US20060149123A1 - Splint assembly for improving cardiac function in hearts, and method for implanting the splint assembly - Google Patents
Splint assembly for improving cardiac function in hearts, and method for implanting the splint assembly Download PDFInfo
- Publication number
- US20060149123A1 US20060149123A1 US11/368,445 US36844506A US2006149123A1 US 20060149123 A1 US20060149123 A1 US 20060149123A1 US 36844506 A US36844506 A US 36844506A US 2006149123 A1 US2006149123 A1 US 2006149123A1
- Authority
- US
- United States
- Prior art keywords
- heart
- marker
- elongate member
- tension member
- assembly
- 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.)
- Abandoned
Links
Images
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
- A61F2/2478—Passive devices for improving the function of the heart muscle, i.e. devices for reshaping the external surface of the heart, e.g. bags, strips or bands
- A61F2/2487—Devices within the heart chamber, e.g. splints
-
- 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
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
- A61B17/00—Surgical instruments, devices or methods, e.g. tourniquets
- A61B17/04—Surgical instruments, devices or methods, e.g. tourniquets for suturing wounds; Holders or packages for needles or suture materials
- A61B17/0401—Suture anchors, buttons or pledgets, i.e. means for attaching sutures to bone, cartilage or soft tissue; Instruments for applying or removing suture anchors
-
- 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
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
- A61B17/00—Surgical instruments, devices or methods, e.g. tourniquets
- A61B17/068—Surgical staplers, e.g. containing multiple staples or clamps
- A61B17/0682—Surgical staplers, e.g. containing multiple staples or clamps for applying U-shaped staples or clamps, e.g. without a forming anvil
-
- 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
- A61B17/04—Surgical instruments, devices or methods, e.g. tourniquets for suturing wounds; Holders or packages for needles or suture materials
- A61B17/0401—Suture anchors, buttons or pledgets, i.e. means for attaching sutures to bone, cartilage or soft tissue; Instruments for applying or removing suture anchors
- A61B2017/0404—Buttons
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
- A61B17/00—Surgical instruments, devices or methods, e.g. tourniquets
- A61B17/04—Surgical instruments, devices or methods, e.g. tourniquets for suturing wounds; Holders or packages for needles or suture materials
- A61B17/0401—Suture anchors, buttons or pledgets, i.e. means for attaching sutures to bone, cartilage or soft tissue; Instruments for applying or removing suture anchors
- A61B2017/0412—Suture anchors, buttons or pledgets, i.e. means for attaching sutures to bone, cartilage or soft tissue; Instruments for applying or removing suture anchors having anchoring barbs or pins extending outwardly from suture anchor body
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
- A61B17/00—Surgical instruments, devices or methods, e.g. tourniquets
- A61B17/04—Surgical instruments, devices or methods, e.g. tourniquets for suturing wounds; Holders or packages for needles or suture materials
- A61B17/0401—Suture anchors, buttons or pledgets, i.e. means for attaching sutures to bone, cartilage or soft tissue; Instruments for applying or removing suture anchors
- A61B2017/0427—Suture anchors, buttons or pledgets, i.e. means for attaching sutures to bone, cartilage or soft tissue; Instruments for applying or removing suture anchors having anchoring barbs or pins extending outwardly from the anchor body
- A61B2017/0437—Suture anchors, buttons or pledgets, i.e. means for attaching sutures to bone, cartilage or soft tissue; Instruments for applying or removing suture anchors having anchoring barbs or pins extending outwardly from the anchor body the barbs being resilient or spring-like
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
- A61B17/00—Surgical instruments, devices or methods, e.g. tourniquets
- A61B17/04—Surgical instruments, devices or methods, e.g. tourniquets for suturing wounds; Holders or packages for needles or suture materials
- A61B17/0401—Suture anchors, buttons or pledgets, i.e. means for attaching sutures to bone, cartilage or soft tissue; Instruments for applying or removing suture anchors
- A61B2017/0464—Suture anchors, buttons or pledgets, i.e. means for attaching sutures to bone, cartilage or soft tissue; Instruments for applying or removing suture anchors for soft tissue
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
- A61B17/00—Surgical instruments, devices or methods, e.g. tourniquets
- A61B17/04—Surgical instruments, devices or methods, e.g. tourniquets for suturing wounds; Holders or packages for needles or suture materials
- A61B17/0469—Suturing instruments for use in minimally invasive surgery, e.g. endoscopic surgery
- A61B2017/048—Suturing instruments for use in minimally invasive surgery, e.g. endoscopic surgery for reducing heart wall tension, e.g. sutures with a pad on each extremity
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
- A61B17/00—Surgical instruments, devices or methods, e.g. tourniquets
- A61B17/04—Surgical instruments, devices or methods, e.g. tourniquets for suturing wounds; Holders or packages for needles or suture materials
- A61B2017/0496—Surgical instruments, devices or methods, e.g. tourniquets for suturing wounds; Holders or packages for needles or suture materials for tensioning sutures
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
- A61B90/00—Instruments, implements or accessories specially adapted for surgery or diagnosis and not covered by any of the groups A61B1/00 - A61B50/00, e.g. for luxation treatment or for protecting wound edges
- A61B90/39—Markers, e.g. radio-opaque or breast lesions markers
Definitions
- the present invention pertains to a device, and a method for placing the device, for treating a failing heart.
- the device and its related method of the present invention are directed toward reducing the wall stress in a failing heart.
- the device reduces the radius of curvature and/or alters the geometry or shape of the heart to thereby reduce wall stress in the heart and improve the heart's pumping performance.
- Heart failure is a common course for the progression of many forms of heart disease.
- Heart failure may be considered as the condition in which an abnormality of cardiac function is responsible for the inability of the heart to pump blood at a rate commensurate with the requirements of the metabolizing tissues, or can do so only at an abnormally elevated filling pressure.
- the process of ventricular dilatation is generally the result of chronic volume overload or specific damage to the myocardium.
- cardiac output requirements for example, that of an athlete
- damage to the myocardium or chronic volume overload there are increased requirements put on the contracting myocardium to such a level that this compensated state is never achieved and the heart continues to dilate.
- the basic problem with a large dilated left ventricle is that there is a significant increase in wall tension and/or stress both during diastolic filling and during systolic contraction.
- the adaptation of muscle hypertrophy (thickening) and ventricular dilatation maintain a fairly constant wall tension for systolic contraction.
- the ongoing dilatation is greater than the hypertrophy and the result is a rising wall tension requirement for systolic contraction. This is felt to be an ongoing insult to the muscle myocyte resulting in further muscle damage.
- the increase in wall stress also occurs during diastolic filling. Additionally, because of the lack of cardiac output, a rise in ventricular filling pressure generally results from several physiologic mechanisms.
- diuretics have been used to reduce the workload of the heart by reducing blood volume and preload.
- preload is defined in several ways including left ventricular end diastolic pressure (LVEDP), or indirectly by left ventricular end diastolic volume (LVEDV):
- LEDP left ventricular end diastolic pressure
- LVEDV left ventricular end diastolic volume
- Diuretics reduce extra cellular fluid which builds in congestive heart failure patients increasing preload conditions.
- Nitrates, arteriolar vasodilators, angiotensin converting enzyme (ACE) inhibitors have been used to treat heart failure through the reduction of cardiac workload by reducing afterload.
- Afterload may be defined as the tension or stress required in the wall of the ventricle during ejection.
- Inotropes function to increase cardiac output by increasing the force and speed of cardiac muscle contraction.
- Assist devices include mechanical pumps. Mechanical pumps reduce the load on the heart by performing all or part of the pumping function normally done by the heart. Currently, mechanical pumps are used to sustain the patient while a donor heart for transplantation becomes available for the patient.
- Heart transplantation has serious limitations including restricted availability of organs and adverse effects of immunosuppressive therapies required following heart transplantation.
- Cardiomyoplasty involves wrapping the heart with skeletal muscle and electrically stimulating the muscle to contract synchronously with the heart in order to help the pumping function of the heart.
- the Batista partial left ventriculectomy surgically remodels the left ventricle by removing a segment of the muscular wall. This procedure reduces the diameter of the dilated heart, which in turn reduces the loading of the heart.
- this extremely invasive procedure reduces muscle mass of the heart.
- Infarction occurs when blood supply to the heart tissue has been obstructed resulting in a region of tissue that loses its ability to contract (referred to as infarcted tissue).
- infarcted tissue a region of tissue that loses its ability to contract.
- the presence of infarcted tissue may lead to three conditions in the heart causing cardiac malfunction. These conditions are ventricular aneurysms (ventricular dyskinesia), non-aneurysmal ischemic or infarcted myocardium (ventricular akinesia), and mitral regurgitation.
- a ventricular aneurysm is formed when the infarction weakens the heart wall to such an extent that the tissue stretches and thins, causing, for example, the left ventricular wall to expand during systole (dyskinesia) and form a bulge in the heart wall.
- Non-aneurysmal ischemic or infarcted myocardium occurs when a major coronary artery is occluded and results in infarction in the myocardial tissue, but without a bulging aneurysm.
- mitral regurgitation is a condition whereby blood leaks through the mitral valve due to an improper positioning of the valve structures that causes it not to close entirely. If the infarcted or aneurysmal region is located in the vicinity of the mitral valve, geometric abnormalities may cause the mitral valve to alter its normal position and dimension, and may lead to annular dilatation and the development of mitral regurgitation.
- the “Dor” and “Jatene” procedures have recently been employed to treat heart conditions resulting from aneurysms and other infarctions.
- the aneurysm is removed and an endocardial patch is placed to cover the dyskinetic septal wall portion of the aneurysm. In this manner, at least the portion of stroke volume “lost” to dyskinesia is restored.
- a purse string suture is placed at the base of the aneurysm. The infarcted septal wall is circumferentially reduced by inbrication with sutures.
- One aspect of the present invention pertains to a non-pharmacological, passive apparatus and method for the treatment of a failing heart due to dilatation.
- the device is configured to reduce the tension in the heart wall, and thereby reverse, stop or slow the disease process of a failing heart as it reduces the energy consumption of the failing heart, decreases isovolumetric contraction, increases isotonic contraction (sarcomere shortening), which in turn increases stroke volume.
- the device reduces wall tension by changing chamber geometry or shape and/or changing the radius of curvature or cross-section of a heart chamber. These changes may occur during the entire cardiac cycle.
- the apparatuses of the present invention which reduce heart wall stress in this way can be referred to generally as “splints.” Splints can be grouped as either “full cycle splints,” which engage the heart to produce these changes throughout the cardiac cycle, or “restrictive splints,” which engage the heart wall for only a portion of the cardiac cycle to produce these changes.
- One aspect of the present invention includes an apparatus for improving cardiac function includes an elongate member configured to extend transverse a heart chamber, a first heart-engaging assembly attached to one end of the elongate member and configured to engage a first exterior location of a heart wall, and a second heart-engaging assembly configured to be secured onto the elongate member and to engage a second exterior location of the heart wall.
- the apparatus further includes a fixation member configured to penetrate the elongate member to thereby hold at least one of the first and second heart-engaging assemblies in a fixed position along the length of the elongate member.
- an apparatus for improving cardiac function includes an elongate member configured to extend transverse a heart chamber, wherein the elongate member is made of a plurality of filament bundles of approximately 180 denier.
- the apparatus further includes a first heart-engaging assembly attached to one end of the elongate member and configured to engage a first exterior location of a heart wall and a second heart-engaging assembly configured to be secured onto the elongate member and to engage a second exterior location of the heart wall.
- an apparatus for improving cardiac function includes an elongate member attached to a leader member at one end thereof and being configured to extend transverse a heart chamber, a first heart-engaging assembly attached to the other end of the elongate member and configured to engage a first exterior location of a heart wall, and a second heart-engaging assembly configured to slidably receive the leader member and the elongate member and to thereby be secured to the elongate member and to engage a second exterior location of the heart wall.
- the second heart-engaging assembly is configured to be secured to the elongate member such that a length of the elongate member between the first and second heart-engaging assemblies can be adjusted during placement of the elongate member transverse the heart chamber.
- Another embodiment of the present invention includes an apparatus for determining and marking locations on a heart wall.
- the apparatus includes a marker delivery mechanism configured to hold a marker and an actuator operatively connected to the marker delivery mechanism for delivering a marker to the location.
- the distal end of the delivery mechanism is configured to be visible relative to internal heart structures.
- Yet another embodiment of the present invention includes a tool for fixing an elongate member to a housing comprising an engagement member configured to engage a fixation member to be advanced within the housing, a wire having a first end secured to the engagement member and being configured to pass through the housing, and a handle connected to a second end of the wire.
- the engagement member and the wire are further configured to move through the housing to advance the fixation member within the housing and into engagement with the elongate member when the handle is actuated.
- a method for placing a splint assembly transverse a heart chamber includes providing an elongate member with a leader member attached to a first end and a first heart-engaging assembly attached to a second end and guiding the leader member through first and second exterior locations on a heart wall so as to extend the elongate member transverse to the heart chamber.
- the method further includes adjusting the length of the elongate member extending through the heart chamber by securing a second heart-engaging assembly to the elongate member at a position along the length of the elongate member exterior the chamber at the second location.
- instruments and related methods for implanting the device for treating a heart and improving cardiac function also are disclosed.
- FIG. 1 is a plan view of an embodiment of the splint assembly and leader assembly according to the present invention
- FIG. 2 is a cross-sectional view of a leader tube and a portion of the splint assembly showing the connection of a fixed pad assembly to the tension member;
- FIG. 2A is a detailed view of section A-A of FIG. 2 showing the connection of the leader tube to the tension member;
- FIG. 3 is a perspective view of the fixed pad assembly of FIG. 2 looking into the pin channels of the assembly;
- FIG. 4 is a magnified view of an embodiment of the cable forming the tension member according to the present invention.
- FIG. 5 is a lateral cross-sectional view of an embodiment of an adjustable pad assembly according to the present invention.
- FIG. 6 is a vertical cross-sectional view of the adjustable pad assembly of FIG. 5 in a pre-deployment configuration according to the present invention
- FIG. 7 is a vertical cross-sectional view of the adjustable pad assembly of FIG. 5 in a post-deployment configuration according to the present invention.
- FIG. 8 is a perspective view of an embodiment of a deployment tool engaged with an adjustable pad assembly according to the present invention.
- FIG. 9 is a cross-sectional view of an embodiment of the deployment tool of FIG. 8 , showing the inner components thereof;
- FIG. 10 is a perspective view of an embodiment of an probe/marking device according to the present invention.
- FIG. 10A is a perspective view of the probe tip in FIG. 10 looking down onto the probe tip;
- FIG. 11 is a perspective view of an embodiment of a tube used for housing a marker of the type shown in FIG. 12 prior to delivery according to the present invention
- FIG. 12 is a perspective view of an embodiment of a marker according to the present invention.
- FIG. 13 is a cross-sectional view of the heart showing a preferred placement of one of the splint assemblies according to an embodiment of the present invention.
- FIG. 14 is a cut-away perspective view of the heart showing a preferred placement of three splint assemblies for treatment of the heart according to the present invention and showing the cross-sectional shape of the left ventricle before and after placement of the splint assemblies with respect thereto.
- the various aspects of the invention to be discussed herein generally pertain to devices and methods for treating heart conditions, including, for example, dilatation and other similar heart failure conditions.
- the device of the present invention preferably operates passively in that, once placed in the heart, it does not require an active stimulus, either mechanical, electrical, or otherwise, to function. Implanting one or more of these devices alters the shape or geometry of the heart, both locally and globally, and thereby increases the heart's efficiency. That is, the heart experiences an increased pumping efficiency through an alteration in its shape or geometry and concomitant reduction in stress on the heart walls.
- the implanted device for treating the heart preferably is a passive device, it is contemplated that the inventive tools and instruments used for implanting the device and the method of using these tools and instruments can be used to implant other treatment devices, such as active devices and the like.
- the inventive device and methods offer numerous advantages over the existing treatments for various heart conditions.
- the device is relatively easy to manufacture and use, and the related inventive surgical techniques and tools for implanting the device do not require the invasive procedures of current surgical techniques.
- the surgical technique does not require removing portions of the heart tissue, nor does it necessarily require opening the heart chamber or stopping the heart during operation.
- the surgical techniques of the present invention also are less risky to the patient than other techniques.
- the disclosed inventive methods and related devices involve geometric reshaping of the heart.
- substantially the entire chamber geometry is altered to return the heart to a more normal state of stress.
- Models of this geometric reshaping which includes a reduction in radius of curvature of the chamber walls, can be found in U.S. Pat. No. 5,961,440, issued Oct. 5, 1999 and entitled “Heart Wall Tension Reduction Apparatus and Method,” the complete disclosure of which is incorporated herein by reference.
- the heart walls Prior to reshaping the chamber geometry, the heart walls experience high stress due to a combination of both the relatively large increased diameter of the chamber and the thinning of the chamber wall.
- Geometric reshaping reduces the stress in the walls of the heart chamber to increase the heart's pumping efficiency, as well as to stop further dilatation of the heart.
- left ventricle has been selected for illustrative purposes because a large number of the disorders that the present invention treats occur in the left ventricle.
- FIG. 1 shows a splint assembly 1 that ultimately is placed in the heart and a leader assembly- 10 connected to splint assembly 1 prior to placement of splint assembly 1 and aiding in the delivery of splint assembly 1 into the heart.
- Splint assembly 1 includes an elongate tension member 2 (shown by the thicker line), a fixed pad assembly 3 , and an adjustable pad assembly 4 .
- Fixed pad assembly 3 is disposed at one end of tension member 2 (which will be referred to as the proximal end of assembly 1 ), while adjustable pad assembly 4 is disposed to slidably engage tension member 2 and secure to tension member 2 opposite to the end attached to fixed pad assembly 3 (which will be referred to as the distal end of assembly 1 ).
- splint assembly 1 is placed transverse a heart chamber to induce a shape change of the heart chamber, for example, the left ventricle, to reduce stress on the heart wall and thereby improve cardiac function.
- a shape change of the heart chamber for example, the left ventricle
- three splint assemblies 1 are placed relative to the left ventricle LV in the manner illustrated to alter the shape of the ventricle from an essentially circular cross-section to an essentially bi-lobed cross-section.
- three splint assemblies are shown in FIG. 14 , it is contemplated that any number of splint assemblies may be placed as desired, depending on the condition of the heart and the desired shape change results. Details on methods and tools used to determine the location for placement of the splint assembly 1 with respect to the heart chamber will be described later in this specification.
- Splint leader assembly 10 includes a leader tube 5 (shown by the thinner line in FIG. 1 leading to tension member 2 ) and a stop band 7 .
- Leader tube 5 facilitates the advancement of tension member 2 through the heart wall and across the heart chamber, as will be described. Once tension member 2 has been placed with respect to the heart and adjustable pad assembly 4 has been secured into place, leader assembly 10 and any excess tension member length can be severed and removed from tension member 2 , for example, by thermal cutting or the like.
- leader tube 5 is made of a high strength, substantially rigid, polymeric tubing, such as polyetheretherketone (PEEK), polyamide, polyimide, acetal, urethane, polyester, or other suitable like material.
- Leader tube 5 has an inner diameter of approximately 0.015 inches, an outer diameter of approximately 0.031 inches, and a length of approximately 24 inches.
- leader tube 5 is hollow and heat-set into a coil shape.
- the coil shape provides leader tube 5 with a more compact configuration prior to implantation of splint assembly 1 .
- This compact configuration is especially important as the splint assembly rests in a sterile environment prior to the implantation procedure.
- the leader tube 5 will be less cumbersome for a surgeon to handle due to its compactness.
- Stop band 7 engages with a measuring/tightening device which will be described in more detail later during a discussion of the implantation procedure of splint assembly 1 .
- stop band 7 is swaged about leader tube 5 and further secured, if necessary, through the use of an adhesive, such as, for example urethane or epoxy, or other suitable adhesive.
- an adhesive such as, for example urethane or epoxy, or other suitable adhesive.
- a “backfill” or fillet 7 ′ of adhesive is placed at the distal end of stop band 7 . This fillet 7 ′ permits a smooth engagement of stop band 7 to the measuring and tightening device. The measuring and tightening device and the engagement of stop band 7 with the device will be described later.
- a portion of leader tube 5 contains a mandrel 6 within the lumen of leader tube 5 .
- Mandrel 6 is secured to leader tube 5 by, for example, a suitable adhesive, such as, epoxy, or other suitable means such as a friction fit within tube 5 .
- a suitable adhesive such as, epoxy, or other suitable means such as a friction fit within tube 5 .
- Mandrel 6 provides stiffness and support to leader tube 5 .
- mandrel 6 provides a base structure upon which stop band 7 can be swaged, thereby strengthening stop band 7 .
- mandrel 6 is made of stainless steel or other suitable material offering stiffness and support.
- Mandrel 6 extends within a proximal portion of leader tube 5 (closest to splint assembly 1 ) to a point within leader tube 5 slightly past stop band 7 before the coiled portion of leader tube 5 . Mandrel 6 also extends from leader tube 5 and into a proximal end of tension member 2 to connect leader tube 5 with tension member 2 .
- mandrel 6 includes a larger diameter portion 6 ′ at its proximal end within tension member 2 .
- This larger diameter portion is formed by centerless grinding of all but the proximal end of the wire forming mandrel 6 .
- this wire is fabricated from a 0.020 inch diameter Wire, with the ground portion having a diameter of 0.010 inch.
- Mandrel 6 is fixed within a distal end of tension member 2 , which includes a covering 11 surrounding an inner cable 11 ′. Mandrel 6 and a surrounding metallic tube 9 are covered with an adhesive 9 ′ and inserted approximately 0.3 inches inside the distal end of tension member 2 .
- An external metallic tube 12 is placed around a distal portion of covering 11 and cable 11 ′ and is swaged down and secured thereto.
- An adhesive 12 ′ is disposed between external metallic tube 12 and covering 11 to more firmly secure tension member 2 and tube 12 .
- adhesive 12 ′′ can be disposed at the distal end of metallic tube 12 to form a tapered connection between metallic tube 12 and leader tube 5 .
- Tension member 2 and particularly cable 11 ′, serves as the primary load-bearing component of the splint assembly. Therefore, cable 11 ′ preferably has a braided-cable construction, for example, a multifilar braided polymeric construction.
- the filaments forming cable 11 ′ should be high performance fibers.
- filaments of ultra high molecular weight polyethylene such as, for example, SpectraTM or DyneemaTM, or some other suitable like material, such as polyester (e.g. DacronTM) or liquid crystal polymers (e.g. VectranTM), for example, will be used to form the braided cable.
- Filaments preferably are combined in yarn bundles of approximately 50 individual filaments, with each yarn bundle being approximately 180 denier.
- two bundles can be paired together (referred to as 2-ply) and then braided with approximately 16 total bundle pairs to form cable 11 ′.
- the preferred braid includes approximately 20 to 50 picks per inch, and more preferably approximately 30 picks per inch, wherein one pick measured along the length of cable 11 ′ is shown in FIG. 4 .
- making the braid as described results in an average diameter of cable 11 ′ of approximately 0.030 to 0.080 inches, and preferably 0.055 inches, having approximately 1600 individual filaments.
- the braided cable 11 ′ appears somewhat oval.
- FIG. 4 shows a magnified view of a cable made according to the preferred embodiment described.
- the preferred embodiment of cable 11 ′ provides cable 11 ′ with several significant properties.
- the ultra high molecular weight polyethylene provides cable 11 ′ with high strength characteristics.
- cable 11 ′ is able to withstand the constant tension that will be placed upon it during use within the heart.
- this material has a high creep resistance, a high corrosion resistance, high fatigue resistance and is biostable. It is contemplated that other materials having similar properties also may be used to form cable 11 ′ and are within the scope of this invention.
- Forming cable 11 ′ as a braided structure, and preferably in the manner described above, further provides cable 11 ′ with high endurance to cyclic fatigue and resistance to shape change without interfering with heart structure. Implantation in the heart subjects cable 11 ′, and therefore tension member 2 , to a dynamic, and often cyclic, bending and stressing environment.
- a multifilar structure results in lower bending stresses than would otherwise occur in a solid structure.
- a braided multifilar structure dissipates concentrated loads to adjacent filaments within relatively short distances as compared with a twisted multifilar structure.
- the braided structure also provides a simple, yet effective, way to anchor tension member 2 to pad assemblies 3 and 4 , as will be explained in greater detail shortly.
- a cable 11 ′ of the preferred diameter range of 0.030 to 0.080 inches, and most preferably 0.055 inches results in a high break strength and a high resistance to creep failure under expected stress conditions when placed in the heart. This resistance to creep strength allows cable 11 ′ to maintain its shape throughout implantation and use of the device. Furthermore, a cable of the preferred diameter range permits pins to penetrate the cable to hold it in place in the fixed pad assembly. If the diameter were too small, the pins may pull on portions of cable 11 ′, thus distorting the uniform shape of the cable. Additionally, it is important that cable 11 ′ not have too large of a diameter.
- the preferred combination of yarn density and material, together with the preferred pick count and cable diameter results in an optimal tension member performance. That is, the tension member is capable of withstanding the cyclical stresses occurring within the heart chamber without breaking or weakening and a strong connection between the tension member and the pad assemblies can be achieved. Also, damage to internal vascular structure and the heart tissue, and obstruction of blood flow within the heart chamber can be avoided.
- the preferred parameters for the braid structure have been described above, it is contemplated that other combinations of material, yarn density, number of bundles, and pick count may be used, as long as the desired characteristics with respect to strength of the braid and interaction of the braid with the heart and blood are achieved.
- Covering 11 surrounding cable 11 ′ also provides tension member 2 with properties that facilitate implantation and use in the heart. Because tension member 2 will be in blood contact as it resides within a chamber of the heart, covering 11 preferably provides tension member 2 with resistance to thrombus generation. Furthermore, as a result of the relative motion that occurs between the heart and the portions of tension member 2 passing through the heart chamber wall, irritation of the heart wall may result. To alleviate such irritation, covering 11 preferably allows for tissue ingrowth to establish a relatively firm bond between the tension member and the heart wall, thus reducing relative motion between the two.
- covering 11 preferably is made of a porous expanded polytetrafluoroethylene (ePTFE) sleeve having an inner diameter of approximately 0.040 inches and a wall thickness of approximately 0.005 inches prior to placement around cable 11 ′.
- the inner diameter of covering 11 stretches to fit around cable 11 ′, which preferably has a diameter of about 0.055 inches, resulting in a frictional fit between covering 11 and cable 11 ′.
- covering 11 made of ePTFE, has an internodal distance of between 20 and 70 microns, and most preferably approximately 45 microns.
- This preferred internodal spacing achieves both secure tissue ingrowth of the adjacent heart wall by allowing cellular infiltration and creating a tissue surface on the outside of the tension member 2 .
- the preferred internodal spacing also achieves a high resistance to thrombus.
- a covering is biostable and tends not to degrade or corrode in the body.
- cable 11 ′ primarily bears the loads placed on tension member 2
- covering 11 also must be adapted to withstand the cyclic bending environment occurring in the heart.
- the porous nature of covering 11 particularly having the internodal spacings discussed above, enables bending without creating high stress regions that may otherwise result in fatigue cracking of the covering if a solid structure were used.
- expanded PTFE has been described as the preferred material with which to make covering 11 , other suitable materials exhibiting similar characteristics also are within the scope of the invention.
- splint assembly 1 shown in FIG. 1 include fixed pad assembly 3 and adjustable pad assembly 4 .
- These pad assemblies essentially function as anchors that engage with the heart wall, providing a surface adjacent the exterior of the heart wall to which the tension member connects and which does not penetrate the heart wall.
- FIGS. 2 and 3 show details of fixed pad assembly 3 and its connection to tension member 2 .
