TECHNICAL FIELD

This disclosure relates generally to interventional medical procedures, such as angioplasty, and, more particularly, to a catheter structure with markings to reduce the usage of fluoroscopy during the procedure.

BACKGROUND

A clinician performing an endovascular procedure, such as angioplasty, will typically use fluoroscopy in the course of performing a diagnostic angiogram to assess the location of a treatment area (such as where a lesion or blockage is present in the vasculature). Upon gaining guidewire access to the vasculature using additional fluoroscopy, and then inserting the catheter along the guidewire, the clinician will then typically use even more fluoroscopy, either continuously or intermittently (e.g., “spot checking), in order to confirm the catheter has reached the location of the treatment area. As can be appreciated, this conventional approach increases the exposure of the patient and others, including the clinician and assistants, to fluoroscopy and, hence, radiation, which is generally desired to be avoided to the greatest extent possible.

Accordingly, a need exists for a manner in which to position a catheter structure into the vasculature at a treatment area while reducing the amount or frequency of fluoroscopy used.

SUMMARY

One object of the disclosure is to provide a catheter structure, such as a balloon catheter, guidewire, or the like, with markings perceptible outside of the vasculature for use in determining at a location external to the body the position of the catheter structure relative to a treatment area.

One embodiment relates to an apparatus for use by a clinician in treating the vasculature. The apparatus may include a catheter structure having a shaft including a first distal portion adapted for positioning at the treatment area and a proximal portion including a marking perceptible by the clinician external to the vasculature without the use of fluoroscopy, the marking being representative of a length from a pre-determined starting point on the catheter structure. Consequently, the markings may be used to position the catheter structure a distance in the vasculature corresponding to the length with minimal use of fluoroscopy.

The marking may comprise a plurality of regularly spaced marks or irregularly spaced marks. In one aspect, the marking may be printed on the catheter structure. The markings may comprise a plurality of first marks and at least one second mark different from the plurality of first marks. For example, the first marks may comprise spaced bands and the second mark may comprise an alphanumerical indicia. The marking may be provided adjacent a hub associated with the catheter structure. In a further aspect, the marking may be luminescent, such as chemiluminescent or photoluminescent.

In a further aspect, the catheter structure may comprise a balloon adjacent to a tip including the pre-determined starting point. One or more radiopaque markings may be adjacent to the balloon.

The catheter structure may include a treatment element selected from the group consisting of a drug, a stent, a graft, a cutter, a focused force wire, or any combination thereof. Additionally, the catheter structure may comprise a guidewire, and may be adapted for slidably receiving the guidewire.

In another embodiment, an apparatus for treating a treatment area at an intravascular location in a body is disclosed. The apparatus may include a catheter including a shaft having a distal portion including a balloon and a proximal portion including at least one marking arranged for being viewed at a reference point external to the body for identifying a distance from the treatment area to the reference point. The balloon may further include a treatment element selected from the group consisting of a stent, a graft, a cutter, a focused force wire, or any combination thereof.

Another embodiment relates to a method of treating a treatment area in a body. The method may comprise inserting a distal portion of a guidewire to the treatment area, determining a position of a first marking on a proximal portion of the guidewire relative to a reference point, and inserting a catheter a distance corresponding to the first marking.

A further embodiment relates to an apparatus for use by a clinician in treating the vasculature. The apparatus may include a catheter structure having a shaft including a first distal portion adapted for positioning at the treatment area and a proximal portion, and means external to the vasculature for determining a length from a pre-determined starting point on the catheter structure, whereby the determining means may be used to position the catheter structure a distance in the vasculature corresponding to the length with minimal use of fluoroscopy.

Another embodiment comprises a catheter including a ruler. A further embodiment comprises a guidewire including a ruler. A catheter comprising a ruler may be provided and/or used in combination with a guidewire comprising a ruler.

In another embodiment, a crossing catheter is provided including a plurality of markings for determining a distance of insertion into a patient's vasculature. The plurality of markings may comprise a ruler.

