WO2021161154A1

WO2021161154A1 - System and method for carrying out a medical procedure

Info

Publication number: WO2021161154A1
Application number: PCT/IB2021/051013
Authority: WO
Inventors: Gareth Davies; John Paul Urbanski
Original assignee: Baylis Medical Company Inc.; Baylis Medical Usa Inc.
Priority date: 2020-02-11
Filing date: 2021-02-08
Publication date: 2021-08-19

Abstract

A system for carrying out a medical procedure includes a medical device for advancing into a patient's body towards an anatomical volume, and a medical imaging system. The medical imaging system is configured to generate a graphical representation of the anatomical volume and to provide in the graphical representation real-time information about the position of the medical device within the anatomical volume. The medical imaging system includes a safety module configured to select one or more regions within the graphical representation for designation as a non-target region, and to monitor the position of the medical device within the anatomical volume and take a safety action if the position of the medical device within the anatomical volume corresponds to one of the non-target regions.

Description

SYSTEM AND METHOD FOR CARRYING OUT A MEDICAL PROCEDURE FIELD:

[0001] This document relates to medical procedures that use medical imaging. More specifically, this document relates to systems for carrying out medical procedures such as cardiac procedures, and related methods.

SUMMARY:

[0002] The following summary is intended to introduce the reader to various aspects of the detailed description, but not to define or delimit any invention.

[0003] Systems for carrying out medical procedures are disclosed. According to some aspects, a system for carrying out a medical procedure includes a medical device for advancing into a patient’s body towards an anatomical volume, and a medical imaging system. The medical imaging system is configured to generate a graphical representation of the anatomical volume and to provide in the graphical representation real-time information about the position of the medical device within the anatomical volume. The medical imaging system includes a safety module configured to select one or more regions within the graphical representation for designation as a non-target region, and to monitor the position of the medical device within the anatomical volume and take a safety action if the position of the medical device within the anatomical volume corresponds to one of the non-target regions.

[0004] In some examples, the safety action includes triggering a visual alert within the graphical representation. In some examples, the safety action includes changing a state of the medical device.

[0005] In some examples, the safety module is further configured to select one or more other regions within the graphical representation for designation as a target region. In some examples, the safety module is configured to designate any region not designated as the target region as the non-target region.

[0006] In some examples, the system is configured to designate an enlarged area around a selected region as the non-target region.

[0007] In some examples, the medical device is a radiofrequency perforation device. [0008] In some examples, the graphical representation is a 3-dimentional graphical representation.

[0009] In some examples, the medical imaging system employs at least one of el ectroan atomi cal mapping, ultrasound, magnetic resonance imaging, fluoroscopy, echocardiography, and computerized tomography to generate the graphical representation.

[0010] Methods for carrying out a medical procedure are also disclosed. According to some aspects, a method for carrying out a medical procedure includes a. using an imaging system to generate a graphical representation of an anatomical volume of a patient; b. using the imaging system to select one or more regions within the graphical representation for designation as a non target region; c. advancing a medical device into the patient’s body towards the anatomical volume; d. using the imaging system to provide in the graphical representation real-time information about the position of the medical device within the anatomical volume; e. using a safety module of the imaging system to monitor the position of the medical device within the anatomical volume and to take a safety action if the position of the medical device within the anatomical volume corresponds to one of the non-target regions.

[0011] In some examples, the anatomical volume is a heart and the medical device is a perforation device (for example, radiofrequency perforation device, mechanical perforation, etc.,).

[0012] In some examples, step b. further includes selecting one or more regions within the graphical representation for designation a target region, and the target region corresponds to a fossa ovalis of the patient’s heart.

[0013] In some examples, step a. includes generating a 3-dimensional graphical representation of the anatomical volume.

[0014] In some examples, step a. includes employing at least one of electro-anatomical mapping, ultrasound, magnetic resonance imaging, fluoroscopy, echocardiography, and computerized tomography to generate the graphical representation.

[0015] In some examples, step e. includes triggering a visual alert within the graphical representation. In some examples, step e. includes changing a state of the medical device. In some examples, step e. comprises preventing the medical device from operating. [0016] In some examples, step b. includes selecting one or more regions within the graphical representation for designation as a target region, and automatically designating any region not identified as the target region as the non-target region.

[0017] In some examples, step b. includes selecting in the graphical representation a representation of an anatomical structure that is not intended for contact with the medical device, and designating an enlarged region around the representation of the anatomical structure as the non-target region.

