WO2017053398A1

WO2017053398A1 - Single catheter device for transvascular delivery of particulate and non particulate agents

Info

Publication number: WO2017053398A1
Application number: PCT/US2016/052843
Authority: WO
Inventors: Ravi Murthy; Armeen MAHVASH
Original assignee: Board Of Regents, The University Of Texas System
Priority date: 2015-09-21
Filing date: 2016-09-21
Publication date: 2017-03-30

Abstract

Disclosed herein are catheter devices and methods for radioembolization that facilitate a unique flow pattern to ensure distal flow.

Description

DESCRIPTION

SINGLE CATHETER DEVICE FOR TRANSVASCULAR DELIVERY OF

PARTICULATE AND NON PARTICULATE AGENTS

CROSS-REFERENCE TO RELATED APPLICATIONS

This application claims priority to U.S. Provisional Patent Application Serial No. 62/221,247 filed September 21, 2015, the contents of which are incorporated herein by reference.

BACKGROUND INFORMATION

Liver cancer is the second largest killer of cancer patients, second only to lung cancer. Liver cancer is a difficult disease to treat effectively, regardless of whether the cancer originated in the liver itself or in another organ. The difficulty in treatment is often due to the location and resistance to particular treatment techniques, including for example, chemotherapy. While radiation has shown to be effective, the treatment risks damage to healthy liver tissue. Because cancer patients usually already have compromised liver function, this could delay their treatment significantly or even indefinitely.

Currently, the most effective treatment is believed to be a surgical resection of the cancerous tissue. However, this technique typically is only successful if the cancer originated from the liver, and if the cancer is in an isolated location. The next treatment steps normally involve chemotherapy and radiation treatments. Chemotherapy typically includes numerous unwanted side effects. In addition, the cancer can also be resistant to chemotherapy, making the treatment ineffective. Radiation often has similar effects to chemotherapy. Although the cancer may not be as resistant to radiation, damage to healthy liver tissue is typically inevitable.

Another method of treatment for liver cancer is radioembolization. In this method, radioactive microspheres are injected into the hepatic arteries, where they lodge themselves into the cancerous tissue. The radioactive microspheres starve the tumor of nutrient and oxygen-rich blood, and deliver radiation directly to the cancerous cells with minimal risk to the surrounding, healthy tissue. However, undesirable effects from radioembolization can occur when the radioactive microspheres do not reach the tumor, and instead are refluxed to the intestines or shunted to other organs (e.g. lungs).

Existing devices and methods have attempted to address issues related to radioembolization techniques. For example, the Surefire™ infusion catheter delivers embolic agents directly to the blood vessel using an expandable tip, which collapses in forward flow and expands to the size of the vessel wall in reverse flow. This design can increase target delivery and minimize reflux that might otherwise cause damage to healthy tissue. An example of such a catheter is shown in FIG. 1.

Another existing option includes the Renegade HI-FLO™ Fathom Kit, which includes the Renegade HI-FLO™ Microcatheter and Fathom- 16 Steerable Guidewire. The microcatheter has a large diameter, is made of a kink-resistant material, and is available in multiple lengths. The guidewire is designed for visibility and customization. It has a variety of stiffness along the wire to allow for flexibility and control. An example of such a kit is shown in FIG. 2.

Another existing option is the ProStream™ Multiple Sidehole Infusion Wire, which allows for more efficient infusion by eliminating the need for a separate core wire. An example of this is shown in FIG. 3.

An additional existing option is the IsoFlow™ Infusion Catheter uses a dual-balloon design in order to keep the blood flow intact during treatment. It allows the physician to increase drug concentrations while reducing systemic exposure by enabling sideways perfusion. The IsoFlow™ catheter requires a guide wire for precise placement. An example is shown in FIG. 4.

