EP3600155A1 - Dispositif implantable de façon minimalement invasive et système d'implant de valve mitrale - Google Patents

Dispositif implantable de façon minimalement invasive et système d'implant de valve mitrale

Info

Publication number
EP3600155A1
EP3600155A1 EP18717858.7A EP18717858A EP3600155A1 EP 3600155 A1 EP3600155 A1 EP 3600155A1 EP 18717858 A EP18717858 A EP 18717858A EP 3600155 A1 EP3600155 A1 EP 3600155A1
Authority
EP
European Patent Office
Prior art keywords
tissue anchor
tissue
mitral valve
annuloplasty ring
ring
Prior art date
Legal status (The legal status is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the status listed.)
Pending
Application number
EP18717858.7A
Other languages
German (de)
English (en)
Inventor
Johannes Albes
Current Assignee (The listed assignees may be inaccurate. Google has not performed a legal analysis and makes no representation or warranty as to the accuracy of the list.)
Immanuel Albertinen Diakonie GmbH
Original Assignee
Immanuel Diakonie GmbH
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 Immanuel Diakonie GmbH filed Critical Immanuel Diakonie GmbH
Publication of EP3600155A1 publication Critical patent/EP3600155A1/fr
Pending legal-status Critical Current

Links

Classifications

    • 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
    • A61F2/24—Heart valves ; Vascular valves, e.g. venous valves; Heart implants, e.g. passive devices for improving the function of the native valve or the heart muscle; Transmyocardial revascularisation [TMR] devices; Valves implantable in the body
    • A61F2/2442—Annuloplasty rings or inserts for correcting the valve shape; Implants for improving the function of a native heart valve
    • A61F2/2445—Annuloplasty rings in direct contact with the valve annulus
    • 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
    • A61F2/24—Heart valves ; Vascular valves, e.g. venous valves; Heart implants, e.g. passive devices for improving the function of the native valve or the heart muscle; Transmyocardial revascularisation [TMR] devices; Valves implantable in the body
    • A61F2/2442—Annuloplasty rings or inserts for correcting the valve shape; Implants for improving the function of a native heart valve
    • A61F2/2466—Delivery 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
    • A61B17/064—Surgical staples, i.e. penetrating the tissue
    • A61B17/0643—Surgical staples, i.e. penetrating the tissue with separate closing member, e.g. for interlocking with staple
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B17/00—Surgical instruments, devices or methods, e.g. tourniquets
    • A61B17/064—Surgical staples, i.e. penetrating the tissue
    • A61B2017/0649—Coils or spirals
    • 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
    • A61F2220/00—Fixations or connections for prostheses classified in groups A61F2/00 - A61F2/26 or A61F2/82 or A61F9/00 or A61F11/00 or subgroups thereof
    • A61F2220/0008—Fixation appliances for connecting prostheses to the body
    • A61F2220/0016—Fixation appliances for connecting prostheses to the body with sharp anchoring protrusions, e.g. barbs, pins, spikes

