US20050148815A1 - Transventricular implant tools and devices - Google Patents

Abstract

A method and implantation tools for placing a transventricular splint including a tension member. The method includes gaining access to the patient's hearts and identifying entry or exit points for the tension member, marking those locations and delivering the tension member. Anchors for the tension member are also delivered. The length of the tensions member is measured and the walls of the heart drawn together. The pads are secured to the tension member and the tension member is trimmed to length. The pads are secured to the heart surface.

Description

RELATED APPLICATIONS
• This application is related to U.S. application Ser. No. ______, filed on date even herewith and entitled “Stress Apparatus and Method” and U.S. application Ser. No. ______, filed on date even herewith and entitled “Heart Wall Tension Reduction Apparatus and Method”, both of which are incorporated herein by reference.
FIELD OF THE INVENTION
• The present invention pertains to the field of apparatus for treatment of a failing heart. In particular, the apparatus of the present invention is directed toward implanting a device for reducing wall stress in the failing heart.
BACKGROUND OF THE INVENTION
• The syndrome of heart failure is a common course for the progression of many forms of heart disease. Heart failure may be considered to be 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 with a resulting difference in pathophysiology of the failing heart, such as the dilatation of the left ventricular chamber. Etiologies that can lead to this form of failure include idiopathic cardiomyopathy, viral cardiomyopathy, and ischemic cardiomyopathy.
• 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 ventricular dilation and 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 is also true for diastolic filling. Additionally, because of the lack of cardiac output, there is generally a rise in ventricular filling pressure 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 art treatments for heart failure fall into three generally categories. The first being pharmacological, for example, diuretics. 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 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 inhibitors have been used to treat heart failure through the reduction of cardiac workload through the reduction of afterload. Afterload may be defined as the tension or stress required in the wall of the ventricle during ejection. Inotropes such as digoxin are cardiac glycosides and 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, for example, 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: 1) heart transplant; 2) dynamic cardiomyoplasty; and 3) the Batista partial left ventriculectomy. Heart transplantation has serious limitations including restricted availability of organs and adverse effects of immunosuppressive therapies required following heart transplantation. Cardiomyoplasty includes 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 includes surgically remodeling 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.
SUMMARY OF THE INVENTION
• The present invention relates to methods and devices for placing a transventricular splint to reduce mechanical heart wall muscle stress. Heart wall muscle stress is a stimulus for the initiation and progressive enlargement of the left ventricle in heart failure. Although the primary focus of the methods of the present invention is heart failure and thus placement of a splint on the left ventricle, the methods and devices of the present invention could be used to place a splint or reduce stress in the heart's other chambers.
• The transventricular splints placed by the tools and methods of the present invention can reduce heart wall stress throughout the cardiac cycle including end diastole and end systole. Alternately, they can be used to reduce wall stress during the portions of the cardiac cycle not including end systole. The splints which operate throughout the cardiac cycle are referred to herein as “full cycle splints”. Those splints which do not operate to reduce wall stress during end systole are referred to as “restrictive devices” or, more specifically, “restrictive splints”. Splints reduce left ventricle wall stress by altering the geometric shape of the left ventricle.
• In the preferred embodiment of the present invention, tools are provided to interconnect oppositely disposed ventricular walls by a transventricular splint, including a tension member and anchors disposed on opposite ends of the tension member. First access is gained to the heart either by opening a patient's chest or less invasively by port or trocar. The points on the ventricular walls to be interconnected by the splint are then identified. The locations are preferably marked. The tension member is then placed to extend between the marked locations. The distance between the marked location is preferably measured. The wall of the ventricles are drawn toward each other. The anchors are secured to the tension member. The tension member is trimmed or cut to size in view of the relative spacing of the anchors. The anchors are then secured to the heart.
• In this manner, portions of the walls of the ventricle are fixed in a drawn position reducing the radius of curvature of the majority of the ventricle and thereby reducing the tension within the ventricle wall.
BRIEF DESCRIPTION OF THE FIGURES
• Referring now to the drawings wherein like reference numerals refer to like elements throughout the several views,FIG. 1 is a cross sectional view of the left ventricle including a transventricular splint;
• FIG. 1A is a generally horizontal cross sectional view of a left ventricle including the transventricular splint ofFIG. 1;
• FIG. 2 is an exterior view of the heart ofFIG. 1 and anchor pad of the transventricular splint;
• FIG. 3 is a location device with bars;
• FIG. 4 is an exterior view of a heart including the location device ofFIG. 3;
• FIG. 5 is a hand including a finger echo locator device;
• FIG. 6 is a top view of the echo locator device ofFIG. 5;
• FIG. 7 is a side view of the echo locator device ofFIG. 6;
• FIG. 8 is a side view of a balloon locator device;
• FIG. 9 is a side view of balloon locator device with balloon inflated;
• FIG. 10 is a view of a mechanical locator disposed within and outside of a left ventricle;
• FIG. 11 is a clamp locator device;
• FIG. 12 is a view of the device ofFIG. 11 disposed on a left ventricle;
• FIG. 13 is a view of an alignment tool;
• FIG. 14 is a view of an alternative alignment tool;
• FIG. 15 is yet another alternative alignment tool;
• FIG. 15A is a detail of the alignment tool ofFIG. 15;
• FIG. 16 is a cross sectional view of an alignment tool pad with stabilizing apparatus;
• FIG. 17 is a side view of an alternate embodiment of an alignment device pad with stabilizing apparatus;
• FIG. 18 is a perspective view of an alignment device pad;
• FIG. 19 is a perspective view of an alternate embodiment of an alignment device pad;
• FIG. 20 is yet another alternate embodiment of an alignment device receiving pad;
• FIG. 21 is a perspective view of an alignment device guide tube;
• FIG. 22 is a side view of a splint delivery guide;
• FIG. 23 is an alternate embodiment of a splint delivery guide;
• FIG. 24 is an alternate embodiment of a stylet;
• FIG. 25 is yet another alternate embodiment of a stylet including a retractable sheath in a retracted position;
• FIG. 26 is a view of the stylet ofFIG. 25 showing the sheath covering the tip of the stylet;
• FIG. 27 is a yet another alternate embodiment of a stylet including a balloon disposed proximate the tip;
• FIG. 28 is a view of the stylet ofFIG. 27 wherein the balloon is inflated to cover the tip of the stylet;
• FIG. 29 is a view of yet another alternate embodiment of a splint delivery guide including an optical fiber;
• FIG. 30 is a view of the tip of the guide ofFIG. 29;
• FIG. 31 is an alternate embodiment of a guide including an optical fiber;
• FIG. 32 is a view of yet another alternate embodiment of a guide including an optical fiber;
• FIG. 33 is a perspective view of a guide clamp;
• FIG. 34 is a perspective view of a wire guide clamp connected to a delivery tube;
• FIG. 35 is a view of an alternate embodiment of a splint and delivery device;
• FIG. 36 is a view of yet another alternate embodiment of a splint and delivery device;
• FIG. 37 is a view of the device ofFIG. 36 connected in a left ventricle;
• FIG. 38 is a tension member delivery catheter shown in a left ventricle;
• FIG. 39 is a view of a hypotube placed in the left ventricle using the catheter ofFIG. 38;
• FIG. 40 is a view of the hypotube ofFIG. 39 being removed from the left ventricle;
• FIG. 41 is a view of two guide members placed in the left ventricle using the catheter ofFIG. 38;
• FIG. 42 is a view of a tension member being advanced over the guide members ofFIG. 41;
• FIG. 43 is a view of a tension member and leads placed in a left ventricle using the catheter ofFIG. 38;
• FIG. 44 is a view of a connector for connecting the lead and tension member ofFIG. 43;
• FIG. 45 is a view of the connector ofFIG. 44 connecting a lead and tension member;
• FIG. 46 is a view of the tension member measuring and tightening device;
• FIG. 47 is a cross sectional view of an anchor pad;
• FIG. 48 is a cross sectional view of an alternate anchor pad;
• FIG. 49 is a perspective view of yet another alternate embodiment of an anchor pad including an anchor pad loosening device;
• FIG. 50 is a perspective view of a tension member clip;
• FIG. 51 is a cross sectional view of an alternate embodiment of the tension member clip;
• FIG. 52 is a cross sectional view of a heart including a tension member having a heat set end;
• FIG. 53 is a cross sectional view of a pad including an anchor envelope;
• FIG. 54 shows the envelope ofFIG. 53;
• FIG. 55 is a view of a heart including a external locating device;
• FIG. 56 is a perspective view of the external locating device ofFIG. 55;
• FIG. 57 is a cross sectional view of the locating device ofFIG. 55 including inflated locating balloons;
• FIG. 58 is a transverse cross section ofFIG. 57;
• FIG. 59 is a vertical cross section of the heart including an internal locating device;
• FIG. 60 is a cross section of a torso taken through the left and right ventricles including a locating clamp;
• FIG. 61 is a view of the locating clamp ofFIG. 60;
• FIG. 62 is a view of an alternate embodiment of a marking clamp;
• FIG. 63 is a cross sectional view of a thread pusher;
• FIG. 64 is a cross sectional view of the left ventricle including two thread pushers and a snare;
• FIG. 65 is a subsequent view of the devices ofFIG. 64;
• FIG. 66 is a subsequent view of the device ofFIG. 65;
• FIG. 67 is a subsequent view of the device ofFIG. 66;
• FIG. 68 is a cross sectional view of a left ventricle including a snare and thread pusher;
• FIG. 69 is a subsequent view of the device ofFIG. 68;
• FIG. 70 is a cross sectional view of an alternate embodiment of a thread pusher;
• FIG. 71 is a cross sectional view of a snare insertion tube;
• FIG. 72 is yet another alternate anchor pad embodiment;
• FIG. 73 is yet another alternate anchor pad embodiment;
• FIG. 74 is yet another alternate anchor pad embodiment;
• FIG. 75 is yet another alternate anchor pad embodiment;
• FIG. 76 is yet another alternate anchor pad embodiment;
• FIG. 77 is a view of an anchor screw;.
• FIG. 78 is a view of yet another alternate anchor pad embodiment;
• FIG. 79 is a view of an anchor epicardial jaw embodiment;
• FIG. 80 is vertical cross sectional view of the heart including anchors deployed from within the heart; and
• FIG. 81 is a vertical cross sectional view of a heart showing tension members deployed from within the heart connected within the heart.
DETAILED DESCRIPTION OF THE INVENTION
• The present invention relates to methods and tools for implanting a transventricular splint. The transventricular splint reduces heart wall stress by changing ventricular geometry. A splint can be full cycle or restrictive. If a splint is full cycle, it engages, i.e., alters the generally globular ventricular shape throughout the cardiac cycle. If the splint is restrictive, it does not change the generally globular shape of the ventricle at end systole.
• FIG. 1 is a vertical cross sectional view of a left ventricle view, B of a heart A. Atypical transventricular splint10 is disposed acrossventricle B. Splint10 includes atension member12. Connected to opposite ends oftension member12 are anchors14.Anchors14 engage the walls of ventricle B to create a shape change either full cycle or restrictively.FIG. 1A is a horizontal cross sectional view of left ventricle B taken fromFIG. 1 showing left ventricle B in a bi-lobe shape as a result of the implantation ofsplint10.FIG. 2 is a vertical exterior view of heartA showing splint10, one end oftension member12 and ananchor14.
