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WO2018129127A1 - Aiguille d'accès à un ganglion lymphatique - Google Patents

Aiguille d'accès à un ganglion lymphatique Download PDF

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Publication number
WO2018129127A1
WO2018129127A1 PCT/US2018/012302 US2018012302W WO2018129127A1 WO 2018129127 A1 WO2018129127 A1 WO 2018129127A1 US 2018012302 W US2018012302 W US 2018012302W WO 2018129127 A1 WO2018129127 A1 WO 2018129127A1
Authority
WO
WIPO (PCT)
Prior art keywords
needle
lymph node
securing device
securing
liquid
Prior art date
Legal status (The legal status 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 status listed.)
Ceased
Application number
PCT/US2018/012302
Other languages
English (en)
Inventor
Maxim ITKIN
Current Assignee (The listed assignees may be inaccurate. Google has not performed a legal analysis and makes no representation or warranty as to the accuracy of the list.)
University of Pennsylvania Penn
Original Assignee
University of Pennsylvania Penn
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 University of Pennsylvania Penn filed Critical University of Pennsylvania Penn
Publication of WO2018129127A1 publication Critical patent/WO2018129127A1/fr
Anticipated expiration legal-status Critical
Ceased legal-status Critical Current

Links

Classifications

    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61M—DEVICES 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
    • A61M5/00—Devices for bringing media into the body in a subcutaneous, intra-vascular or intramuscular way; Accessories therefor, e.g. filling or cleaning devices, arm-rests
    • A61M5/14—Infusion devices, e.g. infusing by gravity; Blood infusion; Accessories therefor
    • A61M5/158—Needles for infusions; Accessories therefor, e.g. for inserting infusion needles, or for holding them on the body

