WO2013189620A1 - Appareil destiné à permettre l'accès à un viscère, système de réalisation d'une cathétérisation cardiaque directe et procédé de chirurgie minimalement invasive - Google Patents

Appareil destiné à permettre l'accès à un viscère, système de réalisation d'une cathétérisation cardiaque directe et procédé de chirurgie minimalement invasive Download PDF

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Publication number
WO2013189620A1
WO2013189620A1 PCT/EP2013/057427 EP2013057427W WO2013189620A1 WO 2013189620 A1 WO2013189620 A1 WO 2013189620A1 EP 2013057427 W EP2013057427 W EP 2013057427W WO 2013189620 A1 WO2013189620 A1 WO 2013189620A1
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WO
WIPO (PCT)
Prior art keywords
base member
wall
tubular member
viscus
heart
Prior art date
Application number
PCT/EP2013/057427
Other languages
English (en)
Inventor
Thomas TÖLLNER
Original Assignee
Jenavalve Technology Inc.
Priority date (The priority date is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the date listed.)
Filing date
Publication date
Application filed by Jenavalve Technology Inc. filed Critical Jenavalve Technology Inc.
Publication of WO2013189620A1 publication Critical patent/WO2013189620A1/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, e.g. tourniquets
    • 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, e.g. tourniquets
    • A61B17/34—Trocars; Puncturing needles
    • A61B17/3462—Trocars; Puncturing needles with means for changing the diameter or the orientation of the entrance port of the cannula, e.g. for use with different-sized instruments, reduction ports, adapter seals
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B17/00—Surgical instruments, devices or methods, e.g. tourniquets
    • A61B17/00234—Surgical instruments, devices or methods, e.g. tourniquets for minimally invasive surgery
    • A61B2017/00238—Type of minimally invasive operation
    • A61B2017/00243—Type of minimally invasive operation cardiac
    • A61B2017/00247—Making holes in the wall of the heart, e.g. laser Myocardial revascularization
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B17/00—Surgical instruments, devices or methods, e.g. tourniquets
    • 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
    • A61B2017/00575—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 closure at remote site, e.g. closing atrial septum defects
    • A61B2017/00606—Implements H-shaped in cross-section, i.e. with occluders on both sides of the opening
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B17/00—Surgical instruments, devices or methods, e.g. tourniquets
    • 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
    • A61B2017/00575—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 closure at remote site, e.g. closing atrial septum defects
    • A61B2017/00623—Introducing or retrieving devices therefor
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B17/00—Surgical instruments, devices or methods, e.g. tourniquets
    • 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
    • A61B17/3421—Cannulas
    • A61B17/3423—Access ports, e.g. toroid shape introducers for instruments or hands
    • A61B2017/3425—Access ports, e.g. toroid shape introducers for instruments or hands for internal organs, e.g. heart ports

Definitions

  • a medical delivery system includes, for example, a medical system with which a stent system can be advanced in minimally invasive fashion to the site of implantation in the patient's heart, for example to treat an aortic valve stenosis and/or aortic valve insufficiency.
  • Minimally invasive includes, for example, a heart- lung machine is not needed when performing the procedure on the anaesthetized patient such that the medical procedure can not only be performed at reasonable cost, but there is also less physical and psychological strain on the patient.
  • transapical or transventrical approach permits the introduction of various surgical devices and tools into the heart without significant disruption of the natural mechanical and electrical heart function
  • this approach also presents certain clinical challenges to the surgical team.
  • the surgeon creates transcutaneous access to the region around the apex of the heart with a surgical thoracotomy, followed by direct access to the left ventricle using a needle or other device aimed to access the left ventricle around the left ventricular apex, which may be followed by one or more dilating instruments to create a temporary access port to the left ventricle.
  • the flange-like base plate of the base member is provided with an arrangement for fixing the base member to the outer wall of the viscus.
  • the fixing arrangement may comprise at least one and preferably a plurality of holes and/or eyelets for receiving a thin wire or thread required for suturing the base member to the outer wall of the viscus.
  • the holes and/or eyelets are preferably uniformly distributed around an outer circumference of the flangelike base plate.
  • the occlusion device comprises a retention area which exhibits a flattened umbrella-shaped contouring in an expanded state of the occlusion device.
  • the retention area of the occlusion device consists of a braiding of thin wires or threads given a suitable form by means of a moulding and heat treatment procedure.
  • the braiding consists of nitinol or of another shape-memory material or material having memory effect.
  • the braiding of the retention area of the occlusion device to be formed from a shape- memory polymer based on, for example, polyanhydride matrixes or on
  • shape-memory polymers such as, for example, block copolymers as described for example in the special edition of Applied
  • the polymer composite to comprise a linear, phase-segregated multiblock copolymer network which can exhibit at least two different phases, whereby the first phase is a hard segment- forming phase in which a plurality of hard segment-forming blocks are formed in the polymer which serve the physical cross-linking of the polymer structure and define and stabilize the permanent shape to the braiding, and whereby the second phase is a switching segment-forming phase, in which a plurality of switching segment-forming blocks are formed in the polymer which serve to fix the temporary shape of the braiding, whereby the transition temperature from the switching segment-forming phase to the hard segment-forming phase is the switching temperature, and whereby conventional methods such as injection moulding or extrusion processes can be used to set the profile form to the braiding above the transition temperature of the hard segment-forming phase.
