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    • 专利摘要:
    BALLOON CATHETER WITH IMPROVED LOCABILITY. The present invention relates to a balloon catheter for insertion into a vessel that includes a catheter shaft and an inflatable balloon attached to the catheter shaft. The markings along a longitudinal axis of the catheter are provided on the inside of the balloon, such as by measuring a distance inside the vessel. A first distance that separates a first point from a second adjacent point may be different from a second distance that separates the second point from a third adjacent point. The markings can also be used to ensure the proper positioning of the balloon and, in particular, the work surface of the balloons, in relation to a treatment area. Related methods are also described.
    公开号:BR112015001497B1
    申请号:R112015001497-6
    申请日:2013-07-24
    公开日:2021-03-09
    发明作者:Im C. Beasley；Stephanie Klocke；Abtihal Raji-Kubba；Rob Righi
    申请人:Clearstream Technologies Limited；
    IPC主号:
    专利说明:

    [001] This application claims the benefit of US Provisional Patent Applications Nos. From Series 61 / 675,168 and 61 / 788,938, descriptions of such orders are hereby incorporated by reference. TECHNICAL FIELD
    [002] The present invention relates generally to balloon catheters for carrying out medical procedures, such as angioplasty and, more particularly, to a catheter having a predetermined part, such as a work surface, that can be precisely located or identified during use. BACKGROUND OF THE INVENTION
    [003] Catheters that include balloons are routinely used to resolve or address flow restrictions or perhaps even complete obstructions in tubular areas of the body, such as veins or arteries. In many clinical situations, restrictions are caused by hard solids, such as calcified plaque, and can sometimes involve the use of high pressures to compact such obstructions. Commercially available balloons employ complex technology to achieve high pressure requirements without sacrificing the balloon's profile. In addition to the high pressure requirements, the balloons must also be puncture-resistant, easy to follow and push, and have a low profile, especially when used for angioplasty.
    [004] In clinical practice, an angioplasty balloon 12 can be expanded from an emptied, folded state (figure 1) to an inflated, expanded state (figure 2) within a vessel to a T treatment area, such as a part of the inner circumferential wall of a blood vessel V. Inflation can be completed using an X-ray contrast agent or medium CM that fills balloon 12 at a DX height to provide better visibility under XR or other XR energy form of radiography during the intervention procedure, as illustrated in figures 3 and 4. Typically, a mixture of 70/30 percent contrast agent and saline is used to inflate the balloon during an angioplasty procedure.
    [005] In general, it is a desirable objective to reduce the inflation and deflation times necessary for balloons without sacrificing the profile of the balloons, especially for large volume balloons (which may require up to two minutes of inflation / deflation times with the contrast). Due to its relatively high viscosity, it would also be desirable to eliminate, or at least reduce the amount of the contrast agent used in the inflation / deflation of the balloons. The use of contrast agents prolongs the times of inflation / deflation and also represents the risk of iodine exposure to patients sensitive to iodine. In this respect, a non-radiopaque substance can be used instead of the contrast agent, such as, for example, saline or carbon dioxide, but such substances are invisible during X-ray imaging, and therefore do not help to locate balloon 12 in the desired manner.
    [006] In addition, the doctor who performs the angioplasty procedure must be able to accurately locate the position of the inflated balloon, so that the balloon is correctly positioned, once inflated. This is conventionally achieved by fixing marker bands on the catheter shaft that corresponds to the ends of the balloon's work surface. This "work surface" is the surface along the part of the balloon that is used to achieve the desired treatment effect, such as the contact of the calcified plaque (the surface of which in the case of a balloon having tapered or tapered sections at the proximal ends and distal is typically coextensive with a generally cylindrical drum section).
    [007] The misalignment of the marker bands during placement along the axis sometimes results in their inability to correspond exactly to the extension of the work surface, as shown in figure 5 (note the amount of misalignment X between each internal marking band that serves as M marking performed by the S axis and the working surface W of the balloon 12, which also typically includes a radiopaque tip P at the distal end). Even when exercising great care to position the marks appropriately on the underlying stem in alignment with the predicted limits of the work surface when the balloon is inflated, a tendency towards incompatibility remains due to several possible factors. One of these factors may be the stacking tolerance that arises as a consequence of affixing the balloon to the distal end of the catheter rod. The balloon also has a tendency to grow in the longitudinal direction when inflated, especially with large and particularly long balloons. Another factor is the tendency of the catheter rod part inside the balloon to bend or flex during inflation. This can lead to misalignment between the M markings attached to the S axis and the work surface W.
    [008] Whatever the cause, the resulting misalignment can prevent the doctor from accurately identifying the location of the balloon's work surface during an interventional procedure. This can lead to a geographical misalignment, or "lack", of the intended contact between the treatment area and the work surface of the balloon. It is especially desirable to avoid such a result, when the balloon is designed to release a payload (such as a drug, stent, or both) or a working element (such as a cutter, focused power cord, or the like) to a specified location within the vasculature, since a lack can prolong the procedure (such as, for example, requiring re-adaptation of the balloon or the use of another balloon catheter in the case of a drug-coated balloon).
