阅读说明：本技术 包括部件的针道辅助装置及其方法 (Needle track assist device including components and method thereof ) 是由 易鹏 孙晓文 贺志秀 N·谢 于 2019-05-24 设计创作，主要内容包括：一种用于建立预定长度的针道的针道辅助装置(100,200),其包括针推进器(110,210)和可移除地装载在针推进器(110,210)中的导管内针组件(130、230)。针推进器(110,210)可包括托架(112,212)、托架(112,212)内的滑架(114,214)、和联接到滑架(114,214)的柱塞(116,216)。滑架(114,214)可以被构造为在托架(112,212)的近端部分和远端部分之间移动。柱塞(116,216)可以被构造为在托架(112,212)内移动滑架(114,214)。柱塞(116,216)还可被构造为允许用户在建立针道之前设定针道的预定长度。导管内针组件(130,230)可包括座部(132,232)、从座部(132,232)的远端部分延伸的导管管子(134,234)、和设置在导管管子(134,234)内的针(137,237)。还描述了针道辅助装置(100、200)的部件和针道辅助装置(100、200)或其部件的方法。(A needle track assist device (100, 200) for establishing a needle track of a predetermined length includes a needle pusher (110, 210) and an intraluminal needle assembly (130, 230) removably loaded in the needle pusher (110, 210). The needle pusher (110, 210) may include a carriage (112, 212), a carriage (114, 214) within the carriage (112, 212), and a plunger (116, 216) coupled to the carriage (114, 214). The carriage (114, 214) may be configured to move between the proximal and distal portions of the cradle (112, 212). The plunger (116, 216) may be configured to move the carriage (114, 214) within the cradle (112, 212). The plunger (116, 216) may also be configured to allow a user to set a predetermined length of the needle track prior to establishing the needle track. An intracatheter needle assembly (130, 230) may include a seat (132, 232), a catheter tube (134, 234) extending from a distal portion of the seat (132, 232), and a needle (137, 237) disposed within the catheter tube (134, 234). Components of the needle track assistance device (100, 200) and methods of the needle track assistance device (100, 200) or components thereof are also described.)

1. A needle track assist device for establishing a needle track of a predetermined length, the needle track assist device comprising:

a needle pusher, the needle pusher comprising:

a bracket;

a carriage within the cradle, the carriage configured to move between proximal and distal end portions of the cradle; and

a plunger coupled to the carriage, the plunger configured to move the carriage within the carriage and allow a user to set a predetermined length of the needle track prior to establishing the needle track; and

an intravascular needle assembly, comprising:

a seat portion;

a catheter tube extending from a distal portion of the seat; and

a needle disposed within the catheter tube, the intra-catheter needle assembly being removably loaded in the carriage of the needle pusher.

2. The needle track assist device of claim 1, wherein the carrier of the needle pusher includes a longitudinal opening between proximal and distal portions of the carrier, the longitudinal opening configured to allow the catheter needle assembly to be removed from the needle pusher through the longitudinal opening.

3. The needle track assist device of claim 1 or 2, wherein the carriage of the needle pusher includes a proximal opening at a proximal end of the carriage through which the plunger extends and a distal opening at a distal end of the carriage through which the catheter tube and the needle extend when the catheter needle assembly is disposed in the needle pusher.

4. The needle track assist device as in any one of claims 1-3, wherein the carriage of the needle pusher comprises a longitudinal guide track extending along an interior surface of the carriage, the longitudinal guide track configured to guide movement of the plunger, the carriage, or both the plunger and the carriage within the carriage.

5. The needle track assist device of claim 4, wherein the plunger of the needle pusher includes a longitudinal channel extending along an outer surface of the plunger, the longitudinal channel configured to receive the longitudinal rail of the carriage.

6. The needle track assist device according to any one of claims 1-3, wherein the carriage of the needle pusher comprises a helical guide track spiraling around an inner surface of the carriage, the helical guide track configured to guide movement of the plunger, the carriage, or both the plunger and the carriage within the carriage and control linear velocity thereof.

7. The needle track assist device of claim 6, wherein the carriage of the needle pusher comprises a helical channel spiraling around an outer surface of the plunger, the helical channel configured to receive a helical track of the carriage.

8. The needle tract assistance device of any one of claims 1-7, wherein the carriage of the needle pusher comprises an unloading mechanism for unloading the intraductal needle assembly from the carriage.

9. The needle track assist device of claim 8, wherein the unloading mechanism includes a compression spring loaded rod shaped to form a proximal portion of a receiver in the carriage, the receiver configured to receive the seat of the catheter inner needle assembly, the rod configured to compress the spring of the unloading mechanism when the rod is pressed toward the carriage, thereby assuming the spring force of the spring of the unloading mechanism, increasing the length of the receiver, and allowing the seat of the catheter inner needle assembly to be removed from the receiver.

10. The needle track assist device of claim 9, wherein the seat of the intraductal needle assembly comprises a loading mechanism for loading the intraductal needle assembly in the carriage.

