1. Field of the Technology
The disclosure relates to the field of introducers for delivering pacing leads and catheters into the heart, and more particularly into the coronary sinus of the heart with the access point being from the right subclavian vein (alternatively the right axillary or right cephalic vein), and subsequently being removed from the vein without dislodging the lead(s) or catheter(s) delivered through the introducer.
2. Description of the Prior Art
It is a routine procedure to provide access and delivery of pacing leads and catheters into the heart from the left subclavian vein, left axillary vein, or left cephalic vein for placement of devices into the right atrium, right ventricle or coronary sinus vein. It is also common to access the heart from the right subclavian vein when left sided access is not practical.
The problem of the prior art is to provide a cardiac introducer which can reliably and easily deliver pacing leads and catheters into the coronary sinus of the heart, from the right side (preferably from the right subclavian vein, or alternatively the right axillary or right cephalic vein), and subsequently removed without dislodging a permanent pacing lead delivered through the introducer. The distal end of a conventional left-side introducer 18 as shown in
An additional problem is that the junction in many, if not most, patients between the right subclavian vein and the superior vena cava can approach that of a right angle. A straight introducer or catheter being inserted through this vascular junction can then easily be kinked, which renders it subsequent use as a telescopic introducer impractical or impossible.
Further, introducers which are employed for inserting a catheter or inner introducer into the right atrium through the right subclavian vein should have a J shaped distal portion with sufficient curvature to direct the catheter or inner introducer toward the coronary ostium in order to facilitate implantation of a cardiac catheter into the coronary sinus. As the conventional introducer is removed from the pacemaker lead the bias built into the curvature of the steerable introducer in combination with the typical curvatures encountered in the human right subclavian-to-superior-vena-cava path are such that the introducer is unavoidably torqued or rotates. The rotation is actually impulsive and the distal end of the conventional introducer flips in a sudden unavoidable rotation as the curved introducer is pulled through the right subclavian-to-superior-vena-cava junction. This in turn causes the pacemaker lead, which has been implanted into the coronary ostium or coronary sinus, to pull out at least to some degree so that the intended implanted position is lost.
A right sided introducer to the coronary sinus was previously developed by one of the inventors in the present application and is set forth within U.S. application publication 2006/0161177. This prior art introducer had as its object, whether used alone or with a dilator or proximal outer introducer, the direct access to the coronary sinus of the heart. The prior art introducer as shown in
The prior art introducer was found to be unacceptably difficult to steer and manipulate to achieve access from the right side subclavian vein into the coronary sinus and thus was regarded as a difficult-to-use device. There was nothing in the teachings relating to the prior art introducer which lead to or gave any reason how to alter its design to gain an acceptable ability to steer and manipulate a coronary catheter to access the coronary sinus from the right side subclavian vein. In fact, it was surprising to find that elements of an unsuccessful design to provide reliable cannulation to the coronary sinus could be altered in some way to achieve successful cannulation to the coronary sinus in the manner disclosed below.
The present invention overcomes the shortcomings of the prior art with an introducer sheath curve shape that follows the right sided vasculature when introduced through the right side subclavian vein and which stops far short of the coronary ostium in the right atrium and which establishes a fulcrum point against the lateral wall of the right atrium. No attempt is made to access the coronary sinus through introducer 11. Instead a second introducer (not shown) is telescopically disposed through introducer 11 to make the final access as described below.
The illustrated embodiments of the invention also include an introducer for right side access which have a first proximal curve approximating a right angle or with a few tens of degrees of a right angle and ending ultimately in a distal reverse curve. However, the embodiments of the introducer disclosed below have a predetermined length and are shaped to have one or both of the characteristics described above, namely establishment of a fulcrum point on the lateral wall of the right atrium and/or the ability to be removed from the implanted pacemaker lead without flipping the distal end of the introducer to cause a pull back of the pacemaker lead. None of the embodiments of the introducer of the invention will by itself or with the use of a dilator or an outer proximal introducer directly cannulate the coronary sinus in any remote sense as was the object and result in the case of the prior art introducer.
The invention includes a cardiac outer introducer with a proximal and distal end. The introducer is for the insertion of a catheter through a right subclavian vein, superior vena cava and right atrium into a heart having a coronary sinus ostium, leading to a coronary sinus and having a right ventricle. The introducer includes a proximal hub or valve coupled to its proximal end with a sheath coupled to it, the introducer having a length as determined by a size of the heart to sufficiently access the superior vena cava or right atrium from the right side subclavian vein. The sheath has a first portion with a first radius of curvature extending from the proximal end of the sheath to a transition point on the sheath, and a second portion with a second radius of curvature opposite to the first radius of curvature extending from the transition point to the distal end or a straight portion extending from the transition point to the distal end. The distal end of the sheath is oriented toward the tricuspid valve or coronary sinus ostium in order to provide a launch point when inserted into the heart for the introduction of a lead or catheter into the coronary sinus through the coronary sinus ostium or into the right ventricle.