• In a preferred method of implanting a transventricular splint, access is gained to the heart. The entry and/or exit points for the splint's tension member are identified. These locations are preferably marked. The tension member is then delivered transventricularly either from outside the heart to the inside, or from the inside of the heart to the outside. The anchors are delivered or deployed. The epicardial length is preferably measured to calibrate the magnitude of the shape change, tension member length, and thus heart wall stress reduction. The magnitude of the stress reduction is a function of the tension member length. (See U.S. patent application Ser. No. 08/933,456, filed Sep. 18, 1997 and incorporated herein by reference.) The heart walls are then drawn together by adjusting the tension member length and/or anchor spacing. The heart walls are drawn toward each other in view of the desired tension member length. The anchors are secured to maintain the length of the tension member. Preferably any portion of the tension member not lying between the anchors is removed. The anchors are preferably secured to the heart to limit relative movement between the anchors and the heart.
• Some of the devices and methods disclosed in this application lend themselves to open chest procedures, whereas others lend themselves either to open chest procedures or less invasive procedures. Various cardiac surgical procedures are being done via partial thoracotomy between ribs. Thoroscopes and trocars are often utilized. Certain embodiments of the invention are amenable to these types of less invasive surgery. As is known to one skilled in the art, ports, windows and trocars are available to access the heart to limit patient trauma relative to open chest procedures. One or more access sites can be used during a less invasive procedure to gain access to the heart through the chest wall from a left lateral direction, right lateral direction, anterior and/or posterior direction. For example, during a less invasive splint implantation procedure, opposite ends of a tension member can be accessed by left and right lateral ports, where an anterior port is used to deliver the tension member. During less invasive procedures, the surgeon's hands preferably remain outside of the patient's body.
• When gaining access to the heart by way of a window trocar, both the diaphragm and lungs should be avoided. If the lungs are an obstruction to placement of the trocar and tension member, in some instances they may be moved without deflation. In yet other instances, if the lungs are substantially disposed between the selected chest access point and the heart, the patient may be placed on heart lung bi-pass and the patient's lungs deflated. Ventilation with or without deflation of the lungs may be desirable.
• Once access to the heart through the chest wall has been gained, the splint placement location should be determined. Determining the desirable location of the splint is important to the performance and safety of the device. It is desirable to avoid external structures such as coronary vessels to avoid negatively effecting the perfusion of blood through the heart wall muscle. It is also desirable to avoid internal structures such as valve apparatus including chordae. To determine where to place the splint, the heart can be viewed with the naked eye, echo imaging, echo transesophageally or epicardially and fluoroscopy. Various devices can be used to locate entry or exit points by echo imaging or fluoroscopy.
• FIG. 3 is a perspective view of a locatingdevice20 including twoknurled bars22 interconnected by anelastic member24.FIG. 4 is a view of a heart A including a left ventricle B and rightventricle C. Device20 is shown disposed on left ventricle B. Bars22 can be echo imaged or viewed by fluoroscopy simultaneously with the left ventricle. When viewed by fluoroscopy, coronary vessels can be advantageously visualized by introducing contrast medium therein. Additionally, bars22 should be made from a substantially radiopaque material if used for fluoroscopic imaging.
• In use, bars22 are placed on heart A as shown inFIG. 4.Bars22 appear to be positioned such that the coronary vessels and internal structures would be avoided, were the tension member to be extended through the heart between the location ofbars22. The location of the bars can be the location of the splint tension member. If not, the bars should be shifted into a better location until an acceptable location is found.
• In addition to avoiding coronary vessels and internal anatomical structures, imaging can be used to determine if the proposed location of the splint will produce the desired shape change of the chamber. This could be accomplished withdevice20 by pushingknurled bars22 into the left ventricle and observing the change in chamber geometry by imaging.
• FIG. 5 is a view of a human hand X including a thumb Y and a forefinger Z. Analternate locating device30 is shown attached to thumb Y and forefinger Z by rings32.Device30 also includes a echovisible pad34.Pads34 can be used in the same way as knurled bars22, but rather than being held together by astring24,pads34 can be held in place by the user.FIG. 6 is a view of the surface ofpad34 which would be in contact with heart A during use.Pad34 preferably includes anechogenic marker36 enclosed within a material which has a similar density to the heart wall. The similar density material will reduce echo scatter/reflection versus transmission at the surface and provide easier visualization ofecho marker36.FIG. 7 is a side view ofpad34 ofFIG. 6.
• FIG. 8 is a side view of a locatingdevice40.Device40 can include asyringe44 having ahypodermic needle42 in which end47 preferably does not include an exit lumen or orifice. The lumen does, however, extend through the remainder ofhypodermic needle42. A balloon envelope is connected to a portion ofhypodermic needle42 proximate itsend47. An orifice provides fluid communication between the lumen throughhypodermic needle42 and insideballoon46.Balloon46 can be inflated with a echo visible or fluoroscopic visible medium.
• FIG. 9 is a view of locatingdevice40 in whichballoon46 is shown inflated within left ventricle B of heart A. By usinglocator40 tension member entry/exit points can be evaluated in closer proximity to internal structures than when a locator is placed on the external surface of the heart.
• FIG. 10 is a vertical cross sectional view of heart A including left ventricle B, right ventricle C and an apex D.A locator device50 is shown disposed on heartA. Locator device50 includesapical insert branch52 which preferably includes an elongate shaft having an inflation lumen and a tension member delivery lumen extending therethrough. The shaft preferably bends transversely near itsdistal end54. Aballoon55 similar to the balloon oflocator device40 ofFIGS. 8 and 9 is connected to the distal end ofbranch52.Balloon55 can be inflated with a medium visible by echo imagery or fluoroscopy to locate a tension member entry or exit point on the internal surface of the ventricle wall in a manner similar to locatingdevice40 ofFIGS. 8 and 9. An optical fiber could be extended throughbranch52 and used as described with respect to the device ofFIG. 29.
• Locator device50 preferably includes anexternal branch arm56 connected to branch52 atconnector59.Branch56 is bent such that itsdistal end57 is disposed adjacentdistal end54 ofbranch arm52. Anadditional marker58 is preferably connected todistal end57 ofbranch arm56.Marker58 is preferably made of material visible either through echo imaging or fluoroscopy.Branch arm56 is preferably connected to brancharm52 such that asbranch arm52 is rotated,marker55 andmarker58 will maintain their relative position to each other, even as their position changes with respect to left ventricle B.
• FIG. 11 is a perspective view of a scissor-like clamp60 which has ahandle61 and two clamps ends62 which are made of a material which is echogenic or by fluoroscopy.Clamp60 can be opened or closed freely as a pair of scissors or have a locking mechanism to releasably fix the spacing between ends62.FIG. 12 is a vertical view of a heart A similar to that view of heart A inFIG. 4. Here rather than placingbars22 on the heart, ends62 ofclamp60 are placed on the heart. Ends62 can be used in a manner similar tobars22 as described above to locate a desirable positioning of a splint on left ventricle B.
• After the tension member entrance/exit points or anchor points on the heart have been identified for the transventricular splint, the locations can be marked in various ways to assist a surgeon in accurate placement of a splint when the locator has been removed. Tissue marking pens can be used to mark the location for splint placement. Additionally, sutures can also be placed to provide a marker. For example, a purse string suture with or without pledgets could be used to enhance sealing of the tissue around the tension member to reduce bleeding as the tension member is advanced through the heart wall.
• After marking tension member entry/exit points or anchoring points, an open chest alignment device, such asalignment device70 ofFIG. 13, can be placed on the heart to aid in the insertion of the tension member through the chamber from outside of the heart.Alignment device70 includes ahandle71 includingholes72 for the thumb and index finger of an operator.Alignment device70 includes two alignment arms having distal pad ends75. Ends75 includeapertures76 for receiving a tension member guide and/or tension member therethrough.Pads75,arm74 and handles71 are preferably aligned onshaft77 such that as handle71 are drawn toward each other by an operator.Arms74 andpads75 will remain generally parallel to each other. Aspring78 biases handles71 apart, andarms74 andpads75 together. A locking mechanism can be provided to fixpads75 in position when a desired spacing has been achieved.Apertures76 preferably remain axially aligned throughout the operational spacing ofpads75.
• In use,pads75 are disposed on the heart such thatapertures76 are placed over the location or markings previously determined for the exit/entry points.Handles71 are pulled apart untilpads75 are in engagement with the exterior surface of the heart.Alignment device70 is now in position for the next step of the splint placement procedure.
• FIG. 14 is an alternate embodiment of analignment device80.Alignment device80 includeshandles81 and anarm84 and86 which are pivotable about apin89. Disposed at the end ofarm82 is analignment pad83. Analignment pad85 is rotatably connected bypin86 toarm84. Athird arm87 is pivotally connected toarm82 bypin90 and pivotally connected to pad85 by apin88.Pads83 and85 each have anaperture91 therethrough.Pads83 and85 haveheart engaging surfaces92 which are preferably parallel to each other within an operational spacing ofpads83 and85.Apertures91 are preferably axially aligned within that operational spacing ofpads83 and85.
• The spacing ofpads83 and85 can be manipulated by movinghandles81 toward each other to increase the spacing ofpads83 and85 or away from each other to decrease the spacing.Pads83 and85 preferably engage the heart such thatapertures91 are axially aligned and disposed on the desired entry/exit point for the tension member. The closer handles81 are moved together, thefurther pads83 and85 move apart.
• FIG. 15 is yet an another alternate embodiment of analignment device100.Alignment device100 includeshandles101 andelongate arms102 pivotable aboutpin104. At the end ofelongate arms102,opposite handles101, arealignment pads103 havingorifices106 extending therethrough. Aflexible band105 extends betweenpads103.
• As described above with respect to the alignment devices ofFIGS. 13 and 14, the opposite pad orifices should be in axial alignment when placed on the heart. In the case ofdevice100, this can be accomplished by pivotally mountingpads103 onarms102 about apin107.FIG. 15A is a detail of apad103 pivotally mounted aboutpin107 toarm102. The arrow inFIG. 15A shows the direction that pad13 can pivot aboutpoint107. It can be appreciated that ifopposite pads103 are mounted as shown inFIG. 15A and ifband105 is sufficiently rigid,band105 can holdorifices106 ofopposite pads103 in axial alignment whilearms102 are pivoted aboutpin104.
• Since during the typical implant procedure the heart is still beating, it is preferable to equip the pads of thealignment devices70,80 and100 with stabilizing apparatus. The apparatus ofFIGS. 16-20 could be incorporated into the pads ofalignment devices70,80 and100.
• FIG. 16 is a cross sectional view of apad111 disposed at an end of analignment device arm110. The pad is shown in engagement with the external wall of leftventricle B. Pad111 includes anaperture114 extending therethrough for receiving a tension member guide (described in more detail below) and/or tension member. Anannular trough112 is disposed aroundaperture114.Annular trough112 is connected to avacuum source line113 such that a vacuum source can be fluidly connected totrough112. When the vacuum source is applied totrough112 as shown inFIG. 16, a suction force will be created intrough112drawing pad111 and the wall of the left ventricle B together.
