WO2025264677A1 - Integrated transjugular intrahepatic portosystemic shunt (tips) access - Google Patents

Abstract

The present disclosure pertains to a catheter device that includes a cannula with a proximal end, a distal end, and a needle guide region between the proximal end and the distal end that is operable to extend a needle from the cannula. The needle guide region may facilitate the controlled release of a needle for various applications, such as a single-point portal vein access. The catheter device may also include a probe associated with the distal end of the cannula. The present disclosure also pertains to methods of using the catheter devices of the present disclosure to perform vascular procedures, such as a transjugular intrahepatic portosystemic shunt (TIPS) procedure in a subject.

Description

TITLE

INTEGRATED TRANSJUGULAR INTRAHEPATIC PORTOSYSTEMIC SHUNT (TIPS) ACCESS

CROSS-REFERENCE TO RELATED APPLICATIONS

[0001] This application claims priority to U.S. Provisional Patent Application No. 63/660,950, filed on June 17, 2024. The entirety of the aforementioned application is incorporated herein by reference.

BACKGROUND

[0002] A need exists for more effective systems and methods for performing vascular procedures, such as transjugular intrahepatic portosystemic shunt (TIPS) procedures. Numerous embodiments of the present disclosure aim to address the aforementioned need.

SUMMARY

[0003] In some embodiments, the present disclosure pertains to a catheter device. In some embodiments, the catheter device includes a cannula with a proximal end, a distal end, and a needle guide region between the proximal end and the distal end that is operable to extend a needle from the cannula. In some embodiments, the needle guide region facilitates the controlled release of a needle for various applications, such as a single-point portal vein access.

[0004] In some embodiments, the catheter devices of the present disclosure also include a probe associated with the distal end of the cannula. In some embodiments, the catheter devices of the present disclosure also include a needle associated with and extendable from the needle guide region.

[0005] Additional embodiments of the present disclosure pertain to methods of using the catheter devices of the present disclosure to perform a vascular procedure, such as a transjugular intrahepatic portosystemic shunt (TIPS) procedure in a subject. In some embodiments, the methods of the present disclosure include: (1) inserting a catheter device of the present disclosure into a vein of a subject; (2) advancing the catheter device to a hepatic vein of the subject; (3) actuating the probe to visualize the hepatic region of the subject on a monitor; (4) inserting a needle into the cannula and through a needle guide region; (5) extending the needle from the hepatic vein to the portal vein under probe guidance; and (6) using the extended needle to establish a shunt between the hepatic vein and the portal vein.

DRAWINGS

[0006] FIG. 1A provides an illustration of a catheter device of the present disclosure, which may be suitable for performing transjugular intrahepatic portosystemic shunt (TIPS) procedures. [0007] FIG. IB illustrates a method of performing a TIPS procedure in accordance with various embodiments of the present disclosure.

[0008] FIGS. 2A-2B provide illustrations of additional catheter devices of the present disclosure.

DETAILED DESCRIPTION

[0009] It is to be understood that both the foregoing general description and the following detailed description are illustrative and explanatory, and are not restrictive of the subject matter, as claimed. In this application, the use of the singular includes the plural, the word “a” or “an” means “at least one”, and the use of “or” means “and/or”, unless specifically stated otherwise. Furthermore, the use of the term “including”, as well as other forms, such as “includes” and “included”, is not limiting. Also, terms such as “element” or “component” encompass both elements or components comprising one unit and elements or components that include more than one unit unless specifically stated otherwise.

[0010] The section headings used herein are for organizational purposes and are not to be construed as limiting the subject matter described. All documents, or portions of documents, cited in this application, including, but not limited to, patents, patent applications, articles, books, and treatises, are hereby expressly incorporated herein by reference in their entirety for any purpose. In the event that one or more of the incorporated literature and similar materials defines a term in a manner that contradicts the definition of that term in this application, this application controls.

[0011] Transjugular intrahepatic portosystemic shunt (TIPS) is a critical, minimally invasive procedure performed to manage complications arising from portal hypertension. It is predominantly performed by accessing the jugular vein and advancing a canula to the hepatic vein, subsequently puncturing the portal vein. Due to the intricate nature of the hepatic region and anatomical variability, needle punctures are often blind and based on assumptions, potentially leading to prolonged procedure times and heightened risks, especially in patients with compromised liver function, coagulation abnormalities, and low platelet counts.

