Patent Publication Number: US-2022225950-A1

Title: Catheter and diagnostic method

Description:
CROSS-REFERENCES TO RELATED APPLICATIONS 
     This application is a continuation of International Application No. PCT/JP2020/030338 filed on Aug. 7, 2020, which claims priority to Japanese Application No. 2019-148492 filed on Aug. 13, 2019, the entire content of both of which is incorporated herein by reference. 
    
    
     FIELD OF THE DISCLOSOURE 
     The present disclosure generally relates to a catheter and a diagnostic method. 
     BACKGROUND DISCUSSION 
     A catheter includes a hollow shaft including a distal end and a proximal end, and a hand-side unit (i.e., proximal side unit) such as a hub that is provided at the proximal end of the shaft. An operator disposes the distal end of the shaft to a position and an orientation as a target, while changing a position or an orientation of the distal end of the shaft by a forward, backward, or rotational operation of the hand-side unit if necessary inside the body of a patient under the radiopaque. 
     In catheters, a radiopaque marker is attached to a shaft in order to allow a position and an orientation of the catheter in a blood vessel to be observed through an angiogram. 
     Examples of the structure including the radiopaque marker can include a structure in which a tubular distal tip including metal powders having a radiopaque property such as tungsten and resin being mixed together is attached to a distal end of a shaft, and a structure in which a tubular marker including an iridium alloy is fixed to a balloon inner tube shaft including a guide wire lumen of a balloon catheter. 
     When the distal tip or the tubular marker each having a cylindrical shape is attached to a distal end of a hollow shaft having a circular cross-section so as to be coaxial with the center of the shaft, the shaft and the tubular marker or the like become left-right symmetrical with a symmetrical plane passing through the center of the shaft. In other words, the tubular marker or the like and the shaft have a symmetrical shape that is left-right symmetrical with respect to a so-called longitudinal section. 
     Accordingly, even when a hand-side unit is turned about the center of the shaft as a rotation axis in the blood vessel, and the incident direction of X-rays is changed such that an X-ray source of an radiopaque device goes around a patient, an angiogram of the distal tip or the pipe marker having a simple cylindrical shape does not change, and no difference occurs. 
     For example, in a case where a portion of the shaft in the vicinity of the distal end is bent in a dogleg shape, in a case where a plane made by the shaped portion of the distal end of the shaft and the X-ray incident direction are parallel to each other, it can be difficult to determine whether an opening portion that is present at the distal end of the shaft of the catheter faces an orientation moving closer to the operator or moving away from the operator for a short time in some cases. 
     SUMMARY 
     In accordance with an one embodiment, ( 1 ) a catheter is disclosed, which includes a hollow shaft including a distal end and a proximal end, a hand-side unit provided to the proximal end of the shaft, and a catheter marker having a radiopaque property; the shaft includes at least one symmetrical plane; the catheter marker includes a first marker and a second marker; the first marker and the second marker have different shapes, and are arranged to the shaft by being spaced from each other; and the catheter marker has a left-right asymmetrical shape with respect to the symmetrical plane. 
     ( 2 ) The catheter may be the catheter according to the abovementioned ( 1 ), in which the catheter marker includes at least one among a welding point of metal wires, an overlapping portion of metal wires that forms a reinforcement body, and a catheter opening portion that contains an radiopaque agent. 
     ( 3 ) The catheter may be the catheter according to the abovementioned ( 1 ), in which the catheter marker forms at least three angiograms having different shapes depending on an incident direction of X-rays. 
     ( 4 ) The catheter may be the catheter according to the abovementioned ( 1 ) in which at least one of the first marker and the second marker has a left-right asymmetrical shape with respect to the symmetrical plane. 
     ( 5 ) A diagnostic method of a distal end orientation of a catheter inside a body of a patient is disclosed, the diagnostic method includes: preparing the catheter that includes a hollow shaft including a distal end and a proximal end, a hand-side unit provided to the proximal end of the shaft, and a catheter marker having a radiopaque property, the shaft includes at least one symmetrical plane, the catheter marker includes a first marker and a second marker, the first marker and the second marker have different shapes, and are arranged to the shaft by being spaced from each other, and the catheter marker has a left-right asymmetrical shape with respect to the symmetrical plane; and determining the distal end orientation of the catheter from angiograms having different shapes depending on an incident direction of X-rays. 
