WO2008011386A2 - Dispositif d'annuloplastie de la valve mitrale avec ancrage torsadé - Google Patents

Dispositif d'annuloplastie de la valve mitrale avec ancrage torsadé Download PDF

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Publication number
WO2008011386A2
WO2008011386A2 PCT/US2007/073624 US2007073624W WO2008011386A2 WO 2008011386 A2 WO2008011386 A2 WO 2008011386A2 US 2007073624 W US2007073624 W US 2007073624W WO 2008011386 A2 WO2008011386 A2 WO 2008011386A2
Authority
WO
WIPO (PCT)
Prior art keywords
anchor
mitral valve
vessel
distal
catheter
Prior art date
Application number
PCT/US2007/073624
Other languages
English (en)
Other versions
WO2008011386A3 (fr
Inventor
Gregory D. Nieminen
Carly A. Thaler
Original Assignee
Cardiac Dimensions, Inc.
Priority date (The priority date is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the date listed.)
Filing date
Publication date
Priority claimed from US11/458,042 external-priority patent/US20060271174A1/en
Priority claimed from US11/458,040 external-priority patent/US9526616B2/en
Application filed by Cardiac Dimensions, Inc. filed Critical Cardiac Dimensions, Inc.
Publication of WO2008011386A2 publication Critical patent/WO2008011386A2/fr
Publication of WO2008011386A3 publication Critical patent/WO2008011386A3/fr

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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
    • A61F2/2451—Inserts in the coronary sinus for correcting the valve shape

