Mixing and injection system including tracking sensor

Abstract

A medical device includes a handle having a first end and a second end, a mixer positioned within the handle, and an adapter coupled to the second end of the handle. The delivery needle includes a distal end, a proximal end, and a lumen extending from the distal end to the proximal end. The proximal end of the delivery needle is coupled to the first end of the handle. The sensor cable includes a distal end and a proximal end, and the proximal end of the sensor cable is positioned within the handle and the distal end extends distally through the lumen of the delivery needle.

Description

[0001] Cross - reference to related applications

[0002] This application claims the benefit of U.S. Provisional Patent Application No. 63 / 418,152, filed on October 21, 2022, the disclosure of which is incorporated herein by reference. Technical field

[0003] The present disclosure relates to medical devices and methods for manufacturing medical devices. More specifically, the present disclosure relates to medical devices including a mixing and injection system having a tracking sensor integrated therein and / or attached thereto. Background art

[0004] Needles are commonly used to deliver treatments, aspirate fluids, or obtain tissue samples, particularly in the prostate. In most cases, the needle must be guided under ultrasound, with the operator controlling a two - dimensional ultrasound probe with one hand and placing the needle with the other hand.

[0005] Placing a needle under ultrasound is difficult and requires the operator to estimate the spatial distance and orientation between the ultrasound probe inside the patient and the needle outside the patient. For example, in the case of a prostate biopsy, the operator first estimates the needle trajectory based on the ultrasound image without any direct indication of where the needle is relative to the anatomical structures shown on the ultrasound image. Once the needle is inserted through the perineum, the operator aligns the ultrasound imaging plane with the needle tip so that the tip is visualized and the needle is placed in the desired position. However, if the needle is tilted relative to the ultrasound imaging plane, the operator may not be able to see the needle tip, and many operators prefer the tilted approach so that they can sample all regions of the prostate through a relatively small area of the perineum and thus reduce the area they need to anesthetize prior to the procedure. Once the needle is visualized and placed in the desired position, the operator estimates the three - dimensional trajectory of the needle as it is advanced forward from the retracted position to ensure that the path the needle will travel through when advanced will only pass through tissue that can be safely biopsied. If the needle turns towards any critical anatomical structures (such as the rectal wall, urethra, seminal vesicles, or blood vessels), the needle may be advanced too quickly for the operator to track or correct the route, causing the critical anatomical structure to be pierced, resulting in complications for the patient. The use of magnetic sensors can allow the operator to track the needle inside the body and avoid such complications. However, the use of magnetic sensors may occupy valuable space inside the needle and impede the injection of viscous fluids or gels, and / or limit the entry of other tools. Therefore, an improved medical device may be needed. Summary of the invention

[0006] The present disclosure provides designs, materials, manufacturing methods, and alternative uses for medical devices. An example medical device can include a handle that includes a housing. The housing can include a first end and a second end, a first fluid inlet positioned near the second end of the housing, a second fluid inlet positioned near the second end of the housing, a mixing chamber in fluid communication with the first fluid inlet and the second fluid inlet, and a fluid outlet in fluid communication with the mixing chamber. The medical device can further include: a delivery needle having a distal end, a proximal end, and a lumen extending from the distal end to the proximal end, wherein the proximal end of the delivery needle can be coupled to the first end of the housing and can be in fluid communication with the fluid outlet; a sensor cable having a distal end and a proximal end, wherein the proximal end of the sensor cable can be positioned within the housing of the handle; and a sensor positioned at the distal end of the sensor cable. The sensor cable can extend distally through the lumen of the delivery needle such that the sensor positioned at the distal end of the sensor cable can be positioned near the distal end of the delivery needle.

[0007] As an alternative or addition to any of the above embodiments, a mixer can be positioned within the mixing chamber.

[0008] As an alternative or addition to any of the above embodiments, a first distal valve can be positioned within the mixing chamber, and a second proximal valve can be positioned within the mixing chamber, wherein the mixer can be configured to be positioned between the first distal valve and the second proximal valve.

[0009] As an alternative or addition to any of the above embodiments, a sensor channel can extend through the mixing chamber, and the sensor cable can be configured to extend through the sensor channel.

[0010] As an alternative or addition to any of the above embodiments, a plurality of rib features can be mounted on the inner wall of the distal end of the mixing chamber, the plurality of rib features extending radially inward from the inner wall and being configured to hold the first distal valve in place.

[0011] As an alternative or addition to any of the above embodiments, an adapter can be configured to be coupled to the second end of the housing of the handle, the adapter being configured to engage with the first fluid inlet and the second fluid inlet.

[0012] As an alternative or addition to any of the above embodiments, the sensor can be a position sensor.

[0013] As an alternative or addition to any of the above embodiments, the sensor cable can be mounted within the mixing chamber by threading.

[0014] As an alternative or addition to any of the above embodiments, the sensor cable can be coupled to the adapter such that when the adapter is separated from the second end portion of the handle housing, the sensor cable is withdrawn proximally from the delivery needle.

[0015] As an alternative or addition to any of the above embodiments, the sensor can have an outer diameter of 0.018 inches.

[0016] As an alternative or addition to any of the above embodiments, the delivery needle can have an outer diameter of 0.038 inches.