  • the polymer composite to exhibit a covalent cross-linked polymer network formed by polymerization, polycondensation and/or polyaddition of difunctional monomers or macromers with additive of tri or higher functional cross-linking, whereby given an appropriate selection of the monomers, their functionality and ratio of cross-linkers, the chemical, thermal and mechanical properties of the polymer network as formed can be specifically and selectively set.
  • This thus enables the precise and advance establishing of the properties for the occlusion device at the transition from the first preliminary definable profile shape to the second preliminary definable profile shape, and in particular, the precise and advance establishing of the course of events upon expansion of the occlusion device.
  • a second synthesis variant for covalent shape-memory polymer networks is given by the subsequent cross-linking of linear or branched polymers.
  • Cross-linking density is hereby heavily dependent on the reaction conditions selected.
  • the crosslinking is usually activated by ionizing radiation or by thermal fission of radical-forming groups.
  • polyethylene films receive heat-shrinking properties from irradiating polyethylene with gamma-radiation or cross-linked polyethylene-polyvinylacetate copolymers obtain shape memory effect by homogenous addition of the dicumylperoxide radical initiator.
  • Implant materials which are synthetically biodegradable.
  • Degradable materials respectively polymers, have bonds which are fissionable under physiological conditions.
  • Degradable implants having shape memory properties are particularly effective in this regard.
  • this type of degradable implant can be introduced into the body in compressed (temporary) form through a small incision and once in place, then assume the memory shape relevant to its application after being warmed by the body temperature. The implant will then degrade after a given interval of time, thereby doing away with the need for a second operation to remove it.
  • the surgical closure apparatus comprises an expandable or self-expandable occlusion device comprising a retention area, wherein the retention area consists of a foldable support frame and a flexible membrane fixed to the foldable support frame.
  • the foldable support frame may be composed of nitinol or of another shape-memory material or material having memory effect.
  • the foldable support frame may be composed in particular of nitinol or of a shape-memory polymer of the kind as already described in connection with the braiding of the retention area.
  • the flexible membrane fixed to the foldable support frame is preferably composed of silicone, polyurethane or a polymer containing material .
  • the fixing arrangement of the occlusion device comprises a tie element fixed to the retention area of the occlusion device, wherein the tie element is configured to extend at least partly into the puncture of the heart wall when the occlusion device is in its implanted state.
  • the fixing arrangement may comprise, for example, a locking element configured to be coupled to the tie element such that the retention area of the occlusion device and the locking element are positioned on the two sides of the puncture to be occluded in the heart wall.
  • the locking element comprises a heat portion having a diameter larger than the diameter of the channel extending through the base member of the apparatus for providing access.
  • an additional step of closing the area of the viscus wall punctured by the medical puncture device by using a surgical closure apparatus is provided.
  • FIG. 4a with assembled coverage; illustrates the exemplary embodiment of a base member with assembled coverage in accordance with Fig . 4a in a side-sectional elevation; illustrates an exemplary embodiment of an apparatus for providing access to a viscus of a patient in a side-sectional elevation, said apparatus comprising a base member assembled with a coverage in accordance with Fig . 4b and a tubular member coupled to the base member; illustrates the exemplary embodiment of an apparatus for providing access to a viscus of a patient in accordance with Fig .
  • FIG. 5 in a side- sectional elevation, wherein an elongate medical instrument is received within a passage defined by the base member and the tubular member coupled to the base member; illustrates the exemplary embodiment of an apparatus for providing access to a viscus of a patient in accordance with Fig . 6 in a side- sectional elevation after removing the elongate medical instrument from the passage defined by the base member and the tubular member of the apparatus;
  • Fig . 8 illustrates the exemplary embodiment of an apparatus for providing access to a viscus of a patient in accordance with Fig .
  • embodiment of the surgical closure apparatus is at least partly released from the tip of the catheter delivery system
  • Fig . 10 illustrates the exemplary embodiment of an apparatus for providing access to a viscus of a patient in accordance with Fig . 9 in a side- sectional elevation after disconnecting and removing the tubular member from the base member fixed to the outer wall of the viscus;
  • Fig . 14 illustrates an exemplary embodiment of a locking element which is part of an occlusion device utilized in the surgical closure apparatus in accordance with Figs. 11a to 11c.
  • Both the right and left halves of the human heart consist of a ventricle and an atrium. These cavities are separated by the septum of the heart, divided into the atrial septum ⁇ septum interatriale) and the ventricular septum ⁇ septum interventriculare).
  • Blood can only flow in one direction through the chambers of the heart due to the cardiac valves situated between the atria and ventricles and in the arteries connected to the ventricles which function like mechanical valves.
  • the superior and inferior vena cava ⁇ vena cava superior et inferior) flow into the right atrium. They supply the oxygen-depleted (venous) blood from the systemic circulation to the heart.
