodiments, the flexible printed circuit board electrically connects the position sensor to the monitoring device. In some embodiments, the position sensor is operably coupled to the processor of the computing device, and the computing device receives the position of the sensor array from the position sensor, and the position of the sensor array is used to generate the pressure map.

[0016] In some embodiments, the active area of ​​the sensor array is approximately 350 mm². 2In some embodiments, the scanning head further comprises a scanning knob on its proximal side. In some embodiments, the base comprises at least one limiter guide configured to limit the insertion depth of the needle. In some embodiments, the scanning knob comprises at least one limiter guide. In some embodiments, the scanning knob comprises two or more limiter guides configured to limit the insertion depth of the needle, and the scanning knob rotates to align one of the two or more limiter guides with the alignment guide.

[0017] In this specification, embodiments of a contact detection system comprising a base and a monitoring device are provided, the base comprising a scanning track, a carriage configured to slide along the scanning track, a scanning head mounted on the carriage, and a sensor array attached to the scanning head comprising one or more pressure sensors, each of which pressure sensors is configured to output a voltage signal in response to a change in pressure; the monitoring device comprising a display screen operably coupled to the sensor array, configured to display a pressure map representing the location of an individual's target tissue based on the voltage signals output by the one or more pressure sensors; and a computing device comprising a processor operably coupled to the sensor unit and the monitoring device, and a non-temporary computer-readable storage medium comprising a computer program that includes instructions executable by the processor to i) convert the voltage signals from the sensor array into the pressure map and display the pressure map on the display screen, and ii) output the location of an alignment guide on the display screen.

[0018] In some embodiments, the base further comprises an interface configured to receive the monitoring device. In some embodiments, when the monitoring device is received by the interface, the interface comprises an electrical coupling such that the sensor array is electrically in communication with the monitoring device. In some embodiments, the sensor array is electrically coupled to the interface by a flexible printed circuit board.

[0019] In some embodiments, the base further comprises a position sensor. In some embodiments, the carriage comprises an alignment guide. In some embodiments, the contact detection system further comprises a needle guide configured to be reversibly attached to the carriage. In some embodiments, the needle guide further comprises a removal tab. In some embodiments, the contact detection system further comprises a needle release gate configured to be reversibly attached to the carriage. In some embodiments, the needle release gate is configured to reversibly secure the injection needle to the carriage concentrically with the needle guide.

[0020] In some embodiments, the scanning head further comprises a scanning knob on its proximal side. In some embodiments, the scanning knob comprises at least one limiter guide configured to limit the insertion depth of the injection needle. In some embodiments, the scanning knob comprises two or more limiter guides configured to limit the insertion depth of the injection needle, and the scanning knob rotates to align one of the two or more limiter guides with the alignment guide.

[0021] In some embodiments, the base further includes a midline indicator. In some embodiments, the distance between the distal surface of the base and the distal surface of the scanning head is approximately 0.1 cm to 5 cm. In some embodiments, the distance between the distal surface of the base and the distal surface of the scanning head is approximately 0.2 cm. In some embodiments, the active area of ​​the sensor array is approximately 350 mm. 2 That is the case.

[0022] In some embodiments, the contact detection device further comprises a bottom pad that forms the distal surface of the contact detection system. In some embodiments, the bottom pad is configured to be on the surface of the patient's skin. In some embodiments, the bottom pad has a concave curve with a radius of approximately 1 m. In some embodiments, the bottom pad has a hardness of approximately 20 Shore A to 35 Shore A.

[0023] In some embodiments, the scanning head is movable relative to the carriage. In some embodiments, the scanning head is biased toward the proximal side of the system. In some embodiments, the scanning head is biased by a spring. In some embodiments, the scanning head includes a spring projection, and the spring guide and the spring projection are configured to center the spring relative to the scanning head and the carriage. In some embodiments, the sensor array is a matrix array. In some embodiments, the sensor array is a flexible sensor array. In some embodiments, the sensor array is mounted in a sensor array mounting area. In some embodiments, the sensor array is attached to the distal surface of the scanning head.

[0024] In some embodiments, the base further comprises a handle. In some embodiments, the handle comprises a grip portion. In some embodiments, the contact detection system further comprises a locking mechanism that prevents the carriage from sliding along the scanning track when the scanning head is pressed against. In some embodiments, the locking mechanism comprises one or more locking tabs having pointed protrusions that engage an elastic strip when the scanning head is pressed against.

[0025] In some embodiments, the monitor device is coupled to the sensor array via a flexible printed circuit board. In some embodiments, the monitor device comprises a printed circuit board. In some embodiments, the contact detection system further comprises a sleeve configured to receive the monitor device. In some embodiments, the contact detection system further comprises a power source. In some embodiments, the power source is a battery within the monitor device.

[0026] In some embodiments, the sensor unit and the monitor device are reversibly connected. In some embodiments, the contact detection system comprises a wireless transmitter operably connected to the sensor array for remotely transmitting the voltage signals output by the plurality of sensors. In some embodiments, the processor is configured with instructions to display the location of the target tissue site and the alignment guide on the display screen in real time. In some embodiments, the processor is configured with instructions to display the force applied to the target tissue site in real time.

[0027] In some embodiments, the method for searching for an insertion site using the system includes sliding the carriage to the target tissue location, pressing the scanning head against the target tissue location to capture a pressure map image on the display screen, reading a measured value of the applied force from the force indicator, releasing the scanning head, sliding the carriage towards an unmapped area of the target tissue location, and repeating the steps until the pressure map is displayed across the target tissue location.

[0028] In some embodiments, the position sensor is operably coupled to the processor of the computing device, the computing device receives the position of the sensor array from the position sensor, and the position of the sensor array is utilized to generate the pressure map. In some embodiments, the position sensor is electrically coupled to the interface via a flexible printed circuit board.

[0029] In some embodiments, the method for marking an insertion site using the system includes sliding the carriage to the target tissue location, pressing the scanning head against the target tissue location to capture a pressure map image on the display screen, reading a measured value of the applied force from the force indicator, releasing the scanning head, sliding the carriage towards an unmapped area of the target tissue location, repeating the previous steps until the pressure map is displayed across the target tissue location, identifying the insertion site, placing the alignment guide at the location of the insertion site on the pressure map, placing the marking device through the alignment guide, and marking the insertion site on the patient's skin surface.

[0030] In some embodiments, a method of using the system to guide a needle to an insertion site comprises sliding the carriage to a target tissue location; pressing the scanning head against the target tissue location to capture a pressure map image on the display screen; releasing the scanning head; sliding the carriage toward an unmapped area of ​​the target tissue location; repeating the steps until a pressure map is displayed across the target tissue location; aligning the location of the alignment guide to the insertion site on the pressure map; positioning the needle through the needle guide; and pressing the scanning head to guide the needle to the insertion site. In some embodiments, the method further comprises the step of removing the system while holding the needle in the insertion site.

[0031] In some embodiments, the method further comprises reading a measurement of the applied force from a force indicator. In some embodiments, a method of treating a patient site by guiding a needle to an insertion site using the system comprises sliding the carriage to the target tissue location, pressing the scanning head against the target tissue location to capture a pressure map image on the display screen, reading a measurement of the applied force from a force indicator, releasing the scanning head, sliding the carriage toward an unmapped area of ​​the target tissue location, repeating the preceding steps until a pressure map is displayed across the target tissue location, aligning the location of the alignment guide to the insertion site on the pressure map, positioning the needle via the needle guide, and inserting the needle into the insertion site. In some embodiments, the needle is a local anesthetic needle, and the method further comprises injecting a local anesthetic into the insertion site. In some embodiments, the method further comprises removing the local anesthetic needle, positioning a spinal anesthetic needle via the needle guide, and inserting the spinal anesthetic needle into the insertion site. In some embodiments, the method further comprises the steps of removing the local anesthetic needle, positioning an introducer needle via the needle guide, and inserting the introducer needle into the insertion site. In some embodiments, the method further comprises the step of removing the system. In some embodiments, the step of removing the system further comprises opening the release gate. In some embodiments, the method further comprises the step of continuing the procedure after the step of removing the system. The method according to claim 109 further comprises the step of unlocking the release gate prior to the step of removing the system.

[0032] In some embodiments, the needle is a local anesthetic needle, and the method further comprises the step of injecting a local anesthetic into the insertion site. In some embodiments, the method further comprises the step of removing the local anesthetic needle, positioning a spinal anesthetic needle via the needle guide, and inserting the spinal anesthetic needle into the insertion site. In some embodiments, the method further comprises the step of removing the local anesthetic needle, positioning an introducer needle via the needle guide, and inserting the introducer needle into the insertion site. In some embodiments, the method further comprises the step of removing the system. In some embodiments, the step of removing the system comprises opening the release gate. In some embodiments, the method further comprises the step of continuing the procedure after the step of removing the system.

[0033] In some embodiments, the needle is an introducer. In some embodiments, the method further comprises the step of configuring a depth limiter prior to the step of positioning the needle through the needle guide. In some embodiments, the step of configuring the depth limiter comprises setting the height of the depth limiter. In some embodiments, setting the height of the depth limiter comprises setting the depth limiter to a lower position.

[0034] In some embodiments, the method further comprises locking the depth limiter in the lower position. In some embodiments, setting the height of the depth limiter comprises setting the depth limiter in the upper position. In some embodiments, the method further comprises locking the depth limiter in the upper position.

[0035] In some embodiments, a method for finding an insertion site using a contact detection device is provided herein, the contact detection device comprising a base and a monitoring device, the base comprising a scanning track, a carriage configured to slide along the scanning track and having alignment guides, a scanning head mounted on the carriage, and a sensor array attached to the scanning head comprising one or more pressure sensors, each of which pressure sensors is configured to output a voltage signal in response to a change in pressure, the monitoring device comprising a display screen operably coupled to the sensor array and configured to display a pressure map representing the target tissue location of an individual based on the voltage signals output by the one or more pressure sensors, and a computing device comprising a processor operably coupled to the sensor unit and the monitoring device. The computing device comprises a non-temporary computer-readable storage medium having a computer program that includes instructions executable by the processor for i) converting the voltage signals from the sensor array into a pressure map and displaying the pressure map on the display screen, and ii) outputting the locations of alignment guides on the display screen, wherein the method comprises (a) sliding the carriage to a target tissue location, (b) pressing the scanning head against the target tissue location to capture a pressure map image on the display screen, (c) releasing the scanning head, (d) sliding the carriage toward an unmapped area of ​​the target tissue location, and (e) repeating steps (b) to (d) until the pressure map is displayed across the target tissue location.

[0036] In some embodiments, the method further comprises identifying an insertion site and positioning the alignment guide at the insertion site. In some embodiments, the method further comprises positioning a needle via the needle guide and inserting the needle into the insertion site. In some embodiments, the method further comprises positioning a marking device via the alignment guide and marking the insertion site on the patient's skin surface. In some embodiments, the method further comprises removing the system while retaining the needle at the insertion site. In some embodiments, the method further comprises unlocking a release gate prior to the step of removing the system.

[0037] In some embodiments, the needle is a local anesthetic needle, and the method further comprises the step of injecting a local anesthetic into the insertion site. In some embodiments, the method further comprises the step of removing the local anesthetic needle, positioning a spinal anesthetic needle via the needle guide, and inserting the spinal anesthetic needle into the insertion site. In some embodiments, the method further comprises the step of removing the local anesthetic needle, positioning an introducer needle via the needle guide, and inserting the introducer needle into the insertion site. In some embodiments, the method further comprises the step of removing the system. In some embodiments, the step of removing the system comprises opening the release gate. In some embodiments, the method further comprises the step of continuing the procedure after the step of removing the system.

[0038] In some embodiments, the needle is an introducer. In some embodiments, the method further comprises the step of configuring a depth limiter prior to the step of positioning the needle via the needle guide. In some embodiments, the step of configuring the depth limiter comprises setting the height of the depth limiter. In some embodiments, setting the height of the depth limiter comprises setting the depth limiter to a lower position. In some embodiments, the method further comprises locking the depth limiter to the lower position. In some embodiments, setting the height of the depth limiter comprises setting the depth limiter to an upper position. In some embodiments, the method further comprises locking the depth limiter to the upper position.

[0039] Novel features of the present invention are described in particular in the appended claims. A further understanding of the features and advantages of the present invention can be obtained by referring to the following detailed description and accompanying drawings illustrating exemplary embodiments in which the principles of the present invention are utilized. [Brief explanation of the drawing]

[0040] [Figure 1] A contact detection and guidance system according to some embodiments is shown. [Figure 2A] The following shows the base components of a contact detection and guidance system according to some embodiments. [Figure 2B] The following shows the base components of a contact detection and guidance system according to some embodiments. [Figure 3A] The carriage component of a contact detection and guidance system according to some embodiments is shown. [Figure 3B] This shows a scanning head subassembly component of a contact detection and guidance system according to some embodiments. [Figure 3C]The image shows a carriage component coupled to the base component of a contact detection and guidance system, according to some embodiments. [Figure 3D] A cross-sectional view of a scanning head subassembly component coupled to the base component of a contact detection and guidance system, according to one embodiment, is shown. [Figure 3E] A cross-sectional view of a scanning head subassembly component coupled to the base component of a contact detection and guidance system, according to one embodiment, is shown. [Figure 4A] This shows a scanning head subassembly of a contact detection and guidance system according to some embodiments. [Figure 4B] This shows a scanning head component of a contact detection and guidance system according to some embodiments. [Figure 5A] This shows a needle guide subassembly of a contact detection and guidance system according to some embodiments. [Figure 5B] This shows a needle guide subassembly of a contact detection and guidance system according to some embodiments. [Figure 5C] The image shows a needle guide subassembly coupled to the carriage component of a contact detection and guidance system, according to one embodiment. [Figure 5D] This shows a needle guide subassembly of a contact detection and guidance system according to some embodiments. [Figure 5E] This shows a needle guide component coupled to a carriage component of a contact detection and guidance system, according to some embodiments. [Figure 5F] The image shows a needle guide subassembly coupled to the carriage component of a contact detection and guidance system, according to one embodiment. [Figure 5G] The image shows a needle guide subassembly coupled to the carriage component of a contact detection and guidance system, according to one embodiment. [Figure 5H]The image shows a needle guide subassembly coupled to the carriage component of a contact detection and guidance system, according to one embodiment. [Figure 6A] The image shows a needle guide subassembly and release gate component coupled to the carriage component of a contact detection and guidance system, according to one embodiment. [Figure 6B] The image shows a needle guide component and a release gate component coupled to the carriage component of a contact detection and guidance system, according to some embodiments. [Figure 6C] The image shows a needle guide component and a release gate component coupled to the carriage component of a contact detection and guidance system, according to some embodiments. [Figure 7A] A cross-sectional view of a monitoring device component of a contact detection and guidance system according to one embodiment is shown. [Figure 7B] An exploded view of a monitoring device component of a contact detection and guidance system according to some embodiments is shown. [Figure 8A] The image shows a monitoring device component that combines sleeve components of a contact detection and guidance system, according to one embodiment. [Figure 8B] The image shows a monitoring device component received by a dock, in preparation for coupling with the base component of a contact detection and guidance system, according to one embodiment. [Figure 9A] This shows a graphical user interface for a monitoring device of a contact detection and guidance system according to some embodiments. [Figure 9B] This shows a graphical user interface for a monitoring device of a contact detection and guidance system according to some embodiments. [Figure 9C] This shows a graphical user interface for a monitoring device of a contact detection and guidance system according to some embodiments. [Figure 9D] This shows a graphical user interface for a monitoring device of a contact detection and guidance system according to some embodiments. [Figure 9E] This shows a graphical user interface for a monitoring device of a contact detection and guidance system according to some embodiments. [Figure 9F] This shows a graphical user interface for a monitoring device of a contact detection and guidance system according to some embodiments. [Figure 10A] A flowchart illustrating the use of a contact detection and guidance system according to some embodiments is shown. [Figure 10B] The following describes how to use a contact detection and guidance system according to some embodiments. [Figure 10C] The following describes how to use a contact detection and guidance system according to some embodiments. [Figure 10D] The following describes how to use a contact detection and guidance system according to some embodiments. [Modes for carrying out the invention]

[0041] Embodiments of contact detection and needle guidance systems are provided herein. In some embodiments, the contact detection and needle guidance system is a sliding system comprising a scanning head mounted on a carriage to facilitate movement along a scanning track. In some embodiments, the contact detection and needle guidance system further comprises a monitoring device that displays a pressure map and alignment guide indicators to facilitate needle marking and / or insertion to a target location on the patient, as needed.

[0042] I. Slide-type contact detection and needle guidance system According to some embodiments, the contact detection device is a sliding contact detection system. The sliding contact detection system and related components are shown in Figures 1-8B. In some embodiments, the contact detection system includes visualization of past and real-time images, and therefore requires a smaller sensor array to construct images for displaying the biological tissue of the object compared to a non-sliding contact detection device.

[0043] Figure 1 shows a contact detection system 100 according to some embodiments. In some embodiments, the contact detection system 100 includes a monitor device 150 that is detachable from a base 110. In some embodiments, the slider contact detection device 100 includes a scanning head subassembly comprising a scanning head 125 and a carriage 130. In some embodiments, the scanning head 125 is combined with a carriage 130 configured to allow a user to press the scanning head 125 against the patient's skin surface and press a sensor array (e.g., a sensor array 435 shown in Figure 4). In some embodiments, the base 110 includes a scanning track 145. In some embodiments, the scanning track is configured to move the scanning head subassembly along a certain distance (e.g., along the patient's vertebrae).