Definitions

  • the lymphatic system plays a key role in fat and protein transport and the removal of interstitial fluid from soft tissues. Imaging of the lymphatic system can be crucial to understanding its role in disease processes and to planning lymphatic interventions. This can be especially important with the development of newer minimally invasive lymphatic interventional techniques (Nadolski, 2013; Itkin, 2010). However, despite growing recognition of the role of the lymphatic system in many disease processes, certain techniques for imaging of the lymphatic system have lagged behind the well-developed methods for imaging of the cardiovascular system (Vogt, 2013; Sharma, 2008).
  • lymphangiogram as the method of choice for imaging of the central lymphatic system during percutaneous lymphatic interventional procedures. As a result, lymphatic imaging and intervention has become more common.
  • the Intranodal lymphangiogram technique has also found use in connection with a Magnetic Resonance ("MR") imaging technique, MR lymphangiogram.
  • MR Magnetic Resonance
  • Intranodal lymphangiogram employs an ultrasound guidance to place a small gauge needle in the center of the lymph node. A contrast material is then slowly injected into the lymph node. The lymphatic system is then imaged.
  • a technical problem with intranodal lymphangiogram can be easy dislodgement of the needle from the lymph node. Such dislodgement can cause the contrast material to be leaked into the surrounding tissue and will result in poor imaging. For at least that reason, there remains a need in the art to secure the needle in the lymph node.
  • the presently disclosed subject matter relates to needles for delivering a liquid into a lymph node, including needles further comprise a securing device.
  • the disclosed subject matter further relates to methods for securing a needle in a lymph node and methods for performing intranodal lymphangiogram.
  • the disclosed subject matter relates to needles for delivering a liquid to a lymph node where the needle has a proximal end, a distal end and a side wall.
  • the proximal end of the needle can be attached to a vessel housing a liquid to be delivered to the lymph node through the needle.
  • the vessel housing a liquid is a syringe.
  • the tip of the needle is at the distal end.
  • the tip of the needle is inserted into the lymph node.
  • the tip of the needle is inserted through the lymph node, and the side wall of the needle is exposed to the interior of the lymph node.
  • the needle has a liquid delivery opening on the side wall of the needle.
  • the needle further includes a securing device.
  • the tip of the needle is closed. In a closed tip, liquid cannot escape from the tip of the needle. In other embodiments, the tip of the needle is open. In an open tip, liquid can escape from the tip of the needle.
  • the securing device can be housed within the channel outside of and adjacent to the side wall of the needle.
  • the securing device can be a deployable securing hook.
  • the deployable securing hook can be arrow shaped, curved, or any other shape capable of securing the needle in the lymph node.
  • the securing device can be glue.
  • the glue can be likewise housed in a channel outside of and adjacent to the side wall of the needle. The glue would be deployable through the channel into tissue surrounding, but not in the lymph node.
  • Certain embodiments can include a securing device that is located within the side wall of the needle.
  • the securing device can be a deployable securing hook.
  • the deployable securing hook can be arrow shaped, curved, or any other shape capable of securing the needle in the lymph node.
  • Certain embodiments can include a securing device that includes a spiral element.
  • the spiral element can be advanced through a separate channel that is located inside the needle.
  • the spiral element is deployed proximal to the lymph node.
  • the spiral element is deployed distal to the lymph node.
  • the securing device is an inflatable member.
  • the inflatable member can be inflated through a separate channel located inside the needle.
  • the inflatable member is deployed proximal to the lymph node.
  • the inflatable member is deployed distal to the lymph node.
  • the inflatable member is a balloon.
  • the presently disclosed subject matter further relates to methods for securing a needle in a lymph node.
  • such methods include placing a needle comprising a securing device in a lymph node and deploying the securing device.
  • the securing device is a deployable securing hook.
  • the securing device is glue.
  • the method can further include administering a liquid through the needle into the lymph node.
  • the liquid is a contrast agent.
  • the liquid is a therapeutic agent.
  • the liquid can be any liquid that needs to be delivered to the lymph node.
  • the method can further include retracting the securing device and removing the needle from the lymph node.
  • the presently disclosed subject matter further relates to methods for performing intranodal lymphangiogram.
  • the methods include placing a needle which includes a securing device in a lymph node and deploying the securing device.
  • the method can also include administering a liquid through the needle into the lymph node.
  • the method can further include retracting the securing device and removing the needle from the lymph node.
  • the liquid administered through the needle into the lymph node is a contrast agent.
  • Figures 1A-1H shows exemplary embodiments of needles according to the presently disclosed subject matter.
  • lymphatic system plays a crucial role in the transport of excess fluid and metabolites from the tissues back to the circulatory system. Lymphatic abnormalities are associated with several disease processes, including cirrhosis and congestive heart failure, among others (Dumont, 1962; Dumont, 1960). Lymphatic malformations and injuries can result in leakage of lymph into tissue, including chylothorax, chylous ascites, and chylous pericardium, conditions that can be associated with substantial mortality and morbidity (Mallick, 2003).