[0018] In some examples, step b. includes selecting in the graphical representation a representation of an anatomical structure that is intended for contact with the medical device, and designating a shrunken region around the representation of the anatomical structure as the target region.

BRIEF DESCRIPTION OF THE DRAWINGS:

[0019] 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:

[0020] Figure 1 is a schematic perspective view of an example system for carrying out a medical procedure;

[0021] Figure 2 is a schematic view of a graphical representation of a heart, in which the region corresponding to the aorta has been designated as a non-target region;

[0022] Figure 3 is a schematic view of a graphical representation of a fossa ovalis, in which a position of a medical device is displayed in real time, and in which the position of the medical device corresponds to a target region;

[0023] Figure 4 is a schematic view of a graphical representation of a fossa ovalis, in which a position of a medical device is displayed in real time, and in which the position of the medical device corresponds to a non-target region; and

[0024] Figure 5 is a flowchart showing an example method for carrying out a medical procedure.

DETAILED DESCRIPTION: [0025] 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.

[0026] Generally disclosed herein are systems that can be used in medical procedures, such as cardiac procedures. For example, the systems 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, mechanical perforation, etc.,) and dilator are guided through the sheath, to the right atrium. When the sheath is adjacent a target region 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 region, 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.

[0027] The systems disclosed herein allow for a graphical representation (e.g. a 3D graphical model) of an anatomical volume (e.g. the patient’s heart) to be generated, and for various regions in the graphical representation to be selected for designation as either “target” regions or “non target” regions. In the graphical representation, the target regions correspond to anatomical regions that the various parts of the system (e.g. the sheath, the dilator, and/or the perforation device) are intended to approach or contact during the medical procedure (e.g. the fossa ovalis of the right atrium), and the non-target regions correspond to anatomical regions that the various parts of the system are not intended to contact during the medical procedure (e.g. the aorta), as contact with such regions may cause damage. During the procedure, the system can provide real-time information about the position of the medical device. For example, a real-time representation of the position of the sheath, the dilator, and/or the perforation device within the patient’s heart can be added to the graphical representation. Furthermore, the system is configured to monitor the position of the medical device within the anatomical volume, and to take a safety action if the position of the medical device corresponds to a non-target region. For example, the system can provide an alert (e.g. a visual alert within the graphical representation) or take another action (e.g. automatically turn-off the perforation device) if the medical devices approach or contact or enter a region in the anatomical volume corresponding to a non-target region. This can enhance patient safety by preventing or minimizing the risk of inadvertently perforating or harming a non-target region.

[0028] The systems disclosed herein can generally include one or more medical devices (e.g. a sheath and/or a dilator and/or an RF perforation device) for advancing towards an anatomical volume (e.g. a heart or another organ), and a medical imaging system for generating a graphical representation of the anatomical volume (e.g. a system employing electro-anatomical mapping, ultrasound, magnetic resonance imaging, computerized tomography, or a combination thereof). The medical imaging system includes a safety module that enhances safety of the medical procedure by taking a safety action (e.g. issuing an alert) if the position of the medical device within the anatomical volume corresponds to a region designated as a non-target region.

[0029] Referring now to Figure 1, an example system 100 for carrying out a medical procedure is shown. In the example shown, the system 100 is a transseptal perforation system, for advancing towards a patient’s heart and perforating a fossa ovalis of the patient’s heart. The system includes a set of medical devices, including a sheath 102, a dilator 104, and a radiofrequency (RF) perforation device 106 having a perforating tip 108. The sheath 102 can be advanced intravenously via the femoral vein towards the right atrium of the patient’s heart. The dilator 104 and RF perforation device 106 can both be advanced towards the patient’s heart via the sheath 102. The RF perforation device 106 can be connected to a radiofrequency generator (not shown), which can in turn be connected to one or more grounding pads (not shown). When in the desired position in the patient’s heart, for example adjacent the fossa ovalis, the RF perforation device 106 can be activated to perforate the fossa ovalis. RF perforation devices, dilators, sheaths, generators, and grounding pads 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.

[0030] In alternative examples, the system can include additional or alternative medical devices, including therapeutic devices such as ablation catheters (e.g. for targeting a pulmonary vein).

