WO2006052687A1 - Fixation device and associated apparatus - Google Patents

Fixation device and associated apparatus Download PDF

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Publication number
WO2006052687A1
WO2006052687A1 PCT/US2005/039851 US2005039851W WO2006052687A1 WO 2006052687 A1 WO2006052687 A1 WO 2006052687A1 US 2005039851 W US2005039851 W US 2005039851W WO 2006052687 A1 WO2006052687 A1 WO 2006052687A1
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WO
WIPO (PCT)
Prior art keywords
shape
fixation device
bodily tissue
stimulus
fixation
Prior art date
Application number
PCT/US2005/039851
Other languages
French (fr)
Inventor
Gregory Dale Buckner
Jason Michael Stevens
Jesse Gabriel Crossen
Stephen Charles Messer
Jonathan Kuniholm
Original Assignee
North Carolina State University
Priority date (The priority date is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the date listed.)
Filing date
Publication date
Application filed by North Carolina State University filed Critical North Carolina State University
Publication of WO2006052687A1 publication Critical patent/WO2006052687A1/en

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Classifications

    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B17/00—Surgical instruments, devices or methods, e.g. tourniquets
    • A61B17/064—Surgical staples, i.e. penetrating the tissue
    • A61B17/0644—Surgical staples, i.e. penetrating the tissue penetrating the tissue, deformable to closed position
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B17/00—Surgical instruments, devices or methods, e.g. tourniquets
    • A61B2017/00831—Material properties
    • A61B2017/00867—Material properties shape memory effect
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B17/00—Surgical instruments, devices or methods, e.g. tourniquets
    • A61B17/064—Surgical staples, i.e. penetrating the tissue
    • A61B2017/0647—Surgical staples, i.e. penetrating the tissue having one single leg, e.g. tacks
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61F—FILTERS IMPLANTABLE INTO BLOOD VESSELS; PROSTHESES; DEVICES PROVIDING PATENCY TO, OR PREVENTING COLLAPSING OF, TUBULAR STRUCTURES OF THE BODY, e.g. STENTS; ORTHOPAEDIC, NURSING OR CONTRACEPTIVE DEVICES; FOMENTATION; TREATMENT OR PROTECTION OF EYES OR EARS; BANDAGES, DRESSINGS OR ABSORBENT PADS; FIRST-AID KITS
    • A61F2/00—Filters implantable into blood vessels; Prostheses, i.e. artificial substitutes or replacements for parts of the body; Appliances for connecting them with the body; Devices providing patency to, or preventing collapsing of, tubular structures of the body, e.g. stents
    • A61F2/02—Prostheses implantable into the body
    • A61F2/24—Heart valves ; Vascular valves, e.g. venous valves; Heart implants, e.g. passive devices for improving the function of the native valve or the heart muscle; Transmyocardial revascularisation [TMR] devices; Valves implantable in the body
    • A61F2/2442—Annuloplasty rings or inserts for correcting the valve shape; Implants for improving the function of a native heart valve
    • A61F2/2445—Annuloplasty rings in direct contact with the valve annulus

Definitions

  • the present invention relates to surgical devices and associated apparatuses and methods and, more particularly, to a fixation device and associated apparatus and method for preliminarily and removably engaging a surgical device or bodily tissue with other bodily tissue so as to allow the surgical apparatus or bodily tissue to be positioned with respect to the other bodily tissue, as desired, wherein the fixation device is then actuatable, via a stimulus applied thereto, to securely fasten the surgical device or bodily tissue in the desired position with respect to the other bodily tissue.
  • Some surgeries are commonly performed, but must often be accomplished under certain conditions in order to maximize the chance of survival of the patient, as well as facilitate the recovery process. In some instances, such surgeries may also require accessing the affected portion of the body through an opening in the body of sufficient size to provide the necessary exposure of the subject of the procedure, and to provide access for the physician to operate on the subject.
  • One consideration, in this respect is that a smaller opening to provide the necessary access may be less traumatic to the patient.
  • a cardiopulmonary bypass procedure for mitral valve replacement includes monitoring of arterial and venous lines, a urinary catheter, and a pre-bypass-placed pulmonary artery catheter to measure pulmonary pressures and cardiac output.
  • a left atrial catheter directly inserted through the left atrial incision may be used to allow measurement of pulmonary vascular resistance.
  • temporary ventricular pacing wires may be placed, and temporary atrial pacing wires my also be placed for possible pacing or diagnosis of various atrial arrhythmias.
  • Cardiopulmonary bypass is generally instituted by placing two right-angle cannulas into the superior and inferior venae cavae. More particularly, a small (22 French) plastic or metal cannula may be placed directly into the superior vena cava, above the sinoatrial node, while the inferior caval cannula is placed at the entrance of the inferior vena cava, relatively low in the right atrium. Such insertion sites keep the caval catheters out of the operative field and maintain bicaval drainage. An arterial cannula may also be placed in the distal ascending aorta. Bypass flows of approximately 1.5 liters/min per m 2 , and moderate hypothermia (about 30 0 C), may also be used.
  • myocardial protection includes antegrade and retrograde blood cardioplegia and profound myocardial hypothermia, where retrograde cardioplegia is useful for all valve surgery to protect the ischemic left ventricle and to help remove ascending aorta bubbles.
  • Antegrade cardioplegia used as an initial loading dose, may be augmented by intermittent retrograde cardioplegia every 20 minutes, hi some instances, when the atrium is retracted during valve replacement, the aortic valve becomes distorted, and antegrade cardioplegia may tend to fill the ventricle.
  • Such indications include a previously placed stented aortic prosthesis; several patent bypass grafts, such as an internal thoracic artery to left anterior descending artery; multiple previous valve replacements so that there is a virtual symphysis between the right ventricle and sternum; and severe, deep, infectious mediastinitis that may make dissection extremely difficult and hazardous.
  • a potential disadvantage of the right thoracotomy incision is the inability to completely evacuate air from the patient's heart. In such instances, intraoperative transesophageal echocardiography and positioning the patient so that the left atrial incision is uppermost may facilitate removal of air in the left heart chambers.
  • Cannulation for right anterior thoracotomy usually involves the right femoral vein and artery, but intrathoracic bicaval cannulation also can be used.
  • An ascending aortic cannula also can be placed through this incision if severe peripheral vascular disease is present, hi such instances, myocardial protection consists of deep systemic hypothermia (2O 0 C), reduction of bypass flow when anatomically critical areas need to be addressed, and maintenance of perfusion throughout the period of cardiopulmonary bypass.
  • the aorta is not cross-clamped, and cardioplegia is not administered.
  • Intracardiac techniques have also been developed, wherein such an operation involves secure fixation of a valve prosthesis to the annulus by suture techniques, without damage to adjacent structures or myocardium, and without tissue interference with valve function.
  • Such implantation may prevent injury to anatomic structures surrounding the mitral valve annulus, since some important cardiac structures are near the mitral valve annulus, including the circumflex coronary artery within the atrioventricular (AV) groove, the left atrial appendage, the aortic valve in continuity with the anterior mitral curtain, and the AV node.
  • AV atrioventricular
  • the anterior leaflet may be partially excised and brought to the posterior leaflet, or the anterior leaflet may be partially excised and "furled" to the anterior annulus by a running suture.
  • preservation of the corneal shape of the ventricle is important to maintain normal cardiac output, and that assumption of a globular shape from cutting papillary muscles is deleterious to left ventricular function.
  • preservation of the posterior leaflet and chordae may particularly reduce incidences of perforation of the left ventricle and atrioventricular separation during mitral valve replacement.
  • suturing techniques may vary according to the type of valve that is implanted.
  • a bioprosthetic valve is preferentially inserted with the sutures placed from ventricle to atrium (noneverting or subannular), in a procedure has been shown to be one of the strongest types of suturing techniques for the mitral annulus, and may also be used with a central-flow Starr-Edwards ball-and-cage valve.
  • sutures atrium to ventricle to sewing ring
  • sutures which urges the prosthetic valve out into the center of the orifice and minimizes any tissue interference with the prosthetic valve leaflets.
  • Such a provision is particularly important if annular-chordal attachments are preserved, and particular sutures suitable for the thin sewing rings of the currently available bileaflet and tilting-disk valves should be used.
