WO2017053310A1 - Catheter device for delivery of particles or fluid - Google Patents

Catheter device for delivery of particles or fluid Download PDF

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Publication number
WO2017053310A1
WO2017053310A1 PCT/US2016/052686 US2016052686W WO2017053310A1 WO 2017053310 A1 WO2017053310 A1 WO 2017053310A1 US 2016052686 W US2016052686 W US 2016052686W WO 2017053310 A1 WO2017053310 A1 WO 2017053310A1
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WO
WIPO (PCT)
Prior art keywords
infusion
infusion catheter
channel
catheter
balloon
Prior art date
Application number
PCT/US2016/052686
Other languages
French (fr)
Inventor
Aaron CALL
Original Assignee
Lighthill Medical, Inc.
Priority date (The priority date is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the date listed.)
Filing date
Publication date
Application filed by Lighthill Medical, Inc. filed Critical Lighthill Medical, Inc.
Publication of WO2017053310A1 publication Critical patent/WO2017053310A1/en

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Classifications

    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61MDEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M25/00Catheters; Hollow probes
    • A61M25/0067Catheters; Hollow probes characterised by the distal end, e.g. tips
    • A61M25/0068Static characteristics of the catheter tip, e.g. shape, atraumatic tip, curved tip or tip structure
    • A61M25/007Side holes, e.g. their profiles or arrangements; Provisions to keep side holes unblocked
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61MDEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M25/00Catheters; Hollow probes
    • A61M25/01Introducing, guiding, advancing, emplacing or holding catheters
    • A61M25/06Body-piercing guide needles or the like
    • A61M25/0662Guide tubes
    • A61M2025/0681Systems with catheter and outer tubing, e.g. sheath, sleeve or guide tube
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61MDEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M25/00Catheters; Hollow probes
    • A61M25/0067Catheters; Hollow probes characterised by the distal end, e.g. tips
    • A61M25/0068Static characteristics of the catheter tip, e.g. shape, atraumatic tip, curved tip or tip structure
    • A61M25/0069Tip not integral with tube
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61MDEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M25/00Catheters; Hollow probes
    • A61M25/10Balloon catheters
    • A61M25/104Balloon catheters used for angioplasty

