WO2020006070A1

WO2020006070A1 - Transesophageal echocardiography probe cover

Info

Publication number: WO2020006070A1
Application number: PCT/US2019/039225
Authority: WO
Inventors: Yoshihisa Morita; Raj MODAK
Original assignee: Henry Ford Health System
Priority date: 2018-06-26
Filing date: 2019-06-26
Publication date: 2020-01-02

Abstract

A cover for a transesophageal echocardiography (TEE) probe having an ultrasound transducer at a distal end thereof includes a first lumen arranged to receive the TEE probe therein, the first lumen having an open proximal end and a distal end. The cover further includes a second lumen generally parallel to the first lumen and arranged to receive an orogastric tube therein, the second lumen having an open proximal end and an open distal end, wherein the distal end of the first lumen extends beyond the distal end of the second lumen. At least one pad is disposed at the distal end of the first lumen for providing cushioning during a TEE procedure. When the TEE probe is received in the first lumen and the orogastric tube is received in the second lumen, the orogastric tube is positioned to provide suction adjacent to the ultrasound transducer during the TEE procedure.

Description

2017-016

TRANSESOPHAGEAL ECHOCARDIOGRAPHY PROBE COVER

CROSS-REFERENCE TO RELATED APPLICATIONS

[oooii This application claims the benefit of U.S. provisional application Serial No.

62/689,928 filed June 26, 2018, the disclosure of which is hereby incorporated in its entirety by reference herein.

TECHNICAL FIELD

[0002] Embodiments relate to a cover for a transesophageal echocardiography (TEE) probe.

BACKGROUND

[0003J Transesophageal echocardiography (TEE) has emerged as a standard intraoperative diagnostic tool for patients undergoing cardiac or non-cardiac surgery. For cardiac applications, TEE uses ultrasound to generate images of the heart structures and associated arteries by passing a TEE probe into a patient’s esophagus. TEE can help in the assessment of cardiac function, valve integrity, pressure gradient and measurement of structure size, and its role is becoming only more significant as novel, less-invasive surgical techniques move into clinical practice. Hence, there is a growing demand for improved imaging quality that would further enhance the value of this technique.

[0004] Although spatial resolution and post-processing have both made rapid strides, there is still room for improving the image quality of TEE in connection with transmitting ultrasound. Surgical decision-making by anesthesiologists and surgeons could be greatly improved by increased image quality, allowing more accurate intraoperative diagnosis. Moreover, there arc some complications that attend the TEE technique, such as probe-related trauma caused by the need to manipulate the probe in the esophagus or stomach to get a better view and by its high temperature with overuse, which it would be desirable to ameliorate.

I SUMMARY

[0005] In one or more embodiments, a cover for a transesophageal echocardiography (TEE) probe having an ultrasound transducer at a distal end thereof includes a first lumen arranged to receive the TEE probe therein, the first lumen having an open proximal end and a distal end. The cover further includes a second lumen generally parallel to the first lumen and arranged to receive an orogastric tube therein, the second lumen having an open proximal end and an open distal end, wherein the distal end of the first lumen extends beyond the distal end of the second lumen. At least one pad is disposed at the distal end of the first lumen for providing cushioning during a TEE procedure, wherein when the TEE probe is received in the first lumen and the orogastric tube is received in the second lumen, the orogastric tube is positioned to provide suction adjacent to the ultrasound transducer during the TEE procedure.

[0006] In one or more embodiments, a cover for a transesophageal echocardiography (TEE) probe having an ultrasound transducer at a distal end thereof includes a first lumen arranged to receive the TEE probe therein, the first lumen having an open proximal end and a closed distal end. The cover further includes a second lumen generally parallel to the first lumen and sharing a common inner wall with the first lumen, the second lumen arranged to receive an orogastric tube and having an open proximal end and an open distal end. At least one pad is embedded in the first lumen at the distal end thereof, wherein the pad contains ultrasound gel which provides media for ultrasound transmission by the ultrasound transducer and is arranged to contact the received TEE probe to restrain a position of the TEE probe with respect to the first lumen.

[0007] In one or more embodiments, a cover for a transesophageal echocardiography (TEE) probe includes a first lumen arranged to receive the TEE probe therein, the first lumen having an open proximal end and a distal end. The cover further includes a second lumen generally parallel to the first lumen and sharing a common inner wall with the first lumen, the second lumen arranged to receive an orogastric tube and having an open proximal end and an open distal end, wherein a length of the second lumen is less than a length of the first lumen. At least one pad containing ultrasound gel is disposed at the distal end of the first lumen, and a guide member is attached to the first lumen adjacent the distal end thereof and extends through the second lumen to facilitate insertion of the orogastric tube into the second lumen.