  • a dental-type mirror is sometimes used to ensure that no annular suture is wrapped around a stent strut.
  • a running PROLENE-type suture for implantation of mitral valves may be used, which makes a clean suture line with minimal knots but runs the risk of valve dehiscence if an infection occurs.
  • valve prosthesis During excision procedure of a previously placed valve prosthesis, either a degenerated bioprosthesis or a dysfunctional mechanical prosthesis, care must be taken to prevent injury to surrounding structures.
  • dissectors are used to expose the sewing ring and sutures by dissecting pannus and other material. Knots of previously placed sutures are cut, and a plane is developed between the sewing ring, the annulus, and other surrounding structures, especially the left ventricular myocardium.
  • an endarterectomy dissector the valve prosthesis can be dissected away without injury to any of the surrounding structures. Following the plane of the device as it lies within the heart rather than trying to excise inside or outside the prosthesis may prevent any injury to adjacent structures.
  • the left atrial appendage is ligated by suture or stapled to prevent clot formation in patients with chronic atrial fibrillation, enlarged left atrium, or left atrial thrombus.
  • the atrium is closed by a running PROLENE-type suture, while ensuring that endocardial surfaces are approximated.
  • a left atrial catheter may also be inserted through the suture line.
  • Transesophageal echocardiography provides information about valve and left ventricular function, may identify any retained material in the left atrium, including thrombus, and facilitates removal of intracardiac air. Once deairing maneuvers are completed, and after the patient is completely rewarmed, veinous return is partially occluded, and the heart is gradually volume loaded. As can be seen from the above description of a mitral valve replacement procedure, many parameters must be considered and accomplished under certain conditions in order to maximize the chance of survival of the patient, as well as to facilitate the recovery process. However, such a procedure may be hampered by the restricted access to the cardiopulmonary system afforded to the physician performing the procedure.
  • access to the cardiopulmonary system is accomplished through an opening in the body of sufficient size to provide the necessary exposure of the subject of the procedure, and to provide access for the physician to operate on the subject.
  • coronary anastomoses insertion of, for example, an annuloplasty band or removal and replacement of, for instance, a mitral valve, may be difficult and time-consuming procedures, particularly in instances requiring suturing about an annular member.
  • the patient's heart is stopped for an extended period of time (and the patient placed on cardiopulmonary bypass), where minimization of the heart stoppage time period may be beneficial to both the chance of survival of the patient and the ease of recovery from the procedure.
  • a method, apparatus, and/or system capable of securing bodily tissue, without suturing or associated knotting of such sutures, so as to minimize the time required to perform a tissue securement procedure.
  • Such a measure should also minimize trauma to the tissue about the securement area, should the secured tissue have to be repositioned during the procedure.
  • Such a method, apparatus, and/or system should also be capable of being readily inserted, manipulated, and secured through minimal access of the physician to the cardiopulmonary system or any other bodily tissue at issue in the procedure.
  • the fixation device provides a method of applying a fixation device to a bodily tissue to secure the fixation device thereto.
  • the fixation device is comprised of a shape- memory material formed into a first shape corresponding to a configuration of the fixation device when secured to the bodily tissue, and then plastically deformed into a second shape corresponding to a configuration of the fixation device for allowing the fixation device to be inserted into the bodily tissue.
  • the fixation device in the second shape, is inserted into the bodily tissue.
  • a stimulus is then applied to the fixation device after insertion thereof into the bodily tissue, wherein the stimulus is configured to be capable of causing a material phase change in the shape-memory material.
  • the material phase change thereby causes the fixation device to change from the second shape to the first shape, in response to the stimulus, and thus results in the fixation device in the first shape being secured to the bodily tissue.
  • Another aspect of the present invention comprises a method of applying a fixation device to a bodily tissue to secure the fixation device thereto.
  • the fixation device comprised of a shape-memory material, is formed into a first shape corresponding to a configuration of the fixation device when secured to the bodily tissue.
  • the fixation device is then plastically deformed into a second shape corresponding to a configuration of the fixation device for allowing the fixation device to be inserted into the bodily tissue.
  • the fixation device in the second shape, is inserted into the bodily tissue, and a stimulus then applied to the fixation device after insertion.
  • the stimulus is configured to be capable of causing a material phase change in the shape-memory material which, in turn, causes the fixation device to change from the second shape to the first shape, in response to the stimulus, and thus results in the fixation device in the first shape being secured to the bodily tissue.
  • Yet another aspect of the present invention comprises a fixation device adapted to be secured to a bodily tissue.
  • a fixation device includes an elongate member having an insertion end configured to be inserted into the bodily tissue, wherein the elongate member is comprised of a shape-memory material formed into a first shape corresponding to a configuration of at least one of the elongate member and the insertion end thereof when secured to the bodily tissue, and then plastically deformed into a second shape corresponding to a configuration of the elongate member for allowing the insertion end thereof to be inserted into the bodily tissue.
  • the shape-memory material of the elongate member is further configured to undergo a material phase change upon application of a stimulus thereto, wherein the stimulus is applied following insertion of the insertion end into the bodily tissue, such that at least one of the elongate member and the insertion end thereof changes from the second shape to the first shape, in response to the stimulus, and secures the elongate member in the first shape to the bodily tissue.
  • Still another aspect of the present invention comprises a method of applying a surgical device to a bodily tissue to secure the surgical device thereto, wherein the surgical device includes a plurality of fixation devices mounted thereto.
  • Each fixation device is comprised of a shape-memory material formed into a first shape corresponding to a configuration of the fixation device when secured to the bodily tissue, and then plastically deformed into a second shape for mounting to the surgical device.
  • the second shape also corresponds to a configuration of the fixation device for allowing the fixation device to be inserted into the bodily tissue.
  • the surgical device is engaged with the bodily tissue.
  • Each fixation device, in the second shape, is then inserted into the bodily tissue such that the fixation devices extend between the surgical device and the bodily tissue, and such that the surgical device is disposed in a desired position with respect to the bodily tissue.
  • a stimulus is thereafter applied to each fixation device, after insertion thereof into the bodily tissue, wherein the stimulus is configured to be capable of causing a material phase change in the shape- memory material, and thereby causes the respective fixation device to change from the second shape to the first shape, in response to the stimulus.
  • the fixation device changing into the first shape thereby secures the fixation device and the surgical device to the bodily tissue.
  • Another aspect of the present invention comprises a method of forming a surgical device capable of being applied to and secured to a bodily tissue.
  • each fixation device being comprised of a shape-memory material.
  • Each fixation device is formed into a first shape corresponding to a configuration of the fixation device when secured to the bodily tissue.
  • Each fixation device is then plastically deformed into a second shape corresponding to a configuration of the fixation device for allowing the fixation device to be inserted into the bodily tissue.
  • the fixation devices in the second shape are then mounted to a surgical member so as to form the surgical device.
  • the plurality of fixation device is mounted to the surgical member such that each fixation device, in the second shape, is capable of being inserted into the bodily tissue so as to extend between the surgical device and the bodily tissue, and such that the surgical device is capable of being disposed in a desired position with respect to the bodily tissue.
  • the fixation devices are further adapted such that a stimulus capable of causing a material phase change in the shape-memory material can then be applied to each fixation device to cause the respective fixation device to change from the second shape to the first shape in response to the stimulus and thereby secure the fixation device and the surgical member to the bodily tissue.
  • Still another aspect of the present invention comprises a surgical device adapted to be secured to a bodily tissue.
  • a surgical device includes a surgical member, and a plurality of fixation devices mounted to the surgical member.
  • Each fixation device includes an elongate member having an insertion end configured to be inserted into the bodily tissue.
  • the elongate member is comprised of a shape-memory material, formed into a first shape corresponding to a configuration of at least one of the elongate member and the insertion end thereof when secured to the bodily tissue, and then plastically deformed into a second shape corresponding to a configuration of the elongate member for allowing the insertion end thereof to be inserted into the bodily tissue.
  • the shape-memory material of the elongate member is further configured to undergo a material phase change upon application of a stimulus thereto.
  • the stimulus is capable of being applied following insertion of the insertion end into the bodily tissue, such that at least one of the elongate member and the insertion end thereof changes from the second shape to the first shape in response to the stimulus to secure the elongate member and the surgical member to the bodily tissue.