     In accordance with a further embodiment, a catheter is disclosed, comprising: a hollow elongated shaft including a distal end and a proximal end; a catheter marker having a radiopaque property, the catheter marker including a first marker and a second marker each having a different shape, and the first marker and the second marker being spaced apart from each other; and wherein the catheter marker has a left-right asymmetrical shape with respect to a symmetrical plane of the hollow elongated shaft. 
     The catheter according to the disclosure, the shape of the catheter marker is left-right asymmetrical with respect to the shaft including a symmetrical plane that is left-right symmetrical, so that angiograms having different shapes depending on the incident direction of X-rays are formed. 
     Accordingly, when the hand-side unit is turned using the center of the shaft as the rotation axis to rotate the shaft, the shape of the angiograms of the catheter marker changes. Therefore, the operator can identify for a short time an orientation of the distal end portion of the shaft in the blood vessel. 
     Moreover, the catheter can attain rather easy recognition of the distal end orientation of the catheter and easy selection determination in a tortuous portion or a bifurcated portion, so that the catheter can rather easily reach a lesion area along a guide wire to shorten the surgery time, thereby allowing the reduction in the burden of a patient, and the reduction in labor costs. 
    
    
     
       BRIEF DESCRIPTION OF THE DRAWINGS 
         FIGS. 1A to 1D  are planar perspective views in which a distal end portion of a shaft in a first embodiment according to the invention is stepwisely rotated in a clockwise direction viewed from a proximal end:  FIG. 1A  illustrates a state at 0°;  FIG. 1B  illustrates a state where the distal end portion of the shaft is rotated by 90°,  FIG. 1C  illustrates a state rotated by 180°; and  FIG. 1D  illustrates a state rotated by 270°. 
         FIGS. 2A to 2E  are views illustrating a distal end portion of a shaft in a second embodiment according to the disclosure:  FIG. 2A  is a planar perspective view illustrating a state at 0°;  FIG. 2B  is a planar perspective view illustrating a state where the distal end portion of the shaft is rotated by 90° in a clockwise direction viewed from a proximal side;  FIG. 2C  is a planar perspective view illustrating a state rotated by 180°;  FIG. 2D  is a planar perspective view illustrating a state rotated by 270°; and  FIG. 2E  is a perspective view. 
         FIGS. 3A to 3C  are views illustrating the distal end portion of the shaft:  FIG. 3A  is a planar perspective view of the distal end portion of the shaft;  FIG. 3B  is a planar perspective view of the shaft viewed from obliquely above at the proximal side; and  FIG. 3C  is a planar perspective view of the shaft viewed from obliquely above at a distal side. 
         FIGS. 4A to 4E  are views illustrating a rapid exchange type (RX) catheter in a third embodiment according to the disclosure: ( FIG. 4A  is a planar perspective view under the radiopaque;  FIG. 4B  is a planar perspective view illustrating a state where the shaft is rotated by 90° in a clockwise direction viewed from a proximal end;  FIG. 4C  is a planar perspective view illustrating a state rotated by 180°; and  FIG. 4D  is a planar perspective view illustrating a state rotated by 270°; and  FIG. 4E  is a vertical cross-sectional view in the vicinity of a symmetrical plane of a proximal side guide wire opening portion of the shaft. 
     
    
    
     DETAILED DESCRIPTION 
     Set forth below with reference to the accompanying drawings is a detailed description of embodiments of a catheter and a diagnostic method. Note that since embodiments described below are preferred specific examples of the present disclosure, although various technically preferable limitations are given, the scope of the present disclosure is not limited to the embodiments unless otherwise specified in the following descriptions. Note that, the size ratios in the drawings may be exaggerated for convenience of explanation, and may be different from the actual ratios in some cases. 
     Note that, a symmetrical plane in which a surface shape of a shaft becomes left-right symmetrical (plane symmetrical) corresponds to any longitudinal section that passes through the centerline serving as a long axis in a case of a catheter having a simple cylindrical shape, or a longitudinal section in which the surface shape of the shaft is left-right symmetrical, in a case of a complicated structure including two lumens. 
     In the case of the cylindrical shape, the number of the symmetrical planes passing through the center of the shaft becomes infinite, and the same applies to a distal end taper of the shaft. Alternatively, a shaft in which a distal end opening portion is obliquely cut, or a shaft having a double lumen structure of including both of a guide wire lumen and an inflation lumen includes at least one symmetrical plane. 
