WO2008010738A2 - Patent foramen ovale occluder with suture based anchor - Google Patents

Patent foramen ovale occluder with suture based anchor Download PDF

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Publication number
WO2008010738A2
WO2008010738A2 PCT/RS2007/000002 RS2007000002W WO2008010738A2 WO 2008010738 A2 WO2008010738 A2 WO 2008010738A2 RS 2007000002 W RS2007000002 W RS 2007000002W WO 2008010738 A2 WO2008010738 A2 WO 2008010738A2
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WO
WIPO (PCT)
Prior art keywords
suture
catheter
knot
proximal
end
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PCT/RS2007/000002
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French (fr)
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WO2008010738A8 (en
WO2008010738A3 (en
Inventor
Uros Babic
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Uros Babic
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Priority to PCT/RS2007/000002 priority Critical patent/WO2008010738A2/en
Publication of WO2008010738A2 publication Critical patent/WO2008010738A2/en
Publication of WO2008010738A8 publication Critical patent/WO2008010738A8/en
Publication of WO2008010738A3 publication Critical patent/WO2008010738A3/en

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Classifications

    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61BDIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B17/00Surgical instruments, devices or methods, e.g. tourniquets
    • A61B17/0057Implements 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
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61BDIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B17/00Surgical instruments, devices or methods, e.g. tourniquets
    • A61B17/04Surgical instruments, devices or methods, e.g. tourniquets for suturing wounds; Holders or packages for needles or suture materials
    • A61B17/0401Suture anchors, buttons or pledgets, i.e. means for attaching sutures to bone, cartilage or soft tissue; Instruments for applying or removing suture anchors
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61BDIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B17/00Surgical instruments, devices or methods, e.g. tourniquets
    • A61B17/34Trocars; Puncturing needles
    • A61B17/3415Trocars; Puncturing needles for introducing tubes or catheters, e.g. gastrostomy tubes, drain catheters
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61BDIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B17/00Surgical instruments, devices or methods, e.g. tourniquets
    • A61B17/34Trocars; Puncturing needles
    • A61B17/3498Valves therefor, e.g. flapper valves, slide valves
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61BDIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B17/00Surgical instruments, devices or methods, e.g. tourniquets
    • A61B17/0057Implements 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
    • A61B2017/00575Implements 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 closure at remote site, e.g. closing atrial septum defects
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61BDIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B17/00Surgical instruments, devices or methods, e.g. tourniquets
    • A61B17/04Surgical instruments, devices or methods, e.g. tourniquets for suturing wounds; Holders or packages for needles or suture materials
    • A61B17/0401Suture anchors, buttons or pledgets, i.e. means for attaching sutures to bone, cartilage or soft tissue; Instruments for applying or removing suture anchors
    • A61B2017/0409Instruments for applying suture anchors
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61BDIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B17/00Surgical instruments, devices or methods, e.g. tourniquets
    • A61B17/04Surgical instruments, devices or methods, e.g. tourniquets for suturing wounds; Holders or packages for needles or suture materials
    • A61B17/0469Suturing instruments for use in minimally invasive surgery, e.g. endoscopic surgery
    • A61B2017/0474Knot pushers

Abstract

Devices and methods are provided for closing a flap- or tunnel like anatomical aperture such as patent foramen ovale (PFO). The system 1 includes a sponge occluder 2 with integrated suture length distally 5 and proximally 8 which are used for guiding, advancement, and securing the occluder to the atrial septal tissue 17. According to an exemplary method, an integrated adapter 6 is used for docking the system device onto the wire track which was created from the venous access through the puncture site 171 of the tissue adjacent the PFO via the PFO 170, and traversed back through the same exit/entry site utilizing conventional transseptal catheter- and snare technique. Pulling back the tracking wire, the docked distal suture 5 follows the tracking pathway in reverse direction creating a suture looping via the PFO and puncture site and out of the body. The loop of the looped knot 9, which is integrated into the proximal suture length 8, is placed over the exteriorized distal suture length 5 and the system is advanced until the sponge occluder is positioned onto the right atrial side of the PFO. The loop knot is tightened providing an 'adjustable' initial tying of the system to the tissue. Additional individual 'stopper knots' are made externally and delivered by pusher catheter. Tying the knots is achieved by catheter- based tourniquet technique. Alternatively, the tying of the two ends of the suture looping is performed using an individually transportable 'pledget loop knot unit'. Free ends of the knotted sutures are cut off with a catheter- based cutter. Procedure is guided by ultrasound and fluoroscopy.