  • FIGS. 1A-1D schematically illustrate a fixation device according to one embodiment of the present invention and an operational sequence therefor;
  • FIGS. 2A-2D schematically illustrate a fixation device according to an alternate embodiment of the present invention and an operational sequence therefor
  • FIGS. 3A-3D schematically illustrate a surgical device, including a surgical element and a plurality of fixation devices, according to one embodiment of the present invention being applied in a sequential surgical procedure
  • FIGS. 4A-4D schematically illustrate a cross-section of a surgical device, including a surgical element and a plurality of fixation devices, according to one embodiment of the present invention being applied in a sequential surgical procedure.
  • FIGS. 1 A-ID and 2A-2D schematically illustrate a fixation device according to various embodiments of the present invention, the device being indicated generally by the numeral 100.
  • a fixation device according to various embodiments of the present invention, the device being indicated generally by the numeral 100.
  • Such a device 100 generally includes an elongate member 200 having an insertion end 250 and an opposing end 300.
  • the insertion end 250 is configured to be insertable into bodily tissue 50 or other material (though the fixation device 100 is described herein as being applicable to bodily tissue 50, one skilled in the art will appreciate such a fixation device 100 may be appropriately used with many different materials and implemented in many different applications, and that the application thereof to bodily tissue 50 as described herein is merely for example and not intended to be limiting in any respect in regard to the applicability of the fixation device 100), and the opposing end 300 is configured stop progress of the elongate member 200 through the bodily tissue 50. Though shown in FIGS.
  • the fixation device 100 is comprised of a material exhibiting a shape-memory property such as, for example, a nickel-titanium alloy.
  • a nickel-titanium alloy is commonly known as NITINOL.
  • Such a shape-memory material after an apparent deformation in the martensitic phase (twinned martensite to deformed martensite), has the ability to recover its original shape upon heating through the phase transformation temperature range above the austenite finish A f temperature.
  • the shape-memory property of the material is distinguished from a superelastic property that may also be exhibited by the material. More particularly, a superelastic property of NITINOL describes a nonlinear recoverable deformation behavior of such NiTi alloys at temperatures above the austenitic finishing A f temperature, which arises from the stress-induced martensitic transformation on loading and the spontaneous reversion of the transformation upon unloading.
  • a certain amount of transformation-induced strain is recoverable in the material and, when deformation exceeds that amount of strain, the material can further extend the deformation via linear elasticity of the stress-induced martensite portion of the material.
  • cold worked NiTi alloys may exhibit extended linear elasticity where a relatively high strain recoverable with minimal plastic deformation, hi sum, once the material is formed into the desired shape, it can be significantly elastically deformed and will then return to its original shape once the deforming forces are relieved.
  • the fixation device 100 should be capable of achieving at least two configurations, hi a first shape or configuration, the fixation device 100 may be linearly or substantially linearly configured such that the exertion of an axial force along the elongate member 200 causes the insertion end 250 to enter the bodily tissue 50. hi some instance, however, the insertion end 250 and/or the elongate member 200 may be curved or otherwise shaped as necessary or appropriate for facilitating insertion of the insertion end 250 into the bodily tissue 50 in the particular bodily locale in which the fixation device 100 is applied.
  • the fixation device 100 is preferably capable of being manipulated into a second shape or configuration so as to secure the fixation device 100 to the bodily tissue 50.
  • the shape memory property of the material comprising the fixation device 100 is used to determine the transition between the first shape or configuration (for example, as shown in FIG. IA, ID, 2A, or 2D), and the second shape or configuration (for example, as shown in FIG. 1C or 2C).
  • a fixation device 100 is first formed into a first shape, as shown in FIG. IA, ID, 2A, or 2D, corresponding to a configuration of the fixation device 100 when the fixation device 100 is secured to the bodily tissue 50.
  • the first shape may be a simple hook, as shown, or any other suitable shape.
  • the insertion end 250 may also include a retaining device 275 such as, for example, a barb or any other suitable mechanism.
  • the fixation device 100 is then plastically deformed into a second shape, as shown in FIG. IB, that allows the insertion end 250 of the elongate member 200 to be inserted into the bodily tissue 50.
  • the fixation device 100 includes a retaining member 275
  • the retaining member 275 may also be plastically deformed to facilitate insertion of the fixation device 100 into the bodily tissue 50.
  • the fixation device 100 can then be inserted into one or more layers of bodily tissue 5OA, 5OB so as to, for example, position the first bodily tissue layer 5OA with respect to the second bodily tissue layer 5OB.
  • a stimulus 400 is then applied to the fixation device 100.
  • the stimulus 400 is configured to be capable of heating the material through the phase transformation temperature range above the austenite finish A f temperature. Heating the material in this manner thus causes the fixation device 100 to revert from the second, plastically-deformed shape back to the first shape.
  • the stimulus 400 is applied to the fixation device 100, while the fixation device 100 is serving to position the bodily tissue layers 5OA, 5OB, the reversion of the fixation device 100 back into the first shape due to the shape memory effect thus secures the bodily tissue layers 5OA, 5OB together, as shown in FIGS. ID and 2D.
  • the stimulus 400 also serve to cause the retaining mechanism 275 to revert to the first shape, or the configuration prior to plastic deformation thereof, so as to provide a further mechanism for securing the fixation device 100 to the bodily tissue 50.
  • the stimulus 400 may comprise any suitable device for providing the necessary heat to the fixation device 100.
  • the stimulus 400 may comprise a laser device for heating the fixation device 100 with laser light, a heater device for heating the fixation device 100 through contact therewith, or a device for providing an electric current to the fixation device 100 so as to heat the same through resistance heating.
  • the stimulus 400 may be provided in many different manners suitable for causing the fixation device 100 to revert from the second, plastically-deformed shape back to the first shape thereof.
  • a fixation device 100 may also be used in many different procedures involving bodily tissue 50 or any other material such as, for example, in artery grafting for coronary artery bypass procedures.
  • one or more of the fixation devices 100 may be mounted to or otherwise operably engaged with a surgical device so as to facilitate attachment of the surgical device to bodily tissue 600.
  • a surgical device may comprise, for example, an annuloplasty band, a replacement mitral valve (a mechanical-type replacement heart valve), or other surgical device implanted, inserted, or otherwise engaged with the bodily tissue 600.
  • FIGS. 3A-3D and 4A-4D comprises an annuloplasty band 500 that may be used during mitral valve repair surgery in order to stiffen and/or stenose the annulus of the mitral valve.
  • Such an annuloplasty band 500 is placed on and attached about the mitral valve annulus during the procedure and, in the illustrated embodiment, includes a plurality of fixation devices 100 mounted thereto and spaced along the length of the band 500.
  • the fixation devices 100 may be evenly spaced apart along the band 500 or placed as needed for the subject procedure.
  • the band 500 may be comprised of, for example, braided polyester or any other suitable material, and may be provided in a length suitable to extend around the mitral valve annulus.
  • the fixation devices 100 are configured in a second shape or configuration whereby the fixation devices 100 are capable of being inserted into the mitral valve annulus comprising the bodily tissue 600.
  • the fixation devices 100 in the second shape or configuration can be inserted into the band 500 so as to be capable of extending therethrough.
  • the band 500 may include, for example, a stiffening plate or like member (not shown) operably engaged with the band 500 and configured to receive the fixation devices 100 so as to, for instance, guide the fixation devices 100 through the band 500 such that all of the fixation devices 100 extend in substantially parallel planes disposed substantially perpendicularly to the band 500.
  • the fixation devices 100 may be mounted to the surgical device, such as the annuloplasty band, a replacement mitral valve, or the like, in any suitable manner consistent with the disclosure herein and within the scope of the present invention.
  • the band 500 may be readily placed on or about the mitral valve annulus at the appropriate time during the procedure, as shown in FIGS. 3 A and 4 A.
  • One or more of the fixation devices 100 can then be actuated so as to extend through the band 500 and become inserted into the bodily tissue 600.
  • Such actuation may be accomplished simply by the physician pushing one or more of the fixation devices 100 through the band 500 and into the adjacent tissue, as shown in FIGS. 3B and 4B.
