Puncture needle

Abstract

A puncture needle is provided. The puncture needle includes a needle housing and a needle shaft having a portion disposed within the needle housing. The puncture needle also includes a lumen within the needle shaft, an inlet at the proximal end of the needle shaft, and a needle tip at the distal end of the needle shaft. The puncture needle further includes an outlet in the sidewall of the needle shaft, where the outlet is disposed closer to the distal end than the proximal end of the needle shaft, and where the lumen extends from the inlet to the outlet. The puncture needle also includes a ramp disposed within the outlet, where the ramp is coupled to an interior of the needle shaft. Embodiments of the present disclosure have the advantage of enabling guidewire penetration into the bile duct, such as for patients with challenging bile duct anatomy.

Description

Technical Field

[0001] The present specification relates generally to medical devices and more particularly to, for example but not limited to, access needles and methods and uses thereof. Background Art

[0002] In 2016, an estimated 1,230,000 endoscopic retrograde cholangiopancreatography (ERCP) procedures were performed in the 28 member states of the European Union and the United States. As part of the ERCP procedure, cannulation must first be achieved in order to puncture the desired duct; however, this can sometimes be challenging. One method is to use a sphincterotomy device (also known as a papillotomy) inserted through the working channel of a duodenoscope. A sphincterotomy is a catheter containing an electrosurgical cutting guide wire at the distal end, which is used to perform a sphincterotomy (e.g., cutting the sphincter to obtain duct access to perform subsequent surgery). However, in some scenarios, ERCP may fail due to cannulation failure (even if a sphincterotomy is used in some cases) and / or due to failure to puncture the papilla.

[0003] The descriptions provided in the background section should not be assumed to be prior art merely because they are mentioned in or related to the background section.The background section may include information describing one or more aspects of the subject technology. Utility Model Content

[0004] In one embodiment, a puncture needle is provided, comprising a needle housing and a needle shaft having a portion disposed within the needle housing. The needle further comprises a lumen within the needle shaft, an inlet at the proximal end of the needle shaft, and a needle tip at the distal end of the needle shaft. The needle further comprises an outlet on a side wall of the needle shaft, wherein the outlet is disposed closer to the distal end of the needle shaft than to the proximal end, and wherein the lumen extends from the inlet to the outlet.

[0005] In a second embodiment, a method is provided, the method comprising placing a needle near an organ, the organ comprising a target portion. The needle comprises: a needle housing, a needle shaft, a lumen within the needle shaft, an inlet at the proximal end of the needle shaft, a needle tip at the distal end of the needle shaft, and an outlet on the side wall of the needle shaft. The method also comprises puncturing the organ with the needle tip, and injecting a contrast medium into the organ through the lumen in the needle shaft. The method also comprises adjusting the position of the needle in the organ based on an image of the organ (the image comprising the contrast agent) so that the outlet points to the target portion, and inserting a guide wire through the inlet, lumen, and outlet to puncture the target portion.

[0006] In yet another embodiment, a system is provided, the system including a puncture needle for directing a guide element to a target portion of an organ, the puncture needle including a needle housing and a needle shaft having a portion disposed within the needle housing. The puncture needle also includes a lumen within the needle shaft, an inlet at the proximal end of the needle shaft, and a needle tip at the distal end of the needle shaft. The puncture needle also includes an outlet on a side wall of the needle shaft, wherein the outlet is disposed closer to the distal end of the needle shaft than the proximal end, and wherein the lumen extends from the inlet to the outlet. The system also includes an imaging device for directing the puncture needle to the vicinity of the organ and puncturing a puncture site in the organ with the needle tip. The imaging device also includes a radiation source configured to direct radiation to the organ, and a radiation detector configured to detect scattered radiation from the organ. The imaging device also includes a controller configured to receive a signal from the radiation detector and convert the signal into an image, and a display configured to display the image from the controller to direct the needle to the vicinity of the organ. BRIEF DESCRIPTION OF THE DRAWINGS

[0007] Figure 1 A schematic diagram showing the structure of the biliary tree.

[0008] Figure 2 A schematic diagram of a portion of an introducer needle according to aspects of the present disclosure is shown.

[0009] Figure 3 The present invention shows various aspects of the present invention. Figure 2 An enlarged cross-sectional view of the distal end of the needle shaft of the puncture needle.

[0010] Figure 4 The present invention shows various aspects of the present invention. Figure 2 An enlarged cross-sectional view of the distal end of the needle shaft of the puncture needle, wherein the guide wire is arranged in the lumen of the needle shaft.

[0011] Figure 5 FIG. 1 shows a method of performing a lock operation in accordance with various aspects of the present disclosure. Figure 2 An enlarged cross-sectional view of a portion of the needle shaft of a puncture needle.

[0012] Figure 6 The present invention shows various aspects of the present invention. Figure 2 An enlarged cross-sectional view of the distal end of the needle shaft of the puncture needle, wherein the puncture needle is arranged in the bile duct.

[0013] Figure 7 The present invention shows various aspects of the present invention. Figure 2 An enlarged cross-sectional view of the distal end of the needle shaft of the puncture needle, wherein the puncture needle is arranged in the bile duct and relative to Figure 6 Rotate the orientation shown in .

[0014] Figure 8A schematic diagram of an introducer needle with a sheath according to aspects of the present disclosure is shown.

[0015] Fig. 9 The present invention shows various aspects of the present invention. Figure 8 A portion of a puncture needle, wherein the puncture needle includes a tapered portion of the sheath.

[0016] Fig.10 An electrocautery enhanced puncture needle for delivering a cautery current to treat bleeding along a puncture site is shown in accordance with aspects of the present disclosure.

[0017] Fig.11 An introducer needle according to aspects of the present disclosure is shown that includes a rotatable mechanism for guiding a guide wire to a target portion in an organ.

[0018] Fig.12 A puncture needle is shown for puncturing a target portion of an organ during surgery on a patient in accordance with aspects of the present disclosure.

[0019] Fig.13 is a flow chart illustrating steps in a method for puncturing a target portion of an organ during surgery on a patient, according to various embodiments.

[0020] Figures 14 to 21 Alternative embodiments of the distal end of an introducer needle in accordance with embodiments of the present disclosure are depicted.