  • the tricuspid valve which, like a mechanical valve, prevents a reverse flow of blood into the atrium upon ventricular contraction (systole) is situated between the right atrium and the right ventricle. It comprises three segments which are affixed like flaps to the ventricular musculature by ligaments (hence also called the "flap valve").
  • the four cardiac valves work like mechanical valves in the heart and prevent a reverse flow of blood in the wrong direction.
  • Each half of the heart has a flap valve (atrioventricular valve) and a semi-lunar valve.
  • the atrioventricular valves are situated between the atrium and the ventricle and are called the bicuspid/mitral valve and the tricuspid valve.
  • the semi-lunar valves are situated between the ventricle and the vascular outflow and are called the pulmonary valve and the aortic valve respectively.
  • aortic valve insufficiency In medicine, the term “aortic valve insufficiency”, or “aortic insufficiency” for short, generally refers to the defective closing of the heart's aortic valve and the diastolic reverse flow of blood from the aorta into the left ventricle as a result. Depending on the severity of the aortic insufficiency and the extent of resistance to aortic depletion, the volume of reverse flow can be up to two thirds of the left ventricle's ejection volume (normal cardiac output: 40 to 70 ml). This results in characteristically high blood pressure amplitude. This regurgitated blood flow increases the diastolic filling of the left chamber and leads to a volume overload of this section of the heart, a consequence of which is eccentric hypertrophy.
  • the left ventricle In individuals with aortic valve stenosis, the left ventricle has to generate an increased pressure in order to overcome the increased afterload caused by the stenotic aortic valve and eject blood out of the left ventricle.
  • the myocardium (muscle) of the left ventricle undergoes hypertrophy (increase in muscle mass).
  • Angina in the setting of aortic valve stenosis is secondary to the left ventricular hypertrophy that is caused by the constant production of increased pressure to overcome the pressure gradient caused by the aortic valve stenosis. While the myocardium (i.e. heart muscle) of the left ventricle gets thicker, the arteries that supply the muscle do not get significantly longer or bigger, so the muscle may become ischemic (i.e. doesn't receive an adequate blood supply). The ischemia may first be evident d uring exercise, when the heart muscle requires increased blood supply to compensate for the increased workload . The individual may complain of exertional angina. At this stage, a stress test with imaging may be suggestive of ischemia .
  • myocardium i.e. heart muscle
  • the regu rgitation opening is larger than 40 mm 2 and the regurgitation volume greater than 60 ml, which can lead to serious and at times life-threatening changes.
  • a valvular prosthesis (hereinafter also referred as "heart valve prosthesis") to perform the valve function of the narrowed, diseased or diseased cardiac valve.
  • the valvular prosthesis is securely positioned and anchored in the implantation site in the heart; i.e. in the plane of the (diseased) cardiac valve to be replaced, so that the valvular prosthesis is not displaced or shifted despite the, at times considerable, forces acting on it.
  • An effective seal during systole is also important.
  • such natural lumen access and delivery systems typically are configured, for example, to reach the aortic valve location 212 inside of the heart 202 from an antegrade approach, i.e. performed in the normal direction of blood flow.
  • An antegrade approach generally requires navigating instrumentation through the right ventricle 222, the left atrium, and the left ventricle 220 of the beating heart 202, by way of the mitral valve 210.
  • a retrograde approach i.e. an access performed backward or against the usual direction of blood flow, is an alternative to reach the aortic valve location 212 inside of the heart 202.
  • a retrograde approach generally requires navigating
  • FIG. 2a A transarterial access to the heart 202 of a patient as an example for a retrograde approach is schematically shown in Fig. 2a.
  • a heart valve stent 100 is advanced with the aid of a medical catheter delivery system (only schematically shown) via the femoral artery to the aortic valve 212.
  • a retrograde approach cannot be used in patients who have small or tortuous femoral or iliac vessels or severe peripheral vascular disease such as persons with previous aortobifemoral grafting.
  • an antegrade approach for example transapical approach, whereby the surgeon creates a transcutaneous access to the region around the apex 224 of the beating heart 202 with a surgical thoracotomy, followed by direct access to the left ventricle 220 using a needle or other puncture device aimed to access the left ventricle 220 around the left ventricular apex 224.
  • a needle or other puncture device aimed to access the left ventricle 220 around the left ventricular apex 224.
  • a guidewire 180 may be advanced toward and through the aortic valve 212 to assist with diagnostic and interventional aspects of the procedure.
  • the apex 224 is closed, for example, by using a purse-string suture technique.
  • a purse-string suture is a continuous suture placed in a circle about a round wound or punctures which needs to be closed. The opening is closed by tightly drawing the ends of the suture together.
  • frequently some negative accompaniments occur with the conventional transapical or transventrical access procedure. These are, for example, unwanted bleedings during procedure and breakage of the tissue around the location of the left ventricular apex 224 while final closing the suture which could lead to death of the patient.
  • the present disclosure provides a system to simplify and standardize the technique for opening and closing the beating heart during a cardiac surgery.