    [009] In order to assess the length of the lesion from a location external to the body, a doctor can also use an external ruler, which in a way is called a "LeMaitre" tape. While the use of such a ruler or tape may allow a more accurate assessment of the length of the lesion and an area treated by a pre-dilation step, this is not without limitations. On the one hand, a displacement or difference in the apparent position of the lesion margins results when viewed along two different lines of vision. This "parallax" can lead to incorrect measurements and, at the very least, contribute to the geographical misalignment of the work surface in relation to the injury. The use of such an external ruler can also lead to lower measurements when the vasculature in question is particularly tortuous.
    [0010] Therefore, there is a need for a balloon so that the work surface can be identified during an interventional procedure with improved accuracy. One solution would be to take into account the possible incompatibility between fixed locations on the catheter shaft and the balloon to define the work surface. Another would be to provide a way in which to position a balloon catheter in the vasculature in a treatment area with greater precision. In general, procedural efficiency would be improved without noticeably increasing cost or complexity, and in a way that can be applied to many existing catheter technologies, without extensive modification. SUMMARY
    [0011] An objective of the invention is to provide a balloon so that the work surface can be located, during an interventional procedure with improved accuracy. Another objective is to facilitate the measurement of a location within the vasculature, such as by providing treatment during a subsequent intervention.
    [0012] According to one aspect of the invention, a balloon catheter for insertion into a vessel to treat a treatment area includes at least three radiopaque markings or markers spaced along a longitudinal axis of the catheter inside the balloon. A first distance that separates a first marker or radiopaque marker from a second adjacent marker or radiopaque marker is different from a second distance that separates the second marker or radiopaque marker from an adjacent third radiopaque marker.
    [0013] In one embodiment, a catheter rod also includes an internal tubular element forming a guidewire lumen, and the tubular element that includes at least three radiopaque markers or markings. The catheter shaft may include an external wall having at least one of the first or second markers or radiopaque markings. The at least three markers or markings can be spaced from a distal tip of the catheter.
    [0014] The first distance may be less than the second distance. The first radiopaque marker or marking may be distal to the second radiopaque marker, which can be moved away to the third radiopaque marker or marker along the longitudinal axis. The radiopaque markers or markings can be arranged in a pattern that comprises a plurality of adjacent pairs, with the adjacent pairs being alternately separated by the first and second distances. A pattern of radiopaque markers or markings may comprise adjacent radiopaque markers or markings spaced at progressively greater distances from one another from a distal point on the catheter to a proximal point on the catheter.
    [0015] In these or other modalities, the balloon includes an uninflated midpoint location and an inflated midpoint location. The catheter shaft includes at least one first radiopaque marker or marker positioned at a displacement site in relation to the uninflated midpoint site. In balloon inflation, the at least one marker or radiopaque marker aligns substantially with the inflated midpoint.
    [0016] The balloon catheter may also include a second marker or radiopaque marker corresponding to at least one end of the balloon's work surface. The second marker or radiopaque marker may be provided on the balloon, or it may be provided along a section of the balloon's end adjacent to one end of the work surface. A third marker or radiopaque marker may also be provided at a location corresponding to the other end of the work surface.
    [0017] The displacement site can be spaced from the uninflated midpoint site in a proximal or distal direction. As an example, the displacement site can be spaced from the uninflated midpoint site a distance of approximately 1 to 15% of a length between a distal end and a proximal end of the balloon in an inflated condition. However, the amount may vary, depending on the circumstances.
    [0018] The balloon catheter may also include, at least, an external radiopaque marker or marking into the balloon. The external radiopaque marker or marking can be located on the stem. An external tubular rod can form an inflation lumen for supplying an inflation fluid to the balloon, and the external radiopaque marker or marking can be located on the external tubular rod. A plurality of markers or radiopaque markings can be placed outside the interior of the balloon, and can be spaced regularly or irregularly.
    [0019] Another aspect of the description refers to a balloon catheter for insertion into a vessel to treat a treatment area, which comprises a catheter shaft and an inflatable balloon attached to the catheter shaft. At least three radiopaque markers or markings extend along a longitudinal axis of the catheter. A first amount of non-radiopaque material that separates a first marker or radiopaque label from a second marker or radiopaque label is different from (for example, having a length greater than or less than) a second quantity of non-radiopaque material that separates the second marker or radiopaque marker of a third radiopaque marker.
    [0020] In another aspect, the invention relates to a balloon catheter including, an elongated tubular rod. An inflatable balloon supported by the rod includes an uninflated midpoint location and an inflated midpoint location. The stem also includes, at least, a first marker or radiopaque marker positioned at a displacement site in relation to the uninflated midpoint site. In balloon inflation, the at least one marker or radiopaque marker aligns substantially with the inflated midpoint.
    [0021] In one embodiment, a second marker or radiopaque marker corresponds to at least one end of the balloon's work surface. The second marker or radiopaque marker may be provided on the balloon, such as along a narrowed end section of the balloon adjacent to one end of the work surface. Alternatively, the second marker or radiopaque marker may be provided on the stem at a location corresponding to a first end of the work surface. A third marker or radiopaque marker may be provided on the stem at a location corresponding to a second end of the working surface.