SUMMARY OF CERTAIN INVENTIVE ASPECTS

Certain embodiments of the present disclosure include a catheter device comprising: a first end and a second end; a tapered portion proximal to the first end; a dual lumen shaft proximal to the second end, where the dual lumen shaft comprises a first lumen and a second lumen; an inflatable balloon in fluid communication with the first lumen of the dual lumen shaft; and a perforated section, where: the perforated section is positioned between the tapered portion and the inflatable balloon; and the perforated section is in fluid communication with the second lumen of the dual lumen shaft. In particular embodiments the perforated section is directly adjacent the inflatable balloon. In some embodiments the perforated section comprises a plurality of perforations, wherein each perforation in the plurality of perforations has a diameter between 500 and 700 microns. In specific embodiments the dual lumen shaft has an outer diameter between 0.030 inches and 0.050 inches. In certain embodiments the dual lumen shaft has an outer diameter of approximately 0.038 inches. In particular embodiments the inflatable balloon can be inflated from a first diameter to a second diameter; the first diameter is between 0.030 inches and 0.050 inches; and the second diameter is between 0.15 inches and 0.25 inches. In some embodiments the inflatable balloon is a urethane balloon. In specific embodiments the dual lumen shaft is malleable. In certain embodiments the tapered portion is less than 0.5 inches long.

Certain embodiments include a method of providing radioembolization, the method comprising: directing a catheter device through an aorta into a common hepatic artery; positioning the catheter device so that the inflatable balloon is located in the common hepatic artery; inflating the inflatable balloon in the hepatic artery; restricting blood flow from the aorta through hepatic artery with the inflatable balloon; and discharging microspheres comprising yttrium-90 (Y-90) from the second lumen through the perforated section into the hepatic artery. In particular embodiments of the method, the catheter device comprises: a first end and a second end; a tapered portion proximal to the first end; a dual lumen shaft proximal to the second end, wherein the dual lumen shaft comprises a first lumen and a second lumen; an inflatable balloon in fluid communication with the first lumen of the dual lumen shaft; and a perforated section, where: the perforated section is positioned between the tapered portion and the inflatable balloon; and the perforated section is in fluid communication with the second lumen of the dual lumen shaft.

In particular embodiments of the method, inflating the inflatable balloon in the hepatic artery creates a reversal in blood flow through branch vessels supplying a stomach and a small intestine. In some embodiments of the method, the reversal in blood flow through the branch vessels supplying the stomach and the small intestine results in blood flow directed from the stomach and the small intestine to the liver. In specific embodiments of the method, the reversal in blood flow through the branch vessels supplying the stomach and the small intestine restricts the flow of the microspheres comprising yttrium-90 (Y-90) to the stomach and the small intestine.

In certain embodiments of the method, directing the catheter device through the aorta into the common hepatic artery comprises directing the catheter device over a guidewire. In particular embodiments of the method, positioning the catheter device so that the inflatable balloon is located in the common hepatic artery is performed using x-ray fluoroscopy. In some embodiments of the method, the inflatable balloon is located in the common hepatic artery between the aorta and branch vessels supplying a stomach and a small intestine. In specific embodiments of the method, the perforated section is directly adjacent the inflatable balloon.

In certain embodiments of the method, the perforated section comprises a plurality of perforations, where each perforation in the plurality of perforations has a diameter between 500 and 700 microns. In specific embodiments of the method, the dual lumen shaft has an outer diameter between 0.030 inches and 0.050 inches. In some embodiments of the method, the dual lumen shaft has an outer diameter of approximately 0.038 inches. In certain embodiments of the method, inflating the inflatable balloon in the hepatic artery comprises: inflating the inflatable balloon from a first diameter to a second diameter; the first diameter is between 0.030 inches and 0.050 inches; and the second diameter is between 0.15 inches and 0.25 inches.

In particular embodiments of the method, the inflatable balloon is a urethane balloon.

In some embodiments of the method, the dual lumen shaft is malleable. In specific embodiments of the method, the tapered portion is less than 0.5 inches long. Certain embodiments of the method further comprise deflating the inflatable balloon and removing the catheter device through an aorta into a common hepatic artery.

In one aspect, the present disclosure provides a single catheter device for radioembolization that facilitates a unique flow pattern that ensures distal flow is provided. In certain embodiments, the device includes of an atraumatic, floppy guidewire-type distal tip, an infusion section proximal to the distal guidewire portion and then a compliant balloon proximal to the infusion section. Proximal to the balloon is a dual-lumen shaft that allows for one port to feed the compliant balloon and another that feeds the infusion section. In the following, the term "coupled" is defined as connected, although not necessarily directly, and not necessarily mechanically.

The use of the word "a" or "an" when used in conjunction with the term "comprising" in the claims and/or the specification may mean "one," but it is also consistent with the meaning of "one or more" or "at least one." The term "about" means, in general, the stated value plus or minus 5%. The use of the term "or" in the claims is used to mean "and/or" unless explicitly indicated to refer to alternatives only or the alternative are mutually exclusive, although the disclosure supports a definition that refers to only alternatives and "and/or."