Definitions

  • This invention relates generally to devices and methods for shaping tissue by deploying one or more devices in body lumens adjacent to the tissue.
  • One particular application of the invention relates to a treatment for mitral valve regurgitation through deployment of a tissue shaping device in the patient's coronary sinus or great cardiac vein.
  • the mitral valve is a portion of the heart that is located between the chambers of the left atrium and the left ventricle. When the left ventricle contracts to pump blood throughout the body, the mitral valve closes to prevent the blood being pumped back into the left atrium. In some patients, whether due to genetic malformation, disease or injury, the mitral valve fails to close properly causing a condition known as regurgitation, whereby blood is pumped into the atrium upon each contraction of the heart muscle. Regurgitation is a serious, often rapidly deteriorating, condition that reduces circulatory efficiency and must be corrected.
  • Two of the more common techniques for restoring the function of a damaged mitral valve are to surgically replace the valve with a mechanical valve or to suture a flexible ring around the valve to support it.
  • Each of these procedures is highly invasive because access to the heart is obtained through an opening in the patient's chest.
  • Patients with mitral valve regurgitation are often relatively frail thereby increasing the risks associated with such an operation.
  • a device to perform mitral valve annuloplasty is therefore needed that can be implanted percutaneously without opening the chest wall.
  • tissue shaping device such as a percutaneous mitral valve annuloplasty device
  • the device comprises a first anchor and a second anchor adapted to be deployed by a catheter to engage a vessel wall
  • the first anchor includes a shaping feature adapted to resist the compression of a first part of the first anchor and resist the expansion of a second part of the first anchor in response to a compressive force on the first part, and a support structure disposed between and operatively connecting the first anchor and the second anchor.
  • the anchors are adapted to engage the walls of a coronary sinus, which can apply the compressive force to a portion of the anchor.
  • the first anchor comprises two arm segments, such as wires.
  • the shaping feature comprises a segment of the arms which are entwisted.
  • the entwisted arms resist the compression of a first part of the anchor and resist the expansion of a second part of the anchor in response to a compressive force on the first part.
  • the entwisted arms resist the compression of a distal part of the anchor and resist the expansion of a proximal part of the anchor in response to a compressive force on the distal part.
  • the entwisted arms resist the compression of a distal part of the anchor and resist the expansion of a proximal part of the anchor in response to a compressive force from the coronary sinus walls.
  • the entwisted arms could also resist the compression of a proximal part of the anchor and resist the expansion of a distal part of the anchor in response to a compressive force on the proximal part.
  • the entwisted arms can be substantially at an apex of the first anchor when the anchor is in its deployed configuration.
  • the two arms have a general f ⁇ gure-8 configuration.
  • the entwisted arm segments can be located generally at a midpoint along the length of the anchor in a deployed configuration.
  • both the first and second anchors comprise a shaping feature which resists the compression of a first part of the first anchor and resists the expansion of a second part of the first anchor in response to a compressive force on the first part.
  • one or both of the anchors comprises more than one shaping features.
  • the first anchor has a deployed configuration in which its width is greater than its height.
  • the anchor may also comprise the shaping features which resists the compression of a first part of the first anchor and resists the expansion of a second part of the first anchor in response to a compressive force on the first part.
  • An anchor whose width is greater than its height in a deployed configuration need not, however, comprise the shaping feature.
  • the device also includes an anchor lock adapted to lock the first anchor and/or the second anchor in an expanded configuration.
  • the device has a coupler, which may include a tether and a hitch wire, which is adapted to couple the device to a delivery tool.
  • the coupler is further adapted to release the device from the delivery tool.
  • the device is adapted to be recaptured by the catheter.
  • the method comprises percutaneously delivering a mitral valve annuloplasty device to a vessel in the patient's heart, where the device comprises first and second anchors and a support structure disposed between and operatively connecting the first and second anchors, resisting compression of a first part of the first anchor and resisting expansion of a second part of the first anchor in response to a compressive force on the first part, expanding the first anchor of the mitral valve annuloplasty device in the vessel to a deployed configuration in which the first anchor's width is greater than its height, and anchoring the second anchor of the mitral valve annuloplasty device.
  • the first anchoring step comprises expanding the first anchor from a delivery configuration to a deployed configuration in which the first anchor engages the coronary sinus.
  • the method includes locking the first anchor in the deployed configuration.
  • the second anchoring step includes expanding the second anchor from a delivery configuration to a deployed configuration in which the second anchor engages the coronary sinus. In some embodiments the method includes locking the second anchor in the deployed configuration. [0013] In some embodiments the method includes capturing the first anchor and/or the second anchor within the catheter after the first anchoring step. The capturing step may include advancing a catheter distally over the anchor to place the anchor inside the catheter in the delivery configuration.
  • the method includes applying a proximally directed force on the mitral valve annuloplasty device after the first anchoring step.
  • the method includes uncoupling the device from a delivery tool after the second anchoring step. The uncoupling may comprise releasing a hitch wire from the device and removing a tether from the device.
  • Figure 1 is a superior view of a heart with the atria removed.
  • Figure 2 illustrates one embodiment of an intravascular device deployed in a coronary sinus.
  • Figure 3 illustrates one embodiment of delivering an intravascular device to a desired location within a patient's body.
  • Figure 4 shows one embodiment of an intravascular device with proximal anchor and distal anchor in their expanded and locked configurations.
  • Figure 5 shows details of the distal anchor of Figure 4 with a shaping feature of two entwisted wire segments.
  • Figure 6 illustrates an exemplary coupler that may be used with an intravascular device.
