This document relates to medical sheaths, such as those used in cardiac procedures. More specifically, this document relates to medical sheaths, methods for carrying out medical procedures using medical sheaths, and medical ultrasound systems including medical sheaths.
The following summary is intended to introduce the reader to various aspects of the detailed description, but not to define or delimit any invention.
According to some aspects, a medical sheath includes an elongate member having a sidewall extending longitudinally between a proximal end portion of the elongate member and an opposed distal end portion of the elongate member, and radially between an outer surface of the elongate member and an inner surface of the elongate member. A lumen is defined by the inner surface and extends through the elongate member from the proximal end portion to the distal end portion. At least a first echogenic band is associated with the distal end portion and is secured to the sidewall.
In some examples, the first echogenic band includes a first coil of echogenic material extending around at least a first portion of the elongate member.
In some examples, the medical sheath includes a second echogenic band associated with the distal end portion and spaced from the first echogenic band. The second echogenic band can include a second coil of echogenic material extending around at least a second portion of the elongate member.
In some examples, the medical sheath includes a third echogenic band associated with the distal end portion and spaced from the first echogenic band and the second echogenic band. The third echogenic band can include a third coil of echogenic material extending around at least a third portion of the elongate member.
In some examples, the echogenic band includes a braid of echogenic material extending around at least a first portion of the elongate member.
In some examples, the echogenic band is embedded in the sidewall. The elongate member can include an inner liner and an outer tube, and the echogenic band can be positioned between the inner liner and outer tube.
In some examples, the first echogenic band includes a band of echogenic-filled polymer.
According to some aspects, a medical ultrasound system includes a 3-dimensional ultrasound catheter for emitting ultrasound signals to an anatomical volume and receiving reflected ultrasound signals from the anatomical volume. The system further includes a medical sheath having a distal end portion that is at least partially echogenic, for reflecting the ultrasound signals emitted by the 3-dimensional ultrasound catheter. The system further includes an ultrasound data processor for receiving ultrasound data from the 3-dimensional ultrasound catheter, based on the reflected ultrasound signals, and processing the ultrasound data. The system further includes an imaging system connected to the ultrasound data processor for generating a 3-dimensional visual model representing the positioning of the distal end portion of the medical sheath within the anatomical volume, based on the processed data.
In some examples, the medical sheath includes an elongate member having a sidewall extending longitudinally between a proximal end portion of the elongate member and an opposed distal end portion of the elongate member, and radially between an outer surface of the elongate member and an inner surface of the elongate member; a lumen defined by the inner surface and extending through the elongate member from the proximal end portion to the distal end portion; and at least a first echogenic band associated with the distal end portion and secured to the sidewall.
In some examples, the first echogenic band includes a first coil of echogenic material extending around at least a first portion of the elongate member.
In some examples, the medical sheath includes a second echogenic band associated with the distal end portion and spaced from the first echogenic band. The second echogenic band can include a second coil of echogenic material extending around at least a second portion of the elongate member.
In some examples, the medical sheath includes a third echogenic band associated with the distal end portion and spaced from the first echogenic band and the second echogenic band. The third echogenic band can include a third coil of echogenic material extending around at least a third portion of the elongate member.
In some examples, the first echogenic band includes a braid of echogenic material extending around at least a first portion of the elongate member.
In some examples, the first echogenic band is embedded in the sidewall. The elongate member can include an inner liner and an outer tube, and the echogenic band can be positioned between the inner liner and outer tube.
In some examples, the first echogenic band includes a band of echogenic-filled polymer.
According to some aspects, a method for carrying out a cardiac procedure includes: a. inserting a 3-dimensional ultrasound catheter into patient's body and using the 3-dimensional ultrasound catheter to create a visual model of the patient's heart; b. inserting a medical sheath into the patient's heart and advancing a distal end portion of the medical sheath towards a target location in the patient's heart, wherein the distal end portion of the sheath is at least partially echogenic; c. using the 3-dimensional ultrasound catheter to determine a location of the distal end portion of the medical sheath with respect to the patient's heart; and d. adding a representation of the distal end portion to the visual model of the patient's heart.
