IMAGING APPARATUS WITH TISSUE RETRIEVAL CHANNEL

Exemplary imaging apparatuses are described. Various embodiments of the imaging apparatuses may implement optical coherence tomography (OCT) and/or optical frequency domain imaging (OFDI) tissue imaging technologies, with the capability to perform tissue retrieval at the same time. Furthermore, the imaging apparatuses may include a rotatable imaging element to scan a bodily lumen, such as the bile duct. The imaging element may be housed within a cylindrical window. Still further, the imaging apparatuses may include an ancillary channel. The ancillary channel may provide access to the tissue in the bile duct, or other bodily lumen.

FIELD OF THE DISCLOSURE

The disclosure relates generally to the field of combined medical imaging and tissue management techniques, and more particularly to catheters for optical imaging and tissue retrieval.

BACKGROUND OF THE DISCLOSURE

Histology is the current gold standard of disease diagnosis and typically requires retrieving tissue samples from the inner body. Examples of tissue retrieval techniques are incisional biopsy, needle aspiration biopsy, brush biopsy, and segmental resection.

Current histology based diagnostic yield in the inner body is limited due to the sampling error of tissue retrieval techniques which typically involve random or imprecise selection of small regions of interest.

Optical imaging of the inner body is an alternative method to assess anatomy and tissue structures, which can highlight the regions of interest and guide the tissue retrieval to further improve the diagnostic yield. Examples of optical imaging techniques are optical coherence tomography (OCT), fluoroscopy, and spectroscopy. Other exemplary methods include confocal, non-linear, and spectrally-encoded confocal microscopy (SECM).

Devices for optical imaging of the inner body include a distal imaging end functionally coupled to a proximal operating end. The imaging end is inserted into the body and is manipulated via the operating end accessible to an external operator.

One example device for optical imaging of the inner body is a fiber optic probe. Fiber optic probes may include an imager, at least one optical fiber, at least one illumination source, and an optical system. Fiber optic probes may also include other components which may be used to record the location of the probe inside the body, such as radiopaque markers and positional sensors.

Current devices for optical imaging of the inner body have a number of operational drawbacks for guiding tissue retrieval. For example, fiber-optic probes may not be used at the same time with the tissue retrieval tools due to limited space and may miss the targeted regions of interest.

It is with respect to these and other considerations that the present improvements are needed.

SUMMARY OF THE DISCLOSURE

In view of the forgoing, exemplary imaging apparatuses are described. Various implementations of the imaging apparatuses may implement optical coherence tomography (OCT) and/or optical frequency domain imaging (OFDI) tissue imaging technologies, with the capability to perform tissue management at the same time. Furthermore, the imaging apparatuses may include a rotatable imaging element to scan a bodily lumen, such as the bile duct. The imaging element may be housed within a cylindrical window. Still further, the imaging apparatuses may include an ancillary channel. The ancillary channel may provide access to the tissue in the bile duct, or other bodily lumen.

DETAILED DESCRIPTION

Various examples, implementations, and illustrative configurations are described herein. In some examples, the bile duct is used as an example bodily lumen. However, this is not intended to be limiting. Furthermore, the various depictions are not drawn to scale. Instead, they are drawn in a manner to facilitate understanding. Additionally, the various examples and illustrations can be combined with each other, even where not specifically so stated. Additionally, the described examples are not intended to limit the claims and present disclosure.

FIGS. 1A and 1Billustrate a first exemplary imaging and tissue management apparatus100. The first exemplary imaging and tissue management apparatus100may implement optical coherence tomography (OCT) and/or optical frequency domain imaging (OFDI) tissue imaging methods and technologies. The first exemplary imaging and tissue management apparatus100may alternatively implement other scanning optical imaging modalities, such as fluorescence, spectroscopy, or the like. Furthermore, the imaging and tissue management apparatus100may implement other tissue imaging methods and technologies. In one implementation, the first exemplary imaging and tissue management apparatus100may include a system utilizing at least one of OCT or OFDI modalities. Specifically, the first exemplary imaging and tissue management apparatus100may be capable of detecting electromagnetic radiation, such as a back reflected light, from one or more portions associated with tissue118. The detected electromagnetic radiation may be processed by the imaging and tissue management apparatus100to ascertain information, such as microstructures, associated with the tissue118.