    [0022] Another aspect of the present invention relates to a balloon catheter having an elongated tubular rod and an inflatable balloon supported by the rod. The balloon includes a work surface that has a midpoint in an inflated condition. At least one first marker or radiopaque marker corresponds to the location of at least one end of the work surface in the inflated condition. At least a second marker or radiopaque marker corresponds to the midpoint of the work surface.
    [0023] The first marker or radiopaque marker can be located on the stem. In addition, a third marker or radiopaque marking corresponding to a second end of the work surface can also be provided. The third radiopaque marker or marking can be located on the nail, and the first radiopaque marker or marking on the balloon.
    [0024] Yet another aspect of the description refers to a balloon catheter, which comprises an elongated tubular rod and an inflatable balloon supported by the rod. The balloon includes a work surface. The first and second markers or radiopaque markings corresponding to the location of the ends of the work surface, respectively, and a third marker or radiopaque marking is positioned between the first and second markers or radiopaque markings.
    [0025] The third marker or radiopaque mark may be closer to one of the first or second markers or markings in the longitudinal direction. One or both of the first and second markers or radiopaque markings can be provided on the stem. The third marker or radiopaque marker may also be provided on the stem or balloon.
    [0026] The first marker or radiopaque marker may be closer to a proximal end of the balloon, and the third marker or radiopaque marker may be closer to the first marker or marker than the second marker. The second marker or radiopaque marker may be closer to a distal end of the balloon, and the third marker or radiopaque marker may be closer to the second marker or marker than the first marker.
    [0027] In any of the described modalities, the balloon may be non-compatible, or it may be compatible or semi-compatible. The balloon may further include a treatment, such as, for example, a drug, stent, endoprosthesis, or combinations of the above. Balloon catheters of any of the foregoing modalities may also include a guidewire to guide the balloon into the vasculature. Markers or markings in any embodiment may comprise bands formed at least partially from a radiopaque material.
    [0028] Any of the above balloon catheters can be used in combination with another balloon catheter that includes a work surface corresponding in length to the spacing of at least two or more markers or radiopaque markings. Another balloon catheter may include a treatment corresponding in length to the spacing of at least two or more radiopaque markers or markings.
    [0029] Another aspect of the present invention relates to a balloon catheter comprising an elongated tubular rod, and an inflatable balloon supported by the rod and having an interior. A plurality of first radiopaque markers or markings are provided proximal to the balloon. A plurality of second markers or radiopaque markings are provided within the interior of the balloon.
    [0030] The tubular rod may comprise an internal tubular rod, and the first radiopaque markers or markings are provided by an external tubular rod coaxial with the internal tubular rod. The first and second markers or radiopaque markings can be spaced equidistantly or non-equidistantly. The plurality of second markers or radiopaque markings may comprise at least three markers or markings.
    [0031] The invention can also be considered to relate to the use of the catheter or balloon catheters of any of the preceding claims in performing an angioplasty.
    [0032] This invention also relates to methods of using a catheter to treat a treatment area. The catheter may include an inflatable balloon carried by a rod, including at least one marker or radiopaque displacement marking from a midpoint location on the balloon in an uninflated condition. The method may comprise the step of aligning the marker or displacement radiopaque marking (which may be on the inflated balloon stem) with a central region of the treatment area. The method can also include the step of inflating the balloon so that a working surface of the balloon when inflated corresponds to the treatment area.
    [0033] Another aspect of the present invention relates to a method of measuring a distance within an individual's vessel in combination with the use of a guidewire. The method comprises providing a catheter including a balloon and at least three radiopaque markers or markings within the balloon. The method further comprises determining a distance within the vessel using the markers or markings. The determination step may include the measurement of a lesion length inside the vessel, and may be completed prior to the introduction of a catheter that includes treatment into the vessel.
    [0034] This description also describes a method of applying a therapeutic agent to a treatment area within an individual's vessel. The method comprises the steps of: providing a measurement catheter including a plurality of radiopaque markers or markings; measure a length of the treatment area using the measuring catheter; and providing a treatment balloon based on or corresponding to the measured length. The measuring catheter may comprise a balloon, and the method may further comprise inflating the balloon at the treatment site. The measurement step can be carried out before the balloon is inflated over the measurement catheter. The measurement step can be carried out subsequent to the inflation of the balloon over the measurement catheter. The method may further comprise the step of positioning the treatment balloon at the treatment site to deliver a therapeutic agent to the treatment area. The method may further include the step of providing treatment of the catheter with a balloon including a plurality of markers or radiopaque markings corresponding to the markers or markings on the measuring catheter. The treatment catheter can include a balloon that is longer than the measurement balloon.
    [0035] The present invention provides a balloon catheter comprising an elongated tubular rod including a guide wire tubular element, an inflatable balloon supported by the rod and having an interior, and a plurality of radiopaque markers along the tubular wire element -guide, both inside the balloon and along the catheter outside the balloon.
    [0036] The catheters of any of the previous modalities can be in combination with a guidewire, including during use. BRIEF DESCRIPTION OF THE DRAWINGS
    [0037] Figure 1 schematically illustrates a balloon catheter in a vessel, and figure 2 illustrates the balloon expanded in the vessel.
    [0038] Figures 3 and 4 schematically illustrate the use of fluorescence to detect the balloon including a radiopaque contrast medium.
    [0039] Figures 5 to 9 illustrate various modalities of balloon catheters.