The terms "comprise" (and any form of comprise, such as "comprises" and

"comprising"), "have" (and any form of have, such as "has" and "having"), "include" (and any form of include, such as "includes" and "including") and "contain" (and any form of contain, such as "contains" and "containing") are open-ended linking verbs. As a result, a method or device that "comprises," "has," "includes" or "contains" one or more steps or elements, possesses those one or more steps or elements, but is not limited to possessing only those one or more elements. Likewise, a step of a method or an element of a device that "comprises," "has," "includes" or "contains" one or more features, possesses those one or more features, but is not limited to possessing only those one or more features. Furthermore, a device or structure that is configured in a certain way is configured in at least that way, but may also be configured in ways that are not listed.

Other objects, features and advantages of the present invention will become apparent from the following detailed description. It should be understood, however, that the detailed description and the specific examples, while indicating specific embodiments of the invention, are given by way of illustration only, since various changes and modifications within the spirit and scope of the invention will be apparent to those skilled in the art from this detailed description. BRIEF DESCRIPTION OF THE DRAWINGS

FIG. 1 is a schematic view of an existing catheter.

FIG. 2 is a schematic view of an existing kit.

FIG. 3 is a schematic view of an existing infusion wire.

FIG. 4 is a schematic view of an existing dual balloon catheter.

FIG. 5 is a side view of a catheter device according to an exemplary embodiment of the present disclosure.

FIG. 6 is a schematic view of the embodiment of FIG. 5 during use.

DETAILED DESCRIPTION OF EXEMPLARY EMBODIMENTS

Exemplary embodiments of the present disclosure include devices and methods to provide radioembolization. Radioembolization typically uses a basic infusion catheter and yttrium 90 (Y-90) microspheres. In certain embodiments, the Y-90 microspheres have a median diameter of 32.5 microns, with a typical range of between 20 and 60 microns. Yttrium-90 is a high-energy beta-emitting isotope with no primary gamma emission. The maximum energy of the beta particles is typically 2.27MeV with an average of 0.93MeV.

These properties of the Y-90 microspheres allow the microspheres to lodge preferentially in the microvasculature surrounding the tumor, maximizing tumoricidal effects and minimizing the effects on healthy liver parenchyma.

Although the liver derives blood supply from both the hepatic arteries and the portal vein, growing tumors obtain most of their blood supply from the hepatic arteries. In typical procedures using existing techniques, the Y-90 radioembolization procedure has at least two outpatient sessions: a diagnostic session followed by a treatment session. During both sessions, a small angiographic catheter is inserted into the femoral artery and advanced under x-ray fluoroscopy guidance through the body into the hepatic artery. The vascular anatomy is adequately mapped, and embolizing coils are placed if deemed necessary by the physician.

Yttrium-90 resin microsphere radioembolization using an antireflux catheter can be employed as an alternative to traditional coil embolization for nontarget protection. Serious complications can result from nontarget embolization during yttrium-90 (Y-90) transarterial radioembolization. Hepatoenteric artery coil embolization has been traditionally performed to prevent nontarget radioembolization.

During a typical treatment session, radioactive Y-90 microspheres are injected in the hepatic arteries that perfuse the tumor. As previously mentioned, undesirable effects of this treatment can occur if the radioactive microspheres do not reach the tumor, and instead are refluxed to the intestines or shunted to the other organs.

In order to avoid these undesirable effect, two methods are typically used. The first method is coil embolization, where coils are inserted into surrounding blood vessels in a procedure prior to the microsphere infusion. This can help to prevent microspheres from traveling down the wrong blood vessel. However, this method requires precise placement of the coils and can lead to extended treatment times.

Another method (which can be used in addition to coiling) uses a balloon infusion catheter placed strategically in the common hepatic artery. This can help to ensure that blood flow travels through the correct blood vessels, carrying the microspheres to the tumor.

Certain catheters are typically used (in addition to coiling) to try and direct the microspheres to the correct blood vessels. For example, the previously-mentioned catheter employing a mesh net (illustrated in FIG. 1) can be used. This configuration can help reduce reflux, but does not fix the problem entirely. Similarly, there are catheters which use balloons and infusion wires to help direct the flow, but the location of the infusion of the microspheres are based on the discretion of the physician performing the procedure.