  • the inventive system makes a transapical or transventrical access and closure procedure required for delivering therapeutic devices to the heart more routine for all surgeons.
  • the port system comprises a base member having a first surface and an opposite second surface, and further having a channel extending through the base member, said base member being preferably a flange-like member and configured to be manually fixed to the outer wall of a viscus, for example, at the left-ventrical apex of the heart of a patient.
  • the port system disclosed herein preferably further comprises a tubular member defining a lumen, the tubular member having a first end and an opposite second end and being configured to be coupled with its first end to the first surface of the base member such that the lumen of the tubular member and the channel of the base member communicate with each other thereby defining a passage through which an elongate medical instrument is moveable in the direction of the viscus wall.
  • the port system is configured to provide a platform securely attached to the viscus, for example, the beating heart. Surgeons can then deliver therapeutic devices, such as a heart valve prosthesis or left ventricular assist devices, into the beating heart without loss of blood or exposure to air.
  • therapeutic devices such as a heart valve prosthesis or left ventricular assist devices
  • an occlusion device closes and seals the access site with a biocompatible implant.
  • the occlusion device can be re-opened if necessary.
  • the occlusion device is adapted and configured to be implanted and placed into the interior of the left ventricle via the port system previously attached to the outer wall of the heart.
  • the occlusion device is an appropriate closure mechanism for the apex, which can be used to replace purse string sutures in TAVI procedures as they are done today.
  • the heart surgery system disclosed herein improves safety, decreases procedure time and reduces the technical challenges associated with minimally invasive procedures. This is achieved by minimizing the incision size to gain access to the beating heart and eliminating the need for conventional sutures. Moreover, with the heart surgery system disclosed herein, an adoption of minimally invasive therapeutic heart procedures can be expanded to a greater number of surgeons and as a result, many underserved patients will receive needed treatment for valve disease and end-stage heart failure.
  • the exemplary port system comprises a flange-like base member 11 which is configured to be manually fixed to the outer wall of a patient's viscus, for example, to the outer wall of the left ventricle at the apex of the beating heart.
  • the port system disclosed herein may serve as an apparatus for providing access to a viscus of a patient required for delivering therapeutic devices into the viscus for a structural repair procedure.
  • FIGs. 3a to 3c An exemplary embodiment of the flange-like base member 11 is illustrated in Figs. 3a to 3c.
  • Figs. 4a and 4b illustrate the flange-like base member 11 in accordance with Figs. 3a to 3c fixed to the outer wall of a viscus (here: the outer wall of the left ventricle at the apex of the beating heart).
  • the base member 11 has a first surface 11a, an opposite second surface l ib, and a channel 12 extending through the base member 11.
  • the base member 11 is a flange-like member configured to be manually fixed to the outer wall of, for example, the left ventricle at the apex of the heart of a patient.
  • Fig . 4a illustrates the exemplary embodiment of the base member 11 in accordance with Fig . 3a, wherein the base member 11 is fixed to the outer wall of a viscus 220.
  • 3a is a flange-like member comprising a base plate 15 and a port 25 fixed to the base plate 15.
  • the port 25 of the flange-like base member 11 is configured to form a releasable connection with a tubular member 16 of the apparatus 10 for providing access in order to couple the tubular member 16 with the base member 11.
  • the base plate 15 of the base member 11 is preferably circular, wherein the port 25 is arranged at a center of the base plate 15.
  • the port 25 is arranged on the first surface 11a of the base plate 15 and surrounds at least partly the opening of the channel 12 which extends through the base plate 15 of the base member 11.
  • sealing arrangement 14b is provided for preventing leakage of fl uid, in particular blood, between the second surface l ib of the base member 11 and the outer wall of a viscus 220 (see Fig . 4a).
  • the base plate 15 and the port 25 of the base member 11 are made of a biocompatible material .
  • At least the base plate 15 of the base member 11 may be made of a rigid material, in particular metal, for example titanium, or a rigid plastic material.
  • the base member 11 of the apparatus 10 is provided with a coverage 9.
  • An exemplary embodiment of such a coverage 9 is illustrated in Fig 3b.
  • the embodiment of the coverage 9 illustrated in Fig . 3b is designed in accordance with the flange-like base member 11 shown in Fig. 3a.
  • Fig. 3c illustrates the exemplary embodiment of the base member 11 in accordance with Fig. 3a and the exemplary embodiment of the coverage 9 in accordance with Fig. 3b in an assembled
  • the exemplary embodiment of the coverage 9 for the base member 11 illustrated in Fig . 3b is a ring-shaped member comprising an opening 8 for receiving the port 25 of the base member 11 in an assembled condition (see
  • the coverage 9 further comprises an arrangement 7 for fixing the coverage 9 to the base plate 15 of the base member 11.
  • the arrangement 7 for fixing the coverage 9 to the base plate 15 of the base member 11 provides a positive locking of the coverage 9 and the base plate 15 in an assembled condition (see Fig . 3c).
  • Fig . 4c illustrates the exemplary embodiment of the base member 11 with the assembled coverage 9 in accordance with Fig . 4a in a side-sectional elevation.