    [0040] Figure 10 is a schematic side view partially in section showing a marker or displacement marking on a balloon catheter according to an embodiment of the invention.
    [0041] Figure 11 is a side view of the catheter in figure 10 with the marker or marking in an aligned condition.
    [0042] Figures 12 and 13 are schematic side views, partially in section, which illustrate the use of the balloon catheter of figure 10.
    [0043] Figures 14 and 15 are additional views of another embodiment of a balloon catheter according to the invention.
    [0044] Figures 16 and 17 are additional views of yet another embodiment of a balloon catheter according to the invention.
    [0045] Figures 18 and 19 are additional views of yet another embodiment of a balloon catheter according to the invention.
    [0046] Figure 20 is a schematic side view partially in section showing a pattern of a marker or marking on a balloon catheter according to an embodiment of the invention.
    [0047] Figure 21 is a schematic side view partially in section showing another version of a marker or marking pattern on a balloon catheter according to an embodiment of the invention.
    [0048] Figures 22 and 23 are schematic side views, partly in section, showing various markers or markings on a balloon catheter according to an embodiment of the invention.
    [0049] Figures 24 and 25 are schematic side views, partly in section, showing markers or markings on a balloon catheter according to an embodiment of the invention.
    [0050] Figures 26, 27 and 28 illustrate an exemplary use of a balloon catheter according to the invention. MODES FOR CARRYING OUT THE INVENTION
    [0051] The description provided below and with respect to the figures applies to all modalities, unless otherwise indicated, and the characteristics common to each modality are similarly numbered and shown.
    [0052] A catheter 10 is provided which has a distal part 11 with a balloon 12 mounted on a catheter tube 14. Referring to figures 6, 7 and 8, the balloon 12 when inflated has an intermediate section 16, or "barrel" ", and end sections 18, 20. In one embodiment, end sections 18, 20 reduce in diameter to adhere intermediate section 16 to catheter tube 14 (and thus sections 18, 20 are generally cone sections or named cones). The balloon 12 is sealed at the ends of the balloon (proximal end 15a and the distal end 15b) over the cone sections 18, 20 to allow inflation of the balloon 12, through one or more lumens of inflation 17 that extend inside the balloon. catheter tube 14 and communicates with the inside of the balloon 12.
    [0053] As noted above and can be understood with reference to figures 5 and 6, the catheter tube 14 also includes a rod S to support the balloon 12. The rod S can be a tubular, elongated rod 24 that forms a lumen of guidewire 23 which directs guidewire 26 through catheter 10, and along the distal end from which the balloon 12 can be located. The cone section 20 at the distal end 15b of the balloon 12 can be attached to this rod 24 adjacent to the tip P. The balloon 12 at the opposite end is connected to the tube 14, and is able to move relative to the rod 24 in order to to allow a degree of expansion in the longitudinal direction.
    [0054] As illustrated in figure 8, this guidewire 26 can extend through the proximal end of catheter 10 and a first hole 25 of a connector 27 within the lumen 23 to achieve an "over the wire" (OTW) arrangement , but it could also be provided in a "quick change" (RX) configuration, in which the guidewire 26 exits a side opening 14a closer to the distal end (see figure 9), or is fed through a passage associated with tip P distally from balloon 12 ("short" RX; not shown). A second orifice 29 can also be associated with catheter 10, such as via connector 27, for introducing a fluid (e.g., saline, a contrast agent, or both) into the interior compartment of the balloon 12 through of the inflation lumen 17.
    [0055] The balloon 12 may include a single or multilayer balloon wall 28 forming the interior to receive the inflation fluid. The balloon 12 can be a non-adherent balloon, having a balloon wall 28 that maintains its size and shape, in one or more directions, when the balloon is inflated. Examples of non-compatible balloons can be found in US Patent No. 6,746,425 and US Patent Application Publication Nos. 2006/0085022, 2006/0085023 and 2006/0085024, the descriptions of which are incorporated by reference. The balloon 12 may comprise PET and / or fiber reinforcements. The balloon 12, in such a case, also has a predetermined surface area, which remains substantially constant, during and after inflation, also has a predetermined length and predetermined diameter that each, or together, remains substantially constant during and after inflation. inflation (subject to a relatively small amount of longitudinal expansion (for example, up to 5%) as a result of material properties). However, balloon 12 may be semi-compatible or compatible instead, depending on the particular use. Examples of materials for compatible balloons include latex and silicone, and for semi-compatible balloons include polyamides (Nylon 11 or Nylon 12), polyamide block copolymers (Peeba), polyurethanes (Pellethane), polycarbonate thermoplastic polyurethanes (Carbothane) ).
    [0056] In order to allow greater locality during an interventional procedure, and potentially without the use of contrast media, catheter 10 may have radiopaque quality. In one embodiment, this radiopaque quality is provided in a way that allows a doctor to ensure the precise positioning of the balloon 12 and, in particular, the work surface W created on the inflation of the balloon, in a specified treatment area T. This it can be especially important in releasing a particular treatment, such as a drug or stent, through the balloon's work surface W, as described in more detail in the description below.