[0012] The main perioperative complications of traditional fluoroscopic TIPS placement stem from the multiple needle passes the operator needs to make from the appropriate hepatic vein into the target portal branch until a direct portohepatic venous connection is made. This may include inadvertent injuries to the liver capsule, extrahepatic portal vein, hepatic artery, biliary ducts or surrounding viscera.

[0013] Hepatic artery injury can occur in up to 6% of the TIPS cases. Moreover, clinically relevant biliary injury is reported in 5% of the TIPS cases. In addition, repeated cannulation prolongs procedure time (including anesthesia time) and increases the radiation dose. Furthermore, CO2 extravasation is reported in 1.8% of cases. This complication can lead to serious morbidities, such as hepatic capsular laceration, which is a known though rare cause of immediate intraprocedural mortality.

[0014] Current enhancements, such as intracardiac echo (ICE) catheters, require additional access and operators, adding to the complexity of TIPS procedures. As such, a need exists for more effective systems and methods for performing various vascular procedures, such as TIPS procedures. Numerous embodiments of the present disclosure aim to address the aforementioned need.

[0015] Catheter devices

[0016] In some embodiments, the present disclosure pertains to a catheter device. An example of a catheter device of the present disclosure is illustrated in FIGS. 1A and 2A-2B as catheter device 10. Catheter device 10 generally includes a cannula 16 with a proximal end 11, a distal end 12, and a needle guide region 15 between proximal end 11 and distal end 12. Needle guide region 15 is generally operable to extend a needle 14 from cannula 16. In some embodiments, needle guide region 15 facilitates controlled release of needle 14. In some embodiments, needle guide region 15 facilitates single-point portal vein (e.g., internal jugular) access.

[0017] In some embodiments, catheter device 10 also includes a probe 13 associated with distal end 12. In some embodiments, catheter device 10 also includes an adaptor 18 operable to connect probe 13 to a monitor. In some embodiments, adaptor 18 is positioned at distal end 11 of catheter device 10. [0018] In some embodiments, catheter device 10 also includes needle 14 associated with and extendable from the needle guide region 15. In some embodiments, needle 14 is in the form of a puncture needle. In some embodiments, needle 14 is operable to be visualized as a line (e.g., a dashed line or X sign) on a probe image (e.g., an ultrasound image and/or a Doppler signal). In some embodiments, needle 14 is visualized as a line (e.g., dashed line or target/X sign) on a probe image (e.g., an ultrasound image and/or a Doppler signal), indicating proper direction for advancing a needle, and thereby aiding in precise and controlled needle advancement. [0019] In some embodiments, catheter device 10 also includes needle hub 24 operable to receive needle 14. In some embodiments, needle hub 24 is positioned at proximal end 11 of cannula 16. In some embodiments, needle hub 24 also includes an arrow to show direction of needle 14 inside the body.

[0020] In some embodiments, catheter device 10 also includes a sidearm 22. In some embodiments, sidearm 22 is positioned at proximal end 11 of cannula 16.

[0021] The catheter devices of the present disclosure can include various types of cannulas. For instance, in some embodiments, the cannula is operable to receive a needle (e.g., needle 14 illustrated in FIG. 1A). In some embodiments, the cannula is in the form of an intracardiac echo (ICE) catheter, a side seeing ultrasound catheter, a Doppler probe, or combinations thereof. In some embodiments, the catheter devices of the present disclosure can include two separate cannulas. In some embodiments, one cannula may accommodate a catheter (e.g., an ICE catheter) while another cannula may accommodate a needle. In some embodiments, the catheter devices of the present disclosure may include a single cannula for accommodating a needle and a catheter.

[0022] The catheter devices of the present disclosure can include various types of needles. For instance, in some embodiments, the needle can be a component of a cannula of the present disclosure. In some embodiments, the needle can include a straight tip or a bent tip. In some embodiments, the needle may be designed in a manner that allows bending and direction change. In some embodiments, the needle can be associated with a metallic cannula to help stabilize the needle before puncture. In some embodiments, the needle is compatible with 16 Gauge Colapinto and/or long Chiba needles. In some embodiments, the needle may be steerable. In some embodiments, the needle has non-zero radius of curvature.