  • Fig . 4a illustrates the exemplary embodiment of the base member 11 in accordance with Fig. 3a, wherein the base member 11 is fixed to the outer wall of a viscus, in particular the outer wall of the left ventricle 220 at the apex 224 of the beating heart 202.
  • Fig . 4b illustrates the exemplary embodiment of the base member 11 in accordance with Fig. 4a with assembled coverage 9.
  • the base member 11 fixed to the outer wall of the viscus (outer wall of the left ventricle 220) provides a platform securely attached to the viscus, wherein this platform is adapted and configured to be implanted and placed into the interior of the patient's body.
  • the base member 11 comprises a first coupling arrangement 13 for receiving corresponding a second coupling arrangement 18 provided at a tubular member 16 for connecting the tubular member 16 with the base member 11 (see Fig. 5).
  • the port system serves as an apparatus for providing access to a viscus of a patient required for delivering therapeutic devices into the viscus for a structural repair procedure.
  • An exemplary embodiment of a port system which serves as apparatus 10 for providing access to a viscus of a patient is illustrated in Fig . 5 in a side-sectional elevation.
  • the apparatus 10 comprises a base member 11 assembled with a coverage 9 in accordance with Fig . 4b and a tubular member 16 coupled to the base member 11.
  • the second coupling arrangement 18 of the tubular member 16 is complementary to the first coupling arrangement 13 of the base member 11 for allowing a releasable coupling between the base member 11 and the tubular member 16.
  • the first and second coupling arrangements 13, 18 are configured, for example, to form a thread connection, a clip connection, a magnetic connection, or a bayonet lock.
  • Fig . 5 illustrates an exemplary embodiment of an apparatus 10 for providing access to a viscus, in particular for providing access to the beating heart 202 of a patient in accordance with the present disclosure.
  • the exemplary embodiment of the apparatus 10 illustrated in Fig . 5 comprises a base member 11 assembled with a coverage 9, wherein the base member 11 is fixed to the outer wal l of a viscus, in particular the outer wall of the left ventricle 220, and the coverage 9 is connected with the fixed base member 11.
  • the apparatus 10 further comprises a tubular member 16 coupled to the base member 11.
  • the tubular member 16 is at least partly hollow and defines a lumen 17.
  • a first end 16a of the tubular member 16 is provided with a second coupling arrangement 18 configured to be coupled with a first coupling arrangement 13 provided at the first surface 11a of the base member 11.
  • the lumen 17 defined by the tubular member 16 and the channel 12 extending through the base member 11 communicate with each other thereby defining a passage 24 through which an elongate medical instrument 30, 30' is movable in the direction of the viscus wall, in particular in the direction of the outer wall of the left ventricle 220.
  • Fig . 6 illustrates the exemplary embodiment of an apparatus 10 in accordance with Fig. 5, wherein an elongate medical instrument 30' is received within the passage 24 defined by the base member 11 and the tubular member 16 coupled to the base member 11.
  • the tubular member 16 is preferably provided with a sealing arrangement for preventing leakage of fluid, in particular blood, through a second end 16b of the tubular member 16, the second end 16b of the tubular member 16 being opposite to the first end 16a, i.e. the end of the tubular member 16 which is coupled to the base member 11 in an assembled condition.
  • the sealing arrangement for preventing leakage of fluid through the second end 16b of the tubular member 16 comprises a mechanical seal 19 arranged in the interior of the lu men 17 defined by the tubular member 16.
  • the mechanical seal 19 is configured to allow passing an elongate medical instrument 30, 30' there through.
  • Fig . 6 illustrates the exemplary embodiment of the apparatus 10 in accordance with Fig . 5, wherein an elongate medical instrument 30' is received within the passage 24 defined by the base member 11 and the tubular member 16 coupled to the base member 11.
  • the mechanical seal 19 arranged in the interior of the lumen 17 defined by the tubular member 16 is preferably self-adjustable to the outer diameter of the elongate medical instrument 30, 30', when the elongate medical instrument 30, 30' passes through the interior of the lumen 17 (see Fig. 6).
  • the mechanical seal 19 arranged in the interior of the lumen 17 defined by the tubular member 16 comprises at least one, preferably at least three and more preferably at least six sealing lips which are movably connected to the inner wall of the lumen 17 defined by the tubular member 16.
  • the at least one sealing lip is preferably pre-tensioned such as to close the lumen 17 thereby preventing leakage of fluid through the second end 16b of the tubular member 16.
  • the sealing arrangement of the tubular member 16 also comprises at least one additional sealing lip 20 arranged inside the tubular member 16.
  • the at least one additional sealing lip 20 is a sprung sealing lip.
  • the sealing arrangement of the tubular member 16 comprises at least one circular seal or O-ring arranged inside the tubular member 16.
  • the exemplary embodiment of the apparatus 10 for providing access simplifies and standardize the technique for opening a viscus, in particular the outer wall of the left ventricle 220 at the apex 224 of the beating heart 202 during cardiac surgery.