• FIG. 17 is a side view of analignment device pad121 disposed at the end of anarm120 including analternate stabilization device122. Anaperture123 for receiving a tension member guide and/or tension member extends throughpad121.Stabilization apparatus122 is preferably a roughened surface disposed onpad121 to increase the friction betweenpad121 and the external wall surface of leftventricle B. Apparatus122 could be made from, for example, either the hook or the loop portion of a hook and loop type fastener.
• If a tension member guide or tension member is inserted into the heart usingalignment device70,80 or100, it is preferable that the pad of the aperture through the pad at the tension member exit point is over sized in comparison to the pad aperture of the alignment device at the tension member entry point. This is because as the tension member guide or tension member passes through the heart, motion of the heart may cause some minor misalignment of the tension member guide or tension member where it exits the heart.
• FIG. 18 is a perspective view of apad131 disposed on the end of analignment device arm130.Pad131 includes anaperture132 therethrough. This aperture has a diameter preferably between 1.5 and 15 times greater than the aperture to the opposite pad.FIG. 18 also shows anotch133 throughpad131 which extends from the exterior of the pad intoaperture132. Notch or opening133 would preferably allow a tension member guide or tension member to be removed transversely fromaperture132 withoutaperture132 having to moved over an end of the tension member guide or tension member.
• FIG. 19 is a perspective view of an alternate embodiment of analignment device pad141.Alternate embodiment141 is disposed at the end of analignment device arm140.Pad141 includes afunnel shape aperture142.Aperture142 includes alarge diameter end144 and asmall diameter end143.Large diameter end144 is preferably disposed adjacent the heart and tension member exit point during use. Aguide tube145 can lead out from smaller diameter end143 ofaperture142.Guide tube145 preferably includes a bend passing through an arc of preferably between about 45° to about 135° and more preferably about 90°. The radius of the bend is preferably long enough that devices advanced throughguide tube145 are not permanently bent as a consequence of being advanced through the arc ofguide tube145. The radius of the arc is preferably about 0.05 inches to about 2 inches, and more preferably between about 0.75 inches and, most preferably about 1 inch as measured to the central axis ofguide tube145.
• FIG. 20 is a perspective view of yet anotheralternate pad embodiment151.Pad151 has a similar shape to that ofFIG. 18 and is disposed at the end of analignment device arm156.Pad151 has anaperture152 therethrough and aside notch153 for transverse removal of a tension member guide and/or tension member. Extending fromarm156 is astop arm155 having a tension member guide stop154 aligned withaperture156 and spaced frompad151. In use, stop154 is disposed on the opposite side ofpad151 from the heart. As atension member guide157 is advanced from the heart throughaperture152, advancement of the tip ofguide157 is limited byneedle stop154. Stop154 thus can limit additional advancement ofguide157 which might injure tissue adjacent to the heart.
• FIG. 21 is a perspective view of an alignmentdevice guide tube165. Alignmentdevice guide tube165 preferably includes a luer lock orsimilar coupling166 releasably connectable to acorresponding coupling161 connected to an alignment device such as70,80 or100 shown above. Coupling161 ofFIG. 21 is shown connected to analignment branch arm160. The end of thealignment branch arm160opposite coupling161 preferably includes a heart engaging pad or surface such as those shown inFIGS. 16 and 17. An aperture169 extends throughcoupling161 in the end ofarm160. A transverse aperture or notch extends into aperture169 such that a tension member guide or tension member can be withdrawn from aperture169 transversely without moving aperture169 over the end of the tension member guide or tension member.Guide tube165 preferably includes a funnel shaped guidetube entry port167opposite connector166.Guide tube165 preferably includes a bend passing through an arc of preferably between about 45° to about 135° or more preferably about 90°. The radius of the bend is preferably long enough that the devices advanced throughguide tube165 are not permanently bent as a consequence of being advanced through the arc ofguide tube165. The radius of the arc is preferably about 0.25 inches to about 2 inches, and more preferably between about 0.75 inches to about 1.5 inches and, most preferably about 1 inch as measured to the central axis ofguide tube165.
• In use, aperture169 is preferably aligned with the desired entry point for the tension member.Guide tube165 can be coupled tocoupling161 of the alignment device. If it is difficult to gain access to aperture169 in order to insert the tension member therethrough because coupling161 is directed transversely or posteriorly within the patient's chest cavity,guide tube165 can be adjusted to dispose guidetube entry port167 generally anteriorly for improved access.
• Oncealignment device70,80 or100 is in place on the entry/exit points, a tension member guide or the tension member can be advanced through the alignment device transventricularly through the heart. Preferably, a tension member guide is used to advance the tension member transventricularly. It is anticipated, however, that if the tension member were sufficiently rigid that it could be advanced transventricularly without a guide.
• FIG. 22 is a side view of atension member guide170 including aguide tube176 andstylet171.Stylet171 preferably includes a sharpeneddistal end172 for advancement into and from the heart. The proximal end ofstylet171 can include a luer lock or similar type connector. Atube176 defines an elongate lumen therethrough sized to receivestylet171 or a tension member.Tube176 preferably includes a luer fitting at itsproximal end175 opposite itsdistal end173.
• In use,stylet171 is advanced throughtube176 as shown by the arrow inFIG. 22.Distal tip172 ofstylet171 preferably extends distally beyonddistal end173 oftube176.Stylet171 andtube176 can be coupled byfittings174 and175. Then with one of thealignment devices70,80 or100 in place, thetension member guide170, includingtube176 andstylet171 is advanced either directly through one of the alignment device apertures or by way of a guide tube such asguide tube165 ofFIG. 21.Tension member guide170 is then advanced through the opposite aperture of the alignment device such as shown in, for example,FIG. 20. The length oftube176 should be long enough to extend through the heart such thatproximal end175 anddistal end173 are disposed outside of the heart. If the alignment device includes transverse notches or slots such asnotch133 ofFIG. 18, the alignment device can be removed transversely fromneedle170.Stylet171 is preferably removed fromtube176. The lumen throughtube176 is now unobstructed, providing a passageway for advancing a tension member therethrough.
• The primary function ofguide170 and, in particular,tube176, is to provide a passageway across the heart.Guide170 should be flexible and resilient such thatguide170 could be advanced through the bend of, for example, guidetube165. Yet, to maintain accurate delivery ofguide170, it preferably does not permanently bend when passing throughtube165. Column/buckling strength oftension member guide170 is preferably sufficiently high such that the needle is not deflected as it engages the heart wall asguide170 is advanced from the heart.
• Tube176 is preferably made from Nitinol, polyimide, reinforced polyimide or other sufficiently flexible biocompatible material.Tube176 preferably has an inside diameter of about 0.01 inch to about 0.05 inch and, more preferably between about 0.02 inches to about 0.03 inches. The outside diameter oftube176 is preferably between about 0.015 inches to about 0.07 inches and more preferably between about 0.02 inches and about 0.05 inches.Stylet171 is preferably formed from Nitinol, stainless steel or other sufficiently rigid biocompatible material.Stylet171 preferably has a diameter of between about 0.005 inches and about 0.05 inches and more preferably about 0.26 inches.
• FIG. 23 is an alternate embodiment of atension member guide180 including astylet181 having ahandle184 disposed at its proximal end and a sharpenedpoint182 disposed at its distal end.Stylet181 is shown extending through atube186 having aproximal end185 and adistal end183.Guide180 is essentially similar to guide170 ofFIG. 22 except thattube186 andstylet181 do not include a coupling mechanism.
• FIG. 24 shows a distal end of astylet190 similar tostylet171 ofFIG. 22. The sharpenedtip191 is shown rounded in comparison to thesharp tip172 ofstylet171 shown inFIG. 22.Tip191 is rounded such that it can be advanced through the heart wall without undue pressure or trauma yet be deflected from, i.e., not pierce, chordae within the left ventricle which may be encountered as the guide is being advanced transventricularly. It should be understood that such a tip could be used on stylets ofguides170 or180 above.
• As an alternative to providing a rounded tip for stylets such astip191 ofstylet90, aretractable sheath203 can be placed around astylet200 having a sharpenedtip202. InFIG. 25,sheath203 is shown in a first position retracted away from sharpenedtip202, such thattip202 is exposed. InFIG. 26,sheath203 is shown in a second position covering sharpenedtip202.Sheath203 andstylet202 are preferably advanced transventricularly in a tube similar totubes176 or186 of tension member guides170 and180.Sheath203 is preferably spring biased into the second position shown inFIG. 26 and moved into the first position as shown inFIG. 25 only as it is advanced through the heart wall. Tobias sheath203 into the second position, a helical coil spring could be placed aroundstylet200 between a proximal end ofsheath203 and the stylet handle.
• FIG. 27 is a view of yet anotheralternate embodiment210 of a stylet for a tension member guide.Stylet210 includes a sharpenedtip211 at the distal end of ashaft214 which defines an inflation lumen therethrough.Tip211 is sealed such that inflation fluid forced throughstylet214 will exit anorifice213 disposed within aballoon212 connected to stylet210 proximate its distal end.
• FIG. 28 is a view ofstylet210 ofFIG. 27 whereinballoon212 has been inflated to cover sharpenedtip211. In use,balloon212 would be inflated afterstylet214 has been advanced into the left ventricle and deflated prior to being advanced from the heart and ventricle through the heart wall.Stylet214 preferably is used in conjunction with a guide tube in a manner similar tostylets171 and181.
• FIG. 29 is yet anotheralternate embodiment215 of atension member guide215 in accordance with the present invention.Guide215 is shown including anelongate tube220 having adistal tip222 partially advanced through left ventricle B of heart A.FIG. 30 is a view ofdistal tip222 ofguide215. By reference toFIG. 30, it can be seen thatshaft222 defines a lumen therethrough in which anoptical fiber224 is disposed.
• To guide215 transventricularly, rather than advancingguide215 through an alignment device, such asdevices70,80 or100, guide215 is advanced through a first left ventricular wall where a tension member entry point has previously been identified. Light is transmitted axially through the lumen withinshaft220 byoptical fiber224. The light axially exitsdistal end222. If the light is sufficiently bright, it should be visible from outside of the heart whenguide215 is being advanced through the left ventricle. If the visible light is directed at a predetermined exit point, marked on the outside of the heart,needle215 can be advanced through the exit point to outside the heart.Fiber optic214 can then be removed from the lumen throughshaft212. The lumen can then be used as the passageway for advancement of a tension member therethrough.
• FIG. 31 is an alternate embodiment of atension member guide230 including anoptical fiber232 disposed around ashaft231.Shaft231 is essentiallysimilar shaft220.Guide230 can be advanced transventricularly in a manner similar to that described with respect to guide215 except thatoptical fiber232 need not be removed andshaft231 which defines an elongate lumen extending therethrough.
• FIG. 32 is yet another embodiment of atension member guide235 having ashaft236 essentially similar toshaft220. Anoptical fiber237 is disposed parallel toshaft236 and connected thereto. In addition to the fiber optic guides ofFIGS. 29-32, real time guidance of the tension member guide transventricularly can be accomplished by echo imagery or fluoroscopy. The guide in such instances should be echogenic or substantially radiopaque.
• The fiber optic guides ofFIGS. 29-30 lend themselves particularly well to both open chest and less invasive procedures. When the fiber optic guides are configured for less invasive procedures, the shaft is preferably advanced through the heart through a lateral port and advanced out the opposite side of the heart and body through an oppositely disposed lateral port. Opposite ends of the shaft then preferably extend outside of the body-through the oppositely disposed lateral ports.