  • Figure 7 shows an exemplary delivery tool that may be used to deliver and deploy an intravascular device.
  • the present invention relates to a medical device and uses thereof that supports or changes the shape of tissue near a vessel in which the device is placed.
  • the present invention is particularly useful in reducing mitral valve regurgitation by changing the shape of or supporting a mitral valve annulus.
  • the device comprises a distal anchor adapted to be anchored in the coronary sinus which resists a compression of a distal part of the anchor and an expansion of a proximal part of the anchor in response to a compressive force on the distal part of the anchor.
  • coronary sinus refers to not only the coronary sinus itself, but also to the venous system associated with the coronary sinus, including the great cardiac vein.
  • FIG. 1 is a superior view of a heart 100 with the atria removed.
  • the heart comprises several valves including mitral valve 102, pulmonary valve 104, aortic valve 106 and tricuspid valve 108.
  • Mitral valve 102 includes anterior cusp 110, posterior cusp 112 and annulus 114.
  • Annulus 114 encircles cusps 110 and 112 and functions to maintain their respective spacing to ensure complete mitral valve closure during left ventricular contractions of the heart 100.
  • coronary sinus 116 partially encircles mitral valve 102 and is adjacent to mitral valve annulus 114.
  • Coronary sinus 116 is part of the venous system of heart 100 and extends along the AV groove between the left atrium and the left ventricle. This places coronary sinus 116 essentially within the same plane as mitral valve annulus 114, making coronary sinus 116 available for placement of shaping device 200 in order to reshape mitral valve geometry and to restore proper valve function.
  • FIG. 2 illustrates one possible embodiment of an intravascular tissue shaping device 400 which is deployable in coronary sinus 116.
  • device 400 generally comprises an elongated connector 220 disposed between a distal anchor 240 and a proximal anchor 260. Both distal anchor 240 and proximal anchor 260 are shown in their deployed, or expanded, configurations, securely positioned within the coronary sinus 116.
  • Figure 2 further depicts, in phantom, a delivery tool 300 comprising catheter 302 for delivering and positioning intravascular device 400 in the coronary sinus 116.
  • Figure 3 illustrates one embodiment of delivering the intravascular device of the present invention to a desired location within a patient's body.
  • An incision 80 is made in the patient's skin to gain access to a blood vessel.
  • the blood vessel may be, for example, the jugular vein.
  • a guide catheter 210 is advanced through the patient's vasculature until its distal end is positioned near the desired location for the intravascular device.
  • a delivery catheter and advancing mechanism 310 are inserted through the guide catheter 210 to deploy the intravascular device at the desired location in the patient's body.
  • the delivery catheter is advanced until its distal end is inside the coronary sinus.
  • FIG 4 shows one embodiment of an intravascular shaping device 400 with proximal anchor 402 and distal anchor 404 in their expanded and locked configurations.
  • proximal anchor 402 is made from a shape memory metal wire, for example Nitinol, extending from a crimp 406. Stress relief portions 408 of the wire extend distal to crimp 406. The wire extends upward from stress relief portions 408 to form vessel engagement portions 410 which cross to form a figure-8 pattern, as shown. Vessel engagement portions 410 and crimp 406 engage the inner wall of the coronary sinus or other vessel in which the device is implanted.
  • the vessel may be a superior vena cava as described in U.S. Patent Application Serial No. 11/279,352, filed April 11, 2006.
  • the wire also forms a lock loop 412 which interacts with an arrowhead-shaped element 414 extending from the proximal end of the crimp to form the proximal anchor lock.
  • the proximal side of proximal anchor 402 may be provided with variable slope recapture features, as described in U.S. Patent Application Serial No. 10/429,172, filed May 2, 2003.
  • the distal anchor is made from a shape memory wire extending from a crimp 418. Stress relief portions 420 of the wire extend distal to crimp 418. The wire extends upward from stress relief portions 420 to form vessel engagement portions 422 which twist around one another, which is described in further detail below. Vessel engagement portions 422 and crimp 418 engage the inner wall of the coronary sinus or other vessel in which the device is implanted. The wire also forms a lock loop 424. A bent portion 407 of connector 426 interacts with wire portion 428 and lock loop 424 to form a distal anchor lock to secure the distal anchor in an expanded configuration. Actuation of the proximal and distal anchor locks is further described in U.S. Patent Application Serial Nos. 10/946,332 and 10/945,855.
  • Extending between anchors 402 and 404 are a substantially flat connector 426 and a wire connector 428.
  • connectors 426 and 428 are both made of shape memory metal, such as Nitinol.
  • tissue shaping devices such as those shown in Figure 4 may be stored in cartridges or other containers, such as described in U.S. Patent Application Serial Nos. 10/946,332 and 10/945,855, then delivered to the coronary sinus or other vessel in a delivery catheter, as shown in Figure 2.
  • the wire forming the distal anchor 404 has one end positioned within crimp 418. After exiting the distal end of the crimp, a first wire segment 452 of the distal anchor extends distally from the distal crimp, then bends radially outward from the longitudinal axis of the crimp. The wire then bends back proximally and radially inward where it twists around a second wire segment 462 at a coupling point substantially at the anchor's apex. The wire then wraps around the connectors 426 and 428 to form distal lock loop 424 before extending radially outwards and distally where it becomes the second wire segment 462.
  • the second wire segment 462 bends proximally into the distal end of the distal crimp 418.
  • the location of the coronary sinus in which the distal anchor may be deployed may be tapered as the diameter along the length of the vessel decreases. Branching vessels may also contribute to a non-uniform diameter of the coronary sinus.
  • the diameter of the coronary sinus where the distal part of the distal anchor contacts the coronary sinus wall may be narrower than the diameter where the proximal part of the distal anchor contacts the coronary sinus wall.
  • the vessel wall may exert a larger compressive force on the distal part of the anchor than on the proximal part when the anchor is in a deployed configuration.
  • This compressive force may cause compression of the distal end of the anchor, which can be transferred through the anchor and cause an expansion in a proximal part of the anchor.
  • the distal anchor may not be able to anchor properly in the vessel.