[0017] An example medical device can include a handle having a housing, wherein the housing can include a first end and a second end, a first fluid inlet positioned near the second end of the housing, a second fluid inlet positioned near the second end of the housing, a mixing chamber in fluid communication with the first fluid inlet and the second fluid inlet, a mixer positioned within the mixing chamber, and a fluid outlet in fluid communication with the mixing chamber. The medical device can further include: a delivery needle having a distal end, a proximal end, and a lumen extending from the distal end to the proximal end, wherein the proximal end of the delivery needle can be coupled to the first end of the housing and in fluid communication with the fluid outlet; a sensor cable having a distal end and a proximal end, wherein the proximal end of the sensor cable is positioned within the housing of the handle; and a sensor positioned at the distal end of the sensor cable. A sensor channel can extend through the mixing chamber, and the sensor cable can be configured to extend through the sensor channel and distally through the lumen of the delivery needle such that the sensor positioned at the distal end of the sensor cable is positioned near the distal end of the delivery needle.

[0018] As an alternative or addition to any of the above embodiments, the adapter can be configured to be coupled to the second end of the handle housing and is configured to engage the first fluid inlet and the second fluid inlet.

[0019] As an alternative or addition to any of the above embodiments, the sensor cable can be coupled to the adapter such that when the adapter is separated from the second end portion of the handle housing, the sensor cable is withdrawn proximally from the delivery needle.

[0020] As an alternative or addition to any of the above embodiments, the adapter can include a first fluid channel configured to engage the first fluid inlet and a second fluid channel configured to engage the second fluid inlet.

[0021] As an alternative or addition to any of the above embodiments, the first fluid chamber can be in fluid communication with the first fluid inlet, and the second fluid chamber can be in fluid communication with the second fluid inlet.

[0022] As an alternative or addition to any of the above embodiments, the electrical port may be located within the adapter, and the sensor cable is operatively coupled to the electrical port.

[0023] Another example of a medical device may include: a handle having a first end and a second end; a mixer located within the handle; an adapter coupled to the second end of the handle; a delivery needle having a distal end, a proximal end, and a lumen extending from the distal end to the proximal end, wherein the proximal end of the delivery needle is coupled to the first end of the handle; and a sensor cable having a distal end and a proximal end, wherein the proximal end of the sensor cable is located within the handle and the distal end extends distally through the lumen of the delivery needle.

[0024] As an alternative or addition to any of the above embodiments, the sensor cable may be coupled to the adapter such that when the adapter is separated from the second end portion of the housing of the handle, the sensor cable is withdrawn proximally from the delivery needle.

[0025] As an alternative or addition to any of the above embodiments, the mixing chamber may be located within the handle, wherein the mixer is located within the mixing chamber.

[0026] The foregoing summary of some embodiments is not intended to describe every disclosed embodiment or every implementation of the present disclosure. The following drawings and detailed description more particularly exemplify these embodiments. BRIEF DESCRIPTION OF THE DRAWINGS

[0027] The present disclosure may be more fully understood in connection with the following detailed description when considered in conjunction with the accompanying drawings, in which:

[0028] Figure 1A An exemplary medical device including a delivery needle and an injection system is shown;

[0029] Figure 1B Shown as Figure 1A An exploded view of an exemplary medical device including a delivery needle and an injection system as shown;

[0030] Figure 2A A side view of an exemplary medical device including a delivery needle, a handle, and an adapter is shown;

[0031] Figure 2B Shown as Figure 2A A bottom view of an exemplary medical device including a delivery needle, a handle, and an adapter as shown;

[0032] Figure 3A Shown as Figure 2A And Figure 2B A cross-sectional view taken along line 3A-3A of an exemplary medical device including a delivery needle, a handle, and an adapter as shown;

[0033] Figure 3B shows an enlarged view of the distal end of the delivery needle taken at circle 3B as Figure 3A shown;

[0034] Figure 4 shows an exemplary medical device including a delivery needle, a handle, and an adapter taken at line 4-4 as Figure 2A and Figure 2B shown;

[0035] Figure 5 shows an exemplary medical device including a delivery needle, a handle, and an adapter taken at line 4-4 as Figure 2A and Figure 2B shown, showing a fully intact mixer;

[0036] Figure 6 shows an exemplary medical device including a delivery needle, a handle, and an adapter taken at line 4-4 as Figure 2A and Figure 2B shown, showing a fully intact mixer, wherein the adapter is removed from the handle.

[0037] Figure 7A shows the adapter being removed from the handle, wherein the sensor cable is removed from the handle together with the adapter;

[0038] Figure 7B shows the adapter and the sensor cable completely removed from the handle as Figure 7A shown;

[0039] Figure 8 shows an exemplary medical device including a delivery needle and an adapter;

[0040] Figure 9 shows an exemplary medical device including a delivery needle and an adapter taken at line 9-9 as Figure 8 shown.

[0041] Figure 10A shows an exemplary medical device, wherein the adapter is separate from the handle and the delivery needle; and

[0042] Figure 10B shows the exemplary medical device as in Figure 10A wherein the adapter is connected to the handle and the delivery needle.

[0043] While the present disclosure may have various modifications and alternative forms, details thereof have been shown by way of example in the drawings and will be described in detail. However, it should be understood that the intention is not to limit the present disclosure to the particular embodiments described. On the contrary, the intention is to cover all modifications, equivalents, and alternatives falling within the spirit of the present disclosure. Detailed implementation manners

[0044] For the terms defined below, these definitions will apply unless a different definition is given in the claims or elsewhere in this specification.

