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EP2257322A1 - Procédé et appareil d accès vasculaire - Google Patents

Procédé et appareil d accès vasculaire

Info

Publication number
EP2257322A1
EP2257322A1 EP08795077A EP08795077A EP2257322A1 EP 2257322 A1 EP2257322 A1 EP 2257322A1 EP 08795077 A EP08795077 A EP 08795077A EP 08795077 A EP08795077 A EP 08795077A EP 2257322 A1 EP2257322 A1 EP 2257322A1
Authority
EP
European Patent Office
Prior art keywords
vessel
access
diaphragm
sheath
self
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.)
Withdrawn
Application number
EP08795077A
Other languages
German (de)
English (en)
Inventor
David Chang
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.)
Individual
Original Assignee
Individual
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
Priority claimed from US12/072,683 external-priority patent/US20080243080A1/en
Application filed by Individual filed Critical Individual
Publication of EP2257322A1 publication Critical patent/EP2257322A1/fr
Withdrawn legal-status Critical Current

Links

Classifications

    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B17/00—Surgical instruments, devices or methods, e.g. tourniquets
    • A61B17/32—Surgical cutting instruments
    • A61B17/320016—Endoscopic cutting instruments, e.g. arthroscopes, resectoscopes
    • 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
    • A61M1/00—Suction or pumping devices for medical purposes; Devices for carrying-off, for treatment of, or for carrying-over, body-liquids; Drainage systems
    • A61M1/36—Other treatment of blood in a by-pass of the natural circulatory system, e.g. temperature adaptation, irradiation ; Extra-corporeal blood circuits
    • A61M1/3621—Extra-corporeal blood circuits
    • A61M1/3653—Interfaces between patient blood circulation and extra-corporal blood circuit
    • 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
    • A61M1/00—Suction or pumping devices for medical purposes; Devices for carrying-off, for treatment of, or for carrying-over, body-liquids; Drainage systems
    • A61M1/36—Other treatment of blood in a by-pass of the natural circulatory system, e.g. temperature adaptation, irradiation ; Extra-corporeal blood circuits
    • A61M1/3621—Extra-corporeal blood circuits
    • A61M1/3653—Interfaces between patient blood circulation and extra-corporal blood circuit
    • A61M1/3655—Arterio-venous shunts or fistulae
    • 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
    • A61M1/00—Suction or pumping devices for medical purposes; Devices for carrying-off, for treatment of, or for carrying-over, body-liquids; Drainage systems
    • A61M1/36—Other treatment of blood in a by-pass of the natural circulatory system, e.g. temperature adaptation, irradiation ; Extra-corporeal blood circuits
    • A61M1/3621—Extra-corporeal blood circuits
    • A61M1/3653—Interfaces between patient blood circulation and extra-corporal blood circuit
    • A61M1/3659—Cannulae pertaining to extracorporeal circulation
    • A61M1/3661—Cannulae pertaining to extracorporeal circulation for haemodialysis
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B17/00—Surgical instruments, devices or methods, e.g. tourniquets
    • A61B2017/00743—Type of operation; Specification of treatment sites
    • A61B2017/00778—Operations on blood vessels