[0044] In some embodiments, the carriage 130 allows the scanning head 125 and sensor array to move over a certain distance (for example, 3 inches along a vertebra). In some embodiments, the scanning head 125 is moved over a distance of approximately 0.5 inches to approximately 10 inches. In some embodiments, the scanning head 125 is moved over a distance of at least approximately 0.5 inches. In some embodiments, the scanning head 125 is moved over a distance of up to approximately 10 inches. In some embodiments, the scanning head 125 is approximately 0.5 inches to 1 inch, approximately 0.5 inches to 2 inches, approximately 0.5 inches to 3 inches, approximately 0.5 inches to 4 inches, approximately 0.5 inches to 5 inches, approximately 0.5 inches to 6 inches, approximately 0.5 inches to 7 inches, approximately 0.5 inches to 8 inches, approximately 0.5 inches to 9 inches, approximately 0.5 inches to 10 inches, approximately 1 inch to 2 inches, approximately 1 inch to 3 inches, approximately 1 inch to 4 inches, approximately 1 inch to 5 inches, approximately 1 inch to 6 inches, approximately 1 inch to 7 inches, approximately 1 inch to 8 inches, approximately 1 inch to 9 inches, approximately 1 inch to 10 inches, approximately 2 inches to 3 inches, approximately 2 inches to 4 inches, approximately 2 inches to 5 inches, approximately 2 inches to 6 inches, approximately 2 inches to 7 inches, approximately 2 inches to 8 inches, approximately 2 inches to 9 inches, approximately 2 inches to The distance traveled is approximately 10 inches, approximately 3 to 4 inches, approximately 3 to 5 inches, approximately 3 to 6 inches, approximately 3 to 7 inches, approximately 3 to 8 inches, approximately 3 to 9 inches, approximately 3 to 10 inches, approximately 4 to 5 inches, approximately 4 to 6 inches, approximately 4 to 7 inches, approximately 4 to 8 inches, approximately 4 to 9 inches, approximately 4 to 10 inches, approximately 5 to 6 inches, approximately 5 to 7 inches, approximately 5 to 8 inches, approximately 5 to 9 inches, approximately 5 to 10 inches, approximately 6 to 7 inches, approximately 6 to 8 inches, approximately 6 to 9 inches, approximately 6 to 10 inches, approximately 7 to 8 inches, approximately 7 to 9 inches, approximately 7 to 10 inches, approximately 8 to 9 inches, approximately 8 to 10 inches, or approximately 9 to 10 inches.In some embodiments, the scanning head 125 is moved a distance of approximately 0.5 inches, 1 inch, 2 inches, 3 inches, 4 inches, 5 inches, 6 inches, 7 inches, 8 inches, 9 inches, or 10 inches.

[0045] In some embodiments, the distal surface of the scanning head 125 relative to the user (i.e., the bottom surface) is equipped with a sensor array. In some embodiments, the scanning head 125 is configured to receive a scanning knob 120. In some embodiments, the sensor array (e.g., sensor array 435 shown in Figure 4) is mounted on the bottom surface of the scanning head 120. In some embodiments, the bottom or distal surface of the scanning head 125 on which the sensor array is provided has a size and curvature designed to mimic palpation and to optimize the spinal resolution of the pressure map generated from the sensing elements of the sensor array or from the sensors. In some embodiments, the bottom surface of the scanning head is approximately 30 mm in length and approximately 21 mm in width. In some embodiments, the bottom surface of the scanning head has a radius of curvature of approximately 37.5 mm. In some embodiments, the scanning head 125 may be pressed against the carriage (i.e., along the Z-axis) toward the bottom surface of the base 110.

[0046] As shown in Figure 1, the base 110 of the contact detection system 100 may include a grip portion 170. In some embodiments, the grip portion 170 is reversibly attachable to the base 110. In some embodiments, the user grasps the grip portion 170 to stabilize the device against the patient. In some embodiments, the grip portion 170 is an ergonomic handle extending to one side of the base 110, similar to a bicycle grip. In some embodiments, the grip portion 170 extends to the left side of the base, allowing the user to grasp the grip portion 170 with their left hand while engaging the scanning head 125 with their right hand. In another embodiment, the grip portion 170 extends to the right side of the base, allowing the user to grasp the grip portion 170 with their right hand while engaging the scanning head 125 with their left hand.

[0047] In some embodiments, the base 110 of the contact detection device includes a support 140. In some embodiments, the support 140 includes a midline indicator 112 of the contact detection device that facilitates alignment with the spine. In some embodiments, the midline indicator 112 is provided on the body of the base 110. In some embodiments, the midline indicator 112 of the contact detection device further includes an alignment guide. In some embodiments, the indicator is a colored notch. In some embodiments, the midline indicator 112 is provided on a carriage 130. In some embodiments, the midline indicator is provided on a scanning knob 120.

[0048] In some embodiments, the scanning head subassembly comprises a scanning head 125, a scanning knob 120, and a carriage 130. In some embodiments, the contact detection device 100 comprises a scanning track 145 (see also 245 in Figure 2A). In some embodiments, the scanning track 145 is part of the base 110. In some embodiments, the scanning track 145 is a removable part assembled to the base 110. In some embodiments, the scanning track 145 comprises a track configured to move the carriage 130 and scanning head 125 along the surface of the patient's skin. In some embodiments, the scanning track 145 is configured to receive the carriage 130. In some embodiments, the carriage 130 fits into the scanning track 145. In some embodiments, the scanning track 145 comprises an elastic strip that aligns with a projection on the carriage 130 when the scanning head 125 is pressed against the carriage and locks the carriage in its current position along the scanning track.

[0049] In some embodiments, the scan track 145 is approximately 2.5 inches to approximately 3 inches long, allowing the carriage 130 to move along the track. In some embodiments, the length of the scan track is based on the distance between the top and bottom of the continuous spinous processes. In some embodiments, the scan track 145 has a length of approximately 1 cm to approximately 10 cm. In some embodiments, the scan track 145 has a length of at least approximately 1 cm. In some embodiments, the scan track 145 allows a scan head travel distance of up to approximately 10 cm. In some administrations, the scanning track 145 is approximately 1cm to 2cm, 1cm to 3cm, 1cm to 4cm, 1cm to 5cm, 1cm to 6cm, 1cm to 7cm, 1cm to 8cm, 1cm to 9cm, 1cm to 10cm, 2cm to 3cm, 2cm to 4cm, 2cm to 5cm, 2cm to 6cm, 2cm to 7cm, 2cm to 8cm, 2cm to 9cm, 2cm to 10cm, 3cm to 4cm, 3cm to 5cm, 3cm to 6cm, 3cm to 7cm, 3cm to 8cm, approx They have lengths of approximately 3cm to 9cm, 3cm to 10cm, 4cm to 5cm, 4cm to 6cm, 4cm to 7cm, 4cm to 8cm, 4cm to 9cm, 4cm to 10cm, 5cm to 6cm, 5cm to 7cm, 5cm to 8cm, 5cm to 9cm, 5cm to 10cm, 6cm to 7cm, 6cm to 8cm, 6cm to 9cm, 6cm to 10cm, 7cm to 8cm, 7cm to 9cm, 7cm to 10cm, 8cm to 9cm, 8cm to 10cm, or 9cm to 10cm. In some embodiments, the scanning track 145 has a length of approximately 1 cm, 2 cm, 3 cm, 4 cm, 5 cm, 6 cm, 7 cm, 8 cm, 9 cm, or 10 cm.

[0050] In some embodiments, the scanning head 130 is biased away from the bottom surface of the support 140 and toward the proximal side of the contact detection device 100 so that a gap is provided between the bottom surface of the support and the sensor array 135 provided on the distal surface of the scanning head 130. In some embodiments, the gap is approximately 1.8 mm. In some embodiments, the gap between the support and the distal surface of the scanning head is approximately 0.1 cm to approximately 5 cm. In some embodiments, the gap between the support and the distal surface of the scanning head is approximately 0.1 cm to approximately 0.5 cm, approximately 0.1 cm to approximately 1 cm, approximately 0.1 cm to approximately 1.5 cm, approximately 0.1 cm to approximately 2 cm, approximately 0.1 cm to approximately 2.5 cm, approximately 0.1 cm to approximately 3 cm, approximately 0.1 cm to approximately 3.5 cm, approximately 0.1 cm to approximately 4 cm, approximately 0.1 cm to approximately 4.5 cm, approximately 0.1 cm to approximately 5 cm, approximately 0.5 cm to approximately 1 cm, approximately 0.5cm~about 1.5cm, about 0.5cm~about 2cm, about 0.5cm~about 2.5cm, about 0.5cm~about 3cm, about 0.5cm~about 3.5cm, about 0.5cm~about 4cm, about 0.5cm~about 4.5cm m, about 0.5cm to about 5cm, about 1cm to about 1.5cm, about 1cm to about 2cm, about 1cm to about 2.5cm, about 1cm to about 3cm, about 1cm to about 3.5cm, about 1cm to about 4cm, about 1cm to about 4.5 cm, approximately 1cm to approximately 5cm, approximately 1.5cm to approximately 2cm, approximately 1.5cm to approximately 2.5cm, approximately 1.5cm to approximately 3cm, approximately 1.5cm to approximately 3.5cm, approximately 1.5cm to approximately 4cm, approximately 1.5cm to approximately 4.5 cm, about 1.5cm to about 5cm, about 2cm to about 2.5cm, about 2cm to about 3cm, about 2cm to about 3.5cm, about 2cm to about 4cm, about 2cm to about 4.5cm, about 2cm to about 5cm, about 2.5cm to about The sizes are 3cm, approximately 2.5cm to 3.5cm, approximately 2.5cm to 4cm, approximately 2.5cm to 4.5cm, approximately 2.5cm to 5cm, approximately 3cm to 3.5cm, approximately 3cm to 4cm, approximately 3cm to 4.5cm, approximately 3cm to 5cm, approximately 3.5cm to 4cm, approximately 3.5cm to 4.5cm, approximately 3.5cm to 5cm, approximately 4cm to 4.5cm, approximately 4cm to 5cm, or approximately 4.5cm to 5cm.In some embodiments, the gap distance between the support and the distal surface of the scan head is approximately 0.1 cm, 0.5 cm, 1 cm, 1.5 cm, 2 cm, 2.5 cm, 3 cm, 3.5 cm, 4 cm, 4.5 cm, or 5 cm. In some embodiments, the gap distance between the support and the distal surface of the scan head is at least approximately 0.1 cm, 0.5 cm, 1 cm, 1.5 cm, 2 cm, 2.5 cm, 3 cm, 3.5 cm, 4 cm, or 4.5 cm. In some embodiments, the gap distance between the support and the distal surface of the scan head is at most approximately 0.5 cm, 1 cm, 1.5 cm, 2 cm, 2.5 cm, 3 cm, 3.5 cm, 4 cm, 4.5 cm, or 5 cm.

[0051] Figures 2A and 2B show embodiments of the base component 210. In some embodiments, the base 210 is reusable. In some embodiments, the base 210 is disposable. In some embodiments, the base 210 is made of medical injection-molded plastic. In some embodiments, the base 210 consists of four parts. In some embodiments, the base 210 includes a handle 270. In some embodiments, a second component forms the bottom of the handle 275. In some embodiments, the base further includes a support 240. In some embodiments, the support 240 houses a flexible printed circuit board and interface 295 for electrically connecting a sensor array and / or position sensors to a monitoring device, as further disclosed herein. In some embodiments, the support includes a midline indicator 212. The base components may be joined together via press fits. The base components may be fastened together by adhesive or one or more fasteners such as screws.

[0052] In some embodiments, the support 240 is provided with a patient contact mechanism on its bottom surface. In some embodiments, the patient contact mechanism is configured for positioning and stabilizing the device. In some embodiments, the patient contact mechanism is configured to prevent the device from slipping during use. In some embodiments, the patient contact mechanism employs a vacuum, adhesive, adhesive substrate, bottom pad, or belt mechanism.

[0053] In some embodiments, the bottom pad 250 forms the surface of the base 210 that contacts the patient. In some embodiments, the bottom pad 250 has a hardness of about 25 to about 35 Shore A. In some embodiments, the bottom pad 250 has a hardness of about 10 to about 40 Shore A. In some embodiments, the bottom surface of the support 240 has a hardness of about 10 to about 15 Shore A, about 10 to about 20 Shore A, about 10 to about 25 Shore A, about 10 to about 30 Shore A, about 10 to about 35 Shore A, about 10 to about 40 Shore A, about 15 to about 20 Shore A, about 15 to about 25 Shore A, about 15 to about 30 Shore A, about 15 to about 35 Shore A, The hardness of the supports is approximately 15 Shore A to 40 Shore A, approximately 20 Shore A to 25 Shore A, approximately 20 Shore A to 30 Shore A, approximately 20 Shore A to 35 Shore A, approximately 20 Shore A to 40 Shore A, approximately 25 Shore A to 30 Shore A, approximately 25 Shore A to 35 Shore A, approximately 25 Shore A to 40 Shore A, approximately 30 Shore A to 35 Shore A, approximately 30 Shore A to 40 Shore A, or approximately 35 Shore A to 40 Shore A. Some sphagnum supports have a hardness of approximately 10 Shore A, approximately 15 Shore A, approximately 20 Shore A, approximately 25 Shore A, approximately 30 Shore A, approximately 35 Shore A, or approximately 40 Shore A. In some embodiments, the bottom surface of the support 240 has a hardness of at least about 10 Shore A, about 15 Shore A, about 20 Shore A, about 25 Shore A, about 30 Shore A, or about 35 Shore A. In some embodiments, the bottom surface of the support 240 has a hardness of up to about 15 Shore A, about 20 Shore A, about 25 Shore A, about 30 Shore A, about 35 Shore A, or about 40 Shore A. In some embodiments, the bottom pad is elastic. In some embodiments, the bottom pad has a length of about 132 mm.

[0054] In some embodiments, the support 240 of the base 110 is curved. In some embodiments, the patient contact surface of the support 240 has a downward concave curve to conform to the curvature of one or more vertebrae. In some embodiments, the radius of the longitudinal downward concave curve (parallel to the direction of the scanning track) is approximately 1 m.

[0055] In some embodiments, the patient contact surface of the support 240 has an upward concave curve to conform to the tissue between the thoracolumbar fascia. In some embodiments, the patient contact surface of the support 240 has an M-shaped curve to optimize conformity in the mid-to-lateral direction.

[0056] In some embodiments, the support 240 includes a grip area for the user's non-dominant hand. In some embodiments, the grip area is on the left side of the support 240 when viewed from the front. In some embodiments, the grip area is rounded. In some embodiments, the grip area comprises multiple materials. In some embodiments, the grip area includes an undercut to improve grip. In some embodiments, the grip area is a removable palm pad to which the support 240 is assembled. In some embodiments, removable palm pads of different sizes and grips are available.

[0057] A. Carriage In some embodiments, the contact detection device comprises a carriage 330. An embodiment of the carriage 330 is shown with reference to Figure 3A. In some embodiments, the carriage 330 comprises an alignment guide 336. In some embodiments, the alignment guide is provided on the front side of the carriage and fixed to the carriage. In other embodiments, the alignment guide may be detachably mounted on the carriage, located on the rear side of the carriage, and / or located on the side of the carriage opposite to the scanning track. The alignment guide 336 may be configured as a guide for a syringe needle assembly. The alignment guide 336 may be configured as a guide to assist in marking a target location by a marking device.

[0058] In some embodiments, the carriage 330 includes one or more projections 344, 346 that engage with the scan track. In some embodiments, projections 344 include ledges that engage with the inner surface of the scan track. In some embodiments, friction is generated by the coupling between the carriage and the scan track. This friction can prevent the carriage from moving relative to the scan track when the device is positioned and operated at a certain angle. In some embodiments, a force of approximately 0.5 to 0.8 pounds (lbs) is required to move the carriage along the scan track.

[0059] In some embodiments, the carriage 330 includes one or more locking tabs 348 configured to engage with an elastic strip when the scan head is pressed against it and to prevent the carriage from moving along the scan track. In some embodiments, the locking tabs 348 include one or more pointed projections that engage with the elastic strip.

[0060] In some embodiments, the carriage 330 further comprises one or more needle guide tabs 343 configured to reversibly receive a needle guide attachment. The carriage may further comprise one or more release gate mounting projections 347 for receiving a release gate.

[0061] In some embodiments, the carriage 330 includes a spring guide 322 configured to guide a spring that biases the scanning head toward the proximal side of the contact detection device. In some embodiments, the spring guide includes a top surface that contacts one end of the spring and side walls that help to hold the spring. The side walls and / or top surface of the spring guide 322 may have concave or recessed surfaces to better hold the spring.

[0062] B. Scanning head subassembly In some embodiments, as shown in Figure 3B, the scanning head subassembly comprises a carriage 330 and a scanning head 325. The scanning head subassembly may further comprise a sensor array and a flexible sensor printed circuit board. In some embodiments, the scanning head further comprises a scanning cap or knob 320 having a surface for the user to press the scanning head against the patient's skin surface. In some embodiments, the carriage 330 is reversibly fixed to one or more sides of the scanning head 325.

[0063] According to some embodiments, the scanning head subassembly comprises a scanning head body on which a sensor and a sensor printed circuit board (PCB) are mounted. The length of the scanning head is adjustable via an integrated spring to allow tissue penetration of up to approximately 2.5 cm relative to the unloaded position. In addition, in the stationary position, the bottom surface of the scanning head is in a raised position that provides a scanning gap.

[0064] Referring to Figures 3C-3E, in some embodiments, the carriage 330 is combined with the scan track to allow the scan head 325 to move along the scan track. In some embodiments, the carriage 330 is inserted into the scan track and used to traverse the scan head 325 along the spine. In some embodiments, the carriage is magnetically combined with the track. In some embodiments, the combination of the carriage 330 and the scan track is further enhanced by the use of a pre-compressed spring. In some embodiments, silicone or other material is used on the sliding surface between the carriage 330 and the scan track to generate friction and support the combination.

