WO2020014502A1 - Système de cathéter pour manipuler et relier de manière sélective des tissus cardiaques - Google Patents

Système de cathéter pour manipuler et relier de manière sélective des tissus cardiaques Download PDF

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Publication number
WO2020014502A1
WO2020014502A1 PCT/US2019/041434 US2019041434W WO2020014502A1 WO 2020014502 A1 WO2020014502 A1 WO 2020014502A1 US 2019041434 W US2019041434 W US 2019041434W WO 2020014502 A1 WO2020014502 A1 WO 2020014502A1
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WO
WIPO (PCT)
Prior art keywords
catheter
clamps
tissue
distal
cord
Prior art date
Application number
PCT/US2019/041434
Other languages
English (en)
Inventor
Lars Erickson
Phoebe Erickson
Michael R. Cole
Original Assignee
Lars Erickson
Priority date (The priority date is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the date listed.)
Filing date
Publication date
Priority claimed from US16/032,903 external-priority patent/US10799358B2/en
Application filed by Lars Erickson filed Critical Lars Erickson
Publication of WO2020014502A1 publication Critical patent/WO2020014502A1/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
    • A61B17/12—Surgical instruments, devices or methods, e.g. tourniquets for ligaturing or otherwise compressing tubular parts of the body, e.g. blood vessels, umbilical cord
    • A61B17/122—Clamps or clips, e.g. for the umbilical cord
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B17/00—Surgical instruments, devices or methods, e.g. tourniquets
    • A61B17/12—Surgical instruments, devices or methods, e.g. tourniquets for ligaturing or otherwise compressing tubular parts of the body, e.g. blood vessels, umbilical cord
    • A61B17/128—Surgical instruments, devices or methods, e.g. tourniquets for ligaturing or otherwise compressing tubular parts of the body, e.g. blood vessels, umbilical cord for applying or removing clamps or clips
    • A61B17/1285—Surgical instruments, devices or methods, e.g. tourniquets for ligaturing or otherwise compressing tubular parts of the body, e.g. blood vessels, umbilical cord for applying or removing clamps or clips for minimally invasive surgery
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B17/00—Surgical instruments, devices or methods, e.g. tourniquets
    • A61B17/28—Surgical forceps
    • A61B17/29—Forceps for use in minimally invasive surgery
    • A61B17/295—Forceps for use in minimally invasive surgery combined with cutting implements
    • 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
    • A61F2/2454—Means for preventing inversion of the valve leaflets, e.g. chordae tendineae prostheses
    • A61F2/2457—Chordae tendineae prostheses
    • 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
    • A61B17/00234—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
    • 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
    • A61B2017/00353—Surgical instruments, devices or methods, e.g. tourniquets for minimally invasive surgery one mechanical instrument performing multiple functions, e.g. cutting and grasping
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B17/00—Surgical instruments, devices or methods, e.g. tourniquets
    • A61B17/28—Surgical forceps
    • A61B17/29—Forceps for use in minimally invasive surgery
    • A61B2017/2901—Details of shaft
    • A61B2017/2906—Multiple forceps

Definitions

  • the invention relates generally to minimally invasive devices and techniques for selectively manipulating and connecting cardiac tissues to treat cardiac anomalies and for adjusting the closing positions of the leaflets of a malfunctioning atrio-ventricular (A-V) valve by selectively adjusting the length of one or more chordae associated with the valve.
  • A-V atrio-ventricular
  • the heart has a left side and a right side, each side including an atrium and a ventricle.
  • the atria receive blood returning through veins to the heart and the ventricles pump blood away from the heart, through arteries, to circulate blood through the body.
  • the blood returns to the right side of the heart through the venous system.
  • the heart also includes four one-way valves (aortic, pulmonary, mitral and tricuspid) that function to maintain unidirectional blood flow as the heart contracts in a pumping stroke (systole) and then relaxes and expands to fill the ventricles (diastole).
  • Each side has an A-V valve (the tricuspid and mitral valves) that controls flow from its atrium to its associated ventricle, and each ventricle has an output valve (the pulmonary valve and aortic valve).
  • A-V valve the tricuspid and mitral valves
  • each ventricle has an output valve (the pulmonary valve and aortic valve).
  • the heart muscle contracts (systole) blood is pumped from both ventricles through their respective output valves.