Definitions

  • the present invention relates to a minimally invasive implantable device and a mitral flap implant system.
  • the medicine is used to detect and eliminate diseases, with the aim of restoring the health of patients.
  • the present disclosure relates to the field of cardiac surgery.
  • instruments, devices or procedures are used to examine the interior of the heart and / or to use it for surgical procedures.
  • the present invention relates to the minimally invasive reconstruction of heart valves using surgical instruments that allow access to the heart to perform various reconstructions and the use of beating heart inventive devices.
  • the device is an implantable device for attachment to a tissue, thereby limiting or restricting an opening in the extension. It is an annuloplasty ring which can be used in a cavity of a body organ, in particular in a heart, to eliminate mitral valve insufficiency.
  • the heart is a muscular hollow organ that pumps blood through the body with rhythmic contractions, thus ensuring the supply of all organs. Disease of the heart may therefore result in various disorders.
  • a malfunction includes e.g. heart failure.
  • Heart failure is the morbid inability of the heart to promote the amount of blood needed by the body without increasing pressure in the atria.
  • Heart failure is divided according to its course, to the predominantly affected part of the heart (right or left) and to the mechanism.
  • Another common heart disease is heart valve failure.
  • Heart valve failure is a functional disorder of one or more heart valves.
  • a heart valve defect can affect each of the four heart valves, with the valves in the left heart, the aortic and mitral valves, being significantly more affected than the valves of the right heart.
  • the dysfunction may consist of a narrowing (stenosis), an inability to fill (insufficiency) or a combination of both (combined vitium).
  • the mitral valve acts as a check valve.
  • the terminal incapacity or leakage of the mitral valve of the heart leads to a pro-portion during the ejection phase (systole) Backflow of oxygenated blood from the left ventricle (left ventricle) to the left atrium (left atrium) while the bulk of the oxygenated blood is forced through the aortic valve into the aorta.
  • Mitral valve regurgitation can result from a variety of different mechanical defects in the mitral valve.
  • the valve leaflets, the valve, the tendon threads connecting the valve leaflets to the papillary muscles, or the papillary muscles themselves may be damaged or otherwise dysfunctional.
  • the valve annulus may be able to adequately withstand the high pressure of the left ventricle due to the ability to close a mitral valve.
  • Mitral valve reconstruction is about restoring valvular valve function and preserving the mitral valve.
  • Surgical procedures include, for example, sternotomy, catheter guided and minimally invasive annuloplasty.
  • annuloplasty rings of all types are employed to relieve leakage in the mitral valve between the posterior leaflet and the anterior leaflet.
  • annuloplasty rings A plethora of different annuloplasty rings are known in the art. For example, rigid, semi-rigid and flexible annuloplasty rings, and closed, semi-closed or open annuloplasty rings.
  • the shape of the annuloplasty rings is different and may be circular, D-shaped, C-shaped or kidney-shaped. Also the materials of the annuloplasty rings differ.
  • One thing all mechanical annuloplasty rings have in common is that they consist on the one hand of non-dissolvable material because they have to grow on the valve ring of the valve leaflets and on the other hand they should retain the function of the natural mitral valve.
  • annuloplasty ring is disclosed, for example, in US Pat. No. 8,545,414 B2.
  • the annuloplasty ring comprises an inner material made of stainless steel, eg titanium or it consists of a flexible material, such as silicone rubber or Dracon.
  • the inner material is covered by a surrounding material, such as biocompatible tissue or cloth.
  • an annuloplasty ring is implanted on the mitral valve annulus to remove regurgitation.
  • the annuloplasty ring is rod-shaped and has the shape of a capital letter "D.” It has an opening in the relatively straight section and is made of plastic with a DACRON mesh covering.This annuloplasty ring is sewn to the front and rear flap rings of the sails.
  • the disadvantage of this annuloplasty ring is the rigid and flat embodiment
  • the disadvantage is that it can only be used with conventional sternotomy in the left atrium of the heart.
  • the type of attachment is disadvantageous.
  • the attachment of the annuloplasty ring is made by sewing a continuous implantation suture along the mitral valve on the valve ring.
  • improper suturing in the anterior segment could cause undesirable intratrigal truncation of the annulus.
  • annuloplasty ring for implantation on a mitral valve is disclosed in US 6,858,039 B2.
  • this embodiment is designed to be semi-rigid.
  • this annuloplasty ring has not only a shape change in the X-Y plane but also in the Z direction, thereby coming much closer to the shape of the central annulus, which is not only in a flat plane.
  • the annuloplasty ring only needs to maintain its posterior curvature against the stresses generated by the heart's musculature during each beat cycle.
  • the attachment of the closed, executed in approximately D-shaped annuloplasty ring is done by sewing.
  • the ring includes an inner ring body and an outer squeeze sheath which allow the ring body to be sewn into the mitral annulus.
  • the squeegee is sufficiently porous and flexible to allow a suture to pass through the ring.
  • this annuloplasty ring can be implanted only by applying the classic sternotomy in the heart.
  • the suturing of an annuloplasty ring is carried out with a continuous implantation suture along the mitral valve on the valve ring.
  • improper sewing in the anterior segment may cause undesirable intratrigal shortening of the annulus.
  • annuloplasty ring A further development of an annuloplasty ring can be taken from EP 0 624 080 B1.
  • the annuloplasty ring has drawstrings, which allows it to be reduced in circumference.
  • the drawstrings are capable of reducing the size of the posterior portion of an anuloplasty ring. Therefore, EP 0 624 080 B1 provides an annuloplasty ring which, after attachment by suturing spaced sutures to the annulus, may still reduce valvular insufficiency , The reduction is accomplished by tensioning one or more drawstrings, whereby the circumference of the annulus can be further reduced to correct or minimize any residual valve insufficiency remaining after ring implantation.
  • the disadvantage of this annuloplasty ring is that it can only be implanted in the heart with the help of classic sternotomy.
  • anulopiastia rings are implanted during open heart surgery in which an annuloplasty ring can be sutured to the valve annulus.
  • Open heart surgery is a highly invasive procedure that requires a heart-lung machine.
  • US 9,433,503 B2 proposes a segmented annuloplasty ring which in its embodiment is configured to be delivered to the heart through a catheter using, for example, a transseptal approach or a transapical approach.
  • the aforementioned rigid and / or semi-rigid annuloplasty rings are not suitable for being inserted into a heart through a catheter.
  • the annuloplasty ring in question comprises an outer hollow member having a plurality of movable segments. Neighboring segments rotate together in a limited angular range.
  • the present disclosure presents systems and methods for the repair of heart valves. This is done by percutaneous transcatheter delivery and fixation of an annuloplasty ring to the heart valves.
  • annuloplasty rings are formed in an elongate delivery geometry for the delivery catheter. Due to the elongated embodiment, an anuioplastic ring may be delivered through a catheter for implantation on a valve annulus. For example, the catheter is delivered to the heart through the ankle access and the subsequent vena cava, eg via the inferior vena cava into the right atrium, via the interatrial septum into the left atrium, where the anuloplastic ring is positioned on the valve ring. Positioning is controlled by means of ultrasound, fluoroscopy and other imaging techniques. During the inspection, the two free ends of the annuloplasty ring are then connected together via a ring closure.
  • the anchors are curved and are driven into the tissue via a balloon and no additional suturing of the anchors is necessary.
  • Such an anuioplastic ring consists of a biological or biocompatible material and contains a Nitinol linkage inside
  • the disadvantages of this annuloplasty ring are the complicated method of implantation through a catheter and the fastening of the anchor, as well as the unspecified change in size and Form of the annuloplasty ring on the valve annulus to completely eliminate regurgitation
  • Another relatively elastic annuloplasty ring implant on an annulus of a mitral valve can be found in US 8,945,210 B2 This implant is inserted through a myocardial incision in the heart when inserting through the Opening in the forecourt is already complete. The implant is releasably attached to an adjustment tool and is guided by this to the Anuius mitral valve.
  • the implant can be adapted to the size and shape of the Anuius. At intended locations on the implant, this is then sutured to the anus by the open operative incision on the heart. Afterwards, the incision on the heart is closed again with the setting tool still remaining on the implant. Once the patient is off-pump again and normal blood flows through the heart, further adjustments to the size of the implant can be made as needed. An adaptation takes place by manipulation of the adjusting tool, which operates in the annular implant, for example, a rack and pinion system.
  • a disadvantage of this embodiment of annuloplasty ring is that it can not be implanted on the beating heart.
  • US Pat. No. 8,470,028 B2 discloses devices as implants.
  • An implant refers to a valve for relieving mitral valve regurgitation. The valve is inserted between the valvular valves of the mitral valve.
  • Another device relates to another implant, which is designed as a stent.
  • the flexible stent is delivered percutaneously, as a preloaded implant, via a steerable delivery catheter through the groin artery and the interatrial septum, the mitral annulus.
  • the collapsed stent opens and adapts to it.
  • the stent has fasteners such as prongs, hooks, and the like. on.
  • the annular stent may be equipped with spaced magnets.
  • the expansion and placement i.e., the adaptation of the stent to the size and shape of the mitral annulus, has problems and therefore this implant could not prevail in cardiac surgeons.
  • the disadvantages of the guided over the inguinal artery catheters are to be avoided.