[0021] Figure 22 to Figure 28 An alternative embodiment of the distal end of the puncture needle is depicted in which the ramp insert is formed from UV or AB glue.

[0022] Figure 29 to Figure 30 An alternative embodiment of the distal end of the introducer needle is depicted wherein the ramp insert is formed from stainless steel.

[0023] Figure 31 to Figure 35 Embodiments of rotatable introducer needles according to embodiments of the present disclosure are depicted.

[0024] In one or more implementations, not all components depicted in each figure are required, and one or more implementations may include additional components not shown in the figures. Changes may be made to the arrangement and type of components without departing from the scope of the present disclosure. Additional components, different components, or fewer components may be utilized within the scope of the present disclosure. DETAILED DESCRIPTION

[0025] The specific embodiments set forth below are intended as descriptions of various implementations and are not intended to represent the only implementation that can practice the subject technology. As will be appreciated by those skilled in the art, the described implementations may be modified in various different ways without departing from the scope of the present disclosure. Therefore, the drawings and descriptions are considered to be illustrative and not restrictive in nature.

[0026] The use of endoscopic ultrasound (EUS) to puncture ducts or cavities is becoming increasingly common, such as for bile duct drainage when ERCP fails or cannot be performed. This usually requires puncturing the duct or cavity with a needle under EUS guidance, and then passing a guide wire to allow other tools to further puncture the cavity over the guide wire. This technique can be used for gallbladder access and drainage when the patient has a gallbladder infection and surgery is not desired, and for drainage of fluids around the gastrointestinal tract, such as drainage of collections around the pancreas or rectum.

[0027] At present, when endoscopic retrograde cholangiography (ERCP) fails due to cannulation failure or inability to puncture the papilla, endoscopic ultrasound-guided (EUS-guided) biliary access is considered a rescue technique. However, endoscopic ultrasound-guided biliary access is technically very challenging. One of the reasons why this operation is technically challenging is the lack of dedicated tools (specifically tools that facilitate biliary access and allow guide wires to be manipulated in the desired direction) to perform rendezvous (e.g., wherein the guide wire is passed down along the papilla, then captured to facilitate standard ERCP) or the guide wire is advanced toward the liver and the direct stent implantation of the bile duct is performed.

[0028] A puncture needle for biliary access is disclosed herein. In addition to being used for puncturing pancreatic cysts and pancreatic ducts, the puncture needle is also used for puncturing gallbladders, and abscesses and effusions beside the gastrointestinal tract. Some puncture needles include 19-gauge puncture needles, which make them rigid and difficult to manipulate and advance into the bile duct. Moreover, these puncture needles generally include an opening for guidewire puncture at the tip of the needle. The opening for guidewire puncture at the tip of the needle creates the risk of the guidewire being sheared by the tip. The risk of guidewire shearing can be reduced by providing a sharp cutting tip on a stylet, and once puncture is achieved, the stylet is removed, thereby allowing the guidewire to be inserted and manipulated. However, even if the stylet reduces the risk of shearing, the puncture needle with a guidewire opening at the tip does not allow the direction of the guidewire to be easily guided, and some shearing risks may still be retained.

[0029] The common bile duct is divided into the left hepatic duct and the right hepatic duct, and the exemplary puncture needle of the present disclosure can help to puncture these ducts more easily. In some operations, a high degree of obstruction of the biliary tree may require the placement of two guide wires. Exemplary embodiments of the present disclosure allow two or more guide wires to be placed in the selected dilated duct for faster puncture, thereby shortening the procedure. In some embodiments of the present disclosure, the exemplary puncture needle makes it easier to place two guide wires by allowing the position of the guide wire entrance to be rotated on one side of the needle.

[0030] According to aspects of the present disclosure, an improved puncture needle is provided. The improved puncture needle can be smaller than currently available needles and can vary in size (e.g., between about 25 gauge and about 18 gauge, such as about 22 gauge) to be easier to manipulate and advance into the bile duct.

[0031] The needle includes an inner lumen extending between the guide wire inlet at the proximal end of the needle and the guide wire outlet on the side wall. The lumen can include a guide feature that guides the guide wire from the lumen to the outlet along a non-sharp curve. In this way, the guide wire outlet does not cause the shearing of the guide wire, forms a wide outlet at a certain angle at a position outside the needle tip, and is conducive to the rotation of the guide wire from the outlet direction of the port. For example, the needle can be rotated in the needle housing and / or rotated by the needle housing to rotate the position of the guide wire outlet. In this way, the disclosed puncture needle allows the guide wire to be manipulated to extend in any desired direction. The needle shaft including the lumen can be formed by a flexible material and includes a tip that is shaped to help advance the needle and cut through tough tissues such as bile ducts.

[0032] Thus, embodiments of the present disclosure may achieve advantages, such as enabling guidewire puncture of the bile duct for patients with challenging bile duct anatomy.

[0033] Figure 1 The duodenum 2 is shown at the location of the sphincter 4 (i.e., the sphincter of Oddi) at the major duodenal papilla. The bile duct 6 and the pancreatic duct 8 are also shown. Figure 1 Shown in.

[0034] Figure 2A side view of an exemplary puncture needle 200 that can be used to puncture, for example, a bile duct 6 is shown (e.g., for inserting a guidewire, such as a guidewire). The puncture needle 200 includes a needle housing 204, in which a needle shaft 202 is arranged. The entrance 201 is an opening that allows the guidewire to puncture at the proximal end of the needle housing 204. The needle shaft 202 can be fixedly arranged in the needle housing 204 so that the needle shaft 202 can be advanced and / or rotated by advancing and / or rotating the housing via a rotatable handle 206. For example, the needle shaft can be fixed to the housing by a locking mechanism 212, or can be permanently fixed to the housing. Alternatively, the needle shaft can be movably arranged in the needle housing so that the needle shaft can be advanced and / or rotated relative to the housing. Figure 2 As shown, introducer needle 200 may also include an inlet 201 at a proximal end 208 of the needle shaft, a handle 206 on needle housing 204 (e.g., for rotating and advancing the needle), a lock 210 for locking needle shaft 202 to an endoscope channel, and a locking mechanism 212. Locking mechanism 212 may be used to lock the needle shaft in place relative to needle housing 204 and / or to lock needle shaft 202 to another object.