  • Oxygenated blood from the left ventricle is pumped through the aortic valve to the aorta and branching arteries while blood from the right ventricle is pumped through the pulmonary valve to the lungs where it is oxygenated.
  • the oxygenated blood from the lungs is returned to the heart and is received in the left atrium.
  • blood in each atrium is drawn through its associated A-V valve to refill its associated ventricle in readiness for the next cardiac contraction.
  • Each of the mitral and tricuspid valves is defined by an arrangement of leaflets flexibly attached to an annular supportive ring. The leaflets have free marginal edges that engage each other during systole to close the flow path between the atrium and its associated ventricle.
  • the closed positions of the leaflets of the L- V valves are limited and defined by tendonous chordae that are attached, at one end, to papillary muscles in the lower portions of the ventricles and, at their upper ends, to the margins and undersides of the leaflets of the A-V valves as suggested in FIG.2.
  • the lengths of the chordae limit the movement of die leaflets during systole so that as the blood pressure in the ventricle increases, the free, marginal edges of the leaflets engage each other to close the valve and prevent backflow from the ventricles to the atria.
  • the leaflets are not restrained by the chordae and their marginal edges are free to separate to allow blood flow from the atria to the associated ventricle.
  • Various cardiac-related diseases may affect the heart by distorting its shape m ways that can impair heart function. Portions of the heart may become enlarged or portions may become weakened or displaced such that the heart does not function as it should.
  • the leaflets of the mitral (left side) or tricuspid (right side) valve may not close properly and may result in backflow during systole.
  • Deformation in the shape or structure of the heart wall may effect a shift in the relative position of the papillary muscles to which the chordae are attached. That in turn, affects the positions of the valve leaflets, tethering them so that they may not close fully during systole.
  • heart muscle deformation may occur in patients with coronary artery disease or those who have had myocardial infarction (heart attack).
  • myxomatous valve disease such as mitral valve prolapse
  • patients with myxomatous valve disease may have abnormally long chordae that do not hold the leaflet margins in a closed position during systole.
  • Patients with chordae that functionally too short (tethered) or too long are prone to developing mitral valve regurgitation which may result in reduced cardiac efficiency. That, in turn, may lead to further cardiac complications such as enlargement of the atria and/or ventricles, pulmonary hypertension, heart failure and other problems.
  • Valve repair may involve, for example, complex, invasive, open-heart surgery to surgically repair the valve, as by reforming or reinforcing the shape of the annulus of the valve or by selectively attaching portions of fee marginal edges of leaflets together.
  • Other remedies may involve replacement of an A- V valve with a mechanical valve or a bioprosthctic valve.
  • a catheter In order to adjust the heart geometry by attaching selected portions of the heart to each other, a catheter is provided with a clamp assembly that includes a pair of tissue clamps or anchors connected to each other by a cord or tether.
  • the length of the tether is selected so feat when fee clamps are anchored to selected portions of the heart they will define a selected relative position of the tethered portions.
  • fee heart may be reshaped or reconfigured to alleviate the anomaly.
  • the catheter is adapted to be advanced through a patient’s vasculature to place the distal end of the catheter within fee chamber of fee heart where the clamp assembly is to be deployed.
  • the catheterization procedure should be done in conjunction wife imaging technology, for example, ultrasound, trans-esophageal echocardiography, intracardiac echocardiography, fluoroscopy, angioscopy, catheter based magnetic resonance imaging, computed tomography and fee like.
  • imaging technology may enable visualization of blood flow and particularly how the placement of the clamp assembly affects heart function. If fee cardiac anomaly has not been adequately corrected fee procedure can be repeated to make further adjustments until fee desired result is achieved.
  • a chord may be severed or folded to a hairpin shape and its ends or folded portions can be connected wife a clamp assembly having a cord of a length to increase or decrease the effective length of the native chord, as described in U.S. patent application S.N. 15/097,181, filed April 12, 2016, the disclosure of which is incorporated herein by reference.
  • the prosthetic clamp assembly is carried at the distal end of the catheter.
  • the clamps are spaced laterally on opposite sides of the central axis of the catheter at diametrically opposite positions on the catheter and are open in a distal direction in order to receive a chord or other tissue oriented transversely to the axis of the catheter.