11. The needle track assist device of claim 10, wherein the loading mechanism comprises a compression spring loaded proximal cap of the seat of the intra-catheter needle assembly, the proximal cap configured to move toward the distal end portion of the seat and compress a spring of the loading mechanism when loading the seat in the receiver of the carriage, thereby allowing a spring force exerted by the spring of the loading mechanism to retain the seat in the receiver of the carriage.

12. The needle tract assistance device of any one of claims 1-11, wherein the seat of the catheter inner needle assembly includes an internal chamber in a proximal end portion of the seat, to which the port of the seat and one or more microcavities extending longitudinally through the catheter tube are fluidly connected.

13. The needle track assist device of claim 12, wherein the needle of the intraductal needle assembly extends through the interior chamber of the seat without fluid connection therewith.

14. The needle track assist device of claim 12 or 13, wherein a distal end of said needle of said catheter inner needle assembly extends distally beyond a distal end of said catheter tube of said catheter inner needle assembly, a distal portion of said catheter tube including said distal end of said catheter tube having a tapered distal tip comprising one or more openings corresponding to said one or more microcavities of said catheter tube.

15. An intravascular needle assembly for establishing a needle track, the intravascular needle assembly comprising:

a seat portion;

a double-walled conduit tube extending from a distal portion of the seat, the conduit tube comprising an outer wall and an inner wall; and

a needle disposed within the catheter tube, the needle secured to a compression spring loaded proximal cap of the seat.

16. The catheter introducer needle assembly of claim 15, wherein the needle is disposed within a needle lumen extending longitudinally through the catheter tube, the needle lumen defined by an inner surface of the inner wall of the catheter tube.

17. The catheter stylet assembly of claim 15 or 16, wherein the catheter tube comprises one or more microcavities extending longitudinally through the catheter tube, each of the one or more microcavities defined by an inner surface of the outer wall of the catheter tube, an outer surface of the inner wall of the catheter tube, and one or more struts extending longitudinally through the catheter tube between the outer wall and the inner wall of the catheter tube.

18. The catheter introducer needle assembly of claim 17, wherein the seat includes an internal chamber in a proximal portion of the seat, the port of the seat and the one or more microcavities being fluidly connected to the internal chamber.

19. The catheter introducer needle assembly of claim 18, wherein the needle extends through the interior chamber of the seat without fluidly connecting with the interior chamber.

20. The endocatheter needle assembly of any one of claims 17-19, wherein a distal end of the needle extends distally beyond a distal end of the catheter tube, a distal end portion of the catheter tube including the distal end of the catheter tube having a tapered distal tip including one or more openings corresponding to the one or more microcavities of the catheter tube.

21. The intravascular needle assembly of any one of claims 15-20, wherein the seat comprises a loading mechanism for loading the intravascular needle assembly in a carriage of a needle pusher, the loading mechanism comprising the proximal end cap of the seat, the proximal end cap being configured to move toward the distal end portion of the seat and compress a spring of the loading mechanism upon loading the seat into a receiver of the carriage, thereby allowing a spring force exerted by the spring of the loading mechanism to retain the seat in the receiver of the carriage.

22. The endocatheter needle assembly of any one of claims 15-21, wherein the seat includes a longitudinal handle extending therefrom between proximal and distal end portions of the seat.

23. A method of establishing a needle track of a predetermined length with a needle track assist device, the method comprising:

inserting an intra-catheter needle assembly into a stiffening sleeve disposed in an introducer sheath located in a hepatic vein, the intra-catheter needle assembly comprising a needle having a distal end extending beyond a distal end of a catheter tube surrounding the needle;

moving a plunger of a needle pusher to position a carriage coupled to the plunger within a cradle of the needle pusher for establishing the predetermined length of needle track;

loading a seat of the catheter inner needle assembly into the carriage of the needle pusher; and

pushing the plunger of the needle pusher toward the distal end of the needle pusher to push the needle and catheter of the intra-catheter needle assembly through the hepatic parenchyma and into the portal vein to form the needle tract of the predetermined length.

24. The method of claim 23, further comprising:

determining the length of the needle track of the predetermined length by radiography before positioning the carriage of the needle pusher in position within the carriage to establish the needle track of the predetermined length.

25. The method of claim 23 or 24, further comprising:

radiographically confirming the length of the needle track after forming the predetermined length of the needle track by counting the number of evenly spaced radiopaque rings on the catheter tube of the intra-catheter needle assembly.

Background

In a healthy person, blood flowing from the stomach, esophagus or intestine first flows through the liver. In unhealthy persons, for example, with damaged liver, there may be a blood flow restriction blockage in the liver such that blood cannot flow easily therethrough. This condition is known as portal hypertension. Common causes of portal hypertension include alcohol abuse, excessive iron in the liver (e.g., hemochromatosis), hepatitis b, hepatitis c, or the presence of blood clots in the veins leading from the liver to the heart. When portal hypertension occurs, the blood flow restriction obstruction raises the pressure within the portal vein, causing it to rupture and severely bleed. Persons with portal hypertension may also have venous bleeding of the stomach, esophagus or intestine (e.g., variceal bleeding), abdominal fluid accumulation (e.g., ascites) or thoracic fluid accumulation (e.g., pleural fluid).

