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WO2008027366A2 - Dispositifs et méthodes pour la création et l'obturation d'ouvertures maîtrisées dans un tissu - Google Patents

Dispositifs et méthodes pour la création et l'obturation d'ouvertures maîtrisées dans un tissu Download PDF

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Publication number
WO2008027366A2
WO2008027366A2 PCT/US2007/018895 US2007018895W WO2008027366A2 WO 2008027366 A2 WO2008027366 A2 WO 2008027366A2 US 2007018895 W US2007018895 W US 2007018895W WO 2008027366 A2 WO2008027366 A2 WO 2008027366A2
Authority
WO
WIPO (PCT)
Prior art keywords
blood vessel
opening
incision
access port
vessel
Prior art date
Application number
PCT/US2007/018895
Other languages
English (en)
Other versions
WO2008027366A3 (fr
Inventor
Elad Benjamin
Jonathan Thomas
Carla Pienknagura
Bauback Safa
Original Assignee
Vascular Precision
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 Vascular Precision filed Critical Vascular Precision
Publication of WO2008027366A2 publication Critical patent/WO2008027366A2/fr
Publication of WO2008027366A3 publication Critical patent/WO2008027366A3/fr

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Classifications

    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B17/00—Surgical instruments, devices or methods
    • A61B17/0057—Implements for plugging an opening in the wall of a hollow or tubular organ, e.g. for sealing a vessel puncture or closing a cardiac septal defect
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B17/00—Surgical instruments, devices or methods
    • A61B17/32—Surgical cutting instruments
    • A61B17/3203—Fluid jet cutting instruments
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B17/00—Surgical instruments, devices or methods
    • A61B17/064—Surgical staples, i.e. penetrating the tissue
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B17/00—Surgical instruments, devices or methods
    • A61B17/34—Trocars; Puncturing needles
    • A61B17/3417—Details of tips or shafts, e.g. grooves, expandable, bendable; Multiple coaxial sliding cannulas, e.g. for dilating
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B18/00—Surgical instruments, devices or methods for transferring non-mechanical forms of energy to or from the body
    • A61B18/04—Surgical instruments, devices or methods for transferring non-mechanical forms of energy to or from the body by heating
    • A61B18/08—Surgical instruments, devices or methods for transferring non-mechanical forms of energy to or from the body by heating by means of electrically-heated probes
    • A61B18/082—Probes or electrodes therefor
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B18/00—Surgical instruments, devices or methods for transferring non-mechanical forms of energy to or from the body
    • A61B18/04—Surgical instruments, devices or methods for transferring non-mechanical forms of energy to or from the body by heating
    • A61B18/12—Surgical instruments, devices or methods for transferring non-mechanical forms of energy to or from the body by heating by passing a current through the tissue to be heated, e.g. high-frequency current
    • A61B18/14—Probes or electrodes therefor
    • A61B18/1492—Probes or electrodes therefor having a flexible, catheter-like structure, e.g. for heart ablation
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B17/00—Surgical instruments, devices or methods
    • A61B17/0057—Implements for plugging an opening in the wall of a hollow or tubular organ, e.g. for sealing a vessel puncture or closing a cardiac septal defect
    • A61B2017/00637—Implements for plugging an opening in the wall of a hollow or tubular organ, e.g. for sealing a vessel puncture or closing a cardiac septal defect for sealing trocar wounds through abdominal wall
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B17/00—Surgical instruments, devices or methods
    • A61B17/0057—Implements for plugging an opening in the wall of a hollow or tubular organ, e.g. for sealing a vessel puncture or closing a cardiac septal defect
    • A61B2017/00646—Type of implements
    • A61B2017/00659—Type of implements located only on one side of the opening
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B17/00—Surgical instruments, devices or methods
    • A61B2017/00831—Material properties
    • A61B2017/00867—Material properties shape memory effect
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B17/00—Surgical instruments, devices or methods
    • A61B17/04—Surgical instruments, devices or methods for suturing wounds; Holders or packages for needles or suture materials
    • A61B2017/0498—Surgical instruments, devices or methods for suturing wounds; Holders or packages for needles or suture materials for advancing a suture filament along a helical path through tissue
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B17/00—Surgical instruments, devices or methods
    • A61B17/22—Implements for squeezing-off ulcers or the like on inner organs of the body; Implements for scraping-out cavities of body organs, e.g. bones; for invasive removal or destruction of calculus using mechanical vibrations; for removing obstructions in blood vessels, not otherwise provided for
    • A61B2017/22038—Implements for squeezing-off ulcers or the like on inner organs of the body; Implements for scraping-out cavities of body organs, e.g. bones; for invasive removal or destruction of calculus using mechanical vibrations; for removing obstructions in blood vessels, not otherwise provided for with a guide wire
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B17/00—Surgical instruments, devices or methods