[0065] In some embodiments, the upper projection 344 of the carriage fits into the upper track 364 of the base. In some embodiments, the lower projection 346 of the carriage fits into the lower track 366 of the base. The combination of the upper and lower projections and the tracks allows for the stabilization of the carriage 330 while still enabling the carriage to move along the scanning track.

[0066] Figures 3D and 3E show cross-sectional views of a contact detection device according to some embodiments. According to some embodiments, Figure 3D shows the scanning head 325 when no force is applied to the proximal end (relative to the user). In contrast, Figure 3E shows a cross-sectional view of the contact detection device according to some embodiments when force is applied to the proximal end (relative to the user). Specifically, Figure 3E shows a contact detection device according to some embodiments when the user presses the scanning knob 320 and presses the scanning head 325 and the attached sensor array 335 against (for example, the surface of a patient's skin). That is, Figure 3E shows a scanning head subassembly at a lower position or depth along the Z-axis compared to the initial position or depth along the Z-axis of the scanning head subassembly shown in Figure 3D. The lower position may be referred to as the pressing position.

[0067] In some embodiments, the carriage includes one or more locking tabs 348 configured to engage with the elastic strip 358 when the scan head is pressed against it and to prevent movement of the carriage along the scan track. In some embodiments, the locking tabs 348 include one or more pointed projections or shafts that engage with the elastic strip 358. In some embodiments, as shown in Figure 3E, the scan head 325 includes an angled ledge 328 that engages with the locking tabs 348, thereby pushing the pointed projections against the elastic strip and preventing movement of the carriage and scan head in the forward or backward direction, or in the proximal or distal direction (i.e., along the Y-axis shown in Figure 1).

[0068] In some embodiments, the device includes a depth lock. In some embodiments, the depth lock locks the scan head position relative to the carriage at a certain depth. In some embodiments, the scan knob includes a button configured to release the scan head from a locked position relative to the carriage. In some embodiments, the scan knob includes a button configured to release the carriage from a locked position along the track. In some embodiments, there is an indicator that warns of the scan head being locked along the track or at a position relative to the carriage. In some embodiments, the movement of the scan head is automated. In some embodiments, the movement of the scan head is not automated and is controlled by the user. In some embodiments, the movement of the scan head is controlled by the user via a button. In some embodiments, movement in the proximal and distal directions is controlled by a mechanism located on top of the scan knob. In some embodiments, movement along the scan track is controlled by a mechanism located on the side of the scan knob. In some embodiments, movement along the scan track is controlled by the user via a push button.

[0069] In some embodiments, the contact detection device includes a position sensor 375 (575 in Figure 3D). In some embodiments, the position sensor tracks the position of the carriage 330 relative to the scanning track. In some embodiments, the position sensor is, but is not limited to, a magnetic linear encoder such as a Hall effect sensor. In some embodiments, the position sensor is a potentiometer connected to a linear or rotary axis, which forms an adjustable voltage divider for two end connections and outputs a resistance proportional to the position of the wiper along the axis. In some embodiments, a reference voltage is applied to a fixed end connection, and the output voltage is taken from there as the wiper contact moves along the axis. In some embodiments, the output voltage is input to the PCBA of the monitoring device. In some embodiments, the output power is transmitted from the position sensor to the PCBA of the monitoring device via a flexible printed circuit board (e.g., flexible PCB 470 shown in Figure 4B).

[0070] In some embodiments, the contact detection device includes a computer program that converts the output voltage into the relative position of the wiper. In some embodiments, the position sensor 375 is a slide potentiometer integrated into a base parallel to the scan track, with the wiper inserted into a cut in the scan head 325, such that the output voltage is proportional to the position of the scan head 325 during scanning. In some embodiments, the calculated position is displayed or reflected in a real-time pressure map displayed on a monitoring device and used to support the construction of the pressure map during the scanning process. In some embodiments, the position sensor is a linear potentiometer with a separate wiper attached to the scan head 325. In some embodiments, the position sensor is a magnetic linear encoder with one or more Hall effect sensors in the frame. In some embodiments, the position sensor is an optical linear encoder. In some embodiments, the position sensor is a time-of-flight sensor.

[0071] In some embodiments further shown in Figures 3D and 3E, the contact detection device includes a position sensor 375. In some embodiments, the position sensor tracks the position of the carriage relative to the scanning track. In some embodiments, the position sensor is a potentiometer connected to a linear or rotary axis, with the wiper contact portion connected to a linear or rotary axis, forming an adjustable voltage divider for two end connections and outputting a resistance proportional to the wiper's position along the axis. In some embodiments, a reference voltage is applied to a fixed end connection, and the output voltage is taken from there as the wiper contact portion moves along the axis.

[0072] In some embodiments, the contact detection device includes a computer program that converts the output voltage into the relative position of the wiper. In some embodiments, the position sensor 375 is a slide potentiometer integrated into a base parallel to the scan track, with the wiper inserted into a cut in the scan head 325, such that the output voltage is proportional to the position of the scan head 325 during scanning. In some embodiments, the calculated position is displayed or reflected in a real-time pressure map displayed on a monitoring device. In some embodiments, the position sensor is a linear potentiometer with a separate wiper mounted on the scan head carriage. In some embodiments, the position sensor is a magnetic linear encoder with one or more Hall effect sensors on the frame. In some embodiments, the position sensor is an optical linear encoder. In some embodiments, the position sensor is a time-of-flight sensor.

[0073] Referring further to Figures 3D and 3E, the spring 365 is positioned between the scan head 325 and the carriage 330. In some embodiments, the carriage 330 includes a spring guide 322 configured to guide a spring that biases the scan head toward the proximal side of the contact sensor. In some embodiments, the spring 365 is received by a projection 370 extending from the surface of the scan head 325. In some embodiments, the projection may extend from the surface of the scan knob 320. In some embodiments, the depth to which the scan head 325 advances under certain conditions is determined by the distance between the projection 370 and the guide 322. In some embodiments, when the projection 370 contacts the guide 322, the advance of the scan head 325 is restricted.

[0074] In some embodiments, a spring facilitates the pressing of the scanning head against the tissue within a range of approximately 2.5 cm. In some embodiments, the scanning head is pressed by applying downward pressure to the top of the scanning head or scanning knob. In some embodiments, the scanning head is moved along the scanning track by applying forward or backward pressure to the scanning head.

[0075] C. Sensor Array Figure 4A shows a scanning head subassembly comprising a sensor array 435 provided on a scanning head 425 combined with a carriage 430, according to some embodiments. In some embodiments, the front and rear edges of the scanning head are rounded to allow the scanning head to traverse more smoothly along the skin surface. In some embodiments, the front and rear edges of the bottom of the scanning head are filleted to a diameter of approximately 8 mm to allow the scanning head to traverse more smoothly along the skin surface. In some embodiments, a filleted edge softener with a diameter of approximately 10 mm is connected to the front and rear edges of the bottom surface of the scanning head. In some embodiments, the sensor array is mounted to the bottom surface of the scanning head by adhesive. In some embodiments, the tail of the sensor is tucked into a clip on the side of the carriage. In some embodiments, the tail of the sensor is aligned with adjustment holes on the inner or outer front and rear surfaces of the scanning head.

[0076] In some embodiments, the user applies force to or presses down on the scanning knob 420 to press the scanning head against the carriage 430. In some embodiments, the user applies force to or presses down on the scanning knob 420 to change the position of the scanning head to a lower position or depth.

[0077] In some embodiments, the user controls the depth of the scanning head subassembly along the Z-axis by changing the amount of force they apply to the scanning knob 420. In some embodiments, the travel depth of the scanning head subassembly ranges from approximately 0 cm to approximately 10 cm. In some embodiments, the travel depth of the scanning head subassembly is at least approximately 0 cm. In some embodiments, the depth of the scanning head subassembly is up to approximately 10 cm. In some embodiments, the depth of the scan head subassembly is about 0 cm to about 1 cm, about 0 cm to about 2 cm, about 0 cm to about 3 cm, about 0 cm to about 4 cm, about 0 cm to about 5 cm, about 0 cm to about 6 cm, about 0 cm to about 7 cm, about 0 cm to about 8 cm, about 0 cm to about 9 cm, about 0 cm to about 10 cm, about 1 cm to about 2 cm, about 1 cm to about 3 cm m, about 1cm to about 4cm, about 1cm to about 5cm, about 1cm to about 6cm, about 1cm to about 7cm, about 1cm to about 8cm, about 1cm to about 9cm, about 1cm to about 10cm, about 2cm to about 3cm, about 2cm to about 4cm, about 2cm to about 5cm, about 2cm to about 6cm, about 2cm to about 7cm, about 2cm to about 8cm, about 2cm to about 9cm, about 2cm to about It extends to 10cm, approximately 3cm-4cm, approximately 3cm-5cm, approximately 3cm-6cm, approximately 3cm-7cm, approximately 3cm-8cm, approximately 3cm-9cm, approximately 3cm-10cm, approximately 4cm-5cm, approximately 4cm-6cm, approximately 4cm-7cm, approximately 4cm-8cm, approximately 4cm-9cm, approximately 4cm-10cm, approximately 5cm-6cm, approximately 5cm-7cm, approximately 5cm-8cm, approximately 5cm-9cm, approximately 5cm-10cm, approximately 6cm-7cm, approximately 6cm-8cm, approximately 6cm-9cm, approximately 6cm-10cm, approximately 7cm-8cm, approximately 7cm-9cm, approximately 7cm-10cm, approximately 8cm-9cm, approximately 8cm-10cm, or approximately 9cm-10cm. In some embodiments, the depth 73 of the scanning head subassembly is approximately 0 cm, 1 cm, 2 cm, 3 cm, 4 cm, 5 cm, 6 cm, 7 cm, 8 cm, 9 cm, or 10 cm.

[0078] In some embodiments, the sensor array 435 is a calibrated custom screen-printed sensor array that enables pressure sensing. This array may consist of two thin polyester sheets, on the inner surface of each sheet, with conductive silver traces deposited in row and column patterns, respectively. Each intersection of the column and row acts as a variable resistor, forming a sensing element whose resistance changes inversely to the applied load. A signal can be sent through one row to all the columns. Current can be measured from a given sensing element through its column by exciting one row and grounding the rest. The current can be converted into a voltage representing the resistance of the sensing element. Sequential scanning of these sensing elements enables 2D mapping of the pressure distribution on the vertebra or other surface where the contact sensing device is located. In some embodiments, the spacing between adjacent sensors in the sensor array is measured from the center of a first sensor to the center of an adjacent sensor, i.e., the intercenter spacing. In some embodiments, the intercenter spacing is approximately 1.9 mm, which effectively resolves the lowest edge of the observed interspinous space. In some embodiments, the sensor is calibrated to an average applied pressure of 20 psi, thereby effectively resolving bone-marked structures in obese patients. The array is mounted on the bottom surface of the scanning head via an adhesive layer extending over its active area.

[0079] In some embodiments, the bottom surface of the scanning head acts as a platform for the sensor array. In some embodiments, the sensor array has 11 rows and 9 columns of sensors spaced 1.9 mm apart. In some embodiments, the sensor array has 12 rows and 8 columns of sensors spaced 1.9 mm apart. In some embodiments, the bottom surface of the scanning head is curved. In some embodiments, the bottom surface of the scanning head has a curve of approximately 75 mm radius on the side opposite to the bottom surface of the vertebra. In some embodiments, the bottom surface of the scanning head is approximately 20 × 16 mm. In some embodiments, the bottom surface of the scanning head is approximately 30 mm × 21 mm. In some embodiments, the active sensing area of ​​the sensor array is 22 mm (12 rows) × 15 mm (8 columns). In some embodiments, the active sensing area of ​​the sensor array is approximately 350 mm 2In some embodiments, the surface area of ​​the sensor array provided on the distal surface of the scanning head is approximately 650 mm². 2 That is the case.

[0080] Figure 4B shows a scan head subassembly comprising a sensor array 435 provided on a scan head 425, according to some embodiments. Figure 4B further shows a flexible printed circuit board (PCB) 470, according to some embodiments. In some embodiments, the contact detection device further comprises a flexible printed circuit board (PCB) 470, as shown in Figure 4B. In some embodiments, the flex PCB 470 is mounted on the scan head 425 and connected to the sensor array 435 at the sensor terminals, so that the sensors can interface with downstream electronic equipment, including multiplexer circuits at the interface of the base and monitoring device. In some embodiments, the sensor array is attached to the flexible PCB with an anisotropic conductive adhesive. In some embodiments, the flexible PCB can be made to move freely along the y and z axes to support the sliding and pushing of the scanner. Figure 4B also shows a position sensor 475, according to some embodiments. In some embodiments, the position sensor 475 is a slide potentiometer with a wiper inserted into a cut in the scan head 425, integrated into a base parallel to the direction in which the carriage moves along the scan track, so that the output voltage is proportional to the position of the scan head 425 during scanning. In some embodiments, the calculated position is displayed or reflected in a real-time pressure map shown on a monitoring device and used to support the construction of the pressure map during the scanning process. In some embodiments, the position sensor is a linear potentiometer with a separate wiper attached to the scanning head 425. In some embodiments, the position sensor is a magnetic linear encoder with one or more Hall effect sensors in the frame. In some embodiments, the position sensor is an optical linear encoder. In some embodiments, the position sensor is a time-of-flight sensor.

[0081] D. Needle guide and limiter Figures 5A–5E show a needle guide / needle depth limiter subassembly 560 that is removable and detachable from the carriage of the contact detection device, according to some embodiments. In some embodiments, the needle guide subassembly 560 comprises a needle guide 540, a depth limiter 570, and a connector 580. In some embodiments, the needle guide 540 is removablely mounted to the carriage 530. The needle guide may also be used as a standalone component without additional components of the needle guide subassembly 560 (as shown in Figure 5D). In some embodiments, the needle guide is received by one or more needle guide tabs 543 (see also 343 in Figures 3A and 3B), in which case the needle guide slides on the carriage and is held in place by the needle guide tabs 543.

[0082] In some embodiments, a portion of the needle guide 540 is inserted into the alignment guide 536 of the carriage 530. In some embodiments, at least a portion of the slot 548 of the needle guide 540 is inserted into the alignment guide 536. In some embodiments, when the needle guide 540 is coupled to the carriage, the needle guide and the alignment guide share a common central axis 537. In some embodiments, the depth limiter 570 also shares a common central axis with the alignment guide and / or the needle guide. In some embodiments, the needle guide shares a common central axis with the sensor array. In some embodiments, the aiming line or target drawn on the monitor is designed to accurately represent the central axis of the alignment guide and the central axis of the needle guide (when inserted and coupled to the carriage), and the aiming line displayed on the monitoring device accurately represents the target area or insertion area when the needle guide or depth limiter is used. In some embodiments, the center of the alignment guide is at a fixed distance from the center of the sensor array. In some embodiments, the center of the alignment guide is approximately 24 mm from the center of the sensor array. Alignment guides 536 without needle guides may act as marker guides for surgical markers or as other markers for marking the target or insertion site on the surface. In some embodiments, contact detection devices comprising an integrated needle guide subassembly do not block more than approximately 67% of a circle with a diameter of approximately 15 mm around the identified target site when viewed from the proximal side.

[0083] The needle guide subassembly 560 may be configured such that the depth limiter 570 slides on and within the aligned needle guide 540, or is movable away from the needle guide 540 without being aligned with it. In some embodiments, the coupling of the connector plate 541 and the connector 580 allows the depth limiter to move laterally by about 12 mm. In some embodiments, the needle guide subassembly is configured such that the depth limiter is vertically movable (i.e., can be raised to a position closer to the user and lowered to a position further away from the user). In some embodiments, the needle guide component further comprises a connector plate 541. In some embodiments, the connector plate 541 comprises a slot 542. In some embodiments, the connector 580 comprises a projection 582 of the needle guide 540 that is received by the slot 542 of the connector plate 541. In some embodiments, the connector plate 541 is inserted into a portion of the connector formed by an overhang 585 extending from the connector. The connector plate 541 may comprise one or more projections 543 for stabilizing the connector 580.

[0084] Figure 5D shows a detailed view of the coupling of the connector 580 to the connector plate 541 of the needle guide 540. In some embodiments, the slot 542 of the connector plate includes a tab 544 that locks a projection 582 into place at the end of the slot. In some embodiments, sufficient force applied by the user may relieve the tab 544, allowing the connector 580 to move along the connector plate 541. In some embodiments, the connector includes an aperture 583. The aperture may provide a grip point for the user. The aperture allows the user to see how the connector 580 is properly coupled to the connector plate 541. In some embodiments, the connector 580 acts as a release tab.

[0085] In some embodiments, the connector plate 541 provides a surface for the user to grasp and acts as a removal tab to remove the needle guide 540 from the carriage 530. In some embodiments, the needle guide 540 is configured to hold and guide the needle-syringe assembly. In some embodiments, the needle guide is located within the alignment guide 536. In some embodiments, the needle guide 540 has a proximal opening 546 that tapers toward the distal end 547 to support the needle or the syringe or hub of the introducer. In some embodiments, the taper forms a relatively conical cross-section. In some embodiments, the taper allows the needle to enter the needle guide channel in either initial entry path. In some embodiments, a slot 548 provides the user with lateral access to the needle guide, allowing the user to remove the contact sensor while the needle is positioned on the patient's skin surface. In some embodiments, the slot 548 is approximately 1 mm wide (i.e., approximately 1 mm in diameter). In some embodiments, a block 549 helps guide the needle toward the slot 548. In some embodiments, the proximal end of the needle guide is chamfered to facilitate the insertion of the needle into the slot 548.