Portal hypertension is typically treated by percutaneous surgery, which involves placing a transjugular intrahepatic portal shunt ("TIPS"), as shown in fig. 13, between the hepatic and portal veins to establish blood flow through the liver. It is generally preferred to place a portal shunt between the right hepatic vein and the right portal vein. A typical procedure for placement of a portal shunt according to the foregoing involves placing an introducer sheath over the distal portion of the right hepatic vein, and then advancing a stiffening sleeve, optionally as part of an inner cannula assembly of the catheter, through the introducer sheath to the distal portion of the right hepatic vein. The intra-catheter needle assembly is then inserted into the reinforcing sleeve, which wedges against the right hepatic vein wall, pushing the intra-catheter needle assembly through the hepatic parenchyma into the right portal vein with a single needle throw. However, such needle throwing is performed blindly. Therefore, there is a risk of exceeding the portal vein in such surgery, which may lead to complications, prolonged surgery time, reduced success rate, and the like.

A needle track assist device including components and methods thereof that address at least the foregoing disadvantages are disclosed herein.

Disclosure of Invention

A needle track assist device for establishing a needle track of a predetermined length is disclosed. In some embodiments, the needle track assist device includes a needle pusher and an in-catheter needle assembly removably loaded in the needle pusher. The needle pusher includes a carriage, a carriage within the carriage, and a plunger coupled to the carriage. The carriage is configured to move between the proximal and distal end portions of the carriage. The plunger is configured to move the carriage within the carriage. The plunger is further configured to allow a user to set a predetermined length of the needle track prior to establishing the needle track. The catheter hub assembly includes a hub, a catheter tube extending from a distal portion of the hub, and a needle disposed within the catheter tube.

In some embodiments, the carrier of the needle pusher includes a longitudinal opening between the proximal and distal portions of the carrier. The longitudinal opening is configured to allow removal of the catheter inner needle assembly from the needle pusher through the opening.

In some embodiments, the carrier of the needle pusher includes a proximal opening at a proximal end of the carrier and a distal opening at a distal end of the carrier. The plunger extends through the proximal opening of the bracket. When the catheter inner needle assembly is disposed in the needle pusher, the catheter tube and the needle extend through the distal opening of the carrier.

In some embodiments, the carriage of the needle pusher includes a longitudinal rail extending along an inner surface of the carriage. The longitudinal rail is configured to guide movement of the plunger, the carriage, or both the plunger and the carriage within the carriage.

In some embodiments, the plunger of the needle pusher includes a longitudinal channel extending along an outer surface of the plunger. The longitudinal channel is configured to receive a longitudinal rail of the carriage.

In some embodiments, the carriage of the needle pusher includes a helical track spiraling around an inner surface of the carriage. The helical guide is configured to guide movement of the plunger, the carriage, or both the plunger and the carriage within the carriage. The helical guide is also configured to control the linear velocity of the plunger, the carriage, or both the plunger and the carriage within the carriage.

In some embodiments, the carrier of the needle pusher includes a helical channel spiraling around the outer surface of the plunger. The helical channel is configured to receive a helical guide of the carriage.

In some embodiments, the carriage of the needle pusher includes an unloading mechanism for unloading the in-catheter needle assembly from the carriage.

In some embodiments, the unloading mechanism includes a compression spring loaded rod shaped to form a proximal portion of the receiver in the carriage. The receiver is configured to receive a seat of a needle assembly within a catheter. The lever is configured to compress the spring of the unloading mechanism when the lever is pressed toward the carriage. By pressing the rod towards the carrier, the rod bears the force of the unloading mechanism spring and increases the length of the receptacle, which allows the seat of the needle assembly in the catheter to be removed from the receptacle.

In some embodiments, the seat of the intravascular needle assembly comprises a loading mechanism for loading the intravascular needle assembly in the carriage.

In some embodiments, the loading mechanism comprises a compression spring loaded proximal cap of the seat of the catheter inner needle assembly. The proximal cap is configured to move toward the distal portion of the seat and compress the spring of the loading mechanism when loading the seat into the receiver of the carriage. The seat is held in the receiver of the carriage by the spring force exerted by the loading mechanism spring.

In some embodiments, the seat of the catheter inner needle assembly includes an internal chamber in a proximal portion of the seat. The port of the seat portion and one or more microcavities extending longitudinally through the catheter tube are fluidly connected to the inner chamber.

In some embodiments, the needle of the catheter inner needle assembly extends through the interior chamber of the seat without being fluidly connected thereto.

In some embodiments, the distal end of the needle of the intra-catheter needle assembly extends distally beyond the distal end of the catheter tube of the intra-catheter needle assembly. A distal portion of the catheter tube, including the distal end of the catheter tube, has a tapered distal tip that includes one or more openings corresponding to the one or more microcavities of the catheter tube.