As explained in further detail below, exemplary embodiments of the present disclosure provide for the proper balloon and infusion cannula to be combined with the correct placement of the catheter. Such configurations and techniques can allow more patients to have a successful radioembolization procedure. Accordingly, the patients will potentially be able to tolerate higher doses and shorter times between doses. Such configurations and techniques can also make the procedure significantly more effective and save lives.

In one exemplary embodiment of the present invention, a single catheter device is disclosed that facilitates a unique flow pattern that ensures distal flow of the Y-90 microspheres. As illustrated in FIG. 5, certain embodiments of device comprise an atraumatic, floppy guidewire-type distal tip, an infusion section proximal to the distal guidewire portion and then a compliant balloon proximal to the infusion section. Proximal to the balloon is a dual-lumen shaft that allows for one lumen to feed the compliant balloon and another lumen that feeds the infusion section.

In the particular embodiment shown in in FIG. 5, a catheter device 100 comprises a first end 101 and a second end 102. Catheter device 100 further comprises a tapered portion 110 proximal to first end 101. In addition, catheter device 100 comprises a dual lumen shaft 120 comprising a first lumen 121 and a second lumen 122. Catheter device 100 also comprises an inflatable balloon 130 in fluid communication with first lumen 121. In the embodiment shown in FIG. 5, catheter device 100 comprises a perforated section 140 in fluid communication with second lumen 122. In addition, perforated section is positioned between tapered portion 110 and inflatable balloon 130. Perforated section 140 comprises a plurality of perforations 145. In exemplary embodiments, perforated section 140 may have a length of approximately 0.4 inches (1 centimeter), and perforations 145 may have a diameter of 400-800 microns, or more particularly 500-700 microns.

In some embodiments, the outer diameter of dual lumen shaft 120 may be between

0.030 inches and 0.050 inches, and in specific embodiments, may be approximately 0.038". In particular embodiments, inflatable balloon 130 can be inflated from a first diameter of between 0.030 inches and 0.050 to a second diameter of between 0.15 inches and 0.35 inches. In a specific embodiment, inflatable balloon 130 can be inflated from a .038 inch folded profile to approximately 0.3 inches (7 millimeter) in diameter. In certain embodiments, tapered portion 110 may be approximately 0.4 inches (1 centimeter) in length.

In certain embodiments, inflatable balloon 130 can be made from a compliant material such as urethane. Other suitable materials may also be employed for this purpose. In particular embodiments, inflatable balloon 130 has narrow shoulders and is configured for concentric inflation at low inflation pressure. Such a configuration can provide an atraumatic occlusion by applying minimal pressure (less than 1 atmosphere) to occlude the vessel with the smallest area.

During use, an operator can transverse catheter device 100 through an aorta 200 into a common hepatic artery 210. In particular embodiments, tapered portion 110 can be a flexible portion approximately 1.0 centimeter in length. In specific embodiments, tapered portion 110 can be shaped to a desired configuration to assist in guiding catheter device 100 to the desired location. Inflatable balloon 130 can then be positioned in the common hepatic artery 210 and inflated. In specific embodiments, inflatable balloon 130 can be positioned in the common hepatic artery between a liver 220 and aorta 200.

Inflating balloon 130 can serve to restrict blood flow coming from aorta 200 to liver 220. This balloon occlusion technique temporarily reverses the blood flow in branch vessels 230 and 240 (e.g. branch vessels supplying the stomach and small intestine) during transarterial embolization. Exemplary embodiments of the device and method also ensure blood flow by constantly supplying the liver tumors to be addressed. In addition, exemplary embodiments can reduce the likelihood that radioembolization does not reflux into undesired locations.

Once the desired blood flow reversal has been confirmed, the radioembolization microspheres 250 can be delivered through second lumen 122 and out through perforated section 140 of catheter device 100. This can serve to effectively perfuse the liver tumor cells.

Once the adequate amount of radioembolization microspheres 250 have been infused, inflatable balloon 130 can be deflated. This can restore normal blood flow and allow for removal of catheter device 100.

All of the devices, systems and/or methods disclosed and claimed herein can be made and executed without undue experimentation in light of the present disclosure. While the devices, systems and methods of this invention have been described in terms of particular embodiments, it will be apparent to those of skill in the art that variations may be applied to the devices, systems and/or methods in the steps or in the sequence of steps of the method described herein without departing from the concept, spirit and scope of the invention. All such similar substitutes and modifications apparent to those skilled in the art are deemed to be within the spirit, scope and concept of the invention as defined by the appended claims.