[0086] In some embodiments, the needle guide assembly includes a depth limiter 570. In some embodiments, the depth limiter includes one or more projections 572 configured to be received by a slot 586 provided in the connector 580. The depth limiter 570 may be coupled to the connector 580 so that the depth limiter can move up and down relative to the skin surface when the device is placed on a patient. In some embodiments, the depth limiter includes a locking projection 577 that locks into a recess 587 in the connector 580 to lock the limiter in an upper position. In some embodiments, the depth limiter has an upper position and a lower position. In some embodiments, a release tab 588 is pressed to release the limiter from the locked position. In some embodiments, the depth limiter 570 includes a proximal opening 573 that tapers toward the distal end to support the needle hub.

[0087] In some embodiments, the depth limiter 570 restricts the needle insertion depth to a depth shallower than the interspinous ligament. In some embodiments, the limiter element allows an insertion depth to which the needle remains safe in the tissue when the device is removed from the tissue. In some embodiments, the limiter element allows insertion to a depth of approximately 2 cm. In some embodiments, the limiter element allows a maximum insertion depth of approximately 0.5 cm to 5 cm. In some embodiments, the upper position is used for the insertion of a 5-inch needle. In some embodiments, the depth limiter restricts the insertion depth of a 5-inch needle to approximately 2 cm to approximately 5 cm. In some embodiments, the lower position is used for the insertion of a 3.5-inch needle. In some embodiments, the depth limiter restricts the insertion depth of a 3.5-inch needle to approximately 2 cm to approximately 3.5 cm. In some embodiments, the depth limiter restricts the needle insertion depth to approximately one-third of the length of the needle shaft. In some embodiments, the depth limiter is held in place by frictional force, and the height of the depth limiter can be set to various positions between the upper and lower positions. In some embodiments, the limiter is provided with graduated markings so that the user can measure the height of the limiter from the bottom surface of the contact detection device or the surface being scanned. The graduated markings also allow the user to set the needle insertion depth. In some embodiments, the adjustment of the limiter height is automated.

[0088] In some embodiments, the depth limiter includes a proximal opening 573 that tapers toward a distal end 574 to support the needle hub. In some embodiments, the introducer is positioned directly via a needle guide without the use of a depth limiter. In some embodiments, the needle guide limits the insertion depth of the introducer to about 1 cm. In some embodiments, the depth limiter includes a grip tab 575 that provides the user with a point to grasp the depth limiter and for adjusting its height or position relative to the needle guide. In some embodiments, the connector 580 acts as a removal tab.

[0089] Figures 5C–5H also show needle release gates 527, as described further herein, according to some embodiments. In some embodiments, the release gate 527 is received by a release gate mounting projection 547 of the carriage 530.

[0090] Figures 5E–5H show different configurations or positions of the needle guide subassembly according to some embodiments. As shown in Figure 5E, the needle guide 540 may be received in the carriage without other components of the needle guide subassembly. As shown in Figure 5F, the depth limiter 570 may be provided in a lower position and move without aligning with the needle guide 540 to allow access to the needle guide. As shown in Figure 5G, the coupling of the connector 580 with the needle guide 540 makes the depth limiter 570 alignable with the needle guide. Figure 5G shows the depth limiter in the lower position according to some embodiments. In some embodiments, the lower position is used to accommodate a 3.5-inch needle. Figure 5H shows the depth limiter 570 in the upper position, aligned with the needle guide 570, according to some embodiments. In some embodiments, the upper position is used to accommodate a 5-inch needle.

[0091] In some embodiments, the needle guide has a fixed angle. In some embodiments, the needle guide is oriented perpendicular to the patient (i.e., parallel to the z-axis). In some embodiments, the needle guide has an adjustable angle. In some embodiments, the needle guide has one or more tracks suitable for the insertion of one or more types of needles. In some embodiments, the tracks of the needle guide have a fixed diameter. In some embodiments, the tracks of the needle guide have a length of approximately 12 mm. In some embodiments, the distal end of the needle guide is approximately 8 mm from the lowest surface of the base so that the insertion point is visible.

[0092] In some embodiments, the needle guide is located in front of or behind the scanning head. In some embodiments, the needle guide is laterally shifted from the scanning head during scanning. In some embodiments, the needle guide is fixed to the carriage. In some embodiments, the needle guide is fixed to the scanning head. In some embodiments, the needle guide is detachable. In some embodiments, once a target tissue location is identified, the scanning head and carriage are manually moved along the scanning track until the alignment guide is positioned at the target tissue location. In some embodiments, once a target tissue location is identified, the scanning head and carriage are automatically moved along a sliding track until the needle guide is aligned with the target tissue location. In some embodiments, once a target tissue location is identified, the scanning head and carriage are removed, and the needle guide is mounted on the device to align with the target tissue location. In some embodiments, a release gate and a slot in the needle guide allow the device to withdraw the needle or introducer after insertion. In some embodiments, the needle is inserted in a location in front of the scanning head 325. In some embodiments, the needle is inserted in a location behind the scanning head.

[0093] Figure 6A shows a scanning head subassembly in some embodiments, comprising a release gate 627 and a needle guide subassembly 660 having a needle guide, a connector, and a depth limiter. In some embodiments, the scanning knob 620 is provided with a notch 629 (see also 329 shown in Figure 3B) to create a gap between the syringe and the scanning subassembly.

[0094] In Figure 6A, the depth limiter is shown in a configuration that is not aligned with the needle guide, as in some embodiments. In this configuration, the needle may be positioned directly on the needle guide when the depth limiter is moved and not aligned with the needle guide. In Figure 6B, the depth limiter is shown in a configuration that is aligned with the needle guide, as in some embodiments. In some embodiments, when the depth limiter is aligned with the needle guide, the needle guide and the depth limiter share a common central axis.

[0095] Figures 6B and 6C show embodiments comprising a needle release gate 627 that is detachably mounted on the carriage. In some embodiments, the release gate 627 is received by a release gate mounting projection (347 in Figures 3A–3B). In some embodiments, the release gate attachment 627 is held by a projection that uses a friction fit. In some embodiments, a force of about 0.2–0.25 pounds-force (lbf) is required to open the release gate.

[0096] Figure 6B shows an embodiment of the needle release gate 627 in the locked position, and Figure 6C shows an embodiment of the needle release gate 627 in the unlocked position. In the locked position, the needle release gate can prevent the removal of the syringe needle assembly engaged with the needle guide. In some embodiments, the release gate locks the needle into the needle guide by blocking the slot 648, thereby creating a complete outer circumference formed by the track of the needle guide and the release gate. In some embodiments, the release gate 627 is secured in the locked position by a press-fit with the outer surface of the needle guide tab.

[0097] E. Scanning knob In some embodiments, the scanning knob is designed to facilitate the sliding (by force applied along the Y-axis) and pushing (by force applied along the Z-axis) of the scanning head and sensor to support the scanning process. In some embodiments, a force of approximately 0.5 to 0.8 pounds is required to slide the scanning head. In some embodiments, a spring is installed on the inner surface of the knob, thereby supporting the pressing of the scanning head against the carriage.

[0098] In some embodiments, the scanning knob is configured to incorporate one or more limiting elements capable of limiting the insertion depth achievable with 3.5 and 5-inch needles, thereby ensuring that the device is reliably removed from these needles before they are inserted into critical structures. In some embodiments, the limiting element includes a slot that allows the needle to move beyond the limiting element while the needle hub is stopped to limit the insertion depth. In some embodiments, the limiting element is configured to receive the hub of a needle-syringe assembly. In some embodiments, the limiting element allows insertion up to approximately 0.5 cm to 4 cm. In some embodiments, the allowed insertion depth depends on the length of the needle. In some embodiments, the allowed insertion depth is adjustable. In some embodiments, the scanning knob is rotatable relative to the scanning head. The user may rotate the scanning knob to select a limiting element to align with an alignment guide (see 336 in Figure 3A), which may be fixed or mounted on the carriage. In some embodiments, the limiting element is fixed or detachably mounted to other components of the scanning head subassembly.

[0099] In some embodiments, a limiting element located below the scanning knob is provided to limit needles of a shorter length compared to a limiting element located above the scanning knob. In some embodiments, the lower limiting element is configured to limit the insertion depth of a 3.5-inch needle. In some embodiments, the upper limiting element is configured to limit the insertion depth of a 5-inch needle. In some embodiments, one side of the scanning knob is provided with a notch so as to provide a gap between the scanning knob and the needle-syringe assembly so as not to limit the insertion depth of the needle-syringe assembly.

[0100] In some embodiments, the scanning knob is removable. In some embodiments, the scanning knob is fixed. In some embodiments, the scanning knob is part of the scanning head. In some embodiments, the scanning knob is mounted on the top surface of the scanning head. In some embodiments, the scanning knob is a convex scanning knob. In some embodiments, the convex scanning knob is a scanning knob having a proximal surface (towards the user) that is curved like the outside of a circle and / or a sphere. In some embodiments, the concave scanning knob has ribs. In some embodiments, the concave scanning knob does not have ribs. In some embodiments, the scanning knob is used to move the scanning head and carriage along the scanning track. In some embodiments, the scanning knob is used to move the scanning head proximal and distal relative to the carriage (i.e., towards and away from the patient, respectively). In some embodiments, the advance of the scanning head along the scanning track and the proximal and distal movements are controlled by the same mechanism. In some embodiments, the advance of the scanning head along the track and the advance of the scanning head relative to the carriage are controlled by independent mechanisms. In some embodiments, movement relative to the carriage interferes with movement along the track. In some embodiments, a shaft is used to lock the carriage and scan head position during proximal and distal movement of the scan head. In some embodiments, the scan knob includes a button configured to release the scan head from a locked position relative to the carriage. In some embodiments, the scan knob includes a button configured to release the carriage from a locked position along the track. In some embodiments, there is an indicator to warn of the scan head being locked along the track or in a position relative to the carriage. In some embodiments, the movement of the scan head is automated. In some embodiments, the movement of the scan head is not automated and is controlled by the user. In some embodiments, the movement of the scan head is controlled by the user via a button. In some embodiments, movement in the proximal and distal directions is controlled by a mechanism located above the scan knob.In some embodiments, movement along the scan track is controlled by a mechanism located on the side of the scan knob. In some embodiments, movement along the scan track is controlled by the user via a push button. In some embodiments, the scan knob is pushed proximal and distally to allow movement relative to the carriage. In some embodiments, the scan knob is pushed forward and backward to allow movement along the scan track. In some embodiments, the scan knob has a rotary dial that is rotated to move the carriage along the scan track. In some embodiments, the scan knob has a rotary dial that is rotated to move the scan head proximal or distal to the carriage. In some embodiments, the scan head is moved relative to the carriage via a mechanical actuator. In some embodiments, the scan head is automatically moved relative to the carriage to a level determined by patient characteristics such as body mass index (BMI). In some embodiments, a contact detection device includes a mechanism for locking movement along the track and relative to the carriage. In some embodiments, a partial image of the supplemental area is displayed while the scan cycle is being completed. In some embodiments, the area currently being acquired is highlighted for clarity. In some embodiments, the scanning process of the slider workflow is very similar to the manual palpation land marking process. In some embodiments, at least one button is included to release the scanning knob. In some embodiments, the carriage is locked in place when the scanning knob is disengaged.

[0101] F. Alternative Needle Guide Alternative needle guides and depth limiting components may be used. In some embodiments, the outer surface of the carriage is provided with a needle guide. In some embodiments, the outer surface of the carriage is provided with an elongated C-shaped opening. In some embodiments, the outer surface of the carriage is provided with a height suitable for limiting the insertion depth to match the needle length. In some embodiments, a depth limiting clip is removably attached to the carriage. In some embodiments, the depth limiting clip is provided with one or more projections that are received by an aperture via the outer surface of the carriage to facilitate attachment. In some embodiments, the depth limiting clip is configured to adjust to limit the insertion depth to match needles of different lengths. In some embodiments, the top of the clip may be raised above the upper edge of the carriage to accommodate longer needles. In some embodiments, the depth limiting clip may be reversibly attached to an aperture closer to the upper edge of the carriage to limit longer needles. In some embodiments, the top of the clip forms a platform that prevents the needle hub or handle from advancing further. In some embodiments, the depth limiting clip is provided with a slot concentric with the C-shaped slot of the needle guide. In some embodiments, the depth limiting clip may be reversibly mounted to an aperture near the upper edge of the carriage to limit longer needles. In some embodiments, the depth limiting clip may be rotatable about the Z-axis relative to the outer surface of the carriage. In some embodiments, the depth limiting clip may be part of a sliding mechanism along the X-axis relative to the outer surface of the carriage.

[0102] In some embodiments, the needle release clip is detachably attached to the carriage. In some embodiments, the needle release clip is rotatable and may be rotated relative to the carriage so as to confine the needle within the outer surface of the carriage.

[0103] In some embodiments, the needle release clip also functions as a needle guide. The syringe needle assembly may then be inserted into the needle guide, and the needle guide may be rotated to secure the needle provided to the depth limiting clip. In some embodiments, the needle release clip is provided with a tab to facilitate rotation by the user. In some embodiments, the needle release clip configured as a needle guide is configured to hold the syringe needle assembly for injecting a local anesthetic into the patient's target tissue as needed.

[0104] In some embodiments, the depth limit clip and needle release clip are detachably mounted on the rear side of the carriage. In some embodiments, the depth limit clip and needle release clip are detachably mounted on the front side of the carriage. The depth limit clip and needle release clip may be detachably mounted on either outer wall of the carriage.

[0105] In some embodiments, the depth limit clip and needle release clip are fixed to the rear side of the carriage. In some embodiments, the depth limit clip and needle release clip are fixed to the front side of the carriage. The depth limit clip and needle release clip may be fixed to either outer wall of the carriage.

[0106] G. Monitoring Unit In some embodiments, the contact detection device includes a detachable monitoring device. In some embodiments, the monitoring device is part of the base. In some embodiments, the monitoring device consists of a two-part housing. In some embodiments, the monitoring device has a backplate for accessing electronic equipment. In some embodiments, the monitoring device is assembled with the base. In some embodiments, the monitoring device is a non-sterile, patient-free portion made of medical injection-molded plastic. In some embodiments, the distal surface of the monitoring unit is raised approximately 12.5 mm relative to the patient contact surface of the device.

[0107] Referring to Figure 1, in some embodiments, the monitoring device 150 comprises one or more pressable user input buttons 155, 157 that can be engaged by a user. In some embodiments, the monitoring device comprises a reset button 155 for resetting the pressure map displayed by the monitoring device. In some embodiments, the monitoring device comprises one or more buttons 157 located on the side of the monitoring device. The buttons 155, 157 may be configured to adjust the settings of the monitoring device. In some embodiments, sensitivity is adjusted via a dial or external button 157. In some embodiments, the monitor 150 may be housed in a protective sleeve 180. The protective sleeve can prevent the monitor from being damaged or contaminated. The protective sleeve can prevent the non-sterile monitor from contaminating a sterile field.

[0108] In some embodiments, the base is provided with hubs for mounting the monitoring device at the top and bottom when the device is viewed from above, to facilitate use by right-handed and left-handed users. Referring to Figure 7A, some embodiments of the contact detection device include a locking mechanism 752 for locking the monitoring device 750 onto the base 110. In some embodiments, the locking mechanism 752 is provided with tabs to facilitate locking the monitoring device 150 onto the base 710. In some embodiments, the locking mechanism 752 is provided with tabs to facilitate removal of the monitoring device 750 from the base 710. In some embodiments, the monitoring device is positioned in a protective sleeve 780, as disclosed herein. In some embodiments, the protective sleeve overlaps a portion of the base 710, creating a seal around the monitoring device 750.

[0109] Referring to Figure 7A, in some embodiments, the monitoring device 750 includes a printed circuit board assembly (PCBA) 755. In some embodiments, the PCBA acts as the motherboard of the contact detection device system. In some embodiments, the PCBA includes a microprocessor. In some embodiments, the PCBA interfaces with a sensor breakout board, a display module, an external sensor, and a user input mechanism. In some embodiments, the PCBA includes fuse, charge, and protection circuits for a rechargeable battery. In some embodiments, the PCBA processes and displays pressure sensor data. In some embodiments, the PCBA processes position sensor data. In some embodiments, the PCBA handles interrupts such as the pressing of a physical or touchscreen menu button and the pressing of a physical or touchscreen refresh button. In some embodiments, a sample runtime task for live imaging (approximately 10 milliseconds (ms)) includes data acquisition, data analysis, error checking, frame drawing, and frame display. In some embodiments, the PCBA includes circuitry to support adjustment of the maximum sensor pressure between approximately 0.14 and approximately 3 times the sensor's pressure rating. In some embodiments, sensitivity is adjusted via a dial, external buttons, or a touchscreen display. In some embodiments, the drive voltage is automatically adjusted based on a balance file. In some embodiments, the PCBA includes sensors and circuitry that track the orientation of the device and warn of movement of the device while locked. In some embodiments, the monitoring device is powered on by a switch. In some embodiments, the monitoring device is powered on in response to a connection between the monitoring unit and the base.

[0110] In some embodiments, the contact detection device includes a sensor breakout board (not shown). In some embodiments, the sensor breakout board includes minimal, disposable electronics. In some embodiments, the sensor breakout board is configured to connect a sensor driver and acquisition circuit from a monitoring device to the sensor array. In some embodiments, the sensor breakout board includes a zero-insertion force (ZIF) connector for sensor array connection. In some embodiments, the sensor breakout board includes an analog multiplexer (MUX) and a bit shifter to support scanning and output. In some embodiments, a position sensor for tracking the movement of the device is provided on the disposable breakout board. In some embodiments, the monitoring device is powered on when connected to the breakout board.