    [0057] In one embodiment, radiopaque quality can be achieved by one or more, at least partially, auxiliary radiopaque markers or markings associated with catheter 10. In a first embodiment, as shown in figure 10, the arrangement includes at least one marker or radiopaque M marking. This marker or M marking can take the form of a radiopaque material, such as a band 30. Band 30 can be associated with the rod 24 which passes through the interior of the balloon 12 (which is schematically illustrated in the figure 10 in the condition of folded, wrapped or inflated, to facilitate travel within the vasculature).
    [0058] The marking, such as band 30, can be positioned at an initial O location. This initial O location can be moved from a midpoint location A of balloon 12, in the condition of not inflated or involved. As illustrated, the midpoint location A is located between and away from the proximal and distal ends 15a, 15b of the balloon 12, along part of the wall of the balloon 28, when folded, which forms the section of the drum 16 when the balloon 12 is inflated.
    [0059] As shown in figure 11, the displacement location O of the marking or band 30 corresponds to the midpoint location B of the work surface W when inflated, as may be the result of the longitudinal expansion of the balloon 12 in the proximal direction C Consequently, the physician can position the inflated balloon 12 in such a way that the mark or band 30 is, at the desired mid or central point of the R region of the treatment area T (such as a lesion), however, displaced from the site midpoint of a rolled-up balloon 12, as shown in figure 12. Since the displacement site S takes into account the amount of longitudinal expansion caused by inflation, the physician is thus ensured that balloon 12, when inflated and expanded , creates the desired profile in such a way that the work surfaces W correspond to the treatment area T.
    [0060] As should be appreciated, the marking or band 30 remains on or adjacent to the central region R of the treatment area T, as it is initially placed in the uninflated condition, despite the expansion of the balloon 12 to form the work surface W and provide the desired treatment. As a result, the incidence of a possible geographical "fault" is low. This is primarily because the balloon 12 expands in the longitudinal direction in relation to its pre-positioning in the central region R of the treatment area T as a result of the displacement marking, instead of being positioned using bands of the markers that do not necessarily coincide with the extension of the working surface W of the inflated balloon (see, for example, figure 5).
    [0061] The displacement location O can be selected based on the forecast of expansion of balloon 12, in the longitudinal direction, during inflation. For example, the displacement location O can be displaced from the midpoint location A approximately 1 to 15% of the total length of the inflated or expanded balloon 12 (i.e., the distance between the distal and proximal ends 15a, 15b). This includes amounts of less than about 1%, about 2%, about 3%, about 4%, about 5%, about 6%, about 7%, about 8%, about 9%, about 10%, about 11%, about 12%, about 13%, about 14%, and about 15%. The actual amount of displacement used can be determined empirically or estimated, as based on the properties of the materials used (including, for example, the type of material, shape, size, wall thickness, thermal expansion characteristics, and the like).
    [0062] As indicated in figure 10, the displacement location O may be responsible for the expansion in the proximal direction C after inflation of the balloon 12. However, it is also possible to explain the expansion in the distal direction D, positioning the marking, as band 30, at a location distal from the midpoint location A, as shown in figure 14. Thus, as indicated in figure 15, the longitudinal expansion of the balloon 12 causes the marking or band 30 to substantially align with the midpoint location B of the work surface W in the desired manner. The positioning of the marker at the displacement location O can also be such that it takes into account the expansion in both the proximal and distal directions, C, D.
    [0063] Moving on to figures 16 and 17, it can be understood that other markers or markings can be provided on the catheter 10, such as inside the balloon 12. For example, markers or markings can be associated with the stem 24 under the in the form of bands 32, 34. These bands 32 can be formed at least partially from a radiopaque material. Bands 30, 32 indicate the locations initially E, F adjacent to proximal and distal ends 15a, 15b of balloon 12, in the condition of not inflated, and thus assist the physician in understanding the relative location of the distal and proximal ends 15a, 15b of balloon 12. The marking, like the band 30, at the displacement site O is therefore used to position the balloon 12 in connection with the other markers or markings (for example, bands 32, 34) before inflation , but the expansion is such that the midpoint location B of the work surface W corresponds to the location of band 30 in inflation.
    [0064] Thus, as can be appreciated, at least three markers or markings are present in this modality, as are bands 30, 32, 34, and whose markers or markings are not spaced equidistantly in the longitudinal direction. For example, in the illustrated embodiment, band 30 is narrower for the proximal band 32 than the distal band 34. In other words, the non-radiopaque part that separates a pair of markers or markings is larger or smaller than the non-radiopaque material. that separates the other pair of markers or markings. Despite this irregular spacing, all three markers or markings in the illustrated mode remain inside the inner compartment of the balloon 12 and, in particular, the part corresponding to the working surface W.
    [0065] Markers or markings can also be provided on balloon 12, in order to help determine the relative location during the procedure. For example, as shown in figures 18 and 19, the displacement marking of the midpoint location A can be provided in the form of a band 30 along axis 24, and a marking 36 can be associated with balloon 12, such as such as along the conical part or section 20 adjacent to the tip P at the distal end of the catheter 10 (but possibly at the proximal end, instead, or at both locations). Thus, as a result of the longitudinal expansion of the balloon 12 in inflation, the marking or band 30 on the rod 24 aligns with the midpoint B location of the work surface W. The marking on the balloon 12 may comprise a sheet, film , adhesive, coating, or the like applied to the surface or within one or more inner layers that form the wall of the balloon 28. In addition, such marking may also be provided on the conical part 18 of the balloon 12 to indicate the proximal end of the surface working W.