Description

Patent foramen ovale occluder with suture based anchor

Technical Field

This invention relates generally to devices for catheter based occlusion of heart defects such as a patent foramen ovale (PFO) and other morphologically similar defects within the cardiovascular system. The invention relates also to delivery system and technique for device implantation.

Background

A patent Foramen Ovale is a flap- like or tunnel-like opening between the right atrium (RA) and left atrium (LA). This opening functions during fetal life and is usually closed in adults.

However it can remain potentially open in about a quarter of adults without having consequences.

Recently, there is evidence that patients with PFO may suffer cerebrovascular events due to paradoxical embolism via this opening. Many studies have confirmed a strong association between the presence of PFO and the risk for recurent cerebrovascular events.

Treatment of such patients includes oral anticoagulation, surgical closure of PFO or catheter based PFO closure using different occlusion systems (Pat. No. WO03103476, US Pat. 20061226, Amplatzer device- US Pat.5846261, Sideris device- US Pat.4917089). All these occlusion devices are made of metal frame (nickel-titanium based alloys, or stainless steel). In order to be safely anchored to the rim of residual tissue around the defect the device must be double the size of the defect.

Complications reported include frame fracture, thrombus formation within the LA and /or RA, cardiac arrhythmias and disturbances of conduction system, perforation, of heart tissue, infection, device dislodgement and device embolization. Many devices have a large profile and include large masses of metal material within the left -and right atrium, which may lead to unfavorable body adaptation of the device and is prone to thrombus formation. Some of these implant related complications occur soon after the implantation but heart perforation has been reported even years afterwards (Divekar A,Gaamanwe T,Shaick N,Raabe M,Ducas J. Cardiac perforation after device closure of atrial septal defects with Amplatzer septal occluder. J Am Coll Cardiol 2005;45: 1213-8. Hanzel GS: Complications of Patent Foramen Ovale and Atrial Septal Defect Closure Devices Interven Cardiol 2006; 19:160-162). All patients with an implanted device may require life-long surveillance, since complications are difficult to predict

The device and technique disclosed herein are designed to address the aforementioned deficiencies of presently existing devices for PFO closure per catheter.

Summary of the invention

It is the principal object of this invention to provide an intracardiac occlusion device which is made of non-metallic components. It is object of this invention to provide an occlusion device which can be fastened to the tissue by catheter based suture-knot that would prevent device dislodgement and embolization. Yet another object of this invention is to provide the delivery system composed of catheter based thread transporters and knot tying- and pushing instruments for completion of a knot within a remote intravascular/intracardial location.

In a preferred embodiment, the occlusion device is made of compressible sponge occluder made of polyurethane or polyvinylalcohol (Ivalon) with integrated suture length made preferable of monofilament such as nylon on proximal and distal occluder end. The distal end of the suture length is incorporated into one piece of "stent -like" spiral wire that serves as a docking adapter. The proximal end of the suture length is preformed into a loop knot, ("bowline loop knot";Palstek, Peter Oven: KnotenJdee&Konzept Verlag, Muenchen 1993 :pp 38. ). Between the proximal part of the suture length and the sponge occluder a silicon tube of variable length is interposed.

In this application, "distal" refers to the direction away from a catheter insertion location (or away from the operators' hand) , "proximal" refers to the direction nearer the insertion site (or nearer to operators' hand), and "medial" refers to central (middle) portion of an item.