Definitions

  • the present invention relates to methods and apparatus that facilitate arterial and/or venous access using a securable/anchored structure such as a diaphragm on an outer/adventitial surface of a vessel, as well as to related structures and features.
  • Vascular access is crucial to the treatment of many disease states in humans. Vascular access is necessary for procedures such as hemodialysis as well as intervention on vessels themselves and to end organs. However, currently, there is no convenient, failsafe and repeatable access to arteries, veins and organ systems for performing medical procedures such as dialysis and other vascular interventions without significant complications. Access to the arterial or venous circulation can be both diagnostic and therapeutic yet vessel bleeding, occlusion and embolization complicate such procedures. For example, in certain processes such as hemodialysis, present long-term access devices have ports/ catheters/ grafts with high failure rates and direct continuous contact to the circulation that risks sepsis and death.
  • Any conventional access port or catheter includes an indwelling intralumenal foreign body that predisposes to occlusion by clotting or scar tissue formation and potentially life threatening infection.
  • a significant contributor to such blood born infections is the presence of a compartment such as a reservoir or conduit where bacteria can grow.
  • compartments may serve as a nidus for clot formation, either within the vessel or in the compartment.
  • catheter conduits protruding from the skin surface may serve as potential sites of cellulites.
  • vascular access extends to procedures involving intervention on vessels themselves and to end organs. This can be critical in the arterial circulation where due to higher blood pressure, bleeding can be life threatening and arrested blood flow can result in damage to end organs. For other vascular intervention, sub-optimal selection of vessel access may occur due to fear of bleeding risks.
  • selection of vessel access is currently driven by avoidance of bleeding risk versus optimal vessel location and vessel health.
  • the current standard access site for arterial procedures is the common femoral artery.
  • it is often the distal end of one of the most diseased and tortuous arterial segments in the body. This results in difficulty delivering treatment to diseases of the aorta and its branches, especially if large caliber endovascular devices are needed.
  • the subclavian artery is a large vessel that is less commonly diseased, can be made ergonomically accessible and is located in a low infection risk area.
  • An obstacle for convenient use of this vessel is the possibility of bleeding, leading to brachial plexus nerve injury, hematoma or hemathorax.
  • inexperienced attempts to access this vessel may result in pneumothorax requiring chest tube decompression.
  • arteries like the common carotid and brachial arteries are of similar range of caliber to the subclavian artery. These vessels are also less commonly diseased, can be made ergonomically accessible and are found in regions at low risk for infection. The anatomic accessibility of all these arteries puts them in much closer proximity to the brain and the heart, two of the most important arterial beds. However, despite their closer proximity to the brain and the heart, housing two of the most important arterial beds, these arteries are rarely sites of direct access as there are significant bleeding risks and drawbacks associated with current devices available.
  • Figure 1 shows exemplary diaphragms, valves and anchoring features consistent with some of the innovations herein;
  • Figure 2 shows some exemplary nipple guide features and valves consistent with some of the innovations herein;
  • FIG. 3 shows some exemplary trocars and locking mechanisms consistent with some of the innovations herein;
  • Figure 4 shows somes exemplary types of wire guides consistent with some of the innovations herein;
  • Figure 5 illustrates an exemplary percutaneous method for vascular access that involves placement of a self-sealing diaphragm on a vessel consistent with some of the innovations herein;[the last portion was copied below into the written description]
  • Figure 6 shows an exemplary vascular embolization protection sheath consistent with some of the innovations herein;
  • the present invention relates to methods and apparatus that facilitate arterial and/or venous access using a securable/anchored structure such as a diaphragm on an outer/adventitial surface of a vessel, as well as to related structures and features. Further methods and apparatus may involve using a semi-permeable sheath with a filter segment to prevent potential embolization. Advantages of some implementations herein relating to eliminating the chamber of a vascular access device may be achieved by making the vessel itself the chamber and incorporating the device as part of the vessel, for example, without reliance of an indwelling catheter sheath to remotely gain access. Some innovations herein relate to facilitating access including methods and devices for automating the access process and preventing embolization.
  • Vascular access is necessary for intervention on vessels themselves (examples including placement of stents and stentgrafts) and for treatment of end organs (examples include heart valves and cellular transplantation) as well as for procedures such as hemodyalysis.
  • a safe and reliable repeatable access apparatus will facilitate entry from less diseased, potentially better situated, preferred upper torso vessels, currently difficult to achieve using existing devices due to limitations described above.
  • Such an apparatus can be utilized for reliable, repeatable venous and arterial access to facilitate certain procedures, which implicate the above considerations, such as: hemodialysis., cardiovascular interventions, blood drawing, blood pressure monitoring, and medication infusion,
  • lmplimentations herein include methods and apparatus that may minimize bleeding, thrombosis, occlusion and/or infection complications of arterial and venous access, in a manner not achieved using currently available devices, as discussed above; and therefore facilitate entry into preferred vascular sites, such as less diseased vessels or those with easier anatomic accessibility to target organs, currently not accessible by existing devices as set forth above.
  • preferred vascular sites such as less diseased vessels or those with easier anatomic accessibility to target organs, currently not accessible by existing devices as set forth above.
  • controlled access preserves rapid physiologic flow within the conduit and there is minimal scarring and disruption to its anti thrombotic endothelial lining.
  • clot formation, occlusion, and embolization are minimized as compared to existing devices, as explained herein.
  • Exemplary apparatus may include a self sealing (re-sealable) structure/feature such as a diaphragm or a nipple-like protrusion attached to the outer surface of the vessel via means such as sutures, penetrating or scaffolding elements, tissue adhesives, combination of the above, and/or other suitable mechanisms.
