WO2008057566A2

WO2008057566A2 - Attachable ultrasound imaging device

Info

Publication number: WO2008057566A2
Application number: PCT/US2007/023463
Authority: WO
Inventors: Amir Belson
Original assignee: Amir Belson
Priority date: 2006-11-07
Filing date: 2007-11-07
Publication date: 2008-05-15
Also published as: WO2008057566A3

Abstract

An ultrasound imaging device is delivered into a body lumen by an endoscope or other elongated probe and attached to a tissue wall. The ultrasound imaging device is then detached from the endoscope so that the endoscope or another instrument can be advanced distally in the body lumen and/or through an opening or incision in the tissue wall for performing a diagnostic or therapeutic procedure while using ultrasound imaging. The ultrasound imaging device may include an expandable fixation device for fixing the ultrasound imaging transducer in a desired position within the body lumen leaving an open passage for advancing an endoscope or other instrument through the body lumen. Alternatively, the ultrasound imaging device may include an incision closure device for attaching the ultrasound imaging transducer to a tissue wall and for closing an incision after withdrawal of an endoscope or other instrument that has been inserted through the incision.

Description

ATTACHABLE ULTRASOUND IMAGING DEVICE

CROSS REFERENCE TO OTHER APPLICATIONS

The present application claims the benefit of U.S. Provisional Application 60/857,280, filed on November 7, 2006.

FIELD OF THE INVENTION

The present invention relates to an ultrasound imaging device for insertion into a body lumen for imaging tissues surrounding the body lumen. The ultrasound imaging device is configured to be delivered into the body lumen with an endoscope or probe and fixed in place within the body lumen. The ultrasound imaging device is then detached from the endoscope or probe. The ultrasound imaging device has a low profile so that it can remain in place without obstructing the body lumen into which it is inserted. The ultrasound imaging device is particularly useful for transesophageal echography and transesophageal echocardiography (TEE).

BACKGROUND OF THE INVENTION

TEE has become an important diagnostic tool in cardiology and an important imaging tool during many catheter-based interventions and minimally invasive surgical procedures. One disadvantage of TEE as it is currently performed is that the TEE probe obstructs the patient's esophagus for the duration of the procedure. Consequently, TEE cannot be used during catheter- based or surgical interventions that are performed via a transesophageal or transgastric route. With a growing interest in transesophageal and transgastric interventions, it would be desirable to provide an ultrasound imaging device that can be used for performing TEE without obstructing the lumen of the esophagus. SUMMARY OF THE INVENTION

In keeping with the foregoing, the present invention provides an ultrasound imaging device that is configured to be delivered into a body lumen by an endoscope or other elongated probe and attached to a tissue wall within the body lumen. The ultrasound imaging device is then detached from the endoscope or the probe so that the endoscope or another instrument can be advanced distally, proximally and/or through an opening or incision in the tissue wall for performing a diagnostic or therapeutic procedure assisted by ultrasonic imaging using the ultrasound imaging transducer. Images from the ultrasound imaging transducer can be transmitted to an imaging monitor through a signal transmission wire or using wireless signal transmission.

In one aspect of the invention, the ultrasound imaging device includes an expandable fixation device for fixing the ultrasound imaging transducer in a desired position within the body lumen. The expandable fixation device is preferably configured so that it leaves an open passage for advancing an endoscope or other instrument through the body lumen. In another aspect of the invention, the ultrasound imaging device includes an incision closure device for attaching the ultrasound imaging transducer to a tissue wall in a desired position within the body lumen and for closing an incision after withdrawal of an endoscope or other instrument that has been inserted through the incision. In another aspect of the invention, the ultrasound imaging device includes the ability to control and change its position/angle to enable change in the area that is being imaged.

BRIEF DESCRIPTION OF THE DRAWINGS

FIG 1 shows a sagittal view of a patient with a flexible endoscope inserted into the esophagus for placement of the ultrasound imaging device.