  • US 9,072,511 B2 disclosed an annuloplasty ring or its attachment with a tissue anchor. Again, this "C-shaped" annuloplasty ring is delivered via a catheter for implantation on the mitral valve annulus in the left atrium, for implantation it is necessary to unfold and position the annuloplasty ring in the left atrium with the aid of the catheter
  • the attachment is made with three or four spiral-shaped tissue anchors, whereby a variety of different anchors can be used.
  • the anuloplastic ring is called an implant element and usually consists of three or four arcuate segments the size of the valve, the size of the elongate segments, and the catheter volume, which are hinged together and can perform a defined but limited pivotal movement Pivoting movement can also take place via provided bending joints.
  • the implant element then consists of a single piece of material.
  • a souloplastic annuloplasty ring has a rigid structure resulting from the segments.
  • a rigid structure to avoid repetition, reference is made to the above-mentioned disadvantages of a rigid structure (too high bending stiffness, insufficient adaptation to the shape of a valve ring, the occurrence of different stresses on the valve ring, etc. after sewing or anchoring).
  • a D-shaped structure for an annuloplasty ring can be achieved for the attachment of an implant element consisting of three segments, in advance three or four individual tissue anchors are used The tissue anchors are secured with guide wires in the provided through holes of the segments of the implant elements and create tension on the rigid implant element and on the tissue of the mitral valve annulus
  • the embodiment of the segmented annuloplasty ring of US 9,072,511 B2 is attached to the implanted spiral tissue anchors.
  • the tissue anchors are advanced in a catheter sleeve into the left atrium.
  • the sites to which the tissue anchors are to be placed were determined in advance with an anchor guide frame and lie on a circle on the mitral annulus.
  • a fin is inserted into the valve gap of the mitral valve.
  • a locating part of the anchor guide frame is placed on the mitral valve.
  • the anchor guide frame is opened and its arms extended to position the fabric anchor.
  • the segments of the implant element are attached at these free ends, advanced through the catheter sleeve and placed on the tissue anchors.
  • the segments of the implant element contain openings which are pushed over the ends of the tissue anchors.
  • a first conical sleeve is pushed onto the end of a tissue anchor.
  • the conical counterpart is also again a sleeve or a conical opening in the segment. If the counterpart is a second sleeve, this is pushed over the first sleeve, wherein both sleeves are then in the rotary joint of two segments. Above the sleeves, a cylindrical compression spring is still arranged.
  • the end of the tissue anchor on an annular groove.
  • the annular groove is located after placing a segment on a tissue anchor above the attachment opening of the segment and above the compression spring.
  • a clamping element is still arranged, which is also supplied via the guide wire.
  • the Ktemmelement may for example consist of a spring ring, with which a segment of the implant element is connected to a tissue anchor. This attachment process of the segments is repeated on all embedded tissue anchors. Due to the large number of individual parts for attaching an anuloplastic ring to the tissue anchors, a disadvantage arises during implantation.
  • Another disadvantage is that the deformed shape of the left ventricle, which leads to limitations in closing the mitral valve, can not be restored with the aforementioned implant elements in order to achieve an optimal valve closure.
  • a remodeling of the mitral annulus can not be achieved sufficiently with rigid and semi-rigid annuloplasty rings.
  • the method used to implant a rigid annuloplasty ring, catheter-guided support has disadvantages as previously indicated. Although catheters have a lot of longitudinal capacity in the longitudinal direction, they have little capacity in the lateral or radial direction. The lumen of a catheter is limited because of the access routes to the heart. The surgical repair of a mitral valve has evolved over the last decade.
  • annuloplasty rings should allow easy attachment to the beating heart.
  • the attachment of an annuloplasty ring is to get along without sewing on mitral valve anulus and it should be a reduction of the variety of technical Components in the rigid and segmented, consisting of segments annuloplasty rings done.
  • Heart valve interventions are catheter-assisted and / or surgical insertions on the heart valves or heart valve sails, with the aim of restoring the functionality of a heart valve.
  • various technical procedures and surgical instruments are available for the production of the functionality.
  • Such techniques include the repair and replacement of heart valves.
  • an operative approach to the heart occurs through thoracotomy in the form of a median sternotomy that allows access to the patient's chest cavity.
  • the star must be cut or sawn lengthwise. With a rib spreader, the two halves of the thorax are then stretched apart.
  • heart surgery is performed using catheters.
  • Transcatheter technology as access to the heart has largely replaced thoracotomy in some areas.
  • Some heart valve defects can be remedied by modern catheter procedures in a gentle way and can sometimes avoid a major operation.
  • defects in the heart valves of the left half of the heart that is to say on the aortic and mitral valve, are nowadays treated by means of a catheter.
  • a plastic catheter is advanced to the heart via a blood vessel in the groin or arm.
  • this access method (transcatheter technology) to the heart is shown here only to document the state of the art.
  • Mitral Valve Reconstruction is a restoration of valve function with preservation of the mitral valve (bicuspid valve). In order to successfully repair the valve function of a mitral valve in the interior of a human heart, the various components of the mitral valve need to be examined and their possible errors verified.
  • the investigation takes place i.a. by means of diagnostics before and during the operation, e.g. with contrast-enhanced angiography, fluoroscopy and transthoracic and transesophageal echocardiography. Only the use and progress in diagnostics enables minimally invasive surgery to perform beating heart surgery.
  • a mitral valve reconstruction takes place in principle as follows: Preliminary examination, eg with ECG, echocardiogram (TEE), swallowing echo (ultrasound probe). Cardiac catheterization, Doppler examination, pulmonary function test and determination of the size of the annulus (diameter of the mitral valve) to determine the valve ring implant to be inserted, narcosis of the patient, approx.
  • An anuioplastic ring must be able to be inserted and attached through narrow tubes, which may increase the complexity of the device structure because there is no direct line of sight to the implantable annuloplasty ring.
  • such an annuloplasty ring must therefore be compressible or compressible in order to be able to be pushed through an access sleeve leading to the heart.
  • the annuloplasty ring in the access sleeve must be easy to guide and must not compress.
  • the annuloplasty ring must self-expand to its original shape in order to easily seat around the fasteners implanted on the annulus of the mitral valve.
  • annuloplasty ring must be suitable for necking tissue, eg a mitral valve annulus or a body orifice, eg an atrium. Therefore, an annuloplasty ring is equipped with simple but effective attachment means. This means that traditional heart valve surgery and minimally invasive cardiac surgery should be advantageously extended with another minimai-invasive surgical procedure.
  • Other important criteria are, above all, the design of the implant and the instruments, because the design has a great influence on the handling when operating without visual contact. That is, a variety of factors must be considered in order to perform a suitable operation for mitral valve repair minimally invasive, the age and the general health of the patient, the extent of damage to the valve, the type of valve and the preference of the patient.
  • mitral flap reconstruction has resulted in significant improvements in mitral valve insufficiency by applying anuioplasty.
  • the goal of mitral valve anuioplasty is to improve mitral valve competence e.g. to restore leaking mitral valves by reconstructing the physiological shape and function of the normal mitral valve.
  • the mitral valves undergo significant dynamic changes in shape and size throughout the cardiac cycle. These changes are mainly due to the dynamic movement of the surrounding mitral valve annulus.
  • the left atrium undergoes sphincter movement and narrows the opening area during systole to facilitate the coupling of the two sails and to expand during diastole to allow easy diastolic filling of the left atrium.
  • the challenge of mitral valve annuloplasty is to improve the diseased and / or distorted shape of the mitral valve annulus and restore the physiological configuration while maintaining normal ring dynamics.
  • the anuioplasty enlarges the coaptation surface of the mitral leaflets and thus reduces the tension forces acting on the reconstructed segments of the mitral valve. It is thanks to the role of anuioplasty that a normal relationship between the valve leaflet surface and the anular surface is ensured in order to restore physiological coaptation.
  • the Anuioplastie is thus an efficient technique and leads to good results for the patients.
  • the inventive annuloplasty ring and its attachment meet these requirements and also simplify implantation on the beating heart.
  • annuloplasty rings Cardiac surgeons can today choose from a variety of different annuloplasty rings to restore the original shape of a mitral valve annulus. The discussion remains controversial in the choice of the type, size, material and shape of an anulopiastia ring to be inserted.
  • the material property of the annuloplasty rings may be flexible, semi-rigid or rigid in nature, incomplete or complete in shape, planar or saddle-shaped, adjustable or non-adjustable.
  • molds are known "C-shaped”, “D-shaped”, “circular”, “kidney-shaped” and “saddle-shaped” Anuloplas tie-rings. The appropriate size of an annuloplasty ring is decided by the surgeon prior to implantation.
  • the material may be titanium alloy and the sewing ring may be silicone rubber or the annuloplasty ring may be made with layers of Elgiloy and plastic strips coated with silicone rubber on the sewing line edge or the inner core of an annuloplasty ring a proprietary metal alloy or polyethylene or has a cell structure design that is capable. imitate the physiological 3-D movement of the native mitral valve annulus and consider the anatomical saddle shape.
  • a shape memory alloy such as Nitional, into consideration.