  • the distal anchor may compress and deform such that the amount of strain on the vessel is not great enough to allow the distal anchor to remain anchored in place.
  • FIG. 4 and 5 illustrates a device with an anchor shaping feature adapted to resist a compressive force exerted on a distal part of an anchor and resisting an expansion of a proximal part of the anchor in response to a compressive force on the distal part.
  • the device of the present invention resists this compressive force on the distal part of the anchor and allows the device to anchor in place.
  • the distal anchor maintains a strain on the vessel which allows for the device to be anchored in the vessel to reduce mitral valve regurgitation, as described below.
  • the distal anchor resists compression of its distal part 502 and resists expansion of its proximal part 504 in response to a compressive force on the distal part 502 of the anchor.
  • coupling of the anchor's arms via the twisted wire as shown acts to prevent a compressive force exerted on the distal part of the anchor from being transmitted through the anchor into the proximal part of the anchor.
  • the twist resists a distally exerted compressive force by creating a resistance to such a force.
  • the anchor as described thus far resists a compressive force on the distal part of the anchor
  • the anchor as adapted may also resist a compressive force on the proximal part of the anchor by creating a resistance when a compressive force is exerted on the proximal part of the anchor.
  • the proximal anchor of an intravascular device may also be adapted to resist compressive forces from a vessel in which it might be deployed.
  • the anchor's width (e.g., the maximum distance between anchor arms 422 in Figure 4) may be greater than its height (e.g., the distance between crimp 418 and the twisted wire of anchor 404).
  • the distal anchor may be about 14 mm high and about 17 mm wide. The height and size may, however, vary while still carrying out the purposes of the invention.
  • the intravascular device comprises a coupler adapted to couple the intravascular device to a delivery tool.
  • Figure 6 illustrates an exemplary coupler in use with a different intravascular device that may be used with the intravascular device of this invention.
  • the coupler comprises a loop 202 at the end of tether 201 and a hitch wire 204.
  • Loop 202 extends through arrowhead-shaped element 414, and the hitch wire 204 passes through loop 202 and into the crimp, thereby preventing loop 202 from being withdrawn from arrowhead-shaped element 414.
  • Figure 7 shows an exemplary delivery tool 300 that may be used to deliver and deploy an intravascular device 400 via a catheter (not shown). Details of the operation of delivery tool 300 may be found in U.S. Patent Application Serial Nos. 10/946,332, filed September 20, 2004, and 10/945,855, filed September 20, 2004.
  • An exemplary method of performing mitral valve annuloplasty on a patient's heart is described.
  • the intravascular device is preferably loaded into and delivered to a desired location within a catheter with the proximal and distal anchors in a delivery or collapsed condition.
  • Medical personnel may deploy the distal end of the intravascular device from the catheter into the lumen of a coronary sinus by advancing the intravascular device or by retracting the catheter, or a combination thereof.
  • a delivery tool such as that of Figure 7 may provide for distal movement of the intravascular device with respect to the catheter, and a tether may provide proximal movement of the device or for maintaining the position of the intravascular device relative to distal motion of a catheter. Because of the inherent recoverability of the material from which it is formed, the distal anchor begins to expand as soon as it is deployed from the catheter.
  • the distal loop of the distal anchor is moved distally so that the distal anchor further expands and locks in place to securely engage the coronary sinus wall and remains in the locked expanded configuration.
  • the vessel may exert a compressive force on the distal part of the distal anchor, due to, for example, the narrowing diameter of the vessel.
  • the distal anchor as adapted resists compression of the distal part therefore resisting expansion of a proximal part in response to this compressive force.
  • the greater width of the distal anchor in comparison to its height helps create strain on the vessel to increase the anchoring action.
  • the intravascular device is tensioned by pulling on the tether to apply a proximally-directed cinching force on the distal anchor, thereby modifying the shape of the coronary sinus and adjacent nearby valve annulus tissue.
  • Fluoroscopy, ultrasound or other imaging technology may be used to detect when the device modifies the shape of the mitral valve annulus sufficiently to reduce mitral valve regurgitation without otherwise adversely affecting the patient.
  • a preferred method of assessing efficacy and safety during a mitral valve procedure is disclosed in co-pending U.S. Patent Application Serial No. 10/366,585, filed February 12, 2003.
  • the proximal anchor is deployed in the coronary sinus, but it may be deployed in other vessels as well.
  • the proximal loop of the proximal anchor is advanced distally over the arrowhead-shaped element by the delivery tool to further expand and lock the proximal anchor, thus engaging the coronary sinus wall or other vessel and maintaining a cinching force of the device on the mitral valve annulus.
  • the coupler that couples the intravascular device to a delivery tool can be released.
  • a hitch wire is first withdrawn (by, for example, a hitch wire actuator of the delivery tool of Figure 7), thereby releasing the loop so it can be pulled through the proximal lock, and thereby uncoupling the intravascular device from the delivery tool.
  • the distal anchor may be recaptured into the delivery catheter by holding the intravascular device in place with a the tether while advancing the catheter distally over the distal anchor so that the entire intravascular device is once again inside the catheter.
  • the distally directed force of the catheter collapses the distal anchor to ease recapture into the catheter.
  • the tether may be used to pull the intravascular device proximally while holding the catheter stationary. Either motion, or a combination of motions, may be used to recapture the distal anchor.
  • the intravascular device may be captured into the delivery catheter by holding the device in place with the tether while advancing a catheter distally first over a proximal anchor, over the support structure, and finally over a distal anchor.
  • the distally directed force of the catheter collapses the anchors such that they can again fit within the catheter.
  • the tether may also be used to pull the device proximally while holding the catheter stationary. If the coupler has been detached from the device prior to capture, the device may be recaptured into the delivery catheter or another catheter by grasping the proximal end of the device with a tether or grasper and by advancing the catheter distally over the device.