In some examples, step d. includes generating an en-face view of the patient's heart from the distal end portion.
In some examples, step d. includes generating a side view of the distal end portion and an area of the patient's heart adjacent the distal end portion.
In some examples, step d. includes generating a rear-view of the distal end portion and an area of the patient's heart adjacent the distal end portion.
In some examples, the method further includes e. advancing a treatment device out of the distal end portion towards the target location, and f. using the treatment device to treat the target location.
In some examples, prior to step e., the method includes adding to the visual model a representation of a predicted contact location of the treatment device and the patient's heart.
In some examples, the treatment device is a radiofrequency perforation device and the target location is a fossa ovalis.
In some examples, the treatment device is a balloon-based system and the target location is a pulmonary vein.
According to some aspects, a kit of parts for a carrying out a cardiac procedure includes a medical sheath, and a radiofrequency perforation device. The medical sheath includes: an elongate member having a sidewall extending longitudinally between a proximal end portion of the elongate member and an opposed distal end portion of the elongate member, and radially between an outer surface of the elongate member and an inner surface of the elongate member; a lumen defined by the inner surface and extending through the elongate member from the proximal end portion to the distal end portion; and at least a first echogenic band associated with the distal end portion and secured to the sidewall. The radiofrequency perforation device has a perforating tip, and is receivable in the lumen with the perforating tip at the distal end portion.
In some examples, the first echogenic band includes a first coil of echogenic material extending around at least a first portion of the elongate member.
In some examples, the kit further includes a second echogenic band associated with the distal end portion and spaced from the first echogenic band. The second echogenic band can include a second coil of echogenic material extending around at least a second portion of the elongate member.
In some examples, the kit further includes a third echogenic band associated with the distal end portion and spaced from the first echogenic band and the second echogenic band. The third echogenic band can include a third coil of echogenic material extending around at least a third portion of the elongate member.
In some examples, the echogenic band includes a braid of echogenic material extending around at least a first portion of the elongate member.
In some examples, the echogenic band is embedded in the sidewall. The elongate member can include an inner liner and an outer tube, and the echogenic band can be positioned between the inner liner and outer tube.
In some examples, the first echogenic band includes a band of echogenic-filled polymer.
According to some aspects, an echogenic device includes an elongate member having a solid body extending longitudinally between a proximal end portion of the elongate member and an opposed distal end portion of the elongate member. The echogenic device includes at least a first echogenic band associated with the distal end portion and secured to the solid body of the elongate member.
According to some aspects, a medical ultrasound system includes a 3-dimensional ultrasound catheter for emitting ultrasound signals to an anatomical volume and receiving reflected ultrasound signals from the anatomical volume. The medical ultrasound system further includes an echogenic device having a distal end portion that is at least partially echogenic for reflecting the ultrasound signals emitted by the 3-dimensional ultrasound catheter. The system further includes an ultrasound data processor for receiving ultrasound data from the 3-dimensional ultrasound catheter and processing the ultrasound data, wherein the ultrasound data is based on the reflected ultrasound signals. The system further includes an imaging system connected to the ultrasound data processor for generating a 3-dimensional visual model representing the positioning of the distal end portion of the catheter within the anatomical volume, based on the processed data.
According to some aspects, a method for carrying out a cardiac procedure includes: a. inserting a 3-dimensional ultrasound catheter into patient's body and using the 3-dimensional ultrasound catheter to create a visual model of the patient's heart; b. inserting the echogenic device into the patient's heart and advancing a distal end portion of the echogenic device towards a target location in the patient's heart, wherein the distal end portion of the echogenic device is at least partially echogenic; c. using the 3-dimensional ultrasound catheter to determine a location of the distal end portion of the medical sheath with respect to the patient's heart; and d. adding a representation of the distal end portion to the visual model of the patient's heart.