  • the core is often covered with tissue, eg made of knitted PET and coated with a carbofilm or made of a knitted PTFE containing one or more radiopaque barium impregnated silicon markers.
  • tissue eg made of knitted PET and coated with a carbofilm or made of a knitted PTFE containing one or more radiopaque barium impregnated silicon markers.
  • the core consists, inter alia, of rigid titanium wire and of highly flexible PTFE tubing. Polyester knit fabric and thin PTFE tubing is covered. If the annuloplasty ring consists exclusively of PTFE and a polyester suture, this ring is fully flexible and maintains the movement of the valve ring. Most annuloplasty rings may contain markers containing barium-impregnated silicon to allow radiographic visualization and thus to better position an annuloplasty ring.
  • An implant can therefore only assume the size that can be passed to the surgical site through a trocar and / or catheter.
  • Another object is to equip the implant with a fastener.
  • Several fasteners are designed to connect an annuloplasty ring to the threads of multiple implanted tissue anchors.
  • a mitral kiappen implant system is provided according to claim 7.
  • Embodiments emerge from the subclaims.
  • the device can be used for the application of minimally invasive beating heart surgery.
  • the device is inserted into an anatomical opening or other lumen, preferably a mitral valve annulus, for adjusting the shape and size of an anatomical opening.
  • the anuioplasty ring of the device is convertible from an initial configuration into a delivery configuration and then into an expanded configuration. In the initial position, the Anuioplastie ring has its preselected, for example, oval embodiment. In its oval open form, the anuioplasty ring is pulled onto the threads of the tissue anchor.
  • the Anuioplastie-ring is inserted into a sleeve of a surgical instrument in which it is compressed introduced into the left atrium.
  • the compressed anuioplasty ring unfolds into an open configuration.
  • the opened shape of the anuioplasty ring corresponds to the original shape before compression.
  • the expanded annuioplasty ring is slid onto the implanted tissue anchors with its original initial shape to affect the geometry of the anatomical opening. The anuioplasty ring is then attached to the implanted tissue anchors.
  • An implantable device which can be deployed on the beating heart with minimally invasive technique and access from the right side of the breast.
  • a mitral valve implant in particular for an Anuioplastie- ring, which is simple and inexpensive to manufacture and on the other hand allows an ergonomic procedure during implantation with easy handling.
  • the device can be used for operative recovery and better function of the mitral valve.
  • the present disclosure is not limited to an embodiment or a special Anuioplastie ring, but allows a variety of different material properties and differently shaped Anuloplastie rings that are suitable to be attached to tissue anchors can.
  • the device in particular with an anuioplasty ring, which is equipped with at least one tissue anchor, preferably with five or more tissue anchors.
  • the number of tissue anchors to be implanted depends on the size or diameter of the mitral valve annulus, to positively influence the shape and size of the mitral valve annulus and to eliminate regurgitation of the blood.
  • tissue anchor may comprise or consist of a helical spiral screw and a plastic thread.
  • a tissue anchor can be inserted with the same surgical instrument into the tissue around the mitral valve annulus.
  • a needle At the free end of the plastic thread of a fabric anchor can still be arranged a needle.
  • Tissue anchors can be inserted individually from the right side of the breast into the left atrium and implanted around the mitral valve annulus.
  • about eight to ten tissue anchors are set for receiving and attaching an annuloplasty ring.
  • each free end of a plastic filament of the implanted tissue anchor is located outside the thoracic cavity and is thus within the surgeon's reach.
  • Each plastic thread can have a marking at the free end.
  • the marking may be colored in nature and / or consist of a code number or the like.
  • the marking shows at which point the associated tissue anchor of the marked plastic thread is positioned at the mitral valve annulus.
  • the positioning of tissue anchors around the mitral valve annulus is demonstrated by the example of FIG. FIG. 2 shows in plan view an anuloplastic ring which is sewn around a mitral valve annulus and the two sails of the mitral valve.
  • the mitral valve annulus has an oval shape that is approximately "D-shaped.”
  • the anterior leaflet AL forms a relatively straight section in the area of the annulus opposite a curved posterior segment of the posterior leaflet PL., Because the path length of the relatively straight section is shorter
  • three tissue anchors are advantageously arranged on the straight section and five tissue anchors are arranged on the curved section Distances of the tissue anchors may be the same or may have different distances due to the anatomical 3-D shape of the annulus.
  • any suture lying outside the thorax may be associated with a tissue anchor implanted in the heart and its position Assignment of a thread and the position of its associated Tissue anchor, advantageously takes place in that the image is given an image structure in top view of the annulus.
  • the biid structure specifies the positions of the tissue anchors to be implanted. Each item is assigned a tag, for example, with simple measures or the like.
  • the first implanted tissue anchor receives, for example, the index 1, wherein the tissue anchor is given a first position for implantation.
  • the first Position of a tissue anchor on the annulus may be, as previously defined, the left transition between the curved portion and the straight portion.
  • the other tissue anchors are then implanted clockwise. That is to say, the second tissue anchor following the first set tissue anchor receives the code number 2 and is implanted in the predetermined position 2, etc.
  • the tissue anchors can also be implanted in a different order. For example, if the first tissue anchor is implanted at position 1, then the next tissue anchor will be implanted at position 3, this tissue anchor will of course receive the index 3 and the subsequent tissue anchor to be implanted will come to position 5 with the marker 5 at the thread, etc. It is also possible to implant tissue anchors in a different order.
  • the tissue anchor or its thread is provided with the appropriate position indication.
  • the implantation procedure involves placing the tissue anchors at selected locations around the mitral valve annulus in the left atrium of a heart, and attaching the tissue anchors by screwing on the mitral valve annulus, thereby surrounding it with embedded tissue anchors.
  • the placement and implantation of the tissue anchors are assisted by a variety of possible assaying measurement techniques.
  • Imaging is accompanied by mitral valve surgery or implantation of the inventive device during the entire minimally invasive procedure.
  • the TEE technique may be used to determine the position of a tissue anchor to be implanted.
  • an anuloplasty ring is inserted with the appropriate surgical instrument. Ultrasound imaging may be used prior to the medical procedure to determine the size of the mitral valve annulus. Such information can be used in the selection of a suitably sized annuloplasty ring. In some cases, the anuloplasty ring may also be selected based on the actual positions of the implanted tissue anchors.
  • the individual threads, each with a needle at the free ends are guided through the fiber ring, eg consisting of PET or PTFE fabric of an anuloplastic ring. To position a thread on the annuloplasty ring, it is necessary to use the same position at which the tissue anchor is positioned at the annulus.
  • the annuloplasty ring to be implanted with respect to the positioning to the tissue anchors has the same image structure as the image structure of the mitral valve annulus.
  • the first tissue anchor is in the first position, at the left transition between the curved portion and the straight portion of the annulus.
  • the thread associated with this fabric anchor 1 carries the code number 1. This means that the thread 1 of the fabric anchor 1 must be passed at the corresponding point 1, in the annuloplasty ring.
  • Position 1 on the annuloplasty ring also corresponds to the first position at the left transition between the curved portion and the straight portion of the annuloplasty ring.
  • the first position on the annuloplasty ring corresponds to the first position of the implanted tissue anchor.
  • the thread 3 of the implanted tissue anchor 3 located at the position 3 on the annulus is passed at the position 3 of the annuloplasty ring, wherein the position 3 at the annulus is identical to the position 3 on the annuloplasty ring, the thread 5 of the implanted tissue anchor 5, located at position 5 on the mitral valve annulus, is passed through at position 5 of the annuloplasty ring, etc.
  • the positions on the annuloplasty ring, on each of which a thread can be pulled through, can already be marked out on position markers on the annuloplasty ring.
  • An annuloplasty ring can be made of a deformable material that can be deformed by hand.
  • the deformation relates to a compression of the eg oval shape of the annuloplasty ring to a minimum.
  • the geometric minimum of the shape is achieved when the relatively straight front portion is the curved rear portion.
  • the diameter of such anulopastial ring is then compressed to a minimum of a few millimeters.
  • the diameter then corresponds to slightly more than twice a cross-section of an annuloplasty ring. Due to the available lumen for the delivery configuration of the annuloplasty ring, it is not necessary to compress the anuloplasty ring to its minimum.
  • the length of the annuloplasty ring in the compressed state has no effect on its delivery to the site of implantation in the atrium.
  • tissue anchor threads are pulled through the initial shape of an annuloplasty ring, this is then compressed or compressed.
  • This compressed state of the annuloplasty ring is referred to as a delivery configuration.
  • the annuloplasty ring is inserted into a sheath.
  • the pod which is passed through a trocar, reaches into the left atrium of the heart.
  • Another surgical instrument is then used to push the annuloplasty ring out of the sheath while the tissue anchor strands continue to remain outside the body.
  • the annuloplasty ring exits the sleeve and enters the left atrium, it thus expands from its delivery configuration to its original initial shape.
  • the original starting shape corresponds to the open oval configuration, with the annuloplasty ring still guided by the threads of the tissue anchor.
  • the annuloplasty ring is now slid onto and placed on the ends of the tissue anchors, securing it to the mitral annulus on the tissue anchor as described above.