• FIG. 33 is a perspective view of a scissor-like guide clamp240 which can be used to guide atension member249 into thetube248 of a tension member guide.Device240 includes scissor-like handles241.Handles241 extend torespective arms242. Eachhandle241 andarms242 form a unit which are pivotable about apin243. At an end ofarms242opposite handles241, a half conical recess is formed inarm242. Recess247 leads to a generally semi-circular crosssectional channel246 which in turn leads distally to a generally semi-circular cross sectional tube receiving groove atdistal end244 ofarm242.
• Whenarms242 are brought together as shown inFIG. 34, receivinggrooves245 form a receiving aperture to receive an end oftension member guide248.Recesses247 form a tension member receiving opening leading to a tube formed bychannels246. Atension member249 is shown being advanced throughtube248 in the direction of the arrows.Tension member249 could also be advanced fromtube248 throughdevice240.Channel246 preferably includes a bend passing through an arc of between about 45° and 135° and more preferably through about 90°.
• Once a tension member guide has been delivery transventricularly, and a passageway is created across the chamber, the tension member is delivered through the passageway. When delivering the tension member, the end of the tension member not being advanced through the passageway preferably has an anchor or anchor pad fixably connected thereto. This eliminates the need to attach the pad later, but it may not be possible in the case where the guide includes a hub such ashub175 oftube176 ofFIG. 22. In the case ofguide180 wheretube186 does not include a hub,tube186 can be withdrawn from the heart over the end of the tension member which was advanced transventricularly. In order to remove atube176 from a tension member which has been advanced therethrough and has an anchor pad fixably connected to the end of the tension member which was not advanced throughtube176, the tension member should be advanced throughtube176 beginning atdistal end173 such that the end of the tension member not having the anchor pad emerges from the heart athub175. Thentube176 can be removed over the end of the tension member to which a pad has not yet been attached.
• Rather than using a tension member guide and/or tension alignment device to align the tension member for delivery through the preselected exit and entry points,tubular members250 such as those shown inFIG. 35 can be advanced into the left ventricle from oppositely disposed predetermined entry points on the heart wall to form asplint253′.Members250 preferably have ends250′ which are sufficiently sharp thatmembers250 can advanced through the heart wall without excessively injuring the wall.Members250 preferably haveanchor pads252′ fixed at their opposite ends250′.Members250 preferably have a lumen define therethrough in fluid communication with a lumen defined throughpads252′.
• Aftermembers250 are advanced into the ventricle through the predetermined entrance points, awire hook253 is advanced from onetension250 and awire loop251 is advanced from theopposite member250.Hook253 is then guided intoloop251 either by feel, or by echo imagery or fluoroscopy.Loop251 preferably has ahook guide252 tochannel hook253 into themember250 disposed to the left inFIG. 35, asloop251 is drawn through thatmember250 by pullingends251′ ofloop251 to the left.Loop253 is preferably drawn throughmember250 disposed to the left in drawingFIG. 35 such that it can be knotted to the left ofpad252′ to form a tension member. The knot will restrain hook253 from being pulled back in the heart. The opposite ends253′ ofhook253 can be knotted to the right of thepad252′ disposed to the right inFIG. 35. The knot should be sufficiently large to prevent ends253′ from being pulled into ventricle B.
• It can be appreciated thatmembers250 can be placed as shown withoutpads252′.Loop256 can be placed across left ventricle B to form a tension member as described above.Members250 can then be withdrawn and pads placed on opposite ends of hook ortension member253. Alternately,hook253, once placed across left ventricle B, could be used as a tension member lead by fastening a tension member to one end ofhook253 and drawing the attached tension member across left ventricle B by withdrawinghook253 from the left ventricle B.
• FIG. 36 is an alternate embodiment of asplint260′. Atension member255 is advanced into left ventricle B.An anchor pad255′ is shown connected to one end oftension member255 outside of chamberB. Tension member255 includes a sharpenedend256 which is advanced through the myocardium. Proximate sharpenedtip256 are a plurality ofcircumferential grooves256. To the left inFIG. 36 is atension member258′ extending into chamber B. Connected to one end oftension member258′ is aanchor pad257′.Tension member258′ includes anouter tube257 andinner receiving tube258. Aloop259 extends to a side of receivingtube258 and out of the ventricle through a lumen defined betweentube257 and258.Ends259′ ofloop259 are shown to the left ofpad257′. Anend261 oftube258 is preferably thin or sharp enough to be advanced through heart wall of chamber B.
• Tension members255 and258′ are advanced into chamber B similarly totension members250 ofsplint253′. Oncetension members258′ and255 have been advanced into chamber B, end256′ oftension member255 is advanced intoloop259. This can be accomplished by feel, or echo imaging or fluoroscopy ifloop259 andtension member255 are echogenic or radiopaque respectively. Aftertension member255 is advanced intoloop259,loop259 is drawn to the left by pullingends259′ to the left. Tensionmember loop guide260 engages with agroove265 andtension member255 and end256′ are drawn into receivingtube258 to unitetension members258′ and255.Ends259′ are then tied to preventloop259 from shifting to the right inFIG. 37.
• It can be appreciated thatmembers255 and258′ can be advanced into left ventricle B while not havingpads255′ and257′ attached thereto respectively. Oncemembers255 and258′ are placed across left ventricle B and connected as shown inFIG. 37 they can be used as a tension member guide tube such asguide tube176 ofFIG. 22.
• FIG. 38 is a vertical cross sectional view of left ventricle B of heart A including apex D showing an alternate device for placing a tension member. Acatheter265 having anelongate shaft265′ is disposed in part withinventricle B. Shaft265′ has adistal end266 and a transverse bendproximate end266.Shaft265′ has aproximal end267. An elongate lumen is defined throughshaft265′ betweenproximal end267 anddistal end266.Shaft265′ is sufficiently rigid thatdistal end266 can be advanced through apex D. A purse string suture is preferably placed on apex D aroundshaft265′ to control bleeding.Catheter265 is advanced into ventricle B such thatdistal tip266 is brought into contact with the ventricular wall at a location where the tension member will exitchamber B. Catheter265 preferably include aretractable brace wire268′ having a distal end fixably connected toshaft265 proximate the transverse bend.Brace wire268′ extends proximally outside ofshaft265′ to an orifice where it entersshaft265.Wire268′ then extends withinshaft265′ proximal to the proximal end ofshaft265′. When advancingcatheter265 into ventricle B,wire268′ can be pulled proximally drawingwire268′ parallel and adjacent toshaft265′. Oncecatheter265 is disposed within ventricle B,wire268′ can be shifted distally to bow transversely andbrace catheter265 against a ventricular wall oppositedistal end266.
• Distal tip266 preferably includes a radiopaque marker such as that shown inFIG. 10, so thattip266 can be viewed by fluoroscopy or an echo marker for echo visualization. The radiopaque or echo marker can be used to locate the tension member exit points. Once a tension member exit point is determined, atension member268 can be advanced through the lumen ofcatheter265. The tension member should be sufficiently rigid and have a distal end sufficiently narrow or sharpened that it can be advanced through the ventricular wall. Aftertension member268 is passed through the ventricular wall,catheter265 is removed from ventricle B andwire268.Catheter265 is then reinserted into left ventricle B through apex D alongside tension member268.
• The location of a second tension member exit point is determined, this time rather than advancing a tension member through the lumen ofcatheter265, ahypotube269 having adistal tip270 and shown inFIG. 39, is advanced throughcatheter265.Distal tip270 passes through the heart wall at the location of the second tension member exit point.Tube269 need not be a hypotube but could be another tube having sufficient pushability to be advanced through the heart wall at the second tension member exit point.Distal tip270 should be narrow enough or sufficiently sharpened to traverse the heart wall. A proximal end ofhypotube268 should remain outside the heart and proximal apex D. InFIG. 39,catheter265 has been removed proximally from hypotube269 as it was fromtension member268. After hypotube269 has been placed as shown inFIG. 39, the proximal end oftension member268 is advanced intoproximal end271 ofhypotube269. The proximal end oftension member268 is advanced throughhypotube269 until it exits chamber B by way of thedistal end270 ofhypotube269.
• InFIG. 40,tension member268 is shown extending fromdistal end270 ofhypotube269.Hypotube269 is shown being withdrawn in the direction of the arrow overtension member268. After hypotube269 is withdrawn, thetension member268 is then in place across ventricle B It can appreciated thattension member268 has been placed without an alignment device such asalignment devices70,80 or100. Anchors or anchor pads can be placed on the tension member on opposite sides of the heart and adjusted as described in more detail below. The remainder of the steps necessary to complete the placement of the transventricular splint will be discussed in detail below.
• FIG. 41 is a vertical cross section of left ventricle B of heart A including apex D showing an alternate method of placing a tension member. Twoguide members270 and271 are shown advanced through apex D and out opposite sides of chamberB. Guide members270 and271 have been placed in this position in a manner similar to the way thattension member268 was placed as shown inFIG. 39.
• FIG. 42 is a view of atension member272 includingguide tubes273 disposed at each of its ends.Guide tubes273 havedistal ends274 which must be sufficiently narrow or sharpened to penetrate the ventricular walls.Guide tubes273 as shown, have been advanced through apex D overguide members270 and271.Tension member272 must be sufficiently rigid to provide sufficient pushability to advanceguide tubes273 through apex D overguidewires270 and271 and through the ventricular walls. Onceguide tubes273 have been advanced through oppositely disposed ventricular walls,tension member272 can be pulled taunt across ventricle B. Oncetension member272 is drawn across ventricle B, anchors can be disposed ontension member272 on opposite sides of heart A as described in more detail below.
• FIG. 43 is a vertical cross section of left ventricle B of heart A including apex D. As shown inFIG. 43, leads275 and276 have been advanced through apex D and opposite ventricular walls in a manner similar toguidewires270 and271 as shown inFIG. 41. Connected to leads275 and276 byconnectors278 is atension member277. This arrangement may be used in a situation whereintension member277 is substantially less pushable or rigid thanleads275 and276.Leads275 and276 must first be placed in a manner similar to guidemembers270 and271 ofFIG. 41, such that the ends ofleads275 and276 extend through the side walls of ventricle B and apex D. Then the relatively flexible tension member can be drawn into ventricle B. As shown inFIG. 43,tension member277 is partially drawn into ventricle B. Ultimately leads275 and276 are drawn in opposite directions untiltension member277 extends transventricularly across ventricle B and passes through the ventricular wall to the exterior of heart A. Oncetension member277 is disposed on opposite sides of the heart, anchors or pads can be attached to opposite ends of the tension member to form the transventricular splint. The splint can be adjusted as described in more detail below.
• FIG. 44 is a view ofconnector278 ofFIG. 43.Lead275 includes aloop280 disposed at one end.Tension member277 includes ahook279 disposed at one end. A lockingtube281 is slidably disposed over a portion ofhook279. To complete the connection betweenlead275 andtension member277,hook279 is hooked toloop280.Hook279 is then collapsed such thathook lock281 can be slid over the collapsed portion ofhook279 to retainloop280 in place onhook279 as shown inFIG. 45.