  • One of the main challenges in finding a treatment for these conditions has been a lack of simple minimally invasive high-spatial- and high-temporal- resolution imaging techniques for visualization of the lymphatic system.
  • a fine-needle is placed into a lymph node while guided by ultrasound. Needle placement is followed by slow injection of a liquid, such as a contrast agent, to opacify the lymphatic system.
  • a liquid such as a contrast agent
  • the presently disclosed subject matter relates to methods and devices for delivering a liquid to a lymph node.
  • the present disclosure relates to needles comprising a securing device for delivering a liquid to a lymph node and methods for securing needles in a lymph node using such devices.
  • it further relates to methods of performing intranodal lymphangiogram using the disclosed needles.
  • the present disclosure relates to needles used to deliver a liquid to a lymph node that further contains a securing device. Accordingly, the present disclosure relates to needles that prevent dislodgement from the lymph node.
  • needles according to the disclosed subject matter can deploy a securing device to anchor the needle inside the lymph node for administration of a liquid to the lymph node.
  • the needle (10) can have a closed tip (11) at the distal end (12) of the needle.
  • the proximal end (13) of the needle can be attached to a vessel housing a liquid to be delivered to the lymph node through the needle.
  • the tip of the needle is pointed. This facilitates puncturing the skin and surrounding tissue to reach the lymph node.
  • the closed tip does not allow liquid to escape out of the distal end (12) of the needle (10).
  • This exemplary embodiment also includes an opening (1) in the side wall of the needle.
  • the opening for example, but not by way of limitation, can be 1-100 mm away from the tip of the needle. In other embodiments, the opening (1) in the side wall can be 1-50, 1- 25, 1-10, 1-5, or 1-2 mm away from the tip of the needle.
  • the opening (1) in the side wall of the needle does allow liquid to escape from the needle into the surrounding tissue.
  • the needle (10) can include a securing device.
  • the securing device is composed of a separate channel (3) and a deployable securing hook (2).
  • the separate channel (3) runs parallel to the needle (10).
  • the channel (3) ends before the opening (1) in the side wall of the needle.
  • the deployable securing hook (2) is housed within the channel (3).
  • the deployable securing hook (2) can be of any shape that provides resistance when deployed and does not interfere with delivery of liquid through the needle (10) to the lymph node.
  • An exemplary, non-limiting deployable securing hook (2) shape is an arrow shape, as depicted in Figure 1A.
  • a further non-limiting example of a deployable securing hook shape (2) is curved out away from the side wall of the needle (10), as depicted in Figure IB.
  • the deployable securing hook (2) is further retractable.
  • the needle (10) has an open tip (14), as depicted in Figure 1C.
  • the deployable securing hook (2) is housed within the needle (10) and no exterior channel is present.
  • the deployable securing hook (2) can have any shape that deploys into the surrounding tissue and secures the needle in the lymph node (4), including an arrow shape, a curved shape, or any other appropriate shape.
  • the deployable securing hook (2) upon deployment, obstructs the open tip (14) of the needle (10) such that liquid can no longer exit through the tip of the needle.
  • the embodiment in Figure 1C also has an opening (1) in the side wall of the needle through which liquid is delivered to the lymph node (4).
  • the disclosed needle has a securing device which includes glue.
  • the glue can be housed within a channel (5) adjacent to the needle (10).
  • the channel (5) can end before or after the opening (1), but should be sufficiently distant from the opening (1) that glue does not get in the opening (1) or in the lymph node (4).
  • the glue in the side channel (5) should not come into contact with the liquid in the needle.
  • Glue described herein can be any biocompatible adhesive compound.
  • the needle has an open tip (14) that is located at the distal end (12) of the needle (10), and the securing device is a spiraling element (6) that is located inside the needle (10), as depicted in Figure IE.
  • the spiraling element (6) is deployed in spinning motion to enter the lymph node (4) and secure it when the needle tip (15) is introduced inside the lymph node.
  • the tip (15) of the needle is positioned inside the lymph node (4) and the liquid is then delivered to the lymph node (4) around the spiraling element (6).
  • the spiraling element (6) is retracted back into the side wall of the needle.
  • the disclosed needle has a securing device which includes a spiral element (6).
  • the spiral element (6) is advanced through a separate channel (7) that is located inside the needle (10).
  • the spiral element (6) is deployed proximal to the lymph node (4) and secure the needle (10) when the needle tip (15) is positioned inside the lymph node (4) and the liquid is then delivered to the lymph node (4) through the opening (1).
  • the opening (1) can locate at the needle tip (15) or on the side of the needle .
  • the spiral element (6) is deployed distal to the lymph node (4) through the separate channel (7) that is located inside the needle (10), and the liquid is delivered to the lymph node (4) through the opening (1) that is located on the side of the needle (10).
  • the disclosed needle has a securing device which includes an inflatable member (8) as depicted in Figure 1H.