Through the single femoral venous sheath (preferable 12-14 Fr) a 0.014 inch (0.35 mm) guide wire with flexible atraumatic J tip is placed across the PFO into left pulmonary vein or LA. Over this wire a snare catheter is advanced into the LA and opened while the wire is left within the LA. Through the same venous sheath the atrial septum adjacent the PFO is punctured under echocardiography and fluoroscopy guidance as reported (Hoepp HW, Deutsch HJ,Babic U.Transseptal puncture for transcatheter closure of an eccentric atrial septal defect. J Interv Cardiol, 1999;12:367-369.). A low profile catheter is placed through the atrial septal puncture site into the LA. A wire of appropriate length (i.e. 200 cm) and thickness 0.014 inch (0.35mm) is advanced through this catheter to the LA where is caught with a snare catheter and exteriorized via the PFO to the RA and out of the body through the same venous sheath. In this way a continuous wire track is created from the femoral vein through the punctured atrial septum back via the PFO to the RA and out of body through the same venous sheath. The device system is mounted onto the exteriorized tip of the wire track. This maneuver is done by crimping the "stent-like" docking adapter onto the exteriorized tip of tracking wire. The loop of the preformed bowline loop knot is placed over the proximal extracorporeal end of the transseptal catheter (through which inner lumen the continuous wire track runs). The occlusion device is then pushed with a pusher catheter over the 0.014 inch guide wire through the same sheath and placed into the PFO position by simultaneous retracting the wire track and pushing the bowline loop knot by separate pusher catheter. During this maneuver the distal suture end of the device is exteriorized through the transseptal catheter and the sponge occluder is positioned onto the RA-side of the PFO. The guide wire is removed and the bowline knot tied with a catheter. The proximal end of the bowline loop is"threaded" through a catheter and pulled while the catheter is being pushed. Hereby the so called "tourniquet technique", well known in open cardiovascular surgery (Netter HF. The Ciba Collection of medical illustrations volume 5 Heart, Ciba Pharmaceutical Company, 1969; pp 192; Kasegawa H,Shimokawa T,Shibazaki I,Hayashi H et al. Mitral Valve Repair for Anterior Leaflet Prolapse With Expanded Polytetrafluoroethylene Sutures. Ann Thorac Surg 2006; 81:1625-31.), is adapted for application at distant intravascular site. An extra "stopper knot "is created externally and slided over the bowline loop knot pusher catheter to the RA site of septal puncture where is tied using the newly developed catheter based knot pusher. The free suture ends are tied together with catheter-based tourniquet- technique and severed by catheter based cutter leaving the occlusion device in place within the PFO location secured to the septal tissue.

To prevent back bleeding through the single access entry/exit site during complex manipulation with a plurality of catheters, wires and sutures traversing the passageway of the single introducer sheath a haemostatic valve apparatus comprising a compliant endoluminal balloon for sealing is provided. The technology. of manufacturing such a highly compliant balloon is reported in Pat. No. WO9220280 and WO0137897 wherein the balloon catheter was used for sizing maneuver of cardiac and /or cardiovascular defects per catheter under ultrasound and x-ray guidance. Brief description of the figures

Fig. 1 is a schematic perspective view of the PFO occlusion device system.

Fig. 2 A, B, C, D show perspective view of instrument for insertion of an exteriorized suture end into a cardiovascular catheter and its modification which is used as a knot pusher within cardiovascular system. .

Fig. 3 is a schematic cross sectional view as seen by transoesophageal echocardiography

(TEE), presenting the arrangement of continuous veno-venous wire track from the venous entry site through the atrial septal puncture site back via the PFO to RA and out of body through the same venous sheath using snare catheter for withdrawal maneuver.

Fig. 4 shows a docking of the exteriorized track- wire tip onto the distal suture end of the device system by crimping the docking adapter.

Fig. 5 a 6 show schematic perspective view of the device during "loading" (Fig. 5) and Over the wire" insertion (Fig. 6) into the venous sheath (lower part), and a cross sectional view of the heart as seen by TEE showing the arranged continuous suture looping and the occluder guiding wire within the LA (upper part).

Fig. 7 illustrates the over the wire advancement of the occlusion system towards the PFO as seen by schematic TEE cross sectional view of the heart.

Fig. 8 shows occlusion device in place and its two suture ends secured to the septal tissue by bowline loop knot.