[0035] Figure 3 An enlarged cross-sectional view of the distal end of the needle shaft 202 is shown. Figure 3 As shown, the needle shaft 202 includes a needle tip 300 at the distal end of the needle shaft and a lumen 302 within the needle shaft. An outlet 304 is also shown on the sidewall of the needle shaft 202, closer to the distal end of the needle shaft than the proximal end. The outlet 304 allows the guide wire to extend out of the needle shaft 202 and puncture the bile duct or other organ portion. In various examples, the needle shaft 202 has a gauge between about 25 and about 18 (e.g., about 22 or higher). Figure 3 Also shown is how the needle shaft 202 can include a guide surface 306 that is gently curved and thus configured to guide the guide wire from the lumen 302 through the outlet 304. According to various embodiments, the guide surface 306 can have a smooth texture to reduce the risk of shearing, snagging, or yanking the guide wire as it passes through the outlet 304 and bends over it. For example, in some embodiments, the system can include a core that is configured to cover and smooth the guide surface 306.

[0036] Figure 4 An arrangement is shown in which a guidewire 400 is disposed within lumen 302, and in which a distal portion 402 of the guidewire 400 has been guided by a guide surface 306 of the lumen to protrude from a side of the needle shaft 202 via an outlet 304 proximal to the needle tip 300. In various scenarios, a second guidewire may also be passed through lumen 302, for example, through a second inlet at the proximal end of the needle shaft for receiving a second guidewire.

[0037] Figure 5 A further enlarged cross-sectional view of the portion of the needle shaft 202 forming the lumen 302 in the vicinity of the lock 210 is shown.

[0038] Figure 6 An arrangement is shown in which the tip 300 of the needle shaft 202 has pierced an organ 600 (e.g., in an expanded state) above a target portion (e.g., an obstruction 602). Figure 1 6), and wherein the guide wire 400 has been inserted into the bile duct along the direction of the obstruction via the outlet 304 on one side of the needle shaft 202. Because the needle shaft 202 (or a portion thereof, such as the distal portion) is rotatable, the outlet 304 can be positioned and oriented so that the distal portion 402 of the guide wire 400 extends out of the needle in the desired direction.

[0039] To achieve Figure 6 The arrangement shown, the needle shaft 202 can be advanced until the tip 300 pierces the bile duct 600. The bile duct can then be aspirated and / or injected with contrast media (such as, developing dye) to verify the position of the needle. The needle shaft 202 and the outlet 304 in the needle shaft side wall can then be rotated to a desired position and / or orientation. A guide wire (such as a guide wire 400) can then be inserted via the entrance 201, passed through the lumen 302 and exited through the outlet 304. For a three-dimensional effect, a needle housing 204 and a handle 206 are also shown.

[0040] Figure 7 An example is shown in which the outlet 304 has been rotated so that the distal end portion 402 of the guide wire 400 is in contact with Figure 6 The outlet 304 can be rotated by rotating the distal portion of the needle shaft 202, by rotating the entire needle shaft 202, and / or by rotating the housing 204 using the handle 206. The inlet 201, the lumen 302, and the organ 600 are also shown.

[0041] Figure 8 A side view of introducer needle 200 is shown in an alternative embodiment in which sheath 800 is formed around at least a portion of needle shaft 202. Sheath 800 may be formed of plastic, metal, or other biocompatible material, and may be softer and / or more flexible than the metal of needle shaft 202. Figure 8 In the example of FIG. 8 , the sheath 800 is positioned such that at least some of the sheath 800 is disposed between the needle housing 204 and the needle shaft 202 .

[0042] In this example, a handle 206 for rotating the position of the outlet 304 is arranged on the proximal side of the needle housing 204. In this example, a locking mechanism 212 is also arranged on the proximal side of the needle housing 204 and is configured to lock the needle shaft 202 in position relative to the sheath 800. For example, when the locking mechanism 212 locks the needle shaft 202 in position relative to the sheath 800, the handle 206 can be manipulated to rotate the sheath 800 within the needle housing 204 or together with the needle housing 204, thereby rotating the needle shaft 202 and thus rotating the outlet 304. When the locking mechanism 212 is unlocked, the needle shaft 202 can be rotatable and / or slidable within the sheath 800. In this example, the lock 210 can lock the puncture needle 200 to the endoscope so that the needle shaft 202 remains movable (e.g., slidable) relative to the tip of the endoscope within the sheath 800 or together with the sheath 800.

[0043] In one arrangement, introducer needle 200 is configured to allow adjustment of the position of needle shaft 202 relative to sheath 800 and, when desired, to allow advancement of sheath 800 over needle shaft 202, thereby allowing puncture of tracts and cavities through sheath 800. Figure 8 In the example of FIG. 8 , the needle 200 is shown in a side view, and for clarity, the distal portion of the sheath 800 is shown in cross-section. Figure 8 As shown, needle 200 may include features 803 for controlling the position and movement of needle shaft 202 relative to sheath 800 .

[0044] exist Figure 8 In the example of , at least one of the needle housing 204, the sheath 800 or the needle shaft 202 is rotatable (e.g., together or separately) to change the direction of the guide wire in the lumen 302 extending from the outlet 304 by rotating the outlet. In this example, the needle shaft 202 can be slidably arranged in the sheath 800 (e.g., when the locking mechanism 212 is unlocked). Figure 8 In the example of FIG. 2 , a removable cover 802 is provided for the inlet 201 near the proximal end 208. The cover 802 can also be configured to removably cover Figure 2 Entrance 201. Figure 2 and Figure 8 In the example of , the inlet 201 is configured to receive a guidewire to pass the guidewire through the lumen 302 and the outlet 304. The inlet 201 may also include an attachment feature (not explicitly shown) for attaching a syringe to provide fluid into the lumen 302 leading to the outlet 304. In an embodiment where a sheath 800 is provided, the sheath may have a tapered distal end.