  • exemplary diaphragms may include rigid structures such as a diaphragm shutter, adjustable structures such as a diaphragm iris or a semi-rigid elastic diaphragm membrane structures.
  • Exemplary materials for a diaphragm include metals, rubber, plastics, fluorine plastics, silicone, and thoralon
  • a nipple form adds the function of a easily palpated structure on the surface of the skin that guides a trocar into the vessel.
  • the nipple may be an extension or thickening of the diaphragm material or may incorporate a diaphragm as a component.
  • the diaphragm or nipple may also have an undersurface that facilitates tissue incorporation with a porous or textured biocompatible layer that anchors the device to the vessel.
  • Creating a chamber-less access device may be enabled by a method of placement of the device on a suitably large access vessel, for example, the carotid, subclavian femoral, axillary, brachial artery or the jugular, axillary, subclavian or femoral vein.
  • the self-sealing function of the diaphragm or nipple reduces vessel bleeding that is a drawback with current devices on the market, consistent with the discussion above.
  • the diaphragm or nipple is chamber-less and catheter-less, bacterial contamination and entry into the blood stream associated with existing devices on the markets, is minimized.
  • Exemplary methods and apparatus are described that facilitate appropriate placement of the access device and allow ease of placement and repeated access without bleeding.
  • the components of such an apparatus may include 1) an anchoring diaphragm 2) sealing element 3) nipple receptacle guide 4) locking trocar and safety valves and/or 5) delivery sheath assembly in percutaneous applications. Differing combinations of the above components may be used in different implementations.
  • a diaphragm can be deployed in the potential space between the vascular sheath and the outer surface of the vessel.
  • the diaphragm may have a fixed shape as part of a nipple or may be collapsible for a percutaneous procedure.
  • the diaphragm may have a frame of material such as nitinol that may include crossbars to create an appropriate arc for the vessel without excess mass.
  • the diaphragm may comprise a suitable solid biocompatible polymer such as silicone or polymer with porosity such as PTFE.
  • a glue tube may be fastened to the underside of a diaphragm delivered rolled up in the sheath. Once the diaphragm is placed along the vessel, the tube with side holes applies the tissue glue and may be removed as pressure is exerted on the neck, shoulder, arm or groin.
  • Exemplary diaphragms may include diaphragms referred to herein as access diaphragms.
  • an access diaphragm may comprise a re-sealable (or self- sealing) membrane having a vessel-contacting surface through which a cannula, needle, catheter, or the like may pass to enter the vessel.
  • the access diaphragm may be shaped to conform to the vessel onto which it is to be applied (e.g., a carotid artery).
  • the vessel-contacting surface may be curved.
  • the access diaphragm may include a support frame.
  • the support frame may help form the curved shape, and may also help anchor the access diaphragm to the vessel.
  • the access diaphragm may also include a holdfast to secure the access diaphragm to the vessel.
  • the holdfast may be one or a plurality of tines, tissue cement, or the like.
  • the access diaphragm is generally a somewhat flexible planar structure having an upper surface and a lower (vessel-contacting) surface.
  • the planar structure may be curved to match the curvature of the target vessel (e.g., artery) onto which it will be applied.
  • the curvature may be slightly smaller than the curvature o the vessel.
  • the majority of the planar surface may be a puncture surface.
  • a support frame extends near the periphery of the device, leaving the central puncture region (puncture surface) free of impediments or may include crossbars. Flexibility and some appropriate directional rigidity can be achieved by reinforcing the diaphragm with a wire frame made of metal such Nitinol.
  • the access diaphragm may be relatively thin compared to the surface area of the upper and lower surfaces.
  • the access diaphragm may be approximately 2mm thick.
  • the edges of the access diaphragm may be tapered, rounded or abrupt. In some variations, the edge of the access diaphragm is tapered so that it may help separate the tissue plane surrounding the vessel (as described below for the dilator) and aid insertion.
  • exemplary access diaphragms may be secured to the vessel and may be pierced by a needle, cannula, catheter or the like (e.g., by a trocar or through a dedicated access port), to provide access within the vessel.
  • a needle, cannula, catheter or the like e.g., by a trocar or through a dedicated access port
  • the access diaphragm closes or re-seals to prevent bleeding.
  • the access diaphragm may self-seal.
  • the access diaphragm may be implanted so that it remains in place and can be re-used as an access site for insertion of needles, cannula, catheters, and the like.
  • an access diaphragm may be configured as an arterial access diaphragm.
  • an arterial access diaphragm may be configured for use on an artery (e.g., carotid artery).
  • An access diaphragm may be implanted either percutaneously or operatively (e.g., by incising tissue to expose the artery).
  • the device may be placed on the adventitia of the artery through a small cutdown incision.
  • the access diaphragm may include a puncture surface that may be made (at least in part) of any suitable biocompatible polymer, such as silicone. Re-sealable materials (e.g., silicone, rubbers, etc.) may be particularly useful.
  • the puncture surface of the access diaphragm typically functions as a self-sealing valve.
  • this may be a polymer that elastically seals around the puncture once the catheter is removed.
  • a preformed aperture cut or pre-formed slit is made into the material, allowing controlled penetration of the artery.
  • access trocar with a sheathed blade or screwdriver like end may also be used to localize and open the diaphragm so as to create a controlled cut the artery wall without damaging the diaphragm
  • holdfasts include tissue glue, collar elements that may be 6 to 9 mm diameter (but need not be circumferential around the artery) or embedded holdfasts that penetrate the wall of the artery but does not obstruct the lumen.
  • These may include needle tines with the proximal end embedded in the diaphragm with process known in the art, or may be of one body with the frame or collar. The distal sharp ends of the tines may embed into the wall of the artery (and may pass only partially or completely through the wall) at an angle from 5 degrees to 60 degrees so as to fix the diaphragm to the artery.
  • the tines may also prevent vessel tissue from prolapsing into the lumen after removal of large shealths (>10 french).
  • the access diaphragm may be fixed to the vessel by counter angled tines or a parallel matrix of tines arranged in an arc configurations to the other anchoring tines.