In one embodiment, the first portion of the introducer comprises two curved subportions, each with a corresponding radius of curvature of the same sense and a straight portion between the two curved subportions.
In another embodiment, the second radius of curvature of the second portion of the introducer is 0.5 to 1.5 inch (1.27-3.81 cm).
The introducer further includes a straight proximal portion that is disposed between the proximal hub and the first portion, the first portion being followed by an adjacent distal straight portion inclined relative to the straight proximal portion at an angle of 30-180°.
In another embodiment, the second portion of the introducer has a projection at its distal end inclined relative to the proximal straight portion at an angle of 0-180°.
In one specific embodiment, the introducer has a total length of 18-35 centimeters.
In yet another embodiment, the introducer has a straight portion extending from the first portion to the distal end of the sheath.
The sheath of the introducer also includes means for bending a conventionally shaped left-sided CS access catheter through the right subclavian vein, superior vena cava, and right atrium to make the left sided CS catheter capable of being manipulated as though it were placed from the left subclavian vein.
In one embodiment, the distal end of the sheath of the introducer does not cannulate or extend to the coronary ostium.
In yet another embodiment, the sheath of the introducer includes specific means for not applying a torque to a pacemaker lead or other catheter disposed through it such that, when the sheath is removed from the pacemaker lead or other catheter, the distal end of the sheath does not turn or flip causing an implanted pacemaker lead or other catheter to be pulled out of the coronary sinus or displaced from its implanted position.
The invention also provides for a cardiac outer introducer for the insertion of a catheter through a right side subclavian vein, superior vena cava and right atrium into a heart having a coronary sinus ostium leading to a coronary sinus. The introducer includes a sheath with a proximal hub or valve coupled to its proximal end, the sheath having a length extending to a distal end. The length of the sheath is determined by the size of the heart in which it is to be inserted and such that it is sufficient to access the superior vena cava or right atrium of the heart from the right side subclavian vein. The sheath itself includes at least a first curve with at least a first radius of curvature extending from the proximal end on the sheath and a second curve with a second radius of curvature opposite to the first radius of curvature extending from the first curve to a distal end of the sheath. The first curve of the sheath is shaped to follow the contour of the subclavian vein and superior vena cava when implanted into the heart. The second curve of the sheath is shaped to contact the lateral wall of the superior vena cava or right atrium when implanted into the heart so that the distal end of the sheath is oriented toward the tricuspid valve or coronary sinus ostium to provide a launch point for introduction of a catheter into the coronary sinus through the coronary sinus ostium or into a right ventricle of the heart.
In one particular embodiment, the sheath of the introducer has a length and a second curve which are arranged and configured to assist a steerable distally curved inner introducer to access the coronary ostium, through which inner introducer a pacemaker lead or catheter is telescopically disposable into the coronary sinus. The second curve of the sheath and curvature of the steerable distally curved inner introducer are such that sequential removal of neither the inner introducer nor the sheath from the pacemaker lead or catheter causes a substantial displacement of the pacemaker lead or catheter from its intended implanted position within the coronary sinus.
The invention further provides a method of using an outer sheath for right sided access to the heart of a patient, the method including disposing the sheath through the right subclavian vein, superior vena cava, and right atrium of the heart and establishing at least one fulcrum point with the sheath against a lateral surface within the superior vena cava or right atrium. The sheath is prebiased with a first radius of curvature which is positioned within the superior vena cava and prebiased with a second radius of curvature opposite to the first radius of curvature distally from the first radius of curvature. The distal end of the sheath is orientated toward the tricuspid valve or coronary sinus ostium to provide a launch point for introduction of a lead or catheter into the coronary sinus through the coronary sinus ostium or into a right ventricle.
In one embodiment, the method further includes biasing the sheath with the first and second radii of curvature prior to disposing the sheath and then inclining the first curvature of the sheath 30-180° relative to a proximal straight portion of the sheath.
In another embodiment, the method further includes biasing the sheath with the second radius of curvature opposite to the first radius of curvature and inclining the sheath at the second radius of curvature 0-180° relative to a proximal straight portion of the sheath.
