HK1225661B - Transjugular intrahepatic portosystemic shunt device - Google Patents

Description

Transjugular intrahepatic portosystemic shunt device

CROSS-REFERENCE TO RELATED APPLICATIONS

This application is a continuation-in-part of co-pending U.S. patent application No. 13/651,682, filed on October 15, 2012, which is a continuation-in-part of U.S. patent application No. 12/644,452, filed on December 22, 2009 (currently U.S. Patent No. 8,287,481), which claims priority to expired U.S. Provisional Patent Application No. 61/140,693, filed on December 24, 2008.

Technical Field

The present application relates to a device and method for rapidly locating the portal vein to establish a shunt between the portal vein and the hepatic vein through the human liver, and more particularly to a transjugular intrahepatic portosystemic shunt ("TIPS") device and a method for establishing a TIPS using the device.

Background Art

The human liver performs numerous functions essential to life, including breaking down fats, metabolizing and storing glucose, producing urea, synthesizing amino acids, filtering toxins, storing vitamins and minerals, and metabolizing cholesterol. Typically, a healthy liver receives approximately 70–75% of its blood supply from the portal vein and 25–30% from the hepatic artery. Blood leaves the liver through the hepatic vein, which connects to the inferior vena cava, located just below the heart.

Cirrhosis is a term that refers to irreparable damage to the liver, in which the liver parenchyma is gradually replaced by scar tissue. Over time, this can progress to complete liver failure. There are many causes of cirrhosis, but the most common ones include alcoholism, hepatitis, non-alcoholic steatohepatitis (NASH), toxin/drug exposure, and various genetic and autoimmune conditions. When the liver becomes cirrhotic, normal blood flow patterns are altered. In particular, pressure in the portal vein increases, causing blood that normally flows to the liver to back up/overflow ("back-up"). Over time, portal blood, which normally flows toward the liver (hepatotropic), can reverse and flow away from the liver (hepatotropic). As portal vein pressure rises, blood finds an alternative route back to the heart. This often occurs in the form of varicose veins, which are particularly prone to bleeding, which has potentially fatal consequences.

In addition, the increased portal vein pressure observed with cirrhosis increases capillary hydrostatic pressure within the visceral vascular bed of the viscera. Coupled with impaired renal function and sodium retention, this increased hydrostatic pressure can lead to the formation of a transudative collection of fluid in the patient's abdomen, known as ascites. While this is often initially managed with medication, the amount of fluid can become substantial and refractory to medication.

First described by Rosch et al. in 1969, TIPS therapy creates a shunt between the portal vein and the hepatic vein that allows blood to bypass the cirrhotic liver parenchyma, which is responsible for elevated portal vein pressure. In doing so, the TIPS procedure lowers portal pressure and is indicated in the management of variceal bleeding refractory to medical therapy, refractory ascites, and refractory hepatic hydrothorax (fluid surrounding the lungs secondary to liver failure).

There are some commercial devices for TIPS therapy. The TIPS procedure is performed under general anesthesia by entering the patient's right internal jugular vein and advancing the catheter through the superior vena cava, heart, and inferior vena cava to the right hepatic vein. Once the catheter is placed in the right hepatic vein, a larger sheath is then placed in the right hepatic vein. Through this sheath, a large needle (usually 16 gauge) is pushed through the wall of the hepatic vein and enters the substance forward, downward, and midway in the expected direction of the right portal vein. After the needle is advanced, a syringe is attached to the back of the needle and the needle is slowly removed. As blood is aspirated, a small amount of contrast agent is injected into the needle to confirm entry into the right portal vein. Subsequently, through the needle, a line is made to enter the right portal vein and the main portal vein. Through this line, the conduit is dilated by a balloon and a covered stent is placed to thereby form a shunt.

Despite the use of preoperative imaging and intraoperative wedge portography, access to the portal vein is often difficult because it requires multiple needle passes through the liver before access is achieved. Needle passes through the liver are associated with complications including intraperitoneal bleeding (frequency 1-13%), biliary bleeding (frequency 1-4%), and fistula formation (frequency <1%). Equally important, difficulty in portal vein access prolongs operative time, increases hospital resource/cost utilization, and increases risks to the patient with prolonged anesthesia and fluoroscopic radiation exposure. Therefore, a TIPS device and method that allows for safer and faster portal vein access is needed.