According to some aspects, a kit of parts for a carrying out a cardiac procedure includes an echogenic device, and a radiofrequency perforation device. The echogenic device includes: an elongate member having a solid body extending longitudinally between a proximal end portion of the elongate member and an opposed distal end portion of the elongate member; and at least a first echogenic band associated with the distal end portion. The radiofrequency perforation devices includes a perforating tip.
The accompanying drawings are for illustrating examples of articles, methods, and apparatuses of the present disclosure and are not intended to be limiting. In the drawings:
Various apparatuses or processes or compositions will be described below to provide an example of an embodiment of the claimed subject matter. No example described below limits any claim and any claim may cover processes or apparatuses or compositions that differ from those described below. The claims are not limited to apparatuses or processes or compositions having all of the features of any one apparatus or process or composition described below or to features common to multiple or all of the apparatuses or processes or compositions described below. It is possible that an apparatus or process or composition described below is not an embodiment of any exclusive right granted by issuance of this patent application. Any subject matter described below and for which an exclusive right is not granted by issuance of this patent application may be the subject matter of another protective instrument, for example, a continuing patent application, and the applicants, inventors or owners do not intend to abandon, disclaim or dedicate to the public any such subject matter by its disclosure in this document.
Generally disclosed herein are medical sheaths (also referred to herein simply as “sheaths”) that can be used in medical procedures, such as cardiac procedures. For example, the sheaths can be used in transseptal perforation procedures, in which a sheath is advanced to the right atrium of a patient's heart via the femoral vein, and a perforation device (e.g. a radiofrequency (RF) perforation device) and dilator are guided through the sheath, to the right atrium. When the sheath is adjacent a target location in the right atrium, for example the fossa ovalis of the atrial septum, the perforation device can be advanced out of the sheath and used to create a perforation in the target location, and the dilator can be advanced out of the sheath to dilate the perforation. Such procedures can be carried out, for example, as a medical treatment, or to gain access to the left atrium for a subsequent medical treatment.
In general, the sheaths disclosed herein are configured to allow for non-fluoroscopic visualization of and/or determination of the location of the distal end portion of the sheath within the body. Furthermore, the sheaths disclosed herein are configured to allow for non-fluoroscopic visualization of the cardiac anatomy from viewpoints associated with the sheath (e.g. an en-face view of the fossa ovalis from the distal end portion of the sheath can be generated). More specifically, the sheaths disclosed herein can have a distal end portion that is at least partially echogenic (i.e. the distal end portion has at least a portion with an acoustic impedance that significantly differs from the acoustic impedance of blood or other tissue). When using a 3-dimensional ultrasound catheter (e.g. an intracardiac echocardiography (ICE) catheter or transesophageal echocardiography (TEE) catheter) to create a visual model of a patient's heart, the ultrasound catheter can also receive a reflected ultrasound signal from the distal end portion of the sheath. Based on the reflected ultrasound signal, a representation of the distal end portion of the sheath can be added to the visual model of the patient's heart (e.g. using standard image processing software features, such as edge detect, or feature detect). Optionally, the ultrasound system can utilize a known model of the sheath, in order to generate the representation of the distal end portion of the sheath based on the ultrasound signal received from the distal end of the sheath. For example, an image of the sheath can be added to the visual model of the patient's heart, and/or as mentioned above, a view of the patient's heart can be generated from a viewpoint associated with the sheath. This can enhance the safety of the procedure. For example, it can allow for a user (e.g. a physician) to ensure that or check whether the sheath is in the desired location with respect to the target location.
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The system can further include one or more treatment devices. Referring still to
In alternative examples, alternative or additional treatment devices may be part of the system.
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In alternative examples, the sheath can include another number of echogenic bands, e.g. one echogenic band, or two echogenic bands, or more than three echogenic bands. In examples in which less than three echogenic bands are used, a 3-dimensional representation of the sheath can be generated via the ultrasound system using known vectors associated with the distal end portion. For example, if the sheath includes only one echogenic band, a 3-dimensional representation of the sheath can be generated via the ultrasound system using two known vectors associated with the distal end portion of the sheath. Alternatively, or in addition, the ultrasound system can utilize a known model of the sheath, in order to generate the representation of the distal end portion of the sheath based on the ultrasound signal received from the distal end of the sheath.