Definitions

  • Liver cancer is the second largest killer of cancer patients, right after lung cancer. Whether the cancer originated in the liver itself or in another organ, it is a difficult disease to treat, often due to location and resistance to treatments (such as chemotherapy). Radiation has shown to be effective, however 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.
  • an infusion catheter in a first aspect, includes a floppy distal tip having a solid core, an infusion section attached at a first end to the distal tip, the infusion section including at least one hole, and a channel attached to a second end of the infusion section, the channel having a lumen in communication with the at least one hole.
  • the channel comprises a braid, a laser cut hypotube, or an electroplated braid.
  • the infusion section comprises a braid, a laser cut hypotube, or an electroplated braid.
  • the distal tip comprises a braid, a laser cut hypotube, or an electroplated braid.
  • the infusion section and the channel are integrally formed.
  • the distal tip and the infusion section are integrally formed.
  • the channel is pushable.
  • the channel is torqueabie.
  • the distal tip is a hand shapeable tip.
  • the distal tip comprises a tapered shape.
  • the distal tip comprises a conical shape.
  • the distal tip comprises a hydrophilic coating.
  • the infusion section comprises a hydrophilic coating.
  • the channel comprises a hydrophilic coating.
  • a transition section at the attachment of the distal tip to the first end of the infusion section is smooth.
  • the at least one hole is configured to control a direction of flow therethrough.
  • the at least one hole is configured to control a velocity of a flow therethrough.
  • the at least one hole is configured to control a flow rate of a flow therethrough.
  • the at least one hole comprises a plurality of holes. In some embodiments, the plurality of holes are configured to control a direction of flow therethrough.
  • the plurality of holes are configured to control a velocity of a flow therethrough. In some embodiments, the plurality of holes are configured to control a flow rate of a flow therethrough. In some embodiments, the plurality of holes comprises a pattern of holes distributed around a circumference of the infusion secti on. In some embodiments, the pattern of holes is configured to achieve a desired flow pattern, a desired flow direction, and/or a desired flow characteristic. In some embodiments, the at least one hole is configured for delivery of chemicals, beads, fluids, and/or devices. In some embodiments, the infusion catheter further comprises a first radiopaque marker positioned on a first side of the infusion section.
  • the first side of the infusion section is opposite the distal tip. In some embodiments, the first side of the infusion section is the same side as the distal tip. In some embodiments, the infusion catheter further comprises a second radiopaque marker on a second side of the infusion section, the second side of the infusion section opposite the first side of the infusion section. In some embodiments, the infusion catheter further comprises a curve. In some embodiments, the curve is a cobra, SOS 2, or Chuang B type curve.
  • an infusion catheter in a second aspect, includes a floppy distal tip having a solid core, an infusion section attached at a first end to the distal tip, the infusion section including at least one hole, a channel attached to a second end of the infusion section, the channel having a lumen in communication with the at least one hole, and a balloon positioned on the second side of the infusion section, wherein the distal tip is positioned on a first side of the infusion section.
  • the balloon is compliant, semi-compliant, or non- compliant.
  • the infusion catheter further includes a first radiopaque marker on a first side of the compliant balloon.
  • the infusion catheter further includes a second radiopaque marker on a second side of the compliant balloon.
  • the infusion catheter further includes a radiopaque marker positioned within the balloon.
  • the infusion catheter further includes a second lumen in fluid connection with the compliant balloon, the second lumen configured for inflating the compliant balloon.
  • the channel comprises a first channel, the second lumen is formed in a second channel, and the first channel extends through the second channel.
  • the first channel is configured to telescope relative to the second channel.
  • the second channel comprises a braid, a laser cut hypotube, or an electroplated braid.
  • the second channel is pushabie.
  • the second channel is torqueabie.
  • the balloon in a deflated configuration, the balloon has an outer diameter of approximately 1 mm or less, and the balloon can be inflated to an inflated configuration of approximately 5 mm or more.
  • the channel extends through the balloon, and the channel, infusion section, and distal tip are configured to telescope together relative to the balloon.
  • the infusion catheter further includes, a locking hub configured to control the telescoping of the channel, infusion section, and distal tip.
  • the channel comprises a braid, a laser cut hypotube, or an electroplated braid.
  • the infusion section comprises a braid, a laser cut hypotube, or an electroplated braid.
  • the distal tip comprises a braid, a laser cut hypotube, or an electroplated braid.
  • the infusion section and the channel are integrally formed.
  • the distal tip and the infusion section are integrally formed.
  • the channel is pushabie.
  • the channel is torqueabie.
  • the distal tip is a hand shapeable tip.
  • the distal tip comprises a tapered shape.
  • the distal tip comprises a conical shape.
  • the distal tip comprises a hydrophilic coating.
  • the infusion section comprises a hydrophilic coating.
  • the channel comprises a hydrophilic coating.
  • the at least one hole is configured to control a direction of flow therethrough. In some embodiments, the at least one hole is configured to control a velocity of a flow therethrough. In some embodiments, the at least one hole is configured to control a flow rate of a flow therethrough. In some embodiments, the at least one hole comprises a plurality of holes. In some embodiments, the plurality of holes are configured to control a direction of flow therethrough. In some embodiments, the plurality of holes are configured to control a velocity of a flow therethrough.
  • the plurality of holes are configured to control a flow rate of a flow therethrough.
  • the plurality of holes comprises a pattern of holes distributed around a circumference of the infusion section.
  • the pattern of holes is configured to achieve a desired flow pattern, a desired flow direction, and/or a desired flow characteristic.
  • the at least one hole is configured for delivery of chemicals, beads, fluids, and/or devices.
  • the infusion catheter also includes an additional radiopaque marker positioned on a first side of the infusion section.
  • the first side of the infusion section is opposite the distal tip.
  • the first side of the infusion section is the same side as the distal tip.
  • the infusion catheter also includes an additional radiopaque marker on a second side of the infusion section, the second side of the infusion section opposite the first side of the infusion section.
  • the infusion catheter also includes a curve.
  • the curve is a cobra, SOS 2, or Chuang B type curve.
  • an infusion catheter in a third aspect, includes a channel including a lumen in communication with an open end of the channel, and a balloon positioned proximal the open end of the channel.
  • the infusion catheter includes a curve.
  • the curve is a cobra, SOS 2, or Chuang B type curve.
  • the curve is a baked curve.
  • the curve is positioned on an opposite side of the balloon than the open end of the channel.
  • the balloon is compliant, semi-compliant, or non- compliant.
  • the infusion catheter includes a first radiopaque marker on a first side of the compliant balloon.
  • the infusion catheter further includes a second radiopaque marker on a second side of the compliant balloon, the second side opposite the first side.
  • the infusion catheter includes a radiopaque marker positioned within the balloon.
  • the infusion catheter includes a second lumen in fluid connection with the balloon and a port, the second lumen and the port configured for inflating the balloon.
  • the channel comprises a braid, a laser cut hypotube, or an electroplated braid.
  • the channel is pushable.
  • the channel is torqueable.
  • the balloon in a deflated configuration, has an outer diameter of approximately 1 mm or less, and the balloon can be inflated to an inflated configuration of approximately 5 mm or more.
  • the channel extends through the balloon.
  • the infusion catheter includes a luer hub positioned at a second end of the channel, the second end opposite the open end.
  • the channel comprises a hydrophiiic coating.
  • the open end of the channel is configured to control a velocity of a flow therethrough.
  • the open end of the channel configured to control a flow rate of a flow therethrough.
  • the open end of the channel is configured for deliver ⁇ ' of chemicals, beads, fluids, and/or devices.
  • the channel is configured to receive a guide wire or catheter therein.
  • a method in another aspect, includes advancing the infusion catheter of the first aspect through a vessel to a deliver ⁇ ' location, and delivering a substance through the at least one hole of the infusion section to the delivery location.
  • said advancing further comprises advancing the infusion catheter along a guide wire.
  • said advancing further does not require use of a guide wire.
  • the vessel is the common hepatic artery.
  • the substance comprises a fluid, beads, a chemical, or a device.
  • a method in another aspect, includes advancing the infusion catheter of the second aspect through a vessel to a delivery location, and delivering a substance through the at least one hole of the infusion section to the deliver ⁇ ' location.
  • the substance comprises a fluid, beads, a chemical, or a device.
  • the method includes inflating the balloon.
  • inflating the balloon occludes blood flow within the vessel.
  • inflating the balloon temporarily reverses blood flow in one or more collateral vessels.
  • said delivering occurs after said inflating.
  • said advancing further comprises advancing the infusion catheter through a guide catheter.
  • the method includes positioning the infusion section relative to the balloon. In some embodiments, the method includes positioning the infusion section relative to the collateral vessel flow reversal. In some embodiments, said positioning comprises telescoping the first channel relative to the second channel. In some embodiments, said positioning comprises telescoping the first channel relative to the balloon. In some embodiments, the vessel is the common hepatic artery. In some embodiments, the deliver ⁇ ' site is the liver. In some embodiments, the method includes deflating the balloon after deliver ⁇ - of the chemical or beads.