  • the length of the prosthetic cord is selected to correspond to the degree of adjustment to be made to the natural chord.
  • the catheter also may include a snare that can be extended axially between the clamps and beyond the distal end of the catheter to engage a selected natural chord. The snare and engaged chord then can be retracted to draw that chord into the open jaws of the clamps.
  • the clamps that are caused to close to clamp the natural chord and a severing element carried by the catheter then may be operated to sever the natural chord between the clamps.
  • the clamps then are released from the catheter. Upon release, the effective length of the selected chord will have been adjusted in an amount determined by the length of the prosthetic clamp assembly.
  • the catheter then may be withdrawn.
  • chordae refers to the cardiac components that connects the A-V valves to a portion of a ventricle wall and the term“cord” refers to the prosthetic tethering element that connects the clamps to each other.
  • the invention also may be employed to adjust the geometry of portions of the heart walls that may have been weakened and/or dilated as a result of any of a number of various cardiac deficiencies.
  • the clamps of the clamp assembly can be placed and activated individually, separately from each other, so that the clamps can be anchored to selected portions of the interior of the heart wall.
  • the clamps can be placed so that the length of the assembly positions the walls of the heart in a desired, modified geometry.
  • the device may be used to connect a papillary muscle to another portion of the heart wall to reorient the position of the papillary muscle to affect valve function.
  • the device may be used to grip regions of the heart wall to connect them to modify the geometry of a heart chamber.
  • the device may include an arrangement by which the cord length can be adjusted after the clamps have been anchored to tissue to draw the connected tissue portions toward each other.
  • the invention provides catheter-based methods to increase or decrease the effective length of one or more chordae to restore the ability of an associated A-V valve to close and reduce or prevent back flow and to correct anomalies in cardiac geometries.
  • the term“effective length” is intended to mean the length of a natural chord as modified by use of the invention. Ideally“effective length” would be an adjusted length that would enable the associated A-V valve leaflets to coapt during systole without backflow' or to reshape the geometry of selected cardiac chambers to remedy cardiac insufficiencies.
  • FIG.1 is a diagrammatic sectional illustration of a heart showing the right and left sides and the four valves that control the direction of blood flow;
  • FIG. 2 is a diagrammatic, cut-away of a heart illustrating the arrangement of chordae and their associated atrio-ventricular valves;
  • FIG. 3 is a diagrammatic plan sectional view of the heart as seen along the line 3-3 of Fig. 1 and showing the arrangement of the four cardiac valves with all of tiie valve leaflets closed to show how their marginal edges coapt when closed;
  • FIG. 4 is a fragmented illustration of a device embodying the invention and including a control handle at the proximal end of the device;
  • FIG. 5 is an exploded illustration of die device;
  • FIG. 6 is an isometric illustration of the jaws, shown separately for ease of description;
  • FIG. 7 is an illustration of the distal end of the catheter with the jaws partly open in a configuration in readiness to be navigated into a patient;
  • FIG. 8 is an illustration similar to FIG; 7 with the snare extended distally to engage a chord;
  • FIG. 9 is a side view of the distal end of the catheter with the snare retracted to draw the chord into the jaws of the clamps;
  • FIG. 10 is an illustration similar to FIG. 8 of the distal end of the catheter of one embodiment of the invention showing the chord engaged by the snare and the cutter blade and with the clamp jaws retracted and closed on the chord;
  • FIG. 11 is an illustration of the device after the chord has been cut and the outer sheath has been withdrawn to release the clamps
  • FIG.12 is an illustration of the connector and attached chord segments after the inner sheath has been withdrawn relative to the chassis to facilitate separation of die clamp assembly from the catheter;
  • FIG. 13 is an enlarged side view' of a clamp with jaws configured to grip a selected portion of a wall of a heart chamber, with the lower jaw in its most forward, open position;
  • FIG. 14 is an illustration of the clamp of FIG. 13 with the lower jaw in its fully retracted, closed and locked position;
  • FIGS. 15A-15G are diagrammatic cross sectional illustrations of the manner in which portions of a left ventricle of a mammalian heart can be connected by the clamp assembly of the invention;
  • FIGS. 16A-16D are side view and isometric illustrations of another clamp configuration in open and closed positions
  • FIG. 17 is an illustration of a clamp assembly and effectively lengthened chord, released from the catheter.