• The tools and methods shown and described with respect toFIGS. 38-43 lend themselves both to open chest and less invasive implantation procedures. They are particularly suited to less invasive procedures where the apex of the heart is accessed through an anterior port and the ventricular walls are accessed through oppositely disposed lateral ports such that opposite ends of the tension member can extend into oppositely disposed lateral ports. Rather than gaining access through the apex, those tools shown inFIG. 38-43 gaining access the left ventricle through the apex could instead access to the left ventricle through the aortic valve or mitral valve. Access through the aortic valve is preferably obtained through the aorta by way of either a carotid or femoral artery access point. Access to the mitral valve can be obtained by way of a port, window or the like and may be a particularly desirable route if mitral valve replacement or repair is done in conjunction with splint implantation.
• With respect to those tension members placed ventricularly through tension member guides as described above, it was indicated that it is preferable to connect an anchor or anchor pad to the end of the tension member not being advanced through the guide tube prior to advancing the tension member through the guide tube. It is not necessary to connect the pad to the tension member at that time, however. In the case of those embodiments where the tension member is advanced into the ventricle from opposite sides as shown inFIGS. 35-37, it is preferable that the anchors or anchor pads are connected to the tension members prior to advancement of the tension members into the ventricle. Here again, having the anchors connected to the tension members at this time is not required, however. With respect to those methods and tools shown inFIGS. 38-43, the pads are preferably placed on opposite ends of the tension member after the tension member is disposed transventricularly and both ends of the tension member are exposed outside of the heart.
• Once the pads or anchors are disposed on the tension member, the length of the tension member disposed between the pads is preferably adjusted. This adjustment is preferably made by fixing the position of one of the pads on the tension member and allowing the other pad to slide along the tension member. With respect to the splints ofFIGS. 35-37, however, both pads can be affixed to the respective tension members prior to adjusting the overall length of the splint (by placement of the knots as described above). The pad which is fixed to the tension member is drawn into engagement with the external wall of the heart by pulling on the end of the tension member opposite the fixed pad. Then the other pad is brought into engagement with the external wall of the heart by sliding it along the tension member toward the pad which is fixed on the tension member. The pads can be placed on opposite ends of the tension member by way of left lateral and right lateral ports to perform the transventricular splint implant less invasively.
• The effective length of the tension member, i.e., the distance between the pads measured along the tension member, can be correlated with the magnitude of heart wall stress reduction. For an idealized calculation of this relationship, please see U.S. patent application Ser. No. 08/933,456, filed Sep. 18, 1997, and incorporated herein by reference. It is also anticipated that the force exerted axially along the tension member by the heart engaging the pads can also be correlated with heart wall stress reduction.
• FIG. 46 is a view of ameasuring device300 through which atension member302 has been threaded. One end oftension member302 extends through left ventricle B of heart A. Ananchor pad304 has been fixedly attached totension member302 and end303 and drawn into engagement with heart A. Thesecond pad306 has been placed ontension member302 but has not been tightened, i.e., fixedly attached totension member302.Pad306 is free to slide alongtension member302. Extending fromanchor pad306 is a tether orstring308. In general, it may be desirable to attach a tether to the anchor pads as shown herein. This would make them easier to retrieve if they were dropped within the chest cavity during a splint implantation procedure.
• Measuringdevice300 includes an elongate tensionmember receiving tube310 having a distal end including apad engagement member312 and aproximal end316 connected to a preferablyclear measuring tube314 having ameasuring scale315 marked thereon.Tension member302 has been threaded throughtube310 andtube314.Tension member302 has also been threaded through atube318 having a retaining block319 and ascrew320 at one end tightened to releasably holdtension member302.Screw320 is preferably connected to a force transducer. Anotherblock322 disposed at the opposite end oftube318. Ascrew326 extends intoblock322 toreleasably hold guidewire302.Block322 is disposedadjacent block324 connected totube314. Interconnectingblock322 and324 is aguide rail330 andadjustment screw328.Adjustment screw328 can be rotated to move screw and block320,tube318, block322,screw326 and thus,tension member302 throughtube314.
• Tension member302 preferably has avisible index mark332 placed along its length a known distance fromend303 oftension member302. Measuringtube314 preferably magnifiesmark332. The length oftube310 and pad engagingmember312 as well astube314 should also be known and correlated toscales315 such that by determining the location ofmark332 relative toscale315, the length of tension member disposed betweenpads304 and306 can be determined. Setscrew328 can be adjusted until the desired length oftension member302 betweenpads304 and306 is achieved. Then pad306 can be fixed in place alongtension member302. Tether308 is preferably removed. It can be appreciated thattube310 can be sufficiently long to be advanced through a port for adjusting the length oftension member302 less invasively.
• The distance betweenpads304 and306 is preferably related to the radius R₁of the unsplinted left ventricle. For purposes of this explanation, 2 R₁can be viewed as the length of the tension member betweenpads34 and36 at end diastole where the pads are spaced such that no shape change is induced by the splint. Whenpads306 and304 are fixed alongtension member302 the distance along the tension member between the pads can be considered l. It can be appreciated that if l were greater than 2 R₁no shape change to the left ventricle would be induced throughout the cardiac cycle. At the opposite extreme, l could be so short that the opposite walls of the left ventricle are held or pressed together betweenpads304 and306 throughout the cardiac cycle. Preferably, however, the ratio l/2 R₁is preferably between about 0.4 to about 0.8 and more preferably between about 0.5 to about 0.7 and most preferably about 0.6.
• In addition to measuring the length oftension member302 betweenpads304 and306 to determine their desired spacing, it is anticipated thatdevice300 can be used to measure axial force on the tension member aspad306 is engaged against heart A and advanced toward304 alongtension member302. To accomplish this, in the preferred embodiment, thedevice300 also includes aforce transducer334 andpin vice336.Pin vice336 can be tightened to fixably holdtension member302. Ifscrews320 and326 are loosened such thatonly pin vice336 retainstension member302 from sliding distally within thedevice300, the distally directed force intension302 will be transferred bypin vice336 to forcetransducer334. The axial force detected by the transducer can be observed by calibrating the transducer or connecting it to a monitor in a manner known to those skilled in the art of force transducers. Setscrew328 can be adjusted until the desired force is obtained. The surface of the pad itself could also be centered to create pores for tissue ingrowth. When the desired force level is achieved,pad306 could be fixed in-place alongtension member302.
• With respect to any of the transventricular splints disclosed herein, the length of the tension member can be adjusted to form a full cycle splint or restrictive splint. If the length of the tension member is such that the anchors or anchor pads engage the heart to create a shape change throughout the cardiac cycle, the splint created is a fill cycle splint. If the anchor or anchor pads do not engage at end systole to create a shape change, the splint formed is a restrictive splint.
• FIG. 47 is a cross sectional view of an embodiment ofanchor pad340 in accordance with the present invention.Anchor pad340 preferably includes a disc shapedpad portion342. Discshape pad portion342 includesside343, which in use is disposed toward the heart. Aconical aperture348 having slopingsides346 extends throughpad342.Collet344 is disposed withinorifice348. A threadedportion350 ofcollet344 extends fromorifice348opposite side343,nut352 is threaded over threadedportion350.Lumen345 extends throughcollet344. Atension member354 is shown extending throughlumen345.Lumen345 has a diameter such that whennut352 is not tightened on threadedportion350,tension member354 can slide freely throughlumen345. Whennut352 is tightened, it drawscollet344 away fromside343.Collet344 is then pinched betweenwalls346 oforifice348. Whencollet344 is pinched, the size oflumen345 is reduced such thattension member354 can no longer move freely withinlumen345, fixing the position ofpad340 ontension member354.
• FIG. 48 is a cross sectional view of an alternate embodiment ananchor pad360 in accordance with the present invention.Anchor pad360 includes a generally disc-shapedpad portion362.Pad362 includes aside363 which when the pad is in use, is disposed toward the heart. Atension member lumen364 extends throughpad362.Lumen364 preferably has a generally conical shapedportion365 disposed towardside363.Tension member370 is shown disposed throughlumen364 inFIG. 48.Pad362 includes a threadedpassage366 extending from an edge ofpad362 tolumen364. Aset screw368 is threaded intopassage366. Setscrew368 can be tightened to engagetension member370 to fix the position ofanchor pad360. When setscrew368 is not tightened, the size oflumen364 is preferably large enough thatanchor pad360 can slide relatively freely overtension member370.
• FIG. 49 is a perspective view of yet another embodiment ofanchor pad380 in accordance with the present invention.Anchor pad380 preferably includes a generally disc-shapedpad portion382 having afirst side383 which in use would be disposed toward the heart and asecond side385.Pad382 as well aspads342 and362 are preferably formed from a metal such as stainless steel alloys or titanium alloys.
• Atension member fastener384 is formed inpad382 by cutting a series of grooves and apertures throughpad382 fromside385 toside383. Afirst groove386 has a generally horseshoe shape.Second groove388 extends between opposite portions of horseshoe shapedgroove386 to form two oppositely disposedcantilever members387. A relativelylarge aperture394 is formed betweencantilever members387 proximate their free ends. A second andsmaller aperture390 is formed closer to the fixed ends ofcantilever members387.Tension member392 is shown extending throughaperture390.
• As shown inFIG. 49,tension member392 is clamped betweencantilever members387 such that the location ofpad382 is fixed alongtension member392.Pad382 can be released by using a spreading device396 to spreadcantilever members387 apart. Spreading device396 includes handle398 to spreadingarms400 each having afinger402.Fingers402 can be placed withinaperture394 thenarms400 andfingers402 can be spread apart by pivoting them around apin404 such thatcantilevers387 are spread apart and pad382 can move freely alongtension member392. It can be appreciated that although spreader396 is shown extending transversely fromtension member392, it could also be configured such thatfingers402 do not curve transversely fromarms400 and thus spreader396 could be disposed parallel totension member392. This would be particularly desirable in a situation whereanchor pad380 was being placed through a port or window during a less invasive splint implantation procedure. It can be appreciated thatcantilever members387 can be held apart such thatpad380 can be moved alongtension member392 by placement of a temporary wedge or pin ingroove388. For example,grooves388 may include an additional small aperture disposed betweenaperture390 andaperture394 into which a pin could be placed to holdopen members387. When it is desired to fix the position ofanchor pad380 ontension member392, device396 could be used to spreadcantilever members387 to remove the pin. The cantilever members could then be released to engagetension member392.Aperture390 ofpad380 can also include a conical portion disposed towardside383 such asconical portion365 ofpad360.
• Cantilever arms384 are preferably configured such that they do not stresstension member392 beyond its elastic limit. It can also be appreciated that the force developed bycantilever members387 impinging ontension member392 is operator independent and defined by the geometry and material characteristics ofmembers387.
• FIG. 50 is a perspective view of ananchor pad360 having atension member370 extending therethrough. Afterpad360 is secured totension member370, that portion oftension member370 which extends from the side ofanchor pad360opposite side363 is preferably removed. This can be accomplished by trimmingtension member370 withwire cutter414 or scissors. Althoughanchor pad360 is used here to illustrate trimmingtension member370, it can be appreciated that in each of the embodiments disclosed herein there may be an excess portion of tension member extending from an anchor, which is preferably removed or trimmed.