FIG 2 shows a sagittal view of the patient with the ultrasound imaging device attached within the esophagus and the flexible endoscope advanced farther down the esophagus. FIG 3 shows a sagittal view of the patient with the ultrasound imaging device attached within the esophagus and the flexible endoscope withdrawn.

FIG 4 shows a cutaway view of the patient's esophagus with the ultrasound imaging device attached to the esophageal wall.

FIG 5 shows a cutaway view of the patient's esophagus with an embodiment of the ultrasound imaging device having a stent-like fixation mechanism.

FIG 6 shows a cutaway view of the patient's esophagus with an embodiment of the ultrasound imaging device having a fixation mechanism with two expandable bands.

FIG 7 shows a cutaway view of the patient's esophagus with an embodiment of the ultrasound imaging device having an inflatable fixation mechanism.

FIG 8 shows a cutaway view of the patient's esophagus with an embodiment of the ultrasound imaging device having an expandable caliper fixation mechanism.

FIG 9 shows a cross section of the patient's esophagus with the ultrasound imaging device of FIG 8 having an expandable caliper fixation mechanism.

FIG 1OA shows an incision closure device with an ultrasound imaging device mounted to it. FIG 1OB shows the closure device in a closed position with the ultrasound imaging device removed.

FIG 1 IA shows another incision closure device with an ultrasound imaging device mounted to it. FIG 11 B shows the closure device in a closed position with the ultrasound imaging device removed.

FIG 12A shows a ring-shaped incision closure device with an ultrasound imaging device mounted to it. FIG 12B shows the closure device in a closed position with the ultrasound imaging device removed. DESCRIPTION OF THE INVENTION

The present invention provides an ultrasound imaging device configured for insertion into a body lumen for imaging tissues surrounding the body lumen. The ultrasound imaging device includes a fixation mechanism to hold the device in place without obstructing the body lumen into which it is inserted. In one embodiment, the device includes a feature that enable it to aim the ultrasound beam or change the position or angle of the device relative to the wall. This will enable it to change the area that is being imaged. The ultrasound imaging device is particularly useful for transesophageal echography (for example: during transesophageal mediastinal procedures) or transesophageal echocardiography (TEE). The ultrasound imaging device is also useful for placement within other organs like the stomach, uterus, vagina, colon, urinary bladder etc. for imaging across a tissue wall. The ultrasound imaging device is can be used for imaging during natural orifice surgery either alone or in combination with other imaging modalities, such as endoscopy and fluoroscopy.

The ultrasound imaging device 100 is configured to be delivered into the esophagus E releasably mounted on the distal end of a flexible endoscope 102 or, alternatively, a dedicated insertion probe device. FIG 1 shows a sagittal view of a patient with a flexible endoscope 102 inserted into the esophagus E for placement of the ultrasound imaging device 100. The ultrasound imaging device 100 is positioned for optimal imaging of the heart or other structures within the thorax or abdomen with the help of the endoscope 102 or probe. The ultrasound imaging device 100 is fixated within the esophagus E, then it is released from the endoscope 102 or probe. Once this is accomplished, the lumen of the esophagus E is free for use by the endoscope 102 or another instrument.

FIG 2 shows a sagittal view of the patient with the ultrasound imaging device 100 attached within the esophagus E using a fixation mechanism. The flexible endoscope 102 can be advanced farther down the esophagus E for performing a diagnostic or therapeutic procedure using a transesophageal or transgastric approach. The procedure can be observed using a combination of endoscopy and TEE imaging. Alternatively, the endoscope or probe can be withdrawn after placement of the ultrasound imaging device 100, leaving the lumen of the esophagus E free for use by another instrument. FIG 3 shows a sagittal view of the patient with the ultrasound imaging device 100 attached within the esophagus E and the flexible endoscope withdrawn. An umbilical cable 104 extends from the ultrasound imaging device out through the patient's esophagus for attachment to an ultrasound imaging console. Alternatively, the ultrasound imaging device 100 may include a wireless transmitter to communicate imaging data to the ultrasound imaging console. Alternatively or in addition, the ultrasound imaging device 100 may include a memory device for recording imaging data that can be downloaded and viewed later. This will enable continuous imaging without the need for the patient to stay at the clinic. The device will be removed a few hours/days later.