  • a method in another aspect, includes advancing the infusion catheter of the third aspect, through a vessel to a deliver ⁇ ' location, and delivering a substance through the through the open end of the channel to the delivery location.
  • the substance comprises a fluid, beads, a chemical, device, guide wire or catheter.
  • the method further includes inflating the balloon.
  • inflating the balloon occludes blood flow within the vessel.
  • inflating the balloon temporarily reverses blood flow in one or more collateral vessels.
  • said delivering occurs after said inflating.
  • the vessel is the common hepatic artery.
  • the delivery site is the liver.
  • the method also includes deflating the balloon after delivery of the substance.
  • FIG. 1 illustrates a perspective view of a SurefireTM infusion catheter.
  • FIG. 2 illustrates a perspective view of a Renegade HI-FLOTM Fathom Kit including a Renegade HI-FLO Microcatheter and Fathom- 16 Steerable Guidewire.
  • FIG. 3 illustrates a perspective view of a ProStreamTM Multiple Sidehole
  • FIG. 4 illustrates use of an IsoFlowTM Infusion Catheter with a dual- balloon design.
  • FIG. 5 illustrates an embodiment of using an infusion catheter within an arterial system.
  • FIG. 6 illustrates an embodiment of an infusion catheter having a solid core, floppy distal tip.
  • FIG. 7 illustrates an embodiment of an infusion catheter having a telescoping feature.
  • FIG. 8 illustrates an embodiment of an infusion catheter disposed within an arterial system.
  • FIG. 9 illustrates a perspective view of an embodiment of the infusion catheter shown in FIG. 7.
  • FIG. 10 illustrates a perspective view of an embodiment of the infusion catheter shown in FIG. 9.
  • Radioactive microspheres are injected into the hepatic arteries, where they lodge themselves into the cancerous tissue. Here they 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.
  • Radioemboiization currently uses a basic infusion catheter and yttrium 90 (Y-90) microspheres.
  • Y-90 yttrium 90
  • the liver derives blood supply from both the hepatic arteries and the portal vein, growing tumors obtain most their blood supply from the hepatic arteries.
  • the Y-90 radioemboiization procedure has at least two outpatient sessions: a diagnostic session followed by a treatment session.
  • 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 radioemboiization using an antireflux catheter can be used as an alternative to traditional coil embolization for nontarget protection. Serious complications can result from nontarget embolization during yttrium-90 (Y-90) transarterial radioemboiization. Hepatoenteric artery coil embolization has been traditionally performed to prevent non target radioembolization. This catheter results in a reduction in procedure time, fluoroscopy time, and contrast material dose and may be an attractive cost-effective alternative to detachable coil embolization for prevention of nontarget radioembolization.
  • radioactive Y-90 microspheres are injected in the hepatic arteries that perfuse the tumor.
  • the downside to this treatment occurs only when the radioactive microspheres do not reach the tumor, and instead are refluxed to the intestines or shunted to the lungs.
  • two methods can be used. The first is coil embolization, where coils are inserted into surrounding blood vessels in a procedure prior to the microsphere infusion. This helps to prevent microspheres from traveling down the wrong blood vessel.
  • Another method (which can be used in addition to coiling) uses a balloon infusion catheter placed strategically in the common hepatic artery. This ensures that blood flow travels through the correct blood vessels, carrying the microspheres directly to the tumor.
  • Certain catheters are used, in addition to coiling, to try and direct the microspheres to the correct blood vessels.
  • the SureFireTM catheter employs a mesh net (illustrated in FIG. 1), which helps prevent reflux, but does not fix the problem entirely.
  • 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 whim of the physician performing the procedure.
  • the proper balloon and infusion cannula are combined with the perfect placement of the catheter, more patients will have a successful procedure. This means that they will potentially be able to tolerate higher doses and shorter times between doses, and it will also make the procedure significantly more effective and save lives.
  • general dimensions are: outer diameter: 0.038"; balloon expansion from .038" folded profile to approximately 5mm+ made from a compliant material such as urethane. Other suitable materials may also be employed for this purpose.
  • the operator would transverse the device through a guiding catheter that was placed into the celiac trunk and into the common hepatic artery.
  • an integrated guidewire, infusion catheter would be advanced into position to facilitate the delivery of particles, or fluids, or treatments, for example, delivery of radioembolization beads for the treatment of cancers.
  • a combination system, containing the integrated guidewire, infusion catheter and a balloon catheter would be advanced through a guiding catheter placed into the celiac trunk, the balloon would be deployed in the common hepatic artery to block all blood flow coming from the aorta to the liver.
  • This balloon occlusion technique temporarily reverses the blood flow in branch vessels supplying the stomach and small intestine during transarterial embolization. It ensures that blood flow in constantly supplying the liver tumors to be addressed and will serve as a way to ensure that radioembolization does not reflux into un desired locations.
  • a guiding catheter with compliant balloon would be placed distal to the celiac trunk, in the common hepatic artery and would embody a compliant balloon. Then the compliant balloon would be expanded to occlude the arterial flow to reverse flow back through the gastroduodenai artery.
  • the integrated guidewire, infusion embodiment of which would then be passed through the guiding catheter with compliant balloon and advanced into position for the delivery of medicines, beads, etc.
  • the radioembolization would be delivered through the infusion lumen and out the infusion section of the catheter. This serves to perfuse the liver tumor cells.
  • a Surefire 11 " 4 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 increases target deliver and minimizes reflux that might otherwise cause damage to healthy tissue. An example is shown in FIG. 1.
  • a Renegade HI-FLO IM Fathom Kit includes the Renegade HI-FLO Microcatheter and Fathom- 16 Steerabie 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 without compromising control. An example is shown in FIG. 2.
  • a ProStream 1 Multiple Sidehole Infusion Wire allows for quick and easy infusion by eliminating the need for a separate core wire. An example of this is shown in FIG. 3.
  • An IsoFlow 1M 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 IsoFlowTM catheter requires a guide wire for precise placement. An example is shown in FIG. 4.
  • FIG. 6 illustrates an embodiment of an infusion catheter 200.
  • the infusion catheter 200 includes a solid core, floppy distal tip 202.
  • the solid core, floppy distal tip 202 may function in a similar manner to a lead or guidewire.
  • the infusion catheter 200 does not require a separate guidewire,
  • the solid core, floppy distal ti 202 has a tapered, conical shape attached to a smooth transition to a larger profile 204, This larger profile 204 is connected to an infusion section 206.
  • the infusion section 206 includes at least one hole 208 for infusion of one or more chemicals or beads from the infusion section 206 to the vessel in proximity to a biological target in vivo.
  • the biological target is a cancer tumor.
  • the cancer tumor is in the liver.
  • the at least one hole 208 could include a pattern of holes distributed around the outer circumference of the infusion section 206. In some embodiments, the pattern provides a uniform distribution of holes around the infusion section 206.
  • the infusion section 206 is attached to a pushable channel 210.
  • the pushable channel 210 is formed of a stiffer material than the solid core, floppy distal tip 202.
  • the pushable channel 210 includes a single interior lumen in fluid communication with the at least one hole 208 in the infusion section 206.
  • FIGS. 7 and 9 illustrate an embodiment of an infusion catheter 400.
  • the infusion catheter 400 includes an inner infusion catheter 402.
  • the inner infusion catheter 402 has a telescoping feature allowing extension or retraction.
  • the infusion catheter 400 includes a compliant balloon 404 designed to occlude fonvard flow within the vessel when the compliant balloon 404 is in an expanded position.
  • On either side of the compliant balloon is a radiopaque marker 406 used to identify the position of the infusion catheter 400 within the vessel.
  • the infusion catheter 400 further includes a lumen 408 fluidly connected to the compliant balloon 404. The lumen 408 can be used for expanding the compliant balloon 404 to the expanded position.
  • a locking hub 410 is positioned to control the advancement or retraction of the telescoping feature of the inner infusion catheter 402.
  • the infusion catheter 400 On the end of the infusion catheter 400 is a solid core, floppy distal tip 412.
  • the solid core, floppy distal tip 12 may function in a similar manner to a lead or guidewire.
  • the infusion catheter 412 does not require a separate guidewire.
  • the solid core, floppy distal tip 412 has a tapered, conical shape attached to a smooth transition to a larger profile.
  • the infusion section 414 of the infusion catheter 400 includes at least one hole 416 for infusion of one or more chemicals or beads to the vessel in proximity to a biological target in vivo.
  • the biological target is a cancer tumor.
  • the cancer tumor is in the liver.
  • the at least one hole 416 could include a pattern of holes distributed around the outer circumference of the infusion section 414. In some embodiments, the pattern provides a uniform distribution of holes around the infusion section 414.
  • FIGS. 8 and 10 illustrate an embodiment of an infusion catheter 600 disposed within an arterial system including the common hepatic artery ("CHA"), which supplies oxygenated blood to the liver.
  • the infusion catheter 600 includes a catheter 602.
  • the catheter 602 includes a curve 604 similar to, for example, a cobra, an SOS 2 or a Chuang B type curve.
  • a compliant balloon 606 is positioned within the CHA, On either side of the compliant balloon 606 along the infusion catheter 600 is radiopaque marker 608.
  • a luer hub 610 is illustrated on an opposite end of the infusion catheter 600 from the compliant balloon 606. In some embodiments, the luer hub 610 is used to accept catheters or guidewires. In some embodiments, the luer hub 610 is used to accept radioactive beads, drugs or other devices or medicines for pushing through the infusion catheter 600. Near the luer hub 610 is a port 612 in fluid communication with the compliant balloon 606. The port 612 can, therefore, be used for inflating the compliant balloon 606 to an expanded position.