    • A61B17/32—Surgical cutting instruments
    • A61B2017/320052—Guides for cutting instruments
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B18/00—Surgical instruments, devices or methods for transferring non-mechanical forms of energy to or from the body
    • A61B2018/00315—Surgical instruments, devices or methods for transferring non-mechanical forms of energy to or from the body for treatment of particular body parts
    • A61B2018/00345—Vascular system
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B18/00—Surgical instruments, devices or methods for transferring non-mechanical forms of energy to or from the body
    • A61B2018/00315—Surgical instruments, devices or methods for transferring non-mechanical forms of energy to or from the body for treatment of particular body parts
    • A61B2018/00345—Vascular system
    • A61B2018/00404—Blood vessels other than those in or around the heart
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B18/00—Surgical instruments, devices or methods for transferring non-mechanical forms of energy to or from the body
    • A61B2018/00571—Surgical instruments, devices or methods for transferring non-mechanical forms of energy to or from the body for achieving a particular surgical effect
    • A61B2018/00601—Cutting
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61F—FILTERS IMPLANTABLE INTO BLOOD VESSELS; PROSTHESES; DEVICES PROVIDING PATENCY TO, OR PREVENTING COLLAPSING OF, TUBULAR STRUCTURES OF THE BODY, e.g. STENTS; ORTHOPAEDIC, NURSING OR CONTRACEPTIVE DEVICES; FOMENTATION; TREATMENT OR PROTECTION OF EYES OR EARS; BANDAGES, DRESSINGS OR ABSORBENT PADS; FIRST-AID KITS
    • A61F2/00—Filters implantable into blood vessels; Prostheses, i.e. artificial substitutes or replacements for parts of the body; Appliances for connecting them with the body; Devices providing patency to, or preventing collapsing of, tubular structures of the body, e.g. stents
    • A61F2/02—Prostheses implantable into the body
    • A61F2/04—Hollow or tubular parts of organs, e.g. bladders, tracheae, bronchi or bile ducts
    • A61F2/06—Blood vessels
    • A61F2/064—Blood vessels with special features to facilitate anastomotic coupling

Definitions

  • the present invention relates generally to medical devices and more particularly to devices and methods for creating and closing controlled, shaped openings in tissue.
  • a first aspect of the invention relates to devices and methods for creating controlled, shaped openings in tissue, such as blood vessel walls or fascia layers.
  • a second aspect of the invention relates to devices and methods for closing arteriotomies, other vascular openings, and other openings in tissue or fascia.
  • the present invention provides devices and methods for creating and closing controlled, shaped openings in tissue, such as blood vessel walls or fascia layers.
  • the invention utilizes an implantable access and closure device, or access port, that is placed on the tissue surface to help create a controlled, shaped opening in the tissue.
  • the access port will preferably include an aperture that demarcates a desired location for the opening in the tissue.
  • the access port can be attached to the tissue with integrated fasteners, such as barbs, staple members and/or adhesives, or with separate fasteners, such as staples or sutures.
  • the devices and methods include an incision means for creating an incision through a wall of the tissue at the desired location demarcated by the aperture in the access port.
  • the incision means includes a crescent or arc-shaped heating element for creating an opening through the tissue.
  • the incision means includes a cutting wire for creating an opening through the tissue.
  • the incision means includes a water jet for creating an opening through the tissue.
  • the incision means includes a cutting edge integrated into the access port for creating an opening through the tissue. A self-sealing incision is also described that can be utilized with the various embodiments of the invention.
  • the invention provides devices and methods for closing arteriotomies, other vascular openings, and other openings in tissue or fascia. These devices and methods can be used in conjunction with the access port and incision means described above or some can be used independently, for example to close arteriotomies that have been created using conventional means.
  • the closure means comprises a net that is deployed externally to the vessel, covering the arteriotomy site.
  • the closure means comprises a patch that is deployed externally to the vessel to cover the arteriotomy site.
  • the closure means comprises a ring that is slid around the vessel to cover the arteriotomy site.
  • the closure means comprises a wire that is wrapped around the vessel, creating a coil shape.
  • the closure means comprises a stent, or tube-like closure mechanism that is inserted through the arteriotomy site and deployed within the vessel.
  • the closure mechanism has a side opening that allows a procedure sheath to enter through the mechanism into the blood vessel. After the procedure, the closure mechanism is rotated within the vessel so that the side opening is no longer aligned with the arteriotomy. The arteriotomy site is sealed, providing hemostasis.
  • FIG. 1 shows an access port being advanced over a guidewire to the vessel wall.
  • FlG. 2 shows the access port being fixated to the vessel wall.
  • FIG. 3 shows the heating element being placed against the vessel wall.
  • FIG. 4 shows the heating element being activated to create an opening in the vessel wall.