  • the inflatable element (8) is inflated through a separate channel (9) located inside the needle (10) and deployed proximal or distal to the lymph node to secure the needle (10).
  • the inflatable member is a balloon.
  • any or all components of the needles described herein can be made from, for example, single or multiple stainless steel alloys, nickel titanium alloys, cobalt-chrome alloys, nickel-cobalt alloys, molybdenum alloys, tungsten-rhenium alloys, polymers such as polyethylene teraphathalate (PET), polyester, polyester amide, polypropylene, aromatic polyesters, such as liquid crystal polymers, ultra high molecular weight polyethylene fiber and/or yarn, polytetrafluoroethylene (PTFE), expanded PTFE (ePTFE), polyether ketone (PEK), polyether ether ketone (PEEK), polyether ketone ketone (PEKK), nylon, polyether-block co-polyamide polymers, aliphatic polyether polyurethanes, polyvinyl chloride (PVC), polyurethane, thermoplastic, fluorinated ethylene propylene (FEP), absorbable or resorbable polymers such as polyglycolic acid (PGA), poly-L-
  • Non-limiting examples of radiopaque materials are barium sulfate, zinc oxide, titanium, stainless steel, nickel-titanium alloys, tantalum, and gold.
  • one or more components of the disclosed devices can be made from a biomaterial or coated with a biomaterial.
  • Non- limiting examples of a biomaterial include tissue, collagen, allograft, autograft, heterograft, xenograft, bone cement, morselized bone, osteogenic powder and beads of bone.
  • one or more components of the disclosed devices can be coated with a polymer, chemical or biomaterial to make it more biocompatible or hydrophilic, or to prevent deposition of lipids or protein onto the walls and/or surfaces of the device.
  • the needles of the disclosed subject matter can be disposable.
  • the needles of the disclosed subject matter are 15 gauge, 16 gauge, 17 gauge, 18 gauge, 19 gauge, 20 gauge, 21 gauge, 22 gauge, 23 gauge, 24 gauge, 25 gauge, 26 gauge, 27 gauge, 28 gauge, 29 gauge, 30 gauge, 31 gauge, 32 gauge, 33 gauge, or 34 gauge.
  • the needle is 25 gauge.
  • the needle is 26 gauge.
  • the presently disclosed subject matter further relates to methods for securing one or more of the needles disclosed above in a tissue.
  • the present disclosure provides methods for securing the disclosed needles within a lymph node.
  • the needle is placed in a lymph node.
  • the opening of the needle is placed so that liquid can be delivered from the needle through the opening of the needle into the lymph node and not the surrounding tissue.
  • the liquid is delivered through an opening in the side wall of the needle.
  • the tip of the needle can extend beyond the lymph node, but the portion of the needle containing the opening must be in the lymph node.
  • the securing device is deployed after the needle is placed in the lymph node.
  • the securing device can be any device suitable for anchoring the needle in place, including, by way of non-limiting example, those discussed in detail above.
  • the liquid is administered through the needle into the lymph node after the securing device is deployed.
  • the securing device is retractable.
  • the method can also include removing the needle.
  • the liquid delivered to the lymph node is a contrast agent.
  • Contrast agents are typically used to enhance image contrast, i.e., to "highlight" an organ of interest from surrounding tissue during medical imaging. Suitable contrast agents are well known to a person of skill in the art. Non-limiting examples of contrast agents include oil based iodinated contrast agent (lipiodol), water soluble iodinated contrast agents, gadolinium based contrast agent, iron based contrast agent and gold nanoparticles contrast agents.
  • the contrast agent is an ethiodized oil.
  • the liquid delivered to the lymph node is a therapeutic agent. Therapeutic agents can include any compound capable of treating a patient, including chemical, biological, genetic and cellular compounds. In certain embodiments, the therapeutic agent treats a condition of the lymphatic system.
  • the presently disclosed subject matter further relates to methods for performing a medical procedure.
  • the present disclosure provides methods for performing intranodal lympangiogram.
  • the method includes placing the needle with a securing device in a tissue.
  • the tissue can be soft tissue such as liver parenchyma or muscles or fat or connecting tissue or kidney tissue.
  • the method can include placing the needle with a securing device in a lymph node.
  • the method can further comprise deploying the securing device into the surrounding tissue, as discussed above.
  • the method can comprise administering a liquid through the needle into the target tissue.
  • the method can comprise administering a liquid through the needle into the lymph nodes.
  • the method can further comprise the step of retracting the securing device, as discussed above.
  • the methods can also include the step of removing the needle from the tissue.
  • the methods can also include the step of removing the needle from the lymph node.
  • the liquid delivered can be a contrast agent, as discussed above.
  • the methods for performing intranodal lymphangiogram can be combined with other medical procedures.
  • other medical procedures include, but are not limited to catheterization of a part of the lymphatic system, catheterization of the thoracic duct, lymphatic embolization, thoracic duct embolization, selective lymphatic embolization, direct percutaneous embolization, injection of the therapeutic agent into the lymphatic system any other type of lymphatic embolization.
  • Cope C Salem R, Kaiser LR. Management of chylothorax by percutaneous catheterization and embolization of the thoracic duct: prospective trial. J Vase Interv Radiol 1999; 10(9): 1248-1254. Dumont AE, Mulholland JH. Alterations in thoracic duct lymph flow in hepatic cirrhosis: significance in portal hypertension. Ann Surg 1962; 156(4):668-675.