Fig. 9 Illustrates the creation of an additional "stopper" knot out of the body (lower part) and its advancement through the introducer sheath with the "sliding" technique (upper part).

Fig. 10 illustrates the catheter-based knot tying maneuver within the heart by catheter-based

"tourniquet technique".

Fig. 11 is cross sectional view of the heart as seen by the TEE after fastening the PFO occluder to the septal tissue with a suture knot and during the catheter based intracardiac cutting off of the exteriorized sutures' end.

Fig. 12 is cross sectional view of the heart as seen by the TEE showing the device secured to the septal tissue by suture knot with occluder covering the right atrial side of the PFO.

Fig. 13 is a schematic perspective view of a prepared individually transportable knot assembly consisting of a pledget bowline loop knot with suture extension threaded through a pushing catheter. .

Fig. 14 is a schematic cross sectional view of the heart as seen by TEE showing the application of the individually transportable pledget loop knot assembly for alternative tying together of the two suture ends during PFO closure.

Fig. 15 is a schematic perspective (A, C) and cross sectional (B,D) view of a haemostatic valve apparatus with a compliant balloon attached endoluminally to provide sealing around the plurality of devices within the passageway showing the balloon initially inflated (A,B) and balloon inflated sufficiently to provide sealing around two catheters (C5D).

Fig. 16 is a schematic perspective (A) and cross sectional (B) view of haemostatic apparatus comprising two individual compliant balloons within the lumen of the apparatus wherein the balloons are inflated sufficiently to provide a barrier against fluid backflow while 2 catheters are placed through the passageway.

Detailed description of the invention

The present invention provides a device for occluding an aperture within body tissue. In particular, the device system of the present invention may be used for closing a PFO in the atrial septum of a heart but it is not considered limited to any particular anatomic structure. The present invention provides also accessories and methods for catheter-based suture- mediated securing of an occlusion device to the surrounding tissue within the remote intravascular-intracardial location of a patient's, body. The invention provides also methods and means for catheter based delivering a suture and tying a knot within a remote cardiovascular location. The essential part of this invention is a sponge occluder without metal components with integrated suture length on both ends. The distal suture ends as a docking connector, while the proximal suture is preformed as a bowline loop knot situated close to the occluder. The proximal suture free end is threaded through a. cardiovascular catheter. Between the bowline loop knot and the basal part of the occluder a short tubular piece preferably made of silicon is interposed. . .

Referring to Fig.1 there is shown a sponge-occluder 2 preferably made of polyurethane or polyvinyl alcohol (Ivalon) with a narrow distal part 4 and wider proximal part 3 reinforced with, a thin polyester fabric both of which can vary in size and shape. The sponge extends proximally as the short piece of a narrow tube (preferable made of silicone) 7. The lumen of the tube 7 accepts a thin wire of 0.014-0.018 inch (0.35-0.45mm). The sponge occluder extends distally as a suture thread 5 preferably made of medical nylon that ends as a stent-like "docking" connector 6 made preferably of stainless steel (a stent is an extendable & compressible spiral wire, a stainless tube with slots. It is mounted on a balloon catheter in a "crimped" or collapsed state and it can be expanded with a balloon).

This stent-like connector 6 with lumen 60, distal 62 - and proximal 61 opening can be crimped manually onto the end of a suture or a guiding wire of appropriate thickness connecting them with the occluder assembly in order to extend their individual length. The connector 6 has a small outer diameter e.g. < 0.038 inch (=<0.95 mm) which is compatible with the lumen of conventional cardiovascular catheters. The silicon tube 7 extends proximally as a suture thread 8 with a preformed loop knot (bowline loop knot) 9. A lumen 70 runs axially through tube 7. The length of the tube 7 corresponds to the distance between the PFO 170 and the tissue puncture site 171. It determines the point where the knot is tied to secure both sutures to the septal tissue 17. This tube prevents suture related folding and/or tearing of the septal tissue between the aperture 170 and the tissue perforation site 171 during knot tying.