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Abstract

Disclosed herein is a catheter device for deliver)-' of particles or fluid to a desired location. Systems and methods of delivery of particles or fluid are also disclosed.

Description

CATHETER DEVICE FOR DELIVERY OF PARTICLES OR FLUID
BACKGROUND
[0001] Liver cancer is the second largest killer of cancer patients, right after lung cancer. Whether the cancer originated in the liver itself or in another organ, it is a difficult disease to treat, often due to location and resistance to treatments (such as chemotherapy). Radiation has shown to be effective, however 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.
[0002] Currently, the most effective treatment is a surgical resection of the cancerous tissue. However, this only works if the cancer originated from the liver and if it is in an isolated location. Next steps normally involve chemotherapy and radiation treatments. Chemotherapy is not only hard on the body, but the cancer can also be resistant, making treatment ineffective. Radiation has similar effects, and although the cancer is not as resistant, damage to healthy liver tissue is inevitable.
SUMMARY
[0003] In a first aspect, an infusion catheter is disclosed. The infusion catheter includes a floppy distal tip having a solid core, an infusion section attached at a first end to the distal tip, the infusion section including at least one hole, and a channel attached to a second end of the infusion section, the channel having a lumen in communication with the at least one hole.
[0004] In some embodiments, the channel comprises a braid, a laser cut hypotube, or an electroplated braid. In some embodiments, the infusion section comprises a braid, a laser cut hypotube, or an electroplated braid. In some embodiments, the distal tip comprises a braid, a laser cut hypotube, or an electroplated braid. In some embodiments, the infusion section and the channel are integrally formed. In some embodiments, the distal tip and the infusion section are integrally formed. In some embodiments, the channel is pushable. In some embodiments, the channel is torqueabie. In some embodiments, the distal tip is a hand shapeable tip. In some embodiments, the distal tip comprises a tapered shape. In some embodiments, the distal tip comprises a conical shape. In some embodiments, the distal tip comprises a hydrophilic coating. In some embodiments, the infusion section comprises a hydrophilic coating. In some embodiments, the channel comprises a hydrophilic coating. In some embodiments, a transition section at the attachment of the distal tip to the first end of the infusion section is smooth. In some embodiments, the at least one hole is configured to control a direction of flow therethrough. In some embodiments, the at least one hole is configured to control a velocity of a flow therethrough. In some embodiments, the at least one hole is configured to control a flow rate of a flow therethrough. In some embodiments, the at least one hole comprises a plurality of holes. In some embodiments, the plurality of holes are configured to control a direction of flow therethrough. In some embodiments, the plurality of holes are configured to control a velocity of a flow therethrough. In some embodiments, the plurality of holes are configured to control a flow rate of a flow therethrough. In some embodiments, the plurality of holes comprises a pattern of holes distributed around a circumference of the infusion secti on. In some embodiments, the pattern of holes is configured to achieve a desired flow pattern, a desired flow direction, and/or a desired flow characteristic. In some embodiments, the at least one hole is configured for delivery of chemicals, beads, fluids, and/or devices. In some embodiments, the infusion catheter further comprises a first radiopaque marker positioned on a first side of the infusion section. In some embodiments, the first side of the infusion section is opposite the distal tip. In some embodiments, the first side of the infusion section is the same side as the distal tip. In some embodiments, the infusion catheter further comprises a second radiopaque marker on a second side of the infusion section, the second side of the infusion section opposite the first side of the infusion section. In some embodiments, the infusion catheter further comprises a curve. In some embodiments, the curve is a cobra, SOS 2, or Chuang B type curve.
[0005] In a second aspect, an infusion catheter is disclosed. The infusion catheter includes a floppy distal tip having a solid core, an infusion section attached at a first end to the distal tip, the infusion section including at least one hole, a channel attached to a second end of the infusion section, the channel having a lumen in communication with the at least one hole, and a balloon positioned on the second side of the infusion section, wherein the distal tip is positioned on a first side of the infusion section.
[0006] In some embodiments, the balloon is compliant, semi-compliant, or non- compliant. In some embodiments, the infusion catheter further includes a first radiopaque marker on a first side of the compliant balloon. In some embodiments, the infusion catheter further includes a second radiopaque marker on a second side of the compliant balloon. In some embodiments, the infusion catheter further includes a radiopaque marker positioned within the balloon. In some embodiments, the infusion catheter further includes a second lumen in fluid connection with the compliant balloon, the second lumen configured for inflating the compliant balloon. In some embodiments, the channel comprises a first channel, the second lumen is formed in a second channel, and the first channel extends through the second channel. In some embodiments, the first channel is configured to telescope relative to the second channel. In some embodiments, the second channel comprises a braid, a laser cut hypotube, or an electroplated braid. In some embodiments, the second channel is pushabie. In some embodiments, the second channel is torqueabie. In some embodiments, in a deflated configuration, the balloon has an outer diameter of approximately 1 mm or less, and the balloon can be inflated to an inflated configuration of approximately 5 mm or more. In some embodiments, the channel extends through the balloon, and the channel, infusion section, and distal tip are configured to telescope together relative to the balloon. In some embodiments, the infusion catheter further includes, a locking hub configured to control the telescoping of the channel, infusion section, and distal tip. In some embodiments, the channel comprises a braid, a laser cut hypotube, or an electroplated braid. In some embodiments, the infusion section comprises a braid, a laser cut hypotube, or an electroplated braid. In some embodiments, the distal tip comprises a braid, a laser cut hypotube, or an electroplated braid. In some embodiments, the infusion section and the channel are integrally formed. In some embodiments, the distal tip and the infusion section are integrally formed. In some embodiments, the channel is pushabie. In some embodiments, the channel is torqueabie. In some embodiments, the distal tip is a hand shapeable tip. In some embodiments, the distal tip comprises a tapered shape. In some embodiments, the distal tip comprises a conical shape. In some embodiments, the distal tip comprises a hydrophilic coating. In some embodiments, the infusion section comprises a hydrophilic coating. In some embodiments, the channel
-J- comprises a hydrophilic coating. In some embodiments, a transition section at the attachment of the distal tip to the first end of the infusion section is smooth. In some embodiments, the at least one hole is configured to control a direction of flow therethrough. In some embodiments, the at least one hole is configured to control a velocity of a flow therethrough. In some embodiments, the at least one hole is configured to control a flow rate of a flow therethrough. In some embodiments, the at least one hole comprises a plurality of holes. In some embodiments, the plurality of holes are configured to control a direction of flow therethrough. In some embodiments, the plurality of holes are configured to control a velocity of a flow therethrough. In some embodiments, the plurality of holes are configured to control a flow rate of a flow therethrough. In some embodiments, the plurality of holes comprises a pattern of holes distributed around a circumference of the infusion section. In some embodiments, the pattern of holes is configured to achieve a desired flow pattern, a desired flow direction, and/or a desired flow characteristic. In some embodiments, the at least one hole is configured for delivery of chemicals, beads, fluids, and/or devices. In some embodiments, the infusion catheter also includes an additional radiopaque marker positioned on a first side of the infusion section. In some embodiments, the first side of the infusion section is opposite the distal tip. In some embodiments, the first side of the infusion section is the same side as the distal tip. In some embodiments the infusion catheter also includes an additional radiopaque marker on a second side of the infusion section, the second side of the infusion section opposite the first side of the infusion section. In some embodiments the infusion catheter also includes a curve. In some embodiments, the curve is a cobra, SOS 2, or Chuang B type curve.