In one implementation, the first exemplary imaging and tissue management apparatus100may include a proximal system including optical fiber, tissue retrieval and treatment functionality, data processing and associated data storage, and the like. As illustrated inFIG. 1, the imaging and tissue management apparatus100includes a sheath102. The sheath102may be generally associated with a catheter body. The sheath102may be made from a suitable transparent or translucent material such as fluorinated ethylene propylene (FEP), polytetrafluoroethylene (PTFE), polyphthalamide, polyimide, Nylon, or the like.

The sheath102may house an actuation translator104. The actuation translator104enables rotation and translation of an imaging element106associated with actuation translator104. The actuation translator104may actuate the proximal end of the imaging element106, such as by torque coil, drive shaft, or the like. The actuation translator104may actuate the distal end of the imaging element106, such as by motor, piezoelectric actuator, or the like.

The imaging and tissue management apparatus100may include one or more ancillary channels108. The ancillary channel108may be alongside of the sheath102. The ancillary channel108may be made from the same material as the sheath102such as fluorinated ethylene propylene (FEP), polytetrafluoroethylene (PTFE), polyphthalamide, polyimide, Nylon, or the like. The sheath102and the ancillary channel108may be made from a multi-lumen extrusion or a bundle of multiple tubing. The distal exit of the ancillary channel108may be at the location covered by the scanning range of an imaging beam110. Multiple ancillary channels108may be included to enable greater coverage of the bodily lumen. In one implementation, the sheath102may be steerable via the proximal system to control the position or the orientation of the ancillary channel108to tissue118associated with the bodily lumen.

The ancillary channel108may house a tissue retrieval device112. The tissue retrieval device112may be in the form of a biopsy forceps, an aspiration needle, or the like. The tissue retrieval device112will be in a retracted state in the ancillary channel108at the time the imaging and tissue management apparatus100is guided through the bodily lumen. The ancillary channel108enables deployment of the tissue retrieval device112at the targeted location. As an example,FIG. 1Aillustrates the tissue retrieval device112in a retracted state whileFIG. 1Billustrates the tissue retrieval device112in an extended or deployed state.

The imaging and tissue management apparatus100may include one or more balloons114. The balloons114may be inflated via the sheath102. The balloon114may be inflated with air, gas, liquid, or the like. The balloon114may be made from a suitable non-compliant, compliant, or semi-compliant material such as polyethylene or other polyolefins, polyurethane, flexible polyvinylchloride, Nylon, or the like. An exterior surface of the balloon114may be smooth or substantially smooth. Alternatively, the exterior surface of the balloon114may be textured with protuberances, or the like, to aid in anchoring the imaging and tissue management apparatus100to tissue associated with the bodily lumen.

The imaging element106may be coupled to a fiber optic line. The fiber optic line may be contained or housed within the sheath102. The fiber optic line may be coupled to a portion of the imaging and tissue management apparatus100that enables OCT and/or OFDI methods and technologies. The imaging element106is functional for circumferential scanning by way of at least the rotation of actuation translator104. Helical scanning can also be accomplished by simultaneous rotation and pull back by the actuation translator104.

The imaging element106is capable of manipulating, directing, and/or focusing the imaging beam110on the tissue118during deployment of the tissue retrieval device112. Light reflected from the tissue118may be processed by the imaging element106and conveyed to data processing systems associated with the imaging and tissue management apparatus100via the fiber optic line, or the like. The processed tissue information enables the guidance of the tissue retrieval process, such as by direct visualization of the tissue retrieval tool112or by the tissue118removed by the tissue retrieval tool112. In one implementation, the reflected light is conveyed wirelessly to the data processing systems associated with the imaging and tissue management apparatus100.