The procedure of insertion and deployment of the occluder necessitates an extension of an extra corporeally exteriorized suture end which is achieved by inserting it across the lumen of a narrow cardiovascular catheter. An instrument for insertion of a suture end into a narrow cardiovascular catheter is illustrated in Fig 2.

Fig. 2 A, B, C, D illustrate instrument for insertion of a suture end into a narrow lumen of a cardiovascular catheter 24. The instrument unit 21 consists of an elongated metal cannula 22 and a looped nylon thread 23 running through the central lumen 220 of the cannula 22; short portion of thread lopping (noose) 230 protrudes over the distal cannula opening 221 while the looping position with a constant diameter of the noose is being kept in place by fastener 223 located on the proximal end 222 of the cannula 22 where both ends of the looping are tied to each other by a knot 231 and fastened with fastener screw 223 as illustrated in Fig.2A. The outer diameter of the cannula is adapted to fit into a narrow lumen (0.038 inch=0.95 mm) of standard cardiovascular catheters, while the cannula's lumen 220 accepts looped suture thread made of thin medical nylon e.g.2xO.OO72 inch (=2x0.18mm). The instrument is first advanced through the catheter 24 such that it protrudes over catheter's distal end. An exteriorized end of extracorporeal suture 25 is passed through the noose 230 of the instrument 21 (Fig.2B) and the cannula 22 is pulled back into the lumen of the catheter from the distal - to the proximal opening of the catheter as illustrated in Fig. 2 C. Alternatively, after passage of the suture end across the noose 230, the cannula can be held in place and the catheter can be advanced into the body over the cannula and further over the exteriorized thread to reach a remote target location by ,in this way created, extended guidance.

Additionally, this instrument can be used as a reliable knot pusher within cardiovascular system. Hereby the suture end of an extra corporeally created knot is placed across the loop and the whole instrument is pushed as a unit sliding the knot towards the target site over the second suture member (Fig.2D). Its pushability is high and the friction during knot sliding is low. Repeating this maneuver as many as necessary throws of individual knots can be accomplished.

Fig. 3A illustrates a section of human heart, as seen by short axis transoesophageal echocardiography (TEE- ultrasound from oesophagus), having a right atrium (RA) 16, aorta 18, left atrium (LA) 15, atrial septum 17, septal puncture site 171, and the PFO 170. This TEE view is typically used during the closure procedure of defects within the atrial septum. An introducer sheath 14 of appropriate diameter (e.g.12- 14 Fr) is placed into the inferior caval vein from the femoral vein in usual manner. Through this sheath the interatrial septum is punctured in a conventional way under TEE guidance (for this purpose a smaller diameter assembly of transseptal elongated needle/catheter custom made kit may be used e.g. 4-5 Fr). The transseptal needle is removed and the catheter 12 is left within the LA 15; a long track wire 11 with a flexible tip is advanced through the catheter until its radiopaque distal end appears in the LA cavity. A snare catheter 13 is placed through the same venous sheath over a separate guidewire across the PFO 170 and opened within the LA 15; the tip of the track wire is caught with the snare catheter and is pulled back towards the RA 16 across the PFO 170 and is exteriorized through the same sheath 14 out of the body. In this way the continuous wire track is created from the femoral vein to the right atrium 16, across the punctured atrial septal site 171, left atrium 15, back via the PFO 170 to the RA 16, and out of the body through the same femoral venous sheath 14. The tip of exteriorized track wire 11 is placed through the distal opening 62 into the lumen 60 of the docking connector 6 of the system device 1 and coupled to the end of the distal suture 5 by crimping the stent like docking adapter manually as illustrated in Fig. 4. Retracting the wire track a suture length looping in reverse direction is created.

In an alternative application, the described method may be used for suturing two margins of an anatomical aperture together (not shown). Hereby two tissue margins adjacent the aperture are punctured sequentially through the same introducer sheath with the elongated needle/catheter assembly. Using the snare catheter placed through the anatomical aperture two suture looping are created sequentially from the single access port through the first and second puncture site respectively back via the aperture and out of the body through the same access sheath leaving 4 suture ends out of the body in front of the single port access. The external suture ends are coupled to each other by knots created and delivered as described bellow and illustrated in Fig. 2D,9,10 or utilizing the device assembly 29 as illustrated in Fig.13 and 14.