  • the surgical device, such as the annuloplasty band 500 can be positioned and held in place by the fixation devices 100 until the band 500 is positioned as desired.
  • the fixation devices 100 may be withdrawn from the bodily tissue 600 and re-inserted as necessary until all of the fixation devices 100 are positioned to the satisfaction of the physician. Such repositioning of the fixation devices 100 may thus be performed with minimal risk of damage to the bodily tissue 600 about the mitral valve annulus since the fixation devices 100 are not yet actuated to change into the first or secured shape.
  • the surgical device such as the annuloplasty band 500 is positioned with respect to the mitral valve annulus and held in place by the fixation devices 100, as shown in FIGS. 3B and 4B, the fixation devices 100 are then exposed to the stimulus 400.
  • such a stimulus 400 may comprise any suitable device for providing the necessary heat to the fixation device 100.
  • the stimulus 400 may comprise a laser device for heating the fixation device 100 with laser light, a heater device for heating the fixation device 100 through contact therewith, or a device for providing an electric current to the fixation device 100 so as to heat the same through resistance heating.
  • the stimulus 400 is suitable for causing the fixation device 100 to revert from the second, plastically-deformed shape back to the first shape thereof, as shown in FIGS. 3C and 3D, as well as FIGS. 4C and 4D.
  • the fixation devices 100 in the first shape thus secure the band 500 or other surgical device to the mitral valve annulus or other affected bodily tissue.
  • embodiments of the present invention facilitate a minimally invasive approach to coronary bypass, as well as many other medical procedures.
  • the fixation devices 100 implementing a shape-memory concept provide an automatic "closure" mechanism, in lieu of sutures, and thereby eliminate knot tying and assisted suture management issues.
  • Use of the shape-memory property also eliminates the need for a physical restraint mechanism for maintaining suitable insertion shape for a "self-closing" device based on a superelastic material property.
  • embodiments of the present invention provide a mechanism for expediting critical surgical procedures, while allowing the physician to operate within close confines and with maximum flexibility to position and reposition the subject(s) of the procedure before final securement and closing.
  • embodiments of the present invention used in cardiopulmonary procedures as described herein by way of example, will provide and promote normal healing of the affected areas with smooth circumferential neointimal resurfacing at the anastomotic and other repair sites addressed in the procedure(s).
  • the fixation device 100 may, in some instances, be configured such that the application of the stimulus 400 thereto (once the fixation device 100 is inserted into the bodily tissue 50) causes the fixation device 100 to advance further into or become more firmly secured to the bodily tissue 50 upon transitioning from the second (plastically deformed) shape or configuration back to the first (original) shape or configuration.
  • the fixation device 100 may, in some instances, be configured such that the application of the stimulus 400 thereto (once the fixation device 100 is inserted into the bodily tissue 50) causes the fixation device 100 to advance further into or become more firmly secured to the bodily tissue 50 upon transitioning from the second (plastically deformed) shape or configuration back to the first (original) shape or configuration.
  • the application of the stimulus 400 to the fixation device 100 causes the insertion end 250 thereof to curl or otherwise change form in a direction toward the opposing end 300 of the fixation device 100.
  • the change in form of the insertion end 250 will cause any bodily tissue 50 engaged with the insertion end 250 to be drawn back toward the opposing end 300 of the fixation device 100, thereby causing the fixation device 100 to become more firmly secured to the bodily tissue 50 (i.e. the elongate member 200 / opposing end 300 of the fixation device 100 is advanced further into the bodily tissue 50 by the change in form of the insertion end 250).
  • fixation device 100 may cause the annuloplasty band 500 to become more firmly or securely held to the mitral valve annulus, upon application of the stimulus 400 to the fixation device(s) 100 mounted to or otherwise operably engaged therewith. Therefore, it is to be understood that the inventions are not to be limited to the specific embodiments disclosed and that modifications and other embodiments are intended to be included within the scope of the appended claims. Although specific terms are employed herein, they are used in a generic and descriptive sense only and not for purposes of limitation.

Abstract

A fixation device (200) to be applied and secured to a bodily tissue is provided. Such a fixation device is comprised of shape-memory material, formed into a first shape corresponding to a fixation device configuration when secured to the bodily tissue, and then plastically deformed into a second shape corresponding to a fixation device configuration for allowing the fixation device to be inserted into the bodily tissue. First, the fixation device, in the second shape, is inserted into the bodily tissue. A stimulus is then applied to the fixation device, after insertion thereof into the bodily tissue, wherein the stimulus is capable of causing a material phase change in the shape-memory material, which changes the fixation device from the second shape to the first shape and thereby secures the fixation device to the bodily tissue. A surgical device comprising a surgical member and a plurality of such fixation devices is also described. The surgical member can be, f. ex. an annuloplasty band or a valve device.

Description

FIXATION DEVICE AND ASSOCIATED APPARATUS
BACKGROUM) OF THE INVENTION Field of the Invention
The present invention relates to surgical devices and associated apparatuses and methods and, more particularly, to a fixation device and associated apparatus and method for preliminarily and removably engaging a surgical device or bodily tissue with other bodily tissue so as to allow the surgical apparatus or bodily tissue to be positioned with respect to the other bodily tissue, as desired, wherein the fixation device is then actuatable, via a stimulus applied thereto, to securely fasten the surgical device or bodily tissue in the desired position with respect to the other bodily tissue.
Description of Related Art
Some surgeries are commonly performed, but must often be accomplished under certain conditions in order to maximize the chance of survival of the patient, as well as facilitate the recovery process. In some instances, such surgeries may also require accessing the affected portion of the body through an opening in the body of sufficient size to provide the necessary exposure of the subject of the procedure, and to provide access for the physician to operate on the subject. One consideration, in this respect is that a smaller opening to provide the necessary access may be less traumatic to the patient. One example of such a surgery is a cardiopulmonary bypass procedure for mitral valve replacement. Such a procedure includes monitoring of arterial and venous lines, a urinary catheter, and a pre-bypass-placed pulmonary artery catheter to measure pulmonary pressures and cardiac output. Following valve replacement, a left atrial catheter directly inserted through the left atrial incision may be used to allow measurement of pulmonary vascular resistance. In some instances, temporary ventricular pacing wires may be placed, and temporary atrial pacing wires my also be placed for possible pacing or diagnosis of various atrial arrhythmias.
Cardiopulmonary bypass is generally instituted by placing two right-angle cannulas into the superior and inferior venae cavae. More particularly, a small (22 French) plastic or metal cannula may be placed directly into the superior vena cava, above the sinoatrial node, while the inferior caval cannula is placed at the entrance of the inferior vena cava, relatively low in the right atrium. Such insertion sites keep the caval catheters out of the operative field and maintain bicaval drainage. An arterial cannula may also be placed in the distal ascending aorta. Bypass flows of approximately 1.5 liters/min per m2, and moderate hypothermia (about 300C), may also be used. In addition, myocardial protection includes antegrade and retrograde blood cardioplegia and profound myocardial hypothermia, where retrograde cardioplegia is useful for all valve surgery to protect the ischemic left ventricle and to help remove ascending aorta bubbles. Antegrade cardioplegia, used as an initial loading dose, may be augmented by intermittent retrograde cardioplegia every 20 minutes, hi some instances, when the atrium is retracted during valve replacement, the aortic valve becomes distorted, and antegrade cardioplegia may tend to fill the ventricle.
Such meticulous and complicated methods of mitral valve repair and reconstruction require optimal exposure of the mitral valve, hi primary operations, a median sternotomy, development of Sondergaard's plane, and incision of the left atrium close to the atrial septum provide the necessary exposure, hi reoperative mitral valve replacement patients, an anterior right thoracotomy approach utilizing femoro- femoral bypass may be used in patients with specific indications that a sternotomy may be difficult and hazardous. Such indications include a previously placed stented aortic prosthesis; several patent bypass grafts, such as an internal thoracic artery to left anterior descending artery; multiple previous valve replacements so that there is a virtual symphysis between the right ventricle and sternum; and severe, deep, infectious mediastinitis that may make dissection extremely difficult and hazardous. A potential disadvantage of the right thoracotomy incision is the inability to completely evacuate air from the patient's heart. In such instances, intraoperative transesophageal echocardiography and positioning the patient so that the left atrial incision is uppermost may facilitate removal of air in the left heart chambers.