In yet another embodiment, the method further includes establishing a second fulcrum point with the sheath against a lateral surface within the superior vena cava or right atrium.
In yet another embodiment, the method further includes inserting a conventionally shaped left sided CS access catheter through the sheath and manipulating the left sided CS access catheter through the right subclavian vein, superior vena cava, and right atrium as though it were placed from the left subclavian vein.
The method in another embodiment further comprises preventing the sheath from cannulating or extending to or near the coronary ostium and disposing a pacemaker lead or catheter through the sheath to access the coronary sinus through the coronary sinus ostium or to access a right ventricle. The sheath may be removed from the pacemaker lead or catheter without displacing the pacemaker lead or catheter from its intended implanted position within the coronary sinus. Furthermore, the method further includes removing the sheath from the pacemaker lead or catheter without applying a torque to the pacemaker lead or catheter or turning or flipping the distal end of the sheath.
While the apparatus and method has or will be described for the sake of grammatical fluidity with functional explanations, it is to be expressly understood that the claims, unless expressly formulated under 35 USC 112, are not to be construed as necessarily limited in any way by the construction of “means” or “steps” limitations, but are to be accorded the full scope of the meaning and equivalents of the definition provided by the claims under the judicial doctrine of equivalents, and in the case where the claims are expressly formulated under 35 USC 112 are to be accorded full statutory equivalents under 35 USC 112. The disclosure can be better visualized by turning now to the following drawings wherein like elements are referenced by like numerals.
The specification contains at least one drawing executed in color. Copies of this patent or patent application publication with color drawing(s) will be provided by the Office upon request and payment of the necessary fee.
The disclosure and its various embodiments can now be better understood by turning to the following detailed description of the preferred embodiments which are presented as illustrated examples of the embodiments defined in the claims. It is expressly understood that the embodiments as defined by the claims may be broader than the illustrated embodiments described below.
In the illustrated embodiment of
Access through the right subclavian vein is shorter though less direct than from the left side subclavian vein, with a greater curve in the right innominate vein. A conventional distal hook (90 degree curve) catheter, not shown, is then introduced through sheath 10 into the coronary sinus 6 of the heart opening into the right atrium 16 for pacemaker lead implant into the sinus system of the heart or other cardiac sinus endovascular intervention. The two stage introduction of the hook catheter from a lateral platform or launch site at the distal end of sheath 10 allows for better control of and success in implantation of the hook catheter into the coronary sinus. The directional positioning of sheath 10 in combination with the torqueable nature of the hook catheter provides the necessary combination of positioning, control and torque in the right atrium 16 to mimic the well known technique used to access the coronary sinus 6 from the left side.
Sheath 10 is curved or manufactured with a pre-bias according to the dimensions as shown in
It is also to be noted in
It is also to be noted in
It is to be understood that the term “first curve” in this specification and claims is used to include in the illustrated embodiment at least curve 34, but also can be understood to include straight portion 35, curved portion 37 and straight portion 39 or other curves in other embodiments as a compound or complex curve with not one but with corresponding multiple radii of curvature. A straight portion can be thought of as having an infinite radius of curvature. Thus, wherever the term, “first curve” is used it may include a single simple curve or a multiple number of curved and straight curves in any combination with different or the same radii of curvature. However, the “first curve” has a radius or radii of curvature which are all in the same sense, i.e. all in the same direction as contrasted with the “second curve” 14 which as a radius of curvature in a sense or direction opposite to that of the “first curve”.
It is to be understood that the prebiased ranges of shape are those profiles which introducer 11 would tend to assume if laid flatly on a planar surface without being subject to outside forces. When implanted into a heart, introducer 11 is flexible and pliable so its prebiased form will readily conform to the forces and shapes of the vascular system and heart. However, whenever the anatomy of the vascular system and heart allows introducer 11 to assume its prebiased configuration, it will tend to do so.
Sheath 10 is led into the right atrium 16 as shown in
The right sided introducer 11 or sheath 10 curves a standard shaped left sided CS access catheter in such a way that makes the CS catheter bend and be able to be manipulated as though it was being placed from the left side.
In one embodiment a second inner catheter or introducer (not shown) is telescopically disposed into sheath 10 and extends from its distal end and is directed by sheath 10 into the coronary ostium 6 of the heart. This inner introducer typically is torqueable so that it may be rotated out of plane with respect to the plane generally defined by sheath 10 to provide a means for steering and a means to accommodate varying scales of anatomies found in patients.