2 BRIEF DESCRIPTION OF THE DRAWINGS

[0008] FIGURE 1 is a cross-sectional illustration of a TEE probe cover according to one or more embodiments which is arranged to receive a TEE probe and an orogastric tube, and includes a gel pad;

[0009] FIGURE 2 is a top, cross-sectional illustration of a TEE probe cover according to one or more embodiments showing a first lumen, the received TEE probe and the gel pad;

[0010] FIGURE 3 is a side, cross-sectional illustration of the TEE probe cover of FIG. 2 showing a second lumen and the received orogastric tube;

[0011] FIGURE 4 is a front, cross-sectional illustration of the TEE probe cover of FIG. 2 showing the first and second lumens and the TEE probe and orogastric tube received therein, respectively;

[0012] FIGURE 5 is a perspective, partially cutaway view of a TEE probe cover according to one or more embodiments illustrating an optional funnel member;

[0013] FIGURE 6 is a cross-sectional illustration of a TEE probe cover according to one or more embodiments which includes a balloon shown in a deflated configuration; and

[0014] FIGURE 7 is a cross-sectional illustration of the TEE probe cover of FIG. 6 with the balloon shown in an inflated configuration.

DETAILED DESCRIPTION

[0015] As required, detailed embodiments of the present invention are disclosed herein; however, it is to be understood that the disclosed embodiments arc merely exemplary of the invention that may be embodied in various and alternative forms. The figures are not necessarily to scale; some features may be exaggerated or minimized to show details of particular components. Therefore, specific structural and functional details disclosed herein are not to be interpreted as limiting, but merely as a representative basis for teaching one skilled in the art to variously employ the present invention.

3 [0016] With an aim to achieve pinpoint suctioning without causing artifacts, enhanced image quality using a TEE probe with an attached orogastric tube (OGT) was investigated (Morita Y. et al., J Cardiothorac Vase Anesth. 2018 Apr 20. pii: SI 053-0770(18)30266-0. doi:

I0.1053/i.jvca.2018.04.035; incorporated by reference herein in its entirety). However, potential clinical complications may exist with the reported device, including damage to the upper gastrointestinal tract due to a rough surface of the TEE-OGT combination or potential OGT dislodgement.

[0017] Therefore, embodiments of a TEE probe cover are disclosed herein for improving echocardiography image quality and simultaneously decreasing the possibility of traumatic complications. With reference first to FIGS. 1 -5, embodiments of a TEE probe cover 10 arc illustrated, wherein the cover 10 may have a double lumen construction equipped to receive both a TEE probe 12 and an OGT 14. In one or more embodiments, the TEE probe cover 10 can be constructed from a plastic material, such as polypropylene, from rubber, or from other suitable materials.

[0018] A typical TEE probe 12 includes a handle 16 and a cable 18 for electrical communication with a TEE machine (not shown), wherein ultrasound imaging signals are displayed on a display (not shown). The TEE probe 12 has an elongated, flexible body 20 with a distal end 22 including an ultrasound transducer 24 and a proximal end 26. The probe handle 16 is near the proximal end 26 and functions to position and articulate the distal end 22 as desired relative to the target tissue. To image the heart, ultrasound pulses are emitted from the probe transducer 24 and the echoes from target structures arc detected by the transducer 24 in order to generate ultrasound images. Although the probe distal end 22 may be manipulated or articulated, it is generally desirable to minimize the contact between the probe distal end 22 and the esophageal wall to avoid traumatic mechanical or thermal injury to the tissue.

[0019] Accordingly, the TEE probe cover 10 has a first lumen 28 arranged to receive the TEE probe 12 and provide protection in the form of an interface between the TEE probe 12 and the esophageal or stomach tissue. As shown in FIGS. 1-3, the first lumen 28 has a proximal end 30 and a distal end 32. In one or more embodiments, the proximal end 30 is open for receiving the TEE probe 12 into the first lumen 28 and the distal end 32 is closed for limiting the insertion depth of the TEE probe 12. A cross-sectional area of the proximal end 30 may be greater than a cross-sectional area of the distal end 32, which may facilitate insertion of the TEE probe 12 into the first lumen 28.