Alternatively, the method, may be used for suturing a remote tissue which has no existing anatomical aperture (not shown): Hereby the said tissue is punctured at two adjacent sites sequentially through the same introducer sheath with the elongated needle/catheter assembly. Using the snare catheter placed through one puncture site the suture length looping is created from the single introducer sheath through the first puncture site back via the second puncture site and out of the body through the same port access leaving 2 suture ends out of the body. The external suture ends are coupled to each other by knot created and delivered as described bellow.

It is understood that this method is applicable to the remote tissue which is accessible for puncture with elongated slightly curved needle catheter assembly. The said tissue (such is heart septal wall) typically has a proximal- and a distal side and cavities proximally and distally from the proximal and distal tissue side respectively wherein et least one side is accessible per catheter. . Pig. 5 shows perspective view of insertion of the device into the introducer sheath (lower part) and cross sectional schematic view of the heart (upper part): After docking onto the system device, the wire track is pulled back. Following the wire track, the distal suture length 5 of the device is pulled backwards into the introducer sheath across the PFO 170, LA 15, through the atrial septal puncture site 171 through the transseptal catheter 12 out of the body. The length of the suture of the device. corresponds to the length of this route (usually 180-200 cm). The occluder sponge 2 is in front of the introducer sheath 14; a guiding wire 19 for device pushing is placed through the same sheath 14 through the PFO 170 into the LA 15. Fig.6 shows further step during device insertion into the introducer sheath; the proximal end of the guiding wire 19 is placed across the sponge occluder and through the central channel of the short silicon tube 7. The loop of the bowline loop knot 9 is placed over the transseptal catheter 12, device pushing catheter 20 is placed over the wire 19 and catheter 10 is placed over the proximal suture 8 for pushing the bowline loop knot. Braided (with reinforced wall for better pushability) 4 or 5 Fr cardiovascular catheters, well known in catheterization practice, can be used as pusher catheters. These catheters usually have stainless steel wire embedded in their wall. .

Fig. 7 shows advancement of the occluder through the venous sheath 14 being pushed over the guiding wire 19 , while the bowline loop knot 9 is being pushed with a catheter 10 over the transseptal catheter 12 in which lumen distal device suture length 5 is situated.

Fig. 8 shows the tying maneuver of the bowline loop knot: the occluder 2 is in place. Short part of the distal suture length 5 is running inside the LA 15 leaning on to the septal tissue 17 between the PFO 170 and septal puncture site 171, the transseptal catheter 12 is withdrawn to the RA 16 , distal exteriorized end of the suture 5 is being pulled to adjust its length so as not to fold the septal tissue between the PFO 170 and puncture site 171 as controlled by the TEE ; the bowline loop knot pushing catheter 10 is advanced while the bowline proximal suture end 8 is being pulled slightly. The aim of this maneuver is to tie the bowline loop knot without folding of the septal tissue between the puncture site 171 and PFO 170. The tube 7 prevents suture related damage of septal tissue. After completion of the bowline loop knot 9x5 tying maneuver, the transseptal catheter 12 is withdrawn and the distal suture end 5 is wrapped (knotted) over the circumference of the bowline loop pushing catheter 10 (in which lumen the proximal device suture length 8 is situated) and the knot 5x8 is created by sliding it over the catheter 10 with the knot pusher catheter (Fig.9) or with the unit 210 as illustrated in Fig. 2D.

Fig. 10 illustrates the tying maneuver of the additional stopper knot 5x8 created externally and advanced to the target site by catheter based tourniquet technique: both ends of the sutures 5 and 8 are being pulled while both pusher catheters 10 and 12 are being pushed. In this way a considerable pushing and tensile strength is applied onto both suture's part providing an effective knot tightening at distant intravascular location.

Fig. 11 shows the occlusion device placed within the PFO 170 secured with the suture knot 5x9+5x8 to the atrial septal tissue 17; both suture ends are free out of the body; the free ends of the sutures are severed one after the another with instrument 28 for cutting off of the free ends of surgical knot at minimal invasive or catheter based procedures 36 ( Pat. No. P-209/94: Serbia &Montenegro Belgrade, Intellectual Property' Gazette 2006;2:258-259).