An additional embodiment relates to a method of forming a catheter structure. The method may comprise comprising providing a marking perceptible to a clinician on a first portion of the catheter structure external to the vasculature to provide a representation of an amount a second portion of the catheter structure has been inserted into the vasculature. The providing step may comprise printing the marking on the catheter structure. The providing step may further comprise providing a plurality of first marks and at least one second mark different from the plurality of first marks. The first marks may comprise spaced bands and the second mark may comprise an alphanumerical indicia. In one aspect, the amount represents a total distance the second portion of the catheter structure has been inserted into the vasculature from a reference point external to the vasculature.

Any of the catheters and/or guidewires disclosed herein may be provided together in a kit for the treatment of a treatment area in a patient's vasculature. For example, one embodiment relates to a kit for treating a treatment area in the vasculature. The kit may include a first crossing catheter having a first shaft including a first distal portion adapted for positioning at or near the treatment area and a first proximal portion including a first marking at a first location, and a second catheter having a second shaft including a second distal portion adapted for positioning at the treatment area and a second proximal portion including a second marking at a second location substantially matching a first location of the first marking. The crossing catheter may be adapted for penetrating into or through an occlusion at the treatment area.

A further embodiment includes a kit for treating a treatment area in the vasculature. The kit may comprise a first crossing catheter having a first shaft including a first distal portion adapted for positioning at or near the treatment area and a first proximal portion including a first marking at a first location corresponding to a first margin of the treatment area and a second marking at a second location corresponding to a second margin of the treatment area, as well as a second catheter having a second shaft including a second distal portion adapted for positioning at the treatment area and a second proximal portion including a third marking at a third location substantially matching the first location or the second location on the first, crossing catheter. The second catheter may further include a fourth marking on the second proximal portion at a fourth location corresponding to the other of the first location or the second location on the first, crossing catheter. The second catheter may also include a technology selected from the group consisting of an artherectomy technology, a thrombectomy technology, a PTA technology, a stent technology, and any combination of the foregoing.

In addition, a method of treating a treatment area in a body is disclosed. The method may include inserting a crossing catheter to at least a proximal portion of the treatment area, determining a position of a first marking on the crossing catheter, and inserting a second catheter at least a distance corresponding to the first marking. The method may further include the steps of, after the determining step, inserting the crossing catheter to a distal portion of the treatment area, and determining a position of a second marking on the crossing catheter. The step of inserting the crossing catheter to the distal portion of the treatment area may comprise passing the crossing catheter through an occlusion. In one aspect, the crossing catheter may be adapted to penetrate into an occlusion or the occlusion at the treatment area. The crossing catheter may be adapted to apply energy for penetrating into the occlusion or the occlusion. For example, the crossing catheter may comprise a cutter, a vibrator, a source of light, a source of fluid, a nozzle, a rigid or tapered distal tip, or any combination of the foregoing.

A further embodiment relates to a kit for treating a treatment area in the vasculature of a patient. The kit of this embodiment may comprise a first crossing catheter having a first shaft including a first distal portion adapted for positioning at or near the treatment area and a first proximal portion including a first marking at a first location, and a second catheter having a second shaft including a second distal portion adapted for positioning at the treatment area and a second proximal portion including a second marking at a second location substantially matching a first location of the first marking. Each of the first marking and the second marking may be visible external to the patient's body without the use of fluoroscopy. In one aspect, the second distal portion of the second catheter comprises a balloon. The second catheter may comprise a treatment element selected from the group consisting of a drug, a stent, a graft, a cutter, a focused force wire, or any combination thereof. Furthermore, the crossing catheter may be adapted for penetrating into or through an occlusion at the treatment area.