• FIG. 51 is a cross sectional view of analternate embodiment420 of a tension member cutter.Device420 includes an elongateouter tube422 having adistal end424.Tube424 defines alumen423 through which extends asecond tube430 having a distal end428. Extending distally from distal end428 are two cuttingarms424 and426 which are shown partially withdrawn intolumen423 and transversely restrained bydistal end424 ofouter tube422. When unrestrained bydistal end424,arms424 and426 are biased apart. Eacharm424 and426 has acutting element425 and427, respectively.Elements425 and427 are shown in contact with each other inFIG. 51. Atension member370 extends betweenarms424 and throughlumen432 ofinner tube430. Arepresentative anchor pad360 is disposedadjacent elements425 and427.Device420 ofFIG. 51 is particularly useful when trimming excess tension member using less invasive techniques as it can be readily advanced over a tension member through a port or window.
• FIG. 52 is a vertical cross sectional view of left ventricle B of heart A. Atransventricular splint443 including atension member370 andanchor pads360 are shown disposed on heart A. To the left of heart A as shown in the figure is acoiled portion442 oftension member470. As an alternative to trimming an excess length of tension member,tension member370 could be formed from a shape memory alloy such thatportion442 could be preset to assume a coil shape when warmed to near body temperature.
• Once the length of the tension member has been adjusted, the anchors are secured in place along the tension member and the excess length of tension member removed if desired, the anchor or anchor pads are preferably secured in place on the heart. The anchor or anchor pads are secured such that relatively movement between the anchors or anchor pads and the heart is limited to reduce abrasion of the heart wall. To secure the anchor or anchor pads to heart A, a biocompatible adhesive could be placed between the pad and the heart to adhere the pad to the heart. Alternately, apertures could be provided in the pad such that sutures could be extended through the apertures and into the heart to secure the pad. In addition to sutures, the pad could include threaded apertures into which anchor screws could be advanced through the pad and into the heart wall to secure the pad to the heart.
• FIG. 53 illustrates yet another alternative approach to securing the anchors or anchor pads to the heart surface.FIG. 53 is a cross sectional view of ananchor pad340 disposed on heartA. Anchor pad340 is disposed within anenvelope446.Envelope446 includes abottom layer447 disposed betweenanchor pad340 and heart A and atop layer448 disposed on the opposite side ofanchor pad340.Layers347 and340 are held together bysutures449.Bottom layer447 is preferably a mesh dacron or expanded PTFE which has a pore size or intranodial dimension sufficient to promote tissue ingrowth. The pore size is preferably between about 10 and about 100 microns and more preferably, between about 20 and about 40 microns. With respect to expanded PTFE, the intranodial dimension is preferably between about 10 to about 100 microns and more preferably between about 20 to about 40 microns. The top material could also be dacron or expanded PTFE or the like having a pore size which preferably does not promote ingrowth and thus resists adhesion to surrounding tissue.
• Envelope446 would preferably be placed aroundpad340 prior to placingpad340 ontension member354. Awindow450 can be provided to provide access tonut352 to secure pads totension member354. After tighteningnut352,window450 can be closed bysuture452.FIG. 54 is a top view ofpad340 andenvelope446 ofFIG. 53. It can be appreciated that a similar envelope can be placed around the various anchor pads disclosed herein. The location of the window may have to vary, however, to provide access to the respective means for securing the anchor pads to the tension member.
• FIG. 55 shows an alternate embodiment of asplint locating device460 disposed on heart A. It can be appreciated, however, that alternate locating device such as that shown inFIGS. 13-15 could also be used. Heart A includes left ventricle B, right ventricle C and apex D.Splint locating device460 which is particularly useful in performing less invasive procedures.Device460 can be advanced through an anterior port or window to apex D and onto heart A as shown inFIG. 55.Device460 includes anelongate catheter shaft462 having a lumen extending therethrough. Extended from the distal end ofcatheter shaft462, are twoarms464 preferably biased to spread apart from each other when advanced distally fromcatheter shaft462. Connected to the distal end ofwires464 is aband466. Band466 preferably readily elongates, i.e., increases in diameter as it is advanced onto heart A, such thatband466 does not substantially alter the pumping performance of heart A.
• FIG. 56 is a view of thedevice460 disposed onheart A. Wires464 are shown extending fromcatheter shaft462 distally to band466 and proximally fromcatheter shaft462. Prior to advancingcatheter460 through a port or window to apex D,wires464 are preferably pulled proximally intoshaft462. Band466 can also be folded and pulled intoshaft462 or folded and disposed parallel toshaft462 for advancement through the port or window. Once the distal end ofshaft462 is advanced to apex D of heart A,wires464 can be shifted distally to deployband466 and the adjacent portions ofwires464 in heart A.
• FIG. 57 is a generally vertical cross sectional view of left ventricle B of heart A includingapex D. Catheter460 is shown deployed onheart A. Band466 has been advanced sufficiently high on heart A such that the adjacent portions ofwires464 will lie proximate potential entry/exit points for the tension member guide or tension member. As can be seen inFIG. 57, twoballoon catheters468 have been advanced overwires464. Those skilled in the art will recognize thatcatheters468 could be configured similarly to an over-the-wire or rapid exchange angioplasty catheter.Balloon catheters468 include a distally disposedballoon469 which would be larger than angioplasty balloons, however.
• FIG. 58 is a transverse cross sectional view of chamber B andcatheter460 taken fromFIG. 57.Balloons469 have been inflated to induce a shape change in chamber B similar to that shown inFIG. 1A.Balloons469 can be inflated with a radiopaque or echogenic inflation fluid such that they can be visualized by fluoroscope or echo imagery. If the balloons are imaged in this way, aportion469′ of eachballoon469 engages heart A can be considered as a location for the exit/entry points for the tension member. The criteria for evaluating the location is similar to that described above with respect to the locators ofFIGS. 3-12 above.Device460 can also be used acutely as a temporary splint.
• FIG. 59 is a vertical cross sectional view of left ventricle B of heart A having an apex D on which anotheralternate embodiment470 of a locator device is shown disposed within chamberB. Locator device470 includes anelongate catheter shaft472 having adistal end478. Extending fromdistal end478 is a wire orelastic ribbon476.Wire476 is shown extending transversely fromdistal end478 to radiopaque orechogenic markers479. Additional wires or leads474 extend proximally frommarkers479 to a ring orhub475 disposed outside of heart A. Toadvance catheter470 into chamber B or withdraw it therefrom,hub475 is pulled distally alongshaft472 to drawwires474,markers479 andwires476 generally parallel to andadjacent shaft472. In this position,catheter470 can be advanced through or withdrawn from chamber B by way of a port or window used for less invasive procedures.Catheter470 andmarkers479 can be used to locate the entry/exit points similarly to the locators shown inFIGS. 4-12 and in particular, themarker55 ofFIG. 10.
• FIG. 60 is a transverse cross section of a human torso through heart A, left ventricle B and right ventricle C, right lung E and leftlung F. Locator60 ofFIG. 11 is shown being advanced less invasively to heart A.FIG. 61 is a same human torso cross section as shown inFIG. 60, except thatlocator60 has been brought, into engagement with heart A as shown from a different perspective inFIG. 12.FIG. 62 is yet another view of the same torso cross section where alocator485 having scissor-like handle486 andarms488 are coupled by anelongate linkage487. As can be appreciated by those skilled in art,arms488 can be drawn together or spread apart by anoperating handle486. The distal end ofarms488 should be echogenic or radiopaque such that they can be viewed by echo imaging or fluoroscopy similarly to end62 oflocator60.Locator485 is shown advanced to heart A through a lateral left approach.Locator485 is preferably advanced through a port not shown of a type known to those skilled in the art. It can be appreciated thatlocator485 can be used to locate a splint at a different location thanlocator60.
• An alternate method of splint placement could advantageously use a thread pusher and snare.FIG. 63 is a view of athread pusher500.Thread pusher500 includes ahousing502 defining alumen503 therethrough. Extending fromlumen503 is ashaft504 having a sharpeneddistal tip506.Shaft504 defines alumen507 in fluid communication withlumen503 ofhousing502. Shown disposed withinlumen503 and advancable intolumen507 is aplunger508.Plunger508 has adistal end510.Plunger508 defines anelongate lumen511 extending the length ofplunger508. Disposed throughlumens503,511 and507 is athread512.Lumen511 preferably has a diameter just slightly greater than the diameter ofthread512.Lumen507, however, has a diameter great enough to coil a substantial length ofthread512 therein. The necessary length ofthread512 can be appreciated in view of the discussion which follows regarding the use ofthread pusher500.
• FIG. 64 is a generally vertical cross sectional view of left ventricle B of heart A having apex D, aortic valve G and mitral valve H. Disposed within chamber B is acatheter520 having anelongate catheter shaft522 extending through apex D of heart A to proximate aortic valve G. A wire orline526 extends through an elongate lumen throughshaft522, loops to form asnare524 at the distal end ofshaft522 and returns back through the lumen. As shown inFIG. 64,snare524 is disposed generally around or preferably through the orifice of aortic valve G. Two thread pushers have been advanced from opposite sides of heart A such thatdistal tips506 ofshafts504 are disposed withinchamber B. Plunger508 ofthread pusher500 has been advanced to release previously coiledportion514 ofthread512 into chamber B. As shown by the arrows, blood flow leaving chamber B exits through aortic valve G. As shown inFIG. 64, this blood flow has carriedthreads512 throughsnare524 and aortic valve G.
• FIG. 65 shows the same cross sectional view of left ventricle B asFIG. 64, except thatsnare524 has been partially retracted by pullingline526 proximally.Catheter520 has also been partially withdrawn in a proximal direction from chamber B.FIG. 66 is yet another view of the cross section of left ventricle B as shown in FIG.64, except thatsnare524 has been withdrawn proximally fromcatheter522 such that an end of eachthread512 is disposed proximally ofshaft522.
• FIG. 67 is yet another view of the cross section of left ventricle B shown inFIG. 64, except thatthreads512 have been joined and extend across left ventricle B. To achieve the configuration ofFIG. 67, the ends ofthreads512 disposed proximally ofshaft522 inFIG. 66 are tied together. Then the opposite ends ofthread522 are pulled proximally relative torespective thread pushers500 untilthreads512 are withdrawn fromcatheter shaft522 and extend across chamberB. Thread pushers500 can be withdrawn proximally fromthreads512. Joinedthreads512 can be used as a tension member to assemble a transventricular splint. Preferably, however, afterthread pushers500 are removed fromthreads512, a tension member is connected to one of the free ends ofthread512 by, for example, tying the end ofthread512 to a loop formed in an end of a tension member. Then the remaining free end ofthread512 can be withdrawn proximally until boththreads512 are pulled from chamber B and the tension member extends across the chamber. Once the tension member extends across the chamber, the remainder of the splint can be assembled in a manner similar to that contemplated for the tension members placed in accordance withFIGS. 38-43.
• It can be appreciated that the method of placing a tension member described with respect toFIG. 64 can advantageously be performed by an open chest or less invasive route. The method described, however, lends itself particularly well to a less invasive approach where oppositely disposed lateral ports are used to manipulatestring pushers500 and an anterior port is used to access apex D bycatheter520. As an alternative to the apical approach, snare524 could be placed from an aortic or mitral valve approach. If the approach is by way of the aortic valve, the snare may be advanced thereto by way of the aorta from a carotid or femoral artery access point. The mitral valve approach could be made by way of a port or window. The mitral valve port may be particularly desirable if mitral valve repair or replacement is preformed in conjunction with splint implantation.