Summary of the Invention

The present invention relates to a device designed to improve the safety and efficacy of portal vein catheterization during a TIPS procedure, and a method for using the device. This is accomplished by simultaneously advancing multiple small needles from the distal end of the device's TIPS needle into the liver parenchyma. In doing so, the device allows sampling from a significantly larger volume with each liver pass, thereby facilitating rapid cannulation of the portal vein from the hepatic vein.

The proposed device offers advantages over existing techniques because it uses multiple needles, each smaller than the needle typically used in a TIPS procedure, that are simultaneously advanced into the liver parenchyma. As the needles are manually advanced into the liver, they gradually unfurl within the area, with their tips correspondingly forming square or polygonal patterns. Compared to the single needle typically used in TIPS procedures, the use of multiple needles increases the likelihood of catheterization into the portal vasculature and reduces the time required to achieve this insertion.

Additionally, the needles used in this device are much smaller than the 16-gauge needles used in typical TIPS procedures. The present invention utilizes needles as small as 21-gauge or 23-gauge. Using smaller needles is less traumatic to liver vessels. This reduces the likelihood of potentially life-threatening complications, including massive bleeding, biliary bleeding, fistula formation, and damage to adjacent organs. The larger needles that accommodate these smaller needles are only pushed a short distance into the liver parenchyma and are therefore much less invasive.

Another embodiment of the present invention includes an insertion device comprising an outer guide with a straight (discussed in the next paragraph) or steerable inner needle. The assembled device with the steerable needle allows the needle to be pointed in the same direction as the outer guide. The steerable needle can be pointed in any direction along a 360-degree arc. Using a steerable inner needle reduces the difficulty of portal vein catheterization by allowing the operator to steer the needle to the desired direction of the portal vein. This offers the same advantages as the multiple-needle embodiment, including reduced treatment time and increased safety. Reduced treatment time offers the advantages of cost savings, reduced anesthesia risk to the patient, and reduced radiation exposure to the patient and operator. Another embodiment of the device includes replacing the curved inner needle (which allows for steerage) with a straight inner needle (which is non-steerable). This would be used in situations where the operator believes the portal vein is directly in front of the curved outer guide. In this case, the straight needle would be optimal for portal vein catheterization because it provides a more direct path.

In some embodiments, the device comprises an elongated hollow outer guide; an outer handle having an inner lumen and a first Luer lock, the outer handle being attached to a proximal end of the outer guide, the outer guide being in fluid communication with the inner lumen and the Luer lock; an elongated hollow inner needle; and a hub having a second Luer lock, the hub being attached to a proximal end of the inner needle, the inner needle being in fluid communication with the second Luer lock. The inner needle is slidably received through the first Luer lock and received into the outer guide through the inner lumen. The inner needle is configured to be rotated within the outer guide by operating the hub; and the distal tip of the inner needle is extended beyond and beyond the distal tip of the outer guide, the distal tip of the inner needle being configured to be advanced into the liver parenchyma to locate the portal vein. To aid in locating the portal vein, the inner needle is capable of aspirating fluid therefrom.

The present invention also includes a method for locating the portal vein using an external guide/inner needle device necessary for performing a transjugular intrahepatic portosystemic shunt procedure, comprising inserting a catheter through the jugular vein into the hepatic vein of a patient receiving a transjugular intrahepatic portosystemic shunt. The device is inserted into the jugular vein and advanced into the hepatic vein. The external handle of the device is rotated until the external guide is in the desired direction of the portal vein. The external handle is stabilized and the inner needle is rotated into the desired direction of the portal vein via the hub. Pressure is applied to the hub and the distal tip of the inner needle is advanced through the wall of the hepatic vein into the liver parenchyma in a direction toward the portal vein. Suction is created within the inner needle to locate the portal vein and establish a shunt to the portal vein.

Therefore, the device described herein can result in considerable cost savings and improved safety by shortening the duration of surgery. The reduction in surgical time is significant because it reduces the incidence of complications associated with the administration of general anesthesia. In addition, the reduction in surgical time provides a cost-saving benefit to the healthcare system.