     A shaft  200  of a catheter according to a first embodiment illustrated in  FIGS. 1A to 1D  includes an outer layer and an inner layer, and a braid  4  is arranged between the outer layer and the inner layer. The braid  4  being metal wires that are woven together as a reinforcement body. 
     An radiopaque metal wire  3 , which is a different metal wire, for example, gold, is coil-wound around an outer side of the braid  4  to form a coil marker, which serves as a first marker  1 . Further, the braid  4  can be cut out, and uses a welding portion  10  generated when an intersection portion of the braids  4  is welded, as a second marker  2 . 
     Materials for the braid  4  may be, for example, tungsten or a stainless steel wire, and the thickness of the wires of the braid  4  is not specifically limited, for example, the wires of the braid  4  can have a diameter of 5 μm to 100 μm, for example, 15 μm to 60 μm. The cross-section of the wires of the braid  4  can be circular, and may be elliptical, rectangular, or oval. 
     As the woven structure of metal wires, a single wire as one of the metal wires and two multiple wires as the other of the metal wires may be crossed and woven together, or single wires or multiple wires may be crossed and woven together. In addition, one of the wires and the other of the metal wires may have different thicknesses or different materials, respectively. 
     The first marker  1  can be a coil marker, which includes a distal side cut plane  3 A and a proximal side cut plane  3 B, and includes a centerline A, which is a longitudinal axis (i.e., long axis) of the shaft  200 , and the shape of the coil marker (i.e., first marker  1 ) is left-right asymmetrical with respect to a symmetrical plane AA to which a surface shape of the shaft  200  is left-right symmetrical. 
     An angiogram of the three-dimensional coil marker is projected on a plane of an X-ray detector, the shape of which is left-right asymmetrical with respect to the center A of the shaft  200 . 
     A distance from a distal end of the welding portion  10  to a distal end of the distal side cut plane  3 A may be determined, for example, as appropriate, and exceeds 0 and equal to or less than 1 mm, more preferably 0.1 mm to 0.5 mm when the outer diameter of the catheter is equal to or less than 1 mm. 
     In catheter marker  100 , the first marker  1  and the second marker  2  are combined to cause the catheter marker  100  have a left-right asymmetrical shape with respect to the symmetrical plane AA. 
     An angiogram of the three-dimensional catheter marker  100  is projected on the plane of the X-ray detector, similarly, as illustrated in  FIGS. 1B and 1D , the shape of which is left-right asymmetrical with respect to the symmetrical plane AA. 
     When the shaft  200  is rotated using the centerline A of the shaft  200  as a rotation axis while turning the hand-side unit, the shape of the catheter marker  100  is seen by being changed viewed from an observer who observes the angiogram. Similarly, the shape of the angiogram of the catheter marker  100  is changed by the rotation of the shaft  200 . 
     Accordingly, an orientation of a distal end portion of the shaft  200  can be identified with the change in the shape of the angiogram of the catheter marker  100 . 
     With the catheter marker  100  formed by the first marker  1  and the second marker  2  in this manner, as illustrated in  FIG. 1A ,  FIG. 1B  in which the shaft  200  is rotated by 90° in a clockwise direction viewed from the proximal side,  FIG. 1C  rotated by 180°, and  FIG. 1D  rotated by 270°, the shapes of the angiogram of the catheter marker  100  are different from one another. 
     Specially, in a case where a plane made by the shape of the distal end portion of the shaft  200  and a base portion of the shaft  200  is parallel to an incident direction of X-rays, specifically in  FIG. 1B  and  FIG. 1D , the distal end orientation of the shaft  200  can be difficult to be identified for a short time only from the angiogram of the shaft  200 . 
     However, when the shapes of the first coil marker  1  are compared, both of the distal end  3 A and the proximal end  3 B of the gold wire  3  can be visually recognized in  FIG. 1B , whereas neither the distal end  3 A nor the proximal end  3 B is hidden in the gold wire  3  in  FIG. 1D , and thus the distal end  3 A and the proximal end  3 B of the gold wire  3  can be visually recognized in  FIG. 1D . 