  • the tines can be angled so that anchoring is achieved in a direction opposite to entry. This allows ease of movement of the diaphragm edge which can acts as a dissecting tool to help create space around the vessel (e.g., in the perivesicular sheath).
  • the access diaphragm includes enhancing the ability to perform a minimally invasive access implant with minimal thrombotic risk, because transluminal fixation is not necessary.
  • the access diaphragm may provide a large target area for repeated access, and may be broadly applicable to a wide range of vessel (e.g., artery) sizes and cannula sizes.
  • Some of the access diaphragms described herein may be delivered in a delivery sheath or catheter, particularly percutaneous delivery of the access diaphragm.
  • the access diaphragm may be rolled or otherwise compressed into a delivery form and placed into a sheath.
  • the access catheter may be applied to the vessel (e.g., after separating the periarterial space as described briefly below) by pushing the access diaphragm from the lumen of the sheath and onto the vessel.
  • a push rod may be used to eject the access diaphragm onto the vessel.
  • the holdfast e.g., tines
  • the holdfast may be arranged so that it does not engage the vessel until it has been positioned.
  • exemplary diaphragms may have an arc of about 60 to about 180 degrees with a diameter between about 90 to about 100% of the arterial diameter. Flexibility and some appropriate directional rigidity can be achieved by reinforcing the diaphragm with a wire frame made of metal such as nitinol. Holdfasts include tissue glue, collar elements that may be about 3 to about 9 mm diameter (but need not be circumferential around the artery) or embedded holdfasts that penetrate the wall of the artery but do not obstruct the lumen. These may include sharp tines with the proximal end embedded in the diaphragm with a process known in the art or may be of one body with the frame or collar.
  • the distal sharp end embeds in the wall of the artery at an angle from about 5 degrees to about 60 degrees so as to fix the diaphragm to the artery or up to about 90 degrees with the use of self-locking tines.
  • the tines also prevent vessel tissue from prolapsing into the lumen after removal of large sheaths (about >10 French). Fixation is achieved with counter angled tines or a parallel matrix of tines in an arc configurations with anchoring tines.
  • the tines can be angled so that anchoring is achieved in a direction opposite to entry.
  • the device can be fixed to the vessel by any combination of penetrating anchors, tissue adhesive, circumferential or arc shaped bands, or textured or porous material that allows cellular in growth or incorporation. Growth factors, matrix elements, or polymer materials such as polyester found in access catheter cuffs may be used to facilitate incorporation. Transmural anchoring holdfasts can also be used for larger vessels. If repeated access is not anticipated for some weeks, the diaphragm anchoring may comprise only the incorporation material. Such a material may line the surface placed on the vessel and on other surfaces of the apparatus to facilitate secure and stable placement of the device in continuity with the vessel.
  • exemplary diaphragm or nipple complexes may include a feature that controls depth of penetration into the vessel by a trocar.
  • a protrusion or pin may be embedded in the diaphragm or made part of the frame of the diaphragm, which engages the wall of the trocar.
  • the protrusion is along the channel or potential channel of the nipple or receptacle of the nipple.
  • Radio-opaque, magnetic or echo lucent markers may be placed along the puncture zone to facilitate automated or image directed access.
  • a suitable diaphragm may be placed on the outer surface of the vessel through a small cut down incision and sutured through the material or attached eyelets to the vessel.
  • Sutures or wire attached to the apparatus through guiding channels may also be placed through or within the vessel wall along the perimeter of the proposed puncture site so as to facilitate immediately anchoring and sealing of a puncture.
  • the sealing element may be the same as the anchoring diaphragm or may be a separate structure.
  • the puncture surface of a diaphragm can function as a self-sealing valve.
  • this may be a polymer that elastically seals around the puncture once the catheter is removed.
  • a preformed aperture or slit(s) cut into the material, allowing controlled a traumatic penetration of the device and artery.
  • Such a preformed potential aperture may be cut perpendicular to the plane of the vessel or at an angle.
  • the sealing element may be the diaphragm and fixed to the wall of the vessel with holdfasts and tissue incorporation elements. This may allow a low profile apparatus suitable for a method of percutaneous delivery.
  • the valve may be a separate cartridge that is slotted next to the anchoring diaphragm and allows replacement of the valve.
  • the self-sealing valve may function as a shutter on top of the vessel or diaphragm surface.
  • the shutter valve may be opened by a trocar-actuated mechanism and may be spring-loaded to close over the puncture site.
  • the shutter may have a opening surrounded by a receptacle or depression that guides a trocar to the opening.
  • the shutter may slide to a guided open position where the vessel wall is exposed or over a preformed aperture in an anchoring section of the diaphragm. After withdrawing the puncturing trocar, such shutters may act as a scaffolding for healing as it slides over the puncture site.
  • the shutter may be opened by movement of the upper part of the nipple against its fixed base.
  • These apparatus function to obtain hemostasis with no requirement for immediate sealing of the vessel wall. This is particularly useful for large diameter entry devices where attempts at a hemostatic seal that rests on complete vessel apposition is likely to be less reliable.
  • a planar undersurface area of a diaphragm that acts as a shutter may be used to increase the flexibility of the access portal by removing any requirement for the puncture hole to act as an anchor, buttress or seal zone for a plug. As such, small and large diameter access trocars may be used in the same postion of the vessel.
  • Exemplary receptacle guide structures/features may be used to facilitate reliable and a traumatic entry of the trocar into the vessel.
  • a tubular structure may be used to guide the trocar to a predetermined vessel entry site or valve.
  • the proximal portion of the guide channel may be funnel shaped to draw the trocar into the narrower portion of the channel.
  • the distal end of the channel may be attached to the vessel or diaphragm. Alternatively, it may be separate from the diaphragm or vessel thereby allowing any potential blood or debris to drain away and preventing obstruction of the channel.
  • Rigidity of the guide and the trocar may be selected to allows consistent vessel entry location without direct guide contact with the vessel or diaphragm.
  • the guide may also be a slot or groove rather than a tube to which the trocar mates. Any of these guiding structures can be fixed to the vessel anchored diaphragm and form a virtual nipple-like protrusion that can be felt on the surface of the skin. This may be aided by using memory metals such as nitinol in the structure.