• FIGS. 68 and 69 illustrate yet another method of placing a tension member across ventricleB using snare524, and athread pusher500. Unlike the method described with respect toFIGS. 64-67, the lateral approaches are preferably used without requiring access toapex D. Catheter520 is advanced from one side of chamber B and placed generally arounddistal tip506 ofshaft504 ofthread pusher500 which is advanced into chamber B from the opposite side.Plunger508 is depressed to push the coiled portion ofthread512 intochamber B. Thread512 drifts toward aortic valve G and throughsnare524 under the influence of blood flow.
• As shown inFIG. 69,snare524 is tightened aroundthread512 and withdrawn from chamber B. It can be appreciated thatcatheter520 andthread pusher512 can be removed fromthread512 and a splint assembled in the manner described above with respect to the tension member placed in accordance with the method described inFIGS. 64-67. It can also be appreciated that this method can advantageously be applied to implant a splint either by an open chest or less invasively using two oppositely disposed lateral ports.
• FIG. 70 is a longitudinal cross sectional view of an alternate embodiment of athread pusher610.Thread pusher610 includes athread insertion shaft612 having alumen612 extending therethrough.Shaft612 can have a curveddistal end614 which preferably includes a sharpenedportion618 for insertion through the heart wall into the left ventricle. Ahandle620 is preferably disposed at the proximal end ofshaft612. Aplunger622 is preferably disposed withinshaft lumen616.Plunger622 includes adistal end626 and a proximal end preferably including ahandle628. Alumen624 extends throughplunger622. A thread orfilament611 is shown disposed withinshaft lumen616 andplunger lumen624. Unlikethread pusher500 ofFIG. 63, the length ofshaft612 is preferably long enough that the portion ofthread611 to be advanced into the left ventricle can be disposed withinlumen616 without being coiled.
• In use,distal tip618 ofthread pusher610 is disposed in left ventricle B in a manner similar to that oftip506 ofthread pusher500.Plunger622 is then advanced intoshaft lumen616 to advancethread611 into the left ventricle.Thread612 is preferably lightly friction withinlumen624 or held withinlumen624 by the user or holdingcap629.
• FIG. 71 is a generally vertical cross section of left ventricle B showing a longitudinal cross sectional of asnare insertion tube630 disposed through apexD. Insertion tube630 preferably includes anelongate shaft632 having an elongate lumen extending therethrough. Anannular flange638 is preferably disposed at the proximal end ofshaft632. Disposed in engagement with, and distally offlange638 is anannular felt pad636. Astylet640 having anelongate shaft642 and ahub644 can be inserted within the lumen ofshaft632.
• In use, snareinsertion tube630 can be used to provide a stable access through apex D forcatheter520 when performing the procedure shown inFIGS. 64-67 above.Insertion tube630 can be advanced into apex D as shown. Asinsertion tube630 is advanced into apex D,stylet640 is preferably disposed therein to limit bleeding through the lumen throughshaft632.Felt pad636 is preferably sutured to apex D to limit bleeding aroundshaft632 and stabilizeinsertion tube630 onapex D. Stylet640 is then removed and thencatheter520 can be advanced throughinsertion tube630 to perform the splint implantation.
• Up to this point, it has been assumed that access was obtained or obtainable to each end of the tension member for placement of an anchor or anchor pad thereon. Access to each end of the tension member placed across the left ventricle is generally obtainable by open chest access or lateral, anterior or posterior ports. It is contemplated, however, that under some circumstances, however, it may be difficult or undesirable to obtain access to one or both ends of the tension member. Under such circumstances, it may be desirable to be able to deliver an anchor or anchor pad to a wall of the ventricle to which direct access by open chest or port has not been obtained. In such an instance, it may be desirable to deliver the anchor or anchor pad from inside the heart to the outside.
• FIG. 72 is a cross sectional view of a portion of left ventricle B including a distal portion of atension member532 havingballoon anchor536 disposed at its distal end and outside of chamber B of heartA. Tension member532 is preferably a tubular member such as a hypotube sealed at its distal end except for anorifice534 disposed withinballoon536. The distal end oftension member532 includingballoon536 can be advantageously and preferably advanced to the position shown by using any of the methods and devices disclosed above which advance the tension member from inside the heart to outside, for example, the method and device described above with respect toFIGS. 38-40. Once the distal end oftension member532 is advanced to the position shown,balloon536 can be inflated from a collapsed position to the expanded position shown.Balloon536 is preferably expanded using quick cure polymer such as cyanoacrylate or mixed two-part epoxy or other biocompatible substance which will allowballoon536 to remain in an expanded position chronically. Saline is preferably used as inflation fluid if the balloon is inflated acutely.
• FIG. 73 is a similar view to that ofFIG. 72 except atension member542 having apad544 is shown disposed in leftventricle B. Pad544 is preferably a coiled pad which can be delivered as described above with respect to the balloon ofFIG. 72, except that it may be preferable to advancepad544 through the heart wall through a tube.Coil544 can be compressed within the tube and upon emerging from the tube and the heart, expand.Coil544 could also could be formed from a shape memory alloy and be preset to expand at approximately body temperature.
• FIG. 74 is yet another example of an anchor pad deployable from inside the heart to outside the heart.Pad554 is shown disposed at the end of thetension member552.Pad554 includes two arms pivotally connected totension member522 byhinge556.Hinge556 preferably allowsarms555 to rotate from a first position parallel and adjacent totension member552, to a second position approximately perpendicular totension member552 as shown. To deploypad554,pad554 is advanced from the heart through the heart wall witharms555 disposed in the first position until the arms are completely advanced to the outside of the wall. Thentension member552 is drawn in the opposite direction such that the ends ofarms555 engage the heart wall and pivot into the second position astension member552 continues to be pulled.
• FIG. 75 is yet another embodiment of ananchor pad565 which can be placed from inside the heart to outside by the methods applicable to the device ofFIG. 72.Pad565 includes twoarms564 hingably connected totension member562.Arms564 include ahinge566.Pad565 can be advanced through the heart wall whilearms564 are parallel and adjacent to each other. Oncearms564 have been advanced to the outside of the heart, a wire orline568 connected to the distal end ofarms566 and extending proximally throughtension member562 can be pulled proximately to shorten the distance between the ends ofarms564 and bendarms564 outward at hinges566.
• FIG. 76 is yet another embodiment of ananchor pad574 disposed on a distal end oftension member572.Pad574 has an umbrella-like shape, the top of the umbrella being disposed away from the heart wall and the broad base of the umbrella being disposed toward the heart wall.Pad574 is advanced through the heart wall in a collapsed position.Pad574 can be biased to expand upon passing through the heart wall or can be expanded in a manner similar to pad554 ofFIG. 74.
• FIG. 77 is a view of anchor oranchor screw584 disposed at the distal end of atension member582.Screw584 unlike the anchor pads ofFIG. 72-76 does not have to pass through the heart wall to securetension member582 in place. Rather,anchor584 has a corkscrew or auger shape.Screw584 is anchored to the myocardium by rotatingtension member582 while advancinganchor584 into the myocardium.
• FIG. 78 is a view of yet another embodiment ofanchor pad612 disposed on an end of atension member610.Pad612 is preferably a fabric such as dacron or PTFE. A fast acting adhesive can securepad612 to the heart wall as shown. The adhesive can be, for example, cyanoacrylate. The adhesive can be triggered by reaction with the heart wall tissue, be pressure sensor, be activated by an accelerator or energy source.
• FIG. 79 is a cross section of a portion of left ventricle B similar to that shown inFIG. 72-78 except that the epicardium I is shown. The device ofFIG. 79 includes atubular tension member592 including an anchor or anepicardial jaw anchor594 disposed at its distal end.Jaw anchor594 is connected to a wire or line disposed through the lumen oftension member592. Thejaw anchor594 is biased to open when unrestrained by the distal end oftension member592. Ifwire596 is pulled proximally,jaws594 will engage the distal end oftension member592 tending to closeanchor jaws594, by a mechanism similar to that of the device ofFIG. 51, except thatanchor jaws594 are not intended to cut but rather grip.
• It should be noted that not only can the anchors and anchor pads ofFIGS. 72-79 be advantageously employed when one of the ends of the tension member extending outside the heart will not be directly accessible to deploy a pad thereon, but also where neither end of the tension member will be accessible to place a pad thereon. In such an instance, two tension members having anchors or anchor pads as shown inFIGS. 72-79 can be placed through an apical approach similarly to how guidemembers270 and271 were placed inFIG. 41. Once the anchors or anchor pads are deployed, however, the two tension members are preferably connected to form effectively a single tension member.
• FIG. 80 is a vertical cross sectional view of the left ventricle B of heart A having apex D. For purposes of illustrating the deployment of two tension members and anchors or anchor pads without direct access to the distal ends of the tension members, outside the heart, for placement of the pads thereon, twotension members532 havingballoons536 disposed at their distal ends are shown placed on left ventricle B. It can be appreciated thattension members532 andballoons536 can be placed on the heart in a manner similar to guidemembers270 and271 ofFIG. 41. Thencatheter tube600 can be advanced overtension members532.Tension members532 can then be drawn proximally to reduce the distance betweenpads536 to create either a full cycle or restrictive splint.
• FIG. 81 is the same cross sectional view asFIG. 80 except thatcatheter600 has been removed from chamber B and atension member fastener602 has been placed to interconnecttension members532.Fastener602 can be formed from a disc similar to pad382 ofFIG. 49, but form with an additional tensionmember receiving aperture390. To placefastener602,fastener602 can be advanced throughcatheter600 overtension members532 by an elongate spreader. The spreader can be removed andfastener602 clamped totension members532. Then thecatheter600 can be removed to obtain the configuration shown inFIG. 80. It should also be noted that prior to removingcatheter600,tension member cutter420 ofFIG. 1 could be advanced over the tension members to remove the excess length shown extending through apex D.
• It can be appreciated that the method ofFIGS. 80 and 81 can be preformed open chest or less invasively. When preformed less invasively, an anterior access port is preferably used. In addition to performing the methods ofFIGS. 80 and 81 by way of apex D, access could be gained to left ventricle B by way of the aortic valve or mitral valve as described above.
• The effective length of the tension member betweenanchor pads536 can be determined by knowing the overall length of each tension member and the length ofcatheter600. The effective length of the tension member will be the sum of the lengths of the tension members less two times the length ofcatheter600 and less the length of each tension member extending proximally fromcatheter600 when the distal end ofcatheter600 abutsfastener602. Ifpads536 were made from echogenic or radiopaque material the effective length of the tension could be estimated by echo imaging or fluoroscopic techniques. It can also be appreciated that the length of the tension member can be measured directly be advancing a measuring device into chamber B.
• Numerous characteristics and advantages of the invention covered by this document have been set forth in the foregoing description. It will be understood, however, that this disclosure is, in many respects, only illustrative. Changes may be made in details, particularly in matters of shape, size and ordering of steps without exceeding the scope of the invention. The invention's scope is, of course, defined in the language in which the appended claims are expressed.