The sheath102may include one or more registration markers116. The registration marker116may be associated with the sheath102in the portion covered by the scanning range of the imaging beam110. The registration marker116may provide contrast for OCT/OFDI and at least one other imaging modality to enable positional registration, such as white light endoscopy, ultrasound, fluoroscopy, or the like. In one implementation, the registration marker116is made from radiopaque materials for visualization in fluoroscopy, such as barium sulfate, bismuth compounds, tungsten, or the like.

FIGS. 2A and 2Billustrate a second exemplary imaging and tissue management apparatus200. The second exemplary imaging and tissue management apparatus200may implement optical coherence tomography (OCT) and/or optical frequency domain imaging (OFDI) tissue imaging methods and technologies. The second exemplary imaging and tissue management apparatus200may alternatively implement other scanning optical imaging modalities, such as fluorescence, spectroscopy, or the like. Furthermore, the imaging and tissue management apparatus200may implement other tissue imaging methods and technologies. In one implementation, the second exemplary imaging and tissue management apparatus200may include a system utilizing at least one of OCT or OFDI modalities. Specifically, the second exemplary imaging and tissue management apparatus200may be capable of detecting electromagnetic radiation, such as a back reflected light, from one or more portions associated with tissue220. The detected electromagnetic radiation may be processed by the imaging and tissue management apparatus200to ascertain information, such as microstructures, associated with the tissue220.

In one implementation, the second exemplary imaging and tissue management apparatus200may include a proximal system including optical fiber, tissue retrieval and treatment functionality, data processing and associated data storage, and the like. As illustrated inFIG. 2, the imaging and tissue management apparatus200includes a sheath202. The sheath202may be generally associated with a catheter body. The sheath202may be made from a suitable transparent or translucent material such as fluorinated ethylene propylene (FEP), polytetrafluoroethylene (PTFE), polyphthalamide, polyimide, Nylon, or the like.

The sheath202may house an actuation translator204. The actuation translator204enables rotation and translation of an imaging element206associated with the actuation translator204. The actuation translator204may actuate the proximal end of the imaging element206, for example by torque coil, drive shaft, or the like. The actuation translator204may actuate the distal end of the imaging element206, for example by motor, piezoelectric actuator, or the like.

The imaging and tissue management apparatus200may include one or more ancillary channels208. The ancillary channel208may be alongside of the sheath202. The ancillary channel208may be made from the same material as the sheath202such as fluorinated ethylene propylene (FEP), polytetrafluoroethylene (PTFE), polyphthalamide, polyimide, Nylon, or the like. The sheath202and the ancillary channel208may be made from a multi-lumen extrusion or a bundle of multiple tubing. The distal exit of the ancillary channel208may be at the location covered by the scanning range of an imaging beam210. Multiple ancillary channels208may be included to enable greater coverage of the bodily lumen. In one implementation, the sheath202may be steerable via the proximal system to control the position or the orientation of the ancillary channel208to tissue220associated with the bodily lumen.

The ancillary channel208may house a tissue retrieval device212. The tissue retrieval device212may be in the form of a biopsy forceps, a cutter, or the like. The tissue retrieval device212will be in a retracted state in the ancillary channel208at the time the imaging and tissue management apparatus200is guided through the bodily lumen. The ancillary channel208enables deployment of the tissue retrieval device212at the targeted location. As an example,FIG. 2Aillustrates the tissue retrieval device212in a retracted state whileFIG. 2Billustrates the tissue retrieval device212in an extended or deployed state.

The imaging and tissue management apparatus200may include one or more balloons214. The balloons214may be inflated via the sheath202. The balloon214may be inflated with air, gas, liquid, or the like. The balloon214may be made from a suitable non-compliant, compliant, or semi-compliant material such as polyethylene or other polyolefins, polyurethane, flexible polyvinylchloride, Nylon, or the like. An exterior surface of the balloon214may be smooth or substantially smooth. Alternatively, the exterior surface of the balloon214may be textured with protuberances, or the like, to aid in anchoring the imaging and tissue management apparatus200to tissue220associated with the bodily lumen.