  • An apparatus that uses a guiding element with a completely extralumenal seal minimizes trauma to a single point on the inner vessel wall which readily heals without weakening the vessel.
  • the apparatus may have one or more nipples that are a chamberless compartment in continuity with the vessel through a potential channel that is compressed by the elastic properties of a suitable polymer, for example, rubber, silicone or plastic.
  • the end away from the vessel may act as an opening that guides a needle or blunt trocar into the potential channel directed at the access site.
  • the potential channel can be facilitated by one or more slits in the material that guides and improves the slidability of the trocar.
  • One exemplary configuration is a T-shaped slit channel that may accommodate varying sizes of trocars with a common reference base orientation.
  • the device material may be sponge-like in its interior and may have an impermeable lining along the potential channel.
  • the device may be of two or more pieces that fit seamlessly together to occlude the potential channel with one or more pieces spring loaded. Bactericidal materials such as silver can be used along the channel and other components.
  • a displaceable strut may be interposed with the distal end abutting a self-sealing shutter valve mechanism.
  • the diaphragm may have a valve over the vessel puncture site or may only cover and anchor the arc of the vessel on either side of the vessel puncture site.
  • the nipple guide directs the trocar to this access site.
  • displacement of the distal strut end opens the shutter valve to enable access to the vessel wall or the diaphragm.
  • a separate nipple component apart from the diaphragm and slidably attached to it can be used in an uncovered and covered position on the vessel wall or diaphragm. These positions can be achieved by sliding the nipple component linearly or through an arc. The default covered position may be spring loaded. As the trocar is removed, the nipple is returned to the covered position. In slider implementations, the nipple with guide is felt through the skin and displaced to the non-covered position. In this position, the guide directs the trocar exactly into the puncture site of the vessel wall or diaphragm.
  • the undersurface of the nipple acts as a scaffold to allow cellular healing as it bridges over the puncture site.
  • a locking feature that is trocar actuated may also be used.
  • the nipple guide has one or more supporting structures fixed to the diaphragm.
  • An axis rod attaches to a nipple guide shaped like an arc of a cogwheel. In the default position, the tooth of the cogwheel covers the access site. The nipple guide is positioned so the trocar passes adjacent to the recessed portion of the cogwheel tooth.
  • the trocar is inserted into the receptacle and the partially inserted trocar within the guide can act as a lever to displace the cogwheel to the open position.
  • the trocar may also displace a lever, lifting a locking feature attached to a surface feature of the fixed component of the apparatus thereby allowing the apparatus to move to the open access position.
  • the vessel is accessed directly through the vessel wall or indirectly through the diaphragm base that acts as a second valve.
  • the diaphragm base can be molded to conform to the arc of the nipple guide, allowing multiple simultaneous trocar accesses by creating multiple sealing zones. Removal of the trocar allows recoil of the locking feature into the covered position.
  • nipple receptacle can also contain a tissue incorporating element such as polyester, or a ingrowth scaffold such as poly polyglycolic acid.
  • the access portal is strengthened by two or more levels of stability at the skin and vessel depth, yet the deeper portion of the device is free to rotate between a open and closed state.
  • the trocar or access needle may be of one or more bodies.
  • a cutting edge may be used.
  • An example of a multibody embodiment is a trocar sleeve with an inner removable sharp trocar.
  • the access needle or trocar may have a lumen that allows wire enabled placement of a larger catheter or sheath. The exit of this lumen may be disposed at the end or side of the accessing instrument.
  • the needle, trocar or sheath may have one or more surface features that mate with the access device, preventing further advancement and thereby prevent inadvertent injury to the intima of the vessel.
  • This lock can be retractable, allow fixation of the access cannula and preventing inadvertent disengagement of the catheter during intervention, monitoring or treatment.
  • Such a locking component can be situated at the tip or shaft of the trocar.
  • a slot or groove may be placed on the tip of the trocar which mates with a protrusion on the diaphragm base, limiting the depth of trocar insertion into the vessel.
  • the slot may be configured so twisting or other movement locks the trocar in a fixed position and prevents vessel injury or disengagement from the vessel.
  • a protrusion or recessed/grooved element may be placed on the shaft of the trocar to mate with a docking receptacle on the nipple.
  • the protrusion may be in the form of a collar with a distinct surface features that form a key into a receptacle latch.
  • One exemplary feature is a series of longitudinal slots, grooves or protrusions of varying spacing or thickness.
  • Another feature are slots, grooves, or protrusions that can be screwed.
  • Trocar implementations may be suitably designed for different access functions and made of a variety of materials.
  • exemplary metal trocars in the range of 27 to 24 gauge may be adequate.
  • the trocar may include a surface feature that mates with the pin or receptacle attached to the diaphragm to prevent back wall puncture.
  • metal or polymer trocars 23 to 18 gauge may be appropriate.
  • a groove or slot at the tip will prevent back wall injury.
  • exemplary trocars 17 to 12 gauge with locking slot features preserves access while preventing back wall injury and bleeding.
  • An inner sharp metal trocar can be mated with a metal or polymer indwelling trocar sleeve.
  • a longitudinal spine on the trocar can be used to mate multiple diameter trocars to one guiding groove on the nipple complex.
  • Male and female safety release valves at the proximal end of the trocar may prevent excessive traction on the access with inadvertent yanking of the dialysis tubes during the hours long dialysis runs.
  • Exemplary cardiovascular access sheaths 5fr to 25 Fr may comprise a sharp metal tip trocar and a slotted locking polymer sheath with proximal hemostatic valve.
  • Exemplary intravenous access catheters for chemotherapy also may have described locking features to prevent inadvertent extravasations of caustic medicines. It is understood that any combination of the apparatus and methods described may be used.
  • semi-permeable sheaths e.g., catheter sheaths
  • a filter segment to prevent embolization
  • a sheath is designed to enable a portion of the sheath wall to function as a filter.
  • the wall may be constructed with a porous section made of polymer fiber or laser drilled holes in metal or polymer.