     Accordingly, it is possible to identify for a short time whether a distal end orientation of a distal end of the shaft  200 , specifically, of a distal end opening portion of the catheter is an orientation in  FIG. 1B  moving closer to the operator (i.e., proximally) or an orientation in  FIG. 1D  moving away from the operator (i.e., distally). 
     In addition, when  FIG. 1A  and  FIG. 1C  in which the shaft  200  is rotated by 180° are compared with each other, positions and relative sizes of the distal end and the proximal end of the first marker  1  with respect to the second marker  2  are different from each other. 
     In this manner, with the catheter marker  100  having a left-right asymmetrical shape with respect to the symmetrical plane AA, the incident direction of X-rays is changed, for example, the hand-side unit is turned using the centerline A of the shaft  200  as the rotation axis, at least four angiograms having different shapes can be obtained on the basis of the shapes of the catheter marker  100 . 
     Accordingly, the orientation of the distal end portion of the shaft  200  can be identified for a short time due to the difference in the shape of the angiogram of the catheter marker  100 . 
     Alternatively, the motion of the hand-side unit and an angiogram are recorded, and the orientation of the distal end portion of the shaft  200  may be determined using the data with the image recognition by artificial intelligence, which can be preferable, for example, in a case of a relatively thin catheter, such as a micro catheter, the diameter of which can be equal to or less than 1 mm, and the orientation of which is difficult to be determined by the naked eye. 
     In a second embodiment, a shaft  200 A includes AA 1  as a symmetrical plane, as illustrated in  FIG. 2E . 
     The shaft  200 A includes an inner layer and an outer layer, and a reinforcement body including a coil wire  5  that is disposed between the inner layer and the outer layer, and when the coil wire  5  is wound in an overlapped manner, the coil wire  5  becomes left-right asymmetrical with respect to the symmetrical plane AA 1  of the shaft. 
     The cross-sectional shape of the coil wire  5  may be circular, elliptical, rectangular, or oval, and the material of the coil wire  5  may be a stainless steel wire and the like. When the cross-sectional shape of the coil wire  5  is rectangular, the width can be, for example, 10 μm to 500 μm, preferably 100 μm to 300 μm, and the thickness is 5 μm to 200 μm, preferably 15 μm to 100 μm. 
     The manufacturer forms the coil wire  5  by coil-winding a plate metal wire made of stainless steel as a reinforcement body on the outer side of inner layer resin coated on a mandrel. 
     The coil wire  5  is wound around the outer side of the inner layer resin from a coil wire end portion  5 A toward a distal side of the shaft  200 A. After the coil wire  5  has been wound to a prescribed position that serves as a coil wire distal end  5 B, the coil wire  5  is wound while being overlapped continuously to the outer side of the wound coil wire  5  (outer side in a radial direction of the shaft  200 A) toward the proximal side. 
     The coil wire end portion  5 A is pressed down by the coil wire  5  wound on the outer side in an overlapped manner. 
     After the coil wire  5  has been wound to the shaft proximal end, the outer side of the reinforcement body formed by the coil wire  5  is coated with outer layer resin, so that the coil wire  5  is fixed by being sandwiched between the resin of the inner layer and the resin of the outer layer, and can be prevented from spreading out (i.e., the coil loosening and the diameter of the coil increasing). The method of winding the coil wire  5  may be determined as appropriate, regardless of this order. 
     The coil wire end portion  5 A may be at a further proximal side than the coil wire distal end  5 B, and the position from the coil wire distal end  5 B to the coil wire end portion  5 A can be, for example, preferably equal to or less than  10  winding of the coil wire, more preferably equal to or less than  5  winding, which results in rather easy manufacturing. 
     When the outer diameter of the catheter, for example, is 2 mm to 3 mm, a distance from the coil wire distal end  5 B to the coil wire end portion  5 A is preferably 1 mm to 10 mm, more preferably 3 mm to 6 mm. 
     Moreover, as illustrated in  FIG. 2A , the two coil wires  5  are overlapped to increase the radiopaque property, and the two coil wires  5  can be used as a marker. 
     A catheter marker  100 A formed by overlapping the coil wires  5  with each other includes a first marker  1 A formed by overlapping the coil wire end portion  5 A at the most proximal side and the coil wires  5  with each other, and a second marker  2 A in which the coil wires  5  are overlapped with each other at the further distal side than the first marker  1 A. 