- fixed pad assembly 3 includes a pad base 15 made of a rigid thermoplastic such as polyetheretherketone (PEEK), or other suitable like material, such as, for example, polysulfone, polymethylpentene, or polyacetal (Celon).
- PEEK polyetheretherketone
- Pad base 15 preferably has a generally disc-shaped configuration with a diameter of approximately 1 cm to 3 cm, preferably approximately 1.9 cm, and a thickness of approximately 0.3 cm to 1.5 cm, preferably 0.9 cm.
- a surface 16 adjacent the heart wall preferably is slightly convex with a radius of curvature of approximately 0.25 in. to 1.0 in, preferably approximately 0.5 in.
- the preferred ranges for the diameter of pad base 15 discussed above results in optimal shape change and compressive forces on the heart chamber.
- the pad base diameter is too large, i.e., above the high end of the preferred range discussed above, an optimal bi-lobed shape change to the heart chamber does not result. That is, the heart wall at the locations of excessively large pads tend to flatten out such that the radius of curvature at those locations is essentially zero.
- Overly large pad base diameters also make it difficult to place the pad assembly to avoid damaging vasculature of the heart.
- a channel 17 extends through approximately the center of pad base 15 from an outer surface 19 to inner convex surface 16 .
- Channel 17 has a diameter of approximately 0.062 inches through which tension member 2 passes.
- channel 17 has a slightly rounded, or tapered, opening 17 ′ leading into channel 17 .
- the tapered opening 17 ′ has a radius of curvature of approximately 0.062 inches at the inlet into the pad and a diameter of approximately 0.064 inches.
- the opening tapers to the channel 17 .
- This tapered opening which has a diameter larger than tension member 2 permits tension member 2 to gently curve around inner surface 16 as relative bending occurs, as opposed to having a sharp bend that would otherwise result if the diameter were not enlarged in this region.
- This tapered opening decreases localized stresses in the region of tension member 2 near the opening to channel 17 that would occur during cyclical motion of the heart. Also, the diameter of channel 17 is slightly larger than the diameter of tension member 2 to permit room for the pins to penetrate the tension member to secure the tension member and pad together.
- Channels 18 extend in direction parallel to surfaces 16 and 19 across pad base 15 .
- Channels 18 house fixation members, such as sharpened pins 14 .
- Channels 18 preferably have a smaller diameter than the pin diameters to create a press fit during connection of fixed pad assembly 3 to tension member 2 .
- channels 18 preferably have a diameter of approximately 0.028 inches, as opposed to pin diameters of approximately 0.030 inches.
- a preferred embodiment of pad base 15 includes a circumferential groove 20 adjacent to outer surface 19 , as shown in FIG. 2 .
- Circumferential groove 20 accomodates windings of suture 21 to be secured to pad base 15 .
- a pad covering 13 (shown in FIG. 2 ) can be placed over inner surface 16 and sides of pad base 15 and secured with respect thereto via suture windings 21 . Any excess pad covering extending past suture windings 21 can be trimmed off.
- Pad covering 13 preferably is made of a velour woven polyester material, such as DacronTM, or other suitable like material, such as, for example, expanded polytetrafluoroethylene (ePTFE).
- the pad covering facilitates ingrowth of the heart wall tissue to secure pad base and thereby prevent long-term, motion-induced irritation of the outside of the heart wall.
- a hole disposed in approximately the center of the pad covering enables the passage of tension member 2 .
- a similar pad covering connects in the same manner to a circumferential groove and sutures located on adjustable pad assembly 4 , as will be described later.
- fixation members such as pins 14
- fixation members extend through channels 18 and penetrate through covering 11 and cable 11 ′.
- Pins 14 can be sharpened on their ends to more easily pierce through covering 11 and cable 11 ′.
- tension member 2 folds over within pad base 15 in a U-shaped configuration.
- pins 14 each penetrate at an additional site along tension member 2 to provide a stronger connection between tension member 2 and fixed pad assembly 3 .
- the penetration of each pin 14 through two points of braided cable 11 provides a reliable connection. This is due to the fact that the braided structure tends to transfer the contact load produced by pins 14 against the filament bundles and to all of the filaments forming braided cable 11 ′, essentially resulting in a load distribution between the pins and filaments.
- a reliable connection could be produced using only a single pin penetrating through the tension member at a single location.
- providing more than one pin and folding tension member 2 into the U-shaped configuration so that each pin intersects tension member 2 at more than one location offers additional strength to the connection.
- this configuration serves as a safety back-up should the connection at a single pin/cable interface become unsecure. Unless a failure at one of the pin sites occurs, however, it is expected that the intersection between the distal-most pin and the location where that pin first intersects tension member 2 , as tension member 2 enters pad base 15 , will carry substantially all of the load transferred by tension member 2 .
- This intersection site is labeled as 14 a in FIG. 2 .
- pins 14 it is preferable for pins 14 to penetrate tension member 2 at approximately the center of the cable to provide the most secure connection. Thus, approximately half of the filament bundles comprising the entire cable will be on one side of a pin and half on the other side. Such a placement of pins 14 assists in inhibiting distortion of the braided structure resulting from a non-equal distribution of the load on the various filaments. Additionally, to inhibit distortion of tension cable 11 ′, preferably a relatively dense braid is formed (i.e., in terms of both pick count and number of bundles) so pins 14 can penetrate and be secured without risk of pulling out or unraveling the braid.
- some length of cable 11 ′ should extend on either side of pins 14 so that pins 14 are not easily pulled through the braid along the length of the braid.
- at least one of pins 14 penetrates cable 11 ′ at a location that leaves a length of cable of approximately 1 to 2 centimeters.
- the folded over configuration of tension member 2 within fixed pad assembly 3 serves to prevent both pins 14 from becoming disengaged with tension member 2 as a result of cable 11 ′ unraveling at its end.
- tension member 2 can be thermally treated or otherwise fused together at its end.
- fixed pad assembly 3 includes two pins 14 of approximately 0.025 to 0.035 inches in diameter and length slightly less than the pad base diameter, as shown in FIG. 2 .
- Pins 14 can be formed of a relatively hard, corrosion-resistant material, such as, for example, a cobalt-nickel-chromium-molybdenum alloy, such as MP 35N, other cobalt-chrome alloys, stainless steel, or other suitable materials having similar characteristics. At least one end of each pin preferably is sharpened to facilitate penetration of tension cable 11 ′ and covering 11 .
- adjustable pad assembly 4 and its connection to tension member 2 will now be described.
- the general outer configuration of adjustable pad assembly 4 is similar to that of fixed pad assembly 3 . That is, adjustable pad assembly 4 includes a convex inner surface 47 that engages with an exterior of the heart wall when splint assembly 1 is implanted in the heart. Also, near an outer surface 48 of adjustable pad assembly 4 is a circumferential groove 80 with suture windings 81 . Although not shown in the Figures, it is contemplated that a pad covering of the type described with reference to fixed pad assembly 3 will be provided and secured via suture windings 81 to facilitate tissue ingrowth between adjustable pad assembly 4 and the heart wall.
- FIGS. 5-7 depict the inner components of adjustable pad base 24 .
- pad base 24 includes a plurality of channels.
- a channel 25 through which tension member 2 passes extends, through pad base 24 in a manner similar to channel 17 passing through pad base 15 of fixed pad assembly 3 .
- FIGS. 5 and 6 more clearly show the tapered opening 25 ′ of this channel 25 (similar to channel 17 ), which permits tension member 2 to gently curve at the surface of adjustable pad assembly 4 .
- channel 25 in adjustable pad assembly 4 includes a further reduction in diameter, preferably approximately 0.059 inches, near an outer surface 48 of pad base 15 . This reduction in diameter helps to assure that the braid of cable 11 ′ is centered in channel 25 prior to fixation of tension member 2 to adjustable pad assembly 4 .
- cable 11 ′ It is important for cable 11 ′ to be centered within channel 25 to ensure that a fixation or securement member, for example in the form of a staple 23 , used to secure tension member 2 to adjustable pad assembly 4 , penetrates cable 11 ′ in its center. In this manner, the yarn bundles of cable 11 ′ evenly divide on either side of staple 23 to evenly distribute the load to tension member 2 .
- Channel 17 in fixed pad base 3 does not require such a reduced diameter region since the securement of tension member 2 to fixed bad assembly 3 occurs under controlled factory conditions prior to implantation of splint assembly 1 in the heart.
- a pair of staple leg channels 26 extend through pad base 24 substantially perpendicular to channel 25 and parallel to inner surface 47 and outer surface 48 of pad base 24 .
- the pair of channels 26 merges into a single staple leg channel disposed on one side of channel 25 .
- Channels 26 receive legs 27 of a staple 23 and are sized to enable staple 23 to slide along the channels from a retracted position (shown in FIG. 6 ) to an advanced position (shown in FIG. 7 ) upon actuation of a deployment tool 22 , as will be described.
- a channel 28 extends between and parallel to staple leg channels 26 .
- Channel 28 is formed within one side of pad base 24 (on the side of a base 23 ′ of staple 23 opposite to the side from which legs 27 extend) and extends for approximately two-thirds of the distance measured from the side of pad base 24 to the center of pad base 24 .
- a deployment tool channel 31 begins at the end of channel 28 and extends through the remaining diameter of pad base 24 . Deployment tool channel is radially offset from channel 28 and extends through pad base 24 so as to avoid intersection with channel 25 .
- a pre-deployment safety pin 32 is located approximately in the center of the portion of channel 28 .
- Pre-deployment safety pin 32 extends essentially perpendicularly to channel 28 and engages with base 23 ′ of staple 23 between staple legs 27 prior to actuation of staple 23 . This engagement tends to hold staple 23 in place to prevent premature advancement.
- a side channel 33 also is formed in pad base 24 .
- Side channel 33 extends perpendicularly to staple leg channels 26 .
- Side channel 33 begins on either surface 47 (which engages the heart wall) or surface 48 (which faces away from the heart wall) and extends to approximately the end of channel 28 , near the beginning of deployment tool channel 31 .
- a post-deployment safety pin 34 is disposed in side channel 33 .
- Post-deployment safety pin 34 has a deflected configuration as it resides in side channel 33 , pressing on the side of one of staple legs 27 .
- tension member 2 After tension member 2 has been extended transverse a heart chamber, for example, the left ventricle, such that the free end of tension member 2 extends through the heart wall at a location opposite to fixed pad assembly 3 , leader tube 5 and tension member 2 are fed through channel 25 of adjustable pad assembly 4 .
- a measuring/tightening device which will be described in more detail shortly, is used to determine and adjust the proper tension member length between fixed pad assembly 3 and adjustable pad assembly 4 .
- This length is the length that is desired for the final implantation of splint assembly 1 in the heart. The determination of this length and the measuring and tightening procedure have been described in prior U.S. application Ser. No. 09/123,977, filed Jul.
- the final length of the tension member when placed in the heart corresponds to a predetermined desired percentage reduction of the heart chamber diameter and the actual measured heart chamber diameter, which may differ from patient to patient.
- adjustable pad assembly 4 is placed in the proper position on tension member 2 , with surface 47 engaging the outer surface of the heart wall.
- a deployment tool 22 shown in FIGS. 8 and 9 is used to secure adjustable pad assembly 4 into place on tension member 2 .
- a deployment tool 22 is pre-engaged with adjustable pad assembly 4 . That is, deployment tool 22 includes an engagement collar 35 disposed in channel 28 , as shown in FIG. 5 , and an actuator wire 36 (not shown in FIG. 5 ) connected to engagement collar 35 at one end and to an actuator knob 37 at the other end.
- engagement collar 35 rests against staple base 23 ′ and actuator wire extends from engagement collar 35 and through the entire diameter of pad base 24 exiting at a side 45 of pad base 24 .
- deployment tool channel 31 ends in a countersink region 38 .
- actuator wire 36 runs through the center of, but is not affixed to, an outer coil 39 .
- a collar 40 surrounds both outer coil 39 and actuator wire 36 .
- Collar 40 rests within countersink region 38 , essentially providing an abutment surface within pad base 24 that creates a counter-resistant force enabling actuator wire 36 to be pulled through pad base 24 .
- actuator wire 36 and outer coil 39 connect to a threaded base portion 41 of deployment tool 22 .
- Outer coil 39 terminates within threaded base portion 41 .
- Actuator wire 36 continues through-threaded base portion 41 and into an actuator 37 .
- Actuator 37 also includes threads that engage with the threads of threaded base portion 41 at an interface 30 .
- Actuator wire 36 fixedly attaches by a crimp fit 42 to a proximal end of actuator 37 .
- An actuator knob 43 preferably is fixedly mounted to the distal end of actuator 37 to provide an ergonomic surface for a user to actuate deployment tool 22 .
- actuator knob 43 is turned. This rotates actuator 37 with respect to threaded base portion 41 , essentially unscrewing actuator 37 from threaded base portion 41 . As actuator 37 turns, actuator wire 36 is pulled through outer coil 39 , exerting a force on engagement collar 35 . Continued rotation of actuator 37 further pulls on actuator wire 36 and engagement collar 35 . Engagement collar 35 thus moves staple 23 within adjustable pad assembly 4 to move staple legs 27 along channels 26 . Staple legs 27 eventually are pulled across channel 25 , piercing through tension member 2 in approximately the center thereof.
- actuator wire 36 preferably rotates with respect to engagement collar 35 as actuator 37 turns without exerting any rotational forces upon engagement collar 35 .
- engagement collar 35 simply pushes against staple 23 , but does not translate with respect to the staple surface.
- abrasive forces acting on staple 23 are avoided, which otherwise may cause scratches and lead to corrosion of the staple.
- excessive torque on actuator wire 36 by engagement collar 35 will be prevented.
- Abutment wall 29 prevents staple 23 from moving in the other direction through pad base 24 .
- pre-deployment safety pin 32 does not lie entirely flush within channel 28 but rather deflects back up so that it extends slightly outside of channel 28 .
- pre-deployment safety pin 32 serves as a safety backup to maintain the advanced position of staple 23 if post-deployment safety pin 34 should for some reason fail to do so.
- both pre-deployment and post-deployment safety pins are press-fit within pad base 24 .
- the pre-deployment safety pin preferably has a diameter of approximately 0.025 inches and the post-deployment safety pin preferably has a diameter of approximately 0.016 inches.
- the pre-deployment pin preferably is made of annealed MP35N and the post-deployment pin preferably is made of spring-tempered MP35N.
- the annealing of pre-deployment pin 32 facilitates the formation of the permanent bend upon deflection resulting from advancing staple 23 .
- the spring-tempering of post-deployment pin 34 enables the pin to recover to a relatively straight condition once the staple is fully deployed.
- pins could be spring-activated with a bias in a particular direction such that the pins would move into their appropriate positions during deployment of staple 23 .
- tension member 2 itself serves as the primary mechanism for preventing retraction of staple 23 . That is, the force exerted by tension member 2 onto staple 23 as a result of tightening tension member 2 in place with respect to the heart chamber tends to prevent staple 23 from moving. Due to this relatively large force exerted between tension member 2 and staple 23 , it is preferred to leave a length of tension member 2 of approximately 1 cm to 2 cm extending beyond the distal end of the distal most staple leg 27 to prevent staple 23 from pulling through the length of tension member 2 .
- tension member 2 is even more desirable in the connection of tension member 2 to adjustable pad assembly 4 than it is for fixed pad assembly 3 since tension member 2 is not folded over in the former. Moreover, as will be explained, it is preferred to melt or otherwise fuse the end of tension member 2 to prevent unraveling of cable 11 ′.
- engagement collar 35 drops into deployment tool channel 31 .
- actuator wire 36 By continuing to pull on actuator wire 36 , engagement collar 35 can be pulled through deployment tool channel 31 and the entire deployment tool (including actuator wire 36 and engagement collar 35 ) can be removed from adjustable pad assembly 4 .
- leader assembly 10 can be separated from tension member 2 using a conventional cauterizing pen, or other suitable like instrument.
- the end of tension member 2 left protruding from adjustable pad assembly 4 is also heated, or melted, and essentially fused together as a result of using the cauterizing pen to separate leader assembly 10 .
- the filaments of cable 11 ′ and covering 11 are joined to prevent potential unraveling of the tension member braid.
- Other suitable mechanisms for severing the leader from the tension member and for fusing the tension member end also are within the scope of the invention. For example, although it is preferred to use the single step to both sever the leader assembly and fuse the tension member, it is also contemplated that the severing and fusing steps can be performed as separate steps.
- FIGS. 10-12 Another aspect of the invention, described herein with reference to FIGS. 10-12 , includes various location and identification tools for assisting in the optimal placement of splint assembly 1 with respect to a heart chamber to avoid damage to both internal cardiac structures, such as the papillary muscles, and external structures, such as blood vessels. Moreover, the tools assist in the placement of splint assemblies to effectively bisect the ventricle to result in optimal radius reduction and stress reduction.
- the splint assembly will be placed across the left ventricle in a plane essentially longitudinally bisecting the ventricle.
- the splint assembly should extend from a location proximate to the anterior papillary muscle on the ventricle free wall to a location proximate to the posterior ventricular septum.
- the preferred location for the splint assembly near the anterior papillary muscle is just lateral to that muscle, while the preferred location near the septum is on the posterior free wall of the right ventricle.
- FIG. 13 shows this preferred placement of a splint assembly.
- three individual splint assemblies 1 are implanted.
- the upper-most (basal) splint assembly is placed according to the description above.
- the remaining two splint assemblies will be positioned in an equidistant relationship between the basal splint assembly and the apex of the left ventricle.
- the three splint assemblies essentially bisect the ventricle, producing optimal radius and stress reduction without excessive ventricular volume reduction.
- the positioning of the splint assemblies in this way also avoids interference with the mitral valve structure, including the chordae tendonae. Additionally, the positions described effectively avoid significant coronary arteries or veins.
- splint assemblies of the present invention can be employed to implant the splint assemblies of the present invention, including minimally invasive techniques through access ports, or endovascular techniques not requiring opening of the chest wall. These splint assemblies also could be implanted as an adjunct to other surgical procedures, such as, for example, CABG or mitral valve replacement.
- a preferred method of implanting the splint assemblies includes through an open chest sternotomy without cardiopulmonary bypass. The description of the identification and location tools and methods for implanting the splint assemblies that follows thus relates to such an open sternotomy procedure.
- a preferred external imaging method includes the use of ultrasound probes. Ultrasound probes can either be used direcly in contact with the outside of the heart or can be positioned in the patient's esophagus (transesophageal)
- a probe/marking device 50 shown in FIG. 10 , operates to both locate positions on the heart wall for splint placement and simultaneously deliver a marker into the heart wall to mark each location.
- Marker 60 shown in FIG. 12 , is initially preloaded within a tube 51 , shown in FIG. 11 .
- Tube 51 houses the entire structure of marker 60 with the exception of a penetrating tip 65 , which extends from a distal end of tube 51 . Marker 60 thus can easily be removed from tube 51 .
- Mounted on an exterior surface of tube 51 is an advancer button 54 , the function of which will become apparent shortly.
- Probe/marking device 50 includes a hollow handle portion 53 , a shaft 52 , and a probe tip 58 .
- Handle 53 defines a slot 57 which opens at a proximal end and is configured to receive advancer button 54 , as will be described shortly.
- Shaft 52 preferably is relatively rigid and may be curved as well, as shown in FIG. 10 , to facilitate access to the exterior heart wall.
- Probe tip 58 preferably has an essentially conical shape with three flat angular faces. As shown in FIG. 10A , the three angular faces meet at the distal most portion of tip 58 to define an opening 56 through which marker 60 is configured to pass upon delivery.
- Probe tip 58 should be made of a material having a density that is sufficiently different than the myocardium in order to enhance echovisualization.
- a preferred material exhibiting this characteristic is a metal, such as stainless steel, for example, with a polyester covering such as DacronTM, or other suitable like material, that provides a gripping surface with respect to the heart tissue, to help stabilize the position of tip 58 with respect to the heart wall during indentation.
- the diameter of the proximal portion of tip 58 that connects to shaft 52 is approximately 0.375 in. This configuration aids in creating a distinct, localized deflection upon contact and indentation of the heart wall.
- the flat angular faces enhance the visualization of probe tip 58 using ultrasound since the reflections off of the edges of the faces produce more discrete lines on the echo-image and the flat faces tend to reflect the ultrasound signals to a greater extent than a curved face.
- a physician inserts the distal end of a tube 51 preloaded with marker 60 into the proximal end of handle 53 of probe/marking device 50 .
- advancer button 54 slides into slot 57 .
- Tube 51 is inserted into probe/marking device 50 until a base 55 of advancer button 54 , which connects advancer button 54 to tube 51 , engages with a detent mechanism (not shown) formed in handle 53 .
- marker tip 66 is disposed at a location just proximal to the distal end of probe tip 58 .
- a portion of the proximal end of tube 51 extends from the proximal end of handle 53 of probe/marking device 50 .
- Probe tip 58 is then iteratively pressed against the outside of the heart wall to create localized indentations. Using ultrasound or other like imaging method, the physician can concurrently visualize these localized indentations, as well as tip 58 , to determine the position of the indentations relative to internal heart structures. In addition, the flat faces and preferred material of probe tip 58 tend to create a shadow that can be seen in the ultrasound picture, thus improving visualization.
- advancer button 54 Upon finding a desired splint placement location, advancer button 54 is moved forward until it abuts the end of slot 57 defined by handle 53 . Moving advancer button 54 forward within slot 57 in turn moves tube 51 forward so as to move marker tip 66 through opening 56 of probe tip 58 . Marker tip 65 thus moves past probe tip 58 and into the heart wall.
- FIG. 12 shows details of a preferred marker 60 to be used with inventive probe/marking device 50 .
- Marker 60 includes a penetrating tip 65 and a suture line 70 .
- Penetrating tip 65 includes a sharpened, conical-shaped end 66 to facilitate shallow penetration into the wall of the heart by spreading the heart wall tissue.
- the remaining portion 67 of penetrating tip 65 extending from conical-shaped end 66 has a cylindrical configuration.
- a series of deflectable barbs 68 protrude radially around the surface of cylindrical portion 67 .
- Barbs 68 essentially act as gripping members to engage with the heart wall and securely hold marker 60 in place until removal is desired. Upon a sufficient force pulling marker 60 away from the heart wall, barbs 68 relatively easily disengage from heart wall to free marker 60 .
- Penetrating tip 65 preferably is constructed from PEEK, or other suitable biocompatible material, such as, for example, polyimide, polyamide, acetal, urethane, or polyester, and has a length less than the thickness of the heart wall and preferably of approximately 0.156 inches, and a diameter preferably of approximately 0.030 inches.
- Barbs 68 preferably extend from cylindrical portion 67 of penetrating tip 65 at angles ranging from approximately 10 degrees to approximately 45 degrees, and have respective lengths of 0.005 inches measured from the outer surface of cylindrical portion 67 .
- a suture line 70 attaches to a proximal end of penetrating tip 65 .
- Suture line 70 can either be formed by necking and drawing the back end of penetrating tip 65 or can be a standard suture material secured directly to penetrating tip 65 by, for example, a knot.
- a standard suture material includes 3-0 polyester, but other materials known in the art also may be utilized.
- Suture line 70 has a length of approximately 2 to 14 inches, thus allowing the marker to be seen more readily, as well as enabling a surgeon to locate the marker through tactile sensation.
- the preloading of marker 60 into tube 51 is preferably performed at a factory prior to implantation, with a number of marker-preloaded tubes 51 being supplied for the splint implantation procedure. Most preferably, 6 preloaded tubes 51 will be supplied for an implantation procedure to deliver six markers corresponding to the intersection points of each of three splint assemblies implanted into the heart, as shown in FIG. 14 . After each marker 60 is delivered, tube 51 is removed from probe/marking device 50 and disposed of as appropriate. A new preloaded tube 51 is thereafter inserted for delivery of the next marker 60 .
- the locating and marking procedure can be repeated at each splint assembly positioning location on both sides of the heart chamber in the manner described above.
- the various splint assemblies are then delivered to each of the locations of the heart indicated by each of the delivered markers.
- the markers are removed once delivery of the splint assembly is complete.
- a splint assembly proceeds in the following manner. Once markers have been delivered to heart wall on both sides of the chamber, an alignment clamp is positioned around the heart at those locations.
- the alignment clamp includes a guide tube, through which a needle is first delivered at the marker locations to penetrate the heart wall. The needle is extended transverse the heart such that each end of the needle penetrates locations on the heart wall corresponding to the ends of the splint assembly to be implanted.
- the needle defines a lumen extending along its length, through which leader tube 5 and tension member 2 are inserted via the guide tube in the alignment clamp. Once leader tube 5 extends through the second marker location, it can be pulled which in turn pulls tension member 2 across the heart wall. Leader tube 5 should be pulled until fixed pad assembly 3 engages the exterior surface of the heart wall. The needle can then be removed from the heart by pulling it off the free end of leader tube 5 . Similarly, markers 60 also can be removed from the heart wall, either before or after removing the needle.
- leader tube 5 is fed into a measuring and tightening device, which also has been described previously in U.S. application Ser. No. 09/123,977.
- stop band 7 on leader tube 5 engages with the measuring and tightening device, and leader tube 5 can be pulled a predetermined distance to tighten tension member 2 to a desired length between fixed pad assembly 3 and adjustable pad assembly 4 .
- Stop band 7 is originally affixed to leader tube 5 at a known distance from fixed pad assembly 3 .
- Stop band 7 serves as a marker to align with a measurement scale on the measuring and tightening device.
- adjustable pad assembly 4 previously fed onto leader tube 5 and tension member 2 , is secured to tension member 2 adjacent the exterior of the heart wall in the manner described above with reference to the description of FIGS. 5-9
- the methods described above to place the splint assemblies with respect to the heart can be repeated for other desired numbers of splint assemblies to achieve a particular configuration.
- the length of the tension members extending between the fixed and adjustable pad assemblies also can be optimally determined based upon the size and condition of the patient's heart. It should also be noted that although the left ventricle has been referred to here for illustrative purposes, the apparatus and methods of this invention can be used to splint multiple chambers of a patient's heart, including the right ventricle or either atrium.
- FIGS. 13 and 14 are illustrative only and may be shifted or rotated about a vertical axis generally disposed through the left ventricle and still avoid the major coronay vessels and papillary muscles.
- inventive device and methods can be implanted to treat a heart having aneurysms or infarcted regions similar to those described in prior U.S. application Ser. No. 09/422,328 discussed earlier herein.
- the various components of the splint assembly to be implanted in the heart should be made of biocompatible material that can remain in the human body indefinitely. Any surface engaging portions of the heart should be atraumatic in order to avoid tissue damage.
Landscapes
- Health & Medical Sciences (AREA)
- Life Sciences & Earth Sciences (AREA)
- Cardiology (AREA)
- Surgery (AREA)
- Animal Behavior & Ethology (AREA)
- General Health & Medical Sciences (AREA)
- Biomedical Technology (AREA)
- Heart & Thoracic Surgery (AREA)
- Veterinary Medicine (AREA)
- Engineering & Computer Science (AREA)
- Public Health (AREA)
- Molecular Biology (AREA)
- Nuclear Medicine, Radiotherapy & Molecular Imaging (AREA)
- Medical Informatics (AREA)
- Rheumatology (AREA)
- Oral & Maxillofacial Surgery (AREA)
- Transplantation (AREA)
- Vascular Medicine (AREA)
- Prostheses (AREA)
- Machines For Laying And Maintaining Railways (AREA)
- Medicines Containing Plant Substances (AREA)
- External Artificial Organs (AREA)
- Measuring Pulse, Heart Rate, Blood Pressure Or Blood Flow (AREA)
Abstract
Description
- The present invention pertains to a device, and a method for placing the device, for treating a failing heart. In particular, the device and its related method of the present invention are directed toward reducing the wall stress in a failing heart. The device reduces the radius of curvature and/or alters the geometry or shape of the heart to thereby reduce wall stress in the heart and improve the heart's pumping performance.