[0111] In some embodiments, the monitoring device 750 includes an interface 790 that forms an electrical coupling with the base interface (e.g., interface 295 of the base 210 as shown in Figure 2A). In some embodiments, the monitoring device includes a locking tab 752 that is received by a locking aperture of the base (e.g., aperture 297 of the base 210 as shown in Figure 2A). The locking tab facilitates locking the monitoring device to the base and ensuring a secure connection between the base interface and the monitoring device interface. The locking tab facilitates removal of the monitoring device from the base by the user. In some embodiments, as shown in Figures 7A-7B, the monitoring device includes a projection 791 inserted into the base that facilitates interface connection between the monitoring device and the base.

[0112] In some embodiments, the monitoring device includes a display screen 760. In some embodiments, the display screen is a touchscreen. In some embodiments, the display screen has an adjustable angle. In some embodiments, the display screen is a full-color LCD display. In some embodiments, the display screen is connected to a PCBA and mechanically integrated into the front of the module housing to enable visualization of the output. In some embodiments, the contact detection device wirelessly interfaces with an external display such as a tablet or computer. In some embodiments, the display is foldable to reduce the footprint of the contact detection device.

[0113] In some embodiments, the monitoring device includes a battery 770. In some embodiments, the battery is a rechargeable battery. In some embodiments, the battery is a lithium-ion battery. In some embodiments, the rechargeable battery interfaces with the PCBA. In some embodiments, the contact detection device includes a battery indicator. In some embodiments, the battery indicator is a charging indicator. In some embodiments, the charging indicator warns the user of low battery. In some embodiments, the charging indicator warns the user of the amount of battery charged during the charging process. In some embodiments, the battery indicator is on a screen. In some embodiments, the battery indicator is an LED. In some embodiments, the device is powered on via a USB connection to a computer.

[0114] In some embodiments, the monitoring unit stores imaging data. In some embodiments, the monitoring unit stores data from the last imaging cycle before the device is powered off. In some embodiments, imaging data is stored when a certain pressure threshold is exceeded. In some embodiments, the stored data includes raw sensor data. In some embodiments, the stored data includes an overall pressure map. In some embodiments, the stored data includes timestamp and position data. In some embodiments, a button on the monitoring unit is pressable to store the position of the alignment guide at its timestamp. In some embodiments, the graphical user interface notifies the user when a position is flagged. In some embodiments, the monitoring unit stores up to five data sets. In some embodiments, the monitoring unit stores a rolling buffer of data sets. In some embodiments, the graphical user interface warns the user of the number of data sets being stored. In some embodiments, the stored data is transferable to a computer. In some embodiments, the monitoring unit is operablely connectable to a computer. In some embodiments, the monitoring unit is located in a charging station and connects to a computer via USB using a cable.

[0115] In some embodiments, a rechargeable battery within the contact detection device is charged using a reusable charging station (not shown). In some embodiments, the charging unit includes standard electronics, including electrical contacts, for use with a computing unit (i.e., a PCBA). In some embodiments, the charging station is housed in a two-part injection-molded plastic. In some embodiments, the charging station includes a charging indicator. In some embodiments, the charging station employs inductive charging. In some embodiments, the battery is charged using a power adapter with a cable that plugs into the inlet of the monitoring device.

[0116] Referring to Figure 7B, an exploded view is shown showing components of the monitoring device 750 according to some embodiments. In some embodiments, the monitoring device 750 includes a protective screen or overlay 751. In some embodiments, the protective screen includes a midline indicator 712. In some embodiments, the midline indicator is printed on the inside of the protective screen to prevent wear. In some embodiments, the monitoring device 750 includes a protective case comprising a front portion 753 and a rear portion 754. In some embodiments, the monitoring device 750 includes a monitor or screen 760. In some embodiments, the monitoring device 750 includes a battery 770. In some embodiments, the monitoring device 750 includes a printed circuit board assembly (PCBA) 755. In some embodiments, the monitoring device 750 includes a button gasket 757. The button gasket may form a moisture barrier for the monitoring device. In some embodiments, the button gasket provides a button surface on the side of the monitoring device. In some embodiments, one or more components of the monitoring device are fastened together by screws 769 or other similar fasteners.

[0117] In some embodiments, the contact detection device comprises a sleeve 880 for receiving a monitoring device. An embodiment of the sleeve 880 is shown in Figure 8A. In some embodiments, the sleeve is a sterile single-component part. In some embodiments, the sleeve is a sterile two-component part. In some embodiments where the sleeve is a two-component part, the bottom component of the sleeve is configured as part of the base. In some embodiments, the sleeve covers the reusable monitoring device in use to provide a sterile outer surface for the non-sterile reusable monitoring device, thereby ensuring that the reusable monitoring device is introduced into a sterile field. In some embodiments, the sleeve is made of medical-grade glycol-modified polyethylene terephthalate (PETG). In some embodiments, the sleeve is made of medical-grade thermoplastic polyurethane (TPU). In some embodiments, the sleeve is vacuum-formed into a mold for the reusable monitoring device. In some embodiments, the sleeve comprises a low-reflectance translucent component in the display area. In some embodiments, the sleeve has an opening and / or a pressable cover for user input buttons. In some embodiments, the sleeve comprises a midline indicator.

[0118] In some embodiments, as shown in Figure 8B, the monitoring device 850 may be loaded into a dock 852. The dock can provide the monitoring device in a position ready to be received by the base 810. The use of the dock 852 can help maintain a sterile field effectively.

[0119] II.How to use A. Visualization of historical and real-time images In some embodiments, the contact detection device includes a computing device. In some embodiments, the computing device includes a computer program. In some embodiments, the computer program is software including computer algorithms, computer code, and / or programs that manage the device's hardware and provide instruction execution services such as real-time imaging. In some embodiments, the contact detection device includes a computer algorithm that constructs one image from at least two images. In some embodiments, the position of the image on the pressure map is determined from data acquired by a position sensor. In some embodiments, the algorithm takes the type of contact detection device in use as input. In some embodiments, the algorithm automatically determines the type of contact detection device in use. In some embodiments, the algorithm automatically selects an image display step depending on the type of contact detection device in use. In some embodiments, the algorithm adjusts the drive voltage based on the header of the balance file. In some embodiments, imaging is initiated by pressing a touchscreen or physical button. In some embodiments, imaging is automatically initiated when the device is pressed against a skin surface. In some embodiments, the imaging sequence is automatically initiated when the monitoring device is powered on. In some embodiments, the drive voltage is approximately between V0 and 3.3V. In some embodiments, the pressure sensor changes its resistance in response to pressure. In some embodiments, the algorithm captures current pressure sensor data. In some embodiments, the algorithm uses a gain register to convert current to voltage. In some embodiments, the algorithm reads the voltage as an analog-digital count based on a reference voltage. In some embodiments, the reference voltage is 2.5V. In some embodiments, the algorithm applies a Gaussian filter to the current data. In some embodiments, the algorithm determines the active region of the current data.In some embodiments, the active region of the current data is determined by obtaining an ordered list of data rows, ignoring rows below the cutoff, and determining the exponent of the largest continuous region in the rows above the cutoff. In some embodiments, the active region of the current data is determined automatically based on a known scanhead size and the current scanhead position. In some embodiments, the current scanhead position is determined by a position sensor such as a potentiometer. In some embodiments, a polynomial approximation of the current data is used to remove artifacts by applying flat-field correction. In some embodiments, the current data is scaled between 0 and 1 by dividing by the sum of the current data and mapping it to the scale of data displayed at past time. In some embodiments, the current display data is determined by finding the maximum value for each pixel when comparing the current data with past display data. In some embodiments, the current display data is the cumulative sum of the past display data. In some embodiments, the current display data is then stored as past display data. In some embodiments, the current display data is displayed on the screen of a contact detection device. In some embodiments, the imaging cycle is completed when the scanhead has moved along the entire length of the scan track.

[0120] In some embodiments, the active area is highlighted on the display using a rectangular or circular patch. In some embodiments, the active area is highlighted by an outline having the same width and height as the active area of ​​the pressure sensor. In some embodiments, the algorithm displays a line corresponding to the midline. In some embodiments, the algorithm displays a reticle corresponding to the location of the alignment guide relative to the current display data. In some embodiments, the location of the alignment guide is determined by position sensor data and a known distance between the center of the alignment guide and the center of the pressure sensor. In some embodiments, the reticle represents the real-time position of the alignment guide. In some embodiments, the circular portion of the reticle represents the functional tolerance of insertion allowed by the guide's track. In some embodiments, the display screen displays an arrow indicating the direction in which the contact detection device should be moved to localize the target tissue location. In some embodiments, the graphical user interface includes checkmarks for the horizontal and vertical axes of the pressure map. In some embodiments, the algorithm takes a patient identifier, patient weight, and patient height as inputs. In some embodiments, the algorithm can change the screen brightness based on brightness input from a touchscreen or physical button. In some embodiments, the algorithm can change the color map based on input from a touchscreen or physical button. In some embodiments, the algorithm takes a sensitivity coefficient as input. In some embodiments, the sensitivity coefficient is selected using a touchscreen, physical buttons, or a dial. In some embodiments, the default sensitivity is 70% of the full sensitivity range. In some embodiments, the sensitivity is adjustable between 30% and 100% of the full sensitivity range. In some embodiments, the sensitivity is adjustable approximately 15% above or 25% below the normal sensitivity. In some embodiments, the sensitivity coefficient is used to rescale the color map of the current display data. In some embodiments, the sensitivity coefficient is used to adjust the drive voltage. In some embodiments, the drive voltage is adjustable between 0V and 3.3V.In some embodiments, the reference voltage is 2.5V. In some embodiments, sensitivity is the ratio of the drive voltage to the reference voltage. In some embodiments, the default ratio of the drive voltage to the reference voltage is 2. In some embodiments, the sensitivity coefficient is used as a cutoff when determining the active region of the current data. In some embodiments, sensitivity is automatically adjusted based on the patient's BMI, such as input or calculated from height and weight. In some embodiments, the algorithm displays a splash screen before imaging begins. In some embodiments, the user can press a touchscreen or physical button to access an input item menu. In some embodiments, the user can scroll through menu items using a touchscreen, physical buttons, or a dial. In some embodiments, the algorithm includes a step of thresholding pressure sensor data. In some embodiments, the algorithm includes a step of balancing and calibrating the sensor array. In some embodiments, the user can remove high points appearing in the current display data by pressing a touchscreen or physical tare button when no force is applied. In some embodiments, the algorithm automatically removes high points when no force is applied. In some embodiments, the user can refresh the current display data by pressing a touchscreen or physical refresh button. In some embodiments, the algorithm can detect whether the device is aligned with the midline. In some embodiments, the algorithm uses a position sensor, such as an accelerometer, to detect whether the device is aligned with the midline. In some embodiments, the algorithm can warn the user if the imaging is off-center. In some embodiments, the algorithm can automatically refresh the current display data when the imaging is off-center. In some embodiments, the algorithm can detect whether the contact detection device has changed orientation or moved laterally during the imaging cycle.In some embodiments, the algorithm can detect movement of the device using position sensors such as potentiometers, magnetic sensors, or optical sensors. In some embodiments, the algorithm can warn the user of device movement during an imaging cycle. In some embodiments, the algorithm can automatically refresh the current display data when it detects an error in device reorientation or movement.

[0121] In some embodiments, the algorithm calibrates runtime memory. In some embodiments, the algorithm captures sensor data using nested loops. In some embodiments, the sensor data is raw sensor data based on changes in resistance due to pressure applied when the scanning head is pushed. In some embodiments, the pressure applied to the sensor results in a decrease in the sensor's resistance. In some embodiments, each reading of a sensing element is the average of at least five analog readings of that sensing element. In some embodiments, the algorithm reads the voltage as an ADC count based on a reference voltage. In some embodiments, the sensor data is converted to 8-bit data. In some embodiments, the algorithm stores the current sensor data in the form of an approximately 12x8 array. In some embodiments, the algorithm stores a composite heatmap. In some embodiments, the algorithm stores a composite heatmap of approximately 34x8. In some embodiments, the algorithm captures the ADC value of a linear position sensor. In some embodiments, the algorithm uses data from the position sensor to map the array of current sensor data onto a composite heatmap. In some embodiments, the algorithm blends the array of current sensor data onto a composite heatmap. In some embodiments, the algorithm determines the maximum value between the composite heatmap and the current sensor data in order to blend the current sensor data into the composite heatmap. In some embodiments, the algorithm performs normalization of the blended sensor data. In some embodiments, the blending process is repeated two or more times in each imaging cycle for each scan head push. In some embodiments, the blending process is repeated as many times as necessary to fill the imaging range. In some embodiments, the algorithm determines the noise level and removes current sensor data before or after blending if it is below a noise level threshold. In some embodiments, the noise level is determined from the average of the current sensor data acquired from the sensor array.In some embodiments, the algorithm performs error checking for dead pixels in the current sensor data before or after blending. In some embodiments, the algorithm performs error checking for saturated or defective rows or columns in the current sensor data before or after blending. In some embodiments, the algorithm issues warnings for errors identified during error checking. In some embodiments, the algorithm subtracts individual error pixels in the current sensor data before or after blending during imaging. In some embodiments, the algorithm performs calibration correction on the current sensor data before or after blending. In some embodiments, the algorithm adjusts the values ​​of the current sensor data before or after blending that are greater than 5 calibration points. In some embodiments, the algorithm applies Gaussian blur to the current sensor data before or after blending. In some embodiments, the Gaussian blur may have a standard deviation of 0.55 pixels. In some embodiments, the algorithm uses bicubic interpolation to interpolate the current sensor data to a size suitable for display. In some embodiments, the algorithm interpolates the area corresponding to the current sensor data before or after blending. In some embodiments, the algorithm interpolates a combined heatmap. In some embodiments, the algorithm interpolates the overall heatmap to approximately 296 x 70 pixels. In some embodiments, the algorithm maps the values ​​of the overall heatmap to the colors on the monitoring device's display screen. In some embodiments, the heatmap is a five-color heatmap with a color scale of black, blue, green, yellow, and red. In some embodiments, the heatmap is a blue-to-red colormap that includes cyan, yellow, and orange. In some embodiments, the lowest RGB value of the colormap is replaced with black. In some embodiments, the blue and red outputs correspond to low-pressure and high-pressure areas, respectively. In some embodiments, the algorithm crops the heatmap to a size suitable for the monitoring device's screen.In some embodiments, the algorithm transmits data to be displayed on the screen of the monitoring device. In some embodiments, the algorithm displays a heatmap to scanned biological structures at a ratio of approximately 1:1 based on the size of the imaging range. In some embodiments, the imaging range is approximately 64.7 mm in height and 15.2 mm in width. In some embodiments, the algorithm refreshes the display at least every 100 ms. In some embodiments, the algorithm displays unscanned areas in black.

[0122] In some embodiments, the algorithm calculates the gradient relative to the previous timestamp. In some embodiments, the algorithm uses Gaussian blurring to remove noisy data through convolution of the entire image. In some embodiments, the algorithm applies a Laplacian filter to the data. In some embodiments, the algorithm applies a Gaussian filter prior to applying a Gaussian filter (Laplacian of Gaussian operation). In some embodiments, the algorithm applies least squares fitting to calculate the bias of the image. In some embodiments, the algorithm uses the histogram and the resulting cumulative distribution function to enhance the pressure map image by expanding the color scale to the dynamic range and increasing the contrast of the colors displayed by the pressure map image. In some embodiments, the algorithm uses nearest neighbor interpolation to generate a histogram of the orientation gradient.

[0123] In some embodiments, Figures 9A–9E illustrate a workflow for a user to use a contact detection system to image the location of a patient's target tissue to the graphical interface of a monitoring device. In some embodiments, the graphical interface includes a pressure map 905, a scanning head location 915, a force indicator 910, an alignment guide indicator 920, a midline indicator 925, a battery level indicator 930, and a sensitivity level indicator 935. In some embodiments, the pressure map further includes X and Y axis coordinates.

[0124] According to some embodiments, Figure 9A shows a graphical interface of a monitoring device before imaging of a target tissue location begins, where an image has not yet been formed on the pressure map.

[0125] In some embodiments, Figure 9B shows a pressure map recorded at a first position. At this first position, the user presses the sensor array against the target tissue area of ​​the patient with a force such as that indicated by the force indicator 910. An image of this first position is captured and displayed on the pressure map 905.

[0126] In some embodiments, Figure 9C shows a pressure map recorded at a second position. At this second position, the user presses the sensor array against the patient's target tissue area with a force such as that indicated by the force indicator 910. An image of this second position is captured and displayed on the pressure map 905.

[0127] In some embodiments, Figure 9D shows a pressure map recorded at a third position. At this third position, the user presses the sensor array against the patient's target tissue area with a force such as that indicated by the force indicator 910. An image of this third position is captured and displayed on the pressure map 905.

[0128] In some embodiments, Figure 9E shows a fully imaged pressure map 905 where the user has aligned the alignment guide indicator 920 at the target location. In some embodiments, the user places a marker via the alignment guide of the contact sensing system to mark the location as indicated by the alignment guide indicator 920. The marked location may indicate the insertion site of the needle. In some embodiments, the user places the needle in the needle guide of the contact sensing system to proceed at the location indicated by the alignment guide indicator.

[0129] In some embodiments, Figure 9F shows a graphical interface in which the user has positioned the alignment guide outside the range of the pressure map. In some embodiments, the user is notified by alert 950 in the graphical interface and is prompted to position the alignment guide in the correct position as shown in Figure 9E.

[0130] In the embodiments shown in Figures 9A–9F, pressure images are generated at three locations along the pressure map. However, it will be recognized that depending on the size of the sensor array and / or the target tissue location during imaging, more or fewer pressure images may be required. In some embodiments, the user can overlap the push positions of the scanning head along the track, resulting in four or more locations.