[0045] Fig. 9 In the example shown, the sheath 800 includes a tapered portion 900. Figure 8In this example, the sheath 800 has a proximal end ( Fig. 9 202) and a distal end, and the distal end includes a tapered portion 900 that tapers toward the cutting tip 300 of the needle shaft 202. In this example, the sheath 800 is tapered at the distal end to, for example, allow the sheath 800 to be advanced over the needle shaft 202 (e.g., by moving the needle shaft 202 parallel to the direction 902 relative to the sheath 800) into a cavity or duct so as to be used as a puncture device when the needle shaft 202 is removed. In one operating scenario, a first guide wire can be inserted into a duct via the lumen 302 in the needle shaft 202, the sheath 800 can be advanced into the duct over the needle shaft, the needle shaft 202 can be removed, and a larger guide wire can be fed into the duct along the first guide wire through the relatively wider lumen of the sheath. The guide surface 306 bends the guide wire and guides it toward the outlet 304.

[0046] It should be understood that the specific order or level of disclosed steps, operations or processes is an explanation of exemplary methods. Unless otherwise clearly stated, it should be understood that the specific order or level of steps, operations or processes can be carried out in different orders. Some of these steps, operations or processes can be carried out simultaneously. The attached method (if any) presents the elements of various steps, operations or processes in a sample order, and is not meant to be limited to the specific order or level presented. These can be carried out continuously, linearly, in parallel or in different orders.

[0047] Fig.10 An electrocoagulation enhanced puncture needle 1000 is shown for delivering an electrocoagulation current to treat bleeding along a puncture site in accordance with various aspects of the present disclosure. A handle 1006 can be used to adjust (e.g., rotate, pitch, and roll) the position of the electrocoagulation enhanced needle 1000 within an organ and point the outlet 1004 in a desired direction (e.g., a target portion of an organ).

[0048] The port 1001 in the handle 1006 receives the current and transmits the current to the tip 1010. In some embodiments, the tip 1010 includes a conductive material, while the rest of the shaft is shielded and non-conductive. Therefore, the tip 1010 delivers the current to the surrounding tissue in the organ. In some embodiments, the current acts as an electrocoagulation current, allowing the bleeding to be treated along the puncture site of the organ (e.g., the point where the tip pierces the organ) by thermal coagulation of the blood. In some embodiments, the current acts as a cutting element to expand the puncture site of the organ and facilitate the insertion of other devices into the organ through the expanded puncture site. The electrocoagulation enhanced puncture needle 1000 also includes a guide surface 1306f to guide a guide wire or any other guide member through the lumen 1002 to extend out of the outlet 1004 (e.g., guide surface 306, lumen 202 and outlet 304). In some embodiments, the electrocoagulation tip is on the shaft of the needle and can be used to treat bleeding or allow the shaft or needle above the guide wire to be advanced into the tissue or duct.

[0049] Fig.11 A puncture needle 1101 according to various aspects of the present disclosure is shown, which includes a rotatable mechanism for guiding a guide wire to a target portion in an organ. The puncture needle 1101 is longitudinally (along the axis of the channel) housed inside a sheath 1112 (e.g., an external catheter). The puncture needle 1101 is coupled to an internal handle 1106a. The internal handle 1106a is housed inside an external handle 1106b. The external handle 1106b can be coupled to a biopsy channel 1150 via an anchoring mechanism 1115 (e.g., a screw connection for fixing to a mirror body (not shown)). The internal handle 1106a rotates internally relative to the external handle 1106b around a common longitudinal axis. The rotation of the internal handle 1106a causes the rotation of the puncture needle 1101 including the needle tip 1100, the needle shaft 1102, and the outlet 1104. The rotation provides the ability to direct the direction of the guide wire toward a target portion of an organ (e.g., the liver or the duodenum). Note that according to some embodiments, as the needle shaft 1102 rotates about the longitudinal axis, the sheath 1112 remains stationary, thereby reducing friction with external tissue or other endoscope components.

[0050] Fig.12A puncture needle 1200 according to various aspects of the present disclosure is shown, which punctures a target portion 602 (e.g., bile duct obstruction, etc.) of an organ 600 during surgery on a patient 1201. In some embodiments, an imaging system 1260 can be used as an auxiliary tool during surgery. The imaging system can include a radiation source 1250 (e.g., an ultrasound source, a light source, an X-ray source, etc.) that emits radiation scattered from at least a portion of the organ 600 and collected by a radiation detector 1251 (e.g., an ultrasound detector, a light detector, an X-ray detector, etc.). The imaging system 1260 reads signals from the radiation detector 1251 and generates an image of the surgical area in a display 1261. To perform these operations, the imaging system 1260 includes a controller 1262 that performs analog and digital electronic data analysis on the signals provided by the radiation detector 1251. In the image, the surgeon or nurse can have an enhanced and clear view of the puncture needle 1200, the organ 600, and the target portion 602. Thus, the surgeon or nurse can assess the relative position and orientation of the outlet 1214 and the target portion 602. Thus, the surgeon or nurse can actuate the handle 1206 to adjust the position of the puncture needle 1200 in the organ 600.

[0051] In some embodiments, the puncture needle 1200 can include one or more markers 1230-1, 1230-2, 1230-3, and 1230-4 (hereinafter collectively referred to as "markers 1230") disposed adjacent to at least one of the needle tip, outlet 1214, needle housing 1204, needle shaft 1202, or handle 1206. In some embodiments, marker 1230 is configured to scatter ultrasonic radiation, electromagnetic radiation, or any other type of radiation or combination thereof. In some embodiments, marker 1230 can be detectable with a radiation detector 1251.

[0052] Fig.13 FIG. 1 is a diagram showing a target portion 602 and an imaging system 1260 for imaging an organ 600 of a patient 1201 using an imaging system (eg, see FIG. 1 ). Fig.12 ) is a flowchart of the steps in method 1300 for puncturing a target portion of an organ during surgery on a patient. Methods and systems consistent with the present disclosure may include at least one or more of the steps in method 1300 performed in the same or different order. For example, in some embodiments, methods consistent with the present disclosure may include one or more steps in method 1300 performed simultaneously, quasi-simultaneously, or overlapping in time.

[0053] Step 1302 includes placing a needle near an organ that includes a target portion (eg, electrocoagulation enhanced puncture needle 1000 and puncture needle 1200, see Figures 1 to 11The needle includes a needle housing, a needle shaft, a lumen in the needle shaft, an inlet at the proximal end of the needle shaft, a needle tip at the distal end of the needle shaft, and an outlet on the side wall of the needle shaft (e.g., housing 204, cutting tip 300, needle shaft 202, handle 206, locking mechanism 212, inlet 201, outlet 304, lumen 302, and guidewire 400, see Figures 1 to 10 ).