- Heart failure is a common course for the progression of many forms of heart disease. Heart failure may be considered as the condition in which an abnormality of cardiac function is responsible for the inability of the heart to pump blood at a rate commensurate with the requirements of the metabolizing tissues, or can do so only at an abnormally elevated filling pressure. There are many specific disease processes that can lead to heart failure. Typically these processes result in dilatation of the left ventricular chamber. Etiologies that can lead to this form of failure include idiopathic, valvular, viral, and ischemic cardiomyopathies.
- The process of ventricular dilatation is generally the result of chronic volume overload or specific damage to the myocardium. In a normal heart that is exposed to long term increased cardiac output requirements, for example, that of an athlete, there is an adaptive process of slight ventricular dilation and muscle myocyte hypertrophy. In this way, the heart fully compensates for the increased cardiac output requirements. With damage to the myocardium or chronic volume overload, however, there are increased requirements put on the contracting myocardium to such a level that this compensated state is never achieved and the heart continues to dilate.
- The basic problem with a large dilated left ventricle is that there is a significant increase in wall tension and/or stress both during diastolic filling and during systolic contraction. In a normal heart, the adaptation of muscle hypertrophy (thickening) and ventricular dilatation maintain a fairly constant wall tension for systolic contraction. However, in a failing heart, the ongoing dilatation is greater than the hypertrophy and the result is a rising wall tension requirement for systolic contraction. This is felt to be an ongoing insult to the muscle myocyte resulting in further muscle damage. The increase in wall stress also occurs during diastolic filling. Additionally, because of the lack of cardiac output, a rise in ventricular filling pressure generally results from several physiologic mechanisms. Moreover, in diastole there is both a diameter increase and a pressure increase over normal, both contributing to higher wall stress levels. The increase in diastolic wall stress is felt to be the primary contributor to ongoing dilatation of the chamber. Prior treatments for heart failure associated with such dilatation fall into three general categories. The first being pharmacological, for example, diuretics and ACE inhibitors. The second being assist systems, for example, pumps. Finally, surgical treatments have been experimented with, which are described in more detail below.
- With respect to pharmacological treatments, diuretics have been used to reduce the workload of the heart by reducing blood volume and preload. Clinically, preload is defined in several ways including left ventricular end diastolic pressure (LVEDP), or indirectly by left ventricular end diastolic volume (LVEDV): Physiologically, the preferred definition is the length of stretch of the sarcomere at end diastole. Diuretics reduce extra cellular fluid which builds in congestive heart failure patients increasing preload conditions. Nitrates, arteriolar vasodilators, angiotensin converting enzyme (ACE) inhibitors have been used to treat heart failure through the reduction of cardiac workload by reducing afterload. Afterload may be defined as the tension or stress required in the wall of the ventricle during ejection. Inotropes function to increase cardiac output by increasing the force and speed of cardiac muscle contraction. These drug therapies offer some beneficial effects but do not stop the progression of the disease.
- Assist devices include mechanical pumps. Mechanical pumps reduce the load on the heart by performing all or part of the pumping function normally done by the heart. Currently, mechanical pumps are used to sustain the patient while a donor heart for transplantation becomes available for the patient.
- There are at least three surgical procedures for treatment of heart failure associated with dilatation: 1) heart transplantation; 2) dynamic cardiomyoplasty; and 3) the Batista partial left ventriculectomy; and 4) the Jatene and Dor procedures for ischemic cardiomyopathy, discussed in more detail below. Heart transplantation has serious limitations including restricted availability of organs and adverse effects of immunosuppressive therapies required following heart transplantation. Cardiomyoplasty involves wrapping the heart with skeletal muscle and electrically stimulating the muscle to contract synchronously with the heart in order to help the pumping function of the heart. The Batista partial left ventriculectomy surgically remodels the left ventricle by removing a segment of the muscular wall. This procedure reduces the diameter of the dilated heart, which in turn reduces the loading of the heart. However, this extremely invasive procedure reduces muscle mass of the heart.
- Another form of heart failure results from the formation of one or more zones of ischemia, or infarction, of the myocardium. Infarction occurs when blood supply to the heart tissue has been obstructed resulting in a region of tissue that loses its ability to contract (referred to as infarcted tissue). The presence of infarcted tissue may lead to three conditions in the heart causing cardiac malfunction. These conditions are ventricular aneurysms (ventricular dyskinesia), non-aneurysmal ischemic or infarcted myocardium (ventricular akinesia), and mitral regurgitation.
- A ventricular aneurysm is formed when the infarction weakens the heart wall to such an extent that the tissue stretches and thins, causing, for example, the left ventricular wall to expand during systole (dyskinesia) and form a bulge in the heart wall. Non-aneurysmal ischemic or infarcted myocardium (akinesia) occurs when a major coronary artery is occluded and results in infarction in the myocardial tissue, but without a bulging aneurysm. Finally, mitral regurgitation is a condition whereby blood leaks through the mitral valve due to an improper positioning of the valve structures that causes it not to close entirely. If the infarcted or aneurysmal region is located in the vicinity of the mitral valve, geometric abnormalities may cause the mitral valve to alter its normal position and dimension, and may lead to annular dilatation and the development of mitral regurgitation.
- The “Dor” and “Jatene” procedures have recently been employed to treat heart conditions resulting from aneurysms and other infarctions. In the “Dor” procedure, the aneurysm is removed and an endocardial patch is placed to cover the dyskinetic septal wall portion of the aneurysm. In this manner, at least the portion of stroke volume “lost” to dyskinesia is restored. In the “Jatene” technique, a purse string suture is placed at the base of the aneurysm. The infarcted septal wall is circumferentially reduced by inbrication with sutures.
- The advantages and purpose of the invention will be set forth in part in the description which follows, and in part will be obvious from the description, or may be learned by practice of the invention. The advantages and purpose of the invention will be realized and attained by means of the elements and combinations particularly pointed out in the appended claims.
- Due to the drawbacks and limitations of the previous devices and techniques for treating a failing heart, including such a heart having dilated, infarcted, and/or aneurysmal tissue, there exists a need for alternative methods and devices that are less invasive, pose less risk to the patient, and are likely to prove more clinically effective. The present invention provides such methods and devices.
- Although throughout this specification, the inventive devices and methods will be discussed in connection with treating dilated heart chambers, it is contemplated that the form of heart failure resulting from aneurysms and the like also can be treated with the inventive device and method for using the device disclosed herein. U.S. application Ser. No. 09/422,328, filed on Oct. 21, 1999, entitled “Methods and Devices for Improving Cardiac Function in Hearts,” which is assigned to the same assignee as the present application and is incorporated by reference herein, discusses this form of heart failure in more detail.
- One aspect of the present invention pertains to a non-pharmacological, passive apparatus and method for the treatment of a failing heart due to dilatation. The device is configured to reduce the tension in the heart wall, and thereby reverse, stop or slow the disease process of a failing heart as it reduces the energy consumption of the failing heart, decreases isovolumetric contraction, increases isotonic contraction (sarcomere shortening), which in turn increases stroke volume.
- The device reduces wall tension by changing chamber geometry or shape and/or changing the radius of curvature or cross-section of a heart chamber. These changes may occur during the entire cardiac cycle. The apparatuses of the present invention which reduce heart wall stress in this way can be referred to generally as “splints.” Splints can be grouped as either “full cycle splints,” which engage the heart to produce these changes throughout the cardiac cycle, or “restrictive splints,” which engage the heart wall for only a portion of the cardiac cycle to produce these changes.
- One aspect of the present invention includes an apparatus for improving cardiac function includes an elongate member configured to extend transverse a heart chamber, a first heart-engaging assembly attached to one end of the elongate member and configured to engage a first exterior location of a heart wall, and a second heart-engaging assembly configured to be secured onto the elongate member and to engage a second exterior location of the heart wall. The apparatus further includes a fixation member configured to penetrate the elongate member to thereby hold at least one of the first and second heart-engaging assemblies in a fixed position along the length of the elongate member.
- According to another aspect of the present invention, an apparatus for improving cardiac function includes an elongate member configured to extend transverse a heart chamber, wherein the elongate member is made of a plurality of filament bundles of approximately 180 denier. The apparatus further includes a first heart-engaging assembly attached to one end of the elongate member and configured to engage a first exterior location of a heart wall and a second heart-engaging assembly configured to be secured onto the elongate member and to engage a second exterior location of the heart wall.
- According to yet another aspect of the present invention an apparatus for improving cardiac function includes an elongate member attached to a leader member at one end thereof and being configured to extend transverse a heart chamber, a first heart-engaging assembly attached to the other end of the elongate member and configured to engage a first exterior location of a heart wall, and a second heart-engaging assembly configured to slidably receive the leader member and the elongate member and to thereby be secured to the elongate member and to engage a second exterior location of the heart wall. The second heart-engaging assembly is configured to be secured to the elongate member such that a length of the elongate member between the first and second heart-engaging assemblies can be adjusted during placement of the elongate member transverse the heart chamber.
- Another embodiment of the present invention includes an apparatus is provided for determining and marking locations on a heart wall. The apparatus includes a marker delivery mechanism configured to hold a marker and an actuator operatively connected to the marker delivery mechanism for delivering a marker to the location. The distal end of the delivery mechanism is configured to be visible relative to internal heart structures.
- Yet another embodiment of the present invention includes a tool for fixing an elongate member to a housing comprising an engagement member configured to engage a fixation member to be advanced within the housing, a wire having a first end secured to the engagement member and being configured to pass through the housing, and a handle connected to a second end of the wire. The engagement member and the wire are further configured to move through the housing to advance the fixation member within the housing and into engagement with the elongate member when the handle is actuated.
- In another embodiment of the present invention, there is provided a method for placing a splint assembly transverse a heart chamber. The method includes providing an elongate member with a leader member attached to a first end and a first heart-engaging assembly attached to a second end and guiding the leader member through first and second exterior locations on a heart wall so as to extend the elongate member transverse to the heart chamber. The method further includes adjusting the length of the elongate member extending through the heart chamber by securing a second heart-engaging assembly to the elongate member at a position along the length of the elongate member exterior the chamber at the second location.
- In accordance with the purposes of the invention as embodied and broadly described herein, instruments and related methods for implanting the device for treating a heart and improving cardiac function also are disclosed.
- It is to be understood that both the foregoing general description and the following detailed description are exemplary and explanatory only and are not restrictive of the invention, as claimed.
- The accompanying drawings, which are incorporated in and constitute a part of this specification, illustrate several embodiments of the invention and, together with the description, serve to explain the principles of the invention. In the drawings,
-
FIG. 1 is a plan view of an embodiment of the splint assembly and leader assembly according to the present invention; -
FIG. 2 is a cross-sectional view of a leader tube and a portion of the splint assembly showing the connection of a fixed pad assembly to the tension member; -
FIG. 2A is a detailed view of section A-A ofFIG. 2 showing the connection of the leader tube to the tension member; -
FIG. 3 is a perspective view of the fixed pad assembly ofFIG. 2 looking into the pin channels of the assembly; -
FIG. 4 is a magnified view of an embodiment of the cable forming the tension member according to the present invention; -
FIG. 5 is a lateral cross-sectional view of an embodiment of an adjustable pad assembly according to the present invention; -
FIG. 6 is a vertical cross-sectional view of the adjustable pad assembly ofFIG. 5 in a pre-deployment configuration according to the present invention; -
FIG. 7 is a vertical cross-sectional view of the adjustable pad assembly ofFIG. 5 in a post-deployment configuration according to the present invention; -
FIG. 8 is a perspective view of an embodiment of a deployment tool engaged with an adjustable pad assembly according to the present invention; -
FIG. 9 is a cross-sectional view of an embodiment of the deployment tool ofFIG. 8 , showing the inner components thereof; -
FIG. 10 is a perspective view of an embodiment of an probe/marking device according to the present invention; -
FIG. 10A is a perspective view of the probe tip inFIG. 10 looking down onto the probe tip; -
FIG. 11 is a perspective view of an embodiment of a tube used for housing a marker of the type shown inFIG. 12 prior to delivery according to the present invention; -
FIG. 12 is a perspective view of an embodiment of a marker according to the present invention; -
FIG. 13 is a cross-sectional view of the heart showing a preferred placement of one of the splint assemblies according to an embodiment of the present invention; and -
FIG. 14 is a cut-away perspective view of the heart showing a preferred placement of three splint assemblies for treatment of the heart according to the present invention and showing the cross-sectional shape of the left ventricle before and after placement of the splint assemblies with respect thereto. - The various aspects of the invention to be discussed herein generally pertain to devices and methods for treating heart conditions, including, for example, dilatation and other similar heart failure conditions. The device of the present invention preferably operates passively in that, once placed in the heart, it does not require an active stimulus, either mechanical, electrical, or otherwise, to function. Implanting one or more of these devices alters the shape or geometry of the heart, both locally and globally, and thereby increases the heart's efficiency. That is, the heart experiences an increased pumping efficiency through an alteration in its shape or geometry and concomitant reduction in stress on the heart walls.
- Although the implanted device for treating the heart preferably is a passive device, it is contemplated that the inventive tools and instruments used for implanting the device and the method of using these tools and instruments can be used to implant other treatment devices, such as active devices and the like.
- The inventive device and methods offer numerous advantages over the existing treatments for various heart conditions. The device is relatively easy to manufacture and use, and the related inventive surgical techniques and tools for implanting the device do not require the invasive procedures of current surgical techniques. For instance, the surgical technique does not require removing portions of the heart tissue, nor does it necessarily require opening the heart chamber or stopping the heart during operation. For these reasons, the surgical techniques of the present invention also are less risky to the patient than other techniques.
- The disclosed inventive methods and related devices involve geometric reshaping of the heart. In certain aspects of the inventive methods and related devices, substantially the entire chamber geometry is altered to return the heart to a more normal state of stress. Models of this geometric reshaping, which includes a reduction in radius of curvature of the chamber walls, can be found in U.S. Pat. No. 5,961,440, issued Oct. 5, 1999 and entitled “Heart Wall Tension Reduction Apparatus and Method,” the complete disclosure of which is incorporated herein by reference. Prior to reshaping the chamber geometry, the heart walls experience high stress due to a combination of both the relatively large increased diameter of the chamber and the thinning of the chamber wall. Filling pressures and systolic pressures are typically high as well, further increasing wall stress. Geometric reshaping according to the present invention reduces the stress in the walls of the heart chamber to increase the heart's pumping efficiency, as well as to stop further dilatation of the heart.
- Although many of the methods and devices are discussed below in connection with their use in the left ventricle of the heart, these methods and devices may be used in other chambers of the heart for similar purposes. One of ordinary skill in the art would understand that the use of the devices and methods described herein also could be employed in other chambers of the heart. The left ventricle has been selected for illustrative purposes because a large number of the disorders that the present invention treats occur in the left ventricle.
- Reference will now be made in detail to the present preferred embodiments of the invention, examples of which are illustrated in the accompanying drawings. Wherever possible, the same reference numbers will be used throughout the drawings to refer to the same or like parts.
-
FIG. 1 shows asplint assembly 1 that ultimately is placed in the heart and a leader assembly-10 connected to splintassembly 1 prior to placement ofsplint assembly 1 and aiding in the delivery ofsplint assembly 1 into the heart.Splint assembly 1 includes an elongate tension member 2 (shown by the thicker line), a fixedpad assembly 3, and anadjustable pad assembly 4.Fixed pad assembly 3 is disposed at one end of tension member 2 (which will be referred to as the proximal end of assembly 1), whileadjustable pad assembly 4 is disposed to slidably engagetension member 2 and secure totension member 2 opposite to the end attached to fixed pad assembly 3 (which will be referred to as the distal end of assembly 1). Preferably,splint assembly 1 is placed transverse a heart chamber to induce a shape change of the heart chamber, for example, the left ventricle, to reduce stress on the heart wall and thereby improve cardiac function. For example, as shown inFIG. 14 , in a preferred embodiment of the present invention, threesplint assemblies 1 are placed relative to the left ventricle LV in the manner illustrated to alter the shape of the ventricle from an essentially circular cross-section to an essentially bi-lobed cross-section. Although three splint assemblies are shown inFIG. 14 , it is contemplated that any number of splint assemblies may be placed as desired, depending on the condition of the heart and the desired shape change results. Details on methods and tools used to determine the location for placement of thesplint assembly 1 with respect to the heart chamber will be described later in this specification. -
Splint leader assembly 10 includes a leader tube 5 (shown by the thinner line inFIG. 1 leading to tension member 2) and astop band 7.Leader tube 5 facilitates the advancement oftension member 2 through the heart wall and across the heart chamber, as will be described. Oncetension member 2 has been placed with respect to the heart andadjustable pad assembly 4 has been secured into place,leader assembly 10 and any excess tension member length can be severed and removed fromtension member 2, for example, by thermal cutting or the like. Preferably,leader tube 5 is made of a high strength, substantially rigid, polymeric tubing, such as polyetheretherketone (PEEK), polyamide, polyimide, acetal, urethane, polyester, or other suitable like material.Leader tube 5 has an inner diameter of approximately 0.015 inches, an outer diameter of approximately 0.031 inches, and a length of approximately 24 inches. - Referring to
FIG. 1 , a distal end ofleader tube 5 is hollow and heat-set into a coil shape. The coil shape providesleader tube 5 with a more compact configuration prior to implantation ofsplint assembly 1. This compact configuration is especially important as the splint assembly rests in a sterile environment prior to the implantation procedure. Moreover, theleader tube 5 will be less cumbersome for a surgeon to handle due to its compactness. - Secured around
leader tube 5, preferably approximately 8 inches from its distal end, is astop band 7.Stop band 7 engages with a measuring/tightening device which will be described in more detail later during a discussion of the implantation procedure ofsplint assembly 1. Preferably, stopband 7 is swaged aboutleader tube 5 and further secured, if necessary, through the use of an adhesive, such as, for example urethane or epoxy, or other suitable adhesive. To provide a smooth, tapered transition betweenstop band 7 andleader tube 5, a “backfill” orfillet 7′ of adhesive is placed at the distal end ofstop band 7. Thisfillet 7′ permits a smooth engagement ofstop band 7 to the measuring and tightening device. The measuring and tightening device and the engagement ofstop band 7 with the device will be described later. - Referring to
FIG. 2A , which shows an enlarged view of region A-A inFIG. 2 , a portion ofleader tube 5 contains amandrel 6 within the lumen ofleader tube 5.Mandrel 6 is secured toleader tube 5 by, for example, a suitable adhesive, such as, epoxy, or other suitable means such as a friction fit withintube 5.Mandrel 6 provides stiffness and support toleader tube 5. Additionally,mandrel 6 provides a base structure upon which stopband 7 can be swaged, thereby strengtheningstop band 7. Preferably,mandrel 6 is made of stainless steel or other suitable material offering stiffness and support.Mandrel 6 extends within a proximal portion of leader tube 5 (closest to splint assembly 1) to a point withinleader tube 5 slightlypast stop band 7 before the coiled portion ofleader tube 5.Mandrel 6 also extends fromleader tube 5 and into a proximal end oftension member 2 to connectleader tube 5 withtension member 2. - Because the connection between
leader tube 5 andtension member 2 undergoes relatively, large tension stresses during tightening of the tension member, especially during implantation, which will be described later, the connection between the two should be strong. Thus, in a preferred embodiment,mandrel 6 includes alarger diameter portion 6′ at its proximal end withintension member 2. This larger diameter portion is formed by centerless grinding of all but the proximal end of thewire forming mandrel 6. In a preferred embodiment, this wire is fabricated from a 0.020 inch diameter Wire, with the ground portion having a diameter of 0.010 inch. -
Mandrel 6 is fixed within a distal end oftension member 2, which includes a covering 11 surrounding aninner cable 11′.Mandrel 6 and a surroundingmetallic tube 9 are covered with an adhesive 9′ and inserted approximately 0.3 inches inside the distal end oftension member 2. An externalmetallic tube 12 is placed around a distal portion of covering 11 andcable 11′ and is swaged down and secured thereto. An adhesive 12′ is disposed between externalmetallic tube 12 and covering 11 to more firmlysecure tension member 2 andtube 12. Furthermore, adhesive 12″ can be disposed at the distal end ofmetallic tube 12 to form a tapered connection betweenmetallic tube 12 andleader tube 5. Once adhesive 12′ is applied andtube 12 is swaged down,mandrel 6 andmetallic tube 9, andtension member 2 are secured together. A smooth and secure mechanical connection thereby results betweenleader tube 5 andtension member 2. -
Tension member 2, and particularlycable 11′, serves as the primary load-bearing component of the splint assembly. Therefore,cable 11′ preferably has a braided-cable construction, for example, a multifilar braided polymeric construction. In general, thefilaments forming cable 11′ should be high performance fibers. Preferably, filaments of ultra high molecular weight polyethylene, such as, for example, Spectra™ or Dyneema™, or some other suitable like material, such as polyester (e.g. Dacron™) or liquid crystal polymers (e.g. Vectran™), for example, will be used to form the braided cable. Filaments preferably are combined in yarn bundles of approximately 50 individual filaments, with each yarn bundle being approximately 180 denier. In a preferred arrangement, two bundles can be paired together (referred to as 2-ply) and then braided with approximately 16 total bundle pairs to formcable 11′. In this manner, the preferred braid includes approximately 20 to 50 picks per inch, and more preferably approximately 30 picks per inch, wherein one pick measured along the length ofcable 11′ is shown inFIG. 4 . Thus, making the braid as described results in an average diameter ofcable 11′ of approximately 0.030 to 0.080 inches, and preferably 0.055 inches, having approximately 1600 individual filaments. In cross-section, thebraided cable 11′ appears somewhat oval.FIG. 4 shows a magnified view of a cable made according to the preferred embodiment described. - The preferred embodiment of
cable 11′ providescable 11′ with several significant properties. First, the ultra high molecular weight polyethylene providescable 11′ with high strength characteristics. Thus,cable 11′ is able to withstand the constant tension that will be placed upon it during use within the heart. Additionally, this material has a high creep resistance, a high corrosion resistance, high fatigue resistance and is biostable. It is contemplated that other materials having similar properties also may be used to formcable 11′ and are within the scope of this invention. - Forming
cable 11′ as a braided structure, and preferably in the manner described above, further providescable 11′ with high endurance to cyclic fatigue and resistance to shape change without interfering with heart structure. Implantation in the heart subjectscable 11′, and thereforetension member 2, to a dynamic, and often cyclic, bending and stressing environment. A multifilar structure results in lower bending stresses than would otherwise occur in a solid structure. Moreover, a braided multifilar structure dissipates concentrated loads to adjacent filaments within relatively short distances as compared with a twisted multifilar structure. The braided structure also provides a simple, yet effective, way to anchortension member 2 to padassemblies - Experiments have shown that a
cable 11′ of the preferred diameter range of 0.030 to 0.080 inches, and most preferably 0.055 inches, results in a high break strength and a high resistance to creep failure under expected stress conditions when placed in the heart. This resistance to creep strength allowscable 11′ to maintain its shape throughout implantation and use of the device. Furthermore, a cable of the preferred diameter range permits pins to penetrate the cable to hold it in place in the fixed pad assembly. If the diameter were too small, the pins may pull on portions ofcable 11′, thus distorting the uniform shape of the cable. Additionally, it is important thatcable 11′ not have too large of a diameter. If the diameter is too large, blood flow in the chamber may be disrupted, increasing the risk of stasis or other flow disruptions, which can lead to thrombus formation and possible embolization. Moreover, an overly large diameter may result in damage to the tissue forming the heart wall at the implantation sites. Also, a larger diameter tension member increases difficulty of delivery and implantation in the heart. - Also under expected stress conditions when
cable 11′ is placed in the heart, the preferred range of picks per inch discussed above produces a braid that will resist fatigue and localized bending due to an increased hold strength. Experiments have shown that if the pick count is too low, for example below approximately 15 picks/inch, a low integrity, less stable braid having a tendency to unravel when connected to the pins, as will be described, will be produced. In addition, too low of a pick count results in less load sharing between yarn bundles and filaments, which, aside from contributing to a less stable braid structure, creates the potential for greater axial fatigue degradation. On the other hand, too high of a pick count, for example, above approximately 60 picks/inch, results in a braid that exhibits excessive wear due to contact stresses between the individual filaments, thereby presenting a risk of the filaments weakening and even fracturing. Moreover, such a high pick count creates a cable that is more susceptible to kinking. - As for the parameters of the yarn filament bundles themselves, pairing two bundles (i.e., two-ply) of 180 denier each has been shown to yield a high break strength, and also to assist in preventing creep under expected stress conditions when a
cable 11′ is placed in the heart. However, a finer yarn can be used if the number of bundles is increased, without departing from the desired strength and size of the overall braided cable. - Overall, the preferred combination of yarn density and material, together with the preferred pick count and cable diameter, results in an optimal tension member performance. That is, the tension member is capable of withstanding the cyclical stresses occurring within the heart chamber without breaking or weakening and a strong connection between the tension member and the pad assemblies can be achieved. Also, damage to internal vascular structure and the heart tissue, and obstruction of blood flow within the heart chamber can be avoided. Although the preferred parameters for the braid structure have been described above, it is contemplated that other combinations of material, yarn density, number of bundles, and pick count may be used, as long as the desired characteristics with respect to strength of the braid and interaction of the braid with the heart and blood are achieved.