  • the TEE technique can also be used to fabricate the tissue anchors with an annuloplasty ring, as well as to lock the fasteners to the threads of an annuloplasty ring.
  • the attachment of an annuloplasty ring to the tissue anchors may be accomplished by a known method such as suturing, knotting, etc.
  • Simple fasteners can be used to attach an annuloplasty ring to the tissue anchors.
  • these fastening means are placed on the tissue bean threads lying outside the body and advanced to the annuloplasty ring. If the attachment means, which can pinch a tissue anchor thread, are placed on the annuloplasty ring in the area of the tissue anchor, they are cut off in the region of the attachment means and possibly knotted. The cut threads of the tissue anchors are removed from the atrium and thus from the heart and the incision in the heart wall is closed.
  • mitral valve returns to normal Function and prevents the unwanted backflow of blood from the left ventricle into the left atrium, because the normal geometry of the mitral valve has been restored.
  • the Mitralklappensegel meet by better contact with each other again their valve function.
  • This is successfully achieved by the implantation of the annularly designed detective device on the mitral valve annulus.
  • This form of mitral valve surgery requires a minimally invasive approach to avoid breast wall incision, cardiopulmonary bypass, and cardiac and pulmonary arrest. Such a procedure is significantly less expensive, does not take up so much time and is associated with a low mortality risk for the patient.
  • the device is provided with functions for percutaneous insertion and deformity of a mitral valve annulus and the use of the superior method of minimally invasive surgery to constrict tissue or a body orifice, such as a mitral valve, a tricuspid valve, or an aortic valve, by such a device ,
  • the device enables the minimally invasive procedure to implant an annuloplasty ring with the associated tissue anchors and attachment means into the tissue around the opening of an anchor.
  • cardiac surgery The described method and apparatus may also be used in other operations where tissue is to be contracted, e.g. in a stomach operation or in bowel surgery, etc., are used.
  • the implant may comprise individual elements that combine with each other to form the mitral valve implant called "MitraRing."
  • the "mitring ring” is formed from three elements.
  • a first element is a spirally formed anchoring element, which consists of a helix screw with artificial thread.
  • the second element is a flexible annuloplasty ring that attaches to multiple tissue anchors.
  • the third element concerns a fastener to connect the annuloplasty ring to the tissue anchors. All three elements can be connected together after fabrication to a mitral valve implant.
  • a system is available for the method for implanting such a device.
  • the system has a mitral valve implant which is suitable for minimally invasive repair of a mitral valve annulus on the beating heart of a patient. It has an outer tube slide I, in particular a lumen access tube, for guiding an inner tube slide II and a first inner tube slide II, in particular a lumen surgical device, for guiding and screwing in a tissue anchor. After implantation of the tissue anchor, the tube slide II is against a second inner tube slide III, in particular a surgical instrument with lumen, for guiding an annuloplasty ring exchanged.
  • a third inner tube slide IV in particular a surgical instrument with lumen, for receiving tissue anchor threads and for pushing out the annuloplasty ring from the tube slide III, introduced until the annuloplasty ring is expanded in the forecourt. Thereafter, the pipe slide III and IV are removed and replaced by a fourth inner pipe slide V.
  • the fourth inner tube slide V in particular a lumen-type surgical instrument for guiding a fastening means, in particular a clamping means, is guided along a tissue anchor thread for fastening an annuloplasty ring,
  • FIG. 1 is a schematic representation of the thorax of a person with access to the heart from the right thoracic side;
  • Figure 2 is a schematic view of a prior art plan view of an implanted device, particularly an annuloplasty ring attached to a mitral valve annulus in the left atrium of a heart;
  • FIG. 3 is a perspective view of another implanted device consisting of a segmented annuloplasty ring with tissue anchors as fastening means from the prior art;
  • FIG. 4a is a perspective view of an inventive implantable device consisting of an annuloplasty ring with tissue anchors as fastening means;
  • FIG. 4b is a schematic representation of a detail from FIG. 4a with fabric anchor and annular body in cross section;
  • FIG. 5 is a schematic representation of an implantation of the fastening means around the mitral valve annulus
  • Fig. 6 is a schematic representation of an annuloplasty ring in a delivery configuration
  • FIG. 7 shows a schematic illustration of a device implanted on the mitral valve annulus
  • the human thorax 1 shown schematically in FIG. 1 shows a minimally invasive access 2 to the heart 3 for minimally invasive mitral valve surgery. Interventions on the mitral valve 14 of the heart 3, see Fig. 5, can be minimally invasive, ie, without the use of the heart-lung machine, made.
  • a hybrid OR scenario can be used in an anesthetized patient for mitral valve repair.
  • a plurality of lateral small access openings are introduced in the right thorax 5 between the 31 or 4 th rib space.
  • This procedure is performed using the minimally invasive technique (also known as keyhole surgery) and picks up trocars, wound spreaders, optics, awning retractor and other instruments.
  • the access 2 to the heart 3 takes place, as indicated above, over a small thoracic opening 4 on the right side 5 between the 3 rd or 4 th rib area 6.
  • the thoracic opening 4 is opened with a wound spreader 7 during the operation held.
  • Other approaches, such as for endoscopy, not shown, are made in the thorax 1.
  • the heart 3, rotated about its longitudinal axis, lies in the left chest cavity 8, so that the right half of the heart rests more against the anterior chest wall, while the left half of the heart tends to point backwards.
  • An implantable device 10 in particular an annuloplasty ring 11, see FIG.
  • a trocar serves e.g. the receptacle and as an access guide for one or more catheters as well as for a, in the left atrium 12, implantable device 10.
  • Analogous reference numerals of Fig. 1 are taken in the following figures.
  • FIG. 2 shows, in a schematic representation and in plan view, a device 10 implanted on the open heart 3, in particular a prior art annuloplasty ring 11, which is sewn around a mitral valve annulus 13 in the left atrium 12 of a heart 3.
  • the mitral valve annulus 13 has a forward leaflet 16 and a posterior leaflet 17.
  • the leaflets 16, 17 of the mitral valve 14 become brought closer together and supported so that they meet when closing the valve 19 in the gap 18.
  • An annuloplasty ring 11 thus eliminates the problem of functional mitral regurgitation.
  • the annuloplasty ring 11 has an oval or approximately "D-shaped" configuration with a relatively straight anterior portion 20 opposite a curved rear portion 21.
  • Two markers 22.1, 22.2 denote the boundaries between the anterior 20 and posterior portions 21 .
  • Several knotted thread loops 23 are typically used to secure the annuloplasty ring 11 to the mitral valve annulus 13.
  • the indicated annuloplasty ring 11 is implanted by opening the thorax 4 to the open heart 3.
  • FIG. 2 the arrangement of the positioning 24.1-24.8 of tissue anchors 15.1-15.8 on the mitral valve annulus 13 and on the annuloplasty ring 11 is shown in dashed lines in FIG. 2.
  • the details of the positioning of eight tissue anchors 15.1-15.8 are given in FIG Figure 2.
  • the possible positions 24.1-24.8 of the eight tissue anchors 15.1-15.8 implanted with minimally invasive technique on the mitral valve annulus 13 are apparent therefrom.
  • the complete inventive device 10 with an annuloplasty ring 11, shown with six tissue anchors 15.1-15.6, is shown in Fig. 4b.
  • the first position 24.1 of a tissue anchor 15.1 is located at the marker 22.1 at the left border of the front 20 to the rear portion 21.
  • the third position 24.3 of a tissue anchor 15.3 is located at the marker 22.2 on the right border of the front to the rear portion 21.
  • the second position 24.2 of a tissue anchor 15 2 is located between the first 24.1 and third position 24.3 in the region of the mitral valve annulus 13 of the anterior leaflet 16, while the other positions 24.4 to 24.8 of the tissue anchors 15.4 to 15.8 are arranged in the region of the mitral valve annulus 13 of the rear sail 17 are.
  • the posterior portion 21 of the annuloplasty ring 11 is shaped and generally follows the altered shape of the mitral valve annulus 13 in the region of the posterior leaflet 17.
  • the tissue anchors 15.4 to 15.8 are implanted such that the annuloplasty ring 11 attached thereto is in the shape of the annulus Mitral valve annulus 13 supports.
  • the annuloplasty ring 11 is not sewn directly to the mitral valve annulus 13 with knotted thread loops 23, as shown in the prior art of FIG. 2, but to the tissue anchor 15.1-15.8 implanted on the mitral valve annulus 13, as shown in FIG. 4a , attached.
  • Analogous reference numerals from this Fig. 2 are taken in the following figures.
  • Fig. 3 shows in perspective view, from the prior art, another implanted device 10 in unfolded configuration.
  • the device consists of a segmented annuloplasty ring 11 with tissue anchors 15.1-15.4 as attachment means 25.
  • the annuloplasty ring 11 has an approximately "C-shaped configuration in order to reinforce an opening in the body tissue or around the natural valve 19 to reinforce.
  • the valve 19 has the form of a mitral valve 14, see Fig. 2.
  • the annuloplasty ring 11 consists, according to the embodiment, of three segments 26 a, 26 b, 26 c. Between the three segments 26a, 26b, 26c and at the free ends 28, 28 'of the segments 26a, 26c, a fabric anchor 15.1-15.4, a total of four fabric anchors 15.1, 15.2, 15.3, 15.4, are arranged. The distance between the fabric anchors 15.1, 15.2, 15.3, 15.4 is predetermined by the length of the arcuate segments 26a, 26b, 26c.
  • hinges 29.1-29.4 are arranged in the segments 26a, 26b, 26c, which have a conical receiving opening (not shown) for the tissue anchors 15.1, 15.2, 15.3, 15.4.
  • the arcuate shape of the segments 26 a, 26 b, 26 c is dimensioned such that they can comprise a part of the mitral valve annulus 13.
  • the indicated annuloplasty ring 11 is introduced into the heart 3 and implanted therein. Analog reference numerals from this Fig. 3 are taken in the following figures.
  • FIG. 4a shows, in a perspective view, an inventive implantable device 10 consisting of an anuloplasty ring 11 with fastening means 25, wherein the fastening means 25 are a plurality of tissue anchors 15.1, 15 2, 15.3, 15.4, 15.5, 15.6 include.