Claims

1. A catheter device comprising:

a first end and a second end;

a tapered portion proximal to the first end;

a dual lumen shaft proximal to the second end, wherein the dual lumen shaft comprises a first lumen and a second lumen;

an inflatable balloon in fluid communication with the first lumen of the dual lumen shaft; and

a perforated section, wherein:

the perforated section is positioned between the tapered portion and the inflatable balloon; and

the perforated section is in fluid communication with the second lumen of the dual lumen shaft.

2. The catheter device of claim 1 wherein the perforated section is directly adjacent the inflatable balloon.

3. The catheter device of claim 1 wherein the perforated section comprises a plurality of perforations, wherein each perforation in the plurality of perforations has a diameter between 500 and 700 microns.

4. The catheter device of claim 1 wherein the dual lumen shaft has an outer diameter between 0.030 inches and 0.050 inches.

5. The catheter device of claim 1 wherein the dual lumen shaft has an outer diameter of approximately 0.038 inches.

6. The catheter device of claim 1 wherein:

the inflatable balloon can be inflated from a first diameter to a second diameter;

the first diameter is between 0.030 inches and 0.050 inches; and

the second diameter is between 0.15 inches and 0.25 inches.

7. The catheter device of claim 1 wherein the inflatable balloon is a urethane balloon.

8. The catheter device of claim 1 wherein the dual lumen shaft is malleable.

9. The catheter device of claim 1 wherein the tapered portion is less than 0.5 inches long.

10. A method of providing radioembolization, the method comprising:

directing a catheter device through an aorta into a common hepatic artery, wherein the catheter device comprises:

a first end and a second end;

a tapered portion proximal to the first end;

a perforated section, wherein:

the perforated section is in fluid communication with the second lumen of the dual lumen shaft;

positioning the catheter device so that the inflatable balloon is located in the common hepatic artery;

inflating the inflatable balloon in the hepatic artery;

restricting blood flow from the aorta through hepatic artery with the inflatable balloon; and

discharging microspheres comprising yttrium-90 (Y-90) from the second lumen through the perforated section into the hepatic artery.

11. The method of claim 10 wherein inflating the inflatable balloon in the hepatic artery creates a reversal in blood flow through branch vessels supplying a stomach and a small intestine.

12. The method of claim 11 wherein the reversal in blood flow through the branch vessels supplying the stomach and the small intestine results in blood flow directed from the stomach and the small intestine to the liver.

13. The method of claim 11 wherein the reversal in blood flow through the branch vessels supplying the stomach and the small intestine restricts the flow of the microspheres comprising yttrium-90 (Y-90) to the stomach and the small intestine.

14. The method of claim 10 wherein directing the catheter device through the aorta into the common hepatic artery comprises directing the catheter device over a guidewire.

15. The method of claim 10 wherein positioning the catheter device so that the inflatable balloon is located in the common hepatic artery is performed using x-ray fluoroscopy.

16. The method of claim 10 wherein the inflatable balloon is located in the common hepatic artery between the aorta and branch vessels supplying a stomach and a small intestine.

17. The method of claim 10 wherein the perforated section is directly adjacent the inflatable balloon.

18. The method of claim 10 wherein the perforated section comprises a plurality of perforations, wherein each perforation in the plurality of perforations has a diameter between 500 and 700 microns.

19. The method of claim 10 wherein the dual lumen shaft has an outer diameter between 0.030 inches and 0.050 inches.

20. The method of claim 10 wherein the dual lumen shaft has an outer diameter of approximately 0.038 inches.

21. The method of claim 10 wherein inflating the inflatable balloon in the hepatic artery comprises:

inflating the inflatable balloon from a first diameter to a second diameter;

the first diameter is between 0.030 inches and 0.050 inches; and

the second diameter is between 0.15 inches and 0.25 inches.

22. The method of claim 10 wherein the inflatable balloon is a urethane balloon.

23. The method of claim 10 wherein the dual lumen shaft is malleable.

24. The method of claim 10 wherein the tapered portion is less than 0.5 inches long.

25. The method of claim 10 further comprising deflating the inflatable balloon and removing the catheter device through an aorta into a common hepatic artery.