  • FIG. 17 is a somewhat diagrammatic illustration of a clamp assembly in which the length of cord connecting the clamps can be adjusted after die clamps have been clamped to tissue.
  • FIG. 1 shows the anatomy of the heart and the direction of blood flow'.
  • the heart has a left side 10 and a right side 12, the sides being separated by a septum 14.
  • the left side which provides the primary pumping function, includes a left atrium 16 that receives oxygenated blood returning to the heart from the lungs and a left ventricle 18 that receives oxygenated blood from the left atrium 16.
  • the left atrium 16 and left ventricle 18 are separated by the mitral valve 20 that, when functioning normally, permits flow in one direction, from the atrium 16 to the ventricle 18 and to the arteries, as indicated by the arrows.
  • the right side 12 of the heart which receives return blood and directs it to the lungs, includes the right atrium 22, the right ventricle 24 and a tricuspid valve 26 between the right atrium and right ventricle.
  • the right atrium receives blood returning to the heart through the venous system 28 and blood flows from the right atrium 22 to the right ventricle 24 through the tricuspid valve 26.
  • the tricuspid valve 26 permits flow in only one direction, from the right atrium 22 to the right ventricle 24.
  • the structure of each of the A-V valves includes leaflets that open freely m response to pressure differential developed during diastole, as the heart expands from its contracted state.
  • the leaflets of the mitral valve 20 are attached flexibly to an annular ring 20a and the leaflets of the tricuspid valve are attached to another annular ring 26a.
  • the mitral valve 20 has two semilunar leaflets including an anterior leaflet 34a and a posterior leaflet 34p as seen in Fig. 3.
  • the marginal edges 36a, 36b of the leaflets 34a, 34b coapt to close the valve during systole and open during diastole.
  • the tricuspid valve 26 of the right side of the heart has three leaflets 38a, 38b, and 38c with associated chordae 30, functions similarly to the mitral valve, and is subject to similar malfunction.
  • the extent of leaflet movement is restrained by a number of tendon-like chordae arranged in a parachute-like array (shown diagrammatically at 30 in Fig. 2) in each ventricle that extend from a papillary muscle 32 at the interior of the ventricle wail to the underside or margins of the leaflets that define the associated A-V valve.
  • the chordae 30 limit the movement of the leaflets so that the marginal free edges of the leaflets coapt as shown in FIGS. 2 and 3.
  • the shape of the heart may become altered such that one or more of the chordae no longer allow the leaflets to close properly, resulting in backflow of blood from the ventricle to file atrium during systole. Backflow results in a reduced ejection fraction and reduced pumping efficiency.
  • Other variations in heart geometry may impair heart function and may be correctible by drawing selected portions of file heart toward each other with the present invention.
  • a malfunctioning A-V valve may be corrected by a procedure to shorten or lengthen the effective length of selected of the chordae associated with that valve so that the marginal edges of the valve leaflets coapt during systole (see the aforementioned patent application S.N,
  • FIGS.4 and 5 illustrate an embodiment of a catheter as may be employed in the practice of the invention, for example, to adjust the effective length of one or more chords 30 sufficiently to limit the closure of its associated valve leaflets so that the margins of the leaflets coapt properly during systole or to connect internal regions of the heart walls to reshape die heart chambers depending on the conditions and anatomy of a particular patient.
  • the catheter may include an elongate, flexible outer sheath 40 and an inner coaxial sheath 41 slidably disposed in the central lumen of the outer sheath 40.
  • the catheter has proximal and distal ends and may include a control handle 39 at the proximal end with controls 39L, 39R, 39A and trigger 39B to control operation of the instrumentalities at the distal end (FIG. 4).
  • the control handle 39 may include an outer body 43 with an attached pistol grip 45 and an inner body 47 that is slidably disposed within the outer body' 43 but is held in fixed position, as by a removable clip 49, until the end of the procedure, as described below.
  • the outer sheath 40 is attached, at its proximal end, to the outer body 43 of the handle 39 and the inner sheath 41 is attached, at its proximal end, to the inner body 47 of the handle 39. Relative movement of the sheaths 40, 41 is effected by moving the handle bodies 43, 47.
  • the catheter components may be constructed from a variety of materials commonly used in catheters and should be dimensioned in association with the selection of materials to be advanceable through the patient’s cardiovascular system.