[0054] Step 1304 includes puncturing the organ with the needle tip. In some embodiments, step 1304 includes directing an electric current through the tip to puncture a puncture point in the organ to cause dilation of the puncture point in the organ.

[0055] Step 1306 includes injecting contrast media into the organ through the lumen in the needle shaft.

[0056] Step 1308 includes adjusting a position of the needle in the organ based on the image of the organ, the image including the contrast agent, such that the outlet is directed toward the target portion. In some embodiments, step 1308 includes rotating the needle housing along a longitudinal axis in the needle shaft. In some embodiments, step 1308 includes directing radiation to the organ and collecting scattered radiation from the organ using an imaging system.

[0057] Step 1310 includes inserting a guide wire through the inlet, lumen, and outlet to access the target portion. In some embodiments, step 1310 includes removing the needle housing and needle shaft and guiding the medical device to the target portion via the guide wire. In some embodiments, the target portion is an obstructed duct, and step 1310 includes removing the needle housing and needle shaft and guiding the stent to the obstructed duct via the guide wire. In some embodiments, step 1310 includes directing an electric current through the needle tip to puncture a puncture point in an organ to coagulate bleeding or create a path for passing a larger device or instrument.

[0058] Unless otherwise specified, referring to an element in the singular does not mean one, but one or more. For example, "a" module may refer to one or more modules. Without further constraints, an element beginning with "a", "an", "the" or "said" does not exclude the presence of other identical elements.

[0059] If any, titles and subtitles are used for convenience only and do not limit the present invention. The word "exemplary" is used to indicate use as an example or illustration. To the extent that the terms "including", "having", etc. are used, these terms are intended to be inclusive in a manner similar to the term "comprising", as explained when "comprising" is used as a transition word in the technical solution of the present disclosure. Relational terms such as first and second, etc. can be used to distinguish one entity or action from another entity or action without requiring or implying any actual such relationship or order between these entities or actions.

[0060] Phrases such as on the one hand, this aspect, on the other hand, some aspects, one or more aspects, implementation, this implementation, another implementation, some implementations, one or more implementations, implementation, this implementation, another implementation, some implementations, one or more implementations, configuration, this configuration, another configuration, some configurations, one or more configurations, subject technology, disclosure, the present disclosure, other variations thereof, etc. are for convenience and do not mean that the disclosure associated with such phrases is essential to the subject technology or that such disclosure is applicable to all configurations of the subject technology. The disclosure associated with such phrases may apply to all configurations or one or more configurations. The disclosure associated with such phrases may provide one or more examples. Phrases such as aspect or some aspects may refer to one or more aspects, and vice versa, and the same applies to other aforementioned phrases.

[0061] The phrase "at least one of" preceding a list of items (using the terms "and" or "or" to separate any items) modifies the list as a whole, rather than each member of the list. The phrase "at least one of" does not require selection of at least one item; rather, the phrase allows for a meaning that includes at least one of any one of the items, and / or at least one of any combination of the items, and / or at least one of each of the items. For example, each of the phrases "at least one of A, B, and C" or "at least one of A, B, or C" means only A, only B, or only C; any combination of A, B, and C; and / or at least one of each of A, B, and C.

[0062] In one aspect, the term coupled or similar terms may refer to a direct coupling. In another aspect, the term coupled or similar terms may refer to an indirect coupling.

[0063] Terms such as top, bottom, front, back, side, horizontal, vertical, distal, proximal, etc. refer to an arbitrary reference frame, not the ordinary gravitational reference frame. Thus, such terms may extend upward, downward, diagonally, or horizontally in a gravitational reference frame.

[0064] The present disclosure is provided to enable any person skilled in the art to practice the various aspects described herein. In some cases, well-known structures and components are shown in the form of block diagrams to avoid confusing the concepts of the subject technology. The present disclosure provides various examples of the present technology, and the subject technology is not limited to these examples. Those skilled in the art will readily understand different modifications to these aspects, and the principles described herein can be applied to other aspects.

[0065] All structural and functional equivalents to the elements of the various aspects described throughout this disclosure that are known or later become known to one of ordinary skill in the art are expressly incorporated herein by reference and are intended to be encompassed by the technical solutions of this disclosure.

[0066] Description of implementation methods

[0067] Embodiments disclosed herein include:

[0068] I. A puncture needle including a needle housing is provided. The puncture needle includes a needle shaft having a portion disposed within the needle housing, a lumen within the needle shaft, and an inlet at the proximal end of the needle shaft. The puncture needle also includes a needle tip at the distal end of the needle shaft, and an outlet on a side wall of the needle shaft, wherein the outlet is disposed closer to the distal end of the needle shaft than to the proximal end, and wherein the lumen extends from the inlet to the outlet.

[0069] II. A method for placing a needle near an organ is provided, the organ including a target portion. The needle includes: a needle housing, a needle shaft, a lumen in the needle shaft, an inlet at the proximal end of the needle shaft, a needle tip at the distal end of the needle shaft, and an outlet on the side wall of the needle shaft. The method includes: puncturing the organ with the needle tip, injecting a contrast medium into the organ through the lumen in the needle shaft; adjusting the position of the needle in the organ based on an image of the organ (the image including a contrast agent) so that the outlet points to the target portion, and inserting a guide wire through the inlet, lumen, and outlet to puncture the target portion.

[0070] III. A system is provided, the system including a puncture needle for guiding a guide element to a target portion of an organ. The puncture needle includes a needle housing, a needle shaft having a portion disposed within the needle housing, a lumen within the needle shaft, and an inlet at the proximal end of the needle shaft. The puncture needle also includes a needle tip at the distal end of the needle shaft, and an outlet on a side wall of the needle shaft, wherein the outlet is disposed closer to the distal end of the needle shaft than to the proximal end, and wherein the lumen extends from the inlet to the outlet. The system includes an imaging device for guiding the puncture needle to the vicinity of the organ and puncturing a puncture site in the organ with the needle tip. The imaging device includes a radiation source configured to direct radiation to the organ, a radiation detector configured to detect scattered radiation from the organ, a controller configured to receive a signal from the radiation detector and convert the signal into an image, and a display configured to display an image from the controller to guide the needle to the vicinity of the organ.