  • FlG. 5 shows the opening created in the vessel wall.
  • FIG. 6 shows an access port being advanced over a guidewire to the vessel wall.
  • FIG. 7 shows the access port being fixated to the vessel wall.
  • FlG. 8 shows the wire being used to create an opening in the vessel wall.
  • FIG. 9 shows an access port being advanced over a guidewire to the vessel wall.
  • FIG. 10 shows the access port being fixated to the vessel wall.
  • FIG. 1 1 shows a high-pressure saline jet being used to create an opening in the vessel wall.
  • FIG. 12 shows an access port being advanced over a guidewire to the vessel wall.
  • FIG. 13 A shows the access port being fixated to the vessel wall and creating an opening in the vessel wall.
  • FlG. 13B is a lateral cross section of the access port of FlG. 12 fixated to the vessel wall.
  • FIG. 14 shows a self-sealing incision made through the tissue layers of the vessel wall.
  • FIG. 15 shows a procedure sheath inserted through the incision.
  • FlG. 16 shows the apposition of the vessel wall after removal of the procedure sheath.
  • FIG. 17 shows a delivery device housing a net introduced and placed flush against the vessel.
  • FIG. 18 shows the net deployed, covering the arteriotomy.
  • FIG. 19 illustrates deployment of a patch around a vessel.
  • FIG. 20 illustrates deployment of a ring around a vessel
  • FIG. 21 illustrates deployment of a wire around a vessel
  • FIG. 22 shows accessing a vessel with a closure mechanism.
  • FlG. 23 shows deployment of the closure mechanism.
  • FIG. 24 shows a procedure sheath inserted through the closure mechanism.
  • FIG. 25 shows the procedure sheath removed and the closure mechanism rotated to close the arteriotomy.
  • FiGS. 1-5 illustrate a first embodiment of the invention that utilizes an implantable access and closure device, or access port 100, that is placed on the tissue surface to help create a controlled, shaped opening in the tissue.
  • the access port 100 includes a frame 1 16, which may be made of a biocompatible metal, such as a nickel-titanium alloy, cobalt-chromium alloy or stainless steel, or a biocompatible polymer or a combination of materials.
  • the frame 1 16 is configured to be attached to the tissue surface, for example with integrated fasteners 1 18, such as barbs, staple members and/or adhesives, or alternatively with separate fasteners, such as staples or sutures.
  • the frame 1 16 may be configured with a curvature to conform to the target tissue, such as the exterior of a blood vessel which has an approximately cylindrical shape.
  • the access port 100 will preferably include an aperture 102 in the frame 1 16 that demarcates a desired location for the opening that will be created in the tissue.
  • the frame 1 16 of the access port 100 may be constructed as a single piece, as in the example shown, or it may comprise two or more components.
  • the aperture 102 may have a closed perimeter or an open perimeter.
  • the aperture 102 may be defined by a space between two adjacent components of a two-piece frame 1 16 that demarcate a desired location for the opening in the tissue, thus defining an aperture with an open perimeter.
  • the access port 100 is constructed with a circular or oval-shaped frame 1 16 with a crescent-shaped aperture 102 that is located between an arcuate inner jaw 104 and an arcuate outer jaw 106.
  • the arcuate inner jaw 104 is flexibly or pivotally attached to the frame 1 16 by a connecting member 120. This configuration allows the inner jaw 104 to be moved out of plane from the frame 1 16 by bending the connecting member 120.
  • Integrated fasteners 118 will be located along at least the inner jaw 104 and outer jaw 106 portions of the frame.
  • Other possible geometries of the access port 100 that can be used with the present invention are described in the copending applications cited above.
  • the apparatus preferably includes a delivery device 124, shown in FIGS. 1-2, for delivering the access port 100 to the target site.
  • the delivery device 124 has an elongate body 126 with a distal end 128 sized and shaped to hold the frame 1 16 of the access port 100.
  • the delivery device 124 may include a gripping mechanism for releasably holding the access port 100 during delivery.
  • a guidewire lumen 130 extends through the body 126, ending at a distal guidewire port 132 positioned to align with the aperture 102 through the frame 1 16.
  • the distal end 128 of the elongate body 126 may be cut at an oblique angle corresponding to the desired angle for inserting devices into the target blood vessel or other tissue. The optimum angle may vary depending on the tissue to be accessed and the procedure to be performed. For percutaneous access for transluminal procedures from the femoral artery, a tip angle of 45 degrees is currently preferred.
  • the apparatus includes an arcuate or crescent-shaped heating element 108 that is shaped to fit within the crescent- shaped aperture 102, as shown in FIGS. 3 and 4.
  • the heating element 108 will preferably be mounted at the distal end of a shaft 1 10 of sufficient length to reach the target vessel from the exterior of the patient's body.