  • the catheter may be advanced by any of numerous, well-known approaches to place and position the distal end 42 of a catheter within a heart chamber (e.g., ventricle 18, 24) to be treated, as will be appreciated by those skilled in the art.
  • a heart chamber e.g., ventricle 18, 24
  • the catheter may be advanced through a guide catheter (not shown) retrograde from a percutaneous puncture in the femoral artery, through the aorta 44 and aortic valve 46 and into the left ventricle 18.
  • a guiding catheter (not shown) and associated guide wires (not shown) may be employed using well known techniques (e.g., Seldinger) to guide the catheter through the aorta 44, aortic arch and aortic valve 46 into the left atrium 16 and then through the mitral valve 20 into the left ventricle 18.
  • the inner sheath 41 may be provided with one or more lumens to receive guide wires, facilitate flushing, injection of contrast agent and the like.
  • the invention may be used to repair the function of a mitral or tricuspid valve, as well as to modify the geometry of cardiac chambers.
  • Procedures with the invention are best performed under visualization, as described above, so that the clinician can determine and control the position of the distal end 42 of the catheter as well as the valve leaflets 36a, 36p and associated chordae 30 as well as to visualize blood flow through the valve and cardiac chambers and whether and to what degree backflow or other insufficiency is present.
  • FIG. 5 illustrates the components of the catheter.
  • the catheter includes a snare 48 that can be extended distally beyond the distal end 42 of the catheter to engage a chord and draw the chord proximal! y into the open jaws of a pair of clamps, described below.
  • the snare may be in the form of an elongate wire with a distal end farmed to define a book 50.
  • the hook preferably is flexible but of sufficient stiffness to engage and manipulate a chord and may be formed, for example, from a nitinol alloy.
  • the snare can be slidably contained in a longitudinally extending slot (not shown) formed along the underside of the inner sheath 41 and is maintained in the slot by the overlying outer sheath 40.
  • the proximal end of the snare 48 can extend out of the proximal end of the handle and can be manipulated by the clinician to be extended, retracted and rotated.
  • the wire snare can be removed by pulling it proximally through the handle, the hooked distal end of the snare being sufficiently flexible for that purpose.
  • the catheter also carries a pair of clamps 52L, 52R each of which is adapted to engage and anchor to tissue such as chords or internal regions of the cardiac walls.
  • the clamps 52L, 52R are operable independently of each other but can be operated simultaneously.
  • the left clamp 52L (as seen from the proximal end of the device) is shown in exploded view while the right clamp 52R is shown as assembled.
  • the damps 52L, 52R may be maintained in the catheter m a partially open initial position receptive to a chord or other cardiac tissue.
  • the clamps 52L, 52R are supported within the catheter by a chassis 54 having opposing sides 56 L, 56R that are formed to receive the clamps 52L, 52R, respectively.
  • the chassis 54 is connected to an elongate control shaft 58 that extends proximally where it is connected to a control in the handle 39, such as a trigger 39B, to enable the chassis to be extended distally beyond the ends of the sheaths 40, 41 to facilitate separation of the clamps from the delivery device at the end of the procedure.
  • the clamps 52L, 52R are releasably mounted to the chassis 54 as described below.
  • the damps 52L, 52R may be as small as about three to four millimeters long, made from a biocompatible material and may be farmed by 3-D printing.
  • Each clamp may include an upper jaw 60 and a lower jaw 62, shown separately in FIG. 6.
  • the upper jaw 60 may be formed in two minor-image halves 60L, 60R (FIG. 5) that are joined after the lower jaw 62 has been positioned between than.
  • the lower jaw 62 is slidable and pivotable relative to the upper jaw 60 and has pivot bearings 64 formed on each side of the proximal end of the lower jaw 62, the bearings being slidably received in longitudinal slots 66 formed in each of the halves 60L, 60R of the assembled upper jaw 60.
  • a transverse aperture 65 is formed through each pivot bearing 64.
  • the lower jaws 62 of the clamps 521,, 52R are separately movable by longitudinally extending control rods 68L, 68R connected at their proximal ends to controls 39L, 39R on the handle and at their distal ends to the lower jaws 62.