[0071] In addition to embodiments I, II, and III, embodiments consistent with the present disclosure may include any one or more of the following elements in any combination.

[0072] Element 1, wherein the needle shaft has a gauge of about 25 or higher. Element 2, further comprising a guide surface configured to guide the guide wire from the lumen through the outlet. Element 3, further comprising a guide wire in the lumen. Element 4, further comprising a second guide wire in the lumen and a second inlet at the proximal end of the needle shaft for receiving the second guide wire. Element 5, further comprising a locking mechanism. Element 6, further comprising a lock for attaching the needle shaft to an endoscope channel of an endoscope. Element 7, wherein the needle shaft is adjustable within the needle housing to allow the needle shaft to move relative to the tip of the endoscope. Element 8, wherein at least one of the needle housing, the needle shaft, or the distal end of the needle shaft is rotatable for changing the direction of extension of the guide wire from the outlet by rotation of the outlet. Element 9, further comprising a sheath arranged around the needle shaft. Element 10, further comprising a locking mechanism configured to lock the needle shaft in position relative to the sheath. Element 11, wherein at least one of the needle housing, the sheath, the needle shaft, or the distal end of the needle shaft is rotatable for changing the direction of extension of the guide wire from the outlet by rotation of the outlet. Element 12, wherein the needle shaft is slidably arranged in the sheath. Element 13, wherein the sheath has a proximal end and a distal end, and wherein the distal end tapers toward the needle tip of the needle shaft. Element 14, further comprising a removable cover for the inlet. Element 15, wherein the inlet is configured to receive a guide wire so as to pass the guide wire through the lumen and the outlet. Element 16, wherein the inlet further comprises an attachment feature for attaching a syringe to provide fluid to the lumen leading to the outlet. Element 17, wherein the lumen forms a guide surface for bending the guide wire within the needle shaft to the outlet. Element 18, further comprising one or more markers arranged adjacent to at least one of the needle tip or the outlet, the one or more markers being detectable with ultrasonic radiation or electromagnetic radiation. Element 19, further comprising one or more markers disposed adjacent to at least one of the needle housing, the needle shaft, or the needle handle, the one or more markers being configured to scatter ultrasonic radiation or electromagnetic radiation.

[0073] Element 20, wherein puncturing an organ with a needle tip further comprises directing an electric current through a puncture point in the organ with the needle tip to dilate the puncture point in the organ. Element 21, wherein adjusting the position of the needle in the organ comprises rotating the needle housing about a longitudinal axis in the needle shaft. Element 22, wherein adjusting the position of the needle in the organ comprises directing radiation to the organ and collecting scattered radiation from the organ with an imaging system. Element 23, further comprising removing the needle housing and the needle shaft and directing a medical device to a target portion via a guidewire. Element 24, wherein the target portion is an obstructed duct, further comprising removing the needle housing and the needle shaft and directing a stent to the obstructed duct via a guidewire. Element 25, further comprising directing an electric current through a puncture point in the organ with the needle tip to electrocoagulate bleeding. Element 26, wherein adjusting the position of the needle in the organ based on an image of the organ comprises receiving ultrasonic radiation or electromagnetic radiation scattered from one or more markers disposed adjacent to at least one of the needle tip or the outlet, and including an image of the needle in an image of the organ using the ultrasonic radiation or electromagnetic radiation. Element 27, wherein adjusting the position of the needle in the organ based on the image of the organ includes receiving ultrasonic radiation or electromagnetic radiation scattered from one or more markers disposed adjacent to at least one of the needle housing, the needle shaft, or the needle handle, and including the image of the needle in the image of the organ based on the ultrasonic radiation or electromagnetic radiation.

[0074] Element 28, wherein the needle shaft has a gauge of about 25 or higher. Element 29, further comprising a guide surface configured to guide a guide wire from the lumen through the outlet. Element 30, further comprising a guide wire in the lumen. Element 31, further comprising a locking mechanism. Element 32, further comprising a lock for attaching the needle shaft to an endoscope channel of an endoscope, wherein the needle shaft is adjustable within the needle housing to allow the needle shaft to move relative to the tip of the endoscope. Element 33, wherein at least one of the needle housing, the needle shaft, or the distal end of the needle shaft is rotatable for changing the direction of extension of the guide wire from the outlet by rotation of the outlet. Element 34, further comprising a sheath disposed about the needle shaft and a locking mechanism configured to lock the needle shaft in position relative to the sheath, wherein at least one of the needle housing, the sheath, the needle shaft, or the distal end of the needle shaft is rotatable to change the direction of extension of the guide wire from the outlet by rotation of the outlet, wherein the needle shaft is slidably disposed within the sheath, and wherein the sheath has a proximal end and a distal end, and wherein the distal end tapers toward the needle tip of the needle shaft. Element 35, further comprising a removable cover for the inlet. Element 36, wherein the inlet is configured to receive a guide wire so as to pass the guide wire through the lumen and the outlet, wherein the inlet further comprises an attachment feature for attaching a syringe so as to provide a fluid into the lumen leading to the outlet, and wherein the lumen forms a guide surface for bending the guide wire within the needle shaft to the outlet. Element 37, wherein the puncture needle also includes one or more markers, which are arranged adjacent to at least one of the needle tip, the outlet, the needle housing, the needle shaft or the needle handle, and the one or more markers are configured to scatter ultrasonic radiation or electromagnetic radiation generated by the radiation source.

[0075] Figures 14 to 21 Depicted Figure 3 to Figure 4 1800. In this embodiment, the needle tip 1800 has a reduced diameter needle tip 1800 near the exit port 1804 to the tip of the needle tip 1800. The reduced diameter allows the guide wire 1810 to bend onto the tip of the needle and smooth edges (except for the guide surface 306) to allow for minimal friction with the guide wire 1810.

[0076] Fig.14 A top view of the distal end of the needle shaft 202 is depicted. The needle tip 1800 has smooth tapered edges 1808 on both sides of the outlet 1804, allowing for a smooth transition of the reduced diameter of the outlet 1804 to the needle tip 1800. Fig.15 A cross section of the needle shaft 202 defining three cross sections A, B and C is depicted. Fig.16 depicts views of the needle shaft 202 taken along sections A and C, and Fig.17 A view of the needle shaft 202 taken along section B is depicted. Fig.16As shown, a smooth tapered edge 1808 forms a smooth transition from the distal end of the needle shaft 202 to the needle tip 1800 near the outlet 1804 .