The echogenic bands can be in various forms, such as a coil or a braid, and can extend around the entirety of the elongate member (e.g. around the outer surface), or can extend around only a portion of the elongate member (e.g. around only the inner liner, so that the echogenic bands are embedded in the sidewall). In an alternative embodiment, where the elongate member comprises a solid body, the echogenic band may be in the form of a disc, making up the entire cross-sectional area of the elongate member (not shown). Embedding the echogenic bands in the sidewall can allow for a smooth transition as the sheath is inserted through tissue. Referring still to
Optionally, in order to fabricate the sheath 110 of
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In an alternative example (not shown), the bands of echogenic material can be formed by echogenic-filled polymer. For example, bands of tungsten-filled polymer can be incorporated into the sheath during manufacture, by assembling an outer tube, bands of tungsten-filled polymer, and an inner liner. Then, the material of the outer tube as well as the tungsten-filled polymer can be re-flowed (e.g. by the application of heat) to join the outer tube, bands of tungsten-filled polymer, and inner liner.
In another alternative example (not shown), instead of or in addition to embedding the echogenic bands in the sidewall, echogenic bands can be applied to the outer surface of the elongate member, and secured in place by gluing, welding, soldering, friction, and/or re-flowing. Optionally, the echogenic bands can be seated in a groove in the outer surface and can be swaged, so that the echogenic bands are flush with the outer surface.
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The representation of the distal end portion 112 of the sheath 110 can be added to the 3-dimensional visual model 108 of the patient's heart 402 in various ways. For example, as shown in
In some examples, the system 100 can be configured to add to the visual model 108 a representation of a predicted contact location of the treatment device (in this case the perforation device 114) and the target location. For example, as shown in
If the mark 418 is in the desired position with respect to the target location, e.g. on the fossa ovalis 408 as shown, the perforation device 114 can be advanced out of the sheath 110. Alternatively, if the mark 418 is not in the desired position, e.g. spaced from the fossa ovalis 408, then the position of the sheath 110 can be adjusted until the mark 418 is in the desired position, and the perforation device 114 can then be advanced out of the sheath 110.
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Once access to the left atrium has been gained, a subsequent medical treatment (not shown) can be carried out. Optionally, the echogenicity of the distal end portion 110 of the sheath 110 can continue to be used during the subsequent medical treatment. For example, the subsequent medical treatment can be a pulmonary vein isolation (PVI) procedure using a balloon-based system. In such cases, another en-face view of the heart from the distal end portion 112 of the sheath 110 can be generated, in order to allow a user to visualize whether blood is leaking past the balloon (which may impact lesion quality).
Upon completion of the medical treatment or at a desired time, the dilator 118, perforation device 114, and sheath 110 can be withdrawn from the heart 402. Optionally, during withdrawal, the representation of the distal end portion 112 of the sheath 110 can continue to be added to the visual model 108 of the patient's heart 402.
While the above description provides examples of one or more processes or apparatuses or compositions, it will be appreciated that other processes or apparatuses or compositions may be within the scope of the accompanying claims.
To the extent any amendments, characterizations, or other assertions previously made (in this or in any related patent applications or patents, including any parent, sibling, or child) with respect to any art, prior or otherwise, could be construed as a disclaimer of any subject matter supported by the present disclosure of this application, Applicant hereby rescinds and retracts such disclaimer. Applicant also respectfully submits that any prior art previously considered in any related patent applications or patents, including any parent, sibling, or child, may need to be re-visited.
Filing Document | Filing Date | Country | Kind |
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PCT/IB2020/057685 | 8/14/2020 | WO |
Number | Date | Country | |
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62886534 | Aug 2019 | US |