  • the apparatus also includes a heating controller 1 12 for heating the heating element 108 to a sufficient temperature to incise tissue.
  • the heating controller 112 can operate by resistance heating, radiofrequency (RF) heating, monopolar or bipolar electrosurgical cutting and coagulation or other known heating technologies.
  • One or more electrical leads 1 15 appropriate to the heating technology used will connect the heating element 108 to the heating controller 1 12.
  • a ground electrode (not shown) may be attached elsewhere on the patient if needed.
  • the shaft 1 10 of the heating element 108 will include a guide lumen 122 that allows the heating element 108 to follow a guidewire or similar device that has been previously placed in the target tissue.
  • the guide lumen 122 may extend the full length of the shaft 1 10 or alternatively a short rapid-exchange style guide lumen may be used.
  • Shapes other than arcuate or crescent-shaped may be used for the aperture 102 and the heating element 108, however it is generally preferred to have a close match between the shapes of the two components.
  • the heating element 108 may be contained within, or delivered through, the delivery device 124.
  • the access port 100 is placed on the exterior surface of a blood vessel or other tissue so that the aperture 102 demarcates the desired location for an opening in the tissue.
  • the access port 100 may be placed using a surgical cutdown or, more preferably, using percutaneous access techniques. Percutaneous access is established by using a modification of the Seldinger technique.
  • An access needle (not shown) is used to puncture the target blood vessel at the desired location for creating an opening.
  • a guidewire 114 is inserted into the vessel through the lumen of the access needle and the access needle is withdrawn.
  • the guidewire 1 14 maintains a pathway through the tissues to the desired location for the opening in the tissue.
  • the guidewire 1 14 is backloaded through the aperture 102 of the access port 100 and through the guidewire lumen 130 of the delivery device 124. Then the delivery device 124 is advanced along the guidewire 1 14 until the access port 100 reaches the target tissue. If necessary, a tract through the tissue can be dilated with one or more tapered dilators that are inserted over the guidewire 114 prior to insertion of the delivery device 124. (It is important to note however, that the puncture through the vessel wall should not be dilated at this point in the procedure.)
  • FIG. 1 shows the access port 100 mounted on the delivery device 124 being advanced over the guidewire 1 14 to the vessel wall. (For clarity, the tissue surrounding the target vessel is not shown in the drawings.)
  • FIG. 2 shows an access port 100 being fixated to the exterior of a vessel wall.
  • Barb-shaped integrated fasteners 1 18, such as those shown, can be pushed into the exterior of the vessel wall to attach the frame 1 16 to the vessel wall.
  • Staple-type integrated fasteners 118 can be actuated using a stapling mechanism (not shown) integrated into or inserted through the delivery device 124.
  • the delivery device 124 is withdrawn so that the guide lumen 122 of the heating element 108 can be threaded onto the guidewire 1 14 and the heating element 108 is advanced to the target tissue.
  • the guide lumen 122 assures that the heating element 108 will be aligned with the aperture 102 through the frame 1 16 of the access port 100.
  • the heating element 108 may be contained within, or delivered through, the delivery device 124, in which case the delivery device 124 would not need to be withdrawn for this step of the procedure.
  • FIG. 3 shows the arcuate or crescent-shaped heating element 108 being placed against the vessel wall at the location demarcated by the crescent-shaped aperture 102.
  • the heating controller 112 activates the heating element 108 to heat up to a temperature sufficient to incise the target tissue.
  • FIG. 4 shows the heating element 108 being activated to create an opening 134 in the vessel wall.
  • the heating element 108 (and the delivery device 124 if it is still in place) is then withdrawn, leaving the guidewire 1 14 in place.
  • FIG. 5 shows the opening 134 that has been created in the vessel wall.
  • the arcuate heating element 108 forms an arcuate incision, which creates a tissue flap 136 in the vessel wall.
  • the tissue flap 136 can be pressed inward into the vessel lumen by bending the connecting member 120 that attaches the inner jaw 104 to the frame 116.
  • the opening 134 opens up the opening 134 to allow catheters or other devices to be inserted into the vessel lumen for performing diagnostic and/or therapeutic procedures on the patient.
  • the opening 134 should be sized for the devices to be inserted so that hemostasis will be maintained during the procedures.
  • the devices may be inserted over the guidewire 1 14 that is in place, or this guidewire can be exchanged for another guidewire appropriate for the procedures to be performed.
  • an introducer sheath (not shown) may be inserted into the opening 134 to facilitate insertion or exchange of catheter devices through the opening 134.
  • the resiliency of the connecting member 120 returns the tissue flap 136 to the opening 134 to prevent excessive bleeding at the incision site.
  • the tissue flap 136 is properly apposed to the vessel wall to encourage hemostasis and promote healing. If necessary, sutures, fasteners, surgical adhesive and/or coagulants may be applied to the incision site to assist in maintaining hemostasis.