Cannulation for right anterior thoracotomy usually involves the right femoral vein and artery, but intrathoracic bicaval cannulation also can be used. An ascending aortic cannula also can be placed through this incision if severe peripheral vascular disease is present, hi such instances, myocardial protection consists of deep systemic hypothermia (2O0C), reduction of bypass flow when anatomically critical areas need to be addressed, and maintenance of perfusion throughout the period of cardiopulmonary bypass. The aorta is not cross-clamped, and cardioplegia is not administered. Intracardiac techniques have also been developed, wherein such an operation involves secure fixation of a valve prosthesis to the annulus by suture techniques, without damage to adjacent structures or myocardium, and without tissue interference with valve function. Such implantation may prevent injury to anatomic structures surrounding the mitral valve annulus, since some important cardiac structures are near the mitral valve annulus, including the circumflex coronary artery within the atrioventricular (AV) groove, the left atrial appendage, the aortic valve in continuity with the anterior mitral curtain, and the AV node.
Collective evidence also indicates that preservation of the papillary muscle and chordal attachments to the annulus is important for maintenance of left ventricular function. In patients with mitral stenosis with agglutinated, fibrotic chordae and papillary muscles, preservation of these structures may have little effect on left ventricular dysfunction, but protects the AV groove from rupture by preserving the posterior leaflet. However, preservation of the posterior mitral leaflet may preclude an adequately sized prosthesis. However, if fibrotic, agglutinated chordae and the posterior leaflet are excised, placement of artificial chordae (comprised of, for example, a GORE-TEX brand and type of material) to reattach the papillary muscles to the annulus may improve early and late preservation of cardiac output. In patients with mitral regurgitation, however, it is important to preserve as much of the papillary muscle and annular interaction as possible. This can be achieved by a variety of techniques. For example, the anterior leaflet may be partially excised and brought to the posterior leaflet, or the anterior leaflet may be partially excised and "furled" to the anterior annulus by a running suture. Experimental and clinical evidence further suggests that preservation of the corneal shape of the ventricle is important to maintain normal cardiac output, and that assumption of a globular shape from cutting papillary muscles is deleterious to left ventricular function. Furthermore, preservation of the posterior leaflet and chordae may particularly reduce incidences of perforation of the left ventricle and atrioventricular separation during mitral valve replacement. Once the site is prepared, the valve must often be implanted and sutured into place as required by current procedures. However, suturing techniques may vary according to the type of valve that is implanted. For example, a bioprosthetic valve is preferentially inserted with the sutures placed from ventricle to atrium (noneverting or subannular), in a procedure has been shown to be one of the strongest types of suturing techniques for the mitral annulus, and may also be used with a central-flow Starr-Edwards ball-and-cage valve. For adequate function of bileaflet or tilting-disk valves, everting sutures (atrium to ventricle to sewing ring) are preferably used, which urges the prosthetic valve out into the center of the orifice and minimizes any tissue interference with the prosthetic valve leaflets. Such a provision is particularly important if annular-chordal attachments are preserved, and particular sutures suitable for the thin sewing rings of the currently available bileaflet and tilting-disk valves should be used. In instances where a bioprosthetic valve is inserted, a dental-type mirror is sometimes used to ensure that no annular suture is wrapped around a stent strut. In other instances, a running PROLENE-type suture for implantation of mitral valves may be used, which makes a clean suture line with minimal knots but runs the risk of valve dehiscence if an infection occurs.
During excision procedure of a previously placed valve prosthesis, either a degenerated bioprosthesis or a dysfunctional mechanical prosthesis, care must be taken to prevent injury to surrounding structures. In one technique, dissectors are used to expose the sewing ring and sutures by dissecting pannus and other material. Knots of previously placed sutures are cut, and a plane is developed between the sewing ring, the annulus, and other surrounding structures, especially the left ventricular myocardium. Using an endarterectomy dissector, the valve prosthesis can be dissected away without injury to any of the surrounding structures. Following the plane of the device as it lies within the heart rather than trying to excise inside or outside the prosthesis may prevent any injury to adjacent structures. Once the prosthesis is removed, all residual debris, pannus, pledgets, and unnecessary valve tissue are carefully debrided before beginning the suturing process for the new valve. Once the new valve is in place, and prior to closure, the left atrial appendage is ligated by suture or stapled to prevent clot formation in patients with chronic atrial fibrillation, enlarged left atrium, or left atrial thrombus. The atrium is closed by a running PROLENE-type suture, while ensuring that endocardial surfaces are approximated. A left atrial catheter may also be inserted through the suture line. Transesophageal echocardiography provides information about valve and left ventricular function, may identify any retained material in the left atrium, including thrombus, and facilitates removal of intracardiac air. Once deairing maneuvers are completed, and after the patient is completely rewarmed, veinous return is partially occluded, and the heart is gradually volume loaded. As can be seen from the above description of a mitral valve replacement procedure, many parameters must be considered and accomplished under certain conditions in order to maximize the chance of survival of the patient, as well as to facilitate the recovery process. However, such a procedure may be hampered by the restricted access to the cardiopulmonary system afforded to the physician performing the procedure. That is, access to the cardiopulmonary system is accomplished through an opening in the body of sufficient size to provide the necessary exposure of the subject of the procedure, and to provide access for the physician to operate on the subject. Accordingly, coronary anastomoses, insertion of, for example, an annuloplasty band or removal and replacement of, for instance, a mitral valve, may be difficult and time-consuming procedures, particularly in instances requiring suturing about an annular member. Also, during such a procedure, the patient's heart is stopped for an extended period of time (and the patient placed on cardiopulmonary bypass), where minimization of the heart stoppage time period may be beneficial to both the chance of survival of the patient and the ease of recovery from the procedure.
Thus, there exists a need for a method, apparatus, and/or system capable of securing bodily tissue, without suturing or associated knotting of such sutures, so as to minimize the time required to perform a tissue securement procedure. Such a measure should also minimize trauma to the tissue about the securement area, should the secured tissue have to be repositioned during the procedure. Such a method, apparatus, and/or system should also be capable of being readily inserted, manipulated, and secured through minimal access of the physician to the cardiopulmonary system or any other bodily tissue at issue in the procedure.
BRIEF SUMMARY OF THE INVENTION
The above and other needs are met by the present invention which, in one embodiment, provides a method of applying a fixation device to a bodily tissue to secure the fixation device thereto. The fixation device is comprised of a shape- memory material formed into a first shape corresponding to a configuration of the fixation device when secured to the bodily tissue, and then plastically deformed into a second shape corresponding to a configuration of the fixation device for allowing the fixation device to be inserted into the bodily tissue. First, the fixation device, in the second shape, is inserted into the bodily tissue. A stimulus is then applied to the fixation device after insertion thereof into the bodily tissue, wherein the stimulus is configured to be capable of causing a material phase change in the shape-memory material. The material phase change thereby causes the fixation device to change from the second shape to the first shape, in response to the stimulus, and thus results in the fixation device in the first shape being secured to the bodily tissue. Another aspect of the present invention comprises a method of applying a fixation device to a bodily tissue to secure the fixation device thereto. First, the fixation device, comprised of a shape-memory material, is formed into a first shape corresponding to a configuration of the fixation device when secured to the bodily tissue. The fixation device is then plastically deformed into a second shape corresponding to a configuration of the fixation device for allowing the fixation device to be inserted into the bodily tissue. The fixation device, in the second shape, is inserted into the bodily tissue, and a stimulus then applied to the fixation device after insertion. The stimulus is configured to be capable of causing a material phase change in the shape-memory material which, in turn, causes the fixation device to change from the second shape to the first shape, in response to the stimulus, and thus results in the fixation device in the first shape being secured to the bodily tissue.