  • the fabric anchors 15.1, 15.2, 15.3, 15.4, 15.5, 15.6, in turn, are formed from spiral-shaped helical screws 30.1-30.6, although other fastening means can also be used.
  • On the representation of the heart 3 and the sails 16, 17 of a mitral valve 14 is omitted here for clarity. This is sufficiently apparent from FIGS. 5-7.
  • the implantation of the device 10 shown is carried out using the minimally invasive surgery according to FIG. 1.
  • the inventive annuloplasty ring 11 has approximately a general annular or oval shape. Furthermore, the annuloplasty ring 11 has an inner layer 43 for stabilization and at least one outer layer 42 through which at least one artificial tissue anchoring thread 33 is pulled.
  • Such an annuloplasty ring 11 comprises in cross section a rounded annular body 27 having a relatively straight front portion 20 and an arcuate rear portion 21, as also shown in FIG. The front section 20
  • An anusoplasty ring 11 is configured with tissue anchor positions 24.1 -24.3 for a forward side 31 of a mitral valve annulus 13 of the anterior leaflet 16, while the posterior portion 21 is configured with tissue anchor positions 24.4-24.6 for a posterior side 32 of a mitral valve annulus 13 of the posterior league 17 is.
  • a tissue anchor position 24.1- 24.6 in the annuloplasty ring 11 is provided with at least one tissue anchor thread 33.1-33.6 of at least one tissue anchor 15.1-15.6.
  • the tissue anchors 15.1-15.6 are arranged around the Mitralklappenanulus 13.
  • Each tissue anchor 15.1-15.6 implanted on the mitral valve annulus 13 is equipped with a tissue anchor 33.1-33.6 to attach an annuloplasty ring 11 to the tissue anchor 15 1-15.6.
  • the tissue anchor position 24 1 in the annuloplasty ring 11 rests on the same longitudinal axis 39 as the tissue anchor position 24'.1 on the mitral valve annulus 13.
  • tissue anchor position 24.1 on the annuloplasty ring 11 and the tissue anchor position 24 '.1 on the mitral valve annulus 13 are congruent whereby a tissue anchor thread 33.1 of a tissue anchor 15.1 can be assigned to the same tissue anchor position 24.1 in the annuloplasty ring 11 for attachment due to its tissue anchor position 24'.1 on the mitral valve annulus 13.
  • the above example is representative of the other tissue anchor positions 24.2-24.6 and 24'.2-24'.6, where always a pair of tissue anchor positions 24.2-24'.2, 24.3-24 '3, etc., belong together and are arranged on a common longitudinal axis 39
  • tissue anchor positions 24 '.1-24'.6 for example of six positions on the mitral valve annulus 13 and the tissue anchors 15.1- 15.6 implanted thereon, an annuloplasty ring 11 can be attached.
  • tissue anchor positions 24 1-24.8 typically used to position and secure an anuioplasty ring 11 with its tissue anchor positions 24.1-24.8 to the tissue anchors 15.1-15.8 implanted in the mitral valve annulus 13.
  • the first position 24.1 of a tissue anchor 15.1 on the annuloplasty ring 11 is, viewed in plan view, at the marker 22.1, which marks the left border of the front 20 to the rear portion 21.
  • the third position 24.3 of a tissue anchor 15.3 is located at the marker 22.2, which marks the right border of the front 20 to the rear portion 21.
  • the second position 24.2 of a tissue anchor 15.2 is located between the first 24.1 and third position 24.3 in the relatively straight front portion 20 of the annuloplasty ring 11, while the other positions 24.4 to 24.8 of the tissue anchor 15.4 to 15.6 are arranged in the region of the curved rear portion 21 are.
  • the posterior portion 21 of the anulopia gs 11 is shaped and generally follows the altered shape of the mitral valve annulus 13 in the region of the posterior sail 17.
  • the tissue anchors 15 4 to 15.8 are so implants that the Anuioplastie ring 11 mounted thereon, the shape of Mitralklappenanu- ius 13 is supported.
  • the first position 24 '. 1 of a tissue anchor 15. 1 is located at the mitral flap annulus 13, viewed in plan view, at the left border of the front 20 to the rear section 21, where the front sail 16 meets the rear sail 17.
  • the second position 24 .2 of a tissue anchor 15. 2 is located between the first 24 '. 1 and third position 24' 3 in the region of the anterior leaflet 16 of the mitral pelvic annulus 13, while the other positions 24 '4 to 24' 15.4 to 15.6 are located in the area of the rear sail 17 of the Mitralklappenanulus 13.
  • the tissue anchor positions 24 .1-24 '.6 and their distances from one another can be indicated for the tissue anchors 15.1-15.5 on the mitral valve annulus 13, also with the aid of a time indication, in a clockwise direction.
  • the tissue anchor position 24 .2 and at 14:00 and 22:00 could be the two tissue anchor positions 24'.1 and 24'.3 delimiting the anterior portion 20 of a mitral valve annulus 13.
  • the tissue anchor positions 24 .4-24 .6 are located for the posterior portion 21 of a mitral valve annulus 13.
  • the distances between the tissue anchors 15.1-15.6 are figuratively 2h.
  • tissue anchors 15 especially in the posterior portion 21 and the caliper area of the mitral valve annulus 13, could be implanted at 5:00 pm and 7:00 pm, respectively, such as e.g. shown in FIG. Figuratively speaking, of course, other time intervals are possible, resulting in other angular distances between the tissue anchors 15 would result.
  • the tissue anchors 15.1-15.6 can also be implanted on the mitral valve annulus 13 such that an annuloplasty ring 11 can also emulate an asymmetrical opening of a mitral valve annulus 13. That is, the shape of an annuloplasty ring 11 can be changed due to many factors.
  • Figures 2 and 4a exemplify two of the many possible embodiments.
  • the shape of an annuloplasty ring 11 can be influenced.
  • the distances of the positions 24 for the tissue anchors 15 can be varied. The positioning of the tissue anchor 15 on Mitralklappenanulus 13 is therefore of particular importance.
  • annuloplasty ring 11 attached to the implanted tissue anchor 15 thus eliminates the problem of functional mitral regurgitation. tion, because the Anuioplastie ring 1 1, together with the implanted tissue anchors 15, a pulling force on the surrounding myocardial tissue 47 exerts.
  • asymmetric annuloplasty rings 11 can be used from the outset if a patient has a malformed anatomy at the mitral valve annulus 13.
  • the material of an annuloplasty ring 11 used herein allows manual deformation, it is stiff enough to withstand further deformation on the mitral valve annulus 13 once implanted and subject to normal physiological stresses.
  • the outer layer 42 of an annuloplasty ring 11 should be sufficiently porous and / or flexible to allow the tissue anchor filaments 33 to pass therethrough.
  • the inner layer 43 is designed to reduce the circumference of a mitral valve annulus 13. It must maintain its posterior bend in the posterior portion 21 against the stresses transmitted by the muscle tissue 47 of the heart 3 during a beating cycle.
  • the materials of such an inner layer 43 has already been exemplified in the description. Analog reference numerals from this Fig. 4a are taken in the following figures.
  • FIG. 4b shows a schematic representation of a section X from FIG. 4a with a fabric anchor 15.1 and a ring body 27 in cross-section, by way of example for all fabric anchors 15.1-156.
  • a tissue anchor 15.1 consists inter alia of a spiral helical screw 30.1, which forms the distal end 36 of a tissue anchor 15.1, while at the proximal end 37 of the tissue anchor 15.1, at the free end of the tissue anchor thread 33.1, a needle 34 is arranged.
  • the helical screw 30.1 of the tissue anchor 15.1 is fastened in a carrier disc 38 which, in the direction of the distal end 36, emerges from the carrier disc 38.
  • the carrier disc 38 holder for a tissue anchor thread 33.1 which emerges on the opposite side of the helical screw 30.1 from the carrier plate 38.
  • the tissue anchor thread 33.1 is attached to the tissue anchor 15.1 and the carrier disc 38 is located at the common attachment point 46 of the thread 33.1 and the Anker.15.1.
  • the carrier disk 38 has an abutment side 40 for the Mitrakalppenanulus 13 and an abutment side 41 for the annular body 27.
  • the two abutment sides 40, 41 contain two contact surfaces I, II 44, 45.
  • the first contact surface I 44 serves the tissue anchor 15 when screwed as a stop on the fabric 47, while the other contact surface II 45 an annular body 27 serves as an investment.
  • the diameter of the carrier disc 38 is designed so that too deep screwing a tissue anchor 15.1 is avoided in the heart muscle tissue 47. If all the tissue anchors 15.1-15.6, see FIG. 4a, are implanted in the cardiac muscle tissue 47 around the mitral valve annulus 13, the annular body 27 of an annuloplasty ring 11 on the carrier discs 38 will next be implanted Tissue anchor 15.1-15.6 placed.
  • a fastening means 25 is used for fixing an annular body 27 on the carrier disk 38 of a fabric anchor 15.1, a fastening means 25 is used. At least one tissue anchor 33.1 of a tissue anchor 15.1 is attached to the annuloplasty ring 11 at least with a fastener 25.
  • the attachment means may preferably consist of a Kiemmffen 35.
  • the clamping means 35 is pushed outside the chest 1 on a tissue anchor thread 33.1. This process is carried out by means of the needle 34, which is guided through the opening of the clamping means 35.
  • a surgical instrument (not shown) pushes the clamping means 35 to the ring body 27 and clamps the ring body 27 between itself and the support plate 38 a.
  • the clamping means 35 is designed such that it can permanently clamp a tissue anchor thread 15.1 in its opening.
  • a clamping means 35 also consist of two components which act against each other and exert a clamping effect on a tissue anchor thread 15.1.
  • the clamping member 35 may consist of a plate spring, which can be relatively easily inserted onto the tissue anchor thread 33.1 in the atrium 12 and at the location of attachment of the ring body 27, a clamping opposite to the insertion direction generated.
  • the fabric anchor yarn 33.1 is passed through the outer layer 42 of the ring body 27 so as not to damage the inner ply 43.
  • the insertion of an annuloplasty ring 11 into the atrium 12 can be seen in FIG. 6. After all clamping means 35 have been placed on the annular body 27, the tissue anchoring threads 33.1-33.6 are severed and removed from the atrium 12 of the heart 3.
  • FIG. 5 Analog reference numerals from this Fig. 4b are taken in the following figures.
  • the heart 3 shown in FIG. 5 in a schematic and basic representation, as shown in FIG. 1, is rotated about its longitudinal axis in the left chest cavity 8, so that the right half of the heart rests more against the anterior chest wall, while the left half of the heart points more towards the back ,