An intravascular needle assembly for establishing a needle track is also disclosed. The catheter hub assembly includes a hub, a catheter tube extending from a distal portion of the hub, and a needle disposed within the catheter tube. The conduit pipe is a double-walled conduit pipe comprising an outer wall and an inner wall. The needle is fixed to a compression spring loaded proximal end cap of the seat.

In some embodiments, the needle is disposed within a needle lumen extending longitudinally through the catheter tube. The needle lumen is defined by the inner surface of the inner wall of the catheter tube.

In some embodiments, the catheter tube includes one or more microcavities extending longitudinally through the catheter tube. Each of the one or more microcavities is defined by an inner surface of the outer wall of the catheter tube, an outer surface of the inner wall of the catheter tube, and one or more struts extending longitudinally through the catheter tube between the outer wall and the inner wall of the catheter tube.

In some embodiments, the seat includes an interior chamber in a proximal end portion of the seat. The port of the seat and the one or more microcavities are fluidly connected to the inner chamber.

In some embodiments, the needle extends through but is not fluidly connected with the internal chamber of the seat.

In some embodiments, the distal end of the needle extends distally beyond the distal end of the catheter tube. A distal portion of the catheter tube, including the distal end of the catheter tube, has a tapered distal tip that includes one or more openings corresponding to the one or more microcavities of the catheter tube.

In some embodiments, the seat includes a loading mechanism including a proximal cap of the seat for loading the intraductal needle assembly into a carriage of the needle pusher. The proximal cap is configured to move toward the distal portion of the seat and compress the spring of the loading mechanism when loading the seat into the receiver of the carriage. The seat is held in the receiver of the carriage by the spring force exerted by the loading mechanism spring.

In some embodiments, the seat includes a longitudinal handle extending from the seat between the proximal end portion and the distal end portion of the seat.

A method of establishing a needle track of a predetermined length using a needle track assist device is also disclosed. In some embodiments, the method comprises: inserting an intra-catheter needle assembly into a stiffening sleeve disposed in an introducer sheath located in a hepatic vein, the intra-catheter needle assembly including a needle having a distal end extending beyond a distal end of a catheter surrounding the needle; moving a plunger of the needle pusher to set a carriage coupled to the plunger in position within a carriage of the needle pusher for establishing a needle track of a predetermined length; loading a seat of an in-catheter needle assembly into a carriage of a needle pusher; the plunger of the needle pusher is advanced toward the distal end of the needle pusher to push the intraluminal needle assembly through the hepatic parenchyma and into the portal vein to form a needle tract of a predetermined length.

In some embodiments, the method further comprises determining the length for the predetermined length of the needle track by radiography prior to positioning the carriage of the needle pusher in position within the carriage to establish the predetermined length of the needle track.

In some embodiments, the method further comprises, after forming the needle track of the predetermined length, radiographically confirming the length of the needle track by counting the number of radiopaque rings evenly spaced on the catheter of the intra-catheter needle assembly.

These and other features of the concepts provided herein will become more readily apparent to those skilled in the art from the following description and drawings that disclose, in greater detail, specific embodiments of these concepts.

Drawings

Fig. 1 illustrates a first view of a first needle assist device according to some embodiments.

Fig. 2 illustrates a second view of a first needle assist device according to some embodiments.

Fig. 3 illustrates a third view of a first needle assist device according to some embodiments.

Fig. 4 illustrates a first view of a second needle track assist device according to some embodiments.

Fig. 5 illustrates a second view of a second needle track assist device according to some embodiments.

Fig. 6 illustrates a third view of a second needle track assist device according to some embodiments.

Fig. 7 illustrates a cross-section of a first needle tract aid or a second needle tract aid according to some embodiments.

Fig. 8 illustrates a first view of a distal portion of a needle disposed in a catheter tube, in accordance with some embodiments.

Fig. 9 illustrates a second view of a distal portion of a needle disposed in a catheter tube, in accordance with some embodiments.

Fig. 10 illustrates a first view of a longitudinal cross-section of a first needle assist device according to some embodiments.

Fig. 11 illustrates a second view of a longitudinal cross-section of a first needle assist device according to some embodiments.

Fig. 12 illustrates a catheter advancement mechanism of a seat of an intravascular needle assembly according to some embodiments.

Fig. 13 illustrates a process involving placement of TIPS between the hepatic and portal veins, according to some embodiments.

Detailed Description

Before some particular embodiments are disclosed in greater detail, it should be understood that the particular embodiments disclosed herein do not limit the scope of the concepts presented herein. It should also be understood that particular embodiments disclosed herein may have features that can be readily separated from the particular embodiments and optionally combined with or substituted for the features of any of the various other embodiments disclosed herein.

With respect to the terminology used herein, it is also to be understood that these terminology is used for the purpose of describing some particular embodiments, and that these terminology is not intended to limit the scope of the concepts provided herein. Ordinals (e.g., first, second, third, etc.) are generally used to distinguish or identify different features or steps in a set of features or steps, and do not provide sequence or numerical limitations. For example, "first," "second," and "third" features or steps need not necessarily occur in that order, and particular embodiments that include such features or steps need not necessarily be limited to these three features or steps. Labels such as "left", "right", "top", "bottom", "front", "back", and the like are used for convenience and do not imply any particular fixed position, orientation, or direction, for example. Rather, such tags are used to reflect, for example, relative position, orientation, or direction. The singular forms "a", "an" and "the" include plural references unless the context clearly dictates otherwise.