Yet another aspect of the present invention comprises a fixation device adapted to be secured to a bodily tissue. Such a fixation device includes an elongate member having an insertion end configured to be inserted into the bodily tissue, wherein the elongate member is comprised of a shape-memory material formed into a first shape corresponding to a configuration of at least one of the elongate member and the insertion end thereof when secured to the bodily tissue, and then plastically deformed into a second shape corresponding to a configuration of the elongate member for allowing the insertion end thereof to be inserted into the bodily tissue. The shape-memory material of the elongate member is further configured to undergo a material phase change upon application of a stimulus thereto, wherein the stimulus is applied following insertion of the insertion end into the bodily tissue, such that at least one of the elongate member and the insertion end thereof changes from the second shape to the first shape, in response to the stimulus, and secures the elongate member in the first shape to the bodily tissue.
Still another aspect of the present invention comprises a method of applying a surgical device to a bodily tissue to secure the surgical device thereto, wherein the surgical device includes a plurality of fixation devices mounted thereto. Each fixation device is comprised of a shape-memory material formed into a first shape corresponding to a configuration of the fixation device when secured to the bodily tissue, and then plastically deformed into a second shape for mounting to the surgical device. The second shape also corresponds to a configuration of the fixation device for allowing the fixation device to be inserted into the bodily tissue. First, the surgical device is engaged with the bodily tissue. Each fixation device, in the second shape, is then inserted into the bodily tissue such that the fixation devices extend between the surgical device and the bodily tissue, and such that the surgical device is disposed in a desired position with respect to the bodily tissue. A stimulus is thereafter applied to each fixation device, after insertion thereof into the bodily tissue, wherein the stimulus is configured to be capable of causing a material phase change in the shape- memory material, and thereby causes the respective fixation device to change from the second shape to the first shape, in response to the stimulus. The fixation device changing into the first shape thereby secures the fixation device and the surgical device to the bodily tissue. Another aspect of the present invention comprises a method of forming a surgical device capable of being applied to and secured to a bodily tissue. First, a plurality of fixation devices is formed, with each fixation device being comprised of a shape-memory material. Each fixation device is formed into a first shape corresponding to a configuration of the fixation device when secured to the bodily tissue. Each fixation device is then plastically deformed into a second shape corresponding to a configuration of the fixation device for allowing the fixation device to be inserted into the bodily tissue. The fixation devices in the second shape are then mounted to a surgical member so as to form the surgical device. The plurality of fixation device is mounted to the surgical member such that each fixation device, in the second shape, is capable of being inserted into the bodily tissue so as to extend between the surgical device and the bodily tissue, and such that the surgical device is capable of being disposed in a desired position with respect to the bodily tissue. The fixation devices are further adapted such that a stimulus capable of causing a material phase change in the shape-memory material can then be applied to each fixation device to cause the respective fixation device to change from the second shape to the first shape in response to the stimulus and thereby secure the fixation device and the surgical member to the bodily tissue.
Still another aspect of the present invention comprises a surgical device adapted to be secured to a bodily tissue. Such a surgical device includes a surgical member, and a plurality of fixation devices mounted to the surgical member. Each fixation device includes an elongate member having an insertion end configured to be inserted into the bodily tissue. The elongate member is comprised of a shape-memory material, formed into a first shape corresponding to a configuration of at least one of the elongate member and the insertion end thereof when secured to the bodily tissue, and then plastically deformed into a second shape corresponding to a configuration of the elongate member for allowing the insertion end thereof to be inserted into the bodily tissue. The shape-memory material of the elongate member is further configured to undergo a material phase change upon application of a stimulus thereto. The stimulus is capable of being applied following insertion of the insertion end into the bodily tissue, such that at least one of the elongate member and the insertion end thereof changes from the second shape to the first shape in response to the stimulus to secure the elongate member and the surgical member to the bodily tissue. Accordingly, embodiments of the present invention provide distinct advantages as further detailed herein.
BRIEF DESCRIPTION OF THE SEVERAL VIEWS OF THE DRAWING(S) Having thus described the invention in general terms, reference will now be made to the accompanying drawings, which are not necessarily drawn to scale, and wherein:
FIGS. 1A-1D schematically illustrate a fixation device according to one embodiment of the present invention and an operational sequence therefor;
FIGS. 2A-2D schematically illustrate a fixation device according to an alternate embodiment of the present invention and an operational sequence therefor; FIGS. 3A-3D schematically illustrate a surgical device, including a surgical element and a plurality of fixation devices, according to one embodiment of the present invention being applied in a sequential surgical procedure; and
FIGS. 4A-4D schematically illustrate a cross-section of a surgical device, including a surgical element and a plurality of fixation devices, according to one embodiment of the present invention being applied in a sequential surgical procedure.
DETAILED DESCRIPTION OF THE INVENTION The present inventions now will be described more fully hereinafter with reference to the accompanying drawings, in which some, but not all embodiments of the invention are shown. Indeed, these inventions may be embodied in many different forms and should not be construed as limited to the embodiments set forth herein; rather, these embodiments are provided so that this disclosure will satisfy applicable legal requirements. Like numbers refer to like elements throughout. FIGS. 1 A-ID and 2A-2D schematically illustrate a fixation device according to various embodiments of the present invention, the device being indicated generally by the numeral 100. Such a device 100 generally includes an elongate member 200 having an insertion end 250 and an opposing end 300. The insertion end 250 is configured to be insertable into bodily tissue 50 or other material (though the fixation device 100 is described herein as being applicable to bodily tissue 50, one skilled in the art will appreciate such a fixation device 100 may be appropriately used with many different materials and implemented in many different applications, and that the application thereof to bodily tissue 50 as described herein is merely for example and not intended to be limiting in any respect in regard to the applicability of the fixation device 100), and the opposing end 300 is configured stop progress of the elongate member 200 through the bodily tissue 50. Though shown in FIGS. 1 A-ID and 2A- 2D as comprising a flat, cap-like end, the opposing end may be configured in many different manners suitable and appropriate for the particular application of the fixation device 100 to the bodily tissue 50, as will be appreciated by one skilled in the art. In one aspect of the present invention, the fixation device 100 is comprised of a material exhibiting a shape-memory property such as, for example, a nickel-titanium alloy. One example of a suitable type of nickel-titanium alloy is commonly known as NITINOL. Such a shape-memory material, after an apparent deformation in the martensitic phase (twinned martensite to deformed martensite), has the ability to recover its original shape upon heating through the phase transformation temperature range above the austenite finish Af temperature. The shape-memory property of the material is distinguished from a superelastic property that may also be exhibited by the material. More particularly, a superelastic property of NITINOL describes a nonlinear recoverable deformation behavior of such NiTi alloys at temperatures above the austenitic finishing Af temperature, which arises from the stress-induced martensitic transformation on loading and the spontaneous reversion of the transformation upon unloading. That is, a certain amount of transformation-induced strain is recoverable in the material and, when deformation exceeds that amount of strain, the material can further extend the deformation via linear elasticity of the stress-induced martensite portion of the material. In addition to heat-treated NiTi alloys which exhibit nonlinear superelasticity, cold worked NiTi alloys may exhibit extended linear elasticity where a relatively high strain recoverable with minimal plastic deformation, hi sum, once the material is formed into the desired shape, it can be significantly elastically deformed and will then return to its original shape once the deforming forces are relieved.
In order to facilitate implementation of the fixation device 100, for instance, for initial insertion thereof into bodily tissue 50 and then for securing the fixation device 100 to the bodily tissue 50, the fixation device 100 should be capable of achieving at least two configurations, hi a first shape or configuration, the fixation device 100 may be linearly or substantially linearly configured such that the exertion of an axial force along the elongate member 200 causes the insertion end 250 to enter the bodily tissue 50. hi some instance, however, the insertion end 250 and/or the elongate member 200 may be curved or otherwise shaped as necessary or appropriate for facilitating insertion of the insertion end 250 into the bodily tissue 50 in the particular bodily locale in which the fixation device 100 is applied. However, once the fixation device 100 is applied to the bodily tissue 50, the fixation device 100 is preferably capable of being manipulated into a second shape or configuration so as to secure the fixation device 100 to the bodily tissue 50. Thus, according to embodiments of the present invention, the shape memory property of the material comprising the fixation device 100 is used to determine the transition between the first shape or configuration (for example, as shown in FIG. IA, ID, 2A, or 2D), and the second shape or configuration (for example, as shown in FIG. 1C or 2C).