Fig. 12 illustrates occlusion device in place after complete deployment ; note that there is only, a short run of the suture 5 within . the LA while the knots 5x9+5x8 and the sponge occluder 2 with silicon tube 7 cover the PFO 170 from the RA 16 septal side. In an alterative embodiment the occlusion unit 1 can be introduced and deployed without an integrated loop knot on the proximal suture. After device placement the proximal and distal sutures are tied together with an individually transportable pledget loop knot unit 29 as illustrated in Fig. 13. The unit consists of a. pledget 30 made preferably of felt or Teflon with an integrated suture which extends proximally as a prepared bowline loop knot 31 and further as a free suture end 32 over which a pusher catheter 33 is placed. Two suture ends may be advanced through the pledget 30 (not shown) and through the loop of looped knot unit. The individually transportable loop knot is delivered over the suture ends 5 and 8 through a guiding sheath as illustrated in Fig.14. The end of the loop knot passage is identified by fluoroscopy and TEE and by the feel of a "stop" by the operator. Tying the bowline knot is accomplished as described above. Additional "stopper knots" are delivered as described above.

The described method of securing the device to the tissue necessitates simultaneous passage of plurality of catheters and/or wires or sutures via a single passageway i.e. introducing sheath placed within the vasculature. During this maneuver there is a need for preventing of back bleeding.

Fig.15 A,B,C,D illustrate a haemostatic apparatus 35 comprising a housing with a haemostatic elastomeric valve 3621 situated at the proximal end 362 of the housing and a compliant balloon 3601 disposed endoluminally and longitudinally within the lumen 360 of the housing. Channels for balloon inflation and deflation 36011 and a channel for flushing the lumen of the housing (not shown) are also incorporated. Distal end of the housing 361 is adapted for connection with the proximal extracorporeal end of conventional introducer sheath or port access cannula:. During passage of 2 cardiovascular catheters 37 and 38 through the access pathway, the endoluminal compliant balloon is inflated via side arm with clear saline solution. The inflated balloon expands inwardly, centripetally and axially - longitudinally contacting all the items within the lumen of the housing sufficiently to provide an effective barrier against the back bleeding and against air aspiration and pushing additionally the elastomeric valve towards closing position. The balloon may be made of a highly compliant material such as latex or polyurethane membrane and the tubular shaft may be constructed of a polymer composite. The balloon is constructed and arranged so that it is capable of conforming upon inflation to all items within a room in which is situated. Since this apparatus is aimed for external (extracorporeal) application its shape and size may vary. Many variant technologies may be used to attach a balloon endoluminally into a tubular apparatus. In one embodiment, the compliant balloon membrane is attached onto one side of a piece of plane polymer composite of appropriate dimensions of which the outer wall (shaft) of the apparatus housing is to be made. Then, the polymer composite piece is formed into a tubular member by longitudinal joining (e.g. welding) such that the side covered with balloon is positioned inwardly. The longitudinal apposition zone of the free margins of the shaft of the apparatus and the apposition zone of the free margins of the endoluminal balloon membrane will not alter the balloon sealing function. It is understood that the endoluminal balloon does not need to be attached to the full circumference of the tubular inner wall. It has to attach only partly to the inner wall surface, but enough to provide stable attachment. In an another embodiment, instead of one endoluminally attached balloon, one or two compliant balloons 3602 , 3603 with individual shafts are situated into the free lumen of the housing comprising inflation/deflation channels 36021, 36031 and side arms incorporated into the housing wall 36 (Fig.l6 A,B).