  • the apparatus 10 as disclosed herein makes a transapical or transventrical access procedure required for delivering therapeutic devices to the heart more routine for all surgeons.
  • the apparatus 10 comprises a sealed port system constituted by the base member 11 fixed to the outer wall of the viscus to be treated and a tubular member 16 which is connected with the base member 11 in a sealed manner such that the lumen 17 defined by the tubular member 16 and the channel 12 extending through the base member 11 communicate with each other and thereby form a passage 24 for receiving an elongate medical instrument 30, 30'.
  • a second funnel-shaped element 22 is provided at the first end 16a of the tubular member 16 in order to simplify an insertion of an elongate medical instrument 30, 30' into the channel 12 of the base member 11 when the tubular member 16 is coupled with the base member 11.
  • first and second funnel-shaped elements 21, 22 are separate elements connected with the respective ends 16a, 16b of the tubular member 16. It is also conceivable, however, that the first and second funnel-shaped elements 21, 22 are integrally formed with the tubular member 16.
  • the base plate 15 of the base member 11 is manually fixed to the outer wall of the heart 202, preferably at the apex of the heart 202.
  • the tubular member 16 is coupled with the port 25 provided at the first surface 11a of the base member 11 (see Fig . 5).
  • an elongate medical puncture device 30' for example, a puncture needle, stylet or trocar, is inserted into the passage 24 formed by the lumen 17 of the tubular member 16 and the channel 12 of the base member 11, said passage 24 serving as a guidance for the medical puncture device 30' (see Fig . 6).
  • the wall of the heart is punctured as can be seen from Fig . 7 by opening an initially placed channel into the heart wall rather than stamping out a hole.
  • a guidewire will be placed through the medical puncture device 30'.
  • the apparatus 10 is ready to insert a catheter system or another delivery system used for implanting a valve prosthesis.
  • Fig . 6 illustrates the exemplary embodiment of the apparatus 10 in accordance with Fig . 5, wherein a medical puncture device 30', for example a puncture needle, stylet or trocar, is received within the passage 24 defined by the base member 11 and the tubular member 16 coupled to the base member 11.
  • a medical puncture device 30' for example a puncture needle, stylet or trocar
  • the port system disclosed herein is a medical instrument which allows a puncture of the wall of the left ventricle 220 at the apex 224 of the beating heart 202 by using, for example, the well-known Seldinger Method .
  • Fig . 7 illustrates the exemplary embodiment of the apparatus 10 in accordance with Fig . 6 after removing the medical puncture device 30' from the passage 24 defined by the base member 11 and the tubular member 16 of the apparatus 10.
  • the apparatus 10 serves as a system for performing direct cardiac catheterization, in particular transapical or transventrical catheterization, because the apparatus 10 provides a platform securely attached to the outer wall of the left ventricle 220 by means of which therapeutic devices, such as a heart valve prosthesis of left ventricular assist devices, can be delivered into the left ventricle 220 of the beating heart 202 without loss of blood or exposure to air.
  • therapeutic devices such as a heart valve prosthesis of left ventricular assist devices
  • the passage 24 formed by the lumen 17 defined by the tubular member 16 and the channel 12 provided in the base member 11 communicates with the opening provided in the wall of the left ventricle 220 by puncturing as illustrated in Fig . 6.
  • a catheter delivery system can be delivered through the puncture 49 in the wall of the left ventricle 220 of the beating heart 202 in order to perform structural repair procedures. Once a therapeutic device has been delivered and surgery is complete, an occlusion device closes and seals the access site with a biocompatible implant.
  • Fig . 8 illustrates the port system, i.e. the exemplary embodiment of the apparatus 10 in accordance with Fig. 7, wherein a tip 31 of a catheter delivery system 30 is past through the puncture 49 previously performed by a medical puncture device 30' (see Fig . 6).
  • a tip 31 of the catheter delivery system 30 schematically illustrated in Fig. 8, an exemplary embodiment of a surgical closure apparatus is accommodated in a collapsed state.
  • Fig . 9 illustrates the exemplary embodiment of the port system in accordance with Fig . 8, wherein the surgical closure apparatus is at least partly released from the tip 31 of the catheter delivery system 30. Accordingly, the surgical closure apparatus is adapted and configured to be implanted and placed into the interior of the left ventricle 220 via the apparatus 10 (port system) previously attached to the outer wall of the left ventricle 220 at the apex 224 of the beating heart 202.
  • FIGs. 12 and 13 illustrating aspects of an exemplary
  • the surgical closure apparatus disclosed herein comprises an expandable or self- expandable occlusion device 50.
  • the occlusion device 50 is introducible into the body of a patient in a minimally invasive fashion via the passage 24 formed by the lumen 17 of the tubular member 16 and the channel 12 of the base member 11 and the punctu re 49 of the viscus wall (left ventricle 220 of the beating heart 202) performed by a medical puncture device 30' (see Fig . 6).
  • the occlusion device 50 exhibits a collapsed shape as the occlusion device 50 is being inserted into the patient's body (see Fig . 8), and an expanded shape as the occlusion device 50 is in the implanted state (see Fig . 9 and 10).