FIG 4 shows a cutaway view of the patient's esophagus E with the ultrasound imaging device 100 attached to the esophageal wall E. The ultrasound imaging device 100 can use any known ultrasound imaging technology, including one or more mechanically scanned transducers or one or more phased array transducers. As shown in FIG 9, the ultrasound imaging device 100 will preferably have the transducers 111 facing a convex curved outer surface 112 that is sized and shaped to interface with the interior surface of the esophagus. Optionally, the ultrasound imaging device 100 may include an acoustic coupling, such as a liquid or gel-filled bladder to provide good acoustic transmission between the transducers and the esophageal wall. Alternatively or in addition an acoustic coupling gel or the like can be released between the ultrasound imaging transducer and the tissue wall. The acoustic coupling gel can be stored in the ultrasound imaging device 100 or delivered through a tube from outside the patient. Preferably, the surface 110 of the ultrasound imaging device 100 that faces the lumen of the esophagus will have a smooth profile with tapered edges and no abrupt edges or surfaces that would interfere with the passage of an endoscope or other instrument through the esophagus once the ultrasound imaging device 100 has been attached to the esophageal wall.

The ultrasound imaging device 100 includes a fixation mechanism 106 for attaching the ultrasound imaging device 100 to the esophageal wall. In the example shown in FIG 4, the fixation mechanism 106 includes a plurality of hooks 108 that pierce the esophageal wall to hold the ultrasound imaging device 100 in place. Alternatively or in addition, the fixation mechanism 106 may utilize sutures, clips, screws, adhesives or suction to attach the ultrasound imaging device 100 to the esophageal wall. FIGS 5-9 show examples of other fixation mechanism 106 that may be used to attach the ultrasound imaging device 100 to the esophageal wall.

Optionally, the ultrasound imaging device 100 may include a servo mechanism or other means, such as a balloon mechanism or wires, for aiming or repositioning the imaging transducers, particularly after the device has been released from the endoscope or probe. Phased array technology can also be used for aiming the ultrasound beam without repositioning the transducers.

Optionally, the ultrasound imaging device 100 may include a hole or guide tube adjacent to or even through the ultrasound imaging transducer to deliver a needle, catheter or other instrument to the imaged area in front of the transducer.

FIG 5 shows a cutaway view of the patient's esophagus E with an embodiment of the ultrasound imaging device 100 having a stent-like fixation mechanism 106. The fixation mechanism 106 includes an expandable stent-like member 114. Many different stent configurations are known that can be used for the expandable stent-like member 114, including a woven or braided tube of wires or filaments, one or more undulated rings, etc. The stent-like member 114 can be self- expanding or it can be expanded using a mechanical, hydraulic, pneumatic or electrical mechanism. Before it is expanded, the stent-like member 114 can be used to releasably attach the ultrasound imaging device 100 to the endoscope or probe for delivery into the esophagus. Once the ultrasound imaging device 100 is properly positioned, the stent-like member 114 is expanded against the interior wall of the esophagus to hold the device in place. After the procedure is completed, the stent-like member 114 is compressed and the ultrasound imaging device 100 is withdrawn through the esophagus.

FIG 6 shows a cutaway view of the patient's esophagus E with an embodiment of the ultrasound imaging device 100 having a fixation mechanism 106 with two expandable bands 116. The expandable bands 116 can be made of metal or polymer or a composite material and can be expanded using a mechanical, hydraulic, pneumatic or electrical actuating mechanism. Before they are expanded, the expandable bands 116 can be used to releasably attach the ultrasound imaging device 100 to the endoscope or probe for delivery into the esophagus. Once the ultrasound imaging device 100 is properly positioned, the expandable bands 116 are expanded against the interior wall of the esophagus to hold the device in place. After the procedure is completed, the expandable bands 116 are retracted again and the ultrasound imaging device 100 is withdrawn through the esophagus.