[0020] In order to improve cchocardiographic image quality, an OGT 14 may be employed during TEE procedures, such as to suction air between the probe transducer 24 and the tissue wall and thereby remove the difference in ultrasound velocity between differing media introduced by intermediating gas, which leads to unwanted reflections of the ultrasound. The suctioning of excess air also prevents distension of the stomach during TEE examination and perioperative aspiration.

[0021] With continuing reference to FIGS. 1 and 3-5, the TEE probe cover 10 may therefore include a second lumen 34 generally parallel to the first lumen 28 and arranged to receive the OGT 14, wherein the first and second lumens 28, 34 may share a common inner wall 36. The second lumen 34 has a proximal end 38 and a distal end 40. The first and second lumens 28, 34 can be designed with different calibers, diameters, and/or lengths to accommodate difierent-sized TEE probes 12 and OGTs 14 as necessary, wherein a cross-sectional area of the first lumen 28 may be larger than a cross- sectional area of the second lumen 34.

[0022] In one or more embodiments, the proximal end 38 is open for receiving the OGT 14 into the second lumen 34 and the distal end 40 is open so that the OGT 14 can provide suctioning. As shown, a length of the second lumen 34 may be less than a length of the first lumen 28, wherein the proximal end 30 of the first lumen 28 may be located adjacent to or extend beyond the proximal end 38 of the second lumen 34 to facilitate insertion of the OGT 14 and so that the location of the OGT 14 will not interfere with the handle 16 or manipulation of the TEE probe 12.

[0023] The distal end 32 of the first lumen 28 may extend beyond the distal end 40 of the second lumen 34. The distal end 40 of the second lumen 34 may terminate adjacent or prior to the location of the probe transducer 24 at the probe distal end 22, allowing the OGT 14 to be positioned optimally to pin-point suction away any air or fluid that may be present between the transducer 24 and the tissue wall during the TEE procedure. Decreasing esophagus and stomach air between the TEE probe transducer 24 and the tissue wall using the OGT 14 retained in optimal position by the TEE probe cover 10 disclosed herein will reduce ultrasound reflection and has the potential to lead to better image quality. Belter image quality has the potential to help surgical decision making with precise assessment and fewer TEE probe-related complications secondary to unnecessary probe manipulation. As with the TEE probe 12, the cover 10 also provides protection in the form of an interface between the OGT 14 and the esophageal or stomach tissue in order to prevent injury.

[0024] Various TEE probes and OGTs may be used in connection with the embodiments of the TEE probe cover 10 disclosed herein. In one non-limiting example, the TEE probe cover 10 can be designed to include a TEE probe such as an X7 TEE probe (Philips Medical Systems, Andover, MA, USA) and can be designed to include an OGT such as a 12-Frcnch orogastric suction tube (COVIDIEN LLC, Mansfield, M A, USA). The OGT may be attached to a conventional suction device (not shown) as used routinely in an operating room. Two-dimensional and three-dimensional TEE images can be collected, for example, using an iE33 cchocardiographic machine (Philips Medical Systems, Andover, MA, USA), where better 3D image quality is based on better 2D image quality serving as a baseline. It is understood that the TEE probe cover 10 can be constructed to accommodate TEE probes and OGTs of various lengths and outer diameters. Furthermore, although a suctioning function of the OGT 14 is described herein, it is understood that irrigation could also be provided via the second lumen 34. Still further, it is contemplated that the second lumen 34 could receive a different type of medical device altogether.

[0025] With reference again to FIGS. 1-3, the TEE probe cover 10 may include at least one pad 42 that functions as a cushion for preventing surrounding tissue trauma. In one or more embodiments, the pad 42 may be located adjacent a distal end 32 of the first lumen 28. Tne pad 42 may be embedded in the first lumen 28 and at least partially surrounding a circumference thereof, wherein the pad 42 may have any suitable shape or size. When the TEE probe 12 is inserted into the first lumen 28, the transducer 24 may be generally aligned with the pad 42. The pad 42 may contain gel, such as ultrasound gel, which may function not only as a cushion to protect surrounding tissue but also as media to transmit ultrasound effectively, further improving ultrasound image quality. Also, the pad 42 may function as a shield to prevent any thermal injury by a warmed TEE probe 12 and/or transducer 24. Although the TEE probe 12 typically has an alarm system to prevent thermal injury, this complication has been reported clinically. Still further, the pad 42 and its contained ultrasound gel may be arranged to contact the TEE probe 12 and provide an adhesive function to restrain the position of the TEE probe 12 inside the first lumen 28. In this way, the TEE probe 12 and transducer 24 can be retained in an optimal position for imaging without possible interference from the OGT 14. [0026] In some instances, the OGT 14 may be received in the second lumen 34 prior to insertion of the TEE probe 12. However, in other instances, insertion of the OGT 14 may happen subsequent to the insertion of the TEE probe cover 10 and contained TEE probe 12 into the esophagus (in situ). As such, insertion of the OGT 14 into and through the second lumen 34 may be facilitated by the TEE probe 12 functioning as a mechanical guide. With reference to FIG. 3, a guide member 44 such as a silk thread, wire, tube or ribbon made of flexible material can also be provided to facilitate insertion and proper positioning of the OGT 14 in the second lumen 34. The guide member 44 may be attached near the distal end 32 of the first lumen 28 and extend through the second lumen 34 and out its proximal end 38. The OGT 14 can then be fed over the guide member 44 and through the second lumen 34 The guide member 44 may serve to restrain the position of the OGT 14 such that a distal end 46 of the OGT 14 will not extend beyond the distal end 40 of the second lumen, thus preventing any trauma to surrounding tissue