    [0066] Referring to figure 20, catheter 10 can be provided with one or more markers or M markings for use in measuring a dimension within a vessel. The M markers or markings can be radiopaque in nature, and can be applied to a tubular element inside the catheter 10, such as the guidewire tubular element 24. The M markers or markings can be applied inside the balloon 12, in order to measure a dimension of a structure, such as a lesion to be dilated, inside a vessel, as can be seen, for example, in figures 27 and 28. In one aspect, M markers or markings can act as a ruler to measure a linear distance when positioned inside the vessel.
    [0067] Figures 21 to 25 illustrate certain modalities of catheter 10 with markers or M markings arranged at different distances from each other and over various elements of catheter 10. As shown in figure 21, the markers or M markings may be equidistant from each other others. These markers or M markings can be placed along the tubular guidewire element 24 inside the balloon 12 alone, as shown in figure 20, or along the tubular guidewire element 24, both inside the balloon 12 and along the catheter 10 on the outside of the balloon 12, as shown in figure 21. As should be appreciated, at least three markers or M markings appear inside the balloon 12 in the illustrated embodiment and, in particular, within the limit of the location providing the work surface W of the balloon (i.e., a mark or marker is provided adjacent to a first edge of the work surface W, a second marker or mark is provided adjacent to a second edge of the work surface W, and a third mark or marker is between the two markings or border markers).
    [0068] In certain embodiments, as shown in figures 20 and 21, the M markings or markers can be placed equidistant from each other along the entire length of the catheter 10, including the part that includes the balloon 12. The distance between the M markings or markers can range from small distances to measure fine measurements (for example, less than about 1 millimeter between M markings or markers and up to about 10 millimeters), averages or mean measurements (for example, about 10 millimeters between M markings or markers), or large (for example, measurements greater than 10 millimeters between M markings or markers).
    [0069] Figure 22 illustrates another modality of catheter 10, including M markings or markers. In this embodiment, M markings or markers can be positioned over catheter tube 14. In one aspect, M markings or markers can be placed in the catheter tube 14, as well as along the outer surface. The M markings or markers may be on the catheter tube 14 alone, or as illustrated, the markings or markers may be on both the catheter tube 14 and the tubular guidewire element 24. The M markings or markers may be equidistant from each other. others, or it may be not equidistant.
    [0070] With reference to figure 23, the M markings or markers can be positioned with a first distance D1 between the M markings or markers in a first location on the catheter, and with a second distance D2 between the M markings or markers in a second location on the catheter. In one example, the M markings or markers inside the balloon 12 can be positioned with a first distance D1 between the markings or markers, while the M marks or markers to an outside position of the balloon along the catheter tube 14 can be positioned with a second D2 distance between the markings or markers. In the illustrated embodiment, the first distance D1 can be less than the second distance D2. This can allow raw distance measurements over a proximal part of the catheter 10, while allowing finer measurements of a distance from a distal part of the catheter 10.
    [0071] Figure 24 illustrates another modality in which the M markings or markers can be positioned with different distances between them, in such a way that the M marks or markers are not equidistant from each other. As shown, a third distance D3 can exist between the first and second markings or adjacent markers M1, M2. In addition, the second and third markings or adjacent markers M2, M3 can be positioned in such a way that a fourth distance D4 separates these markings or markers M2, M3. The third distance D3 can be shorter than the fourth distance D4. In one embodiment, the third distance D3 can be, for example, about 5 millimeters, and the fourth distance D4 can be, for example, about 10 millimeters. The distance between markings or M markers can alternate between the third distance D3 and the fourth distance D4 along the length of catheter 10. This alternating distance between markings or M markers can allow for fine or thick measurements, at various points along along the length of the catheter 10.
    [0072] With reference to figure 25, another embodiment is described in which the M4, M5, M6 ... Mn markings or markers can be placed along the catheter 10 in a non-equidistant manner. As shown, the distance between M markings or markers may increase from a distal end of catheter 10 to a proximal end of catheter 10. For example, a fifth D5 distance may exist between the fourth and fifth M4 markings or markers, M5 at a distal end of catheter 10. Likewise, a sixth distance D6, proximal to the fifth distance D5, can exist between the fifth and sixth markings or markers M5, M6, and a seventh distance D7 can exist between the sixth and the seventh markings or markers M6, M7. The distance between each successive pair of adjacent M markings or markers from a distal end of catheter 10 to a proximal end of catheter 10 can increase incrementally in relation to the previous pair of M markings or markers over a final distance Dn. In the example in figure 25, D5 <D6 <D7 <... Dn. In other words, the distance between the M markings or markers can gradually and continuously decrease from a proximal end of the catheter 10 to a distal end. This decrease in the distance between the M markings or markers may allow progressively thinner adjacent measurements to be taken towards the distal end of the catheter 10.