FIG 7 shows a cutaway view of the patient's esophagus E with an embodiment of the ultrasound imaging device 100 having an inflatable fixation mechanism 106. The inflatable fixation mechanism 106 includes one or more inflatable rings 118 that can be inflated with air or a liquid to expand the inflatable rings 118 against the interior wall of the esophagus to hold the device in place. An inflation tube 120 extends out through the esophagus for inflating and deflating the inflatable rings 118.

FIG 8 shows a cutaway view of the patient's esophagus with an embodiment of the ultrasound imaging device 100 having an expandable caliper fixation mechanism 106. The fixation mechanism 106 includes a plurality of opposing caliper arms 122 pivotally attached to the ultrasound imaging device 100. The caliper arms 122 have a closed or contracted position to releasably attach the ultrasound imaging device 100 to the endoscope or probe for delivery into the esophagus and an open or expanded position to hold the device in place against the interior wall of the esophagus. A mechanical, hydraulic, pneumatic or electrical actuating mechanism can be used to move the caliper arms 122 from the contracted to the expanded position.

FIG 9 shows one example of an actuating mechanism for the expandable caliper fixation mechanism 106 in the ultrasound imaging device 100 of FIG 8. The actuating mechanism utilizes a plurality of inflatable bladders 124 that are configured to force the caliper arms 122 outward to the expanded position and a return spring moves the caliper arms 122 to the retracted position. An inflation tube 120, shown in FIG 8, extends out through the esophagus for inflating and deflating the inflatable bladders 124. FIG 1OA shows an incision closure device 150 with an ultrasound imaging device 100 mounted to it. In this example, the incision closure device 150 has a horseshoe shape or U shape with two arms 152, 154 joined together by a connecting section 156. Extending from each of the two arms 152, 154 is a plurality of hooks, points or barbs 158 that pierce the tissue wall to hold the incision closure device 150 in place. Alternatively or in addition, the incision closure device 150 may utilize sutures, clips, screws, adhesives or suction to attach to the tissue wall. Preferably, the connecting section 156 is malleable to allow the two arms 152, 154 to be moved closer or farther away from each other. Alternatively, the connecting section 156 may include a spring, hinge, pivot or sliding mechanism. The incision closure device 150 includes a clip or ring 160 for holding the ultrasound imaging device 100 in a position to view through the tissue wall.

The incision closure device 150 can be made of a biocompatible metal or polymer or a combination of materials. All or a portion of the incision closure device 150 can be made of a bioabsorbable material. Optionally, shape memory materials can be used to actuate the closure mechanism.