[0023] The catheter devices of the present disclosure can also include various types of needle guide regions 15. For instance, in some embodiments, the needle guide region 15 represents an aperture on a cannula that is operable to extend needle 14 from cannula 16. In some embodiments, the aperture may be configured into various shapes, such as round or oval, depending on needle profile. In some embodiments, the aperture may be reinforced, such as with a circumferential metallic ring. In some embodiments, the metallic reinforcement ensures that the aperture retains its geometry under mechanical stress and helps guide the needle smoothly, minimizing deflection and improving procedural accuracy. [0024] In some embodiments, probes generally refer to components that are operable to detect, transmit and/or convert signals. The catheter devices of the present disclosure can include various probes. For instance, in some embodiments, the probe includes a dopplcr probe (c.g., a dopplcr probe operable to detect a postal vein signal). In some embodiments, the probe includes a transducer. In some embodiments, the transducer includes an ultrasound transducer. In some embodiments, the transducer includes an ultrasound transducer operable to show pictures of the liver and portal vein. In some embodiment, the transducer includes a Doppler transducer. In some embodiments, the transducer includes a Doppler transducer operable to receive a Doppler signal from the portal vein and help locate the portal vein. In some embodiments, the transducer includes a side view (or combination of side view and 360-degree) ultrasound transducer.

[0025] The catheter devices of the present disclosure can also include various types of distal ends. For instance, in some embodiments illustrated in FIGS. 2A-2B, distal end 12 may feature a telescopic module with dynamic length adjustment to enhance needle visualization. In some embodiments, distal end 12 may include a plurality of rods of differing diameters that are operable to extend or retract linearly from the distal end 12. In some embodiments, the distal end 12 may be designed to rotate 0 to 360 degrees, providing comprehensive imaging capabilities. In some embodiments, distal end 12 may include a probe, such as an ICE sensor.

[0026] The catheter devices of the present disclosure can have various applications. For instance, in some embodiments, the catheter devices of the present disclosure may be operable for performing a vascular procedure, such as a transjugular intrahepatic portosystemic shunt (TIPS) procedures. In some embodiments, the catheter devices of the present disclosure may be operable for performing transvenous biopsy of different organs and/or lymph nodes.

[0027] Methods of performing vascular procedures

[0028] Additional embodiments of the present disclosure pertain to methods of using the catheter devices of the present disclosure to perform a vascular procedure in a subject. In some embodiments illustrated in FIG. 1A, such methods include: (1) inserting a catheter device 10 of the present disclosure into a blood vessel of the subject; (2) advancing the catheter device 10 through a first region of the subject; (3) actuating the catheter device probe 13 to visualize the first region of the subject on a monitor; (4) inserting a needle 14 into the cannula 16 and through the needle guide region 15; (5) extending the needle 14 from the first region to a second region under probe guidance; and (6) using the extended needle 14 to establish a shunt between the first region and the second region.

[0029] The catheter devices and methods of the present disclosure can be utilized for various vascular procedures. For instance, in some embodiments, the catheter devices and methods of the present disclosure can be used to perform transseptal puncture of the right atrium to access the left atrium, facilitating procedures such as mitral valve interventions or left atrial appendage closure. In some embodiments, the catheter devices and methods of the present disclosure may be used in sharp recanalization of occluded or stenosed veins near the heart to enhance visualization and treatment of complex cardiovascular anatomy. In some embodiments, the catheter devices and methods of the present disclosure can be utilized for trans-IVC (inferior vena cava) access and embolization of aortic aneurysm sacs. In some embodiments, the catheter devices and methods of the present disclosure can also be utilized to enable percutaneous creation of dialysis arteriovenous fistulas.