In another embodiment, the device uses six small needles extending from the distal end of the TIPS needle.

In yet another embodiment, the device uses eight small needles extending from the distal end of the TIPS needle.

In yet another embodiment, the device utilizes only one sheath through which the TIPS needle passes.

In yet another embodiment, a device utilizes an outer guide that receives a steerable curved inner needle and means for manipulating the inner needle to locate the portal vein during a TIPS procedure.

The object of the present invention is to provide a multi-needle TIPS device that can more safely and quickly obtain access from the hepatic vein to the portal vein.

It is another object of the present invention to provide a method for using a multi-needle TIPS device to reduce the time required to create a shunt.

With these and other objects which will become apparent hereinafter, the present invention will now be described with particular reference to the accompanying drawings.

BRIEF DESCRIPTION OF THE DRAWINGS

FIG1 is a diagram showing a human liver, hepatic vein, and portal vein.

FIG. 2 is a front side cross-sectional view of the present invention in a collapsed state.

3 is a side elevational cross-sectional view of the present invention in an expanded state.

4 is a partially cut-away side elevational view of an outer sheath formed in accordance with the present invention.

5 is a partially cut-away side elevational view of an inner sheath formed in accordance with the present invention.

6 is a side elevational view of a TIPS needle formed in accordance with the present invention in a collapsed state.

7 is a side view of a TIPS needle formed in accordance with the present invention having four engagement needles in an extended state with the tip of the TIPS needle shown in phantom.

8 is a perspective view with the distal portion of a TIPS needle formed in accordance with the present invention cut away.

9 is a side elevational view of the distal end of a TIPS needle formed in accordance with the present invention wherein the stylet portion is shown in phantom.

10 is a side elevational view of a joint needle and common needle hub formed in accordance with the present invention.

11 is a side elevational view of a probe and a common probe hub formed in accordance with the present invention.

12 is a side elevational view in cross section of an aspiration syringe formed in accordance with the present invention.

FIG. 13 is a perspective view of another embodiment of the present invention in a collapsed state.

14 is a perspective view of another embodiment of the present invention in an extended state and showing the hub cap removed from the hub.

FIG. 15 is a close-up perspective view of another embodiment of the present invention.

FIG. 16 is a perspective view of an outer guide member used in one embodiment of the present invention.

FIG. 17 is a perspective view of an inner needle used in one embodiment of the present invention.

18 is a perspective view of an inner needle hub used in one embodiment of the present invention.

19 is a perspective view of a hub cap used in one embodiment of the present invention.

DETAILED DESCRIPTION

1 , a multi-needle TIPS device and method for using the same according to the present invention are described. The device and method described herein are ideal for rapidly locating the correct portal vein for establishing a shunt 103 connecting the right hepatic vein 101 to the right portal vein 102 through a human liver 100.

2, 3, 4, 5, 6 and 7, the device 200 and its basic components are described separately and in both the retracted and extended states. FIG2 shows the device 200 in the retracted state, which is the unengaged default state. The outer sheath 201 is the basic external component of the device 200. The outer sheath has an internal dilator to allow access to the right hepatic vein via a guide wire. The outer sheath 201 is a ten (10) French (for reference, 1 French = 3 mm) sheath made of a semi-rigid material. In FIG4, the outer sheath 201 has a shaft having a length of between 35 cm and 40 cm and an outer hub 203 having an outer port 202 at its proximal end, which is designed to allow flushing of the outer sheath 201.

In FIG5 , the lumen of the outer sheath 201 houses the inner sheath 204. The inner sheath 204 is an eight (8) French sheath made of a semi-rigid material. The shaft of the inner sheath, which is 45 cm in length, has a tapered end 207. The inner sheath 204 also has an inner hub 205 and an inner port 206 at its proximal end to allow flushing of the inner sheath 204. The shaft of the inner sheath 204 also has a braided metal wall to allow passage of an 8 French needle without damaging the inner sheath 204.