- Covering 11 surrounding
cable 11′ also providestension member 2 with properties that facilitate implantation and use in the heart. Becausetension member 2 will be in blood contact as it resides within a chamber of the heart, covering 11 preferably providestension member 2 with resistance to thrombus generation. Furthermore, as a result of the relative motion that occurs between the heart and the portions oftension member 2 passing through the heart chamber wall, irritation of the heart wall may result. To alleviate such irritation, covering 11 preferably allows for tissue ingrowth to establish a relatively firm bond between the tension member and the heart wall, thus reducing relative motion between the two. - To achieve these advantages, covering 11 preferably is made of a porous expanded polytetrafluoroethylene (ePTFE) sleeve having an inner diameter of approximately 0.040 inches and a wall thickness of approximately 0.005 inches prior to placement around
cable 11′. The inner diameter of covering 11 stretches to fit aroundcable 11′, which preferably has a diameter of about 0.055 inches, resulting in a frictional fit between covering 11 andcable 11′. Preferably, covering 11, made of ePTFE, has an internodal distance of between 20 and 70 microns, and most preferably approximately 45 microns. This preferred internodal spacing achieves both secure tissue ingrowth of the adjacent heart wall by allowing cellular infiltration and creating a tissue surface on the outside of thetension member 2. The preferred internodal spacing also achieves a high resistance to thrombus. Furthermore, such a covering is biostable and tends not to degrade or corrode in the body. Althoughcable 11′ primarily bears the loads placed ontension member 2, covering 11 also must be adapted to withstand the cyclic bending environment occurring in the heart. The porous nature of covering 11, particularly having the internodal spacings discussed above, enables bending without creating high stress regions that may otherwise result in fatigue cracking of the covering if a solid structure were used. Although expanded PTFE has been described as the preferred material with which to make covering 11, other suitable materials exhibiting similar characteristics also are within the scope of the invention. - The remaining components of
splint assembly 1 shown inFIG. 1 include fixedpad assembly 3 andadjustable pad assembly 4. These pad assemblies essentially function as anchors that engage with the heart wall, providing a surface adjacent the exterior of the heart wall to which the tension member connects and which does not penetrate the heart wall.FIGS. 2 and 3 show details of fixedpad assembly 3 and its connection totension member 2. - As shown in
FIGS. 2 and 3 , fixedpad assembly 3 includes apad base 15 made of a rigid thermoplastic such as polyetheretherketone (PEEK), or other suitable like material, such as, for example, polysulfone, polymethylpentene, or polyacetal (Celon). The selected material should be machinable and, if desired, moldable.Pad base 15 preferably has a generally disc-shaped configuration with a diameter of approximately 1 cm to 3 cm, preferably approximately 1.9 cm, and a thickness of approximately 0.3 cm to 1.5 cm, preferably 0.9 cm. Asurface 16 adjacent the heart wall preferably is slightly convex with a radius of curvature of approximately 0.25 in. to 1.0 in, preferably approximately 0.5 in. Providing such a smooth,rounded surface 16 adjacent the heart wall tends to reduce localized compressive pressures that may otherwise be exerted on the heart wall. Such reduction in localized compressive pressure reduces the risk of necrosis of the heart tissue, which ultimately could lead topad base 15 migrating through the thickness of the heart wall. - The preferred ranges for the diameter of
pad base 15 discussed above results in optimal shape change and compressive forces on the heart chamber. Experiments have shown that if the pad base diameter is too large, i.e., above the high end of the preferred range discussed above, an optimal bi-lobed shape change to the heart chamber does not result. That is, the heart wall at the locations of excessively large pads tend to flatten out such that the radius of curvature at those locations is essentially zero. Overly large pad base diameters also make it difficult to place the pad assembly to avoid damaging vasculature of the heart. On the other hand, the experiments have shown that if the diameter is below the low end of the preferred range, the tension that is placed on the large tension member to draw the heart walls together will result in a compressive force on the heart that is too large, thus causing necrosis of the heart tissue. Such necrosis of the tissue likely will cause the pad to migrate into the heart wall of the ventricle. The diameter ofpad base 15 should therefore be large enough to prevent such migration. The preferred pad base dimensions indicated above take these considerations into account, preventing migration and preventing undesirable shape changes of the heart wall. - A
channel 17 extends through approximately the center ofpad base 15 from anouter surface 19 to innerconvex surface 16.Channel 17 has a diameter of approximately 0.062 inches through whichtension member 2 passes. Atinner surface 16,channel 17 has a slightly rounded, or tapered, opening 17′ leading intochannel 17. The taperedopening 17′ has a radius of curvature of approximately 0.062 inches at the inlet into the pad and a diameter of approximately 0.064 inches. The opening tapers to thechannel 17. This tapered opening, which has a diameter larger thantension member 2 permitstension member 2 to gently curve aroundinner surface 16 as relative bending occurs, as opposed to having a sharp bend that would otherwise result if the diameter were not enlarged in this region. This tapered opening decreases localized stresses in the region oftension member 2 near the opening to channel 17 that would occur during cyclical motion of the heart. Also, the diameter ofchannel 17 is slightly larger than the diameter oftension member 2 to permit room for the pins to penetrate the tension member to secure the tension member and pad together. - Two
channels 18 extend in direction parallel tosurfaces pad base 15.Channels 18 house fixation members, such as sharpened pins 14.Channels 18 preferably have a smaller diameter than the pin diameters to create a press fit during connection of fixedpad assembly 3 totension member 2. For example,channels 18 preferably have a diameter of approximately 0.028 inches, as opposed to pin diameters of approximately 0.030 inches. - A preferred embodiment of
pad base 15 includes acircumferential groove 20 adjacent toouter surface 19, as shown inFIG. 2 .Circumferential groove 20 accomodates windings ofsuture 21 to be secured to padbase 15. In this way, a pad covering 13 (shown inFIG. 2 ) can be placed overinner surface 16 and sides ofpad base 15 and secured with respect thereto viasuture windings 21. Any excess pad covering extendingpast suture windings 21 can be trimmed off. Pad covering 13 preferably is made of a velour woven polyester material, such as Dacron™, or other suitable like material, such as, for example, expanded polytetrafluoroethylene (ePTFE). The pad covering facilitates ingrowth of the heart wall tissue to secure pad base and thereby prevent long-term, motion-induced irritation of the outside of the heart wall. A hole disposed in approximately the center of the pad covering enables the passage oftension member 2. A similar pad covering connects in the same manner to a circumferential groove and sutures located onadjustable pad assembly 4, as will be described later. - To secure fixed
pad assembly 3 totension member 2, fixation members, such aspins 14, extend throughchannels 18 and penetrate through covering 11 andcable 11′.Pins 14 can be sharpened on their ends to more easily pierce through covering 11 andcable 11′. As shown inFIG. 2 ,tension member 2 folds over withinpad base 15 in a U-shaped configuration. In this way, pins 14 each penetrate at an additional site alongtension member 2 to provide a stronger connection betweentension member 2 and fixedpad assembly 3. The penetration of eachpin 14 through two points ofbraided cable 11 provides a reliable connection. This is due to the fact that the braided structure tends to transfer the contact load produced bypins 14 against the filament bundles and to all of the filaments forming braidedcable 11′, essentially resulting in a load distribution between the pins and filaments. - A reliable connection could be produced using only a single pin penetrating through the tension member at a single location. However, providing more than one pin and
folding tension member 2 into the U-shaped configuration so that each pin intersectstension member 2 at more than one location offers additional strength to the connection. In essence, this configuration serves as a safety back-up should the connection at a single pin/cable interface become unsecure. Unless a failure at one of the pin sites occurs, however, it is expected that the intersection between the distal-most pin and the location where that pin first intersectstension member 2, astension member 2 enterspad base 15, will carry substantially all of the load transferred bytension member 2. This intersection site is labeled as 14 a inFIG. 2 . - It is preferable for
pins 14 to penetratetension member 2 at approximately the center of the cable to provide the most secure connection. Thus, approximately half of the filament bundles comprising the entire cable will be on one side of a pin and half on the other side. Such a placement ofpins 14 assists in inhibiting distortion of the braided structure resulting from a non-equal distribution of the load on the various filaments. Additionally, to inhibit distortion oftension cable 11′, preferably a relatively dense braid is formed (i.e., in terms of both pick count and number of bundles) so pins 14 can penetrate and be secured without risk of pulling out or unraveling the braid. - Furthermore, some length of
cable 11′ should extend on either side ofpins 14 so that pins 14 are not easily pulled through the braid along the length of the braid. In this manner, preferably, at least one ofpins 14 penetratescable 11′ at a location that leaves a length of cable of approximately 1 to 2 centimeters. For example, the folded over configuration oftension member 2 within fixedpad assembly 3 serves to prevent bothpins 14 from becoming disengaged withtension member 2 as a result ofcable 11′ unraveling at its end. To further prevent unraveling ofcable 11′,tension member 2 can be thermally treated or otherwise fused together at its end. - In a preferred embodiment, fixed
pad assembly 3 includes twopins 14 of approximately 0.025 to 0.035 inches in diameter and length slightly less than the pad base diameter, as shown inFIG. 2 .Pins 14 can be formed of a relatively hard, corrosion-resistant material, such as, for example, a cobalt-nickel-chromium-molybdenum alloy, such as MP 35N, other cobalt-chrome alloys, stainless steel, or other suitable materials having similar characteristics. At least one end of each pin preferably is sharpened to facilitate penetration oftension cable 11′ and covering 11. - With reference to
FIGS. 1 and 5 -7,adjustable pad assembly 4 and its connection totension member 2 will now be described. The general outer configuration ofadjustable pad assembly 4 is similar to that of fixedpad assembly 3. That is,adjustable pad assembly 4 includes a convexinner surface 47 that engages with an exterior of the heart wall whensplint assembly 1 is implanted in the heart. Also, near anouter surface 48 ofadjustable pad assembly 4 is acircumferential groove 80 withsuture windings 81. Although not shown in the Figures, it is contemplated that a pad covering of the type described with reference to fixedpad assembly 3 will be provided and secured viasuture windings 81 to facilitate tissue ingrowth betweenadjustable pad assembly 4 and the heart wall. -
FIGS. 5-7 depict the inner components ofadjustable pad base 24. As shown,pad base 24 includes a plurality of channels. Achannel 25 through whichtension member 2 passes extends, throughpad base 24 in a manner similar tochannel 17 passing throughpad base 15 of fixedpad assembly 3.FIGS. 5 and 6 more clearly show thetapered opening 25′ of this channel 25 (similar to channel 17), which permitstension member 2 to gently curve at the surface ofadjustable pad assembly 4. However, unlikechannel 17,channel 25 inadjustable pad assembly 4 includes a further reduction in diameter, preferably approximately 0.059 inches, near anouter surface 48 ofpad base 15. This reduction in diameter helps to assure that the braid ofcable 11′ is centered inchannel 25 prior to fixation oftension member 2 toadjustable pad assembly 4. It is important forcable 11′ to be centered withinchannel 25 to ensure that a fixation or securement member, for example in the form of a staple 23, used to securetension member 2 toadjustable pad assembly 4, penetratescable 11′ in its center. In this manner, the yarn bundles ofcable 11′ evenly divide on either side ofstaple 23 to evenly distribute the load totension member 2.Channel 17 in fixedpad base 3 does not require such a reduced diameter region since the securement oftension member 2 to fixedbad assembly 3 occurs under controlled factory conditions prior to implantation ofsplint assembly 1 in the heart. - A pair of
staple leg channels 26 extend throughpad base 24 substantially perpendicular to channel 25 and parallel toinner surface 47 andouter surface 48 ofpad base 24. The pair ofchannels 26 merges into a single staple leg channel disposed on one side ofchannel 25.Channels 26 receivelegs 27 of a staple 23 and are sized to enablestaple 23 to slide along the channels from a retracted position (shown inFIG. 6 ) to an advanced position (shown inFIG. 7 ) upon actuation of adeployment tool 22, as will be described. - A
channel 28 extends between and parallel tostaple leg channels 26.Channel 28 is formed within one side of pad base 24 (on the side of a base 23′ ofstaple 23 opposite to the side from whichlegs 27 extend) and extends for approximately two-thirds of the distance measured from the side ofpad base 24 to the center ofpad base 24. Adeployment tool channel 31 begins at the end ofchannel 28 and extends through the remaining diameter ofpad base 24. Deployment tool channel is radially offset fromchannel 28 and extends throughpad base 24 so as to avoid intersection withchannel 25. - A
pre-deployment safety pin 32 is located approximately in the center of the portion ofchannel 28.Pre-deployment safety pin 32 extends essentially perpendicularly to channel 28 and engages withbase 23′ ofstaple 23 betweenstaple legs 27 prior to actuation ofstaple 23. This engagement tends to holdstaple 23 in place to prevent premature advancement. - A
side channel 33 also is formed inpad base 24.Side channel 33 extends perpendicularly tostaple leg channels 26.Side channel 33 begins on either surface 47 (which engages the heart wall) or surface 48 (which faces away from the heart wall) and extends to approximately the end ofchannel 28, near the beginning ofdeployment tool channel 31. Apost-deployment safety pin 34 is disposed inside channel 33.Post-deployment safety pin 34 has a deflected configuration as it resides inside channel 33, pressing on the side of one ofstaple legs 27. - After
tension member 2 has been extended transverse a heart chamber, for example, the left ventricle, such that the free end oftension member 2 extends through the heart wall at a location opposite to fixedpad assembly 3,leader tube 5 andtension member 2 are fed throughchannel 25 ofadjustable pad assembly 4. Next, a measuring/tightening device, which will be described in more detail shortly, is used to determine and adjust the proper tension member length between fixedpad assembly 3 andadjustable pad assembly 4. This length is the length that is desired for the final implantation ofsplint assembly 1 in the heart. The determination of this length and the measuring and tightening procedure have been described in prior U.S. application Ser. No. 09/123,977, filed Jul. 29, 1998, and entitled “Transventricular Implant Tools and Devices,” the complete disclosure of which is incorporated by reference herein. In general, the final length of the tension member when placed in the heart corresponds to a predetermined desired percentage reduction of the heart chamber diameter and the actual measured heart chamber diameter, which may differ from patient to patient. - Once the desired implant length of
tension member 2 has been determined,adjustable pad assembly 4 is placed in the proper position ontension member 2, withsurface 47 engaging the outer surface of the heart wall. Adeployment tool 22, shown inFIGS. 8 and 9 is used to secureadjustable pad assembly 4 into place ontension member 2. As mentioned earlier, adeployment tool 22 is pre-engaged withadjustable pad assembly 4. That is,deployment tool 22 includes anengagement collar 35 disposed inchannel 28, as shown inFIG. 5 , and an actuator wire 36 (not shown inFIG. 5 ) connected toengagement collar 35 at one end and to anactuator knob 37 at the other end. Thus, in the pre-deployment condition ofstaple 23,engagement collar 35 rests againststaple base 23′ and actuator wire extends fromengagement collar 35 and through the entire diameter ofpad base 24 exiting at aside 45 ofpad base 24. Atsurface 45 ofpad base 24,deployment tool channel 31 ends in acountersink region 38. At this location,actuator wire 36 runs through the center of, but is not affixed to, anouter coil 39. Acollar 40 surrounds bothouter coil 39 andactuator wire 36.Collar 40 rests within countersinkregion 38, essentially providing an abutment surface withinpad base 24 that creates a counter-resistant force enablingactuator wire 36 to be pulled throughpad base 24. - Referring to
FIG. 9 ,actuator wire 36 andouter coil 39 connect to a threadedbase portion 41 ofdeployment tool 22.Outer coil 39 terminates within threadedbase portion 41.Actuator wire 36 continues through-threadedbase portion 41 and into anactuator 37.Actuator 37 also includes threads that engage with the threads of threadedbase portion 41 at aninterface 30.Actuator wire 36 fixedly attaches by a crimp fit 42 to a proximal end ofactuator 37. Anactuator knob 43 preferably is fixedly mounted to the distal end ofactuator 37 to provide an ergonomic surface for a user to actuatedeployment tool 22. - To deploy
staple 23,actuator knob 43 is turned. This rotatesactuator 37 with respect to threadedbase portion 41, essentially unscrewingactuator 37 from threadedbase portion 41. Asactuator 37 turns,actuator wire 36 is pulled throughouter coil 39, exerting a force onengagement collar 35. Continued rotation ofactuator 37 further pulls onactuator wire 36 andengagement collar 35.Engagement collar 35 thus movesstaple 23 withinadjustable pad assembly 4 to movestaple legs 27 alongchannels 26.Staple legs 27 eventually are pulled acrosschannel 25, piercing throughtension member 2 in approximately the center thereof. - To avoid damage to staple 23,
actuator wire 36 preferably rotates with respect toengagement collar 35 asactuator 37 turns without exerting any rotational forces uponengagement collar 35. In this manner,engagement collar 35 simply pushes againststaple 23, but does not translate with respect to the staple surface. Thus, abrasive forces acting onstaple 23 are avoided, which otherwise may cause scratches and lead to corrosion of the staple. In addition, excessive torque onactuator wire 36 byengagement collar 35 will be prevented. - As
staple 23 moves withinpad base 24, thebase portion 23′ ofstaple 23 bendspre-deployment safety pin 32 into the position illustrated inFIG. 7 . Movement ofstaple 23 withinpad base 24 continues untilengagement collar 35 entersdeployment tool channel 31. At this point, the inner surface ofbase 23′ ofstaple 23 is disposed near or atabutment wall 29 ofpad base 24. Oncestaple 23 advances to this position,base 23′ has traversedpast side channel 33. Thus,post-deployment safety pin 34 moves throughside channel 33 and intodeployment tool channel 31, as shown inFIG. 7 .Post-deployment safety pin 34 moves to a perpendicular position, to serve as a mechanism for preventingstaple 23 from moving back intostaple leg channels 27.Abutment wall 29 prevents staple 23 from moving in the other direction throughpad base 24. Preferably, after deflection,pre-deployment safety pin 32 does not lie entirely flush withinchannel 28 but rather deflects back up so that it extends slightly outside ofchannel 28. Thus,pre-deployment safety pin 32 serves as a safety backup to maintain the advanced position ofstaple 23 ifpost-deployment safety pin 34 should for some reason fail to do so. - Preferably, both pre-deployment and post-deployment safety pins are press-fit within
pad base 24. The pre-deployment safety pin preferably has a diameter of approximately 0.025 inches and the post-deployment safety pin preferably has a diameter of approximately 0.016 inches. The pre-deployment pin preferably is made of annealed MP35N and the post-deployment pin preferably is made of spring-tempered MP35N. The annealing ofpre-deployment pin 32 facilitates the formation of the permanent bend upon deflection resulting from advancingstaple 23. The spring-tempering ofpost-deployment pin 34 enables the pin to recover to a relatively straight condition once the staple is fully deployed. It is contemplated that other means for moving pre- and post-deployment pins into their respective positions prior to and after deployment ofstaple 23, as well as other diameters and materials of such pins, are within the scope of this invention. For example, the pins could be spring-activated with a bias in a particular direction such that the pins would move into their appropriate positions during deployment ofstaple 23. - Although pre- and
post-deployment safety pins tension member 2 and retracting back into its initial position withinpad base 24, it should be noted thattension member 2 itself serves as the primary mechanism for preventing retraction ofstaple 23. That is, the force exerted bytension member 2 ontostaple 23 as a result of tighteningtension member 2 in place with respect to the heart chamber tends to prevent staple 23 from moving. Due to this relatively large force exerted betweentension member 2 andstaple 23, it is preferred to leave a length oftension member 2 of approximately 1 cm to 2 cm extending beyond the distal end of the distal moststaple leg 27 to prevent staple 23 from pulling through the length oftension member 2. Leaving this length oftension member 2 is even more desirable in the connection oftension member 2 toadjustable pad assembly 4 than it is for fixedpad assembly 3 sincetension member 2 is not folded over in the former. Moreover, as will be explained, it is preferred to melt or otherwise fuse the end oftension member 2 to prevent unraveling ofcable 11′. - Once
staple 23 has been deployed throughtension member 2 and can no longer move withinpad base 24,engagement collar 35 drops intodeployment tool channel 31. By continuing to pull onactuator wire 36,engagement collar 35 can be pulled throughdeployment tool channel 31 and the entire deployment tool (includingactuator wire 36 and engagement collar 35) can be removed fromadjustable pad assembly 4. - After removing
deployment tool 22,leader assembly 10 can be separated fromtension member 2 using a conventional cauterizing pen, or other suitable like instrument. The end oftension member 2 left protruding fromadjustable pad assembly 4 is also heated, or melted, and essentially fused together as a result of using the cauterizing pen toseparate leader assembly 10. By fusing the end oftension member 2, the filaments ofcable 11′ and covering 11 are joined to prevent potential unraveling of the tension member braid. Other suitable mechanisms for severing the leader from the tension member and for fusing the tension member end also are within the scope of the invention. For example, although it is preferred to use the single step to both sever the leader assembly and fuse the tension member, it is also contemplated that the severing and fusing steps can be performed as separate steps. - Another aspect of the invention, described herein with reference to
FIGS. 10-12 , includes various location and identification tools for assisting in the optimal placement ofsplint assembly 1 with respect to a heart chamber to avoid damage to both internal cardiac structures, such as the papillary muscles, and external structures, such as blood vessels. Moreover, the tools assist in the placement of splint assemblies to effectively bisect the ventricle to result in optimal radius reduction and stress reduction. - Although a number of possible orientations for splint placement are possible, in the surgical procedure of the present invention, preferably the splint assembly will be placed across the left ventricle in a plane essentially longitudinally bisecting the ventricle. The splint assembly should extend from a location proximate to the anterior papillary muscle on the ventricle free wall to a location proximate to the posterior ventricular septum. The preferred location for the splint assembly near the anterior papillary muscle is just lateral to that muscle, while the preferred location near the septum is on the posterior free wall of the right ventricle.
FIG. 13 shows this preferred placement of a splint assembly. - In a preferred embodiment of the invention, as shown in
FIG. 14 , threeindividual splint assemblies 1 are implanted. The upper-most (basal) splint assembly is placed according to the description above. The remaining two splint assemblies will be positioned in an equidistant relationship between the basal splint assembly and the apex of the left ventricle. In this manner, the three splint assemblies essentially bisect the ventricle, producing optimal radius and stress reduction without excessive ventricular volume reduction. The positioning of the splint assemblies in this way also avoids interference with the mitral valve structure, including the chordae tendonae. Additionally, the positions described effectively avoid significant coronary arteries or veins. - Various types of surgical techniques can be employed to implant the splint assemblies of the present invention, including minimally invasive techniques through access ports, or endovascular techniques not requiring opening of the chest wall. These splint assemblies also could be implanted as an adjunct to other surgical procedures, such as, for example, CABG or mitral valve replacement. However, a preferred method of implanting the splint assemblies includes through an open chest sternotomy without cardiopulmonary bypass. The description of the identification and location tools and methods for implanting the splint assemblies that follows thus relates to such an open sternotomy procedure.
- Visualization of the internal structures of the heart, including both the papillary muscles and the septum, typically occurs through the use of external imaging methods, since the internal structures can generally not be discerned from outside the heart chamber. A preferred external imaging method includes the use of ultrasound probes. Ultrasound probes can either be used direcly in contact with the outside of the heart or can be positioned in the patient's esophagus (transesophageal)
- A probe/marking
device 50, shown inFIG. 10 , operates to both locate positions on the heart wall for splint placement and simultaneously deliver a marker into the heart wall to mark each location.Marker 60, shown inFIG. 12 , is initially preloaded within atube 51, shown inFIG. 11 .Tube 51 houses the entire structure ofmarker 60 with the exception of a penetratingtip 65, which extends from a distal end oftube 51.Marker 60 thus can easily be removed fromtube 51. Mounted on an exterior surface oftube 51 is anadvancer button 54, the function of which will become apparent shortly. - Probe/marking
device 50 includes ahollow handle portion 53, ashaft 52, and aprobe tip 58.Handle 53 defines aslot 57 which opens at a proximal end and is configured to receiveadvancer button 54, as will be described shortly.Shaft 52 preferably is relatively rigid and may be curved as well, as shown inFIG. 10 , to facilitate access to the exterior heart wall. Probetip 58 preferably has an essentially conical shape with three flat angular faces. As shown inFIG. 10A , the three angular faces meet at the distal most portion oftip 58 to define anopening 56 through whichmarker 60 is configured to pass upon delivery. Probetip 58 should be made of a material having a density that is sufficiently different than the myocardium in order to enhance echovisualization. A preferred material exhibiting this characteristic is a metal, such as stainless steel, for example, with a polyester covering such as Dacron™, or other suitable like material, that provides a gripping surface with respect to the heart tissue, to help stabilize the position oftip 58 with respect to the heart wall during indentation. The diameter of the proximal portion oftip 58 that connects toshaft 52 is approximately 0.375 in. This configuration aids in creating a distinct, localized deflection upon contact and indentation of the heart wall. Furthermore, the flat angular faces enhance the visualization ofprobe tip 58 using ultrasound since the reflections off of the edges of the faces produce more discrete lines on the echo-image and the flat faces tend to reflect the ultrasound signals to a greater extent than a curved face. - Prior to use, a physician inserts the distal end of a
tube 51 preloaded withmarker 60 into the proximal end ofhandle 53 of probe/markingdevice 50. Astube 51 is inserted,advancer button 54 slides intoslot 57.Tube 51 is inserted into probe/markingdevice 50 until abase 55 ofadvancer button 54, which connectsadvancer button 54 totube 51, engages with a detent mechanism (not shown) formed inhandle 53. In this position,marker tip 66 is disposed at a location just proximal to the distal end ofprobe tip 58. Also, a portion of the proximal end oftube 51 extends from the proximal end ofhandle 53 of probe/markingdevice 50. Probetip 58 is then iteratively pressed against the outside of the heart wall to create localized indentations. Using ultrasound or other like imaging method, the physician can concurrently visualize these localized indentations, as well astip 58, to determine the position of the indentations relative to internal heart structures. In addition, the flat faces and preferred material ofprobe tip 58 tend to create a shadow that can be seen in the ultrasound picture, thus improving visualization. - Upon finding a desired splint placement location,
advancer button 54 is moved forward until it abuts the end ofslot 57 defined byhandle 53. Movingadvancer button 54 forward withinslot 57 in turn movestube 51 forward so as to movemarker tip 66 through opening 56 ofprobe tip 58.Marker tip 65 thus movespast probe tip 58 and into the heart wall. -
FIG. 12 shows details of apreferred marker 60 to be used with inventive probe/markingdevice 50.Marker 60 includes a penetratingtip 65 and asuture line 70. Penetratingtip 65 includes a sharpened, conical-shapedend 66 to facilitate shallow penetration into the wall of the heart by spreading the heart wall tissue. The remainingportion 67 of penetratingtip 65 extending from conical-shapedend 66 has a cylindrical configuration. A series ofdeflectable barbs 68 protrude radially around the surface ofcylindrical portion 67.Barbs 68 essentially act as gripping members to engage with the heart wall and securely holdmarker 60 in place until removal is desired. Upon a sufficientforce pulling marker 60 away from the heart wall,barbs 68 relatively easily disengage from heart wall tofree marker 60. - Penetrating
tip 65 preferably is constructed from PEEK, or other suitable biocompatible material, such as, for example, polyimide, polyamide, acetal, urethane, or polyester, and has a length less than the thickness of the heart wall and preferably of approximately 0.156 inches, and a diameter preferably of approximately 0.030 inches.Barbs 68 preferably extend fromcylindrical portion 67 of penetratingtip 65 at angles ranging from approximately 10 degrees to approximately 45 degrees, and have respective lengths of 0.005 inches measured from the outer surface ofcylindrical portion 67. - A
suture line 70 attaches to a proximal end of penetratingtip 65.Suture line 70 can either be formed by necking and drawing the back end of penetratingtip 65 or can be a standard suture material secured directly to penetratingtip 65 by, for example, a knot. Such a standard suture material includes 3-0 polyester, but other materials known in the art also may be utilized.Suture line 70 has a length of approximately 2 to 14 inches, thus allowing the marker to be seen more readily, as well as enabling a surgeon to locate the marker through tactile sensation. - In a preferred form of the invention, the preloading of
marker 60 intotube 51 is preferably performed at a factory prior to implantation, with a number of marker-preloadedtubes 51 being supplied for the splint implantation procedure. Most preferably, 6 preloadedtubes 51 will be supplied for an implantation procedure to deliver six markers corresponding to the intersection points of each of three splint assemblies implanted into the heart, as shown inFIG. 14 . After eachmarker 60 is delivered,tube 51 is removed from probe/markingdevice 50 and disposed of as appropriate. A new preloadedtube 51 is thereafter inserted for delivery of thenext marker 60. - Thus, the locating and marking procedure can be repeated at each splint assembly positioning location on both sides of the heart chamber in the manner described above. The various splint assemblies are then delivered to each of the locations of the heart indicated by each of the delivered markers. The markers are removed once delivery of the splint assembly is complete.