[0030] In some embodiments, the first region includes a hepatic vein and the second region includes a portal vein. In some of such embodiments, the catheter devices and methods of the present disclosure may be utilized to perform a transjugular intrahepatic portosystemic shunt (TIPS) procedure in the subject. In some of such embodiments illustrated in FIGS. 1A-1B, the methods of the present disclosure include: (1) inserting a catheter device 10 into a vein of a subject 30 (e.g., the right internal jugular vein); (2) advancing the catheter device to hepatic vein 31 of subject 30 (e.g., the right, middle and/or left hepatic vein); (3) actuating probe 13 to visualize the hepatic region (e.g., portal vein) of the subject on a monitor; (4) inserting needle 14 into cannula 16 and through needle guide region 15; (5) extending needle 14 from hepatic vein 31 to portal vein 32 under probe guidance; and (6) using the extended needle 14 to establish a shunt between the hepatic vein 31 and the portal vein 32.

[0031] The methods of the present disclosure may utilize various steps to establish a shunt between the hepatic vein 31 and the portal vein 32. For instance, in some embodiments, shunt establishment occurs by: (1) advancing a wire through inserted needle 14 and into portal vein 32 under probe guidance such that the wire becomes positioned between hepatic vein 31 and portal vein 32; (2) exchanging cannula 16 over the wire for a catheter and removing the cannula; (3) advancing the catheter over the wire; (4) advancing and expanding an expandable structure over the wire to dilate the hepatic parenchymal tract; (5) deflating and removing the expandable structure; and (6) advancing a sheath over the wire and into portal vein 32. In some embodiments, shunt establishment occurs by positioning cannula 16 within the inferior vena cava (IVC), facing the liver parenchyma, to perform a Direct Intrahepatic Portosystemic Shunt (DIPS) procedure. In this approach, device 10 is advanced from the IVC directly into the portal vein through the liver parenchyma under probe guidance, after which tract dilation and sheath placement proceed similarly to the standard method described above. The DIPS technique may be particularly advantageous in cases where hepatic vein access is limited or in patients with altered hepatic venous anatomy.

[0032] In some embodiments, the expandable structure includes a balloon. In some embodiments, the balloon includes an angioplasty balloon.

[0033] The methods of the present disclosure may be utilized to perform TIPS procedures on various subjects. For instance, in some embodiments, the subject is a human being. In some embodiments, the human subject is an adult or a pediatric patient. In some embodiments, the subject is suffering from or vulnerable to a liver disease, such as liver cirrhosis and/or portal hypertension associated with liver cirrhosis. In some embodiments, the methods of the present disclosure may be utilized to treat or prevent the liver disease. In some embodiments, the liver disease may be associated with variceal bleeding, ascites, hepatic hydrothorax, bud chiarri syndrome, hepatic -renal syndromes, and/or hepatic pulmonary syndromes.

[0034] Advantages

[0035] The catheter devices and methods of the present disclosure provide numerous advantages. For instance, by offering real-time guidance for needle advancement, the catheter devices and methods of the present disclosure are able to minimize the risks associated with multiple needle passes during vascular procedures, such as TIPS procedures. For the same reasons, the catheter devices and methods of the present disclosure can help improve the efficiency, complexity, invasivcncss, safety, and accuracy of vascular procedures, such as TIPS procedures. Moreover, the catheter devices and methods of the present disclosure can help reduce vascular procedural complexity (especially for less experienced healthcare providers) by eliminating the need for additional access and operators. As such, the catheter devices and methods of the present disclosure provide an unmet need because current technical failure rates for vascular procedures are high. For instance, current technical failure rates for TIPS procedures typically range from 5% to 15%.

[0036] Additional embodiments [0037] Reference will now be made to more specific embodiments of the present disclosure and experimental results that provide support for such embodiments. However, Applicant notes that the disclosure below is for illustrative purposes only and is not intended to limit the scope of the claimed subject matter in any way.

[0038] Example 1, Operation of an integrated transjugular intrahepatic portosystemic shunt (TIPS) access and intracardiac echo (ICE) catheter

[0039] This Example describes a specific operation of a transjugular intrahepatic portosystemic shunt (TIPS) access and intracardiac echo (ICE) catheter device 10 illustrated in FIGS. 1A-1B. Device 10 is used to gain access for the TIPS procedure. Device 10 features a probe 13 on tip 12. Needle 14 will emerge from guide region 15 of cannula 16 a few centimeters earlier.