  • the distal tips 72 of the control rods 68L, 68R are bent inwardly and are received in the respective apertures 65 in the pivot bearings 64,
  • the lower jaw also pivots about the pivot bearings 64 to open or close by a camming arrangement 86, 88 that cooperates with the positioning of the pivot bearings, as described below.
  • Each of the control rods may be slidably retained in a tubular sheath 70 that, in turn, extends through the timer sheath 41.
  • a distal segment 67 of each control rod may be shaped to extend radially outward of the axis of the catheter in order to maintain the diameter of the inner sheath 41 at a minimum.
  • the inner sheath may be provided with elongated slots 71 to receive the segments 67 of the control rod and to allow the distal portions 67 of the control rods 68 to spring radially outwardly when released, as described below.
  • the distal portions of the control rods are formed to be resiliently biased toward a transverse, radially outward configuration so that they will detach from the pivot bearings, as illustrated in FIG. 11 when the outer sheath 40 is retracted.
  • the control rods 68L, 68R are connected to the clamps 52L, 52R during the positioning of the distal end of the catheter within the heart and are allowed to spring apart to disengage (he distal tips 72 and release the clamps only after tissue has been securely damped and the device is to be released from the catheter.
  • the distal portions of the control rods are maintained in their radially inward positions by the outer sheath 40 that overlies the slots 71 when the sheath 40 is in its forward position.
  • control rods are released by proximal retraction of the outer sheath 40 to allow the distal portions of the control rods to spring outwardly through the slots 71 causing the tips 72 to disengage from the clamps. So released, the clamps then are free to separate from the chassis 54 after the inner sheath 41 is retracted relative to the chassis, as described below.
  • chassis control shaft 58 may be formed to have a channel 74 that is receptive to a cutter shaft 76.
  • the cutter shaft is 76 has a proximal end that is connected to a handle control 39 A and a distal end that includes a cutting blade 78.
  • the distal tip of the cutting shaft 76 is blunt and preferably is curved and smooth so that it can slide past tissue easily.
  • a rearwardty facing hooked cutting edge 80 is formed on the distal tip and is oriented so that the cutting edge cuts tissue only when the cutting shaft Is moved in a proximal direction.
  • the clamps 52L, 52R are connected by a prosthetic coni 82 and together form a prosthetic clamp assembly 84 (FIG. 17) that may be used to reconnect the severed portions of a natural chord, for example, to increase the effective length of that chord.
  • the prosthetic cord may be formed from any suitable durable biocompatible material such as, for example, expanded polytetrafluoroetbylene (EPTFE).
  • EPTFE expanded polytetrafluoroetbylene
  • the clamps 52L, 52R are carried at the distal end of the catheter by the chassis 54 in diametrically spaced relation with the prosthetic cord 82 being folded and disposed within the catheter body as shown and described in patent application 15/097,181.
  • the clamps are arranged so that they are on opposite sides of the catheter axis and embrace the snare 48 which is movable between the clamps.
  • the clamps may be initially configured in the catheter in a partially open configuration so that they may receive a transversely oriented natural chord 30 that has been engaged by and drawn proximaliy by the snare 48.
  • the clamps preferably may have teeth 73 or other irregular surfaces formed on the inner faces of the clamp legs, with the teeth having edges arranged to be oriented transversely to a chord, leaflet margin or other tissue engaged within the clamp.
  • the jaws may be provided with teeth configured to so engage the heart walls, as described below.
  • each upper jaw half 60L, 60R of each upper jaw 60 has a longitudinally extending camming slot 86L, 86R, respectively, arranged to receive transversely extending cams 88 L, 88R formed on a proximal portion of the lower jaw 62, forwardly of the pivot bearings 64.
  • Each camming slot has an upper edge 90 and a lower edge 92, with the lower edge 92 having a smooth forward portion 93 and a rearward portion having a plurality of teeth 94.
  • the slots 86L, 86R and the cams 88L, 88R are configured to cooperate to guide the lower jaw from an initial, partially open, position intermediate the positions of FIGS.
  • Each cam has an edge 96 that engages the lower edge 92 of the slot 86 and, when the lower jaw is retracted proximaliy, causes the lower jaw 62 to pivot upwardly and rearwardly to the more closed position. In the intermediate position, the cam edge % is in contact with the rearward region of the smooth forward portion 93.