Reference to "proximal", "proximal portion" or "proximal end portion" of a catheter, such as disclosed herein, includes the portion of the catheter intended to be near the clinician when the catheter is used with a patient. Also, for example, a "proximal length" of a catheter includes a length of the catheter that is intended to be near the clinician when the catheter is used on a patient. For example, the "proximal end" of a catheter includes the end of the catheter that is intended to be near the clinician when the catheter is used on a patient. The proximal portion, proximal end portion, or proximal length of the catheter may comprise the proximal end of the catheter; however, the proximal portion, or proximal length of the catheter need not include the proximal end of the catheter. That is, unless the context indicates otherwise, the proximal portion, or proximal length of the catheter is not the distal portion or end length of the catheter.

Reference to a "distal" portion or "distal portion" of a catheter as disclosed herein includes portions of the catheter that are intended to be near or within a patient when the catheter is used with the patient. Also, for example, a "distal length" of a catheter includes a length of the catheter that is intended to be near or within a patient when the catheter is used with the patient. For example, the "distal end" of a catheter includes the end of the catheter that is intended to be near or within a patient when the catheter is used with the patient. The distal portion, or distal length of the catheter may comprise the distal end of the catheter; however, the distal portion, or distal length of the catheter need not include the distal end of the catheter. That is, unless the context indicates otherwise, the distal portion, or distal length of the catheter is not the tip portion or end length of the catheter.

Unless defined otherwise, all technical and scientific terms used herein have the same meaning as commonly understood by one of ordinary skill in the art.

As noted above, portal hypertension is typically treated by percutaneous surgery, which involves placing TIPS between the hepatic and portal veins, as shown in FIG. 13, to establish blood flow through the liver. It is generally preferred to place a portal shunt between the right hepatic vein and the right portal vein. A typical procedure for placement of a portal shunt according to the foregoing involves placing an introducer sheath over the distal portion of the right hepatic vein, and then advancing a stiffening sleeve, optionally as part of an inner cannula assembly of the catheter, through the introducer sheath to the distal portion of the right hepatic vein. The intra-catheter needle assembly is then inserted into the reinforcing sleeve, which wedges against the right hepatic vein wall, pushing the intra-catheter needle assembly through the hepatic parenchyma and into the right portal vein with a single needle throw. However, such needle throwing is performed blindly. Therefore, there is a risk of exceeding the portal vein in such surgery, which may lead to complications, prolonged surgery time, reduced success rate, and the like.

A needle track assist device including components and methods thereof that address at least the foregoing disadvantages are disclosed herein.

Fig. 1-3 illustrate different views of a first needle assist device 100 according to some embodiments. Fig. 4-6 illustrate different views of a second needle tract assistance device 200 according to some embodiments. Fig. 7 illustrates a cross-section of the first needle tract aid 100 or the second needle tract aid 200 according to some embodiments. Fig. 10 and 11 illustrate different views of a longitudinal cross-section of a first needle assist device 100 according to some embodiments. Fig. 12 illustrates a catheter advancement mechanism of the seat 132 of the intracatheter needle assembly 130 or 230 according to some embodiments.

The needle track assist device 100 or 200 includes a needle pusher 110 or 210 and an intra-catheter needle assembly 130 or 230 removably loaded in the needle pusher 110 or 210.

Starting with the needle pusher 110 or 210, the needle pusher 110 includes a carriage 112 or 212, a carriage 114 or 214 movably disposed within the carriage 112 or 212, and a plunger 116 or 216 coupled to the carriage 114 or 214. Each of the carriage 112 or 212, the carriage 114 or 214, and the plunger 116 or 216 will now be described.

The carrier 112 or 212 of the needle pusher 110 or 210 includes a longitudinal opening between proximal and distal portions of the carrier 112 or 212. The longitudinal opening is configured to allow the intraluminal needle assembly 130 or 230 to be inserted into or removed from the needle pusher 110 or 210 through the opening.

The carrier 112 or 212 of the needle pusher 110 or 210 includes a proximal opening at a proximal end of the carrier 112 or 212 and a distal opening at a distal end of the carrier 112 or 212. The plunger 116 or 216 extends through the proximal opening of the bracket 112 or 212. When the intraductal needle assembly 130 or 230 is disposed in the needle pusher 110 or 210, the catheter tube 134 or 234 and the needle 137 or 237 extend through the distal opening of the carrier 112 or 212. Although each needle pusher configuration of the needle pushers 110 and 210 is different, the distal opening at the distal end of the carrier 112 or 212 has a smaller dimension (e.g., diameter, width, etc.) than the distal end of the intraductal needle assembly 130 or 230, thereby providing a stop for the intraductal needle assembly 130 or 230.