  • a mitral valve implant in particular an annuloplasty ring 11, which, using minimally invasive surgery, is applied to the beating heart 3 of a patient via the right thoracic region 5 into the left atrium 12 of the heart 3, using known surgical instruments including a trocar 50, introduced and anchored there.
  • a surgical instrument consists for example of an outer tube slide I 51.1, in particular an access cannula with lumen for guiding an inner tube slide II 51.2.
  • Another surgical instrument consists of a first inner tube slide II 51.2 with lumen for guiding and screwing in a tissue anchor 15.
  • Another surgical instrument consists of a second inner tube slide III 51.3 with lumen for guiding an annuloplasty ring 1 1.
  • the third one inner tube slide IV 51.4 is a surgical instrument with lumen for holding the tissue anchor threads 33.1-33.6 and for pushing out an anuloplasty ring 1 1 from the tube slide III 51.3.
  • the fourth inner tube slide V 51.5 is also a surgical instrument with lumen for guiding a fastening means 25, in particular a clamping means 35, which is guided along a tissue anchor thread 33.1 for fastening an annuloplasty ring 11.
  • the left ventricle 52 is divided into an inflow and outflow path. It is separated from the atrium 12 by the mitral valve 14.
  • the mitral valve 14 is connected by tendon threads (chordae tendineae) 53 with the papillary muscles 54, which arise at the ventricular wall 55 and ensure that the mitral valve 14 at its valve closure 19 and during the tension phase (systole) of the left chamber 52 is not too violent the left atrium 12 strikes back.
  • tendon threads chordae tendineae
  • a mitral valve (Mitral Valve) consists of four functional components The two sails 16, 17 (Mitral Valve Leaflets), consisting of a front sail 16 (cupis anterior), a rear sail 17 (cupis pasterior) and the suspension of the sails 16, 17 in the middle valve ring 13 (mitral valve annulus).
  • the mitral valve annulus 13 consists of a muscle tissue, which is referred to in the description as Mitralklappenanulus 13, the tendon threads 53 (Chordae tendineae), with which the blessing! 16, 17 are movably attached to the papillary muscles 54 (Papulary Muscles) and the papillary muscles 54 themselves, which evade from the myocardium 47 inwards.
  • Mitralklappenanulus 13 the tendon threads 53 (Chordae tendineae)
  • the papillary muscles 54 Paperulary Muscles
  • papillary muscles 54 themselves, which evade from the myocardium 47 inwards.
  • tissue anchors 15.1-15.5 are inserted in the area around the mitral valve annulus 13 in the left atrium. Since the heart 3 is shown in a sectional view, not all possible implanted tissue anchors 15.1-15.8 shown in FIG. 2 can be shown here because only part of the circumference of a mitral valve annulus 13 is shown.
  • the Tissue anchors 15.1-15.5 are representative of all implanted tissue anchors 15.1-15.5.
  • the tissue anchors 15.1-15.5 implanted around the mitral flap annulus 13 are arranged at specific intervals. The distances of the tissue anchors 15.1-15.5 from each other, for example, in the saddle region of the rear portion 21 of a Mitraiklappenanulus 13 compared to the other distances vary.
  • tissue anchors 15.1-15 5 at the distal end 36 an anchoring element 56, wherein an anchoring element 56 consists of a corkscrew-like helical screw 30.1-30.5.
  • the helical screws 30.1-30.5 have a distal end 36 and a proximal end 37, with the proximal end 37 of the turning table screw 30.1-30.5 being connected to the tissue anchoring thread 33.1-33.5.
  • the use of other anchoring means for attaching an annuloplasty ring 11 is conceivable from the known prior art.
  • the screwed-in helical screws 30.1-30.5 are located in the myocardial tissue 47 in the region of the mitral flap annulus 13.
  • the tissue anchors 15.1-15 5 have a carrier disc 38 and a tissue anchor thread 33.1-33.5 at the proximal end 37, which are fastened to the tissue anchors 15.1-15.5 , see in this regard FIG. 4b
  • the tissue anchor threads 33.1-33.5 are guided out of the thorax 1 through a sleeve 51 for further use and are still connected to the helical screws 30.1-30.5.
  • the further use of the tissue anchor filaments 33.1-33.5 can be seen from the description of FIG. Analogous reference symbols from the preceding FIGS. 1-4 are adopted in this figure.
  • FIG. 6 is a schematic illustration of an annuloplasty ring 11 in a delivery configuration 57.
  • the tissue anchor threads 33.1-33.5 coming from the atrium 12 from the tissue anchors 15.1-15.5 are to be passed outside the thorax 1 at predetermined positions 24.1-24.5 on the annuloplasty ring 11.
  • the individual tissue anchor threads 33.1-33.5, at the free ends of which a needle 34 is located are guided through the fiber ring of the outer layer 42 of an annuloplasty ring 11 which still has its initial shape 58.
  • annuloplasty ring 11 In order to be able to guide a tissue anchor 33.1-33.5 through an annuloplasty ring 11, it is necessary to know in advance which tissue anchor 33.1-33.5 is affected and at which point a tissue anchor 33.1-33.5 in the annuloplasty ring 11 is to be passed.
  • the knowledge is required because an annuloplasty ring 11 has various sections 20, 21, a front section 20 which is to be located on the front sail 16 and a rear section 21 which is on the rear sail 17, see Fig. 2.
  • the mitral flap annulus 13 also has these sections 20, 21.
  • An annuloplasty ring 11 is to be placed on the Mitraiklappenanulus 13 so that their sections 20, 21 come to lie one above the other.
  • the tissue anchors 15.1-15.5 are arranged at certain intervals.
  • the tissue anchor filaments 33.1-33.5 therefore contain a corresponding label. It can be clearly seen from the marking at which position 24 '.1-24'.5 a tissue anchor 15.1-15.5 is positioned on the mitral valve annulus 13.
  • the annuloplasty ring 11 to be implanted with respect to the positioning to the tissue anchors 5.1-15.5, has the same image structure as the image structure of the mitral valve annulus 13.
  • the tissue anchor 33.1 associated with this tissue anchor 15.1 carries the characteristic number 1. That is, the code number 1, the position 24 M of a tissue anchor 15.1 on mitral valve annulus 13 is known.
  • tissue anchor thread 33.1 of the tissue anchor 15.1 must be guided at the corresponding point in the annuloplasty ring 11.
  • the annuloplasty ring 1 1 in order to be able to place the annuloplasty ring 1 1 on the tissue anchors 15.1-15.5 on the mitral valve annulus 13, it is necessary to attach the tissue anchoring thread 33.1 with the code number 1 and the position 24'.1 of the tissue anchor 15 1, position 24.1 Assign annuloplasty ring 1 1 and at this point to pass through the fabric of the outer layer 42.
  • the position 24 1 on the annuloplasty ring 1 1 also corresponds to the first position 24. 1 at the left transition between the curved section 21 and the straight section 20 of the annuloplasty ring 11.
  • the first position 24.1 on the annuloplasty ring 11 corresponds to the first position 24'.1 of the implanted tissue anchor 15.1.
  • This tissue anchor 33 2 is felt at the position 24 2 of the annuloplasty ring 1 1, wherein the position 24 .2 at mitral valve annulus 13 is in turn identical to the position 24.2 on annuloplasty ring 1 1., etc.
  • an annuloplasty ring 11 can be fitted to fit the shape of a mitral lobule annulus 13 and fixed on the tissue anchors 15.1-15.5.
  • a tissue anchor thread 33.1-33.5 can be pulled through, for example, position markers 22.1, 22.2 on the annuloplasty ring 11 may already be predetermined.
  • the positions for the tissue anchor threads 33.1-33.5 in the outer layer 42 of an annuloplasty ring 11 are already provided with a passage opening for the needle 34. Through holes facilitate the threading of the tissue anchor filaments 33.1-33.5 and avoid possible damage to the outer layer 42 of the annular body 27th
  • annuloplasty ring 11 is mounted on all of the tissue anchors 33.1-33.5 provided by the tissue anchors 15.1-15.5, this is advanced on the tissue anchor filaments 33.1-33.5 to a receiving surgical instrument 51 and compressed. In this state, the annuloplasty ring 11 has now reached its delivery configuration 57 to be inserted into a sleeve 51 guided in the trocar 50. In this phase, the tissue anchor filaments 33.1-33.5 serve as guide means for the annuloplasty ring 11. The sleeve 51, which is passed through a trocar 50, extends into the left atrium 12 of the heart 3 with another surgical instrument is the annuloplasty ring 11 is then pushed through the sleeve 51 into the atrium 12 along the tissue anchor threads 33.1-33.5.
  • the initial shape of the anchor is 33.1-33.5 58 corresponds, preferably in accordance with FIGS. 2 and 4 a, to an open configuration, the annuloplasty ring 11 still being guided by the tissue anchors 33.1-33.5 of the tissue anchor 15.1-15.5.
  • the annuloplasty ring 11 is now pushed onto the carrier discs 38, which are arranged on the ends of the tissue anchors 15.1-15.5, and placed there.
  • annuloplasty ring 11 is now, as described above, in a form-fitting manner to the mitral lobule annulus 13, attached to the tissue anchors 15.1-15.5 and as shown in FIG. 4b.
  • tissue anchor 33.1-33.5 with a clamping means 35 see Fig. 4b, provided.
  • Analogous reference numbers from the preceding FIGS. 1-5 are adopted in this figure.
  • FIG. 7 shows a schematic representation of a device 10 implanted on the middle crest annulus 13, consisting of a mitral crest implant, in particular in the form of an annuloplasty ring 11, which in principle comprises three elements.
  • a first element is the anchoring element 56, which as a fabric anchor 15 with a helical screw 30, a carrier screw 30, a carrier disc 38 and a tissue anchor thread 33 is formed and performs a fastening of the annuloplasty ring 11 in the heart muscle tissue 47.
  • the anchoring element 56 is not shown in FIG. 7 for reasons of clarity, but shown in detail in FIG. 4b.
  • the second element is the anuloplasty ring 11 as an implant, which has an inner layer 43 and an outer layer 42, the outer layer 42 receiving the tissue anchor filaments 33 which make the connection to the tissue anchor 15.
  • the third element forms the fastener 25, which consists of a clamping center! 35 and is guided along a tissue anchor 33.
  • the clamping means 35 clamps an annuloplasty ring 1 1 between itself and the carrier disc 38 by means of a tissue anchor thread 33 a.
  • the tissue anchor threads 33.1-33.8 are severed and, inter alia, the surgical instruments 50, 51 are removed from the atrium 12 and the access 49 to the heart 3 is closed.
  • tissue anchor positions 24.1-24 5 in the annuloplasty ring 11 now lie with the tissue anchor positions 24 '.1-24' .5 on Mitralklappenanulus 13 on the same longitudinal axis 39 and are thus congruent, whereby a tissue anchor thread 33.1 a Gewebeankerposition 24 '.1 am Mitral valve annulus 13 of the same tissue anchor position 24.1 in annuloplasty ring 11 corresponds.
  • An annuloplasty ring 11 is thus implanted in a form-fitting manner for eliminating mitral valve regurgitation. Analogous reference numerals from the preceding FIGS. 1-6 are adopted in this figure.