[0077] Fig.17 The path of the guidewire 1810 through the lumen 1806 and out of the outlet 1804 is depicted. As shown, the needle tip 1800 has a reduced diameter d to accommodate the guidewire 1810 adjacent to the needle tip 1800 when in use. The difference between the diameter d of the needle shaft 202 and the radius r of the outlet 1804 preferably satisfies the condition rd ≥ the thickness t of the guidewire 1810. The thickness difference between r and d can vary depending on the intended use of the needle shaft 202.

[0078] Fig.18 Depicted Fig.17 1804, with guidewire 1810 passing through lumen 1806 and out of outlet 1804. As shown, all edges 1, 2, and 3 surrounding outlet 1804 are rounded and smooth, allowing for minimal friction with guidewire 1810. This allows guidewire 1810 to travel through the sides of introducer needle 200 to allow introducer needle 200 to be withdrawn from the tract without turning or creating significant friction that interferes with needle withdrawal, and prevents guidewire 1810 of the anchor from entering the tract.

[0079] The depression caused by the reduced diameter d on the top and / or sides of needle tip 1800 allows guidewire 1810 to travel along the sides of introducer needle 200 without creating significant friction. Figures 19 to 21 Describes the Fig.18 1, 2 and 3. As shown, all edges in the cross section have smooth rounded surfaces so that the guide wire 1810 will not get stuck or cause unnecessary friction.

[0080] Figure 22 to Figure 25 Depicted Figure 3 to Figure 4 Another alternative embodiment of the distal end of the needle shaft 202 is depicted in FIG. Figures 14 to 21 , the needle tip 2200 has a reduced diameter needle tip 2200 near the outlet 2204 to the tip of the needle tip 2200. The reduced diameter allows the guide wire 2209 to bend onto the tip of the needle and smooth edges (except for the guide surface 306) to allow for minimal friction with the guide wire 2209. Figures 22 to 33 The dimensions depicted in the drawings are for a particular embodiment of the puncture needle and are not meant to be limiting. It should be clear to one of ordinary skill in the art that any dimensions depicted in these drawings can be modified according to different patient geometries or uses of the puncture needle.

[0081] Fig. 22 A perspective view of the distal end of the needle shaft 202 is depicted, and Fig.23A top view of the distal end of the needle shaft 202 is depicted. The needle tip 2200 has a plurality of inclined or curved guide surfaces 306 to reduce friction and obstruction with the guide wire 2209. In this embodiment, the needle tip 2200, the outlet 2204 and the needle shaft 202 are all formed as a unitary piece, wherein the outlet 2204 has an overall elliptical or oblong shape formed by an opening in the needle shaft 202. From near the end of the outlet 2204 to the needle tip 2200, the sidewalls of the needle shaft 202 taper uniformly on both sides to form the needle tip 2200. For better mechanical properties, the needle tip 2200, the outlet 2204 and the needle shaft 202 are preferably formed of nitinol (NiTi). Nitinol has good flexibility, superelasticity and shape memory.

[0082] In this embodiment, the guide surface 306 is preferably formed of ultraviolet light curing glue (UV glue) or epoxy AB glue as a ramp 2206 leading to the needle shaft 202. This avoids having to form the guide surface from a single piece or by welding, which may be difficult due to the required precision. The ramp 2206 can be prefabricated and adhered to the needle shaft 202, or it can be directly formed in the needle shaft 202 and then cured using UV light as known in the art.

[0083] The bottom of the ramp 2206 has a circular shape that matches the radius of curvature of the needle shaft 202. The top surface of the ramp 2206 is generally formed by a protruding surface 2208, a transition surface 2210, and an angled surface 2214. The protruding surface 2208 has one end of a U shape that slopes upward toward the transition surface 2210. The protruding surface 2208 and the transition surface 2210 are combined to serve as a guide surface 306. After the generally planar transition surface 2210, the ramp 2206 transitions to two inclined surfaces 2214 that eventually taper to the needle tip 2200, as shown in FIG. Fig. 22 and Fig.23 shown.

[0084] Fig.24 and Fig.25 A cross section of the needle shaft 202 is shown showing the geometry of the ramp 2206 and the reduced diameter outlet 2204 near the outlet 2204. The overall geometry of the needle shaft 202 combined with the ramp 2206 provides a guidewire 2209 with an exit angle of approximately 10° to the outlet 2204. The needle is preferably 19G with an outer diameter of 1.1×inner diameter 0.9. Other outer sizes can be used, such as 18G, 22G, 25G, etc. When using a 19G needle, the preferred guidewire diameter is 0.63mm. The angle between the guide wire 2209 and the needle shaft 202 ranges from 5° to 80°, preferably from 10° to 45°, and more preferably from 10° to 20°. The corners around the outlet 2204 and on the ramp 2206 are preferably beveled or rounded (preferably R0.09 on the inside and R0.01 on the outside) to prevent scratching of the guide wire skin (PTFE membrane or sheath) when the guide wire 2209 is pushed or pulled.

[0085] Figure 26 to Figure 28 Needle tip 2200 is depicted for use in conjunction with a J-shaped guidewire (pre-bent guidewire) 2209. Preferably, the J-shaped guidewire is pre-bent within an angle range of 45°-270°, more preferably 180°±30°. When a straight guidewire is used, the angle range of the access function is limited to 0°-10°. Fig.28 As shown, using a J-type guidewire 2209 increases the range of the puncture function to 0°-35°.

[0086] In some embodiments, in addition to outlet port 2204, introducer needle 2200 may include side port 2216. Side port 2216 may be in contact with guidewire 2209 in the same lumen or in contact with a second separate lumen that traverses needle shaft 202 from an entrance near the handle of introducer needle 2200 to outlet port 2200 (or anywhere along needle shaft 202) near outlet port 2204. Side port 2216 may be utilized if contrast injection or flushing is desired.