[0031] Referring still to Figure 1, the system 100 further includes a medical imaging system 110. The medical imaging system 110 is configured to generate a graphical representation 112 of an anatomical volume and to provide in the graphical representation 112 real-time information about the position of the medical device(s) (e.g. the sheath 102, the dilator 104, and/or the RF perforation device 106) within the anatomical volume. The imaging system 110 can employ various imaging technologies in order to generate the graphical representation 112 of the anatomical volume, such as electroanatomical mapping, ultrasound, magnetic resonance imaging, and computerized tomography. Optionally combinations of these technologies can be used and integrated in order to generate the graphical representation 112. Generation of a graphical representation of an anatomical volume is known in the art, and will not be described in detail herein. Examples of systems that can generate a graphical representation of an anatomical volume are sold by Biosense Webster® under the brand name Carto®, by Abbott under the brand name EnSite™, and by Siemens Healthcare Limited under the brand name Acuson Sequoia™. Additional examples can include virtual reality and alternate reality systems, such as Pixel 3D.

[0032] The imaging system 110 includes a safety module. The safety module can be built into the imaging system 110 or can be sold separately and connected to the imaging system 110, and can include various hardware and software not described in detail herein. The safety module is configured to select (e.g. upon user input) one or more regions within the graphical representation for designation as a non-target region, to monitor the position of the medical device(s) (e.g. the sheath 102, the dilator 104, and/or the RF perforation device 106) within the anatomical volume, and to take a safety action if the position of the medical device(s) within the anatomical volume corresponds one of the non-target regions.

[0033] More specifically, referring to Figure 2, once the imaging system has generated the graphical representation 112 of the anatomical volume, the user (e.g. a surgeon or other medical professional) can interact with a user interface (not shown) of the safety module, to select one or more regions within the graphical representation 112 for designation as a non-target region 114. For example, in a transseptal perforation procedure, various anatomical structures can be at risk of inadvertent perforation. One such structure is the aorta. Using the user interface, the user can identify in the graphical representation 112 the region corresponding to the aorta, and select this region for designation as a non-target region 114. This can be done, for example, by touching the graphical representation of the aorta on a touchscreen. Optionally, the safety module can automatically identify various anatomical structures within the graphical representation 112 (e.g. by labelling the graphical representation), to facilitate this step. The safety module can also optionally visually highlight any regions designated as non-target regions 114, for example by displaying the non-target regions in a particular color or using a particular fill (as shown in Figure 2).

[0034] In the example described above, the user actively selects the region for designation as a non-target region 114. In alternative examples, a non-target region 114 can be passively designated. For example, referring to Figure 3, within the graphical representation 112, the user can select a region for designation as a target region 116 (i.e. the region corresponding to the fossa ovalis, as shown) or as a neutral region (e.g. the region corresponding to the right atrium). The safety module can then automatically designate any other regions as non-target regions 114. In further alternative examples, the user can actively select both the non-target regions 114 and the target regions 116 (and also optionally the neutral regions).

[0035] Optionally, in order to further enhance safety, the safety module can be configured to scale the user’s selection when designating the target region 114. That is, the graphical representation 112 may include small errors, and boundaries of various anatomical structures may not be accurately represented. In order to account for this, when the user selects in the graphical representation 112 an anatomical structure that is not intended for contact with the medical device (e.g. when the user selects the aorta for designation as a non-target structure), the safety module can designate an enlarged region around that anatomical structure as the non-target area 114. For example, if the user selects the aorta as a non-target structure, the safety module can designate the aorta and a boundary area around the aorta as the non-target structure 114. This can be achieved by considering each boundary point of the selected region as a sphere, and increasing the diameter of the sphere to create a buffer zone. Optionally, the size of the boundary area can be selected by the user.

[0036] In examples in which the user selects in the graphical representation 112 an anatomical structure that is intended for contact with the medical device (e.g. the fossa ovalis), rather than designating an enlarged region around that anatomical structure, the safety module can designate a shrunken region around that anatomical structure as a target structure.