The carrier 112 of the needle pusher 110 includes a longitudinal rail 118 extending along an inner surface of the carrier 112. Longitudinal rails 118 are configured to guide the movement of plunger 116, carriage 114, or both plunger 116 and carriage 114 within carriage 112. In contrast, the carrier 212 of the needle pusher 210 includes a helical track 218 that spirals around the inner surface of the carrier 212. The helical guide 218 is configured to guide the movement of the plunger 216, the carriage 214, or both the plunger 216 and the carriage 214 within the cradle 212. The helical track 218 is also configured to control the linear velocity of the plunger 216, the carriage 214, or both the plunger 216 and the carriage 214 within the carriage 212.

The carriage 114 or 214 of the needle pusher 110 or 210 is configured to move between the proximal and distal portions of the carriage 112 or 212, for example, along the inner surface of the carriage 112 or 212 on the same or a different track as the longitudinal track 118 or the helical track 218.

The carriage 114 or 214 of the needle pusher 110 or 210 includes an unloading mechanism for unloading the intraductal needle assembly 130 or 230 from the carriage 114 or 214. The unloading mechanism includes a compression spring loaded rod 122 or 222 shaped to form a proximal portion of a receiver 124 or 224 (not shown) in the carriage 114 or 214. (for receiver 224, see receiver 124 of fig. 10 and 11. receiver 224 is similar to receiver 124.) receiver 124 or 224 is configured to receive seat 132 or 232 of an intraductal needle assembly 130 or 230. The lever 122 or 222 is configured to compress a spring 126 or 226 (not shown) of the unloading mechanism when the lever 122 or 222 is pressed toward the bracket 112 or 212. (see spring 126 of FIGS. 10 and 11 for spring 226. spring 226 is similar to spring 126.) by pressing rod 122 or 222 toward bracket 112 or 212, rod 122 or 222 bears the force of the spring 126 or 226 of the unloading mechanism and increases the length of receiver 124 or 224, which allows removal of seat 132 or 232 of the catheter inner needle assembly 130 or 230 from receiver 124 or 224.

The plunger 116 or 216 of the needle pusher 110 or 210 is configured to move the carriage 114 or 214 within the carriage 112 or 212. The plunger 116 of the needle pusher 110 includes a longitudinal channel 120 extending along an outer surface of the plunger 116. The longitudinal channel 120 is configured to receive the longitudinal rail 118 of the carriage 112. In contrast, the carriage 212 of the needle pusher 210 includes a helical channel 220 that spirals around the outer surface of the plunger 216. The helical channel 220 is configured to receive the helical track 218 of the bracket 212.

The plunger 116 or 216 of the needle pusher 110 or 210 is also configured to allow a user to position the carriage 114 or 214 within the carriage 112 or 212 according to a predetermined length of the needle track prior to establishing the needle track. The needle pusher 210 differs from the needle pusher 110 in that the needle pusher 210 is also configured to allow a user to lock the carriage 214 within the cradle 212 once the carriage is positioned according to a predetermined length of the needle track prior to establishing the needle track. As best shown in fig. 6, the needle pusher 210 includes a compression spring loaded rod 228 along a longitudinal side of the carrier 212. The rod 228 includes a tooth configured to extend through a longitudinal side of the bracket 212 and engage a rack gear contained in the carriage 214 when a spring between the rod 228 and the longitudinal side of the bracket 212 is in its most relaxed state, thereby locking the carriage 214 within the bracket 212. When the lever 228 is pressed toward the longitudinal side of the carriage 212, the teeth disengage the rack of the carriage 214 so that the plunger can freely move the carriage 214 to position the carriage 214 according to the predetermined length of the needle track before establishing the needle track.

In addition to the compression spring 126 or 226 being made of, for example, stainless steel, the needle pusher 110 or 210 may be made by molding the components of the needle pusher 110 or 210 and coupling the resulting molded components together to make the needle pusher 110 or 210. The molded part may be molded by injection molding of, for example, polyethylene, polycarbonate, or some other medically acceptable thermoplastic. If configured with snap connectors, the molded articles may be coupled together by pressing the molded articles together, bonding the molded articles together with an adhesive, bonding the molded articles together with a solvent, or a combination thereof.

With respect to the intraductal needle assembly 130 or 230, the intraductal needle assembly 130 or 230 includes a seat portion 132 or 232, a catheter tube 134 or 234 extending from a distal portion of the seat portion 132 or 232, a needle 137 or 237 disposed within the catheter tube 134 or 234 (see fig. 8). Each of the seat portion 132 or 232, the catheter tube 134 or 234, and the needle 137 or 237 will now be described.

Seat 132 or 232 of intracatheter needle assembly 130 or 230 includes a longitudinal handle 133 or 233 extending from seat 132 or 232 between proximal and distal portions of seat 132 or 232. Handle 133 or 233 is configured for handling of the catheter inner needle assembly 130 or 230. For example, when using the intraductal needle assembly 130 or 230 separate from the needle pusher 110 or 210, the handle 133 or 233 may be used to manipulate the intraductal needle assembly 130 or 230, thereby loading the intraductal needle assembly 130 or 230 into the needle pusher 110 or 210, or unloading the intraductal needle assembly 130 or 230 from the needle pusher 110 or 210.