[0027] In order to facilitate insertion of the OGT 14 into the second lumen 34. the OGT 14 may also be provided with a stylet 48 on the distal end 46 thereof as illustrated in FIG. 3, The stylet 48 will not contact the surrounding tissue as it will remain contained in the second lumen 34, and thus the risk of complications would be minimal. A lubricant such as, but not limited to, a silicone spray may be applied to at least part of the OGT 14 (e.g distal end 46) to facilitate insertion of the OGT 14 into the second lumen 34. In one or more embodiments, the TEE probe 12 may be inserted into the first lumen 28 using a funnel member 50 as shown in FIG. 5 After the TEE probe 12 is positioned within the first lumen 28, the funnel member 50 can be separated from the probe 12 and the cover 10 can be secured to the probe 12, such as via a dip or rubber band (not shown)

[0028] In the embodiment shown in FIGS. 6-7, the TEE probe cover 10 may include an inflatable bal loon 52 housed therein to function as a cushion near the distal end 32 of the first lumen 28, or in an additional lumen contained with the cover 10. The balloon 52 is constructed from a flexible, distensible material and may be inflated by introducing a fluid therein under pressure from a fluid source via a conduit (not shown ). Non-limiting examples of materials for the balloon 52 include elastic rubbers and polymers, wherein the lumen in which the balloon 52 is contained should be sufficiently elastic to accommodate inflation of the balloon 52. In one example, the fluid used for inflation may include normal saline (NS), which will provide better media for ultrasound penetrance than air, and thereby improve ultrasound image quality. When balloon 52 is inflated as shown in FIG. 7, the balloon 52 presses against the esophageal or stomach wall. The inflated balloon 52 may function as a cushion and shield to protect patient tissue from trauma and thermal injury, respectively. It is understood that the embodiment of FIGS. 6-7 can be an alternative to the embodiment of FIGS. 1-5, or the embodiments of FIGS, 1-5 and FIGS. 6-7 can be combined to form another embodiment.

[0029] Embodiments of the TEE probe cover 10 disclosed herein offer the advantage not only of superior image quality but also reduced risk of trauma to surrounding tissue, because by achieving the desired image quality sooner the need for the cchocardiographcr to manipulate the probe in order to get a better view is avoided. Traditional TEE examinations without the disclosed TEE probe cover 10 may cause damage to the esophagus and stomach, as evidenced by blood in the orogastric tube. TEE probe-related trauma can be of special concern for cardiac patients for whom full heparinization is necessary, for aortic stenosis patients who have acquired von Willebrand disease and angiodysplasia, and for patients with end-stage liver disease who commonly have esophageal or gastric varices as well as coagulopathy. Among TEE standard views, transgastric or deep transgas trie TEE views arc useful for assessment of aortic valve pressure gradient and valve integrity especially for aortic valvulopalhy patients and aortic valve procedures, where the need to minimize unnecessary manipulation of the TEE probe is acute.