[0131] In some embodiments, the force indicator provides the user with guidance on how much force should be applied to the scanning head while pressing the sensor array against the patient's target tissue location so that consistent pressure is applied across the pressure map 905. In some embodiments, the applied force is entirely at the user's discretion, and the user must match the force applied at the first position. In some embodiments, the system captures a pressure image when a predetermined force is reached. In some embodiments, a mechanism is provided to limit the force that can be applied by the user in order to enable uniform pressure measurement on the pressure map.

[0132] In some embodiments, the force indicator displays a calibration measurement, showing the applied force measured from the sensor. According to some embodiments, the measurement displayed on the force indicator is obtained by averaging the analog-to-digital converter (ADC) values ​​of the array (e.g., a 12 × 8 sensor array) and dividing by 10 to obtain an approximate range in pounds. The approximate range is then scaled by sensitivity, which is the drive voltage divided by twice the reference voltage (e.g., 2). For example, if v_drive = 255 ADC counts, v_ref = 127 ADC counts, and v_avg = 95 ADC counts, the force measurement is calculated as 95 / [10 * (255 / 2 * 127)] = 9.5 lbs.

[0133] In some embodiments, the force measurement is divided by the maximum force value (e.g., 14 pounds), and the ratio of the calculated force to the maximum force value is displayed on the force indicator bar. In some embodiments, the resolution of the force indicator is 0.1 lbs. In some embodiments, the force indicator bar further includes a color-changing scheme for further indicating and displaying the applied force. In some embodiments, the force indicator bar has a single color.

[0134] B. Equipment Configuration and Procedures Referring to Figure 10A, a flowchart is shown detailing how the contact detection device should be configured based on various applications. In the first step, a determination is made as to what procedures should be followed.

[0135] In some embodiments, if the procedure is a spinal anesthesia procedure in which an introducer is used, the introducer insertion configuration and procedure should be followed. In some embodiments, the introducer configuration comprises using a fully assembled contact sensing and needle guidance system with depth limiter in a neutral position (i.e., no depth limiting mechanism is used).

[0136] In some embodiments, referring to Figure 10B, the introducer placement procedure comprises, in a first step 1002, grasping the handle and placing the device on the patient's back. In some embodiments, the procedure comprises, in step 1004, checking and confirming that the target area and aiming line provided on the monitoring device's display are properly aligned. In some embodiments, the procedure comprises, in step 1006, imaging the target tissue location using a contact detection device. In some embodiments, the procedure comprises, in step 1008, sliding the carriage until the aiming line aligns with the target insertion site. In some embodiments, the procedure comprises, in step 1010, injecting local anesthetic (LA) through the needle guide. In some embodiments, the procedure comprises, in step 1012, removing the local anesthetic syringe. In some embodiments, the procedure comprises, in step 1014, inserting the introducer through the needle guide. In some embodiments, the procedure comprises, in step 1016, ensuring the introducer is securely in place and opening the needle release gate. In some embodiments, the procedure includes, in step 1018, removing the contact detection device from the target tissue site while the introducer remains inserted in the patient, and returning the device to the sterile field. In some embodiments, the procedure includes, in step 1020, continuing the insertion of the introducer needle without using the device.

[0137] Referring further to Figure 10A, in some embodiments, if the procedure is a lumbar puncture utilizing a 20-22 gauge needle of a length having a height configuration of associated limiter, the needle insertion configuration and procedure should be followed. In some embodiments, the length of the needle has the configuration of associated limiter. In some embodiments, the needle insertion configuration comprises using a fully assembled contact-sensing and needle guidance system with a depth limiter in a neutral position for the injection of a local anesthetic, and then adjusting the depth limiter according to the size of the needle being used in the procedure.

[0138] In some embodiments, referring to Figure 10C, the needle insertion procedure comprises, in step 1022, grasping the handle and positioning the device on the patient's back. In some embodiments, the procedure comprises, in step 1024, checking and confirming that the target area and aiming line provided on the monitoring device's display are properly aligned. In some embodiments, the procedure comprises, in step 1026, imaging the target tissue location using a contact detection device. In some embodiments, the procedure comprises, in step 1028, sliding the carriage until the aiming line aligns with the target insertion site. In some embodiments, the procedure comprises, in step 1030, injecting local anesthetic (LA) through the needle guide. In some embodiments, the procedure comprises, in step 1032, removing the local anesthetic syringe. In some embodiments, the procedure comprises, in step 1034, adjusting the depth limiter to configure it to the size of the subarachnoid needle. In some embodiments, if the subarachnoid needle is about 3.5 inches, the lower position limiter is used. In some embodiments, if the subarachnoid puncture needle is about 5 inches, an upper position limiter is used. In some embodiments, the procedure comprises, in step 1036, positioning the subarachnoid puncture needle at the target tissue site to a depth permitted by the limiter. In some embodiments, the procedure comprises, in step 1038, opening the needle release gate. In some embodiments, the procedure comprises, in step 1040, removing the contact detection device from the target tissue site while the introducer remains inserted in the patient, and returning the device to the sterile field. In some embodiments, the procedure comprises, in step 1042, proceeding without using the device.

[0139] Referring further to Figure 10A, in some embodiments, if the procedure is a central nervous system axial procedure that does not utilize an introducer and utilizes a needle of less than 20 gauge (i.e., a needle with a diameter larger than a 20 gauge needle), the marking configuration and procedure should be followed. In some embodiments, if the procedure is an epidural anesthesia, the marking configuration and procedure should be followed. In some embodiments, the marking configuration comprises removing the needle guide and release gate to expose the alignment guide. Referring to Figure 10D, according to some embodiments, the procedure for marking the target location comprises confirming that the device is properly set up with the needle guide removed and the alignment guide exposed. In some embodiments, the procedure comprises, in step 1054, grasping the handle and placing the device on the patient's back. In some embodiments, the procedure comprises, in step 1054, checking and confirming that the target area and aiming line provided on the monitoring device's display are properly aligned. In some embodiments, the procedure comprises, in step 1056, imaging the target tissue location using a contact detection device. In some embodiments, the procedure includes, in step 1058, sliding the carriage until the aiming line is aligned with the target insertion site. In some embodiments, the procedure includes, in step 1060, inserting a sterile surgical marker through a guide, and in step 1062, pressing the marker against the patient's back. In some embodiments, the procedure includes, in step 1064, removing the marker from the guide. In some embodiments, the procedure includes, in step 1066, removing the contact detection device from the target tissue site and returning the device to the sterile field. In some embodiments, the procedure includes, in step 1068, injecting a local anesthetic. In some embodiments, the procedure includes, in step 1070, continuing without using the device. In some embodiments, the procedure includes lumbar puncture or insertion of a subarachnoid needle. III. Currently Preferred Embodiments 1. In one currently preferred embodiment, the present invention provides a contact detection device comprising a base, the base comprising: a scanning track; a carriage configured to slide along the scanning track; a scanning head mounted on the carriage; and a sensor array attached to the scanning head, the sensor array comprising one or more pressure sensors, each pressure sensor configured to output a voltage signal in response to a change in pressure. 2. The contact detection device according to paragraph 1, wherein the carriage is equipped with an alignment guide. 3. The contact detection device according to any one of paragraphs 1 to 2, further comprising a needle guide configured to be reversibly attached to the carriage. 4. The contact detection device according to paragraph 3, wherein the needle guide further comprises a removal tab. 5. The contact detection device according to any one of paragraphs 1 to 4, further comprising a needle release gate configured to be reversibly attached to the carriage. 6. The contact detection device according to paragraph 5, wherein the needle release gate is configured to reversibly fix the needle to the carriage in a position concentric with the needle guide. 7. The contact detection device according to paragraph 3, wherein the needle guide further comprises a connector plate. 8. The contact detection device according to paragraph 7, further comprising a connector coupled to a depth limiter, wherein the connector is removably attached to the connector plate of the needle guide, so that the depth limiter is positioned in a first position aligned with the needle guide and in a second position not aligned with the needle guide. 9. The contact detection device according to paragraph 8, wherein the connector is coupled to the depth limiter so that the depth limiter is positioned at an upper position away from the needle guide or at a lower position close to the needle guide. 10. The contact detection device according to paragraph 9, wherein the upper position is configured for the placement of a 5-inch needle. 11. The system as described in paragraph 10, wherein the upper position limits the depth of the 5-inch needle to approximately 0.5 cm to approximately 5 cm. 12. The contact detection device according to paragraph 9, wherein the lower position is configured for the placement of a 3.5-inch needle. 13. The contact detection device according to paragraph 12, wherein the upper position limits the depth of the 3.5-inch needle to approximately 1 cm to approximately 3.5 cm. 14. A contact detection device according to one of paragraphs 7 to 12, further comprising a needle release gate configured to be reversibly attached to the carriage. 15. The contact detection device according to paragraph 14, wherein the needle release gate is configured to reversibly fix the needle to the carriage in a position concentric with the needle guide. 16. The contact detection device according to any one of paragraphs 1 to 15, further comprising a bottom pad that forms the distal surface of the contact detection device. 17. The contact detection device according to paragraph 16, wherein the bottom pad is configured to be on the surface of the patient's skin. 18. The contact detection device according to any one of paragraphs 16 to 17, wherein the bottom pad has a concave curve having a radius of approximately 1 meter. 19. The contact detection device according to any one of paragraphs 16 to 18, wherein the bottom pad has a hardness of approximately 20 Shore A to 35 Shore A. 20. The contact detection device according to any one of paragraphs 1 to 19, wherein the scanning head is movable relative to the carriage. 21. The contact detection device according to paragraph 20, wherein the scanning head is biased toward the proximal side of the device. 22. The contact detection device according to paragraph 21, wherein the scanning head is biased by a spring. 23. The contact detection device according to paragraph 22, wherein the carriage is equipped with a spring guide. 24. The contact detection device according to paragraph 23, wherein the scanning head is provided with a spring projection, and the spring guide and the spring projection are configured to center the spring relative to the scanning head and the carriage. 25. The contact detection device according to any one of paragraphs 1 to 24, wherein the sensor array is a matrix array. 26. A contact detection device according to any one of paragraphs 1 to 25, wherein the sensor array is a flexible sensor array. 27. A contact detection device according to any one of paragraphs 1 to 26, wherein the sensor array is mounted in a sensor array mounting area. 28. The contact detection device according to any one of paragraphs 1 to 27, wherein the sensor array is attached to the distal surface of the scanning head. 29. The contact detection device according to paragraph 28, wherein the distal surface of the scanning head is curved. 30. The contact detection device according to paragraph 29, wherein the radius of curvature of the scanning head is approximately 37.5 mm. 31. The contact detection device according to any one of paragraphs 1 to 30, wherein the base further comprises a handle. 32. The contact detection device according to paragraph 30, wherein the handle comprises a grip portion. 33. The contact detection device according to any one of paragraphs 1 to 32, further comprising a locking mechanism for preventing the carriage from sliding along the scanning track when the scanning head is pressed against it. 34. The contact detection device according to paragraph 33, wherein the locking mechanism comprises one or more locking tabs having pointed projections that engage with an elastic strip when the scanning head is pressed against it. 35. A contact detection device according to any one of paragraphs 1 to 34, further comprising a depth lock for locking the position of the scanning head at a certain depth relative to the carriage. 36. The contact detection device according to paragraph 35, further comprising a button for releasing the scanning head from a locked position relative to the carriage. 37. The contact detection device according to any one of paragraphs 1 to 36, wherein the base further comprises a position sensor. 38. A contact detection device according to any one of paragraphs 1 to 37, further comprising a monitoring device, the monitoring device being configured to display a pressure map representing the location of an individual's target tissue based on the voltage signals output by the one or more pressure sensors, and a computing device comprising a processor operably coupled to the sensor array and the monitoring device, and a non-temporary computer-readable storage medium having a computer program that includes instructions executable by the processor to (i) convert the voltage signals from the sensor array into the pressure map and display the pressure map on the display screen, and (ii) output the location of an alignment guide on the display screen. 39. The contact detection device according to paragraph 38, wherein the base further comprises an interface configured to receive the monitoring device. 40. The contact detection device according to paragraph 39, wherein the interface comprises an electrical coupling such that when the monitoring device is received by the interface, the sensor array is electrically connected to the monitoring device. 41. The detection device according to paragraph 39 or 40, wherein the sensor array is electrically coupled to the interface by a flexible printed circuit board. 42. The contact detection device according to any one of paragraphs 38 to 41, wherein the monitoring device is coupled to the sensor array via a flexible printed circuit board. 43. The contact detection device according to paragraph 42, wherein the flexible printed circuit board electrically connects the position sensor to the monitoring device. 44. The system according to paragraph 43, wherein the position sensor is operably coupled to the processor of the computing device, the computing device receives the position of the sensor array from the position sensor, and the position of the sensor array is used to generate the pressure map. 45. The contact detection device according to any one of paragraphs 38 to 43, wherein the monitoring device comprises a printed circuit board. 46. ​​A contact detection device according to any one of claims 38 to 45, further comprising a sleeve configured to receive the monitoring device. 47. A contact detection device according to any one of paragraphs 38 to 46, comprising a power supply. 48. The contact detection device according to paragraph 47, wherein the power source is a battery in the monitoring device. 49. A contact detection device according to any one of paragraphs 38 to 48, wherein the sensor array and the monitoring device are reversibly connected. 50. A contact detection device according to any one of paragraphs 38 to 49, comprising a wireless transmitter operably connected to the sensor array for remotely transmitting the voltage signals output by the plurality of sensors. 51. The contact detection device according to any one of paragraphs 38 to 50, wherein the processor comprises instructions for displaying the target tissue location and the alignment guide location on the display screen in real time. 52. The contact detection device according to any one of paragraphs 38 to 51, wherein the processor comprises instructions for displaying the force applied to the target tissue location in real time. 53. A contact detection device according to any one of paragraphs 1 to 52, wherein the base further comprises a midline indicator. 54. A contact detection device according to any one of paragraphs 1 to 53, wherein the distance between the distal surface of the base and the distal surface of the scanning head is approximately 0.1 cm to 5 cm. 55. A contact detection device according to any one of paragraphs 1 to 54, wherein the distance between the distal surface of the base and the distal surface of the scanning head is approximately 1.8 cm. 56. The active area of ​​the sensor array is approximately 350 mm². 2 A contact detection device as described in any one of paragraphs 1 to 55. 57. The contact detection device according to any one of paragraphs 1 to 6, wherein the scanning head further comprises a scanning knob on its proximal side. 58. The contact detection device according to paragraph 57, wherein the base comprises at least one limiter guide configured to limit the insertion depth of a needle. 59. The contact detection device according to paragraph 58, wherein the scanning knob comprises at least one limiter guide. 60. The contact detection device according to paragraph 57, wherein the scanning knob comprises two or more limiter guides configured to limit the insertion depth of the needle, and the scanning knob rotates to align one of the two or more limiter guides with the alignment guide. 61. In one currently preferred embodiment, the present invention provides a contact detection system comprising a base and a monitoring device, wherein the base comprises a scanning track, a carriage configured to slide along the scanning track, a scanning head mounted on the carriage, and a sensor array attached to the scanning head, comprising one or more pressure sensors, each pressure sensor configured to output a voltage signal in response to a change in pressure, the monitoring device comprising a display screen operably coupled to the sensor array, configured to display a pressure map representing the location of an individual's target tissue based on the voltage signals output by the one or more pressure sensors, and a computing device comprising a processor operably coupled to the sensor unit and the monitoring device, and a non-temporary computer-readable storage medium comprising a computer program comprising instructions executable by the processor to i) convert the voltage signals from the sensor array into the pressure map and display the pressure map on the display screen, and ii) output the location of an alignment guide on the display screen. 62. The contact detection system according to paragraph 61, wherein the base further comprises an interface configured to receive the monitoring device. 63. The contact detection system according to paragraph 62, wherein the interface comprises an electrical coupling such that when the monitoring device is received by the interface, the sensor array is electrically connected to the monitoring device. 64. The detection system according to any one of paragraphs 62 to 63, wherein the sensor array is electrically coupled to the interface by a flexible printed circuit board. 65. The contact detection system according to any one of paragraphs 61 to 64, wherein the base further comprises a position sensor. 66. The system according to paragraph 65, wherein the position sensor is operably coupled to the processor of the computing device, the computing device receives the position of the sensor array from the position sensor, and the position of the sensor array is used to generate the pressure map. 67. The system according to paragraph 66, wherein the position sensor is electrically coupled to the interface via a flexible printed circuit board. 68. The contact detection system according to any one of paragraphs 61 to 65, wherein the carriage comprises an alignment guide. 69. The contact detection system according to any one of claims 61 to 68, further comprising a needle guide configured to be reversibly attached to the carriage. 70. The contact detection system according to paragraph 69, wherein the needle guide further comprises a removal tab. 71. The contact detection system according to any one of paragraphs 61 to 70, further comprising a needle release gate configured to be reversibly attached to the carriage. 72. The contact detection system according to paragraph 71, wherein the needle release gate is configured to reversibly fix the needle to the carriage concentrically with the needle guide. 73. The contact detection system according to any one of paragraphs 61 to 72, wherein the scanning head further comprises a scanning knob on its proximal side. 74. The contact detection system according to paragraph 73, wherein the scanning knob comprises at least one limiter guide configured to limit the insertion depth of the needle. 75. The contact detection system according to any one of paragraphs 73 to 74, wherein the scanning knob comprises two or more limiter guides configured to limit the insertion depth of the needle, and the scanning knob rotates to align one of the two or more limiter guides with the alignment guide. 76. The contact detection system according to any one of paragraphs 61 to 75, further comprising a bottom pad that forms the distal surface of the contact detection system. 77. The contact detection system according to paragraph 76, wherein the bottom pad is configured to be on the surface of the patient's skin. 78. The contact detection system according to any one of paragraphs 76 to 77, wherein the bottom pad has a concave curve having a radius of approximately 1 m. 79. The contact detection system according to any one of paragraphs 76 to 78, wherein the bottom pad has a hardness of approximately 20 Shore A to 30 Shore A. 80. The contact detection system according to any one of paragraphs 61 to 79, wherein the scanning head is movable relative to the carriage. 81. The contact detection system according to any one of paragraphs 61 to 80, wherein the scanning head is biased toward the proximal side of the system. 82. The contact detection system according to paragraph 81, wherein the scanning head is biased by a spring. 83. The contact detection system according to paragraph 82, wherein the scanning head is provided with a spring projection, and the spring guide and the spring projection are configured to center the spring relative to the scanning head and the carriage. 84. The contact detection system according to any one of paragraphs 61 to 83, wherein the sensor array is a matrix array. 85. The contact detection system according to any one of paragraphs 61 to 84, wherein the sensor array is a flexible sensor array. 86. The contact detection system according to any one of paragraphs 61 to 85, wherein the sensor array is mounted in a sensor array mounting area. 87. The contact detection system according to any one of paragraphs 61 to 86, wherein the sensor array is attached to the distal surface of the scanning head. 88. The contact detection system according to any one of paragraphs 61 to 87, wherein the base further comprises a handle. 89. The contact detection system according to paragraph 88, wherein the handle comprises a grip portion. 90. A contact detection device according to any one of claims 61 to 89, wherein the base further comprises a midline indicator. 91. A contact detection system according to any one of paragraphs 61 to 90, wherein the distance between the distal surface of the base and the distal surface of the scanning head is approximately 0.1 cm to 5 cm. 92. A contact detection system according to any one of paragraphs 61 to 91, wherein the distance between the distal surface of the base and the distal surface of the scanning head is approximately 1.8 cm. 93. The active area of ​​the sensor array is approximately 350 mm². 2 A contact detection device as described in any one of paragraphs 61 to 92. 94. The contact detection system according to any one of paragraphs 61 to 93, further comprising a locking mechanism for preventing the carriage from sliding along the scanning track when the scanning head is pressed against it. 95. The contact detection system according to paragraph 94, wherein the locking mechanism comprises one or more locking tabs having pointed projections that engage with an elastic strip when the scanning head is pressed against it. 96. The contact detection system according to any one of paragraphs 61 to 95, wherein the monitoring device is coupled to the sensor array via a flexible printed circuit board. 97. The contact detection system according to any one of paragraphs 61 to 96, wherein the monitoring device comprises a printed circuit board. 98. The contact detection system according to any one of claims 61 to 97, further comprising a sleeve configured to receive the monitoring device. 99. A contact detection system according to any one of paragraphs 61 to 98, comprising a power supply. 100. The contact detection system according to paragraph 99, wherein the power source is a battery in the monitoring device. 101. A contact detection system according to any one of paragraphs 61 to 100, wherein the sensor array and the monitoring device are reversibly connected. 102. A contact detection system according to any one of paragraphs 61 to 101, comprising a wireless transmitter operably connected to the sensor array for remotely transmitting the voltage signals output by the plurality of sensors. 103. The contact detection system according to any one of paragraphs 61 to 102, wherein the processor comprises instructions for displaying the target tissue location and the alignment guide location on the display screen in real time. 104. The contact detection system according to any one of paragraphs 61 to 103, wherein the processor comprises instructions for displaying the force applied to the target tissue location in real time. 105. In a currently preferred embodiment, the present invention provides an insertion site locating method using a system described in any one of paragraphs 61 to 104, comprising: (a) sliding the carriage to a target tissue location; (b) pressing the scanning head against the target tissue location to capture a pressure map image on the display screen; (c) releasing the scanning head; (d) sliding the carriage toward an unmapped area of ​​the target tissue location; and (e) repeating steps (b) to (d) until a pressure map is displayed across the target tissue location. 106. The method of paragraph 105, further comprising reading a measurement of the applied force from a force indicator. 107. In a currently preferred embodiment, the present invention provides an insertion site marking method using a system described in any one of paragraphs 68 to 104, comprising: (a) sliding the carriage to a target tissue location; (b) pressing the scanning head against the target tissue location to capture a pressure map image on the display screen; (c) releasing the scanning head; (d) sliding the carriage toward an unmapped area of ​​the target tissue location; (e) repeating steps (b) to (d) until a pressure map is displayed across the target tissue location; (f) identifying the insertion site on the pressure map; (g) positioning the alignment guides at the insertion site on the pressure map; (h) positioning the marking device through the alignment guides; and (i) marking the insertion site on the patient's skin surface. 108. In a currently preferred embodiment, the present invention provides a method for guiding a needle to an insertion site using a system described in any one of paragraphs 69 to 104, comprising: (a) sliding the carriage to a target tissue location; (b) pressing the scanning head against the target tissue location to capture a pressure map image on the display screen; (c) releasing the scanning head; (d) sliding the carriage toward an unmapped area of ​​the target tissue location; (e) repeating steps (b) to (d) until a pressure map is displayed across the target tissue location; (f) identifying the insertion site on the pressure map; (g) positioning the alignment guide at the insertion site on the pressure map; (h) positioning the needle through the needle guide; and (i) inserting the needle into the insertion site. 109. The method of paragraph 108, further comprising the step of removing the system while retaining the needle in the insertion site. 110. The method of paragraph 108, further comprising reading a measurement of the applied force from a force indicator. 111. The method of paragraph 109, further comprising the step of unlocking a release gate prior to the step of removing the system. 112. The method according to paragraph 108, wherein the needle is a local anesthetic needle, and the method further comprises the step of injecting a local anesthetic into the insertion site. 113. The method according to paragraph 112, further comprising the steps of removing the local anesthetic needle, positioning a spinal anesthetic needle through the needle guide, and inserting the spinal anesthetic needle into the insertion site. 114. The method according to paragraph 112, further comprising the steps of removing the local anesthetic needle, positioning an introducer needle via the needle guide, and inserting the introducer needle into the insertion site. 115. The method according to any one of paragraphs 112 to 114, further comprising the step of removing the system. 116. The method according to paragraph 115, wherein the step of removing the system comprises opening the release gate. 117. The method according to paragraph 115 or 116, further comprising the step of continuing the treatment method after the step of removing the system. 118. The method according to paragraph 108, wherein the needle is an introducer. 119. The method of paragraph 108, further comprising the step of configuring a depth limiter prior to the step of positioning the needle through the needle guide. 120. The method according to paragraph 119, wherein the step of configuring the depth limiter comprises setting the height of the depth limiter. 121. The method according to paragraph 120, wherein setting the height of the depth limiter is equivalent to setting the depth limiter to a lower position. 122. The method according to paragraph 121, further comprising locking the depth limiter in the lower position. 123. The method according to paragraph 120, wherein setting the height of the depth limiter is equivalent to setting the depth limiter to an upper position. 124. The method according to paragraph 123, further comprising locking the depth limiter in the upper position. 125. In one currently preferred embodiment, the present invention relates to an insertion site locating method using a contact detection device, wherein the contact detection device comprises a base and a monitoring device, the base comprising a scanning track and a carriage configured to slide along the scanning track and having alignment guides, a scanning head mounted on the carriage, and a sensor array attached to the scanning head, comprising one or more pressure sensors, each pressure sensor configured to output a voltage signal in response to a change in pressure, the monitoring device comprising a display screen operably coupled to the sensor array, configured to display a pressure map representing the target tissue location of an individual based on the voltage signals output by the one or more pressure sensors, and a computing device comprising a processor operably coupled to the sensor unit and the monitoring device, and the pro The method provides a computing device comprising a non-temporary computer-readable storage medium having a computer program that includes instructions executable by the processor for i) converting the voltage signals from the sensor array into a pressure map and displaying the pressure map on the display screen, and ii) outputting the locations of alignment guides on the display screen, wherein the method comprises (a) sliding the carriage to a target tissue location, (b) pressing the scanning head against the target tissue location to capture a pressure map image on the display screen, (c) releasing the scanning head, (d) sliding the carriage toward an unmapped area of ​​the target tissue location, and (e) repeating steps (b) to (d) until a pressure map is displayed across the target tissue location. 126. The method according to paragraph 125, further comprising identifying an insertion site and positioning the alignment guide at the location of the insertion site. 127. The method of paragraph 126, further comprising positioning a marking device via the alignment guide and marking the insertion site on the patient's skin surface. 128. The method according to paragraph 126, further comprising positioning a needle via a needle guide and inserting the needle into the insertion site. 129. The method of paragraph 126, further comprising the step of removing the system while retaining the needle in the insertion site. 130. The method according to paragraph 129, further comprising the step of unlocking a release gate prior to the step of removing the system. 131. The method according to paragraph 126, wherein the needle is a local anesthetic needle, and the method further comprises the step of injecting a local anesthetic into the insertion site. 132. The method according to paragraph 1321, further comprising the steps of removing the local anesthetic needle, positioning a spinal anesthetic needle through the needle guide, and inserting the spinal anesthetic needle into the insertion site. 133. The method according to paragraph 132, further comprising the steps of removing the local anesthetic needle, positioning an introducer needle via the needle guide, and inserting the introducer needle into the insertion site. 134. The method according to any one of paragraphs 131 to 133, further comprising the step of removing the system. 135. The method according to paragraph 135, wherein the step of removing the system comprises opening the release gate. 136. The method according to paragraph 1354 or 1365, further comprising the step of continuing the treatment method after the step of removing the system. 137. The method according to paragraph 126, wherein the needle is an introducer. 138. The method of paragraph 126, further comprising the step of configuring a depth limiter prior to the step of positioning the needle through the needle guide. 139. The method according to paragraph 1398, wherein the step of configuring the depth limiter comprises setting the height of the depth limiter. 140. The method according to paragraph 139, wherein setting the height of the depth limiter is equivalent to setting the depth limiter to a lower position. 141. The method of paragraph 1410, further comprising locking the depth limiter in the lower position. 142. The method according to paragraph 139, wherein setting the height of the depth limiter comprises setting the depth limiter to an upper position. 143. The method according to paragraph 1434, further comprising locking the depth limiter in the upper position. 144. A contact detection system having any of the features described herein. 145. A method of using a contact detection system, comprising using any of the methods disclosed herein.