    [0073] Figures 26 to 28 illustrate uses of a catheter 10 with M radiopaque markings or markers for measuring a treatment area T and releasing a treatment balloon 112 into treatment area T. Figure 26 shows a balloon 12 of catheter 10, including a plurality of M markings or markers being inserted along a guidewire 26 into a V vessel for a treatment area T, such as a lesion L, using a device called an introducer I. The balloon 12 can be inflated in the treatment area T, in order to dilate the vessel V and compress the lesion L, as shown in figure 27. The balloon 12 can be deflated and removed after use.
    [0074] The plurality of M markings or markers along the catheter 10 can be spaced at predetermined intervals from another way to demarcate the known distances between them. These M markings or markers can be used to measure the length of the treatment area T, which in the illustrated mode constitutes the distance that measures the length of lesion L. The M marks or markers can be used to measure the length of the treatment area. treatment T before and / or after balloon dilation 12. With the precise measurement of the desired or required treatment area T, the user can select an appropriate treatment balloon 112 for the task (which can also be provided as part of a combination with a measuring balloon). For example, the user can select a treatment balloon 112 with a work surface corresponding to the length of the measurement obtained, or an associated treatment catheter 110 (figure 28) for treatment with markers or markings corresponding to the markers or markings of the catheter 10.
    [0075] As shown in figure 28, the selected treatment catheter 110 (which can again be substantially identical in construction to catheter 10, and can thus include corresponding radiopaque markings or markers, including, for example, a displacement marking for alignment with the central region) can then be inserted to position treatment balloon 112 in treatment area T. Treatment balloon 112 can include a work surface W2 including a treatment, such as, for example, a therapeutic agent (for example, a drug, such as paclitaxel, rapamycin, heparin and the like), a stent, an endoprosthesis or a combination). In some cases, the treatment balloon 112 may be longer than the measuring catheter balloon (in order to ensure complete coverage of lesion L during the subsequent intervention; for example, the first balloon may be 20 mm , and the second balloon can be 40 millimeters). The common positioning of the catheters 10, 110 can be done in relation to a common location inside the body visible under fluoroscopy, such as a bone mark (for example, a particular vertebra).
    [0076] In the case of the release of a treatment, the selection of a working surface length W2 may be important in order to treat the entire treatment area T, but to treat no more than the treatment area T. A balloon treatment 112 with a length of a work surface W2 corresponding to the measured distance from treatment area T can be selected based on the measured length of treatment area T with measuring catheter 10. In this way, a doctor can be sure that the release of treatment is achieved in the manner intended for the entire T treatment area, but not elsewhere, which can help to avoid geographic misalignment, the inability to treat an entire T treatment area, or overdose of the therapeutic agent outside the treatment area T. Therefore, the procedure is potentially shorter, and further intervention can be avoided. The measurement technique can also be used post-dilation, if desired.
    [0077] As suggested by the above, any of the balloons described 12 can carry out the treatment in the form of one or more treatment agents, such as a payload (drug, stent, or both) or a working utensil (cutter, focused power wire, or the like). For example, as shown in figure 17, a balloon 12 with a defined work surface W (such as providing markings or markers M, in the form of radiopaque bands 32, 34 at the transitions between pipe section 16 and end sections 18 , 20), can include at least a part coated with such a drug G, such as one designed to achieve a desired therapeutic effect when applied to the interior of the container. The drug G that forms this treatment can be applied to the balloon 12 as part of the manufacturing process, possibly including before folding for insertion into the vascular system or after the folding is completed. The doctor can, with the benefit of a fluoroscope, determine the precise positioning of the work surface W before inflating the balloon 12 in the vasculature to release the drug G to the desired location and provide the desired treatment, which can be part of a treatment regimen.
    [0078] Examples of radiopaque materials that can be used here for the markings or markers on catheter 10 (balloon 10 or rod 24) include, but are not limited to, finely divided compounds of tungsten, tantalum, bismuth, bismuth trioxide, oxychloride bismuth, bismuth subcarbonate, other bismuth compounds, barium sulfate, tin, silver, silver compounds, rare earth oxides, and many other substances commonly used for X-ray absorption. The amount used may vary depending on the desired degree radiopacity, and in any form (for example, bands, sheets, films (including powders with incorporated radiopaques), decals, coatings, paints, etc.). In one embodiment, the M markings or markers may comprise a polymer loaded with a radiopaque element such as iodine, iopromide, metal ions, gold, barium sulfate, tungsten, bismuth trioxide, or other similarly functional materials. Radiopaque materials can be used in the form of gels, powders, dust, particles, nanoparticles, liquids, stains, adhesives and the like. The radiopaque material that forms the marker or marking can be anywhere from about 5 to 95% radiopaque or, more specifically, in the range of about 70 to 90% radiopacity.
    [0079] The M markings or markers may take the form of metal marker bands, such as platinum, iridium and / or gold markings or markers, which can be stamped, by gluing, or otherwise affixed to the catheter 10. In In one embodiment, the catheter can include heat-bound radiopaque segments interspersed between non-radiopaque segments. In another embodiment, the M markings or markers may comprise a radiopaque tape or film applied to the catheter 10. A radiopaque paint can also be used to form the M markings or markers. While the bands are mentioned above and illustrated in the figures, the markings or M markers can take the form of symbols (numbers, letters), geometric shapes (gradation lines, hash marks, dots, etc.), or combinations of one or more of the previous elements. The aforementioned marker or marker compounds are exemplary of various radiopaque markers or markers currently used in medicine, but the marker or marking may include any other technique that allows visualization of a particular location during use in the vasculature.