[0045] Whether or not explicitly stated, it is assumed herein that all numerical values are modified by the term "about". The term "about" generally refers to a range of numbers that a person of ordinary skill in the art would consider equivalent to the stated value (i.e., having the same function or result). In many instances, the term "about" may include numbers that are rounded to the nearest significant figure.

[0046] Numeric ranges expressed by endpoints include all numbers within that range (e.g., 1 to 5 includes 1, 1.5, 2, 2.75, 3, 3.80, 4, and 5).

[0047] As used in this specification and the appended claims, the singular forms "a", "an", and "the" include plural referents unless the context clearly dictates otherwise. As used in this specification and the appended claims, the term "or" is generally used in its inclusive sense (i.e., "and / or") unless the context clearly dictates otherwise.

[0048] It should be noted that references in this specification to "one embodiment", "some embodiments", "other embodiments", etc. indicate that the described embodiments may include one or more features, structures, and / or characteristics. However, such recitation does not necessarily mean that all embodiments include that feature, structure, and / or characteristic. Additionally, when a feature, structure, and / or characteristic is described in connection with one embodiment, such feature, structure, and / or characteristic may also be used in connection with other embodiments whether or not explicitly described, unless there is a clear contrary indication.

[0049] The following detailed description should be read with reference to the accompanying drawings, in which like elements in different drawings are numbered the same. The drawings (which are not necessarily drawn to scale) depict illustrative embodiments and are not intended to limit the scope of the disclosure.

[0050] Needles are commonly used to deliver treatments, aspirate fluids, or collect tissue samples. In most cases, the needle must be guided under ultrasound, where the user can control a two-dimensional ultrasound probe with one hand and place the needle with the other hand. Placing the needle under ultrasound can be difficult and may require the user to estimate the spatial distance and orientation between the tissue shown in the ultrasound image and the needle as the needle penetrates the tissue. This coordination can be particularly difficult when the ultrasound transducer is far from the access point, such as during prostate surgery.

[0051] Under two-dimensional ultrasound, guiding a needle may require the user to continuously move and rotate the ultrasound probe to locate the position of the needle tip and understand its trajectory. If the user fails to locate and identify the needle under ultrasound or misinterprets the local view of the needle, the user may inadvertently puncture critical structures. Magnetic tracking provides the ability to track the tip of a tool anywhere inside the body using a sensor. Although the magnetic sensor is small and can be fitted inside the needle, the sensor may impede the injection of viscous fluids or gels or other substances into the tool. In some cases, the fluid and / or gel may need to be mixed before being delivered to the patient's body. An in-line static mixer can prevent the sensor from entering the needle. Therefore, an improved medical device for delivering fluids and / or gels may be needed.

[0052] Figure 1A An exemplary medical device 10 including a delivery needle 40 and an injection system 25 is shown. Figure 1B An exploded view of an exemplary medical device 10 including a delivery needle 40 and an injection system 25 is shown. As Figures 1A to 1B shown, the medical device 10 may be a delivery device including a handle 30, a delivery needle 40, an adapter 20, a syringe 15, and a cable 50. The handle 30 may include a housing 29 having a first end 31 and a second end 32. The delivery needle 40 may include a distal end 41 and a proximal end (not explicitly shown in Figure 1A ), and the proximal end of the delivery needle 40 may be coupled to the first end 31 of the housing 29. The delivery needle 40 may be coupled to the housing via adhesive bonding, laser welding, resistance welding, insert injection molding, or any other suitable attachment method. In some cases, the delivery needle 40 may be beveled at the distal end 41 to enhance tissue penetration.

[0053] The adapter 20 can be removably coupled to the second end 32 of the housing 29 via a friction fit, snap fit, or channel lock. The syringe 15 can include a first end 16 and a second end 17. The syringe 15 can be removably coupled to the adapter 20 via the port 22. In some cases, the first end 16 of the syringe 15 can be coupled to the port 22 of the adapter 20 via a Luer lock, snap fit, interference fit, or any other suitable attachment method. In some cases, the syringe 15 can be configured to hold saline to, for example, flush the housing 29 and the delivery needle 40 and / or the target tissue before delivering a treatment. For example, in some cases, the syringe 15 can be configured to hold saline for hydro-dissection. In such cases, the saline contained within the syringe 15 can be used to perfuse the delivery needle 40 to remove air from the lumen of the delivery needle 40 to prevent air from entering the tissue and obscuring the ultrasound image. Once the delivery needle 40 is in the desired position, saline is injected to perform hydro-dissection of the tissue. The second end 17 of the syringe 15 can include a handle 18 and a piston 19. In use, the user can hold the handle 18 and translate the piston 19 in the distal direction to administer the fluid (e.g., saline) contained within the syringe 15.

[0054] The cable 50 can be removably coupled to the adapter 20 via the electrical port 21. In such cases, the cable 50 can include a barrel connector 51 that can be configured to be inserted into the electrical port 21. In some cases, the cable 50 can be configured to be coupled to a controller (not shown) that can receive signals, for example, from a sensor located within the delivery needle 40 and / or transmit signals to, for example, a transmitter device.