Claims (7)

1-13. (canceled)

14. A method for placing on a diseased heart a device including a tether having two ends, said method comprising the steps:

passing the tether along a predetermined line of approximate placement position on the heart of the device,

attaching a first portion of the device to one end of the tether,

pulling a first portion of the device into approximate placement position with the tether,

attaching a second portion of the device to the second end of the tether,

sliding the second portion along the tether and placing the second portion of the device into approximate placement position abutting said first portion, and

connecting the two portions to one another.

15. A method according toclaim 14, further comprising the step of passing the tether and a portion of the device through an opening in a pericardial reflection of the heart.

16. A method for placing on a diseased heart a device including a tether having two ends, said method comprising the steps:

passing a tether having two ends along a predetermined line of approximate placement on the heart of the device,

sliding a sheath over the tether,

attaching one end of the sheath and one end of the tether to a first portion of the device,

pulling the first portion of the device into approximate placement position on the heart,

disconnecting the sheath and sliding the sheath off the tether,

attaching a second portion of the device to the tether,

sliding the second portion along the tether and placing the second portion of the device into approximate placement position, and

connecting the two portions to one another.

17. A method according toclaim 16, further comprising the step of passing the tether, sheath and a portion of the device through an opening in a pericardial reflection of the heart.

18. A method for placing a device in a diseased heart, the device including a first automatically reversibly collapsible anchor and a first tether attached thereto, and a second automatically reversibly collapsible anchor and a second tether attached thereto, said method comprising the steps:

passing a sheath through a lumen into an interior portion of a chamber of the heart,

sliding the first collapsible portion in a collapsed position through the sheath and through a first predetermined portion of a wall of the chamber and causing the first collapsible anchor to expand,

sliding the second collapsible portion in a collapsed position through the sheath and through a second predetermined portion of a wall of the chamber and causing the second collapsible anchor to expand, and

connecting a free end of the first tether to a free end of the second tether.

19. A method for introducing a transventricular tension member between substantially opposing walls of a heart chamber and anchor members on each end thereof, the anchor members being expandable from a compressed configuration in which the anchor is confined to a relatively small diameter to an expanded configuration in which one end of the anchor is expanded to a relatively larger diameter including a relatively planar surface, and the anchor member is attachable to a tension member extending away therefrom, said method comprising the steps:

endoluminally introducing a first anchor into an interior of the chamber in the compressed configuration and causing the first anchor to pass through a wall of the chamber to the exterior thereof,

causing the first anchor to expand to its expanded configuration with the planar surface resting against an exterior surface of the chamber wall,

endoluminally introducing a second anchor into an interior of the chamber in a compressed configuration and causing the second anchor to pass through a wall of the chamber to the exterior thereof,

causing the second anchor to expand to its expanded configuration with the planar surface resting against an exterior surface of the chamber wall, and

connecting the first and second anchors to a tension member.

Images