  • FIGS. 6-8 illustrate another embodiment of the invention that utilizes an access port 100 similar to that described above in connection with FIGS. 1-5.
  • a cutting wire 140 is used create a controlled, shaped opening through the target tissue at the position demarcated by the aperture 102 in the access port 100.
  • FIG. 6 shows an access port 100 mounted on a delivery device 124 being advanced over a guidewire 114 to the vessel wall. Once the access port 100 has reached the target tissue, the frame 1 16 is attached to the target tissue with integrated fasteners 1 18 and/or with separate fasteners.
  • FIG. 7 shows the access port 100 being fixated to the exterior of a vessel wall.
  • a cutting wire 140 is inserted alongside the guidewire 114 and used to create an arcuate opening 134 through the aperture 102 between the inner jaw 104 and outer jaw 106.
  • FIG. 8 shows the cutting wire 140 being used to create an opening 134 in the vessel wall.
  • the cutting wire 140 may be integrated into or inserted through the delivery device 124 or it may be mounted on a separate device inserted after the delivery device 124 is withdrawn.
  • the cutting wire 140 may have a serrated edge or edges to facilitate cutting the target tissue using a reciprocating motion. Alternatively, the cutting wire 140 may be heated or use electrosurgical cutting to create the opening 134.
  • the cutting wire 140 traces the arcuate or crescent-shaped aperture 102 to create an arcuate opening 134 in the vessel wall with a tissue flap 136, as described above that promotes proper tissue apposition and hemostasis when the incision is closed, as described above.
  • Other geometries for the opening 134 are also possible and may be preferred in some applications of the invention.
  • the step-by-step arteriotomy and closure procedure can be summarized as follows: 1- Puncture the skin and the vessel with an access needle; 2- Insert a guidewire and withdraw the access needle;
  • FIGS. 9-1 1 illustrate another embodiment of the invention that utilizes an access port 100 similar to that described above in connection with FIGS. 1-5.
  • a high-pressure saline jet 142 is used create a controlled, shaped opening through the target tissue at the position demarcated by the aperture 102 in the access port 100.
  • FIG. 9 shows an access port 100 mounted on a delivery device 124 being advanced over a guidewire 1 14 to the vessel wall. Once the access port 100 has reached the target tissue, the frame 116 is attached to the target tissue with integrated fasteners 1 18 and/or with separate fasteners.
  • FIG. 10 shows the access port 100 being fixated to the exterior of a vessel wall.
  • a high-pressure saline jet 142 is used to create an arcuate opening 134 through the aperture 102 between the inner jaw 104 and outer jaw 106.
  • FIG. 8 shows the nozzle 144 for the high-pressure saline jet 142 being used to create an opening 134 in the vessel wall.
  • the nozzle 144 for the high-pressure saline jet 142 may be integrated into or inserted through the delivery device 124 or it may be mounted on a separate device inserted after the delivery device 124 is withdrawn.
  • the high-pressure saline jet 142 traces the arcuate or crescent-shaped aperture 102 to create an arcuate opening 134 in the vessel wall with a tissue flap 136 that promotes proper tissue apposition and hemostasis when the incision is closed, as previously described.
  • the step-by-step arteriotomy and closure procedure can be summarized as follows: 1 - Puncture the skin and the vessel with an access needle;
  • FIGS. 12-I 3B illustrate another embodiment of the invention that utilizes an access port 100 similar to that described above in connection with FIGS. 1-5.
  • a cutting edge 146 is integrated into the access port 100 for creating an opening 134 through the tissue.
  • the cutting edge 146 is integrated into the edge of the inner jaw 104 adjacent to the aperture 102.
  • the cutting edge 146 swings away from the opening 134 as the tissue flap 136 flexes inward toward the vessel lumen so that any devices inserted through the opening 134 will not be damaged by the cutting edge.
  • FIG. 12 shows an access port 100 mounted on a delivery device 124 being advanced over a guidewire 1 14 to the vessel wall.
  • FIG. 13A shows the access port 100 being fixated to the vessel wall, while simultaneously the cutting edge 146 creates an opening 134 in the vessel wall.
  • the access port 100 can be configured so that fixation and cutting happen in separate steps of the procedure.
  • FIG. 13B is a lateral cross section of the access port 100 fixated to the vessel wall with the inner jaw 104 and the tissue flap 136 flexed inward toward the vessel lumen to allow a procedure sheath 148 to enter the vessel lumen.
  • the step-by-step arteriotomy and closure procedure can be summarized as follows: 1- Puncture the skin and the vessel with an access needle;
  • FIGS. 14-16 illustrate a self-sealing incision 150 that can be utilized with the various embodiments of the invention.
  • This uniquely shaped incision allows the user to access and close an artery in a less traumatic fashion.