[0040] In operation, patient 30 will be placed in a supine position on an angiographic table. The right neck will be prepped and draped in the standard sterile fashion. A suitable percutaneous approach to the right internal jugular vein will be identified, followed by infiltration of 1% lidocaine into the skin and subcutaneous tissues for local anesthesia.

[0041] Under continuous sonographic guidance, a 21-gauge needle will be used to access the right internal jugular vein. A 0.018-inch wire will then be advanced centrally under fluoroscopic guidance, and the needle will be exchanged for a 5 French micro puncture sheath. The wire will subsequently be upsized to a O.O35-inch J-wire, which will be advanced through the micro puncture sheath into the inferior vena cava.

[0042] The micro puncture sheath will then be removed over the wire, and the tract will be dilated. Finally, a 5 French vascular sheath will be advanced over the wire into the right atrium. A 5 French angled catheter and 0.035-inch Glide wire will be advanced through the right internal jugular sheath. The sheath will be retracted into the right atrium, and the angled catheter and Glide wire will be used to select the right, left, and/or middle hepatic vein, with appropriate positioning confirmed by the injection of dilute contrast material. Representative fluoroscopic images will be stored.

[0043] Next, the J-wire will be removed through the sheath. Pre procedure right heart, free and wedged hepatic pressure will be measured. A 0.035-inch Rosen/ Amplatz wire will then be advanced through the angled catheter well into the right hepatic vein. Next, the neck sheath will be removed over the wire and exchanged with cannula 16. [0044] The access needle and cannula 16 of device 10 will then be advanced inside the hepatic vein with probe 13 facing infero-medially toward the hepatic hilum and aperture 15 at the proximal aspect of the right hepatic vein immediately before IVC drainage. Once the portal vein is identified by probe 13, an X will be placed on the portal vein 32 with a line showing the path of needle 14 on a monitor. Thereafter, needle 14 will be advanced under ultrasound guidance toward portal vein 32. Once access is confirmed, a wire will be advanced through needle 14 deep into the portal vein. Cannula 16 will be exchanged over the wire for a catheter (e.g., a 10 French sheath). Thereafter, cannula 16 can be removed.

[0045] A 5 French marker flush catheter will then be advanced over the wire and positioned at the portal- splenic confluence. Digital subtraction angiography of the portal venous system will then be performed. The Amplatz wire will then be reintroduced through the flush catheter, which will then be removed. Angioplasty balloon will be advanced over the wire and used to dilate the hepatic parenchymal tract under fluoroscopic guidance. Representative fluoroscopic images will be stored. The balloon will then be deflated and removed. The obturator for the 10 French sheath will then be reintroduced over the wire, and the sheath will be advanced over the wire and well into the portal vein 32. The obturator of the sheath will then be removed.

[0046] A covered Viatorr stent graft will be advanced through the sheath and over the wire into the portal vein 32. The sheath will then be retracted, exposing the distal, uncovered portion of the stent graft. The system will be retracted to the distal aspect of the parenchymal tract. The sheath will then be retracted over the proximal aspect of the stent and into the right atrium. The covered portion of the stent will then be deployed in the usual fashion.

[0047] Appropriate size angioplasty balloon will be advanced over the wire and used to postdilatc the stent graft. Representative fluoroscopic images will be stored. The balloon will then be exchanged for the flush catheter, which will be repositioned in the portal vein. Post-TIPS portal venous pressure will be measured. Post-TIPS right atrial pressure will be measured. Final digital subtraction venography will be performed through the flush catheter. The flush catheter and right internal jugular sheath will then be removed, and hemostasis will be achieved with manual compression.

[0048] Without further elaboration, it is believed that one skilled in the ail can, using the description herein, utilize the present disclosure to its fullest extent. The embodiments described herein are to be construed as illustrative and not as constraining the remainder of the disclosure in any way whatsoever. While the embodiments have been shown and described, many variations and modifications thereof can be made by one skilled in the art without departing from the spirit and teachings of the invention. Accordingly, the scope of protection is not limited by the description set out above, but is only limited by the claims, including all equivalents of the subject matter of the claims. The disclosures of all patents, patent applications and publications cited herein are hereby incorporated herein by reference, to the extent that they provide procedural or other details consistent with and supplementary to those set forth herein.