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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)
  • Surgical Instruments (AREA)

Abstract

La présente invention concerne un dispositif de re-formation de tissu adapté de manière à pouvoir être placé dans un vaisseau sanguin situé à proximité du coeur d'un patient pour reformer le coeur de ce patient. Le dispositif comporte un premier ancrage, puis un deuxième ancrage adapté de manière à pouvoir être déployé par un cathéter sur la cloison d'un vaisseau tandis que le premier ancrage est adapté pour résister d'une part à la compression d'une première partie du premier ancrage et, à résister d'autre part à l'expansion à la deuxième partie du premier ancrage en réaction à une force de compression exercée sur la première partie, lorsque le premier ancrage est déployé et que sa largeur est plus importante que sa hauteur.
PCT/US2007/073624 2006-07-17 2007-07-16 Dispositif d'annuloplastie de la valve mitrale avec ancrage torsadé WO2008011386A2 (fr)

Applications Claiming Priority (4)

Application Number Priority Date Filing Date Title
US11/458,040 2006-07-17
US11/458,042 2006-07-17
US11/458,042 US20060271174A1 (en) 2003-12-19 2006-07-17 Mitral Valve Annuloplasty Device with Wide Anchor
US11/458,040 US9526616B2 (en) 2003-12-19 2006-07-17 Mitral valve annuloplasty device with twisted anchor

Publications (2)

Publication Number Publication Date
WO2008011386A2 true WO2008011386A2 (fr) 2008-01-24
WO2008011386A3 WO2008011386A3 (fr) 2008-10-02

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Application Number Title Priority Date Filing Date
PCT/US2007/073624 WO2008011386A2 (fr) 2006-07-17 2007-07-16 Dispositif d'annuloplastie de la valve mitrale avec ancrage torsadé

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WO (1) WO2008011386A2 (fr)

Citations (1)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US20050027351A1 (en) * 2001-05-14 2005-02-03 Cardiac Dimensions, Inc. A Washington Corporation Mitral valve regurgitation treatment device and method

Patent Citations (1)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US20050027351A1 (en) * 2001-05-14 2005-02-03 Cardiac Dimensions, Inc. A Washington Corporation Mitral valve regurgitation treatment device and method

Also Published As

Publication number Publication date
WO2008011386A3 (fr) 2008-10-02

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