MEDICAL SHEATH AND SYSTEMS AND METHODS FOR USING MEDICAL SHEATH

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.

FIELD

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.

SUMMARY

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.

DETAILED DESCRIPTION

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.

Referring now toFIG. 1, an example medical ultrasound system100(also referred to herein simply as a ‘system’) is shown. In the example shown, the system100includes a 3-dimensional ultrasound catheter102(also referred to herein as a U/S catheter), for emitting ultrasound signals to an anatomical volume and receiving reflected ultrasound signals from the anatomical volume. The U/S catheter102can be, for example, an ICE catheter or a TEE catheter. The system100further includes an ultrasound data processor104connected to the U/S catheter102. Ultrasound data based on the reflected ultrasound signals is sent from the U/S catheter102to the ultrasound data processor104, and the ultrasound data processor104receives and processes the ultrasound data using, for example, standard software features. The system100further includes an imaging system106connected to the ultrasound data processor104for generating a 3-dimensional visual model108of the anatomical volume, based on the processed data. Such U/S catheters102, ultrasound data processors104, and U/S imaging systems106are known in the art, are often sold together as an all-in-one system (e.g. such systems are sold by Siemens Healthcare GmbH or by General Electric Company), and will not be described in detail herein.

Referring still toFIG. 1, the system100further includes an elongate cylindrical hollow member, such as a sheath110. In an alternative embodiment, the system may comprise an elongate member comprising a solid body (not shown). The sheath110has a distal end portion112that is at least partially echogenic (described in further detail below), for reflecting the ultrasound signals emitted by the U/S catheter102. As described above, the U/S catheter102can receive the reflected signals, and the ultrasound data processor104can process ultrasound data received from the U/S catheter102. Based on the processed data, the imaging system106can then generate a 3-dimensional visual model representing the positioning of the distal end portion112of the sheath110within the anatomical volume (as mentioned above, this can be done using standard image processing software features). For example, as will be described in further detail below, the imaging system106can generate an en-face view of the patient's heart from the distal end portion112of the sheath110, generate a side view of the distal end portion112of the sheath110and an area of the patient's heart adjacent the distal end portion112of the sheath110, and/or generate a rear-view of the distal end portion112of the sheath110and an area of the patient's heart adjacent the distal end portion112of the sheath110.

The system can further include one or more treatment devices. Referring still toFIG. 1, in the example shown, the system100includes a radiofrequency perforation device114having a perforating tip116, and a dilator118, which can both be advanced towards the target location in the patient's heart via the sheath110. The radiofrequency perforation device114can be connected to a radiofrequency generator (not shown), which can in turn be connected to one or more grounding pads (not shown). Radiofrequency perforation devices, generators, and grounding pads, as well as dilators, are known in the art, and will not be described in detail herein. Examples are sold by Baylis Medical Company, Inc. (Montreal, Canada), for example under the brand names NRG® Transseptal Platform, or SupraCross® Transseptal Platform.

In alternative examples, alternative or additional treatment devices may be part of the system.

Referring now toFIGS. 2A to 2C, the sheath110is shown in greater detail. In the example shown, the sheath110includes an elongate member120. The elongate member120has a sidewall122that extends longitudinally between a proximal end portion124of the elongate member120and the distal end portion112of the elongate member120, and radially between an outer surface126of the elongate member120and an inner surface128(shown inFIG. 2C) of the elongate member120. The inner surface128defines a lumen130(shown inFIG. 2C) of the elongate member120. The lumen130extends through the elongate member120from the proximal end portion124to the distal end portion112, and is open at the distal tip132of the sheath110.

Referring toFIG. 2A, in the example shown, a handle134is mounted to the proximal end portion124of the elongate member120. The handle134can include various hubs and/or ports and/or connection points (not shown) for connection to various external devices.

Referring still toFIGS. 2B and 2C, in the example shown, the elongate member120includes an outer tube136, which defines the outer surface126, and an inner liner138within the outer tube136, which defines the inner surface128. The inner liner138can be, for example, a polyimide or polytetrafluoroethylene liner, and the outer tube136can be, for example, made of a plastic such as high-density polyethylene (HDPE).

Referring toFIGS. 2B and 2C, in the example shown, the sheath110includes a set of echogenic bands associated with the distal end portion112and secured to the sidewall122. In the example shown, the set of echogenic bands includes three echogenic bands—i.e. a first140a, a second140b, and a third140cechogenic band—associated with the distal end portion112. As used herein, the phrase “associated with” indicates that the echogenic bands140a-140care positioned to allow for the determination of the location of the distal end portion112using the ultrasound system100, whether directly (e.g. as shown, where the echogenic bands140a-140care mounted directly to the distal end portion), or indirectly (e.g. in cases where echogenic bands are spaced from the distal end portion112and where a processing step, e.g. an extrapolation, is carried out to determine the location of the distal end portion112based on the location of the echogenic bands). In the example shown, the echogenic bands140a-140care mounted directly to the distal end portion112and are spaced apart along the distal end portion112.

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 toFIGS. 2A to 2C, in the example shown, each echogenic band140a,140b,140cis in the form of a respective coil142a,142b,142cof echogenic material (e.g. a metal or alloy such as stainless steel or platinum-iridium), which extends around the inner liner138and is sandwiched between the inner liner138and outer tube136, so that it is embedded in the sidewall122. Embedding the echogenic bands in the sidewall allows for the puncturing device to be advanced through the inner lumen without being obstructed (i.e., snagged) by the echogenic bands. The echogenic bands140a-140care spaced apart, for example by up to 5 mm (e.g. between 1 mm and 3 mm, or about 2 mm), so that the first echogenic band140aextends around a first portion144aof the inner liner138, the second echogenic band140bextends around a second portion144bof the inner liner138, and the third echogenic band140cextends around a third portion144cof the inner liner138. Each echogenic band140a-140ccan have a length146(where the length is measured longitudinally along the elongate member120) of, for example, up to 5 mm (e.g. between 1 mm and 3 mm, or about 2 mm).