In general, sheath 10 as shown in
The first proximal curved portion 34 may assume other inclinations from proximal portion 20 as shown in
One of the attributes of the illustrated embodiments of the invention as shown in
It must be noted again that the illustrated embodiments of the invention comprise a sheath 10 which is not itself intended to provide direct access to the coronary sinus through the coronary ostium 6. As stated above, a second introducer deployed through sheath 10 is employed to cannulate the coronary sinus 6. This difference distinguishes sheath 10 from the embodiments of conventional introducers disclosed in the cited art, each of which is capable of accessing the coronary sinus. While the position of the second distal curve 14 for any one of the illustrated embodiments will necessarily vary in the right atrium 16 according to the anatomy of the patient in which it is deployed, its intended disposition is that shown in
It is to be understood that in the preferred embodiments the various curves and straight portions, which comprise the shape of sheath 10, smoothly transition into each other so that there are no kinks or sharp corners. In mathematical terms, this property would be defined by stating that the first derivative of the shape of sheath 10 is continuous at each point in space.
Many alterations and modifications may be made by those having ordinary skill in the art without departing from the spirit and scope of the embodiments. Therefore, it must be understood that the illustrated embodiment has been set forth only for the purposes of example and that it should not be taken as limiting the embodiments as defined by the following embodiments and its various embodiments.
For example, the scope of the invention is not limited to the embodiments illustrated in the figures, but include an application of the concept of the invention in a right sided sheath, which is adaptable to a wide range of differing scales of patient anatomy, which is highly variable and for which no closed specification could possibly include all patients. Typically, sheath 10 will have a length in the range of 18-35 cm with most embodiments in the subrange of 23-25 cm. The first proximal curved portion 34 may be inclined relative to the proximal straight portion 20 at angles in the range of 30-180 degrees. The second distal curved portion 14 may be inclined relative to the first proximal curved portion 34 at angles in the range of 0-180 degrees, with the subrange of 120-150 degrees being the most common. The angular inclination of the first proximal curved portion 34 relative to the proximal straight portion 20 is within the range of 30-180 degrees with the subrange of 150-175 degrees being most common.
Therefore, it must be understood that the illustrated embodiment has been set forth only for the purposes of example and that it should not be taken as limiting the embodiments as defined by the following claims. For example, notwithstanding the fact that the elements of a claim are set forth below in a certain combination, it must be expressly understood that the embodiments includes other combinations of fewer, more or different elements, which are disclosed in above even when not initially claimed in such combinations. A teaching that two elements are combined in a claimed combination is further to be understood as also allowing for a claimed combination in which the two elements are not combined with each other, but may be used alone or combined in other combinations. The excision of any disclosed element of the embodiments is explicitly contemplated as within the scope of the embodiments.
The words used in this specification to describe the various embodiments are to be understood not only in the sense of their commonly defined meanings, but to include by special definition in this specification structure, material or acts beyond the scope of the commonly defined meanings. Thus if an element can be understood in the context of this specification as including more than one meaning, then its use in a claim must be understood as being generic to all possible meanings supported by the specification and by the word itself.
The definitions of the words or elements of the following claims are, therefore, defined in this specification to include not only the combination of elements which are literally set forth, but all equivalent structure, material or acts for performing substantially the same function in substantially the same way to obtain substantially the same result. In this sense it is therefore contemplated that an equivalent substitution of two or more elements may be made for any one of the elements in the claims below or that a single element may be substituted for two or more elements in a claim. Although elements may be described above as acting in certain combinations and even initially claimed as such, it is to be expressly understood that one or more elements from a claimed combination can in some cases be excised from the combination and that the claimed combination may be directed to a subcombination or variation of a subcombination.
Insubstantial changes from the claimed subject matter as viewed by a person with ordinary skill in the art, now known or later devised, are expressly contemplated as being equivalently within the scope of the claims. Therefore, obvious substitutions now or later known to one with ordinary skill in the art are defined to be within the scope of the defined elements.
The claims are thus to be understood to include what is specifically illustrated and described above, what is conceptionally equivalent, what can be obviously substituted and also what essentially incorporates the essential idea of the embodiments.
The present application is related to U.S. Provisional Patent Application Ser. No. 61/440,250, filed on Feb. 7, 2011, which is incorporated herein by reference and to which priority is claimed pursuant to 35 USC 120.
Filing Document | Filing Date | Country | Kind | 371c Date |
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PCT/US12/23984 | 2/6/2012 | WO | 00 | 9/5/2013 |
Number | Date | Country | |
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61440250 | Feb 2011 | US |