The lumen of the inner sheath 204 houses a TIPS needle 208 having a total length of 50 cm, including a 7 cm curved portion 211 at the distal end 214 of the TIPS needle. The TIPS needle is an eight (8) French needle made of a semi-rigid material. The curved portion 211 has a 30 degree bend. At the distal end of the TIPS needle 208 is a TIPS needle tip 209 (see FIG6 ). Near the distal end of the TIPS needle 208, before the TIPS needle tip 209, there are four needle holes 212 designed to allow a small needle to pass through. The TIPS needle also has a TIPS needle hub 213 at the proximal end 215 of the TIPS needle.

Returning to FIG. 3 , the figure shows the device 200 shown in an extended state. The extended state is an engaged state and is defined by the extension of four (4) engagement needles 216 from the distal end 214 of the TIPS needle 204. The engagement needles 216 are each twenty-three (23) level needles made of a semi-rigid material and each have a preformed flat curve at the tip. The engagement needles 216 pass through the TIPS needle lumen 210, wherein each engagement needle 216 extends from one of the four needle holes 212 of the TIPS needle 208. Within the TIPS needle lumen 210, the engagement needles 216 are separated by thin horizontal and vertical partitions 218 in the TIPS needle lumen 208. As seen in FIG. 7 , when extended, the engagement needles 216 gradually spread out in a square arrangement. When fully extended, the engagement needles 216 are in a square arrangement with a distance of 2-3 cm between the needles.

Referring now to Figures 8, 9, 10, and 11, the basic components comprising the interior of the device are illustrated. Figure 8 illustrates the proximal end 215 of the TIPS needle 208. At the proximal end 215 of the TIPS needle 208 is a TIPS needle hub 213. The TIPS needle hub 213 serves as the base of the TIPS needle 208 and houses the hub adapter 217. Due to horizontal and vertical dividers 218 within the TIPS needle lumen 208, the TIPS needle lumen 208 contains four distinct chambers, each capable of accommodating an engagement needle 216. The engagement needles are each attached to a common needle hub 223, which allows the engagement needles to be advanced and retracted simultaneously. To ensure proper alignment of the engagement needles 216 as they extend from the TIPS needle 208, each engagement needle 216 has a specific target chamber within the TIPS needle 208. If the engagement needle 216 is inserted into the correct lumen, the common needle hub 223 will engage the hub adapter 217 once the engagement needle 216 is fully advanced into the TIPS needle 208 .

The probe 221 is used to fill the engagement needle lumen 219 and provide additional rigidity to the engagement needle 219 as it is advanced into the engagement needle lumen 219. The probes 221 are available in twenty-three sizes, are made of a semi-rigid material, and are all attached to a common probe hub 222. Additionally, the probes 221 have the same pre-formed curve as the engagement needle 216. The probes 221 are used by first inserting the slide 220, then inserting the common needle hub 223, and finally inserting into the engagement needle lumen 219.

Referring now to FIG. 12 , a specially designed syringe 224 is shown. The syringe 224 is a sixty (60) cc syringe designed to engage a common needle hub 223 ( FIG. 9 ) and provide suction through the engagement needle lumen 219. The syringe has an engagement tip 225 with four separate syringe chambers 227, each chamber 227 corresponding to one of the four engagement needle lumens 219 ( FIG. 8 ). In addition to an opening for each syringe chamber 227, the engagement tip 225 also houses a syringe adapter 228 that mates with the common needle hub 223. When the syringe 224 is engaged to the common needle hub 223 and the plunger 226 of the syringe 224 is pulled, suction is provided through each engagement needle lumen 219.

Operation of the device begins with access to the right hepatic vein 101 from the right jugular vein (Figure 1). Under ultrasound guidance, a twenty-one (21) gauge needle is used to access the right jugular vein. After gaining access, a 0.018" guidewire is advanced through the lumen of the twenty-one (21) gauge needle and its position is confirmed in the superior vena cava by fluoroscopy. A transition dilator is used to enlarge the size of the guidewire. The right hepatic vein 101 is then cannulated. Hepatic venous wedge pressure measurement and portography are performed as needed. The outer sheath 201 and inner dilator are advanced over the guidewire into the right hepatic vein 101. The inner dilator is then removed and the outer port 202 is connected to a heparinized saline flusher.