[0037] Once the non-target areas 114 have been designated, the medical procedure can proceed. Referring to Figure 3, during the medical procedure, the medical imaging system 110 can provide, in the graphical representation 112, real-time information about the position of the medical device(s) within the anatomical volume. For example, as shown, an image of the distal end of the sheath 102 can be added to the graphical representation 112, and its position can be shown in real time as it advances towards the fossa ovalis. If the position of the distal end corresponds to the target region 116, and does not correspond to a non-target region 114, the medical procedure can proceed. Referring to Figure 4, if, during the procedure, the position of the sheath 102 corresponds to a non-target region (e.g. if the distal end of the sheath strays from the fossa ovalis, as shown in Figure 4), the safety module can take a safety action. Various safety actions can be taken, such as issuing an alert (e.g. a visual alert within the graphical representation as shown in Figure 4, or an auditory alert), or changing the state of the medical device(s) (e.g. turning off the RF perforation device, or otherwise preventing the medical device from operating).

[0038] In an alternative example, the safety action can be taken by default, until the position of the medical device(s) corresponds to a target region. For example, the safety module can prevent the medical device(s) from operating (e.g. prevent delivery of an RF pulse) while the medical device is in a position corresponding to a non-target region or a neutral region, and allow the medical device to operate only when the medical device is in a position corresponding to a target region (e.g. when the medical device contacts the fossa ovalis).

[0039] The above described steps are generally shown in Figure 4. [0040] 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.

[0041] 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.

Claims

WE CLAIM:

1. A system for carrying out a medical procedure, comprising: a medical device for advancing into a patient’s body towards an anatomical volume; and a medical imaging system configured to generate a graphical representation of the anatomical volume and to provide in the graphical representation real-time information about the position of the medical device within the anatomical volume; wherein the medical imaging system includes a safety module configured to select one or more regions within the graphical representation for designation as a non target region, and to monitor the position of the medical device within the anatomical volume and take a safety action if the position of the medical device within the anatomical volume corresponds to one of the non-target regions.

2. The system of claim 1 , wherein the safety action comprises triggering a visual alert within the graphical representation.

3. The system of claim 1, wherein the safety action comprises changing a state of the medical device.

4. The system of claim 1, wherein the safety module is further configured to select one or more other regions within the graphical representation for designation as a target region.

5. The system of claim 4, wherein the safety module is configured to designate as the non target region any region not designated as the target region.

6. The system of claim 1, wherein the system is configured to designate as the non-target region an enlarged area around the selected region.

7. The system of claim 1, wherein the medical device is a perforation device.

8. The system of claim 1, wherein the graphical representation is a 3-dimensional graphical representation.

9. The system of claim 1, wherein the medical imaging system employs at least one of electroanatomical mapping, ultrasound, magnetic resonance imaging, and computerized tomography to generate the graphical representation.

10. A method for carrying out a medical procedure, comprising: a. using an imaging system to generate a graphical representation of an anatomical volume of a patient; b. using the imaging system to select one or more regions within the graphical representation for designation as a non-target region; c. advancing a medical device into the patient’s body towards the anatomical volume; d. using the imaging system to provide in the graphical representation real-time information about the position of the medical device within the anatomical volume; e. using a safety module to monitor the position of the medical device within the anatomical volume and to take a safety action if the position of the medical device within the anatomical volume corresponds to one of the non-target regions.

11. The method of claim 10, wherein the anatomical volume is a heart and the medical device is a radiofrequency perforation device.

12. The method of claim 11, wherein step b. further comprises selecting one or more regions within the graphical representation for designation as a target region, and the target region corresponds to a fossa ovalis of the patient’s heart.

13. The method of claim 10, wherein step a. comprises generating a 3 -dimensional graphical representation of the anatomical volume.

14. The method of claim 10, wherein step a. comprises employing at least one of electroanatomical mapping, ultrasound, magnetic resonance imaging, and computerized tomography to generate the graphical representation.

15. The method of claim 10, wherein step e. comprises triggering a visual alert within the graphical representation.

16. The method of claim 10, wherein step e. comprises changing a state of the medical device.

17. The method of claim 16, wherein step e. comprises preventing the medical device from operating.

18. The method of claim 10, wherein step b. comprises selecting one or more regions within the graphical representation for designation as a target region, and automatically designating as the non-target region any region not identified as the target region.

19. The method of claim 10, wherein step b. comprises selecting in the graphical representation a representation of an anatomical structure that is not intended for contact with the medical device, and designating an enlarged region around the representation of the anatomical structure as the non-target region.

20. The method of claim 10, wherein step b. comprises selecting in the graphical representation a representation of an anatomical structure that is intended for contact with the medical device, and designating a shrunken region around the representation of the anatomical structure as a target region.

21. The system of claim 7, wherein the perforation device is a radiofrequency.