More particularly, a fixation device 100 according to one embodiment of the present invention is first formed into a first shape, as shown in FIG. IA, ID, 2A, or 2D, corresponding to a configuration of the fixation device 100 when the fixation device 100 is secured to the bodily tissue 50. For example, the first shape may be a simple hook, as shown, or any other suitable shape. As shown in FIGS. 2A-2D, the insertion end 250 may also include a retaining device 275 such as, for example, a barb or any other suitable mechanism. The fixation device 100 is then plastically deformed into a second shape, as shown in FIG. IB, that allows the insertion end 250 of the elongate member 200 to be inserted into the bodily tissue 50. Where the fixation device 100 includes a retaining member 275, the retaining member 275 may also be plastically deformed to facilitate insertion of the fixation device 100 into the bodily tissue 50. As shown in FIG. 1C and 2C, the fixation device 100 can then be inserted into one or more layers of bodily tissue 5OA, 5OB so as to, for example, position the first bodily tissue layer 5OA with respect to the second bodily tissue layer 5OB. One example of such a situation would be a coronary anastomosis procedure. As further shown in FIGS. 1C and 2C, once the bodily tissue layers 5OA, 5OB are positioned as desired, a stimulus 400 is then applied to the fixation device 100. In light of the shape memory property of the material comprising the fixation device 100, particularly in instances where the material comprises a NiTi alloy, the stimulus 400 is configured to be capable of heating the material through the phase transformation temperature range above the austenite finish Af temperature. Heating the material in this manner thus causes the fixation device 100 to revert from the second, plastically-deformed shape back to the first shape. Where the stimulus 400 is applied to the fixation device 100, while the fixation device 100 is serving to position the bodily tissue layers 5OA, 5OB, the reversion of the fixation device 100 back into the first shape due to the shape memory effect thus secures the bodily tissue layers 5OA, 5OB together, as shown in FIGS. ID and 2D. The stimulus 400 also serve to cause the retaining mechanism 275 to revert to the first shape, or the configuration prior to plastic deformation thereof, so as to provide a further mechanism for securing the fixation device 100 to the bodily tissue 50. The stimulus 400 may comprise any suitable device for providing the necessary heat to the fixation device 100. For example, the stimulus 400 may comprise a laser device for heating the fixation device 100 with laser light, a heater device for heating the fixation device 100 through contact therewith, or a device for providing an electric current to the fixation device 100 so as to heat the same through resistance heating. One skilled in the art will appreciate, however, that the stimulus 400 may be provided in many different manners suitable for causing the fixation device 100 to revert from the second, plastically-deformed shape back to the first shape thereof. One skilled in the art will also appreciate that such a fixation device 100 may also be used in many different procedures involving bodily tissue 50 or any other material such as, for example, in artery grafting for coronary artery bypass procedures.
In another aspect of the present invention, as shown in FIGS. 3A-3D and 4A- 4D, one or more of the fixation devices 100 may be mounted to or otherwise operably engaged with a surgical device so as to facilitate attachment of the surgical device to bodily tissue 600. Such a surgical device may comprise, for example, an annuloplasty band, a replacement mitral valve (a mechanical-type replacement heart valve), or other surgical device implanted, inserted, or otherwise engaged with the bodily tissue 600. One example shown in FIGS. 3A-3D and 4A-4D comprises an annuloplasty band 500 that may be used during mitral valve repair surgery in order to stiffen and/or stenose the annulus of the mitral valve. Such an annuloplasty band 500 is placed on and attached about the mitral valve annulus during the procedure and, in the illustrated embodiment, includes a plurality of fixation devices 100 mounted thereto and spaced along the length of the band 500. The fixation devices 100 may be evenly spaced apart along the band 500 or placed as needed for the subject procedure. The band 500 may be comprised of, for example, braided polyester or any other suitable material, and may be provided in a length suitable to extend around the mitral valve annulus. hi other instances, the free ends of the length of braided polyester or other material maybe spliced or otherwise joined to provide a contiguous loop': As shown, the fixation devices 100 are configured in a second shape or configuration whereby the fixation devices 100 are capable of being inserted into the mitral valve annulus comprising the bodily tissue 600.
In being mounted to the annuloplasty band 500, the fixation devices 100 in the second shape or configuration can be inserted into the band 500 so as to be capable of extending therethrough. In some instances, the band 500 may include, for example, a stiffening plate or like member (not shown) operably engaged with the band 500 and configured to receive the fixation devices 100 so as to, for instance, guide the fixation devices 100 through the band 500 such that all of the fixation devices 100 extend in substantially parallel planes disposed substantially perpendicularly to the band 500. One skilled in the art will appreciate, however, that the fixation devices 100 may be mounted to the surgical device, such as the annuloplasty band, a replacement mitral valve, or the like, in any suitable manner consistent with the disclosure herein and within the scope of the present invention. With the fixation devices 100 mounted or otherwise affixed to the surgical device such as the annuloplasty band 500, the band 500 may be readily placed on or about the mitral valve annulus at the appropriate time during the procedure, as shown in FIGS. 3 A and 4 A. One or more of the fixation devices 100 can then be actuated so as to extend through the band 500 and become inserted into the bodily tissue 600. Such actuation may be accomplished simply by the physician pushing one or more of the fixation devices 100 through the band 500 and into the adjacent tissue, as shown in FIGS. 3B and 4B. In this manner, the surgical device, such as the annuloplasty band 500 can be positioned and held in place by the fixation devices 100 until the band 500 is positioned as desired. Since the fixation devices 100, at this point, are still in the second shape or configuration, the fixation devices 100 may be withdrawn from the bodily tissue 600 and re-inserted as necessary until all of the fixation devices 100 are positioned to the satisfaction of the physician. Such repositioning of the fixation devices 100 may thus be performed with minimal risk of damage to the bodily tissue 600 about the mitral valve annulus since the fixation devices 100 are not yet actuated to change into the first or secured shape. Once the surgical device, such as the annuloplasty band 500 is positioned with respect to the mitral valve annulus and held in place by the fixation devices 100, as shown in FIGS. 3B and 4B, the fixation devices 100 are then exposed to the stimulus 400. As previously discussed, such a stimulus 400 may comprise any suitable device for providing the necessary heat to the fixation device 100. For example, the stimulus 400 may comprise a laser device for heating the fixation device 100 with laser light, a heater device for heating the fixation device 100 through contact therewith, or a device for providing an electric current to the fixation device 100 so as to heat the same through resistance heating. In any instance, the stimulus 400 is suitable for causing the fixation device 100 to revert from the second, plastically-deformed shape back to the first shape thereof, as shown in FIGS. 3C and 3D, as well as FIGS. 4C and 4D. The fixation devices 100 in the first shape thus secure the band 500 or other surgical device to the mitral valve annulus or other affected bodily tissue.
As such, embodiments of the present invention, as described herein, facilitate a minimally invasive approach to coronary bypass, as well as many other medical procedures. The fixation devices 100 implementing a shape-memory concept provide an automatic "closure" mechanism, in lieu of sutures, and thereby eliminate knot tying and assisted suture management issues. Use of the shape-memory property also eliminates the need for a physical restraint mechanism for maintaining suitable insertion shape for a "self-closing" device based on a superelastic material property. Accordingly, embodiments of the present invention provide a mechanism for expediting critical surgical procedures, while allowing the physician to operate within close confines and with maximum flexibility to position and reposition the subject(s) of the procedure before final securement and closing. As such, it is believed that embodiments of the present invention, used in cardiopulmonary procedures as described herein by way of example, will provide and promote normal healing of the affected areas with smooth circumferential neointimal resurfacing at the anastomotic and other repair sites addressed in the procedure(s).