  • each lower jaws is movable independently of the other by manipulation of its associate handle control 39L, 39R by which the control rods 86 are advanced or retracted. (0043) it should be noted that in each of the illustrated embodiments, the rearward portions of the clamps are similarly constructed; the clamps differ only in their structure at the forward ends of their jaws. Thus, in FIGS. 4 and 5, the forward, distal ends of the jaws have tooth configurations adapted to engage chordae while in FIGS.
  • FIGS. 16A-16D illustrate an intermediate configuration in which the teeth at the distal ends of the jaws may be used both for capturing chordae as well as gripping tissue walls.
  • the distal end of the catheter is advanced into the ventricle with the clamps 52L, 52R in their initial, intermediate positions.
  • the lower jaws of the clamps may be urged forwardly by manipulation Of the handle controls 3.9L, 39R, to fully open the jaws (FIGS. 8 and 12) and the snare 48 may be extended (FIG. 8) to engage the selected chord 30 and then retracted proximally to draw the chord into the open clamps (FIG. 9).
  • the lower jaws then are moved proximally by manipulation of the handle controls 39L, 39R and control rods 68, causing the lower jaw to pivot upwardly and move rearwardly toward the upper jaw as guided by the cams 88 and camming slots 86.
  • the cutting blade 78 With the clamps securely attached to a selected natural chord 30, the cutting blade 78 is advanced distally until the chord is engaged within the hook of the blade 78 and then is drawn proximally to cause catting edge 80 to sever the selected chord between the clamps so that when the prosthetic clamp assembly 84, comprised of the two prosthetic damps 52R, 52L and the connecting cord 82 (FIG 17), is released from the catheter the effective length of that chord will be increased by an amount dependent on the length of the prosthetic clamp assembly 84 (FIG.
  • the prosthetic clamp assembly then may be released from the catheter by retracting the outer sheath to free the distal portions of the control rods so that the distal ends 72 can spring out of engagement with the pivot bearings.
  • the chassis then can be extended beyond the inner sheath by operating the trigger 39B (or the inner sheath can be retracted from about the chassis) to fully expose the clamps and enable them to separate from the chassis (FIG. 12 and 17).
  • the length of the prosthetic clamp assembly 84 should be selected to modify the effective length of the chord 30 so that the marginal edges of the valve leaflets will coapt during systole.
  • the clinician may perform the procedure with several chordae, as is deemed appropriate by the clinician to restore proper functioning of the valve leaflets.
  • FIGS. 15A-15G illustrate, diagrammatically, some examples of the manner in which the invention may be employed to adjust the geometry and configuration of cardiac anatomy.
  • FIG. 15A illustrates the manner in which opposite walls of a ventricle may be brought closer together by using a clamp assembly with a desired length of cord, then first anchoring one of the clamps to a first region of the ventricular wall and then, after the first clamp is securely attached, anchoring the other clamp to an opposing region of the ventricular wall, the cord length having been selected to effect the desired degree of separation between the selected portions of the walls.
  • FIG. 15B illustrates an individual clamp used to tie two or more native chordae together.
  • FIG. 15C illustrates reattachment of native chordae to a detached papillary muscle.
  • FIG. 15D shows the device attaching the margins of the leaflets of a mitral valve to a papillary muscle.
  • FIG. 15E illustrates attachment of a papillary muscle to a portion of a mitral valve leaflet at a location otber than the marginal edge.
  • FIG. 1SF illustrates attachment of a chord associated with one papillary muscle attached to a chord of another papillary muscle.
  • FIG. 17 illustrates another aspect of the invention m which the length of the cord connecting the clamps 52L, 52R may be adjusted after the clamps have been attached to tissue.
  • Jii that embodiment the cord 97 is attached securely, as at 98, at the proximal end of one of the clamps (e.gANC 52R).
  • the other end of the cord is passed through an opening 100 in the other of the clamps (e.g., 52L) and the cord is provided with a plurality of stops 102 along its length.
  • the stops 102 and the opening 100 are configured to allow the tail portion 104 of the cord 97 to be passed through the opening 100 only in a direction that will shorten the length of cord extending between the clamps S2L, 52R.
  • the cord and opening 100 may be formed to be similarto adjustable zip-ties or cable ties.