Another embodiment relates to a kit for treating a treatment area in the vasculature, comprising a first crossing catheter having a first shaft including a first distal portion adapted for positioning at or near the treatment area and a first proximal portion including a first marking at a first location corresponding to a first margin of the treatment area and a second marking at a second location corresponding to a second margin of the treatment area, and a second catheter having a second shaft including a second distal portion adapted for positioning at the treatment area and a second proximal portion including a third marking at a third location substantially matching the first location or the second location on the first, crossing catheter. The second catheter may further include a fourth marking on the second proximal portion at a fourth location corresponding to the other of the first location or the second location on the first, crossing catheter. In one aspect, the second catheter may include a technology selected from the group consisting of an artherectomy technology, a thrombectomy technology, a PTA technology, a stent technology, and any combination of the foregoing. In any of the above embodiments, the crossing catheter may be adapted to penetrate into an occlusion or the occlusion at the treatment area. The crossing catheter may be adapted to apply energy for penetrating into an occlusion or the occlusion. In a further aspect, the crossing catheter comprises a cutter, a vibrator, a source of light, a source of fluid, a nozzle, a rigid or tapered distal tip, or any combination of the foregoing.

In still a further embodiment, a kit is disclosed for treating a treatment area in a vasculature of a patient. The kit of this further embodiment may comprise a first crossing catheter having a first shaft including a first distal portion adapted for positioning at the treatment area and a first proximal portion including a plurality of first markings perceptible by the clinician external to the vasculature without the use of fluoroscopy, each of the plurality of first markings being representative of a length from a first predetermined starting point on the first crossing catheter, and a second catheter having a second shaft including a second distal portion adapted for positioning at the treatment area and a second proximal portion including a plurality of second markings perceptible by the clinician external to the vasculature without the use of fluoroscopy, each of the plurality of second markings being representative of a length from a second predetermined starting point of the second catheter, wherein a distance between the first predetermined starting point and each of the first markings corresponds to a distance between the second predetermined starting point and each of the second markings.

In this embodiment, the plurality of first markings may be spaced at regular intervals from one another. Each of the first shaft and the second shaft may further include alphanumeric markings corresponding to each of the first markings and the second markings. At least one of the first markings or the second markings may be chemiluminescent or photoluminescent. In one aspect, at least one of the first markings or the second markings comprises spaced bands.

The second catheter may comprise a balloon adjacent a tip including the second predetermined starting point. In addition, a radiopaque marker may be adjacent the balloon.

In another embodiment, a kit for treating a treatment area in a vasculature of a patient is disclosed. The kit comprises a first crossing catheter having a first shaft including a first distal portion adapted for positioning at the treatment area and a first proximal portion including a first ruler thereon. The first ruler may be perceptible by the clinician external to the vasculature without the use of fluoroscopy for measuring a distance from a first predetermined starting point on the first crossing catheter. A second catheter having a second shaft including a second distal portion adapted is for positioning at the treatment area and a second proximal portion including a second ruler thereon. The second ruler is also perceptible by the clinician external to the vasculature without the use of fluoroscopy for measuring a distance from a second predetermined starting point of the second catheter.

A further embodiment relates to a kit for treating a treatment area in a vasculature of a patient comprising a first crossing catheter having a first shaft including first means for measuring a plurality of first distances from a first predetermined point on the first shaft, and a second catheter having a second shaft including second means for measuring a plurality of second distances from a second predetermined point on the second shaft, wherein the first means for measuring and the second means for measuring are perceptible by the clinician external to the vasculature without the use of fluoroscopy (and may, for example, be non-radiopaque in nature), and wherein each of the plurality of first distances corresponds to at least one of the plurality of second distances. The second catheter may comprise a balloon adjacent a distal end of the second shaft, and wherein the second predetermined point may be an end of the balloon. The second catheter may further comprise a radiopaque marker adjacent the balloon.

An additional embodiment is a kit for treating a treatment area in a vasculature of a patient. The kit comprises a guidewire having a first distal portion adapted for positioning at or near the treatment area and a first proximal portion including a plurality of first markings perceptible by the clinician external to the vasculature without the use of fluoroscopy, each of the plurality of first markings being representative of a length from a first predetermined starting point on the catheter, and a catheter having a shaft including second distal portion adapted for positioning at the treatment area and a second proximal portion including a plurality of second markings perceptible by the clinician external to the vasculature without the use of fluoroscopy, each of the plurality of second markings being representative of a length from a second predetermined starting point of the second catheter, wherein a distance between the first predetermined starting point and each of the first markings corresponds to a distance between the second predetermined starting point and each of the second markings.