Many modifications and other embodiments of the inventions set forth herein will come to mind to one skilled in the art to which these inventions pertain having the benefit of the teachings presented in the foregoing descriptions and the associated drawings. For example, the fixation device 100 may, in some instances, be configured such that the application of the stimulus 400 thereto (once the fixation device 100 is inserted into the bodily tissue 50) causes the fixation device 100 to advance further into or become more firmly secured to the bodily tissue 50 upon transitioning from the second (plastically deformed) shape or configuration back to the first (original) shape or configuration. One aspect of the present invention implementing such a configuration is shown in the figures (for instance, FIGS. IA- ID), wherein the application of the stimulus 400 to the fixation device 100 causes the insertion end 250 thereof to curl or otherwise change form in a direction toward the opposing end 300 of the fixation device 100. One skilled in the art will thus appreciate that the change in form of the insertion end 250 will cause any bodily tissue 50 engaged with the insertion end 250 to be drawn back toward the opposing end 300 of the fixation device 100, thereby causing the fixation device 100 to become more firmly secured to the bodily tissue 50 (i.e. the elongate member 200 / opposing end 300 of the fixation device 100 is advanced further into the bodily tissue 50 by the change in form of the insertion end 250). Accordingly, in instances where the fixation device 100 is mounted to or otherwise operably engaged with a surgical device, such as an annuloplasty band 500, such a fixation device 100 may cause the annuloplasty band 500 to become more firmly or securely held to the mitral valve annulus, upon application of the stimulus 400 to the fixation device(s) 100 mounted to or otherwise operably engaged therewith. Therefore, it is to be understood that the inventions are not to be limited to the specific embodiments disclosed and that modifications and other embodiments are intended to be included within the scope of the appended claims. Although specific terms are employed herein, they are used in a generic and descriptive sense only and not for purposes of limitation.

Claims

THAT WHICH IS CLAIMED:
1. A method of applying a fixation device to a bodily tissue to secure the fixation device thereto, the fixation device being comprised of a shape-memory material, formed into a first shape corresponding to a configuration of the fixation device when secured to the bodily tissue, and then plastically deformed into a second shape corresponding to a configuration of the fixation device for allowing the fixation device to be inserted into the bodily tissue, said method comprising: inserting the fixation device, in the second shape, into the bodily tissue; and applying a stimulus to the fixation device after insertion thereof into the bodily tissue, the stimulus being configured to be capable of causing a material phase change in the shape-memory material, so as to cause the fixation device to change from the second shape to the first shape in response to the stimulus and thereby secure the fixation device to the bodily tissue.
2. A method according to Claim 1 wherein the shape-memory material comprises a nickel-titanium alloy and applying a stimulus further comprises applying heat to the fixation device to cause the material phase change in the nickel-titanium alloy.
3. A method of applying a fixation device to a bodily tissue to secure the fixation device thereto, comprising: forming the fixation device, comprised of a shape-memory material, into a first shape corresponding to a configuration of the fixation device when secured to the bodily tissue; plastically deforming the fixation device into a second shape corresponding to a configuration of the fixation device for allowing the fixation device to be inserted into the bodily tissue; inserting the fixation device, in the second shape, into the bodily tissue; and applying a stimulus to the fixation device after insertion thereof into the bodily tissue, the stimulus being configured to be capable of causing a material phase change in the shape-memory material, so as to cause the fixation device to change from the second shape to the first shape in response to the stimulus and thereby secure the fixation device to the bodily tissue.
4. A method according to Claim 3 wherein the shape-memory material comprises a nickel-titanium alloy and applying a stimulus further comprises applying heat to the fixation device to cause the material phase change in the nickel-titanium alloy.
5. A fixation device adapted to be secured to a bodily tissue, comprising: an elongate member having an insertion end configured to be inserted into the bodily tissue, the elongate member being comprised of a shape- memory material, formed into a first shape corresponding to a configuration of at least one of the elongate member and the insertion end thereof when secured to the bodily tissue, and then plastically deformed into a second shape corresponding to a configuration of the elongate member for allowing the insertion end thereof to be inserted into the bodily tissue, the shape-memory material of the elongate member being further configured to undergo a material phase change upon application of a stimulus thereto, the stimulus being applied following insertion of the insertion end into the bodily tissue, such that at least one of the elongate member and the insertion end thereof changes from the second shape to the first shape in response to the stimulus to secure the elongate member to the bodily tissue.
6. A device according to Claim 5 wherein the shape-memory material comprises a nickel-titanium alloy.
7. A device according to Claim 5 further comprising a stimulus-applying device capable of being operably engaged with at least one of the elongate member and the insertion end thereof for applying the stimulus thereto.
8. A device according to Claim 7 wherein the stimulus-applying device is further configured to be capable of applying heat to at least one of the elongate member and the insertion end thereof, the heat being configured to cause the material phase change in the shape-memory material.
9. A method of applying a surgical device to a bodily tissue to secure the surgical device thereto, the surgical device having a plurality of fixation devices mounted thereto, each fixation device being comprised of a shape-memory material, formed into a first shape corresponding to a configuration of the fixation device when secured to the bodily tissue, and then plastically deformed into a second shape for mounting to the surgical device, the second shape corresponding to a configuration of the fixation device for allowing the fixation device to be inserted into the bodily tissue, said method comprising: engaging the surgical device with the bodily tissue; inserting each fixation device, in the second shape, into the bodily tissue such that the fixation devices extend between the surgical device and the bodily tissue, and such that the surgical device is disposed in a desired position with respect to the bodily tissue; and applying a stimulus to each fixation device after insertion thereof into the bodily tissue, the stimulus being configured to be capable of causing a material phase change in the shape-memory material, so as to cause the respective fixation device to change from the second shape to the first shape in response to the stimulus and thereby secure the fixation device and the surgical device to the bodily tissue.
10. A method according to Claim 9 wherein the shape-memory material comprises a nickel-titanium alloy and applying a stimulus further comprises applying heat to each fixation device to cause the material phase change in the nickel-titanium alloy.
11. A method according to Claim 9 wherein the surgical device further comprises at least one of an annuloplasty band and a valve device, and engaging the surgical device further comprises engaging the at least one of the annuloplasty band and the valve device with the bodily tissue.
12. A method of forming a surgical device capable of being applied to and secured to a bodily tissue, comprising: forming a plurality of fixation devices, each fixation device being comprised of a shape-memory material, into a first shape corresponding to a configuration of the fixation device when secured to the bodily tissue; plastically deforming each fixation device into a second shape corresponding to a configuration of the fixation device for allowing the fixation device to be inserted into the bodily tissue; and mounting the plurality of fixation devices to a surgical member so as to form the surgical device, the plurality of fixation device being mounted to the surgical member such that each fixation device, in the second shape, is capable of being inserted into the bodily tissue so as to extend between the surgical device and the bodily tissue, and such that the surgical device is capable of being disposed in a desired position with respect to the bodily tissue, the fixation devices being adapted such that a stimulus capable of causing a material phase change in the shape-memory material can then be applied to each fixation device to cause the respective fixation device to change from the second shape to the first shape in response to the stimulus and thereby secure the fixation device and the surgical member to the bodily tissue.
13. A surgical device adapted to be secured to a bodily tissue, comprising: a surgical member; and a plurality of fixation devices mounted to the surgical member, each fixation device comprising an elongate member having an insertion end configured to be inserted into the bodily tissue, the elongate member being comprised of a shape-memory material, formed into a first shape corresponding to a configuration of at least one of the elongate member and the insertion end thereof when secured to the bodily tissue, and then plastically deformed into a second shape corresponding to a configuration of the elongate member for allowing the insertion end thereof to be inserted into the bodily tissue, the shape- memory material of the elongate member being further configured to undergo a material phase change upon application of a stimulus thereto, the stimulus capable of being applied following insertion of the insertion end into the bodily tissue, such that at least one of the elongate member and the insertion end thereof changes from the second shape to the first shape in response to the stimulus to secure the elongate member and the surgical member to the bodily tissue.
14. A device according to Claim 13 wherein the surgical member comprises at least one of an annuloplasty band and a valve device.
15. A device according to Claim 13 wherein the shape-memory material comprises a nickel-titanium alloy.
16. A device according to Claim 13 further comprising a stimulus- applying device capable of being operably engaged with at least one of the elongate member and the insertion end thereof for applying the stimulus thereto.
17. A device according to Claim 16 wherein the stimulus-applying device is further configured to be capable of applying heat to at least one of the elongate member and the insertion end thereof, the heat being configured to cause the material phase change in the shape-memory material.
PCT/US2005/039851 2004-11-03 2005-11-02 Fixation device and associated apparatus WO2006052687A1 (en)

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US11969348B2 (en) 2021-08-26 2024-04-30 Edwards Lifesciences Corporation Cardiac valve replacement

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