    [0080] Although the description presents certain modalities to illustrate the concepts of the invention, numerous modifications, alterations and changes to the described modalities are possible without departing from the scope and scope of the present invention, as defined in the appended claims. For example, all ranges and numerical values provided in the various modalities are subject to variation due to tolerances, due to variations in environmental parameters and material quality, and, due to changes in the structure and shape of the balloon, and therefore , can be considered to be approximate and the term "approximately" means that the relevant value may, at a minimum, vary because of such factors. In addition, the drawings, while illustrating the inventive concepts, are not to scale, and should not be limited to any particular dimensions or sizes. Therefore, it is intended that the present invention is not limited to the described modalities, but that it has the full scope defined by the language of the claims that follow, and their equivalents.
    权利要求:
    Claims (7)
    [0001]
    1. Balloon catheter (10) for insertion into a vessel to treat a treatment area comprising: an axis (24); an inflatable balloon (12) attached to the axis (24) and having an interior; and at least three radiopaque markings (30, 32, 34) spaced along a longitudinal axis of the catheter inside the balloon on the inner tubular member, in which a first distance separating a first radiopaque mark from a second adjacent radiopaque mark is different from a second distance separating the second radiopaque mark from a third adjacent radiopaque mark, characterized by the fact that the balloon includes an uninflated midpoint location (A) and an inflated midpoint location (B); the axis (24) includes at least one first radiopaque mark (30) positioned at a displacement location (O) in relation to the uninflated midpoint location (A), whereby, in the balloon inflation, at least one mark radiopaque (30) substantially aligns with the inflated midpoint site (B), and because the axis (24) still includes an inner tubular member forming a wire guide lumen (23), and the inner tubular member understand at least three radiopaque markings.
    [0002]
    2. Balloon catheter according to claim 1, characterized by the fact that the shaft (24) includes an external wall that has at least one of the first or second radiopaque markings.
    [0003]
    3. Balloon catheter, according to claim 1, characterized by the fact that it also includes a second radiopaque mark (32) that corresponds to at least one end of the work surface (W) of the balloon.
    [0004]
    4. Balloon catheter according to claim 1 or 3, characterized in that a third radiopaque mark (34) on the axis is provided at a location that corresponds to the other end of the work surface (W).
    [0005]
    Balloon catheter according to any one of claims 1, 3 and 4, characterized by the fact that the displacement site (O) is spaced from the uninflated midpoint site (A) in a proximal direction.
    [0006]
    Balloon catheter according to any one of claims 1, 3 and 4, characterized by the fact that the displacement site (O) is spaced from the uninflated midpoint site (A) in a distal direction.
    [0007]
    7. Balloon catheter according to any one of claims 1, 3 and 4, characterized by the fact that the displacement site (O) is spaced from the uninflated midpoint site (A) by a distance of approximately 1 to 15% of a length between a distal end and a proximal end of the balloon in an inflated condition.
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    同族专利:
    公开号 | 公开日
    CN104470576B|2019-07-19|
    AU2013295789B2|2018-05-24|
    KR102143444B1|2020-08-12|
    US20150165170A1|2015-06-18|
    AU2013295789A1|2015-02-12|
    MX2015000526A|2015-10-12|
    JP2015527123A|2015-09-17|
    US20190240454A1|2019-08-08|
    CO7240403A2|2015-04-17|
    EP2877229A2|2015-06-03|
    EP2877229B1|2018-09-12|
    NZ704015A|2016-09-30|
    WO2014018659A3|2014-04-17|
    JP6235011B2|2017-11-22|
    WO2014018659A2|2014-01-30|
    MX362797B|2019-02-12|
    EP3064249A3|2016-09-14|
    CA2878578A1|2014-01-30|
    CN109675175A|2019-04-26|
    US11202884B2|2021-12-21|
    EP3064249A2|2016-09-07|
    BR112015001497A2|2017-07-04|
    US20170173302A1|2017-06-22|
    CN110227206A|2019-09-13|
    CA2878578C|2021-04-20|
    CN104470576A|2015-03-25|
    KR20150037872A|2015-04-08|
    US10384035B2|2019-08-20|
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    法律状态:
    2018-12-04| B06F| Objections, documents and/or translations needed after an examination request according [chapter 6.6 patent gazette]|
    2019-11-12| B06U| Preliminary requirement: requests with searches performed by other patent offices: procedure suspended [chapter 6.21 patent gazette]|
    2021-01-26| B09A| Decision: intention to grant [chapter 9.1 patent gazette]|
    2021-03-09| B16A| Patent or certificate of addition of invention granted [chapter 16.1 patent gazette]|Free format text: PRAZO DE VALIDADE: 20 (VINTE) ANOS CONTADOS A PARTIR DE 24/07/2013, OBSERVADAS AS CONDICOES LEGAIS. |
    优先权:
    申请号 | 申请日 | 专利标题
    US201261675168P| true| 2012-07-24|2012-07-24|
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    PCT/US2013/051863|WO2014018659A2|2012-07-24|2013-07-24|Balloon catheter with enhanced locatability|
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