  • the incision creates a traverse cut through the different vessel layers - the tunica adventitia, tunica media and tunica intima.
  • the traverse structure of the cut allows the vessel to close after a surgical procedure without any blood loss.
  • the incision could also pass straight through the tissue, as long as the angle of the cut is shallow enough to provide sufficient self-closure of the tissue when pressurized from within the vessel.
  • FIG. 14 illustrates the preferred path of the self-sealing incision 150 made through the tissue layers of the vessel wall.
  • the incision starts with a shallow angle cut through the tunica adventitia.
  • the tunica media When the tunica media is reached, the incision traverses along the interface between the adventitia and the media. Then, the incision continues through the tunica media at a shallow angle.
  • the tunica intima When the tunica intima is reached, the incision once again traverses along the interface between the media and the intima. Finally, the incision continues through the tunica intima at a shallow angle.
  • FIG. 15 shows a procedure sheath 148 or other device inserted through the incision 150.
  • the incision 150 should be sized for the procedure sheath 148 so that hemostasis will be maintained during the procedure.
  • FIG. 16 shows the apposition of the vessel wall after removal of the procedure sheath 148. Because the layers of the vessel wall are properly apposed, the incision 150 promotes healing of incision with a minimum of scar tissue formation.
  • the self-sealing incision 150 should be made so that the inner part of the incision 150 (shown on the left in the drawings) is on the tissue flap 136. Thus, the blood pressure within the vessel will cause the incision to close tighter to maintain hemostasis and promote healing.
  • the invention consists of an incision mechanism that creates a shallow-angle incision (straight or step-like) through the artery layers (or other tissue).
  • the step-by-step arteriotomy and closure procedure can be summarized as follows:
  • the closure means comprises a net that is deployed externally to the vessel, covering the arteriotomy site.
  • FIGS. 17-18 illustrate a device and method for closing arteriotomies and other openings in tissue utilizing a net 152 that is deployed externally to the vessel, covering the arteriotomy site.
  • RG. 17 shows a net delivery device 154 housing a net 152 introduced and placed flush against the vessel.
  • the net 152 is contained in a lumen or chamber 153 near the distal end of the net delivery device 154.
  • the net delivery device 154 is introduced through the incision tract left when the procedure sheath and other devices are removed after completion of a procedure.
  • the net delivery device 154 can have a guidewire lumen for following a guidewire to the arteriotomy site.
  • the net 152 is contained in a lumen or chamber 153 near the distal end of the net delivery device 154.
  • the net 152 is preferably in a compressed state within the chamber 153 of the net delivery device 154.
  • the net 152 is ejected from the net delivery device 154, whereupon the net 152 expands to cover the arteriotomy.
  • the net 152 may be deployed by fluid pressure or by a pusher rod that ejects the net 152 from the chamber 153.
  • FIG. 18 shows the net 152 deployed, covering the arteriotomy. When used independently or in conjunction with the access port 100 described above, the net 152 helps to assure closure and hemostasis of the arteriotomy.
  • the net 152 may be made from a woven, knitted or non- woven fabric of biocompatible fibers, such as metal, polymer and/or natural fibers. Fibers or additives that enhance clotting may be used to improve hemostasis.
  • the entire net 152 or a portion of it may be made of a bioabsorbable material, for example polyglycolic acid (PGA), poly-L-lactide (PLLA) or a blend thereof.
  • PGA polyglycolic acid
  • PLLA poly-L-lactide
  • FIG. 19 illustrates a device and method for closing arteriotomies and other openings in tissue utilizing a patch 156 that is deployed externally to the vessel to cover the arteriotomy.
  • the patch 156 is delivered to the arteriotomy site by a patch delivery device 158, in a similar fashion to the net 152 described above.
  • the patch delivery device 158 When the patch delivery device 158 has reached the arteriotomy site, the patch 156 is ejected from the patch delivery device 158, whereupon the patch 156 flattens and expands to cover the arteriotomy like a bandage.
  • FIG. 19 shows the patch 156 deployed, covering the arteriotomy. When used independently or in conjunction with the access port 100 described above, the patch 156 helps to assure closure and hemostasis of the arteriotomy.
  • the patch 156 may include adhesive portions that adhere to the exterior of the vessel to further assure closure and hemostasis.
  • the patch 156 may be made from a woven, knitted or non-woven fabric of biocompatible fibers, such as metal; polymer and/or natural fibers. Fibers or additives that enhance clotting may be used to improve hemostasis.
  • the entire patch 156 or a portion of it may be made of a bioabsorbable material, for example polyglycolic acid (PGA), poly-L-lactide (PLLA) or a blend thereof.
  • FIG. 20 illustrates a device and method for closing arteriotomies and other openings in tissue utilizing a ring 160 that is deployed externally to the vessel to cover the arteriotomy.