  • a filter recessed between a outer and inner wall of the sheath tip with blood exiting a side opening downstream from an occluding element can be used.
  • An anchor such as a non- occluding balloon is placed on the sheath downstream of the filter section to prevent dislodgement of the filter in the extravascular space.
  • An occlusive balloon may also be placed on the sheath upstream from the filter section to divert any emboli from unimpended downstream movement.
  • a delivery sheath will be used to introduce the access device.
  • the sheath may be introduced with the aid of ultrasound localization or manual palpation.
  • a wire guide may be inserted into the vessel to localize it or placed on it until transmitted pulsations are noted.
  • the wire guide is a needle that penetrates the vessel, confirming appropriate placement by visualized blood return.
  • a wire with exemplary diameter .014 or .035 is placed into the vessel.
  • the dilator 4 with a tapered but non-piercing tip may have a rail 5 for the wire and is passed alongside the adventitia of the vessel.
  • the rail has a split line so that the dilator sheath can continue to glide along the outer surface of the vessel distal to the insertion site of the wire.
  • the dilator can be removed and the access apparatus inserted or the leading edge of the access apparatus may be used as the dilator.
  • the delivery sheath can be retracted to unfold the apparatus from a distal to proximal direction or two opposing split lines in the main wall of the sheath can facilitate unfolding of the apparatus from a proximal to distal direction as the two pieces of the peel away sheath are removed.
  • the peel away molding can be fashioned with contact points that enlarge the delivery space and facilitate unimpended expansion of the diaphragm and prevent device anchor zones from activating before proper positioning and seating.
  • the wire guide is a specialized needle having a side port opening that directs a wire along the adventitial plane and a protruding element on the needle shaft that preventing further intralumenal advancement of the needle.
  • the side port can serve both functions or an added needle feature such as a step off in needle shaft size may be utilized. This allows the side port opening to rest on the outer surface of the vessel and facilitate accurate advancement of the guide wire along the surface of the vessel contained within the vessel sheath.
  • the wire guide is removed and a dilator delivery sheath passed through the wire to create a space alongside the vessel outer surface.
  • the wire guide is placed on the outer surface of the vessel without penetrating the vessel lumen.
  • the guide may also be curvilinear to assist in directing the wire along the plane between the vascular sheath and the outer surface of the vessel.
  • a dilator is used to create the space for apparatus placement.
  • no wire is used and a tapered but a non-piercing dilator such as a polymer rod is passed along the vessel surface.
  • the correct plane can be visualized on ultrasound as the dilator depresses the upper wall of the vessel into a concave configuration that acts as a grove for the dilator.
  • Serial dilators of increasing diameter may also be used or a balloon expanded along the tract to create space between the outer wall and the vessel sheath.
  • a method for vascular access involves placement of a self sealing diaphragm or nipple protrusion on a vessel such as the supraclavicular or infraclavicular subclavian artery.
  • the supraclavicular portion of the vessel can be accessed most readily by downward displacement of the shoulder, locating the curve of the vessel by its pulsation or by ultrasound.
  • Further landmarks for a large individual include the mid clavicle and the external jugular vein as it courses to the clavicle.
  • a venous catheter may be inserted into the external jugular or the subclavian vein to assist in deployment of the artery delivery sheath.
  • an exemplary needle, 22-18 guage is advanced into the artery parallel to the clavicle to avoid the possibility of puncture of the lung.
  • the needle with or without ultrasound guide is advanced as a steeper angle but not more than the level of the artery as determined by palpation or imaging study.
  • a wire is inserted through the needle and used to guide a blunt dissector along the adventitial-soft tissue plane. This dissector may be a delivery sheath through which the access device is then inserted and deployed.
  • open surgical exposure of the vessel is performed and the diaphragm or nipple attached to the vessel.
  • a sheath is designed to enable a portion of the sheath wall to function as a filter.
  • the wall may be constructed with a porous section made of polymer fiber or laser drilled holes in metal or polymer.
  • a filter recessed between an outer and inner wall of the sheath tip with blood exiting a side opening(s) downstream from an occluding element can be used.
  • a retractable anchor such as a non-occluding balloon or protrusion is placed on the sheath downstream of the filter section to prevent dislodgement of the filter into the extra vascular space.
  • An occlusive balloon may also be placed on the sheath upstream from the filter section to divert any emboli from unimpeded downstream movement.
  • One new method for hemodialysis using this invention uses one artery with an access device, for example, the left subclavian artery for the venous cannula for hemodialysis and another, for example, the right subclavian artery for the arterial cannula.
  • the returning cannula can also be placed in any other suitable vessel, for example, the jugular, subclavian, or femoral veins.
  • the larger access tracers may facilitate hem dialysis by dispensing with the need for a pump and allows return of detoxified blood to circulation while minimum zing risk of stroke.
  • a dilator for preparing a body vessel (e.g., an artery) for implantation of a medical device in the perivessicular space.
  • a dilator may include a blunt separator (e.g., a blunt trocar), and a guiderail may include a side-exit portion for separation of the guidewire from the side of the guiderail.
  • Figure 1a and 1 b show one variation of a dilator as described.
  • the dilator may be moved along the outside of the vessel to form a space around the vessel (e.g., the periarterial space) where an implant can subsequently be inserted, as shown in Figure 1 b.
  • the guidewire 2 may be anchored within the vessel (or nearby) and may stay in place as the dilator is moved, so that the wire leaves the side of the guiderail and does not inhibit motion of the blunt dissector.
  • the guiderail may include a longitudinal notch or opening, or the guiderail may include a break-away or separable opening so that the wire may exit.
  • Figure 1a' shows one variation of a dilator as described.
  • the dilator may be moved along the outside of the vessel to form a space around the vessel (e.g., the periarterial space) where an implant can subsequently be inserted, as shown in Figure 1 b.
  • the guidewire 2 may be anchored
  • the blunt trocar region of the dilator has a curved surface so that it may follow along the outer surface of the vessel.