In addition to the ancillary channel208, the imaging and tissue management apparatus200may include a distal container216located distal of the imaging and tissue management apparatus200. The distal container may be a smooth shape. For example, the distal container216may include a cylinder with a hemispherical end. In general, the distal container216may be made of a polymer, such as polyamides, polyurethanes, Nylon, polyethylenes, polyether block amide, polyester, polycarbonate, polypropylene, or the like. The distal container216may be used to collect or store the tissue samples removed by the tissue retrieval tool212, without the need to retract the tissue retrieval tool212into the ancillary channel208. As an example,FIG. 2Bshows a biopsy sample222of tissue220removed by the tissue retrieval tool212and retained by the distal container216.

The imaging element206may be coupled to a fiber optic line. The fiber optic line may be contained or housed within the sheath202. The fiber optic line may be coupled to a portion of the imaging and tissue management apparatus200that enables OCT and/or OFDI methods and technologies. The imaging element206is functional for circumferential scanning by way of at least the rotation of actuation translator204. Helical scanning can also be accomplished by simultaneous rotation and pull back by the actuation translator204.

The imaging element206is capable of manipulating, directing, and/or focusing the imaging beam210on the tissue220during deployment of the tissue retrieval device212. Light reflected from the tissue220may be processed by the imaging element206and conveyed to data processing systems associated with the imaging and tissue management apparatus200via the fiber optic line, or the like. The processed tissue information enables the guidance of the tissue retrieval process, such as direct visualization of the tissue retrieval tool212or the tissue220removed by the tissue retrieval tool212. In one implementation, the reflected light is conveyed wirelessly to the data processing systems associated with the imaging and tissue management apparatus200.

The sheath202may include one or more registration markers218. The registration marker218may be associated with the sheath202in the portion covered by the scanning range of the imaging beam210. The registration marker218may provide contrast for OCT/OFDI and at least one other imaging modality to enable positional registration, such as white light endoscopy, ultrasound, fluoroscopy, or the like. In one implementation, the registration marker218is made from radiopaque materials for visualization in fluoroscopy, such as barium sulfate, bismuth compounds, tungsten, or the like.

FIGS. 3A and 3Billustrate a third exemplary imaging and tissue management apparatus300. The third exemplary imaging and tissue management apparatus300may implement optical coherence tomography (OCT) and/or optical frequency domain imaging (OFDI) tissue imaging methods and technologies. The third exemplary imaging and tissue management apparatus300may alternatively implement other scanning optical imaging modalities, such as fluorescence, spectroscopy, or the like. Furthermore, the imaging and tissue management apparatus300may implement other tissue imaging methods and technologies. In one implementation, the third exemplary imaging and tissue management apparatus300may include a system utilizing at least one of OCT or OFDI modalities. Specifically, the third exemplary imaging and tissue management apparatus300may be capable of detecting electromagnetic radiation, such as a back reflected light, from one or more portions associated with tissue318. The detected electromagnetic radiation may be processed by the imaging and tissue management apparatus300to ascertain information, such as microstructures, associated with the tissue318.

In one implementation, the third exemplary imaging and tissue management apparatus300may include a proximal system including optical fiber, tissue retrieval and treatment functionality, data processing and associated data storage, and the like. As illustrated inFIG. 3, the imaging and tissue management apparatus300includes a sheath302. The sheath302may be generally associated with a catheter body. The sheath302may be made from a suitable transparent or translucent material such as fluorinated ethylene propylene (FEP), polytetrafluoroethylene (PTFE), polyphthalamide, polyimide, Nylon, or the like.

The sheath302may house an actuation translator304. The actuation translator304enables rotation and translation of an imaging element306associated with actuation translator304. The actuation translator304may actuate the proximal end of the imaging element306, for example by torque coil, drive shaft, or the like. The actuation translator304may actuate the distal end of the imaging element306, for example by motor, piezoelectric actuator, or the like.