The catheter may comprise a balloon. In one aspect, the balloon may be located at a distal end of the catheter, and the second predetermined starting point may be located at a proximal end or a distal end of the balloon. In addition, a radiopaque marker may be adjacent the balloon.

The kit may also be provided such that the catheter comprises a treatment element selected from the group consisting of a drug, a stent, a graft, a cutter, a focused force wire, or any combination thereof. The catheter may include a technology selected from the group consisting of an artherectomy technology, a thrombectomy technology, a PTA technology, a stent technology, and any combination of the foregoing.

In one aspect, the plurality of first markings are spaced at regular intervals from one another.

The guidewire and the catheter may further include alphanumeric markings corresponding to each of the first markings and the second markings. At least one of the first markings or the second markings may be chemiluminescent or photoluminescent. In another aspect, at least one of the first markings or the second markings may comprise spaced bands.

As disclosed in another embodiment, a kit for treating a treatment area in a vasculature of a patient comprises a guidewire including a first distal portion adapted for positioning at the treatment area and a first proximal portion including a first ruler thereon. The first ruler is perceptible by the clinician external to the vasculature without the use of fluoroscopy, and may be non-radiopaque. The first ruler may be adapted for measuring a distance from a first predetermined starting point on the guidewire, and a catheter having a shaft including a second distal portion adapted for positioning at the treatment area and a second proximal portion including a second ruler thereon. The second ruler may be perceptible by the clinician external to the vasculature without the use of fluoroscopy, such as for example, being non-radiopaque. The second ruler may be adapted for measuring a distance from a second predetermined starting point of the catheter.

A still further embodiment relates to a kit for treating a treatment area in a vasculature of a patient. The kit comprises a guidewire including first means for measuring a plurality of first distances from a first predetermined point on the guidewire, and a catheter including second means for measuring a plurality of second distances from a second predetermined point on the catheter. The first means for measuring and the second means for measuring may be non-radiopaque in nature and are perceptible by the clinician external to the vasculature without the use of fluoroscopy. Each of the plurality of first distances may correspond (e.g., be equal to) at least one of the plurality of second distances. The catheter may comprise a balloon adjacent a distal end of the catheter, and the second predetermined point may be an end of the balloon. The catheter may further comprise a radiopaque marker adjacent the balloon.

In another embodiment, a device for treating a treatment area in the vasculature of a patient is disclosed, said device comprising a crossing catheter having a shaft including a distal portion adapted for positioning at or near the treatment area and a proximal portion including a plurality of markings, said markings being visible external to the patient's body without the use of fluoroscopy.

In one aspect, the plurality of markings may comprise a first marking at a first location corresponding to a first margin of the treatment area and a second marking at a second location corresponding to a second margin of the treatment area.

In another aspect, each of the plurality of markings may be representative of at least one known length from a predetermined starting point on the crossing catheter. These plurality of markings may be spaced at regular intervals from one another. The shaft may additionally include alphanumeric markings corresponding to each of the plurality of markings.

In any of the above embodiments, at least one of the markings may be chemiluminescent or photoluminescent. Furthermore, at least one of the markings may comprise a spaced band.

In a further embodiment, a device for treating a treatment area in a vasculature of a patient is disclosed, said device comprising a crossing catheter having a shaft including a distal portion adapted for positioning at the treatment area and a proximal portion including a ruler thereon, said ruler being perceptible by the clinician external to the vasculature without the use of fluoroscopy for measuring a distance from a predetermined starting point on the crossing catheter.

In any of the above embodiments, the crossing catheter may be adapted for penetrating into or through an occlusion at the treatment area.

In any of the above embodiments, a marking perceptible by the clinician external to the vasculature without the use of fluoroscopy may be a non-radiopaque marking.