Seat 132 or 232 of the intraductal needle assembly 130 or 230 includes a catheter tube advancing mechanism for advancing catheter tube 134 or 234 relative to needle 137 or 237. The catheter tube advancement mechanism includes a threaded distal plug 139 or 239 (not shown) of the seat portion 132 or 232 of the catheter inner needle assembly 130 or 230. (see distal plug 139 of fig. 12 for distal plug 239. distal plug 239 is similar to distal plug 139.) distal plug 139 or 239 of the catheter tube advancement mechanism is configured to advance from the distal portion of seat 132 or 232 when distal plug 139 or 239 is rotated in a first direction. Upon rotating distal plug 139 or 239 in a second direction, the catheter tube advancement mechanism is configured to retract distal plug 139 or 239 into the distal portion of seat 132 or 232. Because catheter tube 134 or 234 is fixedly attached to distal plug 139 or 239, upon rotating distal plug 139 or 239 in the first direction, catheter tube 134 or 234 is also advanced from the distal portion of seat 132 or 232; and upon rotating distal plug 139 or 239 in a second direction, catheter tube 134 is retracted into the distal portion of seat 132 or 232. The catheter tube advancement mechanism allows the catheter tube 134 or 234 to be advanced to or beyond the distal tip of the needle 137 or 237, such as after establishing a needle track of a predetermined length with the in-catheter needle assembly 130 or 230. The needle 137 or 237 may then be removed from the intra-catheter assembly 130 or 230 by disconnecting the compression spring-loaded proximal cap 135 or 235 of the seat 132 or 232 of the intra-cannula needle assembly 130 or 230 and withdrawing the needle 137 or 237 from the intra-catheter needle assembly 130 or 230.

Seat 132 or 232 of the intraductal needle assembly 130 or 230 comprises a loading mechanism for loading the intraductal needle assembly 130 or 230 into carriage 114 or 214. The loading mechanism includes a compression spring loaded proximal cap 135 or 235 of the seat portion 132 or 232 of the intraductal needle assembly 130 or 230. The proximal cap 135 or 235 is configured to move toward the distal portion of the seat 132 or 232 and compress the spring 136 or 236 (not shown) of the loading mechanism when the seat 132 or 232 is loaded into the receptacle 124 or 224 of the carriage 114 or 214. (see spring 136 of fig. 10 and 11 for spring 236. spring 236 is similar to spring 136.) the spring force exerted by the loading mechanism spring 136 or 236 retains the seat 132 or 232 in the receiver 124 or 224 of the carriage 114 or 214.

Seat 132 or 232 of the intra-catheter needle assembly 130 or 230 optionally includes a needle advancement mechanism for advancing needle 137 or 237 relative to catheter tube 134 or 234, or advancing both needle 137 or 237 and catheter tube 134 or 234 together relative to seat 132 or 232. Such a needle advancement mechanism may comprise a threaded needle advancement mechanism configured to advance the needle 137 or 237, or both the needle and the catheter tube 134 or 234 together, upon rotating a threaded element (e.g., proximal end cap 135 or 235) of the threaded advancement mechanism in a first direction. Upon rotating the threaded element in the second direction, the threaded needle advancement mechanism is configured to retract the needle 137 or 237, or both the needle and the catheter tube 134 or 234 together. Such a needle advancement mechanism may alternatively comprise a slide-based needle advancement mechanism configured to advance the needle 137 or 237, or both the needle and the catheter tube 134 or 234 together, as a slidable element of the slidable needle advancement mechanism (e.g., a tab disposed on a longitudinal slot of the handle 133 or 233) is slid in a first direction. When the slidable element is slid in the second direction, the slidable needle advancement mechanism is configured to retract the needle 137 or 237, or both the needle and the catheter tube 134 or 234 together.

The seat 132 or 232 of the intraductal needle assembly 130 or 230 includes an internal chamber 138 or 238 (not shown) in a proximal portion of the seat 132 or 232. (for the inner chamber 238, see the inner chamber 138 of fig. 10 and 11. the inner chamber 238 is similar to the inner chamber 138.) the port 140 or 240 of the seat portion 132 or 232 and the one or more microcavities 141 or 241 extending longitudinally through the catheter tube 134 or 234 are fluidly connected to the inner chamber 138 or 238. The needle 137 or 237 of the intraluminal needle assembly 130 or 230 extends through the interior chamber 138 or 238 of the seat 132 or 232 while not being fluidly connected to the interior chamber 138 or 238 of the seat 132 or 232. The needle 137 or 237 is fixed to the proximal end cap 135 or 235 of the seat 132 or 232.

Fig. 8 and 9 illustrate different views of the distal portion of the needle 137 or 237 disposed in the catheter tube 134 or 234 according to some embodiments.