- Various delivery techniques have been described in prior applications, such as U.S. patent application Ser. No. 09/123,977, filed on Jul. 29, 1998, and entitled “Transventricular Implant Tools and Devices,” the entire disclosure of which is incorporated herein by reference. Briefly, the delivery of a splint assembly proceeds in the following manner. Once markers have been delivered to heart wall on both sides of the chamber, an alignment clamp is positioned around the heart at those locations. The alignment clamp includes a guide tube, through which a needle is first delivered at the marker locations to penetrate the heart wall. The needle is extended transverse the heart such that each end of the needle penetrates locations on the heart wall corresponding to the ends of the splint assembly to be implanted. The needle defines a lumen extending along its length, through which
leader tube 5 andtension member 2 are inserted via the guide tube in the alignment clamp. Onceleader tube 5 extends through the second marker location, it can be pulled which in turn pullstension member 2 across the heart wall.Leader tube 5 should be pulled until fixedpad assembly 3 engages the exterior surface of the heart wall. The needle can then be removed from the heart by pulling it off the free end ofleader tube 5. Similarly,markers 60 also can be removed from the heart wall, either before or after removing the needle. - Next,
leader tube 5 is fed into a measuring and tightening device, which also has been described previously in U.S. application Ser. No. 09/123,977. Essentially stopband 7 onleader tube 5 engages with the measuring and tightening device, andleader tube 5 can be pulled a predetermined distance to tightentension member 2 to a desired length between fixedpad assembly 3 andadjustable pad assembly 4.Stop band 7 is originally affixed toleader tube 5 at a known distance from fixedpad assembly 3. Thus, upon engagement ofstop band 7 with the measuring and tightening device, it may be determined how much to pullleader tube 5 to adjust the length oftension member 2 that will extend between the two pad assemblies.Stop band 7 serves as a marker to align with a measurement scale on the measuring and tightening device. - Once
tension member 2 has been adjusted to the desired length,adjustable pad assembly 4, previously fed ontoleader tube 5 andtension member 2, is secured totension member 2 adjacent the exterior of the heart wall in the manner described above with reference to the description ofFIGS. 5-9 - Although preferably three splint assemblies are placed with respect to the heart, the methods described above to place the splint assemblies with respect to the heart can be repeated for other desired numbers of splint assemblies to achieve a particular configuration. The length of the tension members extending between the fixed and adjustable pad assemblies also can be optimally determined based upon the size and condition of the patient's heart. It should also be noted that although the left ventricle has been referred to here for illustrative purposes, the apparatus and methods of this invention can be used to splint multiple chambers of a patient's heart, including the right ventricle or either atrium.
- Furthermore, the alignments shown in
FIGS. 13 and 14 are illustrative only and may be shifted or rotated about a vertical axis generally disposed through the left ventricle and still avoid the major coronay vessels and papillary muscles. - In addition, the inventive device and methods can be implanted to treat a heart having aneurysms or infarcted regions similar to those described in prior U.S. application Ser. No. 09/422,328 discussed earlier herein.
- Other mechanisms for locating and marking the positions on the heart wall through which to implant the splint assemblies are also within the scope of the present invention. Several of these techniques have been described in prior U.S. application Ser. No. 09/123,977, filed Jul. 29, 1998.
- The various components of the splint assembly to be implanted in the heart should be made of biocompatible material that can remain in the human body indefinitely. Any surface engaging portions of the heart should be atraumatic in order to avoid tissue damage.
- It will be understood that this disclosure, in many respects, is only illustrative. Changes may be made in details, particularly in matters of shape, size, material, number and arrangement of parts without exceeding the scope of the invention. Accordingly, the scope of the invention is as defined in the language of the appended claims.
- Other embodiments of the invention will be apparent to those skilled in the art from consideration of the specification and practice of the invention disclosed herein. It is intended that the specification and examples be considered as exemplary only, with a true scope and spirit of the invention being indicated by the following claims.
Claims (26)
Priority Applications (1)
Application Number | Priority Date | Filing Date | Title |
---|---|---|---|
US11/368,445 US20060149123A1 (en) | 2000-03-21 | 2006-03-07 | Splint assembly for improving cardiac function in hearts, and method for implanting the splint assembly |
Applications Claiming Priority (3)
Application Number | Priority Date | Filing Date | Title |
---|---|---|---|
US09/532,049 US6537198B1 (en) | 2000-03-21 | 2000-03-21 | Splint assembly for improving cardiac function in hearts, and method for implanting the splint assembly |
US10/278,847 US7044905B2 (en) | 2000-03-21 | 2002-10-24 | Splint assembly for improving cardiac function in hearts, and method for implanting the splint assembly |
US11/368,445 US20060149123A1 (en) | 2000-03-21 | 2006-03-07 | Splint assembly for improving cardiac function in hearts, and method for implanting the splint assembly |
Related Parent Applications (1)
Application Number | Title | Priority Date | Filing Date |
---|---|---|---|
US10/278,847 Continuation US7044905B2 (en) | 2000-03-21 | 2002-10-24 | Splint assembly for improving cardiac function in hearts, and method for implanting the splint assembly |
Publications (1)
Publication Number | Publication Date |
---|---|
US20060149123A1 true US20060149123A1 (en) | 2006-07-06 |
Family
ID=24120173
Family Applications (3)
Application Number | Title | Priority Date | Filing Date |
---|---|---|---|
US09/532,049 Expired - Lifetime US6537198B1 (en) | 2000-03-21 | 2000-03-21 | Splint assembly for improving cardiac function in hearts, and method for implanting the splint assembly |
US10/278,847 Expired - Lifetime US7044905B2 (en) | 2000-03-21 | 2002-10-24 | Splint assembly for improving cardiac function in hearts, and method for implanting the splint assembly |
US11/368,445 Abandoned US20060149123A1 (en) | 2000-03-21 | 2006-03-07 | Splint assembly for improving cardiac function in hearts, and method for implanting the splint assembly |
Family Applications Before (2)
Application Number | Title | Priority Date | Filing Date |
---|---|---|---|
US09/532,049 Expired - Lifetime US6537198B1 (en) | 2000-03-21 | 2000-03-21 | Splint assembly for improving cardiac function in hearts, and method for implanting the splint assembly |
US10/278,847 Expired - Lifetime US7044905B2 (en) | 2000-03-21 | 2002-10-24 | Splint assembly for improving cardiac function in hearts, and method for implanting the splint assembly |
Country Status (6)
Country | Link |
---|---|
US (3) | US6537198B1 (en) |
EP (1) | EP1265534B1 (en) |
AT (1) | ATE268143T1 (en) |
AU (1) | AU2001247602A1 (en) |
DE (1) | DE60103618T2 (en) |
WO (1) | WO2001070116A1 (en) |
Cited By (58)
Publication number | Priority date | Publication date | Assignee | Title |
---|---|---|---|---|
US20040260317A1 (en) * | 2003-06-20 | 2004-12-23 | Elliot Bloom | Tensioning device, system, and method for treating mitral valve regurgitation |
US20060089711A1 (en) * | 2004-10-27 | 2006-04-27 | Medtronic Vascular, Inc. | Multifilament anchor for reducing a compass of a lumen or structure in mammalian body |
US20070025009A1 (en) * | 2005-07-29 | 2007-02-01 | Fuji Photo Film Co., Ltd. | Magnetic recorder |
US20070066863A1 (en) * | 2005-08-31 | 2007-03-22 | Medtronic Vascular, Inc. | Device for treating mitral valve regurgitation |
US20070203391A1 (en) * | 2006-02-24 | 2007-08-30 | Medtronic Vascular, Inc. | System for Treating Mitral Valve Regurgitation |
US20070265658A1 (en) * | 2006-05-12 | 2007-11-15 | Aga Medical Corporation | Anchoring and tethering system |
US20080065046A1 (en) * | 2006-09-08 | 2008-03-13 | Sabbah Hani N | Intramyocardial patterning for global cardiac resizing and reshaping |
US20080269720A1 (en) * | 2007-04-11 | 2008-10-30 | Sabbah Hani N | Cardiac repair, resizing and reshaping using the venous system of the heart |
WO2008121880A3 (en) * | 2007-03-30 | 2008-12-18 | Micardia Corp | Adjustable annuloplasty ring and activation system |
US20090012413A1 (en) * | 2006-09-08 | 2009-01-08 | Sabbah Hani N | Cardiac patterning for improving diastolic function |
US20090259212A1 (en) * | 2008-04-10 | 2009-10-15 | Sabbah Hani N | Apparatus and method for controlled depth of injection into myocardial tissue |
US7666224B2 (en) | 2002-11-12 | 2010-02-23 | Edwards Lifesciences Llc | Devices and methods for heart valve treatment |
US7678145B2 (en) | 2002-01-09 | 2010-03-16 | Edwards Lifesciences Llc | Devices and methods for heart valve treatment |
US7883539B2 (en) | 1997-01-02 | 2011-02-08 | Edwards Lifesciences Llc | Heart wall tension reduction apparatus and method |
US8206280B2 (en) | 2007-11-13 | 2012-06-26 | C. R. Bard, Inc. | Adjustable tissue support member |
US8425455B2 (en) | 2010-03-30 | 2013-04-23 | Angiodynamics, Inc. | Bronchial catheter and method of use |
US8465500B2 (en) | 2005-01-21 | 2013-06-18 | Mayo Foundation For Medical Education And Research | Thorascopic heart valve repair method and apparatus |
US8480559B2 (en) | 2006-09-13 | 2013-07-09 | C. R. Bard, Inc. | Urethral support system |
US8758393B2 (en) | 2007-10-18 | 2014-06-24 | Neochord, Inc. | Minimally invasive repair of a valve leaflet in a beating heart |
US8845512B2 (en) | 2005-11-14 | 2014-09-30 | C. R. Bard, Inc. | Sling anchor system |
US9044221B2 (en) | 2010-12-29 | 2015-06-02 | Neochord, Inc. | Exchangeable system for minimally invasive beating heart repair of heart valve leaflets |
US9198757B2 (en) | 2000-10-06 | 2015-12-01 | Edwards Lifesciences, Llc | Methods and devices for improving mitral valve function |
US9598691B2 (en) | 2008-04-29 | 2017-03-21 | Virginia Tech Intellectual Properties, Inc. | Irreversible electroporation to create tissue scaffolds |
US9757196B2 (en) | 2011-09-28 | 2017-09-12 | Angiodynamics, Inc. | Multiple treatment zone ablation probe |
US9867652B2 (en) | 2008-04-29 | 2018-01-16 | Virginia Tech Intellectual Properties, Inc. | Irreversible electroporation using tissue vasculature to treat aberrant cell masses or create tissue scaffolds |
US9888956B2 (en) | 2013-01-22 | 2018-02-13 | Angiodynamics, Inc. | Integrated pump and generator device and method of use |
US9895189B2 (en) | 2009-06-19 | 2018-02-20 | Angiodynamics, Inc. | Methods of sterilization and treating infection using irreversible electroporation |
US10117707B2 (en) | 2008-04-29 | 2018-11-06 | Virginia Tech Intellectual Properties, Inc. | System and method for estimating tissue heating of a target ablation zone for electrical-energy based therapies |
US10154874B2 (en) | 2008-04-29 | 2018-12-18 | Virginia Tech Intellectual Properties, Inc. | Immunotherapeutic methods using irreversible electroporation |
US10238447B2 (en) | 2008-04-29 | 2019-03-26 | Virginia Tech Intellectual Properties, Inc. | System and method for ablating a tissue site by electroporation with real-time monitoring of treatment progress |
US10245105B2 (en) | 2008-04-29 | 2019-04-02 | Virginia Tech Intellectual Properties, Inc. | Electroporation with cooling to treat tissue |
US10272178B2 (en) | 2008-04-29 | 2019-04-30 | Virginia Tech Intellectual Properties Inc. | Methods for blood-brain barrier disruption using electrical energy |
US10292755B2 (en) | 2009-04-09 | 2019-05-21 | Virginia Tech Intellectual Properties, Inc. | High frequency electroporation for cancer therapy |
US10471254B2 (en) | 2014-05-12 | 2019-11-12 | Virginia Tech Intellectual Properties, Inc. | Selective modulation of intracellular effects of cells using pulsed electric fields |
US10470822B2 (en) | 2008-04-29 | 2019-11-12 | Virginia Tech Intellectual Properties, Inc. | System and method for estimating a treatment volume for administering electrical-energy based therapies |
US10588620B2 (en) | 2018-03-23 | 2020-03-17 | Neochord, Inc. | Device for suture attachment for minimally invasive heart valve repair |
US10695178B2 (en) | 2011-06-01 | 2020-06-30 | Neochord, Inc. | Minimally invasive repair of heart valve leaflets |
US10694972B2 (en) | 2014-12-15 | 2020-06-30 | Virginia Tech Intellectual Properties, Inc. | Devices, systems, and methods for real-time monitoring of electrophysical effects during tissue treatment |
US10702326B2 (en) | 2011-07-15 | 2020-07-07 | Virginia Tech Intellectual Properties, Inc. | Device and method for electroporation based treatment of stenosis of a tubular body part |
US10765517B2 (en) | 2015-10-01 | 2020-09-08 | Neochord, Inc. | Ringless web for repair of heart valves |
US10966709B2 (en) | 2018-09-07 | 2021-04-06 | Neochord, Inc. | Device for suture attachment for minimally invasive heart valve repair |
US11173030B2 (en) | 2018-05-09 | 2021-11-16 | Neochord, Inc. | Suture length adjustment for minimally invasive heart valve repair |
US11254926B2 (en) | 2008-04-29 | 2022-02-22 | Virginia Tech Intellectual Properties, Inc. | Devices and methods for high frequency electroporation |
US11253360B2 (en) | 2018-05-09 | 2022-02-22 | Neochord, Inc. | Low profile tissue anchor for minimally invasive heart valve repair |
US11272979B2 (en) | 2008-04-29 | 2022-03-15 | Virginia Tech Intellectual Properties, Inc. | System and method for estimating tissue heating of a target ablation zone for electrical-energy based therapies |
US11311329B2 (en) | 2018-03-13 | 2022-04-26 | Virginia Tech Intellectual Properties, Inc. | Treatment planning for immunotherapy based treatments using non-thermal ablation techniques |
US11376126B2 (en) | 2019-04-16 | 2022-07-05 | Neochord, Inc. | Transverse helical cardiac anchor for minimally invasive heart valve repair |
US11382681B2 (en) | 2009-04-09 | 2022-07-12 | Virginia Tech Intellectual Properties, Inc. | Device and methods for delivery of high frequency electrical pulses for non-thermal ablation |
US11453873B2 (en) | 2008-04-29 | 2022-09-27 | Virginia Tech Intellectual Properties, Inc. | Methods for delivery of biphasic electrical pulses for non-thermal ablation |
US11589989B2 (en) | 2017-03-31 | 2023-02-28 | Neochord, Inc. | Minimally invasive heart valve repair in a beating heart |
US11607537B2 (en) | 2017-12-05 | 2023-03-21 | Virginia Tech Intellectual Properties, Inc. | Method for treating neurological disorders, including tumors, with electroporation |
US11638603B2 (en) | 2009-04-09 | 2023-05-02 | Virginia Tech Intellectual Properties, Inc. | Selective modulation of intracellular effects of cells using pulsed electric fields |
US11707629B2 (en) | 2009-05-28 | 2023-07-25 | Angiodynamics, Inc. | System and method for synchronizing energy delivery to the cardiac rhythm |
US11723710B2 (en) | 2016-11-17 | 2023-08-15 | Angiodynamics, Inc. | Techniques for irreversible electroporation using a single-pole tine-style internal device communicating with an external surface electrode |
US11766331B2 (en) | 2020-05-27 | 2023-09-26 | Politecnico Di Milano | Device and assembly to repair a heart valve |
US11925405B2 (en) | 2018-03-13 | 2024-03-12 | Virginia Tech Intellectual Properties, Inc. | Treatment planning system for immunotherapy enhancement via non-thermal ablation |
US11931096B2 (en) | 2010-10-13 | 2024-03-19 | Angiodynamics, Inc. | System and method for electrically ablating tissue of a patient |
US11950835B2 (en) | 2019-06-28 | 2024-04-09 | Virginia Tech Intellectual Properties, Inc. | Cycled pulsing to mitigate thermal damage for multi-electrode irreversible electroporation therapy |
Families Citing this family (211)
Publication number | Priority date | Publication date | Assignee | Title |
---|---|---|---|---|
US6776754B1 (en) * | 2000-10-04 | 2004-08-17 | Wilk Patent Development Corporation | Method for closing off lower portion of heart ventricle |
US6050936A (en) | 1997-01-02 | 2000-04-18 | Myocor, Inc. | Heart wall tension reduction apparatus |
US6332893B1 (en) | 1997-12-17 | 2001-12-25 | Myocor, Inc. | Valve to myocardium tension members device and method |
US6260552B1 (en) * | 1998-07-29 | 2001-07-17 | Myocor, Inc. | Transventricular implant tools and devices |
US20060161159A1 (en) * | 1999-02-02 | 2006-07-20 | Dreyfuss Peter J | PEEK ribbed suture anchor |
US7582051B2 (en) * | 2005-06-10 | 2009-09-01 | Cardiokinetix, Inc. | Peripheral seal for a ventricular partitioning device |
US8529430B2 (en) * | 2002-08-01 | 2013-09-10 | Cardiokinetix, Inc. | Therapeutic methods and devices following myocardial infarction |
US10307147B2 (en) | 1999-08-09 | 2019-06-04 | Edwards Lifesciences Corporation | System for improving cardiac function by sealing a partitioning membrane within a ventricle |
US8246671B2 (en) * | 1999-08-09 | 2012-08-21 | Cardiokinetix, Inc. | Retrievable cardiac devices |
US9694121B2 (en) | 1999-08-09 | 2017-07-04 | Cardiokinetix, Inc. | Systems and methods for improving cardiac function |
US7674222B2 (en) * | 1999-08-09 | 2010-03-09 | Cardiokinetix, Inc. | Cardiac device and methods of use thereof |
US8388672B2 (en) * | 1999-08-09 | 2013-03-05 | Cardiokinetix, Inc. | System for improving cardiac function by sealing a partitioning membrane within a ventricle |
US20060229491A1 (en) * | 2002-08-01 | 2006-10-12 | Cardiokinetix, Inc. | Method for treating myocardial rupture |
US8257428B2 (en) * | 1999-08-09 | 2012-09-04 | Cardiokinetix, Inc. | System for improving cardiac function |
US7279007B2 (en) * | 1999-08-09 | 2007-10-09 | Cardioklnetix, Inc. | Method for improving cardiac function |
US20030109770A1 (en) * | 1999-08-09 | 2003-06-12 | Sharkey Hugh R. | Device with a porous membrane for improving cardiac function |
WO2009033100A1 (en) * | 2007-09-07 | 2009-03-12 | Intrinsic Therapeutics, Inc. | Bone anchoring systems |
EP1624832A4 (en) | 1999-08-18 | 2008-12-24 | Intrinsic Therapeutics Inc | Devices and method for augmenting a vertebral disc nucleus |
US7258700B2 (en) | 1999-08-18 | 2007-08-21 | Intrinsic Therapeutics, Inc. | Devices and method for nucleus pulposus augmentation and retention |
US7998213B2 (en) | 1999-08-18 | 2011-08-16 | Intrinsic Therapeutics, Inc. | Intervertebral disc herniation repair |
US8323341B2 (en) | 2007-09-07 | 2012-12-04 | Intrinsic Therapeutics, Inc. | Impaction grafting for vertebral fusion |
US7717961B2 (en) * | 1999-08-18 | 2010-05-18 | Intrinsic Therapeutics, Inc. | Apparatus delivery in an intervertebral disc |
US7972337B2 (en) | 2005-12-28 | 2011-07-05 | Intrinsic Therapeutics, Inc. | Devices and methods for bone anchoring |
US8398537B2 (en) * | 2005-06-10 | 2013-03-19 | Cardiokinetix, Inc. | Peripheral seal for a ventricular partitioning device |
US7862500B2 (en) * | 2002-08-01 | 2011-01-04 | Cardiokinetix, Inc. | Multiple partitioning devices for heart treatment |
US20060030881A1 (en) * | 2004-08-05 | 2006-02-09 | Cardiokinetix, Inc. | Ventricular partitioning device |
US7399271B2 (en) * | 2004-01-09 | 2008-07-15 | Cardiokinetix, Inc. | Ventricular partitioning device |
US9078660B2 (en) * | 2000-08-09 | 2015-07-14 | Cardiokinetix, Inc. | Devices and methods for delivering an endocardial device |
US9332992B2 (en) | 2004-08-05 | 2016-05-10 | Cardiokinetix, Inc. | Method for making a laminar ventricular partitioning device |
US10064696B2 (en) | 2000-08-09 | 2018-09-04 | Edwards Lifesciences Corporation | Devices and methods for delivering an endocardial device |
US7762943B2 (en) * | 2004-03-03 | 2010-07-27 | Cardiokinetix, Inc. | Inflatable ventricular partitioning device |
US9332993B2 (en) | 2004-08-05 | 2016-05-10 | Cardiokinetix, Inc. | Devices and methods for delivering an endocardial device |
US20060106278A1 (en) * | 2004-05-14 | 2006-05-18 | Ample Medical, Inc. | Devices, systems, and methods for reshaping a heart valve annulus, including the use of an adjustable bridge implant system |
US20060106279A1 (en) * | 2004-05-14 | 2006-05-18 | Ample Medical, Inc. | Devices, systems, and methods for reshaping a heart valve annulus, including the use of a bridge implant having an adjustable bridge stop |
US6893459B1 (en) * | 2000-09-20 | 2005-05-17 | Ample Medical, Inc. | Heart valve annulus device and method of using same |
US20050228422A1 (en) * | 2002-11-26 | 2005-10-13 | Ample Medical, Inc. | Devices, systems, and methods for reshaping a heart valve annulus, including the use of magnetic tools |
US8784482B2 (en) * | 2000-09-20 | 2014-07-22 | Mvrx, Inc. | Method of reshaping a heart valve annulus using an intravascular device |
WO2004030568A2 (en) * | 2002-10-01 | 2004-04-15 | Ample Medical, Inc. | Device and method for repairing a native heart valve leaflet |
US20090287179A1 (en) | 2003-10-01 | 2009-11-19 | Ample Medical, Inc. | Devices, systems, and methods for reshaping a heart valve annulus, including the use of magnetic tools |
US20080091264A1 (en) | 2002-11-26 | 2008-04-17 | Ample Medical, Inc. | Devices, systems, and methods for reshaping a heart valve annulus, including the use of magnetic tools |
US20050222489A1 (en) | 2003-10-01 | 2005-10-06 | Ample Medical, Inc. | Devices, systems, and methods for reshaping a heart valve annulus, including the use of a bridge implant |
US8956407B2 (en) * | 2000-09-20 | 2015-02-17 | Mvrx, Inc. | Methods for reshaping a heart valve annulus using a tensioning implant |
US6616684B1 (en) * | 2000-10-06 | 2003-09-09 | Myocor, Inc. | Endovascular splinting devices and methods |
US8202315B2 (en) | 2001-04-24 | 2012-06-19 | Mitralign, Inc. | Catheter-based annuloplasty using ventricularly positioned catheter |
US20020188170A1 (en) * | 2001-04-27 | 2002-12-12 | Santamore William P. | Prevention of myocardial infarction induced ventricular expansion and remodeling |
PT1423066E (en) * | 2001-09-07 | 2008-09-29 | Mardil Inc | Method and apparatus for external heart stabilization |
AU2002362442B2 (en) * | 2001-10-01 | 2008-08-07 | Ample Medical, Inc. | Methods and devices for heart valve treatments |
US8172856B2 (en) | 2002-08-02 | 2012-05-08 | Cedars-Sinai Medical Center | Methods and apparatus for atrioventricular valve repair |
US20040092973A1 (en) * | 2002-09-23 | 2004-05-13 | Nmt Medical, Inc. | Septal puncture device |
AU2003277116A1 (en) * | 2002-10-01 | 2004-04-23 | Ample Medical, Inc. | Devices, systems, and methods for reshaping a heart valve annulus |
AU2003277118A1 (en) * | 2002-10-01 | 2004-04-23 | Ample Medical, Inc. | Devices for retaining native heart valve leaflet |
US7087064B1 (en) * | 2002-10-15 | 2006-08-08 | Advanced Cardiovascular Systems, Inc. | Apparatuses and methods for heart valve repair |
NZ539136A (en) | 2002-10-21 | 2008-04-30 | Mitralign Inc | Method and apparatus for performing catheter-based annuloplasty using local plications |
US8979923B2 (en) | 2002-10-21 | 2015-03-17 | Mitralign, Inc. | Tissue fastening systems and methods utilizing magnetic guidance |
US7485143B2 (en) * | 2002-11-15 | 2009-02-03 | Abbott Cardiovascular Systems Inc. | Apparatuses and methods for heart valve repair |
US7404824B1 (en) * | 2002-11-15 | 2008-07-29 | Advanced Cardiovascular Systems, Inc. | Valve aptation assist device |
US9149602B2 (en) | 2005-04-22 | 2015-10-06 | Advanced Cardiovascular Systems, Inc. | Dual needle delivery system |
US7335213B1 (en) | 2002-11-15 | 2008-02-26 | Abbott Cardiovascular Systems Inc. | Apparatus and methods for heart valve repair |
US7981152B1 (en) | 2004-12-10 | 2011-07-19 | Advanced Cardiovascular Systems, Inc. | Vascular delivery system for accessing and delivering devices into coronary sinus and other vascular sites |
US8187324B2 (en) | 2002-11-15 | 2012-05-29 | Advanced Cardiovascular Systems, Inc. | Telescoping apparatus for delivering and adjusting a medical device in a vessel |