In use, the incision closure device 150 with the ultrasound imaging device 100 mounted to it is delivered into the esophagus or other organ on the distal end of an endoscope or other probe. The incision closure device 150 is attached to the tissue wall at a point where an incision is intended to be made. The ultrasound imaging device 100 is used to view the tissue and organs on the other side of the tissue wall to be sure that an incision can be made without damaging adjoining tissues. An incision 162 is made in the space between two arms 152, 154 and the endoscope 102 or another instrument is inserted through the incision 162 for performing a diagnostic or therapeutic procedure. The ultrasound imaging device 100 can be used as an adjunct to the endoscopic imaging during the procedure. When the procedure is complete, the endoscope 102 is withdrawn through the incision 162 and the connecting section 156 is bent to push the two arms 152, 154 together to close the incision. When it is no longer needed, the ultrasound imaging device 100 is detached from the closure device 150 and withdrawn along with the endoscope 102. FIG 1OB shows the closure device 150 in a closed position with the ultrasound imaging device 100 removed. FIG HA shows another incision closure device 170 with an ultrasound imaging device 100 mounted to it. In this example, the incision closure device 170 has first and second curved sides 172, 174 that are hinged together with pivots 176, 178 at the top and bottom, or, alternatively, joined together with a malleable or spring-like connecting section. Extending from each of the curved sides 172, 174 is a plurality of hooks, points or barbs 158 that pierce the tissue wall to hold the incision closure device 170 in place. Alternatively or in addition, the incision closure device 170 may utilize sutures, clips, screws, adhesives or suction to attach to the tissue wall. The ultrasound imaging device 100 includes a clip 180 for attaching to the incision closure device 170 in a position to view through the tissue wall. This arrangement reduces the implanted mass of the incision closure device 170. The incision closure device 170 is used in the same manner as the closure device described above. When the procedure is completed, the endoscope 102 is withdrawn and the incision 162 is closed by pivoting the curved sides 172, 174 of the closure device 170 toward one another to approximate the incision. The ultrasound imaging device 100 is detached from the closure device 170 and withdrawn with the endoscope 102. FIG 1 IB shows the closure device 170 in a closed position with the ultrasound imaging device 100 removed.

FIG 12A shows another incision closure device 190 with an ultrasound imaging device 100 mounted to it. The incision closure device 190 has a ring-shaped member 192 with multiple undulations 194 that allow it to expand and contract. The undulated ring 192 can be made of a malleable material, an elastic or superelastic material or a shape-memory material. A plurality of hooks, points or barbs 158 are arranged around the undulated ring 192 to pierce the tissue wall to hold the incision closure device 190 in place. Alternatively or in addition, the incision closure device 190 may utilize sutures, clips, screws, adhesives or suction to attach to the tissue wall. The incision closure device 190 can be made of a biocompatible metal or polymer or a combination of materials. All or a portion of the incision closure device 190 can be made of a bioabsorbable material. The ultrasound imaging device 100 includes one or more clips 180 for attaching to the incision closure device 190 in a position to view through the tissue wall. The incision closure device 190 is used in the same manner as the closure device described above.

When the procedure is completed, the endoscope 102 is withdrawn and the incision 162 is closed by radially contracting the closure device 190 to approximate the incision. The ultrasound imaging device 100 is detached from the closure device 190 and withdrawn with the endoscope 102. FIG 12B shows the closure device 190 in a closed position with the ultrasound imaging device 100 removed.

In addition to ultrasound imaging, the ultrasound imaging device 100 can be configured to deliver therapeutic ultrasound and/or ultrasonic signals or energy through a tissue wall to actuate or energize another device within the field of the device.

While the present invention has been described herein with respect to the exemplary embodiments and the best mode for practicing the invention, it will be apparent to one of ordinary skill in the art that many modifications, improvements and subcombinations of the various embodiments, adaptations and variations can be made to the invention without departing from the spirit and scope thereof.

Claims

What is claimed is:

1. An ultrasound imaging device for use in a hollow body organ, comprising: an ultrasound imaging transducer mounted to an expandable fixation device; the expandable fixation device having a contracted position and an expanded position, wherein, when in the expanded position, the expandable fixation device expands against a wall of the hollow organ to fix the ultrasound imaging transducer in a desired position and wherein, when in the expanded position, the expandable fixation device leaves an open lumen in the hollow organ.

2. The ultrasound imaging device of claim 1, wherein the ultrasound imaging transducer is mounted on the expandable fixation device facing outward away from the open lumen in the hollow organ for imaging tissue through the wall of the hollow organ.

3. The ultrasound imaging device of claim 1, wherein, when the expandable fixation device is in the contracted position, the ultrasound imaging device is configured to be delivered into the hollow organ on an endoscope or elongated probe.