  • the edge of the blunt trocar is blunt enough so that it doesn't penetrate the vessel (e.g., artery), but sharp enough to separate the tissue layers surrounding the vessel.
  • Fig 1 there may exist various device locking tines, as shown by way of example in Fig 1 Some may be radially disposed (93) or in a parallel matrix (94). Some may have barbs (95). Some may be deployed like sutures (96). Some may be embedded in polymer or be part of a frame (97). Some may follow a guiding channel in the diaphragm (98) and weave in and out of the vessel wall and diaphragm. Some may circumscribe the perimeter of the vessel access site (99) or overlap access site including as mirror image U configuration (111) or a purse string.
  • Fig 1 Some may be radially disposed (93) or in a parallel matrix (94). Some may have barbs (95). Some may be deployed like sutures (96). Some may be embedded in polymer or be part of a frame (97). Some may follow a guiding channel in the diaphragm (98) and weave in and out of the vessel wall and diaphragm. Some may circumscribe the perimeter of the vessel access site (99) or overlap access site
  • the entry site complex may also have a protrusion (100) embedded in the diaphragm or attached to the frame that locks or mates with trocar.
  • a strut (120) resting in the trocar channel (130) is displaced with passage of the trocar (140), opening the shutter valve.
  • the trocar can engage a surface feature (121) on the shutter to slide it to an open position.
  • a nipple 150
  • the nipple may be slidably attached to the vessel by rails (78) on the anchoring diaphragm.
  • the diaphragm may be fixed by tissue incorporation or other means along the entire arc (76) or on either side of the vessel wall puncture site (77).
  • a replaceable valve cartridge (79) can be attached to the nipple and mated to the fixed portion of the diaphragm.
  • the nipple complex can slide between a covered access site (160) position and an open access site position (180).
  • the fixed portion (201) is anchored to the vessel.
  • the slidable arc (205) is attached via an axial rod (202) and supported by the sides of the fixed section.
  • the rod has an attached lever (204) that actuates a locking feature (206).
  • the trocar (210) is used as handle to switch the nipple to the open access position.
  • Fig 3 There exist various trocars features (Fig 3). Some may have one (220) or more slots. Some may have a collar (222) feature that acts as a key with slots (223) or protrusions (224). The trocar may also actuate a locking pin via a lever mechanism. (230) The locking pin may have a spring (232) and a lever displacement surface (233). Some trocars may have a safety valve (310) with a dialysis tube sleeve (315).
  • the conventional needle wire guide is a tube (10) with a needle end hole (12).
  • Another wire guide has a step off (20 in the shaft diameter .5 to 1 cm from the tip and a side opening (22) flush with the step off.
  • Another wire guide has a sharp solid tip or burr (24) and a side opening that directs a guidewire (14) in the adventitial plane.
  • Another wire guide directs the wire with a a curvilinear shaft (30) segment and end hole (32).
  • Figure 5 illustrates an exemplary percutaneous method for vascular access that involves placement of a self-sealing or re-sealing diaphragm on a vessel.
  • the self-sealing diaphragm may be placed on a vessel such as the supraclavicular or infraclavicular subclavian artery.
  • there exists (fig 5) a method for percutaneous repeatable access of vessels such as the subclavian artery.
  • a guide wire (14) is passed into the vessel sheath (40) abutting the vessel.
  • a dilator (50) follows the wire to enlarge the potential space on top of the vessel.
  • the dilator indents the vessel, creating a groove (60) that facilitates keeping the space along the axis of the vessel.
  • the dilator delivery sheath (52) contains an access diaphragm (70) that has blunt dilating tip (51) or is inserted after removing a dilating trocar (50). The diaphragm is unfolded as the sleeve is retracted or a peel away sheath is removed (58).
  • the sheath sleeve may have a co-axial rail (54) with a split line (55) or a longitudinal groove (56) if the wire guide is placed within the vessel instead of in the adventitial plane. This permits the sleeve to advance beyond the wire entrance site in the vessel.
  • the diaphragm may have a tissue incorporation lining (72) and angled tines (90) that seat the apparatus to the vessel well. Once positioned, one or more locking tines (92) have been deployed with a pusher rod. (80) In another embodiment a peel away sheath (300) may assist unfolding of the access device which has a latch feature (301) Fig 5b
  • Figure 1a and b shows a cross section of an artery demonstrating a tissue plane developed by a dilator 1 discussed earlier.
  • a wire guide 2 may be inserted first into the vessel to localize it or the dilator pushed down until transmitted pulsations are noted.
  • the dilator may have a rail (guiderail) 3 for the wire and is passed alongside the adventitia of the vessek.
  • the rail has a split line (side-exit portion) so that the dilator can continue to glide along the adventitia distal to the insertion site of the wire.
  • Figure 2 shows an artery with a 9 to 24 French introducing sheath 4 inserted in the dilator tract.
  • the sheath may be introduced with the aid of ultrasound or manual palpation.
  • the diaphragm 5 may have a frame with crossbars 6 to create an appropriate arc for the vessel without excess mass.
  • a glue tube 7 fastens to the underside of the diaphragm delivered rolled up in the sheath. Once the diaphragm is placed along the vessel, the glue tube with side holes applies the tissue glue and is removed as pressure is exerted on the neck or groin.
  • Figure 3a shows an artery with a similar diaphragm and a frame with tines in the introducer sheath attached to a rod and and/or a pusher.
  • 3b is a cross sectional view showing a compressed diaphragm in the sheath.
  • 3c shows deployment and unrolling of the access diaphragm.
  • Tines 8 are embedded in the diaphragm angled away from the direction of insertion (for example, if done in a minimally invasive fashion) or in the same direction of insertion.
  • a stiff rod 9 attaches to the diaphragm frame through several guides 11.
  • the rod is pulled in the same direction as the tines while pressure is held on the neck or groin, thereby seating the diaphragm to the vessel.
  • the rod is used to test the security of the attachment. If satisfactory, one way self locking anchoring counter ties 12 are embedded the artery wall with the aid of a pusher 13 Fig 3d.
  • the rod is removed and sheath are remove Figure 3e.
  • a balloon may be inserted into the vein to act as an anvil to enable secure purchase of the anchoring elements.
  • Figure 4a shows another embodiment shows radially oriented tines with collar elements as holdfasts.
  • 4b shows a diaphragm with a pre cut slit and an introducer for controlled access with large sheaths.
  • Figure 5 shows the an artery with an applied diaphragm closure device and a sheath with an occluding element distally and filter segment proximally.