Landscapes

  • Health & Medical Sciences (AREA)
  • Vascular Medicine (AREA)
  • Engineering & Computer Science (AREA)
  • Anesthesiology (AREA)
  • Biomedical Technology (AREA)
  • Heart & Thoracic Surgery (AREA)
  • Hematology (AREA)
  • Life Sciences & Earth Sciences (AREA)
  • Animal Behavior & Ethology (AREA)
  • General Health & Medical Sciences (AREA)
  • Public Health (AREA)
  • Veterinary Medicine (AREA)
  • Infusion, Injection, And Reservoir Apparatuses (AREA)

Abstract

La présente invention concerne des aiguilles qui peuvent être fixées dans un tissu d'intérêt et des procédés d'utilisation de celles-ci. En particulier, la présente invention concerne des aiguilles qui peuvent être fixées dans un ganglion lymphatique et leurs procédés d'utilisation. Dans d'autres modes de réalisation, l'invention concerne des procédés de réalisation d'un lymphangiogramme intranodal à l'aide des aiguilles décrites.
PCT/US2018/012302 2017-01-06 2018-01-04 Aiguille d'accès à un ganglion lymphatique Ceased WO2018129127A1 (fr)

Applications Claiming Priority (2)

Application Number Priority Date Filing Date Title
US201762443469P 2017-01-06 2017-01-06
US62/443,469 2017-01-06

Publications (1)

Publication Number Publication Date
WO2018129127A1 true WO2018129127A1 (fr) 2018-07-12

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PCT/US2018/012302 Ceased WO2018129127A1 (fr) 2017-01-06 2018-01-04 Aiguille d'accès à un ganglion lymphatique

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Cited By (3)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
WO2021151101A1 (fr) * 2020-01-23 2021-07-29 Kassab Ghassan S Dispositifs à aiguille pour accéder à des ganglions lymphatiques et à des conduits thoraciques
WO2023023353A1 (fr) * 2021-08-19 2023-02-23 Kassab Ghassan S Aiguille intranodale et sa méthode d'utilisation
WO2023183630A1 (fr) * 2022-03-24 2023-09-28 Sureax, Inc. Dispositifs à aiguille stabilisant l'accès à un tissu, systèmes et procédés

Citations (9)

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Publication number Priority date Publication date Assignee Title
US5011473A (en) * 1989-06-06 1991-04-30 Mitek Surgical Products Inc. Device for securing and positioning a wire to a needle
US5167239A (en) * 1991-05-30 1992-12-01 Endomedix Corporation Anchorable guidewire
US5234426A (en) * 1989-06-15 1993-08-10 Research Corporation Technologies, Inc. Helical-tipped lesion localization needle device and method of using the same
US20020007130A1 (en) * 1998-03-03 2002-01-17 Senorx, Inc. Methods and apparatus for securing medical instruments to desired locations in a patients body
US20020019595A1 (en) * 2000-08-10 2002-02-14 Cook Incorporated Localizer needle
US20020115943A1 (en) * 1998-03-03 2002-08-22 Senorx, Inc. Sentinel node location and biopsy
US20040106891A1 (en) * 2002-08-30 2004-06-03 Inrad, Inc. Localizing needle with fluid delivery
US20080065029A1 (en) * 2006-09-11 2008-03-13 Racz N S Nerve block needle and related methods
US20160074626A1 (en) * 2014-09-15 2016-03-17 Ethicon, Inc. System and Method for Targeted Delivery of Therapeutic Agents to Tissue

Patent Citations (9)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US5011473A (en) * 1989-06-06 1991-04-30 Mitek Surgical Products Inc. Device for securing and positioning a wire to a needle
US5234426A (en) * 1989-06-15 1993-08-10 Research Corporation Technologies, Inc. Helical-tipped lesion localization needle device and method of using the same
US5167239A (en) * 1991-05-30 1992-12-01 Endomedix Corporation Anchorable guidewire
US20020007130A1 (en) * 1998-03-03 2002-01-17 Senorx, Inc. Methods and apparatus for securing medical instruments to desired locations in a patients body
US20020115943A1 (en) * 1998-03-03 2002-08-22 Senorx, Inc. Sentinel node location and biopsy
US20020019595A1 (en) * 2000-08-10 2002-02-14 Cook Incorporated Localizer needle
US20040106891A1 (en) * 2002-08-30 2004-06-03 Inrad, Inc. Localizing needle with fluid delivery
US20080065029A1 (en) * 2006-09-11 2008-03-13 Racz N S Nerve block needle and related methods
US20160074626A1 (en) * 2014-09-15 2016-03-17 Ethicon, Inc. System and Method for Targeted Delivery of Therapeutic Agents to Tissue

Cited By (6)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
WO2021151101A1 (fr) * 2020-01-23 2021-07-29 Kassab Ghassan S Dispositifs à aiguille pour accéder à des ganglions lymphatiques et à des conduits thoraciques
US20230082493A1 (en) * 2020-01-23 2023-03-16 Sureax, Inc. Needle devices for accessing lymph nodes and thoracic ducts
JP2023512198A (ja) * 2020-01-23 2023-03-24 シュアアックス インコーポレイテッド リンパ節及び胸管にアクセスするための針デバイス
EP4093465A4 (fr) * 2020-01-23 2024-03-20 Sureax, Inc. Dispositifs à aiguille pour accéder à des ganglions lymphatiques et à des conduits thoraciques
WO2023023353A1 (fr) * 2021-08-19 2023-02-23 Kassab Ghassan S Aiguille intranodale et sa méthode d'utilisation
WO2023183630A1 (fr) * 2022-03-24 2023-09-28 Sureax, Inc. Dispositifs à aiguille stabilisant l'accès à un tissu, systèmes et procédés

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