US8562646B2 (en) * | 2002-12-19 | 2013-10-22 | Boston Scientific Scimed, Inc. | Anchoring to soft tissue |
US7658747B2 (en) * | 2003-03-12 | 2010-02-09 | Nmt Medical, Inc. | Medical device for manipulation of a medical implant |
JP4283022B2 (en) * | 2003-03-31 | 2009-06-24 | 東芝医用システムエンジニアリング株式会社 | Ultrasonic probe for body cavity |
US7341584B1 (en) | 2003-05-30 | 2008-03-11 | Thomas David Starkey | Device and method to limit filling of the heart |
US7513867B2 (en) * | 2003-07-16 | 2009-04-07 | Kardium, Inc. | Methods and devices for altering blood flow through the left ventricle |
WO2005034763A1 (en) * | 2003-09-11 | 2005-04-21 | Nmt Medical, Inc. | Devices, systems, and methods for suturing tissue |
US7998112B2 (en) | 2003-09-30 | 2011-08-16 | Abbott Cardiovascular Systems Inc. | Deflectable catheter assembly and method of making same |
JP4496223B2 (en) | 2003-11-06 | 2010-07-07 | エヌエムティー メディカル, インコーポレイティッド | Septal penetration device |
US8292910B2 (en) | 2003-11-06 | 2012-10-23 | Pressure Products Medical Supplies, Inc. | Transseptal puncture apparatus |
US8864822B2 (en) | 2003-12-23 | 2014-10-21 | Mitralign, Inc. | Devices and methods for introducing elements into tissue |
US7431726B2 (en) | 2003-12-23 | 2008-10-07 | Mitralign, Inc. | Tissue fastening systems and methods utilizing magnetic guidance |
US20060106447A1 (en) * | 2004-01-26 | 2006-05-18 | Nmt Medical, Inc. | Adjustable stiffness medical system |
WO2005099374A2 (en) * | 2004-04-05 | 2005-10-27 | Genesee Biomedical, Inc. | Method and apparatus for the surgical treatment of congestive heart failure |
US20060199995A1 (en) * | 2005-03-02 | 2006-09-07 | Venkataramana Vijay | Percutaneous cardiac ventricular geometry restoration device and treatment for heart failure |
US7320665B2 (en) * | 2005-03-02 | 2008-01-22 | Venkataramana Vijay | Cardiac Ventricular Geometry Restoration Device and Treatment for Heart Failure |
US10219902B2 (en) | 2005-03-25 | 2019-03-05 | Mvrx, Inc. | Devices, systems, and methods for reshaping a heart valve anulus, including the use of a bridge implant having an adjustable bridge stop |
US7621866B2 (en) * | 2005-05-31 | 2009-11-24 | Ethicon, Inc. | Method and device for deployment of a sub-pericardial sack |
US7766816B2 (en) | 2005-06-09 | 2010-08-03 | Chf Technologies, Inc. | Method and apparatus for closing off a portion of a heart ventricle |
US8951285B2 (en) | 2005-07-05 | 2015-02-10 | Mitralign, Inc. | Tissue anchor, anchoring system and methods of using the same |
US8506474B2 (en) * | 2005-08-19 | 2013-08-13 | Bioventrix, Inc. | Method and device for treating dysfunctional cardiac tissue |
WO2007022519A2 (en) | 2005-08-19 | 2007-02-22 | Chf Technologies, Inc. | Steerable heart implants for congestive heart failure |
US7695510B2 (en) * | 2005-10-11 | 2010-04-13 | Medtronic Vascular, Inc. | Annuloplasty device having shape-adjusting tension filaments |
EP1959865B1 (en) * | 2005-12-15 | 2014-12-10 | The Cleveland Clinic Foundation | Apparatus for treating a regurgitant valve |
AU2006332514B2 (en) * | 2005-12-28 | 2013-01-17 | C.R. Bard, Inc. | Apparatus and method for introducing implants |
WO2007130724A2 (en) * | 2006-02-06 | 2007-11-15 | Northwind Ventures | Systems and methods for volume reduction |
US7749249B2 (en) * | 2006-02-21 | 2010-07-06 | Kardium Inc. | Method and device for closing holes in tissue |
US20070208217A1 (en) | 2006-03-03 | 2007-09-06 | Acorn Cardiovascular, Inc. | Self-adjusting attachment structure for a cardiac support device |
US20070270688A1 (en) | 2006-05-19 | 2007-11-22 | Daniel Gelbart | Automatic atherectomy system |
US8920411B2 (en) * | 2006-06-28 | 2014-12-30 | Kardium Inc. | Apparatus and method for intra-cardiac mapping and ablation |
US9119633B2 (en) | 2006-06-28 | 2015-09-01 | Kardium Inc. | Apparatus and method for intra-cardiac mapping and ablation |
US10028783B2 (en) | 2006-06-28 | 2018-07-24 | Kardium Inc. | Apparatus and method for intra-cardiac mapping and ablation |
US8449605B2 (en) | 2006-06-28 | 2013-05-28 | Kardium Inc. | Method for anchoring a mitral valve |
US11389232B2 (en) | 2006-06-28 | 2022-07-19 | Kardium Inc. | Apparatus and method for intra-cardiac mapping and ablation |
US7837610B2 (en) * | 2006-08-02 | 2010-11-23 | Kardium Inc. | System for improving diastolic dysfunction |
US20080091057A1 (en) * | 2006-10-11 | 2008-04-17 | Cardiac Pacemakers, Inc. | Method and apparatus for passive left atrial support |
US11660190B2 (en) | 2007-03-13 | 2023-05-30 | Edwards Lifesciences Corporation | Tissue anchors, systems and methods, and devices |
US20080228266A1 (en) * | 2007-03-13 | 2008-09-18 | Mitralign, Inc. | Plication assistance devices and methods |
US8911461B2 (en) | 2007-03-13 | 2014-12-16 | Mitralign, Inc. | Suture cutter and method of cutting suture |
US8092363B2 (en) * | 2007-09-05 | 2012-01-10 | Mardil, Inc. | Heart band with fillable chambers to modify heart valve function |
DE102007043830A1 (en) | 2007-09-13 | 2009-04-02 | Lozonschi, Lucian, Madison | Heart valve stent |
US20090076597A1 (en) * | 2007-09-19 | 2009-03-19 | Jonathan Micheal Dahlgren | System for mechanical adjustment of medical implants |
CA2702615C (en) * | 2007-10-19 | 2017-06-06 | Guided Delivery Systems, Inc. | Systems and methods for cardiac remodeling |
US8906011B2 (en) | 2007-11-16 | 2014-12-09 | Kardium Inc. | Medical device for use in bodily lumens, for example an atrium |
US8489172B2 (en) * | 2008-01-25 | 2013-07-16 | Kardium Inc. | Liposuction system |
US20090259210A1 (en) * | 2008-04-10 | 2009-10-15 | Sabbah Hani N | Method, apparatus and kits for forming structural members within the cardiac venous system |
US20090287304A1 (en) * | 2008-05-13 | 2009-11-19 | Kardium Inc. | Medical Device for Constricting Tissue or a Bodily Orifice, for example a mitral valve |
US8394138B2 (en) * | 2008-09-05 | 2013-03-12 | Cook Medical Technologies Llc | Multi-strand helical stent |
US20100210899A1 (en) * | 2009-01-21 | 2010-08-19 | Tendyne Medical, Inc. | Method for percutaneous lateral access to the left ventricle for treatment of mitral insufficiency by papillary muscle alignment |
CA2768797A1 (en) * | 2009-01-21 | 2010-08-12 | Tendyne Medical, Inc. | Apical papillary muscle attachment for left ventricular reduction |
US8641753B2 (en) * | 2009-01-31 | 2014-02-04 | Cook Medical Technologies Llc | Preform for and an endoluminal prosthesis |
US20100274227A1 (en) * | 2009-02-13 | 2010-10-28 | Alexander Khairkhahan | Delivery catheter handle cover |
US20110015476A1 (en) * | 2009-03-04 | 2011-01-20 | Jeff Franco | Devices and Methods for Treating Cardiomyopathy |
EP2482749B1 (en) | 2009-10-01 | 2017-08-30 | Kardium Inc. | Kit for constricting tissue or a bodily orifice, for example, a mitral valve |
JP5875986B2 (en) | 2009-10-26 | 2016-03-02 | カーディオキネティックス・インコーポレイテッドCardiokinetix, Inc. | Ventricular volume reduction |
EP2509538B1 (en) | 2009-12-08 | 2017-09-20 | Avalon Medical Ltd. | Device and system for transcatheter mitral valve replacement |
EP2519189B1 (en) | 2009-12-28 | 2014-05-07 | Cook Medical Technologies LLC | Endoluminal device with kink-resistant regions |
US10058323B2 (en) | 2010-01-22 | 2018-08-28 | 4 Tech Inc. | Tricuspid valve repair using tension |
US9307980B2 (en) | 2010-01-22 | 2016-04-12 | 4Tech Inc. | Tricuspid valve repair using tension |
US8475525B2 (en) | 2010-01-22 | 2013-07-02 | 4Tech Inc. | Tricuspid valve repair using tension |
US9107749B2 (en) * | 2010-02-03 | 2015-08-18 | Edwards Lifesciences Corporation | Methods for treating a heart |
WO2011101385A2 (en) | 2010-02-19 | 2011-08-25 | Airbus Operations Gmbh | Toilet assembly for a means of transportation |
US8579964B2 (en) | 2010-05-05 | 2013-11-12 | Neovasc Inc. | Transcatheter mitral valve prosthesis |
US9050066B2 (en) | 2010-06-07 | 2015-06-09 | Kardium Inc. | Closing openings in anatomical tissue |
US8940002B2 (en) | 2010-09-30 | 2015-01-27 | Kardium Inc. | Tissue anchor system |
US11259867B2 (en) | 2011-01-21 | 2022-03-01 | Kardium Inc. | High-density electrode-based medical device system |
US9486273B2 (en) | 2011-01-21 | 2016-11-08 | Kardium Inc. | High-density electrode-based medical device system |
US9452016B2 (en) | 2011-01-21 | 2016-09-27 | Kardium Inc. | Catheter system |
CA2764494A1 (en) | 2011-01-21 | 2012-07-21 | Kardium Inc. | Enhanced medical device for use in bodily cavities, for example an atrium |
US9072511B2 (en) | 2011-03-25 | 2015-07-07 | Kardium Inc. | Medical kit for constricting tissue or a bodily orifice, for example, a mitral valve |
US9308087B2 (en) | 2011-04-28 | 2016-04-12 | Neovasc Tiara Inc. | Sequentially deployed transcatheter mitral valve prosthesis |
US9554897B2 (en) | 2011-04-28 | 2017-01-31 | Neovasc Tiara Inc. | Methods and apparatus for engaging a valve prosthesis with tissue |
AU2012203620B9 (en) | 2011-06-24 | 2014-10-02 | Cook Medical Technologies Llc | Helical Stent |
EP4289398A3 (en) | 2011-08-11 | 2024-03-13 | Tendyne Holdings, Inc. | Improvements for prosthetic valves and related inventions |
US9827092B2 (en) | 2011-12-16 | 2017-11-28 | Tendyne Holdings, Inc. | Tethers for prosthetic mitral valve |
USD777926S1 (en) | 2012-01-20 | 2017-01-31 | Kardium Inc. | Intra-cardiac procedure device |
USD777925S1 (en) | 2012-01-20 | 2017-01-31 | Kardium Inc. | Intra-cardiac procedure device |
AU2013221670A1 (en) * | 2012-02-13 | 2014-10-02 | Mitraspan, Inc | Method and apparatus for repairing a mitral valve |
US10076414B2 (en) | 2012-02-13 | 2018-09-18 | Mitraspan, Inc. | Method and apparatus for repairing a mitral valve |
US9821145B2 (en) | 2012-03-23 | 2017-11-21 | Pressure Products Medical Supplies Inc. | Transseptal puncture apparatus and method for using the same |
US10827977B2 (en) | 2012-05-21 | 2020-11-10 | Kardium Inc. | Systems and methods for activating transducers |
US9198592B2 (en) | 2012-05-21 | 2015-12-01 | Kardium Inc. | Systems and methods for activating transducers |
US9693832B2 (en) | 2012-05-21 | 2017-07-04 | Kardium Inc. | Systems and methods for selecting, activating, or selecting and activating transducers |
US9345573B2 (en) | 2012-05-30 | 2016-05-24 | Neovasc Tiara Inc. | Methods and apparatus for loading a prosthesis onto a delivery system |
WO2014022124A1 (en) | 2012-07-28 | 2014-02-06 | Tendyne Holdings, Inc. | Improved multi-component designs for heart valve retrieval device, sealing structures and stent assembly |
WO2014021905A1 (en) | 2012-07-30 | 2014-02-06 | Tendyne Holdings, Inc. | Improved delivery systems and methods for transcatheter prosthetic valves |
US20140046347A1 (en) * | 2012-08-10 | 2014-02-13 | W. L. Gore & Associates, Inc. | Devices, systems and methods for engaging tissue |
WO2014059433A2 (en) | 2012-10-12 | 2014-04-17 | Mardil, Inc. | Cardiac treatment system and method |
US9788948B2 (en) | 2013-01-09 | 2017-10-17 | 4 Tech Inc. | Soft tissue anchors and implantation techniques |
WO2014138284A1 (en) | 2013-03-07 | 2014-09-12 | Cedars-Sinai Medical Center | Catheter based apical approach heart prostheses delivery system |
WO2014138482A1 (en) | 2013-03-07 | 2014-09-12 | Cedars-Sinai Medical Center | Method and apparatus for percutaneous delivery and deployment of a cardiovascular prosthesis |
WO2014141239A1 (en) | 2013-03-14 | 2014-09-18 | 4Tech Inc. | Stent with tether interface |
US10463489B2 (en) | 2013-04-02 | 2019-11-05 | Tendyne Holdings, Inc. | Prosthetic heart valve and systems and methods for delivering the same |
US11224510B2 (en) | 2013-04-02 | 2022-01-18 | Tendyne Holdings, Inc. | Prosthetic heart valve and systems and methods for delivering the same |
US9486306B2 (en) | 2013-04-02 | 2016-11-08 | Tendyne Holdings, Inc. | Inflatable annular sealing device for prosthetic mitral valve |
US9572665B2 (en) | 2013-04-04 | 2017-02-21 | Neovasc Tiara Inc. | Methods and apparatus for delivering a prosthetic valve to a beating heart |
US10478293B2 (en) | 2013-04-04 | 2019-11-19 | Tendyne Holdings, Inc. | Retrieval and repositioning system for prosthetic heart valve |
US9610159B2 (en) | 2013-05-30 | 2017-04-04 | Tendyne Holdings, Inc. | Structural members for prosthetic mitral valves |
WO2014210124A1 (en) | 2013-06-25 | 2014-12-31 | Mark Christianson | Thrombus management and structural compliance features for prosthetic heart valves |
JP6465883B2 (en) | 2013-08-01 | 2019-02-06 | テンダイン ホールディングス,インコーポレイテッド | Epicardial anchor device and method |
US10070857B2 (en) | 2013-08-31 | 2018-09-11 | Mitralign, Inc. | Devices and methods for locating and implanting tissue anchors at mitral valve commissure |
USD717954S1 (en) | 2013-10-14 | 2014-11-18 | Mardil, Inc. | Heart treatment device |
WO2015058039A1 (en) | 2013-10-17 | 2015-04-23 | Robert Vidlund | Apparatus and methods for alignment and deployment of intracardiac devices |
CA2924389C (en) | 2013-10-28 | 2021-11-09 | Tendyne Holdings, Inc. | Prosthetic heart valve and systems and methods for delivering the same |
US9526611B2 (en) | 2013-10-29 | 2016-12-27 | Tendyne Holdings, Inc. | Apparatus and methods for delivery of transcatheter prosthetic valves |
US10022114B2 (en) | 2013-10-30 | 2018-07-17 | 4Tech Inc. | Percutaneous tether locking |
US10052095B2 (en) | 2013-10-30 | 2018-08-21 | 4Tech Inc. | Multiple anchoring-point tension system |
WO2016112085A2 (en) | 2015-01-07 | 2016-07-14 | Mark Christianson | Prosthetic mitral valves and apparatus and methods for delivery of same |
WO2015120122A2 (en) | 2014-02-05 | 2015-08-13 | Robert Vidlund | Apparatus and methods for transfemoral delivery of prosthetic mitral valve |
US9986993B2 (en) | 2014-02-11 | 2018-06-05 | Tendyne Holdings, Inc. | Adjustable tether and epicardial pad system for prosthetic heart valve |
CN110338911B (en) | 2014-03-10 | 2022-12-23 | 坦迪尼控股股份有限公司 | Apparatus and method for positioning and monitoring tether load of prosthetic mitral valve |
JP6559161B2 (en) | 2014-06-19 | 2019-08-14 | 4テック インコーポレイテッド | Tightening heart tissue |
US10799359B2 (en) | 2014-09-10 | 2020-10-13 | Cedars-Sinai Medical Center | Method and apparatus for percutaneous delivery and deployment of a cardiac valve prosthesis |
CA2962747C (en) | 2014-09-28 | 2023-02-28 | Cardiokinetix, Inc. | Apparatuses for treating cardiac dysfunction |
WO2016077783A1 (en) | 2014-11-14 | 2016-05-19 | Cedars-Sinai Medical Center | Cardiovascular access and device delivery system |
US10722184B2 (en) | 2014-11-17 | 2020-07-28 | Kardium Inc. | Systems and methods for selecting, activating, or selecting and activating transducers |
US10368936B2 (en) | 2014-11-17 | 2019-08-06 | Kardium Inc. | Systems and methods for selecting, activating, or selecting and activating transducers |
WO2016087934A1 (en) | 2014-12-02 | 2016-06-09 | 4Tech Inc. | Off-center tissue anchors |
AU2016215197B2 (en) | 2015-02-05 | 2020-01-02 | Tendyne Holdings Inc. | Expandable epicardial pads and devices and methods for their delivery |
WO2016144391A1 (en) | 2015-03-11 | 2016-09-15 | Mvrx, Inc. | Devices, systems, and methods for reshaping a heart valve annulus |
EP3283010B1 (en) | 2015-04-16 | 2020-06-17 | Tendyne Holdings, Inc. | Apparatus for delivery and repositioning of transcatheter prosthetic valves |
WO2017015632A1 (en) | 2015-07-23 | 2017-01-26 | Cedars-Sinai Medical Center | Device for securing heart valve leaflets |
US10327894B2 (en) | 2015-09-18 | 2019-06-25 | Tendyne Holdings, Inc. | Methods for delivery of prosthetic mitral valves |
WO2017096157A1 (en) | 2015-12-03 | 2017-06-08 | Tendyne Holdings, Inc. | Frame features for prosthetic mitral valves |
US10278818B2 (en) | 2015-12-10 | 2019-05-07 | Mvrx, Inc. | Devices, systems, and methods for reshaping a heart valve annulus |
CN108366859B (en) | 2015-12-28 | 2021-02-05 | 坦迪尼控股股份有限公司 | Atrial capsular bag closure for prosthetic heart valves |
US10433952B2 (en) | 2016-01-29 | 2019-10-08 | Neovasc Tiara Inc. | Prosthetic valve for avoiding obstruction of outflow |
US10799675B2 (en) | 2016-03-21 | 2020-10-13 | Edwards Lifesciences Corporation | Cam controlled multi-direction steerable handles |
US10835714B2 (en) | 2016-03-21 | 2020-11-17 | Edwards Lifesciences Corporation | Multi-direction steerable handles for steering catheters |
US11219746B2 (en) | 2016-03-21 | 2022-01-11 | Edwards Lifesciences Corporation | Multi-direction steerable handles for steering catheters |
US10470877B2 (en) | 2016-05-03 | 2019-11-12 | Tendyne Holdings, Inc. | Apparatus and methods for anterior valve leaflet management |
EP3468480B1 (en) | 2016-06-13 | 2023-01-11 | Tendyne Holdings, Inc. | Sequential delivery of two-part prosthetic mitral valve |
JP6968113B2 (en) | 2016-06-30 | 2021-11-17 | テンダイン ホールディングス,インコーポレイテッド | Transapical delivery device for artificial heart valves |
WO2018013515A1 (en) | 2016-07-12 | 2018-01-18 | Tendyne Holdings, Inc. | Apparatus and methods for trans-septal retrieval of prosthetic heart valves |
CN113893064A (en) | 2016-11-21 | 2022-01-07 | 内奥瓦斯克迪亚拉公司 | Methods and systems for rapid retrieval of transcatheter heart valve delivery systems |
US11439501B2 (en) | 2017-01-25 | 2022-09-13 | Cedars-Sinai Medical Center | Device for securing heart valve leaflets |
DE102018107407A1 (en) | 2017-03-28 | 2018-10-04 | Edwards Lifesciences Corporation | POSITIONING, INSERTING AND RETRIEVING IMPLANTABLE DEVICES |
EP3651695B1 (en) | 2017-07-13 | 2023-04-19 | Tendyne Holdings, Inc. | Prosthetic heart valves and apparatus for delivery of same |
CN111263622A (en) | 2017-08-25 | 2020-06-09 | 内奥瓦斯克迪亚拉公司 | Sequentially deployed transcatheter mitral valve prosthesis |
JP7291124B2 (en) | 2017-08-28 | 2023-06-14 | テンダイン ホールディングス,インコーポレイテッド | Heart valve prosthesis with tethered connections |
US11110251B2 (en) | 2017-09-19 | 2021-09-07 | Edwards Lifesciences Corporation | Multi-direction steerable handles for steering catheters |
US11291544B2 (en) | 2018-02-02 | 2022-04-05 | Cedars-Sinai Medical Center | Delivery platforms, devices, and methods for tricuspid valve repair |
CN113271890B (en) | 2018-11-08 | 2024-08-30 | 内奥瓦斯克迪亚拉公司 | Ventricular deployment of transcatheter mitral valve prosthesis |
EP3934591A4 (en) | 2019-03-08 | 2022-11-23 | Neovasc Tiara Inc. | Retrievable prosthesis delivery system |
AU2020256195B2 (en) | 2019-04-01 | 2022-10-13 | Neovasc Tiara Inc. | Controllably deployable prosthetic valve |
WO2020210652A1 (en) | 2019-04-10 | 2020-10-15 | Neovasc Tiara Inc. | Prosthetic valve with natural blood flow |
US11779742B2 (en) | 2019-05-20 | 2023-10-10 | Neovasc Tiara Inc. | Introducer with hemostasis mechanism |
AU2020295566B2 (en) | 2019-06-20 | 2023-07-20 | Neovasc Tiara Inc. | Low profile prosthetic mitral valve |
US11648110B2 (en) | 2019-12-05 | 2023-05-16 | Tendyne Holdings, Inc. | Braided anchor for mitral valve |
US11648114B2 (en) | 2019-12-20 | 2023-05-16 | Tendyne Holdings, Inc. | Distally loaded sheath and loading funnel |
US11951002B2 (en) | 2020-03-30 | 2024-04-09 | Tendyne Holdings, Inc. | Apparatus and methods for valve and tether fixation |
WO2022039853A1 (en) | 2020-08-19 | 2022-02-24 | Tendyne Holdings, Inc. | Fully-transseptal apical pad with pulley for tensioning |
Citations (87)
Publication number | Priority date | Publication date | Assignee | Title |
---|---|---|---|---|
US670065A (en) * | 1900-05-03 | 1901-03-19 | Richard Schulz | Water-tube boiler. |
US4192293A (en) * | 1978-09-05 | 1980-03-11 | Manfred Asrican | Cardiac assist device |
US4372293A (en) * | 1980-12-24 | 1983-02-08 | Vijil Rosales Cesar A | Apparatus and method for surgical correction of ptotic breasts |
US4997431A (en) * | 1989-08-30 | 1991-03-05 | Angeion Corporation | Catheter |
US5192314A (en) * | 1991-12-12 | 1993-03-09 | Daskalakis Michael K | Synthetic intraventricular implants and method of inserting |
US5284488A (en) * | 1992-12-23 | 1994-02-08 | Sideris Eleftherios B | Adjustable devices for the occlusion of cardiac defects |
US5385528A (en) * | 1993-06-17 | 1995-01-31 | Wilk; Peter J. | Intrapericardial assist device and associated method |
US5389096A (en) * | 1990-12-18 | 1995-02-14 | Advanced Cardiovascular Systems | System and method for percutaneous myocardial revascularization |
US5496305A (en) * | 1985-03-22 | 1996-03-05 | Massachusetts Institue Of Technology | Catheter for laser angiosurgery |
US5593424A (en) * | 1994-08-10 | 1997-01-14 | Segmed, Inc. | Apparatus and method for reducing and stabilizing the circumference of a vascular structure |
US5607471A (en) * | 1993-08-03 | 1997-03-04 | Jacques Seguin | Prosthetic ring for heart surgery |
US5713954A (en) * | 1995-06-13 | 1998-02-03 | Abiomed R&D, Inc. | Extra cardiac ventricular assist device |
US5718725A (en) * | 1992-12-03 | 1998-02-17 | Heartport, Inc. | Devices and methods for intracardiac procedures |
US5855601A (en) * | 1996-06-21 | 1999-01-05 | The Trustees Of Columbia University In The City Of New York | Artificial heart valve and method and device for implanting the same |
US5855614A (en) * | 1993-02-22 | 1999-01-05 | Heartport, Inc. | Method and apparatus for thoracoscopic intracardiac procedures |
US5865791A (en) * | 1995-06-07 | 1999-02-02 | E.P. Technologies Inc. | Atrial appendage stasis reduction procedure and devices |
US5876436A (en) * | 1994-10-21 | 1999-03-02 | St. Jude Medical, Inc. | Rotatable cuff assembly for a heart valve prosthesis |
US5888240A (en) * | 1994-07-29 | 1999-03-30 | Baxter International Inc. | Distensible annuloplasty ring for surgical remodelling of an atrioventricular valve and nonsurgical method for post-implantation distension thereof to accomodate patient growth |
US6019722A (en) * | 1997-09-17 | 2000-02-01 | Guidant Corporation | Device to permit offpump beating heart coronary bypass surgery |
US6024756A (en) * | 1996-03-22 | 2000-02-15 | Scimed Life Systems, Inc. | Method of reversibly closing a septal defect |
US6024096A (en) * | 1998-05-01 | 2000-02-15 | Correstore Inc | Anterior segment ventricular restoration apparatus and method |
US6169922B1 (en) * | 1998-11-18 | 2001-01-02 | Acorn Cardiovascular, Inc. | Defibrillating cardiac jacket with interwoven electrode grids |
US6174279B1 (en) * | 1999-09-21 | 2001-01-16 | Acorn Cardiovascular, Inc. | Cardiac constraint with tension indicator |
US6174332B1 (en) * | 1997-12-05 | 2001-01-16 | St. Jude Medical, Inc. | Annuloplasty ring with cut zone |
US6179791B1 (en) * | 1999-09-21 | 2001-01-30 | Acorn Cardiovascular, Inc. | Device for heart measurement |
US6182664B1 (en) * | 1996-02-19 | 2001-02-06 | Edwards Lifesciences Corporation | Minimally invasive cardiac valve surgery procedure |
US6183411B1 (en) * | 1998-09-21 | 2001-02-06 | Myocor, Inc. | External stress reduction device and method |
US6183512B1 (en) * | 1999-04-16 | 2001-02-06 | Edwards Lifesciences Corporation | Flexible annuloplasty system |
US6190408B1 (en) * | 1998-03-05 | 2001-02-20 | The University Of Cincinnati | Device and method for restructuring the heart chamber geometry |
US6193648B1 (en) * | 1999-09-21 | 2001-02-27 | Acorn Cardiovascular, Inc. | Cardiac constraint with draw string tensioning |
US6338712B2 (en) * | 1997-09-17 | 2002-01-15 | Origin Medsystems, Inc. | Device to permit offpump beating heart coronary bypass surgery |
US20020007216A1 (en) * | 1996-01-02 | 2002-01-17 | Melvin David Boyd | Heart wall actuation device for the natural heart |
US20020013571A1 (en) * | 1999-04-09 | 2002-01-31 | Evalve, Inc. | Methods and devices for capturing and fixing leaflets in valve repair |
US6343605B1 (en) * | 2000-08-08 | 2002-02-05 | Scimed Life Systems, Inc. | Percutaneous transluminal myocardial implantation device and method |
US20020016628A1 (en) * | 2000-01-31 | 2002-02-07 | Langberg Jonathan J. | Percutaneous mitral annuloplasty with hemodynamic monitoring |
US20020019580A1 (en) * | 2000-03-10 | 2002-02-14 | Lilip Lau | Expandable cardiac harness for treating congestive heart failure |
US20020022880A1 (en) * | 1996-01-02 | 2002-02-21 | Melvin David B. | Device and method for restructuring heart chamber geometry |
US20020026092A1 (en) * | 1998-05-01 | 2002-02-28 | Buckberg Gerald D. | Ventricular restoration patch |
US20030004396A1 (en) * | 2000-01-14 | 2003-01-02 | Acon Cardiovascular, Inc. | Delivery of cardiac constraint jacket |
US20030009081A1 (en) * | 1999-07-08 | 2003-01-09 | Chase Medical, Lp | Device and method for isolating a surface of a beating heart during surgery |
US6508756B1 (en) * | 1995-06-13 | 2003-01-21 | Abiomed, Inc. | Passive cardiac assistance device |
US6511426B1 (en) * | 1998-06-02 | 2003-01-28 | Acuson Corporation | Medical diagnostic ultrasound system and method for versatile processing |