Optionally, in order to fabricate the sheath110ofFIGS. 2A to 2C, the outer tube136, coils142a-142cof echogenic material, and inner liner138can first be assembled together. Then, the material of the outer tube136can be re-flowed (e.g. by the application of heat) to join the outer tube136, coils142a-142cof echogenic material, and inner liner138.

Referring now toFIGS. 3A and 3B, an alternative example of a sheath is shown. InFIGS. 3A and 3B, features that are like those ofFIG. 2will be referred to with like reference numerals, incremented by 100. The sheath310ofFIGS. 3A and 3Bincludes a single band340of echogenic material, in the form of a coil344of echogenic material. The band340of echogenic material has a greater length346than the bands of echogenic material ofFIG. 2.

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.

Referring now toFIGS. 4 to 11, a method for carrying out a cardiac procedure, specifically for creation of a transseptal perforation, will be described. As will be described in more detail, during the method, a representation of the distal end portion112of the sheath110can be added to the visual model108of the patient's heart. This can enhance the safety of the procedure. The method will be described with reference to the system100and sheath110as shown inFIGS. 1 to 2C; however, the method is not limited to being carried out with the system100and the sheath110ofFIGS. 1 to 2C, and the system100and sheath110ofFIGS. 1 to 2Care not limited to use according to the described method.

Referring toFIG. 4, as a first step, the U/S catheter102(not visible inFIG. 4) can be inserted into patient's body400and in conjunction with the ultrasound data processor104and imaging system106, can be used to create the 3-dimensional visual model108of the patient's heart402(shown inFIG. 5). Optionally, the ultrasound data can be registered with computerized tomography (CT) and/or magnetic resonance imaging (MRI) data, to enhance the resolution of the visual model108. Optionally, the visual model108can be used to check for a thrombus in the patient's heart402(this can be done repeatedly throughout the procedure).

Referring toFIG. 5, a guidewire404then be advanced via the femoral vein towards the heart402, and “parked” in the superior vena cava (SVC)406.

Referring toFIG. 6, with the dilator118(not visible inFIG. 6) shrouded in the sheath110, the dilator118and sheath110can be advanced over the guidewire404towards the SVC406. The guidewire404can then be removed, and the RF perforation device114(not visible inFIG. 6) can be advanced through the dilator118until the perforating tip116(not visible inFIG. 6) of the RF perforation device114is just shy of the distal end of the dilator118.

Referring now toFIG. 7, with the dilator118and radiofrequency perforation device114(not visible inFIG. 7) shrouded in the sheath110, the distal end portion112of the sheath110can be advanced towards a target location in the patient's heart402, to position the distal tip132of the sheath110adjacent the target location. The target location can be for example, the fossa ovalis408of the atrial septum410. As the sheath110is advanced to the target location, the U/S catheter102, ultrasound data processor104, and imaging system106(not shown inFIG. 7) can be engaged, and used to determine a location of the distal end portion112of the sheath110with respect to the patient's heart402. A representation of the distal end portion112can then be added to the visual model108of the patient's heart402, as shown inFIGS. 8A to 8C. Optionally, the imaging system106can be updated in real-time as the sheath112is advanced towards the target location.

The representation of the distal end portion112of the sheath110can be added to the 3-dimensional visual model108of the patient's heart402in various ways. For example, as shown inFIG. 8A, the imaging system106can generate an en-face view412from the distal end portion112of the sheath110(not shown inFIG. 8A), to show the atrial septum410and fossa ovalis408. For further example, as shown inFIG. 8B, the imaging system106can generate a side view414of the distal end portion112of the sheath110and an area of the patient's heart adjacent the distal end portion (e.g. the atrial septum410and fossa ovalis408). For further example, as shown inFIG. 8C, the imaging system106can generate a rear-view416of the distal end portion112of the sheath110and an area of the patient's heart adjacent the distal end portion (e.g. the atrial septum410and fossa ovalis408). Optionally, the various views can be presented simultaneously, for example in a split-screen view. Optionally, the user can select a desired view from multiple options. Optionally, the view can be fixed on the target location while the sheath110is advanced towards the target location.

In some examples, the system100can be configured to add to the visual model108a representation of a predicted contact location of the treatment device (in this case the perforation device114) and the target location. For example, as shown inFIG. 8A, prior to the perforation device114being advanced out of the sheath110, the imaging system106can add a mark418to the 3-dimensional visual model108, indicating the location where the perforation device114is predicted to contact tissue when it is advanced. This prediction can be made based the location of the sheath110as determined by the system100, and based on known parameters (e.g. curvature) of the perforation device114.

If the mark418is in the desired position with respect to the target location, e.g. on the fossa ovalis408as shown, the perforation device114can be advanced out of the sheath110. Alternatively, if the mark418is not in the desired position, e.g. spaced from the fossa ovalis408, then the position of the sheath110can be adjusted until the mark418is in the desired position, and the perforation device114can then be advanced out of the sheath110.

Referring toFIGS. 9 to 11, the perforation device114can then be engaged to perforate the fossa ovalis408, and the dilator118can be advanced from the sheath110to dilate the perforation. The sheath110can then be advanced through the perforation, to the left atrium.

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 portion110of the sheath110can 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 portion112of the sheath110can 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 dilator118, perforation device114, and sheath110can be withdrawn from the heart402. Optionally, during withdrawal, the representation of the distal end portion112of the sheath110can continue to be added to the visual model108of the patient's heart402.

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.