4. The ultrasound imaging device of claim 1 , wherein the expandable fixation device comprises an inflatable ring.

5. The ultrasound imaging device of claim 1, wherein the expandable fixation device comprises an expandable stent.

6. The ultrasound imaging device of claim 1, wherein the expandable fixation device comprises an expandable ring.

7. The ultrasound imaging device of claim 1, wherein the expandable fixation device comprises an expandable caliper.

8. The ultrasound imaging device of claim 1, wherein the expandable fixation device comprises an expandable caliper having a plurality of caliper arms, wherein, when the expandable fixation device is in the contracted position, the caliper arms are positioned to grip an exterior of an endoscope, and wherein, when the expandable fixation device is in the expanded position, the caliper arms are positioned to press outward against the wall of the hollow organ.

9. The ultrasound imaging device of claim 1, further comprising a signal transmission wire connected to the ultrasound imaging transducer for transmitting image signals to an imaging monitor.

10. The ultrasound imaging device of claim 1, further comprising a wireless transmitter connected to the ultrasound imaging transducer for transmitting image signals to an imaging monitor.

11. The ultrasound imaging device of claim 1, further comprising means for aiming the ultrasound imaging transducer after the ultrasound imaging transducer has been fixed in the desired position on the wall of the hollow organ.

12. An ultrasound imaging device for use on a tissue wall, comprising: an ultrasound imaging transducer mounted to an incision closure device; the incision closure device having at least one member configured for attachment to the tissue wall adjacent to an intended incision site, the incision closure device having an incision closure position wherein the at least one member places pressure on the tissue wall to urge the incision toward closure; wherein the ultrasound imaging transducer is mounted on the incision closure device facing toward the tissue wall for imaging tissue through the tissue wall.

13. The ultrasound imaging device of claim 12, wherein the incision closure device is configured in a U shape with first and second arm members joined together by a connecting section, the first and second arm members having means for attaching to the tissue walls, the connecting section being deformable to urge the first and second arm members toward one another to place pressure on the tissue wall to urge the incision toward closure.

14. The ultrasound imaging device of claim 12, wherein the incision closure device is configured with first and second members hinged together with pivots at top and bottom ends, the first and second members having means for attaching to the tissue walls, the first and second members being pivotable toward one another to place pressure on the tissue wall to urge the incision toward closure.

15. The ultrasound imaging device of claim 12, wherein the incision closure device is configured with a ring-shaped member having an expanded and contracted position, the ring-shaped member having means for attaching to the tissue walls, wherein, when in the contracted position, the ring-shaped member places pressure on the tissue wall to urge the incision toward closure.

16. The ultrasound imaging device of claim 12, wherein the ultrasound imaging transducer is releasably mounted on the incision closure device.

17. The ultrasound imaging device of claim 12, wherein a clip on the ultrasound imaging transducer is releasably attachable to the incision closure device.

18. A method comprising: positioning an ultrasound imaging device on an elongated probe; advancing the elongated probe into a body lumen; attaching the ultrasound imaging device to a wall of the body lumen; releasing the ultrasound imaging device from the elongated probe; imaging tissue through the wall of the body lumen with the ultrasound imaging device; advancing an instrument distal to the ultrasound imaging device; and performing a diagnostic or therapeutic procedure using the instrument.

19. The method of claim 18, wherein the elongated probe comprises an endoscope.

20. The method of claim 18, wherein the ultrasound imaging device is attached to the wall of the body lumen by expanding an expandable fixation device within the body lumen while leaving an open passage through the body lumen past the ultrasound imaging device.

21. The method of claim 18, wherein the ultrasound imaging device is attached to the wall of the body lumen by an incision closure device; and wherein the instrument is advanced distal to the ultrasound imaging device through an incision made in the wall of the body lumen adjacent to the incision closure device.

22. The method of claim 18, wherein the body lumen comprises an esophageal lumen.

23. The method of claim 18, wherein the body lumen comprises a stomach lumen.

24. The method of claim 18, wherein the body lumen comprises a vaginal or uterine lumen.