US20030023132A1 (en) * | 2000-05-31 | 2003-01-30 | Melvin David B. | Cyclic device for restructuring heart chamber geometry |
US6514194B2 (en) * | 1997-01-02 | 2003-02-04 | Myocor, Inc. | Heart wall tension reduction apparatus and method |
US20030028077A1 (en) * | 1998-07-13 | 2003-02-06 | Acorn Cardiovascular, Inc. | Cardiac disease treatment and device |
US20030032979A1 (en) * | 1998-07-29 | 2003-02-13 | Myocor, Inc. | Transventricular implant tools and devices |
US6520904B1 (en) * | 1996-01-02 | 2003-02-18 | The University Of Cincinnati | Device and method for restructuring heart chamber geometry |
US20040002719A1 (en) * | 1997-06-27 | 2004-01-01 | Oz Mehmet C. | Method and apparatus for circulatory valve repair |
US6673009B1 (en) * | 2000-11-08 | 2004-01-06 | Acorn Cardiovascular, Inc. | Adjustment clamp |
US20040003819A1 (en) * | 1999-04-09 | 2004-01-08 | Evalve, Inc. | Methods and apparatus for cardiac valve repair |
US6676702B2 (en) * | 2001-05-14 | 2004-01-13 | Cardiac Dimensions, Inc. | Mitral valve therapy assembly and method |
US20040010305A1 (en) * | 2001-12-05 | 2004-01-15 | Cardiac Dimensions, Inc. | Device and method for modifying the shape of a body organ |
US20040015039A1 (en) * | 2002-07-16 | 2004-01-22 | The University Of Cincinnati | Modular power system and method for a heart wall actuation system for the natural heart |
US20040015041A1 (en) * | 2002-07-18 | 2004-01-22 | The University Of Cincinnati | Protective sheath apparatus and method for use with a heart wall actuation system for the natural heart |
US20040015040A1 (en) * | 2002-07-18 | 2004-01-22 | The University Of Cincinnati | Flexible, torsionable cardiac framework for heart wall actuation of the natural heart |
US6682476B2 (en) * | 2000-06-13 | 2004-01-27 | Acorn Cardiovascular, Inc. | Cardiac disease treatment and device |
US6681773B2 (en) * | 2001-02-28 | 2004-01-27 | Chase Medical, Inc. | Kit and method for use during ventricular restoration |
US6682475B2 (en) * | 2002-06-11 | 2004-01-27 | Acorn Cardiovascular, Inc. | Tension indicator for cardiac support device and method therefore |
US20040019378A1 (en) * | 2001-04-24 | 2004-01-29 | Hlavka Edwin J. | Method and apparatus for performing catheter-based annuloplasty |
US20040019377A1 (en) * | 2002-01-14 | 2004-01-29 | Taylor Daniel C. | Method and apparatus for reducing mitral regurgitation |
US6685627B2 (en) * | 1998-10-09 | 2004-02-03 | Swaminathan Jayaraman | Modification of properties and geometry of heart tissue to influence heart function |
US6685646B2 (en) * | 1996-11-01 | 2004-02-03 | Jomed Inc. | Measurement of volumetric fluid flow and its velocity profile |
US6685620B2 (en) * | 2001-09-25 | 2004-02-03 | The Foundry Inc. | Ventricular infarct assist device and methods for using it |
US20040034271A1 (en) * | 2002-08-19 | 2004-02-19 | The University Of Cincinnati | Heart wall actuation system for the natural heart with shape limiting elements |
US6695768B1 (en) * | 1999-03-30 | 2004-02-24 | Robert A. Levine | Adjustable periventricular ring/ring like device/method for control of ischemic mitral regurgitation and congestive heart disease |
US6695866B1 (en) * | 1998-07-15 | 2004-02-24 | St. Jude Medical, Inc. | Mitral and tricuspid valve repair |
US20040039443A1 (en) * | 1999-06-30 | 2004-02-26 | Solem Jan Otto | Method and device for treatment of mitral insufficiency |
US20050004668A1 (en) * | 2003-07-02 | 2005-01-06 | Flexcor, Inc. | Annuloplasty rings and methods for repairing cardiac valves |
US20050004665A1 (en) * | 2003-07-02 | 2005-01-06 | Lishan Aklog | Annuloplasty rings and methods for repairing cardiac valves |
US20050004666A1 (en) * | 2001-05-17 | 2005-01-06 | Ottavio Alfieri | Annular prosthesis for mitral valve |
US20050004428A1 (en) * | 2000-06-12 | 2005-01-06 | Acorn Cardiovascular, Inc. | Cardiac disease treatment and device |
US20050010240A1 (en) * | 2003-06-05 | 2005-01-13 | Cardiac Dimensions Inc., A Washington Corporation | Device and method for modifying the shape of a body organ |
US20050010283A1 (en) * | 2003-07-11 | 2005-01-13 | Vedic Biotechnology, Inc. | Heart failure mitral annuloplasty ring with multiple sets of suture placement indicia |
US20050010286A1 (en) * | 2003-07-11 | 2005-01-13 | Vedic Biotechnology, Inc. | Heart failure mitral annuloplasty ring with removable central posterior portion |
US6846296B1 (en) * | 2000-09-14 | 2005-01-25 | Abiomed, Inc. | Apparatus and method for detachably securing a device to a natural heart |
US20050021135A1 (en) * | 2001-03-15 | 2005-01-27 | Ryan Timothy R. | Annuloplasty band and method |
US20050021121A1 (en) * | 2001-11-01 | 2005-01-27 | Cardiac Dimensions, Inc., A Delaware Corporation | Adjustable height focal tissue deflector |
US20050027351A1 (en) * | 2001-05-14 | 2005-02-03 | Cardiac Dimensions, Inc. A Washington Corporation | Mitral valve regurgitation treatment device and method |
US20050027369A1 (en) * | 2002-05-10 | 2005-02-03 | Eldridge Stephen N. | Prosthetic repair fabric with erosion resistant edge |
US20050038506A1 (en) * | 2002-11-15 | 2005-02-17 | Webler William E. | Apparatuses and methods for heart valve repair |
US20050038509A1 (en) * | 2003-08-14 | 2005-02-17 | Ashe Kassem Ali | Valve prosthesis including a prosthetic leaflet |
US6858039B2 (en) * | 2002-07-08 | 2005-02-22 | Edwards Lifesciences Corporation | Mitral valve annuloplasty ring having a posterior bow |
US20050043792A1 (en) * | 1999-06-29 | 2005-02-24 | Edwards Lifesciences Ag | Device and method for treatment of mitral insufficiency |
US20060004443A1 (en) * | 2000-10-23 | 2006-01-05 | Liddicoat John R | Automated annular plication for mitral valve repair |
US20060030885A1 (en) * | 2002-10-15 | 2006-02-09 | Hyde Gregory M | Apparatuses and methods for heart valve repair |
US20060036317A1 (en) * | 2002-11-12 | 2006-02-16 | Myocor, Inc. | Decives and methods for heart valve treatment |
US20060041306A1 (en) * | 2002-01-09 | 2006-02-23 | Myocor, Inc. | Devices and methods for heart valve treatment |
Family Cites Families (85)
Publication number | Priority date | Publication date | Assignee | Title |
---|---|---|---|---|
ES474582A1 (en) | 1978-10-26 | 1979-11-01 | Aranguren Duo Iker | Process for installing mitral valves in their anatomical space by attaching cords to an artificial stent |
US4409974A (en) | 1981-06-29 | 1983-10-18 | Freedland Jeffrey A | Bone-fixating surgical implant device |
IT1155105B (en) | 1982-03-03 | 1987-01-21 | Roberto Parravicini | PLANT DEVICE TO SUPPORT THE MYOCARDIUM ACTIVITY |
US4690134A (en) | 1985-07-01 | 1987-09-01 | Snyders Robert V | Ventricular assist device |
US4705040A (en) | 1985-11-18 | 1987-11-10 | Medi-Tech, Incorporated | Percutaneous fixation of hollow organs |
USRE34021E (en) | 1985-11-18 | 1992-08-04 | Abbott Laboratories | Percutaneous fixation of hollow organs |
DE3614292C1 (en) | 1986-04-26 | 1987-11-19 | Alexander Prof Dr Bernhard | Holder for unframed biological mitral valve implant |
SU1604377A1 (en) | 1987-02-23 | 1990-11-07 | Благовещенский государственный медицинский институт | Artificial pericardium |
US4925443A (en) | 1987-02-27 | 1990-05-15 | Heilman Marlin S | Biocompatible ventricular assist and arrhythmia control device |
US4960424A (en) | 1988-06-30 | 1990-10-02 | Grooters Ronald K | Method of replacing a defective atrio-ventricular valve with a total atrio-ventricular valve bioprosthesis |
US4944753A (en) | 1988-09-26 | 1990-07-31 | Burgess Frank M | Method for producing retro-sternal space |
WO1990009153A1 (en) | 1989-02-13 | 1990-08-23 | Baxter International Inc. | Selectively flexible annuloplasty ring |
US5290300A (en) | 1989-07-31 | 1994-03-01 | Baxter International Inc. | Flexible suture guide and holder |
US5131905A (en) | 1990-07-16 | 1992-07-21 | Grooters Ronald K | External cardiac assist device |
US5169381A (en) | 1991-03-29 | 1992-12-08 | Snyders Robert V | Ventricular assist device |
US5584803A (en) | 1991-07-16 | 1996-12-17 | Heartport, Inc. | System for cardiac procedures |
US5452733A (en) | 1993-02-22 | 1995-09-26 | Stanford Surgical Technologies, Inc. | Methods for performing thoracoscopic coronary artery bypass |
US5571215A (en) | 1993-02-22 | 1996-11-05 | Heartport, Inc. | Devices and methods for intracardiac procedures |
US5458574A (en) | 1994-03-16 | 1995-10-17 | Heartport, Inc. | System for performing a cardiac procedure |
US5344385A (en) | 1991-09-30 | 1994-09-06 | Thoratec Laboratories Corporation | Step-down skeletal muscle energy conversion system |
US5250049A (en) | 1992-01-10 | 1993-10-05 | Michael Roger H | Bone and tissue connectors |
US5758663A (en) | 1992-04-10 | 1998-06-02 | Wilk; Peter J. | Coronary artery by-pass method |
DE4234127C2 (en) | 1992-10-09 | 1996-02-22 | Herbert Dr Vetter | Heart valve prosthesis |
US5814097A (en) | 1992-12-03 | 1998-09-29 | Heartport, Inc. | Devices and methods for intracardiac procedures |
US5972030A (en) | 1993-02-22 | 1999-10-26 | Heartport, Inc. | Less-invasive devices and methods for treatment of cardiac valves |
US5728151A (en) | 1993-02-22 | 1998-03-17 | Heartport, Inc. | Intercostal access devices for less-invasive cardiovascular surgery |
US6125852A (en) | 1993-02-22 | 2000-10-03 | Heartport, Inc. | Minimally-invasive devices and methods for treatment of congestive heart failure |
US20020029783A1 (en) * | 1993-02-22 | 2002-03-14 | Stevens John H. | Minimally-invasive devices and methods for treatment of congestive heart failure |
DE4306277C2 (en) | 1993-03-01 | 2000-11-02 | Leibinger Gmbh | Operation marking tool |
US6258021B1 (en) | 1993-06-17 | 2001-07-10 | Peter J. Wilk | Intrapericardial assist method |
US5971911A (en) | 1993-06-17 | 1999-10-26 | Wilk; Peter J. | Intrapericardial assist device and associated method |
US5533958A (en) | 1993-06-17 | 1996-07-09 | Wilk; Peter J. | Intrapericardial assist device and associated method |
US5800334A (en) | 1993-06-17 | 1998-09-01 | Wilk; Peter J. | Intrapericardial assist device and associated method |
US6572529B2 (en) | 1993-06-17 | 2003-06-03 | Wilk Patent Development Corporation | Intrapericardial assist method |
US6155968A (en) | 1998-07-23 | 2000-12-05 | Wilk; Peter J. | Method and device for improving cardiac function |
US5450860A (en) | 1993-08-31 | 1995-09-19 | W. L. Gore & Associates, Inc. | Device for tissue repair and method for employing same |
US5509428A (en) | 1994-05-31 | 1996-04-23 | Dunlop; Richard W. | Method and apparatus for the creation of tricuspid regurgitation |
US6217610B1 (en) | 1994-07-29 | 2001-04-17 | Edwards Lifesciences Corporation | Expandable annuloplasty ring |
US5433727A (en) | 1994-08-16 | 1995-07-18 | Sideris; Eleftherios B. | Centering buttoned device for the occlusion of large defects for occluding |
JPH08196538A (en) | 1994-09-26 | 1996-08-06 | Ethicon Inc | Tissue sticking apparatus for surgery with elastomer component and method of attaching mesh for surgery to said tissue |
US5849005A (en) | 1995-06-07 | 1998-12-15 | Heartport, Inc. | Method and apparatus for minimizing the risk of air embolism when performing a procedure in a patient's thoracic cavity |
DE19538796C2 (en) | 1995-10-18 | 1999-09-23 | Fraunhofer Ges Forschung | Device for supporting the heart function with elastic filling chambers |
US5755783A (en) | 1996-07-29 | 1998-05-26 | Stobie; Robert | Suture rings for rotatable artificial heart valves |
US5800531A (en) | 1996-09-30 | 1998-09-01 | Baxter International Inc. | Bioprosthetic heart valve implantation device |
US5702343A (en) * | 1996-10-02 | 1997-12-30 | Acorn Medical, Inc. | Cardiac reinforcement device |
EP0951313A4 (en) | 1996-10-18 | 2001-12-19 | Cardio Tech Inc | Method and apparatus for assisting a heart |
DE29619294U1 (en) | 1996-11-07 | 1997-07-17 | Caić, Pero, 63450 Hanau | Heart cuff |
US6071303A (en) | 1996-12-08 | 2000-06-06 | Hearten Medical, Inc. | Device for the treatment of infarcted tissue and method of treating infarcted tissue |
US6045497A (en) * | 1997-01-02 | 2000-04-04 | Myocor, Inc. | Heart wall tension reduction apparatus and method |
US6077214A (en) * | 1998-07-29 | 2000-06-20 | Myocor, Inc. | Stress reduction apparatus and method |
US5961440A (en) | 1997-01-02 | 1999-10-05 | Myocor, Inc. | Heart wall tension reduction apparatus and method |
US6406420B1 (en) * | 1997-01-02 | 2002-06-18 | Myocor, Inc. | Methods and devices for improving cardiac function in hearts |
US5928281A (en) | 1997-03-27 | 1999-07-27 | Baxter International Inc. | Tissue heart valves |
US5961549A (en) | 1997-04-03 | 1999-10-05 | Baxter International Inc. | Multi-leaflet bioprosthetic heart valve |
US6245102B1 (en) * | 1997-05-07 | 2001-06-12 | Iowa-India Investments Company Ltd. | Stent, stent graft and stent valve |
DE19826675A1 (en) * | 1997-06-21 | 1999-03-04 | Haindl Hans | Bag for shrouding the heart |
US6086532A (en) * | 1997-09-26 | 2000-07-11 | Ep Technologies, Inc. | Systems for recording use of structures deployed in association with heart tissue |
CA2308426A1 (en) | 1997-11-03 | 1999-05-14 | William A. Easterbrook, Iii | Method and apparatus for assisting a heart to pump blood |
US6332893B1 (en) | 1997-12-17 | 2001-12-25 | Myocor, Inc. | Valve to myocardium tension members device and method |
US6001126A (en) | 1997-12-24 | 1999-12-14 | Baxter International Inc. | Stentless bioprosthetic heart valve with coronary protuberances and related methods for surgical repair of defective heart valves |
US5944738A (en) | 1998-02-06 | 1999-08-31 | Aga Medical Corporation | Percutaneous catheter directed constricting occlusion device |
US6314322B1 (en) | 1998-03-02 | 2001-11-06 | Abiomed, Inc. | System and method for treating dilated cardiomyopathy using end diastolic volume (EDV) sensing |
US5902229A (en) | 1998-03-30 | 1999-05-11 | Cardio Technologies, Inc. | Drive system for controlling cardiac compression |
US6095968A (en) | 1998-04-10 | 2000-08-01 | Cardio Technologies, Inc. | Reinforcement device |
US6110100A (en) | 1998-04-22 | 2000-08-29 | Scimed Life Systems, Inc. | System for stress relieving the heart muscle and for controlling heart function |
US6221104B1 (en) | 1998-05-01 | 2001-04-24 | Cor Restore, Inc. | Anterior and interior segment cardiac restoration apparatus and method |
US6250308B1 (en) | 1998-06-16 | 2001-06-26 | Cardiac Concepts, Inc. | Mitral valve annuloplasty ring and method of implanting |
US6085754A (en) | 1998-07-13 | 2000-07-11 | Acorn Cardiovascular, Inc. | Cardiac disease treatment method |
US6251061B1 (en) * | 1998-09-09 | 2001-06-26 | Scimed Life Systems, Inc. | Cardiac assist device using field controlled fluid |
DE19947885B4 (en) | 1998-10-05 | 2009-04-09 | Cardiothoracic Systems, Inc., Cupertino | Device for positioning the heart during cardiac surgery while maintaining cardiac output |
US6360749B1 (en) * | 1998-10-09 | 2002-03-26 | Swaminathan Jayaraman | Modification of properties and geometry of heart tissue to influence heart function |
US6230714B1 (en) | 1998-11-18 | 2001-05-15 | Acorn Cardiovascular, Inc. | Cardiac constraint with prior venus occlusion methods |
US6432039B1 (en) * | 1998-12-21 | 2002-08-13 | Corset, Inc. | Methods and apparatus for reinforcement of the heart ventricles |
US6155972A (en) | 1999-02-02 | 2000-12-05 | Acorn Cardiovascular, Inc. | Cardiac constraint jacket construction |
US6701929B2 (en) | 1999-03-03 | 2004-03-09 | Hany Hussein | Device and method for treatment of congestive heart failure |
US6994669B1 (en) * | 1999-04-15 | 2006-02-07 | Heartport, Inc. | Apparatus and method for cardiac surgery |
US6231602B1 (en) | 1999-04-16 | 2001-05-15 | Edwards Lifesciences Corporation | Aortic annuloplasty ring |
US6260820B1 (en) * | 1999-05-21 | 2001-07-17 | Nordstrom Valves, Inc. | Valve with rotatable valve member and method for forming same |
US7192442B2 (en) | 1999-06-30 | 2007-03-20 | Edwards Lifesciences Ag | Method and device for treatment of mitral insufficiency |
US6241654B1 (en) | 1999-07-07 | 2001-06-05 | Acorn Cardiovasculr, Inc. | Cardiac reinforcement devices and methods |
US6231561B1 (en) * | 1999-09-20 | 2001-05-15 | Appriva Medical, Inc. | Method and apparatus for closing a body lumen |
US6312447B1 (en) | 1999-10-13 | 2001-11-06 | The General Hospital Corporation | Devices and methods for percutaneous mitral valve repair |
US6702732B1 (en) * | 1999-12-22 | 2004-03-09 | Paracor Surgical, Inc. | Expandable cardiac harness for treating congestive heart failure |
US6409759B1 (en) * | 1999-12-30 | 2002-06-25 | St. Jude Medical, Inc. | Harvested tissue heart valve with sewing rim |
US6406422B1 (en) * | 2000-03-02 | 2002-06-18 | Levram Medical Devices, Ltd. | Ventricular-assist method and apparatus |
-
2000
- 2000-03-21 US US09/532,049 patent/US6537198B1/en not_active Expired - Lifetime
-
2001
- 2001-03-20 AU AU2001247602A patent/AU2001247602A1/en not_active Abandoned
- 2001-03-20 WO PCT/US2001/008892 patent/WO2001070116A1/en active IP Right Grant
- 2001-03-20 DE DE60103618T patent/DE60103618T2/en not_active Expired - Lifetime
- 2001-03-20 AT AT01920566T patent/ATE268143T1/en not_active IP Right Cessation
- 2001-03-20 EP EP01920566A patent/EP1265534B1/en not_active Expired - Lifetime
-
2002
- 2002-10-24 US US10/278,847 patent/US7044905B2/en not_active Expired - Lifetime
-
2006
- 2006-03-07 US US11/368,445 patent/US20060149123A1/en not_active Abandoned
Patent Citations (99)
Publication number | Priority date | Publication date | Assignee | Title |
---|---|---|---|---|
US670065A (en) * | 1900-05-03 | 1901-03-19 | Richard Schulz | Water-tube boiler. |
US4192293A (en) * | 1978-09-05 | 1980-03-11 | Manfred Asrican | Cardiac assist device |
US4372293A (en) * | 1980-12-24 | 1983-02-08 | Vijil Rosales Cesar A | Apparatus and method for surgical correction of ptotic breasts |
US5496305A (en) * | 1985-03-22 | 1996-03-05 | Massachusetts Institue Of Technology | Catheter for laser angiosurgery |
US4997431A (en) * | 1989-08-30 | 1991-03-05 | Angeion Corporation | Catheter |
US5389096A (en) * | 1990-12-18 | 1995-02-14 | Advanced Cardiovascular Systems | System and method for percutaneous myocardial revascularization |
US5192314A (en) * | 1991-12-12 | 1993-03-09 | Daskalakis Michael K | Synthetic intraventricular implants and method of inserting |
US5718725A (en) * | 1992-12-03 | 1998-02-17 | Heartport, Inc. | Devices and methods for intracardiac procedures |
US5284488A (en) * | 1992-12-23 | 1994-02-08 | Sideris Eleftherios B | Adjustable devices for the occlusion of cardiac defects |
US5855614A (en) * | 1993-02-22 | 1999-01-05 | Heartport, Inc. | Method and apparatus for thoracoscopic intracardiac procedures |
US5385528A (en) * | 1993-06-17 | 1995-01-31 | Wilk; Peter J. | Intrapericardial assist device and associated method |
US5607471A (en) * | 1993-08-03 | 1997-03-04 | Jacques Seguin | Prosthetic ring for heart surgery |
US5888240A (en) * | 1994-07-29 | 1999-03-30 | Baxter International Inc. | Distensible annuloplasty ring for surgical remodelling of an atrioventricular valve and nonsurgical method for post-implantation distension thereof to accomodate patient growth |
US5593424A (en) * | 1994-08-10 | 1997-01-14 | Segmed, Inc. | Apparatus and method for reducing and stabilizing the circumference of a vascular structure |
US5876436A (en) * | 1994-10-21 | 1999-03-02 | St. Jude Medical, Inc. | Rotatable cuff assembly for a heart valve prosthesis |
US5865791A (en) * | 1995-06-07 | 1999-02-02 | E.P. Technologies Inc. | Atrial appendage stasis reduction procedure and devices |
US6508756B1 (en) * | 1995-06-13 | 2003-01-21 | Abiomed, Inc. | Passive cardiac assistance device |
US5713954A (en) * | 1995-06-13 | 1998-02-03 | Abiomed R&D, Inc. | Extra cardiac ventricular assist device |
US20040024286A1 (en) * | 1996-01-02 | 2004-02-05 | The University Of Cincinnati | Heart wall actuation device for the natural heart |
US6520904B1 (en) * | 1996-01-02 | 2003-02-18 | The University Of Cincinnati | Device and method for restructuring heart chamber geometry |
US20020022880A1 (en) * | 1996-01-02 | 2002-02-21 | Melvin David B. | Device and method for restructuring heart chamber geometry |
US20020007216A1 (en) * | 1996-01-02 | 2002-01-17 | Melvin David Boyd | Heart wall actuation device for the natural heart |
US6182664B1 (en) * | 1996-02-19 | 2001-02-06 | Edwards Lifesciences Corporation | Minimally invasive cardiac valve surgery procedure |
US6024756A (en) * | 1996-03-22 | 2000-02-15 | Scimed Life Systems, Inc. | Method of reversibly closing a septal defect |
US5855601A (en) * | 1996-06-21 | 1999-01-05 | The Trustees Of Columbia University In The City Of New York | Artificial heart valve and method and device for implanting the same |
US6685646B2 (en) * | 1996-11-01 | 2004-02-03 | Jomed Inc. | Measurement of volumetric fluid flow and its velocity profile |
US6514194B2 (en) * | 1997-01-02 | 2003-02-04 | Myocor, Inc. | Heart wall tension reduction apparatus and method |
US20040002719A1 (en) * | 1997-06-27 | 2004-01-01 | Oz Mehmet C. | Method and apparatus for circulatory valve repair |
US6338712B2 (en) * | 1997-09-17 | 2002-01-15 | Origin Medsystems, Inc. | Device to permit offpump beating heart coronary bypass surgery |
US6019722A (en) * | 1997-09-17 | 2000-02-01 | Guidant Corporation | Device to permit offpump beating heart coronary bypass surgery |
US6174332B1 (en) * | 1997-12-05 | 2001-01-16 | St. Jude Medical, Inc. | Annuloplasty ring with cut zone |
US6190408B1 (en) * | 1998-03-05 | 2001-02-20 | The University Of Cincinnati | Device and method for restructuring the heart chamber geometry |
US6024096A (en) * | 1998-05-01 | 2000-02-15 | Correstore Inc | Anterior segment ventricular restoration apparatus and method |
US6837247B2 (en) * | 1998-05-01 | 2005-01-04 | Correstore, Inc. | Method of using ventricular restoration patch |
US20020026092A1 (en) * | 1998-05-01 | 2002-02-28 | Buckberg Gerald D. | Ventricular restoration patch |
US6511426B1 (en) * | 1998-06-02 | 2003-01-28 | Acuson Corporation | Medical diagnostic ultrasound system and method for versatile processing |
US20030028077A1 (en) * | 1998-07-13 | 2003-02-06 | Acorn Cardiovascular, Inc. | Cardiac disease treatment and device |
US6695866B1 (en) * | 1998-07-15 | 2004-02-24 | St. Jude Medical, Inc. | Mitral and tricuspid valve repair |
US20030032979A1 (en) * | 1998-07-29 | 2003-02-13 | Myocor, Inc. | Transventricular implant tools and devices |
US6183411B1 (en) * | 1998-09-21 | 2001-02-06 | Myocor, Inc. | External stress reduction device and method |
US6685627B2 (en) * | 1998-10-09 | 2004-02-03 | Swaminathan Jayaraman | Modification of properties and geometry of heart tissue to influence heart function |
US6169922B1 (en) * | 1998-11-18 | 2001-01-02 | Acorn Cardiovascular, Inc. | Defibrillating cardiac jacket with interwoven electrode grids |
US6695768B1 (en) * | 1999-03-30 | 2004-02-24 | Robert A. Levine | Adjustable periventricular ring/ring like device/method for control of ischemic mitral regurgitation and congestive heart disease |
US20040003819A1 (en) * | 1999-04-09 | 2004-01-08 | Evalve, Inc. | Methods and apparatus for cardiac valve repair |
US20020013571A1 (en) * | 1999-04-09 | 2002-01-31 | Evalve, Inc. | Methods and devices for capturing and fixing leaflets in valve repair |
US20050033446A1 (en) * | 1999-04-09 | 2005-02-10 | Evalve, Inc. A California Corporation | Methods and apparatus for cardiac valve repair |
US20050021057A1 (en) * | 1999-04-09 | 2005-01-27 | Evalve, Inc. | Leaflet structuring |
US20050021056A1 (en) * | 1999-04-09 | 2005-01-27 | Evalve, Inc. | Leaflet structuring |
US20040039442A1 (en) * | 1999-04-09 | 2004-02-26 | Evalve, Inc. | Methods and apparatus for cardiac valve repair |
US20040030382A1 (en) * | 1999-04-09 | 2004-02-12 | Evalve, Inc. | Methods and apparatus for cardiac valve repair |
US6183512B1 (en) * | 1999-04-16 | 2001-02-06 | Edwards Lifesciences Corporation | Flexible annuloplasty system |
US20050043792A1 (en) * | 1999-06-29 | 2005-02-24 | Edwards Lifesciences Ag | Device and method for treatment of mitral insufficiency |
US20040039443A1 (en) * | 1999-06-30 | 2004-02-26 | Solem Jan Otto | Method and device for treatment of mitral insufficiency |
US20030009081A1 (en) * | 1999-07-08 | 2003-01-09 | Chase Medical, Lp | Device and method for isolating a surface of a beating heart during surgery |