  • the occlusion device 50 comprises a retention area 51 which exhibits a flattened umbrella-shaped contouring in the expanded state of the occlusion device 50.
  • the retention area 51 may consist of a braiding of thin wires or threads given a suitable form, for example, by means of a moulding and heat treatment procedure.
  • the retention area 51 of the occlusion device 50 may consist of a foldable support frame 52 and a flexible membrane 53 fixed to the foldable support frame 52.
  • the foldable support frame 52 is composed of nitinol or of another shape-memory material, for example, a shape-memory polymer, preferably based on a polyanhydride matrix or on polyhydroxycarboxylic acid .
  • the foldable support frame 52 is formed from a shape-memory polymer of block copolymer form.
  • the flexible membrane 53 fixed to the foldable support frame 52 at the retention area 51 of the occlusion device 50 is preferably composed of silicone, polyurethane or a polymer containing material .
  • the flexible membrane 53 and/or the support frame 52 of the occlusion device 50 are/is at least partly formed of a biologically degradable material .
  • a biologically degradable material may comprise a polymer composite which exhibits a hydrolytically degradable polymer, in particular polyhydroxycarboxylic acids or corresponding copolymers.
  • the biologically degradable material may comprise a polymer composite which exhibits enzymatically degradable polymers.
  • the biologically degradable material comprises the polymer composite which exhibits a biodegradable thermoplastic amorphous polyurethane-copolyester polymer network.
  • the biologically degradable material may comprise a polymer composite which exhibits biodegradable elastic polymer network, obtained from cross-linking of oligomer diols with diisocyanate.
  • the occlusion device 50 is inserted into the ventricle of the heart 202 by using a catheter delivery system 30 comprising a guiding stylet 32 and an insertion tube 33.
  • the insertion tube 33 of the catheter delivery system 30 is removed (see Fig . 9).
  • the connection between the tubular member 16 and the base member 11 of the apparatus 10 is released and the tubular member 16 is removed from the patient's body (see Fig . 10).
  • the bleeding through the puncture 49 of the heart wall is then sealed unfolding the retention area 51 of the occl usion device 50. This can be initiated, for example, by pulling a guidewire which is screwed into the retention area 51 of the occlusion device 50.
  • other means for manipulating the retention area 51 of the occlusion device 50 are also conceivable.
  • a fixing arrangement is provided .
  • the fixing arrangement is configured to fix the retention area 51 of the occlusion device 50 to the base member 11 which is already arranged at and fixed to the outer wall of the viscus.
  • the fixing arrangement may comprise a tie element 55 fixed to the retention area 51 of the occlusion device 50.
  • the tie element 55 is configured to extend at least partly into the punctu re 49 of the viscus wall when the occlusion device 50 is in its implanted state (see Fig. 10 and Figs. 11a to 11c).
  • the fixing arrangement further comprises a locking element 56 configured to be coupled to the tie element 55 such that the retention area 51 of the occlusion device 50 and the locking element 56 are positioned on the two sides of the puncture 49 to be occl uded in the viscus wall (here: heart wall). As illustrated in Figs.
  • the locking element 56 may comprise a heat portion 57 having a diameter larger than the diameter of the channel 12 extending through the base member 11 of the apparatus 10. Moreover, the locking element 56 preferably comprises a tie element 58 fixed to the heat portion 57. The tie element 58 fixed to the heat portion 57 is connectable to the tie element 55 fixed to the retention area 51 of the occlusion device 50.
  • the retention area 51 of the occlusion device 50 and, in particular, the support frame 52 with the membrane 53 attached thereto, is located inside the viscus (here: inside the left ventricle 220 of the beating heart 202).
  • the occlusion device 50 is fixed in the implantation area by means of the locking element 56.
  • the locking element 56 comprises a disk-like heat portion 57.
  • the disk-like heat portion 57 of the locking element 56 may comprise a tie element 58 fixed to the heat portion 57.
  • the tie element 58 of the locking element 56 is connectable to a corresponding tie element 55 fixed to the retention area 51 of the occlusion device 50. Accordingly, in the implanted state of the medical closure system, the retention area 51 of the occlusion device 50 and the locking element 56 are positioned on the two sides of the puncture 49 to be occluded in the viscus.
  • the tie element 55 fixed to the retention area 51 of the occlusion device 50 and the tie element 58 fixed to the heat portion 57 of the locking element 56 are preferably provided with a threaded area 60, 60' respectively configured to be engageable with each other. Alternatively, any other engagement of the two tie elements is conceivable.
  • the tie element 55 fixed to the retention area 51 of the occlusion device 50 is preferably also configured to be connectable with the tip of a stylet, catheter or cannular 32 for implanting the occlusion device 50 and positioning the retention area 51 of the occlusion device 50 (see Fig . 10).
  • the volume bordered by the two sides of the puncture 49 to be occluded in the viscus may be filled with a corresponding filling material in order to tidily occlude the puncture 49.
  • the locking element 56 may be provided with at least one port for supplying the filling material in the volume. It is also conceivable that naturally occurring tissue material grows into the volume via holes 59 provided in the locking element 56.