[0087] Figure 29 to Figure 30 An alternative embodiment of a puncture needle 2900 is depicted. In this embodiment, the ramp 2902 is preferably formed of stainless steel, such as SUS304 (JIS / Japanese Standard), which is distinguished from the needle shaft 202, which is preferably formed of stainless steel (SUS304) or NiTi. For example, the needle shaft 202 can be coupled to the ramp 2902 by laser welding. Fig.29 As depicted in FIG. 29 , the exit angle of guidewire 2904 is preferably 10°-20°. Fig.30 Depicted is a method for use with a pre-curved guidewire 2904 (eg, J-shaped). Fig.29 The puncture needle is 2900.

[0088] Figure 31 to Figure 35An alternative embodiment of a puncture needle 3100 having a needle tip 2200 is depicted. The puncture needle 3100 generally includes a ramp 3102, a sheath 3104, a mirror connector 3106, a sheath indicator 3108, a sheath lock 3110, a lower handle 3112, a needle indicator 3114, a needle lock 3116, an upper handle 3118, a fixed housing 3120, a rotating spindle 3122, a housing cap 3124, an O-ring 3126, and a rotatable proximal connector 3128. The puncture needle 3100 can be manipulated by pushing the button of the sheath lock 3110 and moving the lower handle 3112 to adjust the length of the sheath 3104. Push the button of the needle lock 3116 to move a distance equal to the length of the currently extended needle. By moving the upper handle 3118 back and forth, the puncture needle 3100 moves out of the sheath 3104 and punctures into the tissue. A guidewire (e.g., 0.63 mm) is placed in rotatable proximal connector 3128 and passed through the lumen of introducer needle 3100 until it protrudes at about 10°-80° at ramp 3104. Rotation of rotatable proximal connector 3128 controls rotation of introducer needle 3100, allowing proper placement of the guidewire.

[0089] Fig.31 The coupling between the fixed housing 3120 and the upper handle 3118 is depicted. The housing cover 3124 is welded to the fixed housing 3120. The rotating mandrel 3122 is laser welded to the puncture needle 3100 and the rotatable proximal connector 3128. By rotating the rotatable proximal connector 3128, the rotating mandrel 3122 (together with the puncture needle 2900) rotates inside the fixed housing 3120. Fig.35 As shown, two O-rings 3126 prevent needle leakage under high pressure. The rotatable proximal connector 3128 preferably includes a plurality of radial angle markings to indicate the rotation angle, such as Fig.34 shown.

[0090] The title, background, brief description of the drawings and the drawings are hereby incorporated into the present disclosure and are provided as illustrative examples of the present disclosure, rather than as limiting descriptions. They are submitted with the understanding that they are not used to limit the scope or meaning of the technical solutions of the present disclosure. In addition, in the detailed description, it can be seen that the description provides illustrative examples, and for the purpose of streamlining the present disclosure, various features are grouped together in various embodiments.

Claims

1. A puncture needle, characterized in that: include: needle housing; a needle shaft having a portion disposed within the needle housing; a lumen within the needle shaft; an inlet port at a proximal end of the needle shaft; a needle tip at the distal end of the needle shaft; an outlet port on a side wall of the needle shaft, wherein the outlet port is disposed closer to the distal end of the needle shaft than to the proximal end, and wherein the lumen extends from the inlet port to the outlet port; and a ramp arranged in said outlet, Wherein, the ramp is coupled to the interior of the needle shaft.

2. The puncture needle according to claim 1, characterized in that: The slope is formed of ultraviolet (UV) glue, and Wherein, the distal end of the needle shaft is formed of nitinol.

3. The puncture needle according to claim 1, characterized in that: The ramp is formed from epoxy resin.

4. The puncture needle according to claim 1, characterized in that: The slope includes: A first inclined surface is inclined upward from the bottom of the needle shaft toward the outlet.

5. The puncture needle according to claim 4, characterized in that: The first inclined surface is at an angle of approximately 10°-45° to a central longitudinal axis of the needle shaft.

6. The puncture needle according to claim 1, characterized in that: The ramp is formed of stainless steel, and Wherein, the distal end of the needle shaft is formed of nitinol.

7. The puncture needle according to claim 1, characterized in that: The radius of curvature of the bottom of the ramp matches the radius of curvature of the interior of the needle shaft.

8. The puncture needle according to claim 1, characterized in that: The height of the needle shaft is higher than the height of the slope by a predetermined distance.

9. The puncture needle according to claim 1, characterized in that: The ramp includes a plurality of smooth inclined guide surfaces for preventing obstruction of the guide wire.

10. The puncture needle according to claim 1, characterized in that: The first portion of the outlet is formed by a U-shaped cutout in the top of the needle shaft, and Wherein, the second portion of the outlet is formed by an end of the inclined surface of the ramp.

11. The puncture needle according to claim 1, characterized in that: The slope includes: a first inclined surface that is inclined upward from the bottom of the needle shaft toward the outlet; a second flat surface adjoining the first inclined surface near the outlet; A third inclined surface is inclined downward from the second flat surface toward the needle tip.

12. The puncture needle according to claim 1, characterized in that: The ramp is coupled to the needle shaft via gluing.

13. The puncture needle according to claim 1, characterized in that: The ramp is coupled to the needle shaft via laser welding.

14. The puncture needle according to claim 1, characterized in that: The slope is molded by UV glue.

15. The puncture needle according to claim 14, characterized in that: The ramp is coupled to the needle shaft using UV glue.

16. The puncture needle according to claim 1, characterized in that: The length of the outlet is greater than the height of the ramp.

17. The puncture needle according to claim 1, characterized in that: The height of the first end of the outlet is greater than the height of the second end of the outlet.

18. A puncture needle, characterized in that: include: a handle having a rotatable connector coupled thereto; a needle housing coupled to the handle; a needle shaft having a portion disposed within the needle housing; a lumen within the needle shaft; an inlet port at a proximal end of the needle shaft; a needle tip at the distal end of the needle shaft; an outlet port on a side wall of the needle shaft, wherein the outlet port is disposed closer to the distal end of the needle shaft than to the proximal end, and wherein the lumen extends from the inlet port to the outlet port; and a ramp arranged in said outlet, wherein the ramp is coupled to the interior of the needle shaft, and wherein rotation of the rotatable connector causes rotation of the needle tip without causing rotation of the needle housing.

19. The puncture needle according to claim 18, characterized in that: The rotatable connector includes a plurality of radial markers for identifying a rotation angle of the rotatable connector.

Images