US6174279B1 (en) * | 1999-09-21 | 2001-01-16 | Acorn Cardiovascular, Inc. | Cardiac constraint with tension indicator |
US6179791B1 (en) * | 1999-09-21 | 2001-01-30 | Acorn Cardiovascular, Inc. | Device for heart measurement |
US6193648B1 (en) * | 1999-09-21 | 2001-02-27 | Acorn Cardiovascular, Inc. | Cardiac constraint with draw string tensioning |
US20030004396A1 (en) * | 2000-01-14 | 2003-01-02 | Acon Cardiovascular, Inc. | Delivery of cardiac constraint jacket |
US6689048B2 (en) * | 2000-01-14 | 2004-02-10 | Acorn Cardiovascular, Inc. | Delivery of cardiac constraint jacket |
US20020016628A1 (en) * | 2000-01-31 | 2002-02-07 | Langberg Jonathan J. | Percutaneous mitral annuloplasty with hemodynamic monitoring |
US20020019580A1 (en) * | 2000-03-10 | 2002-02-14 | Lilip Lau | Expandable cardiac harness for treating congestive heart failure |
US6682474B2 (en) * | 2000-03-10 | 2004-01-27 | Paracor Surgical, Inc. | Expandable cardiac harness for treating congestive heart failure |
US20030023132A1 (en) * | 2000-05-31 | 2003-01-30 | Melvin David B. | Cyclic device for restructuring heart chamber geometry |
US20050004428A1 (en) * | 2000-06-12 | 2005-01-06 | Acorn Cardiovascular, Inc. | Cardiac disease treatment and device |
US6682476B2 (en) * | 2000-06-13 | 2004-01-27 | Acorn Cardiovascular, Inc. | Cardiac disease treatment and device |
US6343605B1 (en) * | 2000-08-08 | 2002-02-05 | Scimed Life Systems, Inc. | Percutaneous transluminal myocardial implantation device and method |
US6846296B1 (en) * | 2000-09-14 | 2005-01-25 | Abiomed, Inc. | Apparatus and method for detachably securing a device to a natural heart |
US20060004443A1 (en) * | 2000-10-23 | 2006-01-05 | Liddicoat John R | Automated annular plication for mitral valve repair |
US6673009B1 (en) * | 2000-11-08 | 2004-01-06 | Acorn Cardiovascular, Inc. | Adjustment clamp |
US6681773B2 (en) * | 2001-02-28 | 2004-01-27 | Chase Medical, Inc. | Kit and method for use during ventricular restoration |
US20050021135A1 (en) * | 2001-03-15 | 2005-01-27 | Ryan Timothy R. | Annuloplasty band and method |
US20040019378A1 (en) * | 2001-04-24 | 2004-01-29 | Hlavka Edwin J. | Method and apparatus for performing catheter-based annuloplasty |
US20050033419A1 (en) * | 2001-05-14 | 2005-02-10 | Alferness Clifton A. | Mitral valve therapy device, system and method |
US6676702B2 (en) * | 2001-05-14 | 2004-01-13 | Cardiac Dimensions, Inc. | Mitral valve therapy assembly and method |
US20050027351A1 (en) * | 2001-05-14 | 2005-02-03 | Cardiac Dimensions, Inc. A Washington Corporation | Mitral valve regurgitation treatment device and method |
US20050027353A1 (en) * | 2001-05-14 | 2005-02-03 | Alferness Clifton A. | Mitral valve therapy device, system and method |
US20050038507A1 (en) * | 2001-05-14 | 2005-02-17 | Alferness Clifton A. | Mitral valve therapy device, system and method |
US20050004666A1 (en) * | 2001-05-17 | 2005-01-06 | Ottavio Alfieri | Annular prosthesis for mitral valve |
US6685620B2 (en) * | 2001-09-25 | 2004-02-03 | The Foundry Inc. | Ventricular infarct assist device and methods for using it |
US20050021121A1 (en) * | 2001-11-01 | 2005-01-27 | Cardiac Dimensions, Inc., A Delaware Corporation | Adjustable height focal tissue deflector |
US20040010305A1 (en) * | 2001-12-05 | 2004-01-15 | Cardiac Dimensions, Inc. | Device and method for modifying the shape of a body organ |
US20060041306A1 (en) * | 2002-01-09 | 2006-02-23 | Myocor, Inc. | Devices and methods for heart valve treatment |
US20040019377A1 (en) * | 2002-01-14 | 2004-01-29 | Taylor Daniel C. | Method and apparatus for reducing mitral regurgitation |
US20050027369A1 (en) * | 2002-05-10 | 2005-02-03 | Eldridge Stephen N. | Prosthetic repair fabric with erosion resistant edge |
US6682475B2 (en) * | 2002-06-11 | 2004-01-27 | Acorn Cardiovascular, Inc. | Tension indicator for cardiac support device and method therefore |
US6858039B2 (en) * | 2002-07-08 | 2005-02-22 | Edwards Lifesciences Corporation | Mitral valve annuloplasty ring having a posterior bow |
US20040015039A1 (en) * | 2002-07-16 | 2004-01-22 | The University Of Cincinnati | Modular power system and method for a heart wall actuation system for the natural heart |
US20040015040A1 (en) * | 2002-07-18 | 2004-01-22 | The University Of Cincinnati | Flexible, torsionable cardiac framework for heart wall actuation of the natural heart |
US20040015041A1 (en) * | 2002-07-18 | 2004-01-22 | The University Of Cincinnati | Protective sheath apparatus and method for use with a heart wall actuation system for the natural heart |
US20040034271A1 (en) * | 2002-08-19 | 2004-02-19 | The University Of Cincinnati | Heart wall actuation system for the natural heart with shape limiting elements |
US20060030885A1 (en) * | 2002-10-15 | 2006-02-09 | Hyde Gregory M | Apparatuses and methods for heart valve repair |
US20060036317A1 (en) * | 2002-11-12 | 2006-02-16 | Myocor, Inc. | Decives and methods for heart valve treatment |
US20050038506A1 (en) * | 2002-11-15 | 2005-02-17 | Webler William E. | Apparatuses and methods for heart valve repair |
US20050010240A1 (en) * | 2003-06-05 | 2005-01-13 | Cardiac Dimensions Inc., A Washington Corporation | Device and method for modifying the shape of a body organ |
US20050004668A1 (en) * | 2003-07-02 | 2005-01-06 | Flexcor, Inc. | Annuloplasty rings and methods for repairing cardiac valves |
US20050004665A1 (en) * | 2003-07-02 | 2005-01-06 | Lishan Aklog | Annuloplasty rings and methods for repairing cardiac valves |
US20050010286A1 (en) * | 2003-07-11 | 2005-01-13 | Vedic Biotechnology, Inc. | Heart failure mitral annuloplasty ring with removable central posterior portion |
US20050010283A1 (en) * | 2003-07-11 | 2005-01-13 | Vedic Biotechnology, Inc. | Heart failure mitral annuloplasty ring with multiple sets of suture placement indicia |
US20050038509A1 (en) * | 2003-08-14 | 2005-02-17 | Ashe Kassem Ali | Valve prosthesis including a prosthetic leaflet |
Cited By (105)
Publication number | Priority date | Publication date | Assignee | Title |
---|---|---|---|---|
US7883539B2 (en) | 1997-01-02 | 2011-02-08 | Edwards Lifesciences Llc | Heart wall tension reduction apparatus and method |
US8460173B2 (en) | 1997-01-02 | 2013-06-11 | Edwards Lifesciences, Llc | Heart wall tension reduction apparatus and method |
US8267852B2 (en) | 1997-01-02 | 2012-09-18 | Edwards Lifesciences, Llc | Heart wall tension reduction apparatus and method |
US9198757B2 (en) | 2000-10-06 | 2015-12-01 | Edwards Lifesciences, Llc | Methods and devices for improving mitral valve function |
US8070805B2 (en) | 2002-01-09 | 2011-12-06 | Edwards Lifesciences Llc | Devices and methods for heart valve treatment |
US8506624B2 (en) | 2002-01-09 | 2013-08-13 | Edwards Lifesciences, Llc | Devices and methods for heart valve treatment |
US7678145B2 (en) | 2002-01-09 | 2010-03-16 | Edwards Lifesciences Llc | Devices and methods for heart valve treatment |
US7666224B2 (en) | 2002-11-12 | 2010-02-23 | Edwards Lifesciences Llc | Devices and methods for heart valve treatment |
US20080065047A1 (en) * | 2002-11-29 | 2008-03-13 | Sabbah Hani N | Intramyocardial patterning for treating localized anomalies of the heart |
US7316706B2 (en) | 2003-06-20 | 2008-01-08 | Medtronic Vascular, Inc. | Tensioning device, system, and method for treating mitral valve regurgitation |
US20040260317A1 (en) * | 2003-06-20 | 2004-12-23 | Elliot Bloom | Tensioning device, system, and method for treating mitral valve regurgitation |
US20060089711A1 (en) * | 2004-10-27 | 2006-04-27 | Medtronic Vascular, Inc. | Multifilament anchor for reducing a compass of a lumen or structure in mammalian body |
US9700300B2 (en) | 2005-01-21 | 2017-07-11 | Mayo Foundation For Medical Education And Research | Thorascopic heart valve repair apparatus |
US11534156B2 (en) | 2005-01-21 | 2022-12-27 | Mayo Foundation For Medical Education And Research | Thorascopic heart valve repair method and apparatus |
US10582924B2 (en) | 2005-01-21 | 2020-03-10 | Mayo Foundation For Medical Education And Research | Thorascopic heart valve repair method |
US9364213B2 (en) | 2005-01-21 | 2016-06-14 | Mayo Foundation For Medical Education And Research | Thorascopic heart valve repair method |
US8968338B2 (en) | 2005-01-21 | 2015-03-03 | Mayo Foundation For Medical Education And Research | Thorascopic heart valve repair method and apparatus |
US8465500B2 (en) | 2005-01-21 | 2013-06-18 | Mayo Foundation For Medical Education And Research | Thorascopic heart valve repair method and apparatus |
US20070025009A1 (en) * | 2005-07-29 | 2007-02-01 | Fuji Photo Film Co., Ltd. | Magnetic recorder |
US20070066863A1 (en) * | 2005-08-31 | 2007-03-22 | Medtronic Vascular, Inc. | Device for treating mitral valve regurgitation |
US8845512B2 (en) | 2005-11-14 | 2014-09-30 | C. R. Bard, Inc. | Sling anchor system |
US20070203391A1 (en) * | 2006-02-24 | 2007-08-30 | Medtronic Vascular, Inc. | System for Treating Mitral Valve Regurgitation |
US20070265658A1 (en) * | 2006-05-12 | 2007-11-15 | Aga Medical Corporation | Anchoring and tethering system |
US20080065048A1 (en) * | 2006-09-08 | 2008-03-13 | Sabbah Hani N | Intramyocardial patterning for global cardiac resizing and reshaping |
US20090012413A1 (en) * | 2006-09-08 | 2009-01-08 | Sabbah Hani N | Cardiac patterning for improving diastolic function |
US9375313B2 (en) | 2006-09-08 | 2016-06-28 | The Regents Of The University Of California | Intramyocardial patterning for global cardiac resizing and reshaping |
US20080065046A1 (en) * | 2006-09-08 | 2008-03-13 | Sabbah Hani N | Intramyocardial patterning for global cardiac resizing and reshaping |
US9782258B2 (en) | 2006-09-08 | 2017-10-10 | The Regents Of The University Of California | Intramyocardial patterning for global cardiac resizing and reshaping |
US8480559B2 (en) | 2006-09-13 | 2013-07-09 | C. R. Bard, Inc. | Urethral support system |
WO2008121880A3 (en) * | 2007-03-30 | 2008-12-18 | Micardia Corp | Adjustable annuloplasty ring and activation system |
US7875017B2 (en) | 2007-04-11 | 2011-01-25 | Henry Ford Health System | Cardiac repair, resizing and reshaping using the venous system of the heart |
US8419711B2 (en) | 2007-04-11 | 2013-04-16 | Henry Ford Health System | Cardiac repair, resizing and reshaping using the venous system of the heart |
US20110087190A1 (en) * | 2007-04-11 | 2011-04-14 | Henry Ford Health System | Cardiac Repair, Resizing and Reshaping Using the Venous System of the Heart |
US20080269720A1 (en) * | 2007-04-11 | 2008-10-30 | Sabbah Hani N | Cardiac repair, resizing and reshaping using the venous system of the heart |
US8758393B2 (en) | 2007-10-18 | 2014-06-24 | Neochord, Inc. | Minimally invasive repair of a valve leaflet in a beating heart |
US9192374B2 (en) | 2007-10-18 | 2015-11-24 | Neochord, Inc. | Minimally invasive repair of a valve leaflet in a beating heart |
US11419602B2 (en) | 2007-10-18 | 2022-08-23 | Neochord, Inc. | Minimally invasive repair of a valve leaflet in a beating heart |
US10507018B2 (en) | 2007-10-18 | 2019-12-17 | Neochord, Inc. | Minimally invasive repair of a valve leaflet in a beating heart |
US8206280B2 (en) | 2007-11-13 | 2012-06-26 | C. R. Bard, Inc. | Adjustable tissue support member |
US8574149B2 (en) | 2007-11-13 | 2013-11-05 | C. R. Bard, Inc. | Adjustable tissue support member |
US8801665B2 (en) | 2008-04-10 | 2014-08-12 | Henry Ford Health System | Apparatus and method for controlled depth of injection into myocardial tissue |
US20090259212A1 (en) * | 2008-04-10 | 2009-10-15 | Sabbah Hani N | Apparatus and method for controlled depth of injection into myocardial tissue |
US10272178B2 (en) | 2008-04-29 | 2019-04-30 | Virginia Tech Intellectual Properties Inc. | Methods for blood-brain barrier disruption using electrical energy |
US11655466B2 (en) | 2008-04-29 | 2023-05-23 | Virginia Tech Intellectual Properties, Inc. | Methods of reducing adverse effects of non-thermal ablation |
US12059197B2 (en) | 2008-04-29 | 2024-08-13 | Virginia Tech Intellectual Properties, Inc. | Blood-brain barrier disruption using reversible or irreversible electroporation |
US11974800B2 (en) | 2008-04-29 | 2024-05-07 | Virginia Tech Intellectual Properties, Inc. | Irreversible electroporation using tissue vasculature to treat aberrant cell masses or create tissue scaffolds |
US10117707B2 (en) | 2008-04-29 | 2018-11-06 | Virginia Tech Intellectual Properties, Inc. | System and method for estimating tissue heating of a target ablation zone for electrical-energy based therapies |
US11952568B2 (en) | 2008-04-29 | 2024-04-09 | Virginia Tech Intellectual Properties, Inc. | Device and methods for delivery of biphasic electrical pulses for non-thermal ablation |
US10154874B2 (en) | 2008-04-29 | 2018-12-18 | Virginia Tech Intellectual Properties, Inc. | Immunotherapeutic methods using irreversible electroporation |
US10238447B2 (en) | 2008-04-29 | 2019-03-26 | Virginia Tech Intellectual Properties, Inc. | System and method for ablating a tissue site by electroporation with real-time monitoring of treatment progress |
US10245098B2 (en) | 2008-04-29 | 2019-04-02 | Virginia Tech Intellectual Properties, Inc. | Acute blood-brain barrier disruption using electrical energy based therapy |
US10245105B2 (en) | 2008-04-29 | 2019-04-02 | Virginia Tech Intellectual Properties, Inc. | Electroporation with cooling to treat tissue |
US9867652B2 (en) | 2008-04-29 | 2018-01-16 | Virginia Tech Intellectual Properties, Inc. | Irreversible electroporation using tissue vasculature to treat aberrant cell masses or create tissue scaffolds |
US10286108B2 (en) | 2008-04-29 | 2019-05-14 | Virginia Tech Intellectual Properties, Inc. | Irreversible electroporation to create tissue scaffolds |
US11272979B2 (en) | 2008-04-29 | 2022-03-15 | Virginia Tech Intellectual Properties, Inc. | System and method for estimating tissue heating of a target ablation zone for electrical-energy based therapies |
US10959772B2 (en) | 2008-04-29 | 2021-03-30 | Virginia Tech Intellectual Properties, Inc. | Blood-brain barrier disruption using electrical energy |
US11890046B2 (en) | 2008-04-29 | 2024-02-06 | Virginia Tech Intellectual Properties, Inc. | System and method for ablating a tissue site by electroporation with real-time monitoring of treatment progress |
US10470822B2 (en) | 2008-04-29 | 2019-11-12 | Virginia Tech Intellectual Properties, Inc. | System and method for estimating a treatment volume for administering electrical-energy based therapies |
US11737810B2 (en) | 2008-04-29 | 2023-08-29 | Virginia Tech Intellectual Properties, Inc. | Immunotherapeutic methods using electroporation |
US10537379B2 (en) | 2008-04-29 | 2020-01-21 | Virginia Tech Intellectual Properties, Inc. | Irreversible electroporation using tissue vasculature to treat aberrant cell masses or create tissue scaffolds |
US9598691B2 (en) | 2008-04-29 | 2017-03-21 | Virginia Tech Intellectual Properties, Inc. | Irreversible electroporation to create tissue scaffolds |
US11254926B2 (en) | 2008-04-29 | 2022-02-22 | Virginia Tech Intellectual Properties, Inc. | Devices and methods for high frequency electroporation |
US10828085B2 (en) | 2008-04-29 | 2020-11-10 | Virginia Tech Intellectual Properties, Inc. | Immunotherapeutic methods using irreversible electroporation |
US11607271B2 (en) | 2008-04-29 | 2023-03-21 | Virginia Tech Intellectual Properties, Inc. | System and method for estimating a treatment volume for administering electrical-energy based therapies |
US11453873B2 (en) | 2008-04-29 | 2022-09-27 | Virginia Tech Intellectual Properties, Inc. | Methods for delivery of biphasic electrical pulses for non-thermal ablation |
US10828086B2 (en) | 2008-04-29 | 2020-11-10 | Virginia Tech Intellectual Properties, Inc. | Immunotherapeutic methods using irreversible electroporation |
US11382681B2 (en) | 2009-04-09 | 2022-07-12 | Virginia Tech Intellectual Properties, Inc. | Device and methods for delivery of high frequency electrical pulses for non-thermal ablation |
US11638603B2 (en) | 2009-04-09 | 2023-05-02 | Virginia Tech Intellectual Properties, Inc. | Selective modulation of intracellular effects of cells using pulsed electric fields |
US10448989B2 (en) | 2009-04-09 | 2019-10-22 | Virginia Tech Intellectual Properties, Inc. | High-frequency electroporation for cancer therapy |
US10292755B2 (en) | 2009-04-09 | 2019-05-21 | Virginia Tech Intellectual Properties, Inc. | High frequency electroporation for cancer therapy |
US11707629B2 (en) | 2009-05-28 | 2023-07-25 | Angiodynamics, Inc. | System and method for synchronizing energy delivery to the cardiac rhythm |
US9895189B2 (en) | 2009-06-19 | 2018-02-20 | Angiodynamics, Inc. | Methods of sterilization and treating infection using irreversible electroporation |
US8425455B2 (en) | 2010-03-30 | 2013-04-23 | Angiodynamics, Inc. | Bronchial catheter and method of use |
US11931096B2 (en) | 2010-10-13 | 2024-03-19 | Angiodynamics, Inc. | System and method for electrically ablating tissue of a patient |
US10080659B1 (en) | 2010-12-29 | 2018-09-25 | Neochord, Inc. | Devices and methods for minimally invasive repair of heart valves |
US10130474B2 (en) | 2010-12-29 | 2018-11-20 | Neochord, Inc. | Exchangeable system for minimally invasive beating heart repair of heart valve leaflets |
US9044221B2 (en) | 2010-12-29 | 2015-06-02 | Neochord, Inc. | Exchangeable system for minimally invasive beating heart repair of heart valve leaflets |
US11974920B2 (en) | 2011-06-01 | 2024-05-07 | Neochord, Inc. | Minimally invasive repair of heart valve leaflets |
US10695178B2 (en) | 2011-06-01 | 2020-06-30 | Neochord, Inc. | Minimally invasive repair of heart valve leaflets |
US10702326B2 (en) | 2011-07-15 | 2020-07-07 | Virginia Tech Intellectual Properties, Inc. | Device and method for electroporation based treatment of stenosis of a tubular body part |
US9757196B2 (en) | 2011-09-28 | 2017-09-12 | Angiodynamics, Inc. | Multiple treatment zone ablation probe |
US11779395B2 (en) | 2011-09-28 | 2023-10-10 | Angiodynamics, Inc. | Multiple treatment zone ablation probe |
US9888956B2 (en) | 2013-01-22 | 2018-02-13 | Angiodynamics, Inc. | Integrated pump and generator device and method of use |
US11957405B2 (en) | 2013-06-13 | 2024-04-16 | Angiodynamics, Inc. | Methods of sterilization and treating infection using irreversible electroporation |
US10471254B2 (en) | 2014-05-12 | 2019-11-12 | Virginia Tech Intellectual Properties, Inc. | Selective modulation of intracellular effects of cells using pulsed electric fields |
US11406820B2 (en) | 2014-05-12 | 2022-08-09 | Virginia Tech Intellectual Properties, Inc. | Selective modulation of intracellular effects of cells using pulsed electric fields |
US10694972B2 (en) | 2014-12-15 | 2020-06-30 | Virginia Tech Intellectual Properties, Inc. | Devices, systems, and methods for real-time monitoring of electrophysical effects during tissue treatment |
US11903690B2 (en) | 2014-12-15 | 2024-02-20 | Virginia Tech Intellectual Properties, Inc. | Devices, systems, and methods for real-time monitoring of electrophysical effects during tissue treatment |
US11484409B2 (en) | 2015-10-01 | 2022-11-01 | Neochord, Inc. | Ringless web for repair of heart valves |
US10765517B2 (en) | 2015-10-01 | 2020-09-08 | Neochord, Inc. | Ringless web for repair of heart valves |
US11723710B2 (en) | 2016-11-17 | 2023-08-15 | Angiodynamics, Inc. | Techniques for irreversible electroporation using a single-pole tine-style internal device communicating with an external surface electrode |
US11589989B2 (en) | 2017-03-31 | 2023-02-28 | Neochord, Inc. | Minimally invasive heart valve repair in a beating heart |
US11607537B2 (en) | 2017-12-05 | 2023-03-21 | Virginia Tech Intellectual Properties, Inc. | Method for treating neurological disorders, including tumors, with electroporation |
US11925405B2 (en) | 2018-03-13 | 2024-03-12 | Virginia Tech Intellectual Properties, Inc. | Treatment planning system for immunotherapy enhancement via non-thermal ablation |
US11311329B2 (en) | 2018-03-13 | 2022-04-26 | Virginia Tech Intellectual Properties, Inc. | Treatment planning for immunotherapy based treatments using non-thermal ablation techniques |
US10588620B2 (en) | 2018-03-23 | 2020-03-17 | Neochord, Inc. | Device for suture attachment for minimally invasive heart valve repair |
US11612389B2 (en) | 2018-03-23 | 2023-03-28 | Neochord, Inc. | Device for suture attachment for minimally invasive heart valve repair |
US11173030B2 (en) | 2018-05-09 | 2021-11-16 | Neochord, Inc. | Suture length adjustment for minimally invasive heart valve repair |
US11957584B2 (en) | 2018-05-09 | 2024-04-16 | Neochord, Inc. | Suture length adjustment for minimally invasive heart valve repair |
US11253360B2 (en) | 2018-05-09 | 2022-02-22 | Neochord, Inc. | Low profile tissue anchor for minimally invasive heart valve repair |
US10966709B2 (en) | 2018-09-07 | 2021-04-06 | Neochord, Inc. | Device for suture attachment for minimally invasive heart valve repair |
US11918468B2 (en) | 2019-04-16 | 2024-03-05 | Neochord, Inc. | Transverse helical cardiac anchor for minimally invasive heart valve repair |
US11376126B2 (en) | 2019-04-16 | 2022-07-05 | Neochord, Inc. | Transverse helical cardiac anchor for minimally invasive heart valve repair |
US11950835B2 (en) | 2019-06-28 | 2024-04-09 | Virginia Tech Intellectual Properties, Inc. | Cycled pulsing to mitigate thermal damage for multi-electrode irreversible electroporation therapy |
US11766331B2 (en) | 2020-05-27 | 2023-09-26 | Politecnico Di Milano | Device and assembly to repair a heart valve |
Also Published As
Publication number | Publication date |
---|---|
US6537198B1 (en) | 2003-03-25 |
AU2001247602A1 (en) | 2001-10-03 |
DE60103618T2 (en) | 2005-06-16 |
US20030050529A1 (en) | 2003-03-13 |
DE60103618D1 (en) | 2004-07-08 |
WO2001070116A1 (en) | 2001-09-27 |
EP1265534A1 (en) | 2002-12-18 |
ATE268143T1 (en) | 2004-06-15 |
EP1265534B1 (en) | 2004-06-02 |
US7044905B2 (en) | 2006-05-16 |
Similar Documents
Publication | Publication Date | Title |
---|---|---|
US6537198B1 (en) | Splint assembly for improving cardiac function in hearts, and method for implanting the splint assembly | |
US11331189B2 (en) | Systems and devices for setting an anchor | |
US6406420B1 (en) | Methods and devices for improving cardiac function in hearts | |
EP1322259B1 (en) | Endovascular splinting devices | |
US9198757B2 (en) | Methods and devices for improving mitral valve function | |
US9131928B2 (en) | Elongated body for deployment in a heart | |
US7588582B2 (en) | Methods for remodeling cardiac tissue | |
US7316706B2 (en) | Tensioning device, system, and method for treating mitral valve regurgitation | |
US6537314B2 (en) | Percutaneous mitral annuloplasty and cardiac reinforcement | |
US20130030522A1 (en) | Devices and methods for heart treatments | |
WO2001028455A1 (en) | Methods and devices for improving cardiac function in hearts | |
US20120232645A1 (en) | Devices, systems, and methods for reshaping a heart valve annulus, including the use of magnetic tools | |
US20030233022A1 (en) | Devices and methods for heart valve treatment | |
US20110015476A1 (en) | Devices and Methods for Treating Cardiomyopathy | |
EP1865887A1 (en) | Device, systems, and methods for reshaping a heart valve annulus | |
WO2011047201A2 (en) | Devices and methods for treatment of cardiomyopathy | |
US20230255616A1 (en) | Intra-lumen suture knot deployment | |
US20230414825A1 (en) | Suture encapsulation processes and systems |
Legal Events
Date | Code | Title | Description |
---|---|---|---|
AS | Assignment |
Owner name: VENTURE LENDING & LEASING IV, INC., CALIFORNIA Free format text: SECURITY AGREEMMENT;ASSIGNOR:MYOCOR, INC.;REEL/FRAME:019805/0072 Effective date: 20070820 Owner name: VENTURE LENDING & LEASING IV, INC.,CALIFORNIA Free format text: SECURITY AGREEMMENT;ASSIGNOR:MYOCOR, INC.;REEL/FRAME:019805/0072 Effective date: 20070820 |
|
AS | Assignment |
Owner name: EDWARDS LIFESCIENCES LLC, CALIFORNIA Free format text: ASSIGNMENT OF ASSIGNORS INTEREST;ASSIGNOR:MYOCOR, INC.;REEL/FRAME:022277/0011 Effective date: 20081029 Owner name: EDWARDS LIFESCIENCES LLC,CALIFORNIA Free format text: ASSIGNMENT OF ASSIGNORS INTEREST;ASSIGNOR:MYOCOR, INC.;REEL/FRAME:022277/0011 Effective date: 20081029 |
|
STCB | Information on status: application discontinuation |
Free format text: ABANDONED -- FAILURE TO RESPOND TO AN OFFICE ACTION |