[0030] Perioperative TEE assessment of cardiac function, volume status, valve size, and valve integrity are very important information on which surgical decision-making is dependent Precise and quick surgical decisions would lead io better patient outcomes, less procedure time, less surgical complications due to shortened cardiopulmonary bypass time, and less chance of the revision of procedures. Fewer complications from trauma to the surrounding tissues would be also expected due to less necessity for TEE probe manipulation as well as due to the ultrasound gel-containing pads functioning as a cushion. Also, the expected enhanced image quality should encourage more use of the TEE probe cover 10, which would simplify the TEE probe washing process and contribute to rapid turnover of cases, better sterility, and better maintenance and protection of the TEE probe. The use of the TEE probe cover 10 disclosed herein may provide a defense against cross-contamination, chemical injury due to residual detergent, and bum injury due to an increased temperature of the transducer. Cost reduction accompanying utilization of the disclosed TEE probe cover 10 would be beneficial to patients, hospitals and insurance companies. [0031] While exemplary embodiments arc described above, it is not intended that these embodiments describe all possible forms of the invention. Rather, the words used in the specification are words of description rather than limitation, and it is understood that various changes may be made without departing from the spirit and scope of the invention. Additionally, the features of various implementing embodiments may be combined to form further embodiments of the invention.

Claims

WHAT IS CLAIMED IS:

1. A cover for a transesophageal echocardiography (TEE) probe having an ultrasound transducer at a distal end thereof, the cover comprising;

a first lumen arranged to receive the TEE probe therein, the first lumen having an open proximal end and a distal end;

a second lumen generally parallel to the first lumen and arranged to receive an orogastric tube therein, the second lumen having an open proximal end and an open distal end, wherein the distal end of the first lumen extends beyond the distal end of the second lumen; and

at least one pad disposed at the distal end of the first lumen for providing cushioning during a

TEE procedure,

wherein when the TEE probe is received in the first lumen and the orogastric tube is received in the second lumen, the orogastric tube is positioned to provide suction adjacent to the ultrasound transducer during the TEE procedure.

2. The cover of claim 1, wherein Ihe at least one pad is embedded in the first lumen and arranged to contact the received TEE probe.

3. The cover of claim 1 , wherein the at least one pad contains ultrasound gel.

4. The cover of claim 1, wherein the distal end of the first lumen is closed.

5. The cover of claim I, wherein the proximal end of the first lumen extends beyond the proximal end of the second lumen.

6. The cover of claim 1, further comprising a guide member extending through the second lumen to facilitate insertion of the orogastric tube into the second lumen.

7. The cover of claim 6, wherein the guide member is attached to the first lumen adjacent the distal end thereof.

8 The cover of claim 1, further comprising an inflatable balloon disposed adjacent the distal end of the first lumen.

9, A cover for a transesophageal echocardiography (TEE) probe having an ultrasound transducer at a distal end thereof, the cover comprising:

a first lumen arranged to receive the TEE probe therein, the first lumen having an open proximal end and a closed distal end;

a second lumen generally parallel to the first lumen and sharing a common Inner wall with the first lumen, the second lumen arranged to receive an orogastric tube and having an open proximal end and an open distal end; and

at least one pad embedded in the first lumen at the distal end thereof, wherein the pad contains ultrasound gel which provides media for ultrasound transmission by the ultrasound transducer and is arranged to contact the received TEE probe to restrain a position of the TEE probe with respect to the first lumen.

10 The cover of claim 9, wherein the distal end of the first lumen extends beyond the distal end of the second lumen.

1 1. The cover of claim 9, wherein the proximal end of the first lumen extends beyond the proximal end of the second lumen.

12. The cover of claim 9, further comprising a guide member extending through the second lumen to facilitate insertion of the orogastric tube into the second lumen.

13. The cover of claim 12, wherein the guide member is attached to the first lumen adjacent the distal end thereof.

14. The cover of claim 9 further comprising an inflatable balloon di sposed adjacent the di stal end of the first lumen.

15. A cover for a transesophageal echocardiography (TEE) probe, the cover comprising: a first lumen arranged to receive the TEE probe therein, the first lumen having an open proximal end and a distal end;

a second lumen generally parallel to the first lumen and sharing a common inner wall with the first lumen, the second lumen arranged to receive an oro gastric tube and having an open proximal end and an open distal end, wherein a length of the second lumen is less than a length of the first lumen; at least one pad containing ultrasound gel is disposed at the distal end of the first lumen; and a guide member attached to the first lumen adjacent the distal end thereof and extends through the second lumen to facilitate insertion of the orogastric tube in to the second lumen.

16. The cover of claim 15, wherein the guide member includes a silk thread,

17. The cover of claim 15, wherein the at least one pad is embedded in the first lumen and arranged to contact the received TEE probe.

18. The cover of claim 15, wherein the proximal end of the first lumen extends beyond the proximal end of the second lumen

19. The cover of claim 1 5, wherein the distal end of the first lumen extends beyond the distal end of the second lumen.

20. The cover of claim Ϊ 5, fort her comprising an inflatable balloon disposed adjacent the distal end of the first lumen.