Claims

Claims
1. A medical device system for occluding an anatomical aperture comprising a sponge occluder with suture length integrated into both proximal and distal occluder ends for catheter- based introduction, advancement- and device securing to the tissue.
2. The medical device of claim 1, wherein a short flexible polymer tube made preferable but not exclusively of silicone is incorporated between the proximal basal part of the sponge occluder and its integrated, proximal suture part.
3. The medical device of claim 1, wherein said proximal suture length has a preformed loop knot situated close to the said polymer tube of claim 2.
4. The device of claim 1, wherein a "stent like" docking connector is integrated into the distal suture end.
5. An instrument for insertion (back loading) of a free suture end into a narrow lumen of cardiovascular catheter comprising: an elongated metal cannula made preferably of surgical grade stainless steel with a looped thread made preferably of nylon in its lumen such that the distal looping end with a constant diameter of the noose is protruding over the distal opening of the cannula while the proximal free ends of the looped thread are fastened by a knot and by a screw mechanism located on the proximal opening of the cannula wherein the said instrument is sized and shaped for introduction into the lumen of conventional cardiovascular catheter.
6. A medical device for knot pushing and knot tying maneuver within a patient's vasculature comprising the instrument of claim 5 situated within the lumen of a braided cardiovascular catheter wherein the said catheter covers the total length of the metal cannula leaving only the static nylon noose to protrude over the distal catheter end.
7. A method for catheter based delivering a suture at cardiac septal tissue comprising: puncturing the septal tissue at one or two sites adjacent the anatomical aperture and creating a looping of the suture length from the access sheath through one puncture site, back via the another puncture site or via the aperture and out of the body through the same sheath leaving both ,proximal and distal, ends of the suture looping extra corporeally utilizing conventional transseptal catheter- and snare technique.
8. A method for creating and delivering of an extra corporeally made knot for tying together two exteriorized ends of a suture delivered at the target tissue within a remote cardiovascular location comprising: inserting one exteriorized suture end into a lumen of a narrow catheter using the device of claim 5 and advancing the catheter over the first suture until it contacts the target tissue; forming a knot externally with the second suture end by wrapping it around the circumference of the catheter covering the first suture part; placing the second suture end across the noose of the pusher device of claim 6 ; advancing the knot by sliding it over the catheter by pushing the pusher device up to the target tissue; pulling the second suture end while simultaneously pushing the knot pusher device; withdrawing the pusher device; inserting the second suture end into a narrow catheter lumen using the device of claim 5 and advancing the catheter over the second suture close to the target site to be sutured; Tying the knot by pulling both, suture ends while simultaneously pushing both catheters over them ; repeating this maneuver as many times as necessary; severing the free suture ends with catheter based cutter.
9. An individually transportable pledget- knot assembly for use within the remote cardiovascular locations consisting of a surgical pledget preferably made of felt or Teflon with integrated suture length which creates a preformed loop knot (preferable but not exclusively bowline loop) and extends proximally through a cardiovascular catheter, wherein the said assembly is shaped and sized for introduction into cardiovascular delivery sheath.
10. A method for tying together two exteriorized ends of a suture for suturing a target tissue site within a remote cardiovascular location utilizing the medical device of claim 9 comprising: advancing the assembly of claim 9 over both exteriorized suture ends up to the target tissue; tightening of the loop knot by puling the suture of the assembly and pushing its catheter; creating and delivering additional stopper knots with methods of claim 8.
11. An apparatus for preventing fluid backflow from a cardiovascular access sheath or port access cannula comprising: a tubular member comprising a proximal end, a distal end, and a lumen extending between both ends sized and shaped for external connection with the proximal end of a cardiovascular access sheath or port access cannula; a haemostatic elastomeric valve incorporated into proximal end, and an endoluminally attached compliant balloon extending longitudinally between proximal and distal end wherein the said balloon expands when inflated inwardly ,centripetally, and axially within the passageway and is adapted to contact one- or plurality of medical devices passing through the lumen sufficiently to prevent fluid backflow; comprising further connecting channels and side arms for balloon inflation/deflation and lumen flushing.
12. The apparatus of claim 11 wherein one or two balloons with individual shafts are situated into the free lumen of the housing, instead of one endoluminally attached balloon, comprising further one or two inflation /deflation channels traversing laterally through the outer housing wall.
PCT/RS2007/000002 2007-01-24 2007-01-24 Patent foramen ovale occluder with suture based anchor WO2008010738A2 (en)

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