  • the ring 160 is delivered to the arteriotomy site by a ring delivery device 162, in a similar fashion to the net 152 described above.
  • the ring delivery device 162 When the ring delivery device 162 has reached the arteriotomy site, the ring 160 is ejected from the ring delivery device 162, whereupon the ring 160 deploys to cover the arteriotomy like a bandage.
  • the ring 160 will have a geometry that allows it to wrap around the artery.
  • the ring 160 may be constructed with a split in it that allows it to wrap around the artery.
  • the ring 160 may be constructed as an elongated sheet that wraps around the artery greater than 360 degrees to form a substantially continuous ring.
  • the ring 160 will be made from a biocompatible material, such as a metal, polymer and/or natural material.
  • the material of the ring 160 may be solid or it may be fibrous, i.e. a woven, knitted or non-woven fabric of biocompatible fibers. Fibers or additives that enhance clotting may be used to improve hemostasis.
  • the entire ring 160 or a portion of it may be made of a bioabsorbable material, for example polyglycolic acid (PGA), poly-L-lactide (PLLA) or a blend thereof.
  • the ring 160 deployed around the vessel and covering the arteriotomy.
  • the ring 160 helps to assure closure and hemostasis of the arteriotomy.
  • the ring 160 may include adhesive portions that adhere to the exterior of the vessel to further assure closure and hemostasis.
  • FIG. 21 illustrates a device and method for closing arteriotomies and other openings in tissue utilizing a wire 164 that is deployed externally to the vessel to cover the arteriotomy.
  • the wire 164 in a straightened or undeployed state, is delivered to the arteriotomy site by a wire delivery device 166.
  • the wire delivery device 166 When the wire delivery device 166 has reached the arteriotomy site, the wire 164 is deployed from the wire delivery device 166, whereupon the wire 164 wraps around the vessel to cover the arteriotomy.
  • the wire 164 has been treated so that it has a shape memory that causes it to curve and wrap around the vessel as it exits the wire delivery device 166.
  • a highly resilient biocompatible material such as a nickel-titanium alloy or a shape-memory polymer, is well suited to this application.
  • the wire 164 will have a blunt distal end, 165 e.g. a bead, loop or J-tip, to avoid dissecting the surrounding tissue during deployment.
  • a malleable biocompatible material such as annealed stainless steel wire, can be formed by rollers or a wire bending anvil as it exits the wire delivery device 166, causing it to wrap around the vessel.
  • the entire wire 164 or a portion of it may be made of a bioabsorbable material, for example polyglycolic acid (PGA), poly-L-lactide (PLLA) or a blend thereof.
  • FIG. 20 shows the wire 164 deployed around the vessel and covering the arteriotomy. Multiple wraps of the wire 164 around the vessel will help to cover the arteriotomy.
  • the diameter of the wire 164 will vary somewhat depending on the material it is made from and the deployment mechanism used.
  • the wire 164 will preferably have a diameter of approximately 0.5 mm or larger. When used independently or in conjunction with the access port 100 described above, the wire 164 helps to assure closure and hemostasis of the arteriotomy.
  • FIGS. 22-25 illustrate a device ,and method for creating and closing arteriotomies and other openings in tissue utilizing a stent, or tube-like closure mechanism 170 that is inserted through the arteriotomy site and deployed within the vessel lumen.
  • the closure mechanism 170 will be made from a biocompatible material, such as a metal, polymer or a combination thereof.
  • the closure mechanism 170 may be woven or braided from wire or it may be formed, e.g. laser cut, from a tube of material. Suitable materials for the closure mechanism 170 include, but are not limited to, stainless steel, cobalt-chromium alloys and nickel-titanium alloys.
  • the entire closure mechanism 170 or a portion of it may be made of a bioabsorbable material, for example polyglycolic acid (PGA), poly-L-lactide (PLLA) or a blend thereof.
  • the dimensions of the closure mechanism 170 will vary depending on the target vessel that it is intended for use in. For use in a femoral artery of an adult patient, the closure mechanism 170 will typically have a diameter of approximately 8- 12 mm and a length of approximately 15-20 mm.
  • the closure mechanism 170 has a side opening 172 that allows a procedure sheath to enter through the mechanism into the blood vessel. In a preferred embodiment, the side opening 172 is preformed in the closure mechanism 170 in the shape of an arch, therefore forming a side flap 176 in the wall of the closure mechanism 170.
  • a side opening 172 is preformed in the closure mechanism 170 in the shape of an arch, therefore forming a side flap 176 in the wall of the closure mechanism 170.
  • a side opening 172 is preformed
  • FIG. 22 shows the closure mechanism 170 being introduced into a blood vessel through an arteriotomy puncture.
  • the closure mechanism 170 is in a compressed, undeployed state within the lumen of.a delivery sheath 174.