Next, the TIPS needle 208 is partially inserted into the inner hub 205 and then into the inner sheath 204, so that the TIPS needle tip 209 does not extend beyond the distal end of the inner sheath 204. The combined TIPS needle 208 and inner sheath 204 assembly is then inserted into the outer hub 203 and then into the outer sheath 201 and extended to the wall of the right hepatic vein 101. Once placed, the inner port 206 can be connected to a heparinized saline flusher as needed.

The engagement needle 216 and its attached stylet 221 are then advanced into the TIPS needle hub 213, but the tip of the engagement needle 216 does not extend into the hole near the end of the TIPS needle 208. At this point, the assembled device appears as shown in FIG2. The TIPS needle 208 is then slowly advanced a short distance forward and centrally into the liver parenchyma in the desired direction of the right portal vein 102. The TIPS needle is advanced into the liver parenchyma approximately 1 cm, rather than the typical distance of approximately 5 cm used with typical TIPS devices.

Once the TIPS needle 208 is secured in place, the engagement needles 216 and their inner stylets 221 are slowly advanced into the liver parenchyma. At this point, the assembled device will be as shown in Figure 3. The engagement needles 216 are advanced approximately 3-6 cm. As the engagement needles 216 are pushed into the liver parenchyma through the pinholes 212 near the end of the TIPS needle 208, they gradually expand into a square pattern, as shown in Figure 7. When fully extended, the tips of the engagement needles will be located in a square pattern with a distance of 2-3 cm between the needles. As the needles gradually expand with further advancement, extending the engagement needles 216 by a smaller distance will result in the needle tips being located closer together in a smaller square pattern.

The probes 221 are removed from the engagement needle lumen 219 by pulling on the common probe hub 222. As the probes 221 are withdrawn from the engagement needle 216, their tips are covered by the needle cover 220. The needle cover 220 is designed to prevent needle stick injuries to the operator and to hold the probe tips together during removal from the engagement needle 216. The probes 221, with their tips covered by the needle cover 220, can then be set aside.

With the stylet removed, syringe 224 is then attached to the common needle hub 223, with each syringe chamber 227 corresponding to one engagement needle lumen 219. The operator then pulls plunger 226, creating suction through the engagement needle lumen 219 and the tip of engagement needle 216. Engagement needle 219 is then slowly retracted through the liver parenchyma by pulling syringe 224 and common needle hub 223, while simultaneously aspirating with syringe 224. As the operator retracts engagement needle 216, each syringe chamber 227 is carefully inspected for the presence of portal blood. If blood is not aspirated, engagement needle 216 can be retracted into TIPS needle 208 and stylet 221 replaced in engagement needle 216. Engagement needle 216 is then advanced in a different direction, and the process is repeated until blood is successfully aspirated.

When blood is drawn into one of these syringe chambers 227, retraction of the engagement needle 216 is immediately stopped. The syringe chamber 227 containing blood and the corresponding engagement needle lumen 219 are recorded. The syringe 224 is then removed from the common needle hub 223. A small amount of contrast medium is then injected into the engagement needle lumen 219 into which the blood was drawn. This is performed under fluoroscopy to confirm entry into the right portal vein 102. Next, under fluoroscopy, a 0.018" guidewire is advanced into the appropriate engagement needle lumen 219 into which the blood was drawn. The guidewire fully advances the right portal vein 102 and then into the main portal vein, splenic vein, and if necessary, the superior mesenteric vein to gain sufficient confidence for further intervention.

Once sufficient control is achieved, the TIPS needle 208 and attached engagement needle 216 are pulled back together over the guidewire as a unit. Serial dilations are then performed over the 0.018" guidewire and the 0.018" guidewire is enlarged to a larger 0.035" guidewire. Over the 0.035" guidewire, balloon angioplasty and stent graft placement can be performed as with a typical TIPS procedure. Completion of the procedure includes repeat portography and portal pressure measurement and possible varicose vein embolization as needed.

13-19, another embodiment of the present invention is shown, providing another suitable and improved method of locating and accessing the portal vein as part of a TIPS procedure.