     As illustrated in  FIG. 2A , the length and the angle when the coil wires cross each other are different between the first marker  1 A and the second marker  2 A, so that the first marker  1 A and the second marker  2 A have different shapes. 
     In  FIGS. 2A to 2E , five portions in which the coil wires  5  are brought into direct contact and overlapped with each other (portions in which the coil wires are overlapped with each other in the radial direction of the shaft  200 A) are formed, so that another overlapping portion may be used as the second marker  2 A, or all the overlapping portions other than the first marker  1 A may be used as the second markers  2 A. 
     The first marker  1 A and the second marker  2 A become left-right asymmetrical with respect to the symmetrical plane AA 1  having a shaft centerline A 1 . 
     In addition, the angiogram varies depending on the incident direction of X-rays to the shaft  200 A. 
     Specially, portions illustrated by black coating, in each of the coil wire wound in the inner side and the coil wire wound in the outer side, a hand-side marker in  FIGS. 2A to 2E  and a back-side marker are overlapped with each other in the drawings, are seen that the four coil wires  5  are overlapped. Therefore, on the angiogram, a high radiopaque property region  6  having a higher radiopaque property can be formed. 
     In  FIG. 2A , the high radiopaque property regions  6  are disposed on both ends of the shaft  200 A. In  FIG. 2B  in which the shaft  200 A is rotated by 90° in a clockwise direction viewed from the proximal side, the high radiopaque property regions  6  can be seen with the larger area. In  FIG. 2C  in which the shaft  200 A is further rotated by 90°, in other words, rotated by 180° with respect to the state in FIG.  2 A, on the other hand, the area of the high radiopaque property regions  6  becomes smaller. In  FIG. 2D  in which the shaft  200 A is further rotated by 90°, rotated by 270° with respect to the state in  FIG. 2A , the area and the number of the high radiopaque property regions  6  are increased. 
     The angiogram with the catheter marker  100 A in  FIGS. 2A to 2D  have different shapes, respectively. When a hand-side unit of the catheter marker  100 A is turned or the X-ray source is turned, the incident direction of X-rays with respect to the shaft  200 A changes, so that at least four angiograms having different shapes of the catheter marker  100 A can be obtained. 
     As describe above, the catheter marker  100 A has a left-right asymmetrical shape with respect to the symmetrical plane AA 1  to which the shaft  200 A is left-right symmetrical. Therefore, by turning the hand-side unit of the shaft  200 A, at least four angiograms having different shapes can be obtained based on the shapes of the catheter marker  100 A. 
     Therefore, the operator can identify the distal end orientation of the shaft  200 A for a short time due to the difference in the shapes of the angiogram of the catheter marker  100 A. 
     Alternatively, in order to identify a distal end position of the shaft  200 A, a resin tip having a high radiopaque property on the shaft distal end may be used as a different marker  101 . 
     Moreover, as in  FIGS. 3A to 3C , with respect to  FIG. 3A  in which the coil wire end portion  5 A is viewed from directly above (direction perpendicular to the shaft centerline A 1 ), in  FIG. 3B  in which the coil wire end portion  5 A is viewed from obliquely above at the shaft base portion side and in  FIG. 3C  viewed from obliquely above at the shaft distal side, an overlap between the hand-side coil wire and the back-side coil wire of the shaft  200 A changes. 
     Specifically, in  FIG. 3A , high radiopaque regions  6 A and  6 B formed by overlapping four middle coil wires  5  are present, whereas, in  FIG. 3B , the high radiopaque regions  6 A and  6 B disappear, and a high radiopaque region  6 C is newly formed. Meanwhile, in  FIG. 3C , the high radiopaque region  6  disappears. 
     In this case, not only the shape but also the shade of the coil wire  5  in the angiogram changes. Depending on the relative position and/or size of the first marker  1 A and the second marker  2 B, based on the shapes of the catheter marker  100 A, different angiograms having at least three shapes can be obtained. 
     Accordingly, the operator can identify for a short time, due to the change in the shape of the angiogram of the catheter marker  100 A, whether the distal end portion of the shaft faces an orientation moving closer to or moving away from the operator. 
     As a third embodiment, a catheter in which a catheter marker is arranged to a rapid exchange (RX) type catheter will be described. 