[0055] Figures 2A to 7B An exemplary medical device 100 is shown. Figure 2A A side view of an exemplary medical device 100 including a delivery needle 140, a handle 130, and an adapter 120 is shown. Figure 2B As shown Figure 2A including a delivery needle 140 (not shown in the Figure 2B view), a handle 130 (not shown in the Figure 2B view), and an adapter 120, a bottom view of the exemplary medical device 100 is shown. The medical device 100 can be considered an example of the medical device 10 as Figures 1A to 1B shown. As Figures 2A to 2B shown, the medical device 100 can include a handle 130, a delivery needle 140, and an adapter 120. The handle 130 can include a housing 129 having a first end 131 and a second end 132. The delivery needle 140 can include a distal end 141 and a proximal end (not shown in the Figure 2A(not shown explicitly), and the proximal end of the delivery needle 140 may be coupled to the first end 131 of the housing 129. The delivery needle 140 may be coupled to the housing 129 via adhesive bonding, laser welding, resistance welding, insert injection molding, or any other suitable attachment method. In some cases, the delivery needle 140 may be beveled at the distal end 141 to enhance tissue penetration.

[0056] The adapter 120 may be removably coupled to the second end 132 of the housing 129 via a channel lock. As Figures 2A to 2B shown, the adapter 120 may include a plurality of channels 124a, 124b, 124c, 124c. As visible in Figure 2A the channel 124a may interact with a stop 158 on the housing 129 of the handle 130 and lock the adapter 120 to the second end 132 of the housing 129. For example, the user may align the opening 126a of the channel 124a with the stop 158, advance the adapter 120 in the distal direction onto the second end 132 of the housing 129, and twist the adapter 120 such that the stop 158 engages along the channel 124a and with the end 127a of the channel 124a, thereby coupling the adapter 120 to the second end 132 of the housing 129. If the user desires to separate the adapter 120 from the housing 129, the user may twist the adapter 120 in the opposite direction such that the stop 158 moves along the channel 124a from the end 127a of the channel 124a to the opening 126a of the channel 124a, and the user may retract the adapter 120 in the proximal direction, thereby separating the adapter 120 from the housing 129. In some cases, the adapter 120 may not include a plurality of channels 124a, 124b, 124c, 124d, but may be coupled to the housing 129 via a friction fit, snap fit, or any other suitable attachment method.

[0057] The adapter 120 may include a port 122 that may be configured to engage with a syringe (e.g., syringe 15). The port 122 may be configured to engage with the syringe via a Luer lock, interference fit, snap fit, or any other suitable engagement method. The adapter may further include an electrical port 121 that may be configured to engage with a cable (e.g., cable 50). In some cases, the cable may include a cylindrical connector (e.g., cylindrical connector 51) that may be configured to be inserted into the electrical port 121.

[0058] Figure 3A is shown as Figure 2A and Figure 2B an exemplary medical device 100 including a delivery needle 140, a handle 130, and an adapter 120 taken along line 3A-3A. As referencedFigure 2A And Figure 2B As discussed, the handle 130 may include a housing 129. The housing 129 may include a first end 131 and a second end 132. The housing 129 may include a mixing chamber 133 that may be in fluid communication with a fluid outlet 139, a first fluid inlet, and a second fluid inlet. The fluid outlet 139 may be located near the first end 131 of the housing 129. The first fluid inlet and the second fluid inlet are shown in Figure 4 As shown. A mixer 135 may be located within the mixing chamber 133, between the fluid outlet 139 and the first fluid inlet and the second fluid outlet. The mixer 135 may be a static mixer, such as a ribbon mixer, an in-line mixer, and / or any other suitable static mixer. In some cases, the mixer 135 may be a non-static mixer that includes moving parts, although this is not shown. The mixer 135 may include a plurality of vanes 128 that extend into the mixing chamber 133. The plurality of vanes 128 are fixed and provide a stop for the fluids injected into the mixing chamber 133, such that the injected fluids are mixed together within the mixing chamber 133. For example, in some cases, there may be one type of fluid injected into the mixing chamber 133, such as saline. For example, in some cases, there may be more than one type of fluid injected into the mixing chamber 133, such as water and polyethylene glycol (PEG).

[0059] The sensor cable 160 may include a distal end 163 and a proximal end 164. The proximal end 164 of the sensor cable 160 may be located within the handle 130, and the distal end 163 may extend distally through the lumen 145 of the delivery needle 140. The proximal end 164 of the sensor cable 160 may be operatively connected to an electrical port 121 in the adapter 120 via a thin flexible circuit. A sensor channel 161 may extend from the adapter 120 through the housing 129 and through the mixer 135 within the mixing chamber 133. The sensor cable 160 may be configured to extend from the electrical port 121 in the adapter 120 through the sensor channel 161 and distally through the lumen 145 of the delivery needle 140. In some cases, the sensor cable 160 may be threadably mounted within the sensor channel 161. In some cases, the sensor cable 160 may be coupled to the adapter 120 such that when the adapter 120 is separated from the second end 132 of the housing 129, the sensor cable 160 is withdrawn proximally from the lumen 145 of the delivery needle 140 and the sensor channel 161 within the mixer 135, as Figures 7A to 7B shown.

[0060] The sensor 165 can be positioned at the distal end 163 of the sensor cable 160. In some cases, the sensor 165 can be a position sensor, such as an electromagnetic sensor or an optical sensor. The sensor 165 can enable tracking of the position and / or orientation of the distal end 141 of the delivery needle 140. In some cases, the sensor 165 can facilitate tracking of the position and / or orientation of the distal end 141 of the delivery needle 140 relative to the ultrasound imaging plane such that the position and / or orientation of the delivery needle 140 can be displayed in the imaging plane, although this is not shown. Reference will be made Figure 3B to the distal end 141 of the delivery needle 140 including the sensor 165 described in more detail.