[0140] IV. Definition Unless otherwise defined, all technical terms, notation, and other technical and scientific or specialized terms used herein shall have the same meaning as those commonly understood by those skilled in the art to which the subject matter described in the claims belongs. In some cases, terms with a commonly understood meaning are defined herein for clarity and / or reference, and the inclusion of such definitions herein should not necessarily be construed as representing a substantial difference from matters commonly understood in the art.

[0141] Throughout this application, various embodiments may be expressed in range form. It should be understood that range form descriptions are merely for convenience and conciseness and should not be interpreted as inflexible limitations on the scope of this disclosure. Therefore, a description relating to a range should be considered to specifically disclose the individual numbers within that range and all possible partial ranges. For example, a description of a range such as 1 to 6 should be considered to specifically disclose the individual numbers within that range, such as 1, 2, 3, 4, 5, and 6, as well as partial ranges such as 1 to 3, 1 to 4, 1 to 5, 2 to 4, 2 to 6, 3 to 6. This applies regardless of the width of the range.

[0142] The terminology used herein is intended to describe specific cases only and is not intended to be restrictive. As used herein, the singular forms “a,” “an,” and “the” also include plural nouns unless the context clearly indicates otherwise. Furthermore, to the extent that the terms “including,” “includes,” “having,” “has,” “with,” or variations thereof are used in any of the detailed description and / or claims, such terms are as inclusive as the term “comprising.”

[0143] The terms “determining,” “measuring,” “evaluating,” “assessing,” “assaying,” and “analyzing” are often used interchangeably in this specification to refer to different forms of measurement. These terms include determining whether an element is present or not (e.g., detection). These terms may include quantitative, qualitative, or both quantitative and qualitative judgments. Assessment can be relative or absolute. “Detecting the presence” may, depending on the context, include determining the quantity of something that is present, in addition to determining whether it is present or not.

[0144] The terms “subject,” “individual,” and “patient” are often used interchangeably herein. None of these terms require, and are not limited to, a situation characterized by the supervision (e.g., continuous or intermittent) of a healthcare worker (e.g., physician, registered nurse, nurse practitioner, physician's assistant, hospital staff, or hospice worker). A “subject” can be a biological entity containing expressed genetic material. A biological entity can be a plant, an animal, or a microorganism, including, for example, bacteria, viruses, fungi, and protozoa. A subject can be a tissue, cell, or offspring of a biological entity obtained in vivo or cultured in vitro. A subject can be a mammal. A mammal can be a human. A subject may be diagnosed or suspected of being at high risk of disease. In some cases, a subject may not necessarily be diagnosed or suspected of being at high risk of disease.

[0145] The terms “about” or “approximately” mean within an acceptable error range of a particular value as determined by a person skilled in the art, which in part depends on how the value is measured or determined, for example, on the limitations of the measuring system. In certain embodiments, the terms “about” or “approximately” mean within 1, 2, 3, or 4 standard deviations. In certain embodiments, the terms “about” or “approximately” mean within 30%, 25%, 20%, 15%, 10%, 9%, 8%, 7%, 6%, 5%, 4%, 3%, 2%, 1%, 0.5%, 0.1%, or 0.05% of a given value or range. In certain embodiments, the terms “about” or “approximately” mean within 20.0 degrees, 15.0 degrees, 10.0 degrees, 9.0 degrees, 8.0 degrees, 7.0 degrees, 6.0 degrees, 5.0 degrees, 4.0 degrees, 3.0 degrees, 2.0 degrees, 1.0 degrees, 0.9 degrees, 0.8 degrees, 0.7 degrees, 0.6 degrees, 0.5 degrees, 0.4 degrees, 0.3 degrees, 0.2 degrees, 0.1 degrees, 0.09 degrees, 0.08 degrees, 0.07 degrees, 0.06 degrees, 0.05 degrees, 0.04 degrees, 0.03 degrees, 0.02 degrees, or 0.01 degrees of a given value or range.

[0146] As used herein, the term “proximal” is defined, unless otherwise specified, as being closest to or closer to the user holding and / or operating the contact detection device. For example, the user pressing the contact detection device against a patient.

[0147] As used herein, the term “distal” is defined, unless otherwise specified, as being furthest from the user holding and / or operating the contact detection device. For example, pressing the contact detection device against a patient.

[0148] As used herein, the term “needle” may also refer to “injection needle,” “introducer needle,” “syringe,” or “syringe-needle assembly,” and these terms may be used interchangeably herein. Furthermore, these terms encompass syringe-needle assembly and introducer needles having a hub and / or handle, including additional components known in the industry.

[0149] Reference numerals used herein and in the corresponding drawings may refer to similar components or parts that use similar reference numerals. For example, reference numeral 30 may be used to indicate similar components in multiple drawings. That is, component #30 may be labeled 130 in Figure 1, and a similar component may be labeled 530 in Figure 5. For example, in this application, 130 refers to some embodiments of the carriage component shown in Figure 1, and 330 refers to some embodiments of the carriage component in Figures 3A-3E.

[0150] The section headings used in this specification are for organizational purposes only and should not be construed as limiting the subject matter described.

[0151] While preferred embodiments of the present invention have been described herein, it will be apparent to those skilled in the art that such embodiments are provided for illustrative purposes only. Those skilled in the art will conceive of numerous variations, modifications, and substitutions without departing from the present invention. It should be understood that various alternatives to the embodiments of the present invention described herein may be employed when carrying out the present invention. The following claims define the scope of the present invention, thereby covering methods and structures within the scope of these claims and their equivalents.

Claims

1. A contact detection device having a base, The aforementioned base, Scanning truck and A carriage configured to slide along the aforementioned scanning track, The scanning head mounted on the carriage, A sensor array attached to the scanning head, comprising one or more pressure sensors, each pressure sensor configured to output a voltage signal in response to a change in pressure, and A contact detection device equipped with the following features.

2. The contact detection device according to claim 1, wherein the carriage is provided with an alignment guide.

3. The contact detection device according to claim 2, further comprising a needle guide configured to be reversibly attached to the carriage.

4. The contact detection device according to claim 3, wherein the needle guide further comprises a removable tab.

5. The contact detection device according to claim 3, further comprising a needle release gate configured to be reversibly attached to the carriage.

6. The contact detection device according to claim 5, wherein the needle release gate is configured to reversibly fix the needle to the carriage in a position concentric with the needle guide.

7. The contact detection device according to claim 3, wherein the needle guide further comprises a connector plate.

8. The contact detection device according to claim 7, further comprising a connector coupled to a depth limiter, wherein the connector is detachably attached to the connector plate of the needle guide, so that the depth limiter is positioned in a first position aligned with the needle guide and in a second position not aligned with the needle guide.

9. The contact detection device according to claim 8, wherein the connector is coupled to the depth limiter so that the depth limiter is positioned at an upper position away from the needle guide or at a lower position close to the needle guide.

10. The contact detection device according to claim 9, wherein the upper position is configured for arranging a 5-inch needle.

11. The contact detection device according to claim 10, wherein the upper position limits the depth of the 5-inch needle to approximately 0.5 cm to approximately 5 cm.

12. The contact detection device according to claim 9, wherein the lower position is configured for arranging a 3.5-inch needle.

13. The contact detection device according to claim 12, wherein the upper position limits the depth of the 3.5-inch needle to approximately 1 cm to approximately 3.5 cm.