[0007] In a third aspect, an infusion catheter is disclosed. The infusion catheter includes a channel including a lumen in communication with an open end of the channel, and a balloon positioned proximal the open end of the channel. In some embodiments, the infusion catheter includes a curve. In some embodiments, the curve is a cobra, SOS 2, or Chuang B type curve. In some embodiments, the curve is a baked curve. In some embodiments, the curve is positioned on an opposite side of the balloon than the open end of the channel. In some embodiments, the balloon is compliant, semi-compliant, or non- compliant. In some embodiments, the infusion catheter includes a first radiopaque marker on a first side of the compliant balloon. In some embodiments, the infusion catheter further includes a second radiopaque marker on a second side of the compliant balloon, the second side opposite the first side. In some embodiments, the infusion catheter includes a radiopaque marker positioned within the balloon. In some embodiments, the infusion catheter includes a second lumen in fluid connection with the balloon and a port, the second lumen and the port configured for inflating the balloon. In some embodiments, the channel comprises a braid, a laser cut hypotube, or an electroplated braid. In some embodiments, the channel is pushable. In some embodiments, the channel is torqueable. In some embodiments, in a deflated configuration, the balloon has an outer diameter of approximately 1 mm or less, and the balloon can be inflated to an inflated configuration of approximately 5 mm or more. In some embodiments, the channel extends through the balloon. In some embodiments the infusion catheter includes a luer hub positioned at a second end of the channel, the second end opposite the open end. In some embodiments, the channel comprises a hydrophiiic coating. In some embodiments, the open end of the channel is configured to control a velocity of a flow therethrough. In some embodiments, the open end of the channel configured to control a flow rate of a flow therethrough. In some embodiments, the open end of the channel is configured for deliver}' of chemicals, beads, fluids, and/or devices. In some embodiments, the channel is configured to receive a guide wire or catheter therein.
[0008] In another aspect, a method is disclosed. The method includes advancing the infusion catheter of the first aspect through a vessel to a deliver}' location, and delivering a substance through the at least one hole of the infusion section to the delivery location. In some embodiments, said advancing further comprises advancing the infusion catheter along a guide wire. In some embodiments, said advancing further does not require use of a guide wire. In some embodiments, the vessel is the common hepatic artery. In some embodiments, the substance comprises a fluid, beads, a chemical, or a device.
[0009] In another aspect, a method is disclosed. The method includes advancing the infusion catheter of the second aspect through a vessel to a delivery location, and delivering a substance through the at least one hole of the infusion section to the deliver}' location. In some embodiments, the substance comprises a fluid, beads, a chemical, or a device. In some embodiments, the method includes inflating the balloon. In some embodiments, inflating the balloon occludes blood flow within the vessel. In some embodiments, inflating the balloon temporarily reverses blood flow in one or more collateral vessels. In some embodiments, said delivering occurs after said inflating. In some embodiments, said advancing further comprises advancing the infusion catheter through a guide catheter. In some embodiments, the method includes positioning the infusion section relative to the balloon. In some embodiments, the method includes positioning the infusion section relative to the collateral vessel flow reversal. In some embodiments, said positioning comprises telescoping the first channel relative to the second channel. In some embodiments, said positioning comprises telescoping the first channel relative to the balloon. In some embodiments, the vessel is the common hepatic artery. In some embodiments, the deliver}' site is the liver. In some embodiments, the method includes deflating the balloon after deliver}- of the chemical or beads.
[0010] In another aspect, a method is disclosed. The method includes advancing the infusion catheter of the third aspect, through a vessel to a deliver}' location, and delivering a substance through the through the open end of the channel to the delivery location. In some embodiments, the substance comprises a fluid, beads, a chemical, device, guide wire or catheter. In some embodiments, the method further includes inflating the balloon. In some embodiments, inflating the balloon occludes blood flow within the vessel. In some embodiments, inflating the balloon temporarily reverses blood flow in one or more collateral vessels. In some embodiments, said delivering occurs after said inflating. In some embodiments, the vessel is the common hepatic artery. In some embodiments, the delivery site is the liver. In some embodiments, the method also includes deflating the balloon after delivery of the substance.
BRIEF DESCRIPTION OF THE DRAWINGS
[0011] FIG. 1 illustrates a perspective view of a Surefire™ infusion catheter.
[0012] FIG. 2 illustrates a perspective view of a Renegade HI-FLO™ Fathom Kit including a Renegade HI-FLO Microcatheter and Fathom- 16 Steerable Guidewire.
[0013] FIG. 3 illustrates a perspective view of a ProStream™ Multiple Sidehole
Infusion Wire.
[0014] FIG. 4 illustrates use of an IsoFlow™ Infusion Catheter with a dual- balloon design. 15] FIG. 5 illustrates an embodiment of using an infusion catheter within an arterial system.
[0016] FIG. 6 illustrates an embodiment of an infusion catheter having a solid core, floppy distal tip.
[0017] FIG. 7 illustrates an embodiment of an infusion catheter having a telescoping feature.
[0018] FIG. 8 illustrates an embodiment of an infusion catheter disposed within an arterial system.
[0019] FIG. 9 illustrates a perspective view of an embodiment of the infusion catheter shown in FIG. 7.
[0020] FIG. 10 illustrates a perspective view of an embodiment of the infusion catheter shown in FIG. 9.
DETAILED DESCRIPTION OF CERTAIN INVENTIVE EMBODIMENTS
[0021] One promising method of treatment of cancers is radioemboiization. Radioactive microspheres are injected into the hepatic arteries, where they lodge themselves into the cancerous tissue. Here they 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.
[0022] Radioemboiization currently uses a basic infusion catheter and yttrium 90 (Y-90) microspheres. Although the liver derives blood supply from both the hepatic arteries and the portal vein, growing tumors obtain most their blood supply from the hepatic arteries. Usually the Y-90 radioemboiization 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.
[0023] Yttrium-90 resin microsphere radioemboiization using an antireflux catheter can be used as an alternative to traditional coil embolization for nontarget protection. Serious complications can result from nontarget embolization during yttrium-90 (Y-90) transarterial radioemboiization. Hepatoenteric artery coil embolization has been traditionally performed to prevent non target radioembolization. This catheter results in a reduction in procedure time, fluoroscopy time, and contrast material dose and may be an attractive cost-effective alternative to detachable coil embolization for prevention of nontarget radioembolization.
[0024] During the treatment session, radioactive Y-90 microspheres are injected in the hepatic arteries that perfuse the tumor. The downside to this treatment occurs only when the radioactive microspheres do not reach the tumor, and instead are refluxed to the intestines or shunted to the lungs. In order to avoid this, two methods can be used. The first is coil embolization, where coils are inserted into surrounding blood vessels in a procedure prior to the microsphere infusion. This helps to prevent microspheres from traveling down the wrong blood vessel.
[0025] Another method (which can be used in addition to coiling) uses a balloon infusion catheter placed strategically in the common hepatic artery. This ensures that blood flow travels through the correct blood vessels, carrying the microspheres directly to the tumor.
[0026] Certain catheters are used, in addition to coiling, to try and direct the microspheres to the correct blood vessels. The SureFire™ catheter employs a mesh net (illustrated in FIG. 1), which helps prevent 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 whim of the physician performing the procedure. When the proper balloon and infusion cannula are combined with the perfect placement of the catheter, more patients will have a successful procedure. This means that they will potentially be able to tolerate higher doses and shorter times between doses, and it will also make the procedure significantly more effective and save lives.