[0061] The first distal valve 134 and the second proximal valve 136 can be positioned within the mixing chamber 133, and the mixer 135 can be positioned between the first distal valve 134 and the second proximal valve 136. The first distal valve 134 and the second proximal valve 136 can be configured to provide a seal around the mixer 135 to respectively prevent fluid and / or air from entering or leaving the mixer 135. Providing a sensor channel 161 within the mixer 135 allows the sensor cable 160 and the sensor 165 to pass through the mixer 135 within the mixing chamber 133 and into the lumen 145 of the delivery needle 140 without impeding the delivery of any fluid and / or air to the patient via the mixing chamber 133. The mixing chamber 133 can include a plurality of rib features 148 mounted on the inner wall 127 of the mixing chamber 133. The plurality of rib features 148 can be positioned near the first end 131 of the housing 129. The plurality of rib features 148 can be configured to extend radially inward from the inner wall 127 and can be configured to hold the first distal valve 134 in place. Holding the first distal valve 134 in place allows fluid to flow through the mixing chamber 133, around the mixer 135 and into the lumen 145 of the delivery needle 140.

[0062] As previously described, the delivery needle 140 includes a distal end 141 and a proximal end 142 and a lumen 145 extending from the distal end 141 to the proximal end 142. The proximal end 142 can be coupled to the first end 131 of the housing 129. The proximal end 142 of the delivery needle 140 can be configured to fit within the first end 131 of the housing 129 and can be secured to the housing 129 via adhesive bonding, laser welding, resistance welding, insert injection molding or any other suitable attachment method. The lumen 145 of the delivery needle 140 can be in fluid communication with the fluid outlet 139 of the housing 129.

[0063] As previously referenced Figure 2A and Figure 2BAs described, the adapter 120 can be removably coupled to the second end 132 of the housing 129. The adapter 120 can include a port 122 that can be configured to engage a syringe (e.g., syringe 15). The port 122 can be configured to engage the syringe via a Luer lock, an interference fit, a snap fit, or any other suitable engagement method. The port 122 can include a port lumen 123. The port lumen 123 can be configured to engage a first fluid inlet and a second fluid inlet, as will be further described with reference to Figure 4 The adapter can further include an electrical port 121 that can be configured to engage a cable (e.g., cable 50). In some cases, the cable can include a barrel connector (e.g., barrel connector 51) that can be configured to be inserted into the electrical port 121.

[0064] Figure 3B As shown Figure 3A An enlarged view of the distal end 141 of the delivery needle 140 taken at circle 3B is shown. As Figure 3B shown, the distal end 141 of the delivery needle 140 can be beveled to enhance tissue penetration. The delivery needle 140 can include a lumen 145, and the sensor cable 160 can extend distally through the lumen 145 of the delivery needle 140 such that the sensor 165 can be positioned near the distal end 141 of the delivery needle 140. In some cases, the delivery needle 140 can include an outer diameter in the range of about 0.012 inches to 0.180 inches. In some cases, the delivery needle 140 can include an outer diameter in the range of about 0.030 inches to 0.075 inches. In some cases, the delivery needle 140 can include an outer diameter D of 0.038 inches 1 . In some cases, the sensor 165 can include an outer diameter in the range of about 0.005 inches to 0.149 inches. In some cases, the sensor 165 can include a diameter in the range of about 0.015 inches to 0.071 inches. In some cases, the sensor 165 can include an outer diameter D of 0.018 inches 2 .

[0065] Figure 4 As shown Figure 2A and Figure 2B A cross-sectional view of an exemplary medical device including a delivery needle 140, a handle 130, and an adapter 120 taken at line 4-4 is shown. Figure 4The cross-sectional view therein shows a first fluid inlet 137 positioned near the second end 132 of the housing 129 and a second fluid inlet 138 positioned near the second end 132 of the housing 129. The adapter 120 can be configured to engage with the first fluid inlet 137 and the second fluid inlet 138. For example, the adapter 120 includes a first fluid chamber 151 in fluid communication with the first fluid inlet 137 and a second fluid chamber 152 in fluid communication with the second fluid inlet 138. In some cases, the first fluid chamber 151 can extend distally within the first fluid inlet 137, and the second fluid chamber 152 can extend distally within the second fluid inlet 138. In use, a user can inject fluid through the port lumen 123 of the port 122. The fluid can then flow through the first fluid chamber 151 and the second fluid chamber 152 respectively, flow into the first fluid inlet 137 and the second fluid inlet 138, and subsequently flow into the mixing chamber 133. The fluid then flows from the mixing chamber 133 into the lumen 145 of the delivery needle 140 and into the patient's tissue.