Catheter tube 134 or 234 of catheter inner needle assembly 130 or 230 is a double-walled catheter tube including an outer wall 142 or 242 and an inner wall 144 or 244. The distal portion of the catheter tube 134 or 234, including the distal end of the catheter tube 134 or 234, has a tapered distal tip that includes one or more openings corresponding to the one or more microcavities 141 or 241 of the catheter tube 134 or 234. Each of the one or more microcavities 141 or 241 is defined by an inner surface of the outer wall 142 or 242 of the catheter tube 134 or 234, an outer surface of the inner wall 144 or 244 of the catheter tube 134 or 234, and one or more struts 146 or 246 extending longitudinally through the catheter tube 134 or 234 between the outer wall 142 or 242 and the inner wall 144 or 244 of the catheter tube 134 or 234. The one or more microcavities 141 or 241 are configured to allow bodily fluids (e.g., blood) to flash back into the interior chamber 138 or 238 for withdrawal of bodily fluids from the port 140 or 240 without withdrawal of the needle 137 or 237.

The catheter tube 134 or 234 of the intraductal needle assembly 130 or 230 may include a plurality of evenly spaced radiopaque rings 148 or 248 on the catheter tube 134 or 234 for confirming the length of the needle track radiographically after forming a predetermined length of the needle track by counting the number of intraductal needle assemblies 130 or 230.

As shown, the needle 137 or 237 of the intra-catheter needle assembly 130 or 230 may be a hollow needle or a solid needle. The distal end of the needle 137 or 237 extends distally beyond the distal end of the catheter tube 134 or 234 of the intra-catheter needle assembly 130 or 230. The needle 137 or 237 is disposed within a needle lumen that extends longitudinally through the catheter tube 134 or 234. The needle lumen is defined by the inner surface of the inner wall 144 or 244 of the catheter tube 134 or 234.

In addition to cannula tube 134 or 234, needle 137 or 237, and compression spring 136 or 236, which may be made of polyurethane, stainless steel, and stainless steel, respectively, an intraductal needle assembly 130 or 230 (e.g., hub 132 or 232) may be made by molding components of the intraductal needle assembly 130 or 230 and coupling the resulting molded components together to make the intraductal needle assembly 130 or 230. The molded part may be molded, for example, by injection molding using polyethylene, polycarbonate, or some other medically acceptable thermoplastic. If configured with snap connectors, the molded parts may be coupled together by pressing the molded parts together, bonding the molded parts together with an adhesive, bonding the molded parts together with a solvent, or a combination thereof.

Method

Each of the needle track assist devices 100 and 200 is configured for establishing a needle track of a predetermined length at least during procedures that involve placement of a portal shunt between the hepatic vein and the portal vein, which reduces the risk of exceeding the portal vein. Accordingly, the needle track assisting devices 100 and 200 can reduce complications, shorten the operation time, improve the success rate of the operation (such as the above-described operation), and the like.

The method of establishing a needle track of a predetermined length using the needle track assisting device 100 or 200 includes: inserting an intra-catheter needle assembly 130 or 230 into a stiffening sleeve disposed in an introducer sheath located in a hepatic vein, the intra-catheter needle assembly 130 or 230 including a needle 137 or 237, the needle 137 or 237 having a distal end extending beyond a catheter tube 134 or 234 surrounding the needle 137 or 237; moving the plunger 116 or 216 of the needle pusher 110 or 210 to position the carriage 114 or 214 coupled to the plunger 116 or 216 within the carriage 112 or 212 of the needle pusher 110 or 210 in a position to establish a needle track of a predetermined length; loading the seat 132 or 232 of the intraductal needle assembly 130 or 230 in the carriage 114 or 214 of the needle pusher 110 or 210; and pushing the plunger 116 or 216 of the needle pusher 110 or 210 toward the distal end of the needle pusher 110 or 210 to push the needle 137 or 237 and the catheter tube 134 or 234 of the intra-catheter needle assembly 130 or 230 through the hepatic parenchyma and into the portal vein to form a needle tract of a predetermined length.

The method further includes advancing the catheter tube 134 or 234 to or beyond the distal tip of the needle 137 or 237 after establishing a needle track of a predetermined length by rotating the distal plug 139 or 239 in a first direction; and removing the needle 137 or 237 from the intra-catheter needle assembly 130 or 230 by disconnecting the proximal cap 135 or 235 of the hub 132 or 232 of the intra-catheter needle assembly 130 or 230 and withdrawing the needle 137 or 237 from the intra-catheter needle assembly 130 or 230.

The method further includes radiographically determining the length of the needle track of the predetermined length before positioning the carriage 114 or 214 of the needle pusher 110 or 210 in position within the carriage 114 or 214 to establish the needle track of the predetermined length.

The method further includes radiographically confirming the length of the needle track by counting the number of evenly spaced radiopaque rings 148 or 248 on the catheter tube 134 or 234 of the intra-catheter needle assembly 130 or 230 after forming the needle track of the predetermined length.

Although some specific embodiments have been disclosed herein, and although specific embodiments have been disclosed in detail, the specific embodiments are not intended to limit the scope of the concepts presented herein. Additional adaptations and/or modifications will be apparent to those skilled in the art and are intended to be included in the broader aspects. Accordingly, departures may be made from the specific embodiments disclosed herein without departing from the scope of the concepts provided herein.