The imaging and tissue management apparatus300may include one or more ancillary channels308. The ancillary channel308may be alongside of the sheath302. The ancillary channel may be made from the same material as the sheath302, or a suitable compliant or semi-compliant material such as polyethylene or other polyolefins, polyurethane, flexible polyvinylchloride, Nylon, or the like. The sheath302and the ancillary channel may be made from a multi-lumen extrusion or a bundle of multiple tubing. The distal exit of the ancillary channel308may be at the location covered by the scanning range of an imaging beam310. Multiple ancillary channels308may be included to enable greater coverage of the bodily lumen. In one implementation, the sheath302may be steerable via the proximal system to control the position or the orientation of the ancillary channel308to tissue associated with the bodily lumen.

The ancillary channel308may allow the introduction of a tissue management device312. The tissue management device312may be in the form of a biopsy forceps, an aspiration needle, an injection needle, an ablation catheter, a coagulation catheter, or the like. The tissue management device312may be introduced through the ancillary channel308after the imaging and tissue management apparatus300reaches the targeted location through the bodily lumen, or in a retracted state in the ancillary channel308at the time the imaging and tissue management apparatus300is guided through the bodily lumen. The ancillary channel308enables deployment of the tissue management device312at the targeted location. As an example,FIG. 3Aillustrates the ancillary channel without the tissue retrieval device312(e.g., with the tissue retrieval device312in a retracted state) whileFIG. 3Billustrates the tissue retrieval device312within the ancillary channel308in an extended or deployed state.

The imaging and tissue management apparatus300may include one or more balloons314. The balloons314may be inflated via the sheath302. The balloon314may be inflated with air, gas, liquid, or the like. The balloon314may be made from a suitable non-compliant, compliant, or semi-compliant material such as polyethylene or other polyolefins, polyurethane, flexible polyvinylchloride, Nylon, or the like. An exterior surface of the balloon314may be smooth or substantially smooth. Alternatively, the exterior surface of the balloon314may be textured with protuberances, or the like, to aid in anchoring the imaging and tissue management apparatus300to tissue318associated with the bodily lumen.

The imaging element306may be coupled to a fiber optic line. The fiber optic line may be contained or housed within the sheath302. The fiber optic line may be coupled to a portion of the imaging and tissue management apparatus300that enables OCT and/or OFDI methods and technologies. The imaging element306is functional for circumferential scanning by way of at least the rotation of actuation translator304. Helical scanning can also be accomplished by simultaneous rotation and pull back by the actuation translator304.

The imaging element306is capable of manipulating, directing, and/or focusing the imaging beam310on the tissue318during deployment of the tissue management device312. Light reflected from the tissue318may be processed by the imaging element306and conveyed to data processing systems associated with the imaging and tissue management apparatus300via the fiber optic line, or the like. The processed tissue information enables the guidance of the tissue management process, such as direct visualization of the tissue management tool312or the tissue318processed by the tissue management tool312. In one implementation, the reflected light is conveyed wirelessly to the data processing systems associated with the imaging and tissue management apparatus300.

The sheath302may include one or more registration markers316. The registration marker316may be associated with the sheath302in the portion covered by the scanning range of the imaging beam310. The registration marker316may provide contrast for OCT/OFDI and at least one other imaging modality to enable positional registration, such as white light endoscopy, ultrasound, fluoroscopy, or the like. In one implementation, the registration marker316is made from radiopaque materials for visualization in fluoroscopy, such as barium sulfate, bismuth compounds, tungsten, or the like.

FIGS. 4 and 4Billustrate a fourth exemplary imaging and tissue management apparatus400. The fourth exemplary imaging and tissue management apparatus400may implement optical coherence tomography (OCT) and/or optical frequency domain imaging (OFDI) tissue imaging methods and technologies. The fourth exemplary imaging and tissue management apparatus400may alternatively implement other scanning optical imaging modalities, such as fluorescence, spectroscopy, or the like. Furthermore, the imaging and tissue management apparatus400may implement other tissue imaging methods and technologies. In one implementation, the fourth exemplary imaging and tissue management apparatus400may include a system utilizing at least one of OCT or OFDI modalities. Specifically, the fourth exemplary imaging and tissue management apparatus400may be capable of detecting electromagnetic radiation, such as a back reflected light, from one or more portions associated with tissue416. The detected electromagnetic radiation may be processed by the imaging and tissue management apparatus400to ascertain information, such as microstructures, associated with the tissue416.