The combined device shown in FIG13 depicts one embodiment of the present invention in its assembled state. An outer handle A (shown separately in FIG15 ) is connected to an outer guide (guide sleeve) K (shown separately in FIG16 ). The outer handle A has finger grips B along its lower edge. These finger grips B allow the operator to twist the outer guide K as needed with one hand (typically the left hand). The outer handle A also has finger wings C. These wings are used by the other hand (typically the right hand) to assist in deploying the inner needle J, providing leverage so that the base of the hand can push against the inner needle hub F. The proximal end of the outer guide K has a Luer lock D, which not only allows the inner needle J to be inserted into the outer guide K but also allows a standard syringe to be attached thereto for aspiration or injection as needed. An inner lumen E is disposed within the outer handle A and extends therefrom into communication with the outer guide K and the Luer lock D. In some embodiments, the inner lumen E is large enough to accommodate the passage of a 4-French catheter. The outer handle's inner lumen E is continuous with and in fluid communication with the outer guide K and the Luer lock D. In some embodiments, the outer guide K measures 40 to 50 cm and has a gentle curve at its distal end that creates an arc between 20 and 45 degrees. In some embodiments, the distal end of the outer guide K is flush without a bevel.

The inner needle J is slidably and removably received in the outer guide, passing through the Luer lock D, through the inner lumen E, and into the outer guide K. At the proximal end of the inner needle J is a hub F. The hub F has a hub cap G that covers the Luer lock I that provides a passage between the hub F and the lumen of the inner needle J. This Luer lock will not only allow a 0.035-inch guide wire to pass through the hub F and into the inner needle J, but will also allow a standard syringe to be attached for aspiration or injection as needed. The inner needle hub F and hub cap G are shown separately in Figures 18 and 19, respectively, with Figure 18 showing the Luer lock I protruding from the hub F.

The inner needle hub F allows the operator to rotate and twist the inner needle J within a 360-degree range within the outer guide K. Because the hub F is fixed to the proximal end of the inner needle J, this motion is accomplished in a 1:1 manner. The inner needle hub F has a marking H that indicates the direction of the curve of the inner needle J, thereby allowing the operator to understand the direction in which the inner needle J is pointing. This allows the user to manually determine the orientation of the distal tip of the inner needle J without having to rely on imaging techniques such as fluoroscopy.

In some embodiments, the inner needle J is between 45 and 55 cm long and has a gentle curve at its distal end that creates an arc between 20 and 45 degrees. Therefore, the distal end of the inner needle J will substantially match the curvature and contour of the distal end of the outer guide K. A straight inner needle J of the same length is an alternative embodiment of the present device. Both the straight and curved inner needles J have a beveled tip to provide the necessary sharpness for penetrating the liver parenchyma. This differs from the embodiment of the non-beveled distal tip of the outer guide K because the outer guide K does not need to be used to penetrate the liver.

In some embodiments, the inner needle J has a hydrophilic or Teflon coating to reduce friction between the inner needle J and the outer guide K. As an alternative embodiment of the device, the inner needle may have a 4 French plastic polymer sleeve/catheter surrounding the outside of the inner needle J. This sleeve/catheter would have a Luer lock at the end (allowing it to lock into the inner needle hub F) and would be very similar to a standard diagnostic angiography catheter. When using the device, the sleeve/catheter would be advanced along with the inner needle J. The purpose of the sleeve/catheter is to reduce friction and facilitate insertion of the catheter into the portal vein and advancement of the guidewire once the inner needle J has found the portal vein.

The operation of an embodiment of the present invention is as follows: As with any standard TIPS procedure, the goal is to create a shunt between the hepatic vein and the portal vein, using the stent graft as a conduit for blood flow through the liver. This is illustrated in Figure 1 , where blood flows from the portal vein 102 to the hepatic vein 101. Typically, this involves connecting the right hepatic vein to the right portal vein, but this can vary depending on the patient's anatomy and the need for additional shunt flow.

Using standard angiographic techniques, the right jugular vein, inferior vena cava, and then the hepatic vein (usually the right) are cannulated. After confirming that the appropriate hepatic vein is cannulated, a rigid guidewire is placed distally within the vein. Over the rigid guidewire, a 10-French sheath is fully advanced into the hepatic vein. During this time, portal wedge pressure and wedge portography of the occluded globe can be performed at the operator's discretion to reveal the location of the target portal vein and assess the grade of portal hypertension.