[0066] Figure 5 shows a cross-sectional view taken along line 4-4 of an exemplary medical device 100 including a delivery needle 140, a handle 130, and an adapter 120, as Figure 2A and Figure 2B shown, showing a fully intact mixer 135. Figure 6 shows a cross-sectional view taken along line 4-4 of an exemplary medical device including a delivery needle 140, a handle 130, and an adapter 120, as Figure 2A and Figure 2B shown, showing a fully intact mixer, where the adapter 120 is removed from the handle 130. As Figures 5 to 6 shown, the mixer 135 can be positioned within the mixing chamber 133, between the first fluid outlet 139 and the first fluid inlet 137 and the second fluid inlet 138. The mixer 135 can be a static mixer, such as a helical ribbon mixer, an in-line mixer, and / or any other suitable static mixer. In some cases, the mixer 135 can be a non-static mixer including moving parts, although this is not shown. The mixer 135 can include a plurality of vanes 128 extending into the mixing chamber 133. The plurality of vanes 128 are fixed, providing a stop for the fluid injected into the mixing chamber 133, such that the injected fluids are mixed together within the mixing chamber 133. For example, in some cases, there may be one type of fluid injected into the mixing chamber 133, such as saline. For example, in some cases, there may be more than one type of fluid injected into the mixing chamber 133, such as water and polyethylene glycol (PEG).

[0067] When removing the adapter 120 from the handle 130, the adapter 120 is retracted proximally from the handle 130. When the adapter 120 is retracted proximally, the first fluid chamber 151 is disengaged from the first fluid inlet 137, and the second fluid chamber 152 is disengaged from the second fluid inlet 138. As Figure 6 shown, the sensor cable 160 is coupled to the adapter 120 such that when the adapter 120 is disengaged from the handle 130, the sensor cable 160 is retracted proximally from the delivery needle 140 and the handle 130.

[0068] Figure 7A Shown is the removal of the adapter 120 from the handle 130, wherein by removing the adapter 120, the sensor cable 160 is retracted proximally from the delivery needle 140 and the handle 130. Figure 7B Shown is as Figure 7A shown, the adapter 120 and the sensor cable 160 that are completely removed from the delivery needle 140 and the handle 130. As previously described, referring to Figures 2A to 2B , the adapter 120 can be removably coupled to the second end 132 of the housing 129 via a channel lock. The adapter 120 can include a plurality of channels 124a, 124b, 124c, 124c, although only channels 124a, 124b can be seen in Figures 7A to 7B . When the user separates the adapter 120 from the housing 129, the user can twist the adapter 120 in a certain direction such that the stop 158a moves along the channel 124a from the end of the channel 124a (e.g., end 127a) to the opening of the channel 124 (e.g., opening 126a), and the stop 158b moves along the channel 124b from the first end of the channel 124b to the opening of the channel 124b, and the user can retract the adapter 120 in the proximal direction to separate the adapter 120 from the housing 129. In some cases, the adapter 120 may not include a plurality of channels 124a, 124b, 124c, 124d, but may be coupled to the housing 129 via a friction fit, snap fit, or any other suitable attachment method.

[0069] Figure 8 Shown is an exemplary medical device 300 including a delivery needle 340 and an adapter 320. Figure 9 Shown is as Figure 8Cross-sectional view of the medical device 300 including the delivery needle 340 and the adapter 320 taken along line 9-9. The medical device 300 may include a handle 330, a delivery needle 340, and an adapter 320. The handle 330 may include a housing 329 having a first end 331 and a second end 332. The delivery needle 340 may include a distal end 341 and a proximal end 342 and a lumen 345 extending from the distal end 341 to the proximal end 342. The proximal end 342 of the delivery needle 340 may be coupled to the first end 331 of the housing 329. The delivery needle 340 may be coupled to the housing 329 by adhesive bonding, laser welding, resistance welding, insert injection molding, or any other suitable attachment method. In some cases, the delivery needle 340 may be beveled at the distal end 341 to enhance tissue penetration.

[0070] The adapter 320 may be removably coupled to the second end 332 of the housing 329 via a channel lock, as will be referenced Figure 10A and further shown. As Figures 8 to 9 shown, the adapter 320 may include a plurality of channels 324a, 324b. As visible in Figures 8 to 9 , the channel 324a may interact with a stop 358 located on the housing 329 of the handle 330 and lock the adapter 320 to the second end 332 of the housing 329. For example, the user may align the opening 326a of the channel 324a with the stop 358, advance the adapter 320 in the distal direction onto the second end 332 of the housing 329, and twist the adapter 320 such that the stop 358 travels along the channel 324a and engages the end 327a of the channel 324a, thereby coupling the adapter 320 to the second end 332 of the housing 329. If the user desires to separate the adapter 320 from the housing 329, the user may twist the adapter 320 in the opposite direction such that the stop 358 travels along the channel 324a from the end 327a of the channel 324a to the opening 326a of the channel 324, and the user may retract the adapter 320 in the proximal direction, thereby separating the adapter 320 from the housing 329. In some cases, the adapter 320 may not include a plurality of channels 324a, 324b, but may be coupled to the housing 329 by a friction fit, snap fit, or any other suitable attachment method.

[0071] The adapter 320 may include a barrel 350, a handle 355, and a piston 325. As Figure 9As shown, in some cases, the adapter 320 can be a dual-barrel syringe, and the barrel 350 can include a first inner barrel 353 and a second inner barrel 354. In some cases, the adapter 320 can be a single-barrel syringe. The piston 325 can include a first piston 325a configured to engage the first inner barrel 353 and a second piston 325b configured to engage the second inner barrel 354. The first inner barrel 353 can be configured to engage a first fluid chamber 351 within the adapter 320. The second inner barrel 354 can be configured to engage a second fluid chamber 352.