[0027] In some embodiments, general dimensions are: outer diameter: 0.038"; balloon expansion from .038" folded profile to approximately 5mm+ made from a compliant material such as urethane. Other suitable materials may also be employed for this purpose.
[0028] During use, the operator would transverse the device through a guiding catheter that was placed into the celiac trunk and into the common hepatic artery. In one embodiment, an integrated guidewire, infusion catheter would be advanced into position to facilitate the delivery of particles, or fluids, or treatments, for example, delivery of radioembolization beads for the treatment of cancers. In another embodiment a combination system, containing the integrated guidewire, infusion catheter and a balloon catheter would be advanced through a guiding catheter placed into the celiac trunk, the balloon would be deployed in the common hepatic artery to block all blood flow coming from the aorta to the liver. This balloon occlusion technique temporarily reverses the blood flow in branch vessels supplying the stomach and small intestine during transarterial embolization. It ensures that blood flow in constantly supplying the liver tumors to be addressed and will serve as a way to ensure that radioembolization does not reflux into un desired locations. In another embodiment, a guiding catheter with compliant balloon would be placed distal to the celiac trunk, in the common hepatic artery and would embody a compliant balloon. Then the compliant balloon would be expanded to occlude the arterial flow to reverse flow back through the gastroduodenai artery. The integrated guidewire, infusion embodiment of which would then be passed through the guiding catheter with compliant balloon and advanced into position for the delivery of medicines, beads, etc.
[0029] Once the desired blood flow reversal has been confirmed the radioembolization would be delivered through the infusion lumen and out the infusion section of the catheter. This serves to perfuse the liver tumor cells.
[0030] Once the adequate amount of active beads have been infused, the balloon would be deflated, restoring normal flow. An embodiment of use is illustrated in FIG. 5,
Existing Devices
[0031] A Surefire11"4 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 increases target deliver and minimizes reflux that might otherwise cause damage to healthy tissue. An example is shown in FIG. 1.
[0032] A Renegade HI-FLO IM Fathom Kit includes the Renegade HI-FLO Microcatheter and Fathom- 16 Steerabie 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 without compromising control. An example is shown in FIG. 2. [0033] A ProStream 1 Multiple Sidehole Infusion Wire allows for quick and easy infusion by eliminating the need for a separate core wire. An example of this is shown in FIG. 3.
[0034] An IsoFlow1M 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.
[0035] FIG. 6 illustrates an embodiment of an infusion catheter 200. The infusion catheter 200 includes a solid core, floppy distal tip 202. The solid core, floppy distal tip 202 may function in a similar manner to a lead or guidewire. Thus, in contrast to some systems requiring both a guidewire and a catheter, the infusion catheter 200 does not require a separate guidewire,
[0036] In some embodiments, the solid core, floppy distal ti 202 has a tapered, conical shape attached to a smooth transition to a larger profile 204, This larger profile 204 is connected to an infusion section 206. The infusion section 206 includes at least one hole 208 for infusion of one or more chemicals or beads from the infusion section 206 to the vessel in proximity to a biological target in vivo. In some embodiments, the biological target is a cancer tumor. In some embodiments, the cancer tumor is in the liver. The at least one hole 208 could include a pattern of holes distributed around the outer circumference of the infusion section 206. In some embodiments, the pattern provides a uniform distribution of holes around the infusion section 206. The infusion section 206 is attached to a pushable channel 210. The pushable channel 210 is formed of a stiffer material than the solid core, floppy distal tip 202. The pushable channel 210 includes a single interior lumen in fluid communication with the at least one hole 208 in the infusion section 206.
[0037] FIGS. 7 and 9 illustrate an embodiment of an infusion catheter 400. The infusion catheter 400 includes an inner infusion catheter 402. In some embodiments, the inner infusion catheter 402 has a telescoping feature allowing extension or retraction. The infusion catheter 400 includes a compliant balloon 404 designed to occlude fonvard flow within the vessel when the compliant balloon 404 is in an expanded position. On either side of the compliant balloon is a radiopaque marker 406 used to identify the position of the infusion catheter 400 within the vessel. The infusion catheter 400 further includes a lumen 408 fluidly connected to the compliant balloon 404. The lumen 408 can be used for expanding the compliant balloon 404 to the expanded position.
[0038] A locking hub 410 is positioned to control the advancement or retraction of the telescoping feature of the inner infusion catheter 402.
[0039] On the end of the infusion catheter 400 is a solid core, floppy distal tip 412. The solid core, floppy distal tip 12 may function in a similar manner to a lead or guidewire. Thus, in contrast to some systems requiring both a guidewire and a catheter, the infusion catheter 412 does not require a separate guidewire. In some embodiments, the solid core, floppy distal tip 412 has a tapered, conical shape attached to a smooth transition to a larger profile.
[0040] The infusion section 414 of the infusion catheter 400 includes at least one hole 416 for infusion of one or more chemicals or beads to the vessel in proximity to a biological target in vivo. In some embodiments, the biological target is a cancer tumor. In some embodiments, the cancer tumor is in the liver. The at least one hole 416 could include a pattern of holes distributed around the outer circumference of the infusion section 414. In some embodiments, the pattern provides a uniform distribution of holes around the infusion section 414.
[0041] FIGS. 8 and 10 illustrate an embodiment of an infusion catheter 600 disposed within an arterial system including the common hepatic artery ("CHA"), which supplies oxygenated blood to the liver. The infusion catheter 600 includes a catheter 602. The catheter 602 includes a curve 604 similar to, for example, a cobra, an SOS 2 or a Chuang B type curve.
[0042] As illustrated in FIG. 8, a compliant balloon 606 is positioned within the CHA, On either side of the compliant balloon 606 along the infusion catheter 600 is radiopaque marker 608. A luer hub 610 is illustrated on an opposite end of the infusion catheter 600 from the compliant balloon 606. In some embodiments, the luer hub 610 is used to accept catheters or guidewires. In some embodiments, the luer hub 610 is used to accept radioactive beads, drugs or other devices or medicines for pushing through the infusion catheter 600. Near the luer hub 610 is a port 612 in fluid communication with the compliant balloon 606. The port 612 can, therefore, be used for inflating the compliant balloon 606 to an expanded position.
[0043] The disclosure above encompasses multiple distinct inventions with independent utility. While each of these inventions has been disclosed in a particular form, the specific embodiments disclosed and illustrated above are not to be considered in a limiting sense as numerous variations are possible. The subject matter of the inventions includes ail novel and nonobvious combinations and subcombinations of the various elements, features, functions and/or properties disclosed above and inherent to those skilled in the art pertaining to such inventions.
[0044] Where the disclosure or subsequently filed claims recite "a" element, "a first" element, or any such equivalent term, the disclosure or claims should be understood to incorporate one or more such elements, neither requiring nor excluding two or more such elements.
[0045] Applicant reserves the right to submit claims directed to combinations and subcombinations of the disclosed inventions that are believed to be novel and non-obvious. Inventions embodied in other combinations and subcombinations of features, functions, elements and/or properties may be claimed through amendment of those claims or presentation of new claims in the present application or in a related application. Such amended or new claims, whether they are directed to the same invention or a different invention and whether they are different, broader, narrower or equal in scope to the original claims, are to be considered within the subject matter of the inventions described herein.