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  • Health & Medical Sciences (AREA)
  • Surgery (AREA)
  • Life Sciences & Earth Sciences (AREA)
  • Medical Informatics (AREA)
  • Nuclear Medicine, Radiotherapy & Molecular Imaging (AREA)
  • Engineering & Computer Science (AREA)
  • Biomedical Technology (AREA)
  • Heart & Thoracic Surgery (AREA)
  • Molecular Biology (AREA)
  • Animal Behavior & Ethology (AREA)
  • General Health & Medical Sciences (AREA)
  • Public Health (AREA)
  • Veterinary Medicine (AREA)
  • Pathology (AREA)
  • Cardiology (AREA)
  • Prostheses (AREA)

Abstract

La présente invention concerne un appareil (10) destiné à permettre l'accès à un viscère (220) d'un patient nécessaire pour la mise en place de dispositifs thérapeutiques dans le viscère (220) pour des procédures de réparation structurelle. L'appareil (10) comprend un élément de base (11) ayant une première surface (11a) et une seconde surface opposée (11b) et un canal (12) s'entendant entre les deux surfaces, l'élément de base (11) étant configuré pour être manuellement fixé à la paroi extérieure du viscère (220). L'appareil (10) comprend en outre un élément tubulaire (16) définissant une lumière (17), l'élément tubulaire (16) ayant une première extrémité (16a) et une seconde extrémité opposée (16b) et étant configuré pour être accouplé par sa première extrémité (16a) à la surface (11a) de l'élément de base (11) de sorte que la lumière (17) et le canal (12) communiquent l'un avec l'autre définissant ainsi un passage (18) à travers lequel un instrument médical allongé (30, 30') est amovible en direction de la paroi viscérale.
PCT/EP2013/057427 2012-06-19 2013-04-10 Appareil destiné à permettre l'accès à un viscère, système de réalisation d'une cathétérisation cardiaque directe et procédé de chirurgie minimalement invasive WO2013189620A1 (fr)

Applications Claiming Priority (2)

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EP12172583 2012-06-19

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Cited By (6)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US9532773B2 (en) 2011-01-28 2017-01-03 Apica Cardiovascular Limited Systems for sealing a tissue wall puncture
US9950146B2 (en) 2007-04-24 2018-04-24 Emory Univeristy Conduit device and system for implanting a conduit device in a tissue wall
US10028741B2 (en) 2013-01-25 2018-07-24 Apica Cardiovascular Limited Systems and methods for percutaneous access, stabilization and closure of organs
US10485909B2 (en) 2014-10-31 2019-11-26 Thoratec Corporation Apical connectors and instruments for use in a heart wall
US10499949B2 (en) 2011-02-01 2019-12-10 Emory University Systems for implanting and using a conduit within a tissue wall
US10518012B2 (en) 2013-03-15 2019-12-31 Apk Advanced Medical Technologies, Inc. Devices, systems, and methods for implanting and using a connector in a tissue wall

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WO2000078226A1 (fr) * 1999-06-18 2000-12-28 Radi Medical Systems Ab Outil, dispositif de fermeture, systeme et procede de fermeture de plaie
US20020045846A1 (en) * 2000-08-14 2002-04-18 Kaplon Richard J. Valved apical conduit with trocar for beating-heart ventricular assist device placement
WO2004030515A2 (fr) * 2002-09-30 2004-04-15 Ethicon, Inc. Dispositif de suture automatique d'une incision
US20050137609A1 (en) * 2003-12-17 2005-06-23 Gerald Guiraudon Universal cardiac introducer
WO2011060386A2 (fr) * 2009-11-15 2011-05-19 Thoratec Corporation Système, dispositif et procédé de fixation

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Cited By (9)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US9950146B2 (en) 2007-04-24 2018-04-24 Emory Univeristy Conduit device and system for implanting a conduit device in a tissue wall
US11027103B2 (en) 2007-04-24 2021-06-08 Emory University Conduit device and system for implanting a conduit device in a tissue wall
US9532773B2 (en) 2011-01-28 2017-01-03 Apica Cardiovascular Limited Systems for sealing a tissue wall puncture
US10357232B2 (en) 2011-01-28 2019-07-23 Apica Cardiovascular Limited Systems for sealing a tissue wall puncture
US10499949B2 (en) 2011-02-01 2019-12-10 Emory University Systems for implanting and using a conduit within a tissue wall
US10028741B2 (en) 2013-01-25 2018-07-24 Apica Cardiovascular Limited Systems and methods for percutaneous access, stabilization and closure of organs
US11116542B2 (en) 2013-01-25 2021-09-14 Apica Cardiovascular Limited Systems and methods for percutaneous access, stabilization and closure of organs
US10518012B2 (en) 2013-03-15 2019-12-31 Apk Advanced Medical Technologies, Inc. Devices, systems, and methods for implanting and using a connector in a tissue wall
US10485909B2 (en) 2014-10-31 2019-11-26 Thoratec Corporation Apical connectors and instruments for use in a heart wall

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