[0072] The housing 329 can include a first fluid inlet 337 positioned near the second end 332 of the housing 329 and a second fluid inlet 338 positioned near the second end 332 of the housing 329. The adapter 320 can be configured to engage the first fluid inlet 337 and the second fluid inlet 338. For example, the first fluid chamber 351 can be in fluid communication with the first fluid inlet 337, and the second fluid chamber 352 can be in fluid communication with the second fluid inlet 338. In some cases, the first fluid chamber 351 can extend distally within the first fluid inlet 337, and the second fluid chamber 352 can extend distally within the second fluid inlet 338. In use, the first inner barrel 353 can include a first fluid (e.g., water), and the second inner barrel 354 can include a second fluid (e.g., PEG). The user can push the piston 325 in the distal direction, which can inject the first fluid into the first fluid chamber 351 and inject the first fluid through the first fluid inlet 337, and inject the second fluid into the second fluid chamber 352 and inject the second fluid through the second fluid inlet 338. The fluids can then flow through the first fluid chamber 351 and the second fluid chamber 352, flow into the first fluid inlet 337 and the second fluid inlet 338, and subsequently flow into the mixing chamber 333. The fluids then flow from the mixing chamber 333 into the lumen 345 of the delivery needle 340 and into the patient's tissue.

[0073] As Figure 8 and Figure 9As shown, the handle 330 may include a housing 329. The housing 329 may include a first end 331 and a second end 332. The housing 329 may include a mixing chamber 333 that may be in fluid communication with a fluid outlet 339, a first fluid inlet 337, and a second fluid inlet 338. The fluid outlet 339 may be positioned near the first end 331 of the housing 329. A mixer 335 may be positioned within the mixing chamber 333, between the fluid outlet 339 and the first fluid inlet 337 and the second fluid inlet 338. The mixer 335 may be a static mixer, such as a ribbon mixer, an in-line mixer, and / or any other suitable static mixer. In some cases, the mixer 335 may be a non-static mixer that includes moving parts, although this is not shown. The mixer 335 may include a plurality of vanes 328 that extend into the mixing chamber 333. The plurality of vanes 328 are fixed and provide a stop for the fluids injected into the mixing chamber 333, such that the injected fluids are mixed together within the mixing chamber 333. For example, in some cases, there may be one type of fluid injected into the mixing chamber 333, such as saline. For example, in some cases, there may be more than one type of fluid injected into the mixing chamber 333, such as water and polyethylene glycol (PEG).

[0074] A first distal valve 334 and a second proximal valve 336 may be positioned within the mixing chamber 333, and the mixer 335 may be positioned between the first distal valve 334 and the second proximal valve 336. The first distal valve 334 and the second proximal valve 336 may be configured to provide a seal around the mixer 335, thereby preventing fluids and / or air from entering or leaving the mixer 335, respectively.

[0075] Figure 10A An exemplary medical device 300 is shown, where the adapter 320 is separate from the handle 330 and the delivery needle 340, and Figure 10B is shown as Figure 10A An exemplary medical device 300 is shown, where the adapter 320 is connected to the handle 330 and the delivery needle 340. The medical device 300 may be a delivery device that includes a handle 330, a delivery needle 340, and an adapter 320. As previously described, the adapter 320 may be a dual-syringe. The handle 330 may include a housing 329 having a first end 331 and a second end 332. The delivery needle 340 may include a distal end 341 and a proximal end (not explicitly shown in Figure 10A and Figure 10B ), and the proximal end of the delivery needle 340 may be coupled to the first end 331 of the housing 329.

[0076] The adapter 320 may be removably coupled to the second end 332 of the housing 329 via a friction fit, a snap fit, or a channel lock. As Figures 10A to 10BAs shown, the adapter 320 may include a plurality of channels 324a, 324b. As seen in Figure 10B , the channel 324a may interact with a stop 358 located on the housing 329 of the handle 330 and lock the adapter 320 to the second end 332 of the housing 329. For example, the user may align the opening 326a of the channel 324a with the stop 358, advance the adapter 320 in the distal direction onto the second end 332 of the housing 329, and twist the adapter 320 such that the stop 358 engages along the channel 324a and with the end 327a of the channel 324a, thereby coupling the adapter 320 to the second end 332 of the housing 329. If the user desires to separate the adapter 320 from the housing 329, the user may twist the adapter 320 in the opposite direction such that the stop 358 travels along the channel 324a from the end 327a of the channel 324a to the opening 326a of the channel 324, and the user may retract the adapter 320 in the proximal direction to separate the adapter 320 from the housing 329. In some cases, the adapter 320 may not include a plurality of channels 324a, 324b, but may be coupled to the housing 329 via a friction fit, snap fit, or any other suitable attachment method.

[0077] In some cases, the adapter 320 may be configured to hold saline to, for example, flush the housing 329 and the delivery needle 340 and / or the target tissue prior to delivering treatment. For example, in some cases, the adapter 320 may be configured to hold saline for hydrodissection. In some cases, the adapter 320 may be configured to hold multiple fluids, such as water and PEG. In such cases, when the user translates the piston 325 in the distal direction, the water and PEG flow into a mixing chamber 333 within the housing 329 before being injected into the patient via the delivery needle 340, where the two fluids mix.