Claims

WHAT IS CLAIMED IS:
1 . An infusion catheter, comprising:
a floppy distal tip having a solid core;
an infusion section attached at a first end to the distal tip, the infusion section including at least one hole; and
a channel attached to a second end of the infusion section, the channel having a lumen in communication with the at least one hole.
2. The infusion catheter of Claim 1 , wherein the channel comprises a braid, a laser cut hypotube, or an electroplated braid.
3. The infusion catheter of any of Claims 1 -2, wherein the infusion section comprises a braid, a laser cut hypotube, or an electroplated braid.
4. The infusion catheter of any of Claims 1-3, wherein the distal tip comprises a braid, a laser cut hypotube, or an electroplated braid.
5. The infusion catheter of any of Claims 1-4, wherein the infusion section and the channel are integrally formed.
6. The infusion catheter of any of Claims 1 -5, wherein the distal tip and the infusion section are integrally formed,
7. The infusion catheter of any of Claims 1 -6, wherein the channel is pushable.
8. The infusion catheter of any of Claims 1 -7, wherein the channel is torqueable.
9. The infusion catheter of any of Claims 1-8, wherein the distal tip is a hand shapeable tip.
10. The infusion catheter of any of Claims 1-9, wherein the distal tip comprises a tapered shape.
11. The infusion catheter of any of Claims 1-10, wherein the distal tip comprises a conical shape.
12. The infusion catheter of any of Claims 1-1 1 , wherein the distal tip comprises a hydrophilic coating.
13. The infusion catheter of any of Claims 1-12, wherein the infusion section comprises a hydrophilic coating.
14. The infusion catheter of any of Claims 1-13, wherein the channel comprises a hydrophilic coating.
15. The infusion catheter of any of Claims 1.-14, wherein a transition section at the attachment of the distal tip to the first end of the infusion section is smooth.
16. The infusion catheter of any of Claims 1-15, wherein the at least one hole is configured to control a direction of flow therethrough.
17. The infusion catheter of any of Claims 1-16, wherein the at least one hole is configured to control a velocity of a flow therethrough,
18. The infusion catheter of any of Claims 1 -17, wherein the at least one hole is configured to control a flow rate of a flow therethrough.
19. The infusion catheter of any of Claims 1-18, wherein the at least one hole comprises a plurality of holes.
20. The infusion catheter of Claim 19, wherein the plurality of holes are configured to control a direction of flow therethrough.
21. The infusion catheter of any of Claims 19-20, wherein the plurality of holes are configured to control a velocity of a flow therethrough.
22. The infusion catheter of any of Claims 19-21, wherein the plurality of holes are configured to control a flow rate of a flow therethrough,
23. The infusion catheter of any of Claims 19-22, wherein the plurality of holes comprises a pattern of holes distributed around a circumference of the infusion section.
24. The infusion catheter of Claim 23, wherein the pattern of holes is configured to achieve a desired flow pattern, a desired flow direction, and/or a desired flow characteristic.
25. The infusion catheter of any of Claims 1 -24, wherein the at least one hole is configured for delivery of chemicals, beads, fluids, and/or devices,
26. The infusion catheter of any of Claims 1-25, further comprising a first radiopaque marker positioned on a first side of the infusion section.
27. The infusion catheter of Claim 26, wherein the first side of the infusion section is opposite the distal tip.
28. The infusion catheter of Claim 26, wherein the first side of the infusion section is the same side as the distal tip.
29. The infusion catheter of any of Claims 26-28, further comprising a second radiopaque marker on a second side of the infusion section, the second side of the infusion section opposite the first side of the infusion section.
30. The infusion catheter of any of Claims 1-29, further comprising a curve.
31. The infusion catheter of Claim 30, wherein the curve is a cobra, SOS 2, or Chuang B type curve.
32. An infusion catheter, comprising:
a floppy distal tip having a solid core;
an infusion section attached at a first end to the distal tip, the infusion section including at least one hole;
a channel attached to a second end of the infusion section, the channel having a lumen in communication with the at least one hole; and
a balloon positioned on the second side of the infusion section, wherein the distal tip is positioned on a first side of the infusion secti on.
33. The infusion catheter of Claim 32, wherein the balloon is compliant, semi- compliant, or non-compliant.
34. The infusion catheter of any of Claims 32-33, further comprising a first radiopaque marker on a first side of the compliant balloon.
35. The infusion catheter of Claim 34, further comprising a second radiopaque marker on a second side of the compliant balloon.
36. The infusion catheter of any of Claims 32-35, further comprising a radiopaque marker positioned within the balloon.
37. The infusion catheter of any of Claims 32-36, further comprising a second lumen in fluid connection with the compliant balloon, the second lumen configured for inflating the compliant balloon.
38. The infusion catheter of Claim 37, wherein the channel comprises a first channel, wherein the second lumen is formed in a second channel, wherein the first channel extends through the second channel.
39. The infusion catheter of any of Claim 38, wherein the first channel is configured to telescope relative to the second channel.
40. The infusion catheter of any of Claims 38-39, wherein the second channel comprises a braid, a laser cut hypotube, or an electroplated braid.
41. The infusion catheter of any of Claims 38-40, wherein the second channel is pushable.
42. The infusion catheter of any of Claims 38-41, wherein the second channel is torqueable.
43. The infusion catheter of any of Claims 32-41 , wherein, in a deflated configuration, the balloon has an outer diameter of approximately 1 mm or less, and the balloon can be inflated to an inflated configuration of approximately 5 mm or more.
44. The infusion catheter of any of Claims 32-43, wherein the channel extends through the balloon, and wherein the channel, infusion section, and distal tip are configured to telescope together relative to the balloon.
45. The infusion catheter of Claim 44, further comprising a locking hub configured to control the telescoping of the channel, infusion section, and distal tip.
46. The infusion catheter of any of Claims 32-45, wherein the channel comprises a braid, a laser cut hypotube, or an electroplated braid.
47. The infusion catheter of any of Claims 32-46, wherein the infusion section comprises a braid, a laser cut hypotube, or an electroplated braid.
48. The infusion catheter of any of Claims 32-47, wherein the distal tip comprises a braid, a laser cut hypotube, or an electroplated braid.
49. The infusion catheter of any of Claims 32-48, wherein the infusion section and the channel are integrally formed.
50. The infusion catheter of any of Claims 32-49, wherein the distal tip and the infusion section are integrally formed.
51. The infusion catheter of any of Claims 32-50, wherein the channel is pushable.
52. The infusion catheter of any of Claims 32-51, wherein the channel is torqueable.
53. The infusion catheter of any of Claims 32-52, wherein the distal tip is a hand shapeable tip.
54. The infusion catheter of any of Claims 32-53, wherein the distal tip comprises a tapered shape.
55. The infusion catheter of any of Claims 32-54, wherein the distal tip comprises a conical shape.
56. The infusion catheter of any of Claims 32-55, wherein the distal tip comprises a hydrophilic coating.
57. The infusion catheter of any of Claims 32-56, wherein the infusion section comprises a hydrophilic coating.
58. The infusion catheter of any of Claims 32-57, wherein the channel comprises a hydrophilic coating.
59. The infusion catheter of any of Claims 32-58, wherein a transition section at the attachment of the distal tip to the first end of the infusion section is smooth.
60. The infusion catheter of any of Claims 32-59, wherein the at least one hole is configured to control a direction of flow therethrough.
61. The infusion catheter of any of Claims 32-60, wherein the at least one hole is configured to control a velocity of a flow therethrough.
62. The infusion catheter of any of Claims 32-61, wherein the at least one hole is configured to control a flow rate of a flow therethrough.
63. The infusion catheter of any of Claims 32-62, wherein the at least one hole comprises a plurality of holes.
64. The infusion catheter of Claim 63, wherein the plurality of holes are configured to control a direction of fl ow therethrough.
65. The infusion catheter of any of Claims 63-64, wherein the plurality of holes are configured to control a velocity of a flow therethrough.
66. The infusion catheter of any of Claims 63-65, wherein the plurality of holes are configured to control a flow rate of a flow therethrough.
67. The infusion catheter of any of Claims 63-66, wherein the plurality of holes comprises a pattern of holes distributed around a circumference of the infusion section.
68. The infusion catheter of Claim 67, wherein the pattern of holes is configured to achieve a desired flow pattern, a desired flow direction, and/or a desired flow characteristic.
69. The infusion catheter of any of Claims 32-68, wherein the at least one hole is configured for deliver}' of chemicals, beads, fluids, and/or devices.
70. The infusion catheter of any of Claims 32-69, further comprising an additional radiopaque marker positioned on a first side of the infusion section.
71. The infusion catheter of Claim 70, wherein the first side of the infusion section is opposite the distal tip.
72. The infusion catheter of Claim 70, wherein the first side of the infusion section is the same side as the distal tip.
73. The infusion catheter of any of Claims 70-72, further comprising an additional radiopaque marker on a second side of the infusion section, the second side of the infusion section opposite the first side of the infusion section.
74. The infusion catheter of any of Claims 32-73, further comprising a curve.
75. The infusion catheter of Claim 74, wherein the curve is a cobra, SOS 2, or Chuang B type curve.
76. An infusion catheter, comprising:
a channel including a lumen in communication with an open end of the channel; and
a balloon positioned proximal the open end of the channel.
77. The infusion catheter of Claim 76, further comprising a curve.
78. The infusion catheter of any of Claims 76-77, wherein the curve is a cobra, SOS 2, or Chuang B type curve.
79. The infusion catheter of any of Claims 76-78, wherein the curve is a baked curve.
80. The infusion catheter of any of Claims 76-79, wherein the curve is positioned on an opposite side of the balloon than the open end of the channel.
81. The infusion catheter of any of Claims 76-80, wherein the balloon is compliant, semi -compliant, or non-compliant.
82. The infusion catheter of any of Claims 76-81, further comprising a first radiopaque marker on a first side of the compliant balloon.
83. The infusion catheter of Claim 82, further comprising a second radiopaque marker on a second side of the compliant balloon, the second side opposite the first side.
84. The infusion catheter of any of Claims 76-83, further comprising a radiopaque marker positioned within the balloon.
85. The infusion catheter of any of Claims 76-84, further comprising a second lumen in fluid connection with the balloon and a port, the second lumen and the port configured for inflating the balloon.
86. The infusion catheter of any of Claims 76-85, wherein the channel comprises a braid, a laser cut hypotube, or an electroplated braid.
87. The infusion catheter of any of Claims 76-86, wherein the channel is pushable.
88. The infusion catheter of any of Claims 76-87, wherein the channel is torqueable.
89. The infusion catheter of any of Claims 76-88, wherein, in a deflated configuration, the balloon has an outer diameter of approximately 1 mm or less, and the balloon can be inflated to an inflated configuration of approximately 5 mm or more.
90. The infusion catheter of any of Claims 76-89, wherein the channel extends through the balloon.
91. The infusion catheter of any of Claims 76-90, further comprising a iuer hub positioned at a second end of the channel, the second end opposite the open end.
92. The infusion catheter of any of Claims 76-91, wherein the channel comprises a hydrophiiic coating.
93. The infusion catheter of any of Claims 76-92, wherein the open end of the channel is configured to control a velocity of a flow therethrough.
94. The infusion catheter of any of Claims 76-93, wherein the open end of the channel configured to control a flow rate of a flow therethrough.
95. The infusion catheter of any of Claims 76-94, wherein the open end of the channel is configured for delivery of chemicals, beads, fluids, and/or devices.
96. The infusion catheter of any of Claims 76-95, wherein the channel is configured to receive a guide wire or catheter therein.
97. A method comprising:
advancing the infusion catheter of any of Claims 1-31 through a vessel to a delivery location; and delivering a substance through the at least one hole of the infusion section to the delivery location.
98. The method of Claim 97, wherein said advancing further comprises advancing the infusion catheter along a guide wire.
99. The method of Claim 97, wherein said advancing further does not require use of a guide wire.
100. The method of any of Claims 97-99, wherein the vessel is the common hepatic artery,
101. The method of any of Claims 97-100, wherein the substance comprises a fluid, beads, a chemical, or a device.
102. A method comprising:
advancing the infusion catheter of any of Claims 32-75 through a vessel to a delivery location; and
delivering a substance through the at least one hole of the infusion section to the delivery location.
103. The method of Claim 102, wherein the substance comprises a fluid, beads, a chemical, or a device,
104. The method of any of Claims 102-103, further comprising inflating the balloon.
105. The method of Claim 104, wherein inflating the balloon occludes blood flow within the vessel.
106. The method of Claim 104-105, wherein inflating the balloon temporarily reverses blood flow in one or more collateral vessels.
107. The method of any of Claims 104-106, wherein said delivering occurs after said inflating.
108. The method of any of Claims 102-107, wherein said advancing further comprises advancing the infusion catheter through a guide catheter.
109. The method of any of Claims 102-108, further comprising positioning the infusion section relative to the balloon.
110. The method of any of Claims 102-109, further comprising positioning the infusion section relative to the collateral vessel flow reversal.
1 11. The method of Claim 109, wherein said positioning comprises telescoping the first channel relative to the second channel.
112. The method of Claim 109, wherein said positioning comprises telescoping the first channel relative to the balloon.
1 13. The method of any of Claims 102-112, wherein the vessel is the common hepatic artery.
1 14. The method of any of Claims 102-1 13, wherein the delivery site is the liver.
115. The method of any of Claims 102-1 14, further comprising deflating the balloon after delivery of the substance,
116. A method comprising:
advancing the infusion catheter of any of Claims 76-96, through a vessel to a delivery location; and
delivering a substance through the through the open end of the channel to the delivery location.
117. The method of Claim 116, wherein the substance comprises a fluid, beads, a chemical, device, guide wire or catheter.
1 18. The method of any of Claims 116-1 17, further comprising inflating the balloon.
119. The method of Claim 1 16-1 18, wherein inflating the balloon occludes blood flow within the vessel.
120. The method of Claim 116-119, wherein inflating the balloon temporarily reverses blood flow in one or more collateral vessels.
121. The method of any of Claims 1 16-120, wherein said delivering occurs after said inflating.
122. The method of any of Claims 1 16-121 , wherein the vessel is the common hepatic artery.
123. The method of any of Claims 116-122, wherein the delivery site is the liver.
124. The method of any of Claims 1 16-123, further comprising deflating the balloon after delivery of the substance.
- l -
PCT/US2016/052686 2015-09-21 2016-09-20 Catheter device for delivery of particles or fluid WO2017053310A1 (en)