The device of the present invention is then passed through the sheath and pushed to the tip of the sheath. The combined device is advanced while the inner needle J and hub F are retracted so that the sharp tip of the inner needle J does not initially extend beyond the tip of the outer guide K. Once the distal tip of the combined device reaches the tip of the sheath, the sheath is slowly withdrawn to expose the outer guide K.

Using outer handle A, the device is rotated to the generally intended direction of the target portal vein. The operator then uses their left hand to stabilize outer handle A, and thus outer guide K. The inner needle hub F is then rotated by the operator's right hand to the intended direction of the target portal vein to fine-tune the portal vein's target position. Using the right hand, two fingers are placed on finger wings C. The bottom of the right hand is then used to apply pressure to the base of the inner needle hub F, advancing the distal tip of the inner needle into the liver parenchyma.

The hub cap G of the inner needle hub F is then removed, exposing the Luer lock I of the inner needle hub F. A syringe containing saline is attached to the Luer lock I, and a small amount of saline is injected to clean the lumen of the inner needle J. The syringe A containing saline is removed, and a control dye syringe is attached. Gentle aspiration is performed and a small amount of dye is injected, while the inner needle J and inner needle hub F are slowly retracted toward the outer guide K. Once the portal vein is found, a guidewire can be advanced directly through the lumen of the inner needle J into the portal vein, or the sleeve/catheter of the inner needle J can be advanced over the inner needle J into the portal vein, at which point the inner needle J and inner needle hub F can be removed. If the portal vein is not found during the initial deployment of the inner needle J, the hub cap G can be replaced, and the inner needle J and inner needle hub F can be rotated to a new orientation and the process repeated until the portal vein is found.

Regardless of the exact technique, once the guidewire has been successfully advanced into the portal vasculature, the remainder of the TIPS procedure is accomplished using standard techniques. This requires advancing a 4-French catheter over the guidewire and into the portal vein via the outer guide handle A and outer guide K. The initial guidewire that was advanced is then replaced with a stiff guidewire over which a diagnostic 4-French irrigation catheter can be advanced and used to perform portovenography and obtain portal vein pressures. The stiff guidewire is replaced and the diagnostic irrigation catheter removed. Outer guide K and outer handle A can now be safely removed. Balloon dilation is then performed through areas of the liver parenchyma until a 10-French sheath can be successfully advanced from the hepatic vein through the liver parenchyma to the portal vein. Once the sheath is advanced into the portal vein, the TIPS stent is deployed according to the manufacturer's instructions and the diameter is adjusted using balloon angioplasty until the desired portosystemic gradient is achieved.

While the present invention has been shown and described herein in what is considered to be the most practical and preferred embodiment, it will be appreciated that modifications can be made thereto within the scope of the invention and that modifications will be apparent to those skilled in the art.

Claims (6)

1. A device for rapidly establishing a transjugular intrahepatic portosystemic shunt by locating the portal vein in the liver for shunt reception, comprising: Slender, hollow outer guide component; An outer handle having an inner cavity and a first Luer joint lock, the outer handle being attached to the proximal end of an outer guide, the outer guide being in fluid communication with the inner cavity and the first Luer joint lock; Slender, hollow inner needle; A hub sleeve having a second Luer connector lock, the hub sleeve being attached to the proximal end of the inner pin, the inner pin being in fluid communication with the second Luer connector lock; The inner needle is slidably received by the first Luer connector lock and enters the outer guide through the inner cavity; The inner needle is configured to rotate within the outer guide member via an operating hub; and The distal tip of the inner needle extends beyond and beyond the distal tip of the outer guide, and the distal tip of the inner needle is configured to advance into the liver parenchyma to locate the portal vein. 2. The device as claimed in claim 1, wherein the inner needle is capable of drawing fluid through it. 3. The apparatus of claim 1, further comprising a hub cap removably received on the hub sleeve. 4. The device as claimed in claim 1, characterized in that it further includes finger wings on the outer handle to help the inner needle unfold. 5. The apparatus of claim 1, further comprising an indicator on the hub sleeve, the indicator providing an indication of the orientation of the inner pin. 6. The apparatus of claim 1, wherein the distal tips of the outer guide and the inner needle have matching curved geometries.