In one implementation, the fourth exemplary imaging and tissue management apparatus400may include a proximal system including optical fiber, tissue retrieval and treatment functionality, data processing and associated data storage, and the like. As illustrated inFIG. 4, the imaging and tissue management apparatus400includes an external sheath402and an internal sheath404. The external sheath402may be generally associated with a catheter body and house the internal sheath404. The external sheath402and internal sheath404may be made from a suitable material such as fluorinated ethylene propylene (FEP), polytetrafluoroethylene (PTFE), polyphthalamide, polyimide, Nylon, or the like. In one implementation, the external sheath402and the internal sheath404can be made from a combination of optically clear material in the distal end and kink-resistant material in the remaining portions of the sheaths402and404.

The internal sheath404may house an actuation translator406. The actuation translator406enables rotation and translation of an imaging element408associated with actuation translator406. The actuation translator406may actuate the proximal end of an imaging element408, for example by torque coil, drive shaft, or the like. The actuation translator406may actuate the distal end of the imaging element408, for example by motor, piezoelectric actuator, or the like.

The imaging and tissue management apparatus400may include one or more cytology brushes410. The cytology brush410may include one or more individual bristles or sponges on the distal circumference of the internal sheath404, excluding the location covered by the scanning range of an imaging beam412. The cytology brush410may be made from suitable flexible material such as Nylon, stainless steel, or the like. In one implementation, the external sheath402may be steerable via the proximal system to operate the cytology brush410to retrieve tissue416associated with the bodily lumen.

The internal sheath404and the cytology brush410may be fully retracted inside of the external sheath402at the time the imaging and tissue management apparatus400is guided through the bodily lumen. The external sheath402enables deployment of the internal sheath404and the cytology brush410at the targeted location. As an example,FIG. 4Aillustrates the cytology brush410in a retracted state whileFIG. 4Billustrates the cytology brush410in an extended or deployed state.

The imaging element408may be coupled to a fiber optic line. The fiber optic line may be contained or housed within the internal sheath404. The fiber optic line may be coupled to a portion of the imaging and tissue management apparatus400that enables OCT and/or OFDI methods and technologies. The imaging element408is functional for circumferential scanning by way of at least the rotation of actuation translator406. Helical scanning can also be accomplished by simultaneous rotation and pull back by the actuation translator406.

The imaging element408is capable of manipulating, directing, and/or focusing the imaging beam412on the tissue416during deployment of the internal sheath404and the cytology brush410. Light reflected from the tissue416may be processed by the imaging element406and conveyed to data processing systems associated with the imaging and tissue management apparatus400via the fiber optic line, or the like. The processed tissue reflection information enables the guidance of the tissue brushing process. In one implementation, the reflected light is conveyed wirelessly to the data processing systems associated with the imaging and tissue management apparatus400.

The external sheath402and the internal sheath404may include one or more registration markers414. The registration markers414may be associated with the external sheath402and/or the internal sheath404in the portion covered by the scanning range of the imaging beam412. The registration markers414may provide contrast for OCT/OFDI and at least one other imaging modality to enable positional registration, such as white light endoscopy, ultrasound, fluoroscopy, or the like. In one implementation, the registration markers414are made from radiopaque materials for visualization in fluoroscopy, such as barium sulfate, bismuth compounds, tungsten, or the like.

The embodiments have been described and illustrated as including various structures, elements, and operational functionalities. Those described various structures, elements, and operational functionalities may apply to and be used with each of the embodiments described herein.

Furthermore, while imaging apparatuses with tissue removal channels have been described with reference to certain embodiments, it will be understood by those skilled in the art that various changes may be made and equivalents may be substituted without departing from the spirit and scope of the claims of the application. Other modifications may be made to adapt a particular situation or material to the teachings disclosed above without departing from the scope of the claims. Therefore, the claims should not be construed as being limited to any one of the particular embodiments disclosed, but to any embodiments that fall within the scope of the claims.