14. The contact detection device according to claim 6, further comprising a needle release gate configured to be reversibly attached to the carriage.

15. The contact detection device according to claim 14, wherein the needle release gate is configured to reversibly fix the needle to the carriage in a position concentric with the needle guide.

16. The contact detection device according to any one of claims 1 to 15, further comprising a bottom pad that forms the distal surface of the contact detection device.

17. The contact detection device according to claim 6, wherein the bottom pad is configured to be on the surface of the patient's skin.

18. The contact detection device according to claim 16, wherein the bottom pad has a concave curve having a radius of approximately 1 meter.

19. The contact detection device according to claim 16, wherein the bottom pad has a hardness of approximately 20 Shore A to 35 Shore A.

20. The contact detection device according to claim 6, wherein the scanning head is movable relative to the carriage.

21. The contact detection device according to claim 20, wherein the scanning head is biased toward the proximal side of the device.

22. The contact detection device according to claim 21, wherein the scanning head is biased by a spring.

23. The contact detection device according to claim 22, wherein the carriage is equipped with a spring guide.

24. The contact detection device according to claim 23, wherein the scanning head is provided with a spring projection, and the spring guide and the spring projection are configured to center the spring relative to the scanning head and the carriage.

25. The contact detection device according to claim 6, wherein the sensor array is a matrix array.

26. The contact detection device according to claim 25, wherein the sensor array is a flexible sensor array.

27. The contact detection device according to claim 26, wherein the sensor array is mounted in the sensor array mounting area.

28. The contact detection device according to claim 27, wherein the sensor array is attached to the distal surface of the scanning head.

29. The contact detection device according to claim 28, wherein the distal surface of the scanning head is curved.

30. The contact detection device according to claim 29, wherein the radius of curvature of the scanning head is approximately 37.5 mm.

31. The contact detection device according to claim 6, wherein the base further comprises a handle.

32. The contact detection device according to claim 30, wherein the handle is provided with a grip portion.

33. The contact detection device according to claim 6, further comprising a locking mechanism for preventing the carriage from sliding along the scanning track when the scanning head is pressed against it.

34. The contact detection device according to claim 33, wherein the locking mechanism comprises one or more locking tabs having pointed projections that engage with an elastic strip when the scanning head is pressed against it.

35. The contact detection device according to claim 33, further comprising a depth lock for locking the position of the scanning head at a certain depth relative to the carriage.

36. The contact detection device according to claim 35, further comprising a button for releasing the scanning head from a locked position relative to the carriage.

37. The contact detection device according to any one of claims 1 to 36, wherein the base further comprises a position sensor.

38. The device further includes a monitoring device, and the monitoring device is A display screen operably coupled to the sensor array, configured to display a pressure map representing the location of an individual's target tissue based on the voltage signals output by one or more pressure sensors, A computing device comprising: a processor operably coupled to the sensor array and the monitoring device; and a non-temporary computer-readable storage medium having a computer program that includes instructions executable by the processor for i) converting the voltage signals from the sensor array into a pressure map and displaying the pressure map on the display screen; and ii) outputting the location of the alignment guide on the display screen. A contact detection device according to claim 33, comprising:

39. The contact detection device according to claim 38, wherein the base further comprises an interface configured to receive the monitoring device.

40. The contact detection device according to claim 39, wherein the interface is equipped with an electrical coupling such that when the monitoring device is received by the interface, the sensor array is electrically connected to the monitoring device.

41. The contact detection device according to claim 40, wherein the sensor array is electrically coupled to the interface by a flexible printed circuit board.

42. The contact detection device according to claim 38, wherein the monitoring device is coupled to the sensor array via a flexible printed circuit board.

43. The contact detection device according to claim 42, wherein the flexible printed circuit board electrically connects the position sensor to the monitoring device.

44. The system according to claim 43, wherein the position sensor is operably coupled to the processor of the computing device, the computing device receives the position of the sensor array from the position sensor, and the position of the sensor array is used to generate the pressure map.

45. The contact detection device according to claim 38, wherein the monitoring device comprises a printed circuit board.

46. The contact detection device according to claim 38, further comprising a sleeve configured to receive the monitoring device.

47. A contact detection device according to claim 38, comprising a power supply.

48. The contact detection device according to claim 47, wherein the power source is a battery in the monitoring device.

49. The contact detection device according to claim 38, wherein the sensor array and the monitoring device are reversibly connected.

50. The contact detection device according to claim 38, further comprising a wireless transmitter operably connected to the sensor array for remotely transmitting the voltage signals output by the plurality of sensors.

51. The contact detection device according to claim 38, wherein the processor comprises commands for displaying the location of the sensor array and / or the location of the alignment guide on the display screen in real time.

52. The contact detection device according to claim 38, wherein the processor is configured to display in real time an approximate force applied to the target tissue location.

53. The contact detection device according to claim 6, wherein the base further comprises a midline indicator.

54. The contact detection device according to claim 6, wherein the distance between the distal surface of the base and the distal surface of the scanning head is approximately 0.1 cm to 5 cm.

55. The contact detection device according to claim 6, wherein the distance between the distal surface of the base and the distal surface of the scanning head is approximately 1.8 cm.

56. The active area of ​​the aforementioned sensor array is approximately 350 mm. ２ The contact detection device according to claim 26.

57. The contact detection device according to claim 6, wherein the scanning head further comprises a scanning knob on its proximal side.

58. The contact detection device according to claim 57, wherein the base comprises at least one limiter guide configured to limit the insertion depth of the needle.

59. The contact detection device according to claim 58, wherein the scanning knob comprises at least one limiter guide.

60. The contact detection device according to claim 57, wherein the scanning knob comprises two or more limiter guides configured to limit the insertion depth of the needle, and the scanning knob rotates to align one of the two or more limiter guides with the alignment guide.

61. A contact detection system comprising a base and a monitoring device, The aforementioned base, Scanning truck and A carriage configured to slide along the aforementioned scanning track, The scanning head mounted on the carriage, A sensor array attached to the scanning head, comprising one or more pressure sensors, each pressure sensor configured to output a voltage signal in response to a change in pressure, and Equipped with, The aforementioned monitoring device A display screen operably coupled to the sensor array, configured to display a pressure map representing the location of an individual's target tissue based on the voltage signals output by one or more pressure sensors, A computing device comprising: a processor operably coupled to the sensor unit and the monitoring device; and a non-temporary computer-readable storage medium having a computer program that includes instructions executable by the processor, i) causing the processor to convert the voltage signals from the sensor array into a pressure map and display the pressure map on the display screen; and ii) causing the processor to output the location of the alignment guide on the display screen. A contact detection system equipped with the following features.

62. The contact detection system according to claim 61, wherein the base further comprises an interface configured to receive the monitoring device.

63. The contact detection system according to claim 62, wherein the interface is equipped with an electrical coupling such that when the monitoring device is received by the interface, the sensor array is electrically connected to the monitoring device.

64. The contact detection system according to claim 63, wherein the sensor array is electrically coupled to the interface by a flexible printed circuit board.

65. The contact detection system according to claim 61, wherein the base further comprises a position sensor.

66. The system according to claim 65, wherein the position sensor is operably coupled to the processor of the computing device, the computing device receives the position of the sensor array from the position sensor, and the position of the sensor array is used to generate the pressure map.

67. The system according to claim 66, wherein the position sensor is electrically coupled to the interface via a flexible printed circuit board.

68. The contact detection system according to claim 61, wherein the carriage is provided with an alignment guide.

69. The contact detection system according to claim 68, further comprising a needle guide configured to be reversibly attached to the carriage.

70. The contact detection system according to claim 69, wherein the needle guide further comprises a removable tab.

71. The contact detection system according to claim 69, further comprising a needle release gate configured to be reversibly attached to the carriage.

72. The contact detection system according to claim 71, wherein the needle release gate is configured to reversibly fix the needle to the carriage in a position concentric with the needle guide.

73. The contact detection system according to claim 69, wherein the scanning head further comprises a scanning knob on its proximal side.

74. The contact detection system according to claim 73, wherein the scanning knob comprises at least one limiter guide configured to limit the insertion depth of the needle.

75. The contact detection system according to claim 74, wherein the scanning knob comprises two or more limiter guides configured to limit the insertion depth of the needle, and the scanning knob rotates to align one of the two or more limiter guides with the alignment guide.

76. The contact detection system according to claim 69, further comprising a bottom pad that forms the distal surface of the contact detection system.

77. The contact detection system according to claim 76, wherein the bottom pad is configured to be on the surface of the patient's skin.

78. The contact detection system according to claim 77, wherein the bottom pad has a concave curve having a radius of approximately 1 m.

79. The contact detection system according to claim 77, wherein the bottom pad has a hardness of approximately 20 Shore A to 35 Shore A.

80. The contact detection system according to claim 69, wherein the scanning head is movable relative to the carriage.

81. The contact detection system according to claim 80, wherein the scanning head is biased toward the proximal side of the system.

82. The contact detection system according to claim 81, wherein the scanning head is biased by a spring.

83. The contact detection system according to claim 82, wherein the scanning head is provided with a spring projection, the carriage is provided with a spring guide, and the spring guide and the spring projection are configured to center the spring relative to the scanning head and the carriage.

84. The contact detection system according to claim 83, wherein the sensor array is a matrix array.

85. The contact detection system according to claim 84, wherein the sensor array is a flexible sensor array.

86. The contact detection system according to claim 84, wherein the sensor array is mounted in the sensor array mounting area.

87. The contact detection system according to claim 84, wherein the sensor array is attached to the distal surface of the scanning head.

88. The contact detection system according to claim 84, wherein the base further comprises a handle.

89. The contact detection system according to claim 88, wherein the handle is provided with a grip portion.

90. The contact detection device according to claim 88, wherein the base further comprises a midline indicator.

91. The contact detection system according to claim 90, wherein the distance between the distal surface of the base and the distal surface of the scanning head is approximately 0.1 cm to 5 cm.

92. The contact detection system according to claim 91, wherein the distance between the distal surface of the base and the distal surface of the scanning head is approximately 1.8 cm.

93. The active area of ​​the aforementioned sensor array is approximately 350 mm. ２ The contact detection device according to claim 90.

94. The contact detection system according to claim 90, further comprising a locking mechanism for preventing the carriage from sliding along the scanning track when the scanning head is pressed against it.

95. The contact detection system according to claim 94, wherein the locking mechanism comprises one or more locking tabs having pointed projections that engage with an elastic strip when the scanning head is pressed against it.

96. The contact detection system according to claim 94, wherein the monitoring device is coupled to the sensor array via a flexible printed circuit board.

97. The contact detection system according to claim 94, wherein the monitoring device comprises a printed circuit board.

98. The contact detection system according to claim 97, further comprising a sleeve configured to receive the monitoring device.

99. A contact detection system according to claim 98, comprising a power supply.

100. The contact detection system according to claim 99, wherein the power source is a battery in the monitoring device.

101. The contact detection system according to claim 99, wherein the sensor array and the monitoring device are reversibly connected.

102. The contact detection system according to claim 99, further comprising a wireless transmitter operably connected to the sensor array for remotely transmitting the voltage signals output by the plurality of sensors.

103. The contact detection system according to claim 99, wherein the processor comprises commands for displaying the target tissue location and the alignment guide location on the display screen in real time.

104. The contact detection system according to claim 103, wherein the processor is configured to display in real time the force applied to the target tissue location.

105. A method for searching for an insertion site using the system described in claim 99, a. Sliding the carriage to the target tissue location, b. Pressing the scanning head against the target tissue location and capturing a pressure map image on the display screen, c. Releasing the scanning head, d. Sliding the carriage toward an area of ​​the target organization that has not been mapped, e. Repeat steps (b) to (d) until a pressure map is displayed across the target tissue locations. A method for providing this.

106. The method according to claim 105, further comprising reading a measured value of the applied force from a force indicator.

107. A method for marking an insertion site using the system described in claim 99, a. Sliding the carriage to the target tissue location, b. Pressing the scanning head against the target tissue location and capturing a pressure map image on the display screen, c. Releasing the scanning head, d. Sliding the carriage toward an area of ​​the target organization that has not been mapped, e. Repeat steps (b) to (d) until a pressure map is displayed across the target tissue location, f. Identifying the insertion site on the pressure map, g. Placing the alignment guide at the insertion site on the pressure map, h. Placing the marking equipment via the alignment guide, i. Marking the insertion site on the patient's skin surface. A method for providing this.

108. A method for guiding a needle to an insertion site using the system described in claim 99, a. Sliding the carriage to the target tissue location, b. Pressing the scanning head against the target tissue location and capturing a pressure map image on the display screen, c. Releasing the scanning head, d. Sliding the carriage toward an area of ​​the target organization that has not been mapped, e. Repeat steps (b) to (d) until a pressure map is displayed across the target tissue location, f. Identifying the insertion site on the pressure map, g. Placing the alignment guide at the insertion site on the pressure map, h. Positioning the needle via the needle guide, i. Inserting the needle into the insertion site A method for providing this.

109. The method according to claim 108, further comprising reading a measured value of the applied force from a force indicator.

110. The method according to claim 108, further comprising the step of removing the system while holding the needle in the insertion site.

111. The method according to claim 109, further comprising the step of unlocking a release gate prior to the step of removing the system.

112. The method according to claim 108, wherein the needle is a local anesthetic needle, and the method further comprises the step of injecting a local anesthetic into the insertion site.

113. The method according to claim 112, further comprising the steps of removing the local anesthetic needle, positioning a spinal anesthetic needle via the needle guide, and inserting the spinal anesthetic needle into the insertion site.

114. The method according to claim 112, further comprising the steps of removing the local anesthetic needle, positioning an introducer needle via the needle guide, and inserting the introducer needle into the insertion site.

115. The method according to claim 113, further comprising the step of removing the system.

116. The method according to claim 115, wherein the step of removing the system comprises opening the release gate.

117. The method according to claim 115 or 116, further comprising the step of continuing the treatment method after the step of removing the system.

118. The method according to claim 108, wherein the needle is an introducer.

119. The method according to claim 108, further comprising the step of configuring a depth limiter prior to the step of positioning the needle via the needle guide.

120. The method according to claim 119, wherein the step of configuring the depth limiter comprises setting the height of the depth limiter.

121. The method according to claim 120, wherein setting the height of the depth limiter comprises setting the depth limiter to the lower position.

122. The method according to claim 121, further comprising locking the depth limiter in the lower position.

123. The method according to claim 120, wherein setting the height of the depth limiter comprises setting the depth limiter to an upper position.

124. The method according to claim 123, further comprising locking the depth limiter in the upper position.

125. A method for searching for an insertion site using a contact detection device, The aforementioned contact detection device Bass and, Equipped with a monitoring device, The aforementioned base, Scanning truck and A carriage configured to slide along the aforementioned scanning track and equipped with alignment guides, The scanning head mounted on the carriage, A sensor array attached to the scanning head, comprising one or more pressure sensors, each pressure sensor configured to output a voltage signal in response to a change in pressure, and Equipped with, The aforementioned monitoring device A display screen operably coupled to the sensor array, configured to display a pressure map representing the location of an individual's target tissue based on the voltage signals output by one or more pressure sensors, A computing device comprising: a processor operably coupled to the sensor unit and the monitoring device; and a non-temporary computer-readable storage medium having a computer program that includes instructions executable by the processor, i) causing the processor to convert the voltage signals from the sensor array into a pressure map and display the pressure map on the display screen; and ii) causing the processor to output the location of the alignment guide on the display screen. Equipped with, The method described above is a. Sliding the carriage to the target tissue location, b. Pressing the scanning head against the target tissue location to capture a pressure map image on the display screen, c. Releasing the scanning head, d. Sliding the carriage toward an area of ​​the target organization that has not been mapped, e. Repeat steps (b) to (d) until a pressure map is displayed across the target tissue locations. A method for providing this.

126. The method according to claim 125, further comprising identifying an insertion site and positioning the alignment guide at the location of the insertion site.

127. The method according to claim 126, further comprising reading the measured value of the applied force from a force indicator.

128. The method according to claim 125, further comprising positioning a marking device via the alignment guide and marking the insertion site on the patient's skin surface.

129. The method according to claim 125, further comprising positioning a needle via a needle guide and inserting the needle into the insertion site.

130. The method according to claim 129, further comprising the step of removing the system while holding the needle in the insertion site.

131. The method according to claim 130, further comprising the step of unlocking a release gate prior to the step of removing the system.

132. The method according to claim 129, wherein the needle is a local anesthetic needle, and the method further comprises the step of injecting a local anesthetic into the insertion site.

133. The method according to claim 132, further comprising the steps of removing the local anesthetic needle, positioning a spinal anesthetic needle via the needle guide, and inserting the spinal anesthetic needle into the insertion site.

134. The method according to claim 132, further comprising the steps of removing the local anesthetic needle, positioning an introducer needle via the needle guide, and inserting the introducer needle into the insertion site.

135. The method according to claim 134, further comprising the step of removing the aforementioned system.

136. The method according to claim 135, wherein the step of removing the system comprises opening the release gate.

137. The method according to claim 135 or 136, further comprising the step of continuing the treatment method after the step of removing the system.

138. The method according to claim 129, wherein the needle is an introducer.

139. The method according to claim 129, further comprising the step of configuring a depth limiter prior to the step of positioning the needle via the needle guide.

140. The method according to claim 139, wherein the step of configuring the depth limiter comprises setting the height of the depth limiter.

141. The method according to claim 140, wherein setting the height of the depth limiter comprises setting the depth limiter to the lower position.

142. The method according to claim 141, further comprising locking the depth limiter in the lower position.

143. The method according to claim 140, wherein setting the height of the depth limiter comprises setting the depth limiter to an upper position.

144. The method according to claim 143, further comprising locking the depth limiter in the upper position.

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