Applications Claiming Priority (2)

Application Number Priority Date Filing Date Title
US201562221263P 2015-09-21 2015-09-21
US62/221,263 2015-09-21

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Citations (4)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US6315757B1 (en) * 1995-12-04 2001-11-13 Target Therapeutics, Inc. Braided body balloon catheter
US20070106258A1 (en) * 2003-03-12 2007-05-10 Jessica Chiu Retrograde pressure regulated infusion
US20090105642A1 (en) * 2007-10-22 2009-04-23 Abbott Cardiovascular Systems Inc. Low profile agent delivery perfusion catheter having reversibly expanding frames
EP1683541B1 (en) * 2005-01-24 2012-04-25 Makram R. Ebeid Balloon catheter for use in positioning a stent in a curved segment of a blood vesel

Patent Citations (4)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US6315757B1 (en) * 1995-12-04 2001-11-13 Target Therapeutics, Inc. Braided body balloon catheter
US20070106258A1 (en) * 2003-03-12 2007-05-10 Jessica Chiu Retrograde pressure regulated infusion
EP1683541B1 (en) * 2005-01-24 2012-04-25 Makram R. Ebeid Balloon catheter for use in positioning a stent in a curved segment of a blood vesel
US20090105642A1 (en) * 2007-10-22 2009-04-23 Abbott Cardiovascular Systems Inc. Low profile agent delivery perfusion catheter having reversibly expanding frames

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