[0078] The medical devices 10, 100, 300, and / or their various parts may be made of metal, metal alloy, polymer (some examples of which are disclosed below), metal-polymer composite, ceramic, combinations thereof, etc., or other suitable materials. Some examples of suitable polymers may include polytetrafluoroethylene (PTFE), ethylene tetrafluoroethylene (ETFE), fluorinated ethylene propylene (FEP), polyoxymethylene (POM, e.g., available from DuPont as ), polyether block ester, polyurethane (e.g., polyurethane 85A), polypropylene (PP), polyvinyl chloride (PVC), polyether ester (e.g., available from DSM Engineering Plastics as ) ether-based or ester-based copolymers (e.g., butene / poly(alkylene ether) phthalate and / or other polyester elastomers, such as those available from DuPont ) polyamides (e.g., those available from Bayer or those available from Elf Atochem ), elastic polyamides, block polyamide / ether, polyether block amides (PEBA, e.g., available under the trade name ), ethylene vinyl acetate copolymers (EVA), silicones, polyethylene (PE), high density polyethylene, low density polyethylene, linear low density polyethylene (e.g., ), polyesters, polybutylene terephthalate (PBT), polyethylene terephthalate (PET), polypropylene terephthalate, polyethylene naphthalate (PEN), polyether ether ketone (PEEK), polyimide (PI), polyetherimide (PEI), polyphenylene sulfide (PPS), polyphenylene oxide (PPO), poly(p-phenylene terephthalamide) (e.g., ), polysulfones, nylons, nylon-12, (e.g., those available from EMS American Grilon ), perfluoro(propyl vinyl ether) (PFA), ethylene vinyl alcohol, polyolefins, polystyrenes, epoxy resins, polyvinylidene chloride (PVdC), poly(styrene-b-isobutylene-b-styrene) (e.g., SIBS and / or SIBS 50A), polycarbonates, ionomers, biocompatible polymers, other suitable materials, or mixtures, compositions, copolymers, polymer / metal composites, etc. In some embodiments, the sheath may be blended with a liquid crystal polymer (LCP). For example, the mixture may contain up to about 6% LCP.

[0079] In at least some embodiments, some or all of the medical devices 10, 100, 300 may also be doped with radiopaque materials, made of radiopaque materials, or otherwise include radiopaque materials. Radiopaque materials are understood to be materials that can produce a relatively bright image on a fluoroscopic screen or another imaging technique during a medical procedure. This relatively bright image helps the user of the medical devices 10, 100, 300 to determine the position of the medical device. Some examples of radiopaque materials may include, but are not limited to, gold, platinum, palladium, tantalum, tungsten alloys, polymer materials loaded with radiopaque fillers, etc. Additionally, other radiopaque markers and / or coils may be incorporated into the design of the medical devices 10, 100, 300 to achieve the same result.

[0080] This disclosure is illustrative in many respects. Changes may be made in the details, especially in the arrangement of the shape, size, and steps, without departing from the scope of this disclosure. To the extent appropriate, this may include using any features of one exemplary embodiment in other embodiments. Of course, the scope of this disclosure is defined in the language expressing the appended claims.

Claims

1. A medical device, comprising: a handle having a first end and a second end; a mixer positioned within the handle; an adapter coupled to the second end of the handle; a delivery needle having a distal end, a proximal end, and a lumen extending from the distal end to the proximal end, wherein the proximal end of the delivery needle is coupled to the first end of the handle; and a sensor cable having a distal end and a proximal end, wherein the proximal end of the sensor cable is positioned within the handle and the distal end extends distally through the lumen of the delivery needle.

2. The medical device according to claim 1, wherein the mixer is a static mixer.

3. The medical device according to any one of claims 1 or 2, further comprising: a mixing chamber positioned within the handle, wherein the mixer is positioned within the mixing chamber.

4. The medical device according to any one of claims 1 to 3, further comprising: a first fluid inlet positioned near the second end of the housing and a second fluid inlet positioned near the second end of the housing.

5. The medical device according to claim 4, wherein a first fluid chamber is in fluid communication with the first fluid inlet, and a second fluid chamber is in fluid communication with the second fluid inlet.

6. The medical device according to any one of claims 3 to 5, wherein a fluid outlet is in fluid communication with the mixing chamber.

7. The medical device according to any one of claims 3 to 6, wherein a first distal valve is positioned within the mixing chamber, and a second proximal valve is positioned within the mixing chamber, wherein the mixer is configured to be positioned between the first distal valve and the second proximal valve.

8. The medical device according to any one of claims 3 to 7, wherein a sensor channel extends through the mixer, and the sensor cable is configured to extend through the sensor channel.

9. The medical device according to any one of claims 4 to 8, wherein the adapter is configured to engage with the first fluid inlet and the second fluid inlet.

10. The medical device according to any one of claims 1 to 9, wherein the sensor cable is coupled to the adapter such that when the adapter is separated from the second end of the housing of the handle, the sensor cable is withdrawn proximally from the delivery needle.

11. The medical device according to any one of claims 1 to 10, wherein a sensor is positioned at the distal end of the sensor cable.

12. The medical device according to any one of claims 7 to 11, wherein a plurality of rib features are mounted on the inner wall of the mixing chamber, the plurality of rib features extending radially inwardly from the inner wall and configured to hold the first distal valve in place.

13. The medical device according to claim 11, wherein the sensor is a position sensor.

14. The medical device according to any one of claims 8 to 13, wherein, the sensor cable is mounted in the sensor channel by threading.

15. The medical device according to any one of claims 1 to 14, wherein, the electrical port is positioned within the adapter, and the sensor cable is operatively coupled to the electrical port.

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