Claims

1. A catheter device comprising: a cannula comprising a proximal end, a distal end, and a needle guide region between the proximal end and the distal end, wherein the needle guide region is operable to extend a needle from the cannula; and a probe associated with the distal end.

2. The catheter device of claim 1, wherein the cannula is operable to receive the needle.

3. The catheter device of claim 1, wherein the cannula is in the form of an intracardiac echo (ICE) catheter, a side seeing ultrasound catheter, a Doppler probe, or combinations thereof.

4. The catheter device of claim 1, wherein the needle guide region facilitates controlled release of the needle.

5. The catheter device of claim 1, wherein the needle guide region facilitates single-point portal vein access.

6. The catheter device of claim 1, further comprising a needle associated with and extendable from the needle guide region.

7. The catheter device of claim 6, wherein the needle is in the form of a puncture needle.

8. The catheter device of claim 6, wherein the needle is operable to be visualized as a line on a probe image.

9. The catheter device of claim 1, further comprising an adaptor operable to connect the probe to a monitor.

10. The catheter device of claim 9, wherein the adaptor is positioned at the distal end of the catheter device.

11. The catheter device of claim 1, further comprising a needle hub operable to receive the needle.

12. The catheter device of claim 11, wherein the needle hub is positioned at the proximal end of the cannula.

13. The catheter device of claim 1, further comprising a sidearm, wherein the sidearm is positioned at the proximal end of the cannula.

14. The catheter device of claim 1, wherein the catheter device is operable for performing transjugular intrahepatic portosystemic shunt (TIPS) procedures.

15. The catheter device of claim 1, wherein the probe comprises a transducer.

16. The catheter device of claim 1, wherein the distal end comprises a plurality of rods of differing diameters, wherein the plurality of rods are operable to extend or retract linearly from the distal end.

17. A method of performing a vascular procedure in a subject, said method comprising: inserting a catheter device into a blood vessel of the subject, wherein the catheter device comprises: a cannula comprising a proximal end, a distal end, and a needle guide region between the proximal end and the distal end, and a probe associated with the distal end; advancing the catheter device through a first region of the subject; actuating the probe to visualize the first region of the subject on a monitor; inserting a needle into the cannula and through the needle guide region; extending the needle from the first region to a second region under probe guidance; and using the extended needle to establish a shunt between the first region and the second region.

18. The method of claim 17, wherein the first region comprises a hepatic vein, and wherein the second region comprises a portal vein, and wherein the method is utilized to perform a transjugular intrahepatic portosystemic shunt (TIPS) procedure in the subject.

19. The method of claim 18, wherein the TIPS procedure comprises: inserting the catheter device into a vein of the subject; advancing the catheter device to the hepatic vein of the subject; actuating the probe to visualize the hepatic region of the subject on a monitor; inserting a needle into the cannula and through the needle guide region; extending the needle from the hepatic vein to the portal vein under probe guidance; and using the extended needle to establish a shunt between the hepatic vein and the portal vein.

20. The method of claim 19, wherein the establishment of the shunt comprises: advancing a wire through the inserted needle and into the portal vein under probe guidance, wherein the wire becomes positioned between the hepatic vein and the portal vein; exchanging the cannula over the wire for a catheter and removing the cannula; advancing the catheter over the wire; advancing and expanding an expandable structure over the wire to dilate the hepatic parenchymal tract; deflating and removing the expandable structure; and advancing a sheath over the wire and into the portal vein.

21. The method of claim 19, wherein the catheter device is inserted into the right internal jugular vein of the subject.

22. The method of claim 19, wherein the catheter device is advanced to the right hepatic vein of the subject.

23. The method of claim 19, wherein the subject is a human being.

24. The method of claim 19, wherein the subject is vulnerable to or suffering from a liver disease.

25. The method of claim 19, wherein the method is used to treat or prevent a liver disease in the subject.

26. The method of claim 24 or 25, wherein the liver disease comprises liver cirrhosis.