  • a guidewire 1 14 is threaded through the lumen of a delivery sheath 174 and the side opening 172 of the closure mechanism 170 so that the side opening 172 will be aligned with the arteriotomy when it is deployed.
  • the closure mechanism 170 is self-expanding so that it will automatically expand to the inner diameter of the vessel when it is deployed.
  • the closure mechanism 170 can be balloon-expandable or balloon assisted in its deployment.
  • FIG. 23 shows the deployment of the closure mechanism 170 within the vessel lumen.
  • the delivery sheath 174 has been withdrawn to allow the closure mechanism 170 to expand to its deployed tubular state.
  • An incision 134 is made in the vessel wall in alignment with the side opening 172, for example using one of the incision methods described above.
  • the incision 134 will be made with an arcuate shape forming a tissue flap 136 closely matching the shape of the side flap 176 in the wall of the closure mechanism 170.
  • FIG. 24 shows a procedure sheath 148 inserted through the side opening 172 of the closure mechanism 170.
  • the tissue flap 136 and the flap 176 in the wall of the closure mechanism 170 flex inward in order to allow the procedure sheath 148 or another device to enter the vessel lumen.
  • the procedure sheath 148 is withdrawn and the closure mechanism 170 is rotated and/or translated within the vessel so that the side opening 172 is no longer aligned with the arteriotomy.
  • the arteriotomy site is sealed, providing hemostasis.
  • FlG. 25 shows the procedure sheath 148 removed and the closure mechanism rotated or translated 170 to close the arteriotomy.
  • the step-by-step arteriotomy and closure procedure can be summarized as follows: 1- Puncture the skin and the vessel with an access needle;
  • the tissue flap 136 can be made slightly smaller than the side flap 176 in the wall of the closure mechanism 170, the incision will be self-sealing like a flapper valve, without the need to rotate or translated the stent-like closure mechanism 170 after the procedure.

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  • Heart & Thoracic Surgery (AREA)
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Abstract

Selon l'invention, des dispositifs et des méthodes servant à créer et obturer des ouvertures formées et maîtrisées dans un tissu, tel que les parois d'un vaisseau sanguin ou des couches du fascia, utilisent un dispositif d'accès et d'obturation implantable ou un orifice d'accès, une ouverture délimitant un emplacement souhaité destiné à une ouverture dans le tissu. Un dispositif d'incision servant à créer une ouverture dans le tissu peut comporter un élément chauffant en forme d'arc ou de croissant, un fil coupant, un jet d'eau ou un bord coupant intégré à l'orifice d'accès. Cette invention a aussi pour objet une incision auto-obturante. Un dispositif d'obturation conçu pour fermer l'artériotomie ou une autre ouverture et permettre une hémostase peut comprendre un filet, un timbre, un anneau ou un fil qui est déployé à l'extérieur du vaisseau, ce qui se solde par le recouvrement du site d'artériotomie. Un autre dispositif d'obturation comprend un stent ou un mécanisme d'obturation tubulaire qui est inséré dans le site d'artériotomie et déployé au sein du vaisseau. Une ouverture latérale permet à une gaine d'intervention de pénétrer dans le vaisseau sanguin. Après l'intervention, le mécanisme d'obturation est amené à tourner dans le vaisseau, de manière que l'ouverture latérale n'est plus alignée avec l'artériotomie.
PCT/US2007/018895 2006-08-28 2007-08-28 Dispositifs et méthodes pour la création et l'obturation d'ouvertures maîtrisées dans un tissu WO2008027366A2 (fr)

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WO2021234638A1 (fr) * 2020-05-20 2021-11-25 Puzzle Medical Devices Inc. Dispositif d'étanchéité implantable entièrement endovasculaire de corps de mammifère consécutif à une rupture de paroi de cavité
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US12053623B2 (en) 2019-03-26 2024-08-06 Puzzle Medical Devices Inc. Modular mammalian body implantable fluid flow influencing device and related methods
US12161853B2 (en) 2022-11-01 2024-12-10 Puzzle Medical Devices Inc. Implantable medical devices and related methods thereof

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US11690997B2 (en) 2018-04-06 2023-07-04 Puzzle Medical Devices Inc. Mammalian body conduit intralumenal device and lumen wall anchor assembly, components thereof and methods of implantation and explanation thereof
JP2020110588A (ja) * 2019-01-08 2020-07-27 コヴィディエン リミテッド パートナーシップ アクセス部位を覆うための回転可能なステント送達装置
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WO2021234638A1 (fr) * 2020-05-20 2021-11-25 Puzzle Medical Devices Inc. Dispositif d'étanchéité implantable entièrement endovasculaire de corps de mammifère consécutif à une rupture de paroi de cavité
US12161853B2 (en) 2022-11-01 2024-12-10 Puzzle Medical Devices Inc. Implantable medical devices and related methods thereof

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