       FIG. 4E  is a cross-sectional view by a symmetrical plane AA 2  of a proximal-side guide wire opening portion  201  (catheter opening portion) of a guide wire lumen  211  of the RX catheter, which is used in a balloon catheter or a stent delivery catheter, for example. 
     A shaft  200 B includes the guide wire lumen  211  and an inflation lumen  223 , and has a left-right symmetrical shape with respect to the symmetrical plane AA 2 . 
     The shaft  200 B includes a distal end guide wire shaft  210  at the distal side that forms the guide wire lumen  211 . Resin containing radiopaque powders is disposed to the proximal-side guide wire opening portion  201  of the distal end guide wire shaft  210  of the shaft  200 B to form a first marker  1 B. In addition, in the inflation lumen  223  that extends from a proximal side of the shaft  200 B, a proximal portion  220  that includes a metal pipe  221  with slits  222  being provided is formed. A distal end of the metal pipe  221  includes a reduced diameter portion  11  in which the diameter is reduced. 
     The second marker  2 B such as a disc-shaped iridium alloy having an radiopaque property is provided to the reduced diameter portion  11 , whereby it is possible to rather easily determine an orientation of the proximal-side guide wire opening portion  201  of the guide wire shaft  210 . A plurality of second markers  2 B, the respective shapes and lengths of which are varied, may preferably be provided, alternatively, the plurality of second markers  2 B may have the same shape such as an elliptical or oval shape and be provided to different positions and at different angles with respect to the symmetrical plane AA 2 . 
     When the outer diameter of the catheter is from 1 to equal to or less than 2 mm, a shortest distance between the first marker  1 B and the second marker  2 B closest to the first marker  1 B can be, for example, equal to or more than 0 mm and equal to or less than 10 mm, more preferably 0.1 mm to 5 mm in the long axis (i.e., longitudinal axis) direction, as illustrated in  FIG. 4B , and in a top view  FIG. 4C , equal to or more than 0 mm and equal to or less than 1.5 mm, more preferably 0.1 mm to 1 mm, in a vertical direction (i.e., transverse direction) with respect to the long axis (i.e., longitudinal axis). 
     In the third embodiment, two elliptical-shaped markers having the same shape are arranged as the second markers  2 B at positions left-right asymmetrical with respect to the symmetrical plane AA 2 . 
     The first marker  1 B and the second marker  2 B in the proximal-side guide wire opening portion  201  of the shaft  210  have different shapes, and are arranged so as to be spaced from each other to form a catheter marker  100 B. 
     Accordingly, when an operator turns a hand-side unit of the RX catheter to rotate the shaft, as illustrated in  FIGS. 4A to 4D , the operator can obtain at least four angiograms having different shapes of the catheter marker  100 B, and can determine an orientation of the proximal-side guide wire opening portion  201  of the shaft, and a distal end orientation of the corresponding shaft  200 B. 
     Therefore, the operator can grasp the orientation of the catheter and cause the catheter to follow the guide wire and pass through a bifurcated blood vessel of the coronary artery, a tortuous blood vessel of the hepatic artery, or a branched blood vessel of the lower limb artery. 
     In the above, the present disclosure has been described with the preferred embodiments, however, the present disclosure is not limited to the embodiments, and it is needless to say that various modifications are possible without deviating from the scope of the disclosure. 
     For example, in the second embodiment, the orientation of the catheter may be determined due to the change in the shape of the portion where metal wires are not overlapped with each other or the gap where no metal wire is present, not the marker portion that is formed by metal wires having an radiopaque property. The arrangement of the markers so as to be spaced from each other may include the arrangement as in  FIGS. 3A-3C  in which the markers are spaced by a distance that allows the shapes thereof to change depending on the direction from which the markers are seen, or may be the arrangement as in  FIGS. 1A to 1D  in which the markers are arranged so as to be close to each other. Alternatively, the arrangement in which the marker are seen as being spaced from each other under the radiopaque, the arrangement in which the marker are seen as being overlapped with each other in the irradiation direction of the X-rays may be employed. 
     The detailed description above describes embodiments of a catheter and diagnostic method. The invention is not limited, however, to the precise embodiments and variations described. Various changes, modifications and equivalents may occur to one skilled in the art without departing from the spirit and scope of the invention as defined in the accompanying claims. It is expressly intended that all such changes, modifications and equivalents which fall within the scope of the claims are embraced by the claims.