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  • Health & Medical Sciences (AREA)
  • Heart & Thoracic Surgery (AREA)
  • Life Sciences & Earth Sciences (AREA)
  • Vascular Medicine (AREA)
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  • Animal Behavior & Ethology (AREA)
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  • General Health & Medical Sciences (AREA)
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  • Nuclear Medicine, Radiotherapy & Molecular Imaging (AREA)
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  • Prostheses (AREA)

Abstract

La présente invention concerne des procédés et un appareil qui facilitent l’accès artériel et/ou veineux en utilisant une structure sécurisable/ancrée telle qu’un diaphragme sur une surface externe/adventitielle d’un vaisseau, aussi que des structures et caractéristiques associées. En outre, les procédés et l’appareil peuvent impliquer l’utilisation d’une gaine semi-perméable avec un segment de filtre pour empêcher une embolisation potentielle. Les avantages de certaines mises en œuvre de la présente invention concernant l’élimination de la chambre d’un dispositif d’accès vasculaire peuvent être obtenus en faisant du vaisseau lui-même la chambre et en incorporant le dispositif comme élément du vaisseau, par exemple, sans compter sur la fiabilité d’une gaine de cathéter à demeure pour accéder à distance. Certaines innovations de la présente invention concernent le fait de faciliter l’accès y compris des procédés et des dispositifs permettant d’automatiser le processus d’accès et d’empêcher l’embolisation.
EP08795077A 2008-05-16 2008-08-05 Procédé et appareil d accès vasculaire Withdrawn EP2257322A1 (fr)

Applications Claiming Priority (2)

Application Number Priority Date Filing Date Title
US12/072,683 US20080243080A1 (en) 2007-03-27 2008-05-16 Method and apparatus for vascular access
PCT/US2008/009450 WO2009108164A1 (fr) 2008-02-26 2008-08-05 Procédé et appareil d’accès vasculaire

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EP2257322A1 true EP2257322A1 (fr) 2010-12-08

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