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  • Health & Medical Sciences (AREA)
  • Cardiology (AREA)
  • Oral & Maxillofacial Surgery (AREA)
  • Transplantation (AREA)
  • Engineering & Computer Science (AREA)
  • Biomedical Technology (AREA)
  • Heart & Thoracic Surgery (AREA)
  • Vascular Medicine (AREA)
  • Life Sciences & Earth Sciences (AREA)
  • Animal Behavior & Ethology (AREA)
  • General Health & Medical Sciences (AREA)
  • Public Health (AREA)
  • Veterinary Medicine (AREA)
  • Prostheses (AREA)

Abstract

La présente invention se rapporte, de manière générale, au domaine de la chirurgie cardiaque. Dans le domaine chirurgical, des instruments sont employés pour examiner l'intérieur d'organismes vivants et/ou pour effectuer des interventions de type opérations. Des implants sont également utilisés pour permettre le bon fonctionnement d'un cœur. Cette invention concerne un tel dispositif implantable et un procédé pour corriger une régurgitation dans la région du cœur. Le dispositif implantable selon l'invention se présente sous la forme d'un anneau d'annuloplastie comportant une pluralité d'éléments d'ancrage tissulaire. Un anneau d'annuloplastie déployé est positionné dans la cavité d'un élément corporel pour rétrécir une ouverture corporelle. Préalablement, chaque élément d'ancrage tissulaire de l'anneau d'annuloplastie est placé de manière intravasculaire dans une position précise sur le bord de l'anneau de la valve mitrale, au moyen de ladite technique minimalement invasive. L'anneau d'annuloplastie à configuration arquée ou annulaire est disposé et fixé sur les éléments de fixation ainsi ancrés pour influer sur les dimensions et la forme de l'anneau septal et latéral de la valve mitrale et pour fermer l'interstice entre la cuspide antérieure et la cuspide postérieure dans la valve.
EP18717858.7A 2017-03-28 2018-03-28 Dispositif implantable de façon minimalement invasive et système d'implant de valve mitrale Pending EP3600155A1 (fr)

Applications Claiming Priority (2)

Application Number Priority Date Filing Date Title
DE102017002976.8A DE102017002976B4 (de) 2017-03-28 2017-03-28 Minimal-invasiv implantierbare Vorrichtung zur Beseitigung einer Mitralklappeninsuffizienz am schlagenden Herzen und Mitralklappen-Implantat-System
PCT/EP2018/058026 WO2018178208A1 (fr) 2017-03-28 2018-03-28 Dispositif implantable de façon minimalement invasive et système d'implant de valve mitrale

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EP3600155A1 true EP3600155A1 (fr) 2020-02-05

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US (2) US11529232B2 (fr)
EP (1) EP3600155A1 (fr)
JP (2) JP2020512172A (fr)
CN (2) CN115381599A (fr)
CA (1) CA3095227A1 (fr)
DE (1) DE102017002976B4 (fr)
WO (1) WO2018178208A1 (fr)

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US20210161662A1 (en) 2021-06-03
JP7421248B2 (ja) 2024-01-24
WO2018178208A1 (fr) 2018-10-04
CN110709029B (zh) 2022-07-12
JP2020512172A (ja) 2020-04-23
CA3095227A1 (fr) 2018-10-04
CN110709029A (zh) 2020-01-17
US11529232B2 (en) 2022-12-20
DE102017002976A1 (de) 2018-10-04
JP2023055952A (ja) 2023-04-18
US20230181319A1 (en) 2023-06-15
CN115381599A (zh) 2022-11-25
DE102017002976B4 (de) 2021-08-26

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