  • the tail 104 of the cord can pass through the catheter to the proximal end of the catheter where it can be pulled through the opening 100 to achieve the desired length between the clamps, thereby achieving a desired distance between connected portion of the cardiac anatomy.
  • the tail portion 104 of the cord then can be severed by manipulating cutler shaft 76 to position the cutting edge 80 of the blade 78 adjacent the tail 104 and operating the cutter shaft to sever the tail 104.
  • the snare may be used to facilitate positioning the tail 104 to be cut.
  • the severed tail then can be removed from the patient.
  • proximal, distal, forward, rearward, upward, downward, upper and lower are intended as relative directions or positions to indicate the relative positions or directional movements of the components of the invention.
  • the invention provides a minimally invasive approach to correcting the geometry of cardiac components as well as providing devices and techniques to treat mitral and tricuspid valve insufficiency. It should be understood, however, that the foregoing description is intended merely to be illustrative and that other modifications and equivalents may be apparent without departing from the principles of the invention.

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Abstract

La présente invention concerne un cathéter à invasion minimale et des procédés pour ajuster les cordages associés à une valvule auriculo-ventriculaire et pour modifier la géométrie de cavités cardiaques sélectionnées. Des clamps portés par le cathéter font partie d'un ensemble clamp prothétique qui comprend les clamps et un cordon fixé à chacun des clamps. La longueur du cordon peut être ajustée après la fixation des clamps au tissu. Les clamps peuvent être utilisés simultanément ou indépendamment.
PCT/US2019/041434 2018-07-11 2019-07-11 Système de cathéter pour manipuler et relier de manière sélective des tissus cardiaques WO2020014502A1 (fr)

Applications Claiming Priority (2)

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US16/032,903 2018-07-11
US16/032,903 US10799358B2 (en) 2016-04-12 2018-07-11 Catheter system for selectively manipulating and connecting cardiac tissues

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Citations (8)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US4576165A (en) * 1984-01-23 1986-03-18 United States Surgical Corporation Surgical ligation and cutting device with safety means
US20040193197A1 (en) * 1993-04-30 2004-09-30 Vidal Claude A. Surgical instrument having an articulated jaw structure and a detachable knife
US20060095025A1 (en) * 2002-08-01 2006-05-04 The General Hospital Corporation Cardiac devices and methods for minimally invasive repair of ischemic mitral regurgitation
US20080255589A1 (en) * 2007-04-11 2008-10-16 Terumo Cardiovascular Systems Corporation Multi-function clipping and harvesting device
US20160015410A1 (en) * 2013-03-11 2016-01-21 Mayo Foundation For Medical Education And Research Pericardial modification systems and methods for heart failure treatment
US20160213377A1 (en) * 2015-01-28 2016-07-28 Covidien Lp Surgical clip applier with integrated cutter
US20170290663A1 (en) * 2016-04-12 2017-10-12 Lars Erickson Minimally invasive atrio-ventricular valve treatment by chordae adjustment
US20190053904A1 (en) * 2016-04-12 2019-02-21 Lars Erickson Catheter System foir Selectively Manipulating and Connecting Cardiac Tissues

Patent Citations (8)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US4576165A (en) * 1984-01-23 1986-03-18 United States Surgical Corporation Surgical ligation and cutting device with safety means
US20040193197A1 (en) * 1993-04-30 2004-09-30 Vidal Claude A. Surgical instrument having an articulated jaw structure and a detachable knife
US20060095025A1 (en) * 2002-08-01 2006-05-04 The General Hospital Corporation Cardiac devices and methods for minimally invasive repair of ischemic mitral regurgitation
US20080255589A1 (en) * 2007-04-11 2008-10-16 Terumo Cardiovascular Systems Corporation Multi-function clipping and harvesting device
US20160015410A1 (en) * 2013-03-11 2016-01-21 Mayo Foundation For Medical Education And Research Pericardial modification systems and methods for heart failure treatment
US20160213377A1 (en) * 2015-01-28 2016-07-28 Covidien Lp Surgical clip applier with integrated cutter
US20170290663A1 (en) * 2016-04-12 2017-10-12 Lars Erickson Minimally invasive atrio-ventricular valve treatment by chordae adjustment
US20190053904A1 (en) * 2016-04-12 2019-02-21 Lars Erickson Catheter System foir Selectively Manipulating and Connecting Cardiac Tissues

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