Apparatus for providing an adjustable mechanism for a radial ultrasonic port and a flash port

Abstract

To provide a probe assembly, and systems and methods of use thereof.SOLUTION: The present invention relates generally to the field of medical devices. More specifically, the present invention relates to an assembly with an adjustable ultrasound port and flush port for lateral and axial positioning of a radial ultrasound probe within a patient.SELECTED DRAWING: Figure 1A

Description

Technical Field

[0001] The present invention relates to the field of medical devices. More particularly, the present invention relates to an assembly having an adjustable ultrasonic port and a flush port for lateral and axial positioning of a radial ultrasonic probe within a patient.

Background Art

[0002] Ports for radial ultrasonic catheters may lack the ability to reposition ports for a radial ultrasonic probe and / or ports for flushing fluid through one or more lumens of a radial ultrasonic catheter while performing visual imaging of pulmonary nodules within peripheral regions of the lung.

[0003] Various advantageous medical results can be achieved by the adjustable assemblies, systems, and methods of use of the present invention.

Summary of the Invention

[0004] In one aspect, the present invention relates to an adjustable probe assembly comprising a housing defining an internal chamber. An ultrasonic port is formed within a proximal portion of the housing. The ultrasonic port has the same extent as the internal chamber. A flush port is disposed along a central portion of the housing. The flush port defines a fluid channel therethrough. The fluid channel has the same extent as the internal chamber. A fitting is disposed around a distal portion of the housing. The housing is configured to rotate relative to the fitting to change an axial position of the flush port relative to the fitting.

[0005] In the described embodiment and in another embodiment, the outer surface of the distal portion of the housing includes surface elements that frictionally engage the inner surface of the fitting. The fitting includes a protrusion. The first seal is disposed within the distal portion of the internal chamber. The second seal is disposed within the proximal portion of the internal chamber. The bearing is within the proximal portion of the internal chamber and is disposed proximal to the second seal. The housing and the ultrasonic port are configured to receive a radial ultrasonic probe therethrough. The bearing is configured to support rotation of the radial ultrasonic probe. The radial ultrasonic probe includes a drive cable. The drive cable extends through the ultrasonic port and is supported by the bearing. The radial ultrasonic probe includes a sheath. The proximal end of the sheath is disposed within the housing between the first seal and the second seal. The housing is configured to be rotated relative to the fitting to change the axial position of the radial ultrasonic probe. The proximal portion of the housing is configured to be rotated relative to the remainder of the housing to change the axial position of the radial ultrasonic probe.

[0006] In another aspect, the present invention relates to a system including a handle of a catheter. An adjustable probe assembly is attached to the handle. The adjustable probe assembly is configured to move laterally and axially relative to the handle. A radial ultrasonic probe extends through the adjustable probe assembly, the handle, and the shaft of the catheter.

[0007] In the described embodiments and in other embodiments, the adjustable probe assembly includes a housing that defines an internal chamber. An ultrasonic port is formed within the proximal portion of the housing. A flush port is disposed along the central portion of the housing. The radial ultrasonic probe includes a drive cable. The drive cable extends through the ultrasonic port. The flush port includes a fluid channel configured to convey fluid through the sheath of the radial ultrasonic probe into the internal chamber. A first seal is disposed within the distal portion of the internal chamber. A second seal is disposed within the proximal portion of the internal chamber. The first and second seals prevent fluid introduced through the flush port from flowing out of the internal chamber.

[0008] In yet another aspect, the present invention relates to a method that includes attaching an adjustable probe assembly to a catheter handle, wherein the radial ultrasonic probe attached to the adjustable probe assembly extends through the catheter handle and shaft. The lateral position of the adjustable probe assembly can be adjusted relative to the handle. The axial position of the adjustable probe assembly can be adjusted relative to the handle.

[0009] In the described embodiments and other embodiments, the lateral position of the adjustable probe assembly is readjusted relative to the handle to change the lateral position of the radial ultrasonic probe within the lumen of the catheter shaft. The housing of the adjustable probe assembly is rotated relative to the handle to rotate the radial ultrasonic probe within the lumen of the catheter. The housing of the adjustable probe assembly is rotated relative to the handle to change the axial position of the flush port disposed along the central portion of the housing relative to the handle. Fluid is introduced through the flush port into the internal chamber of the adjustable probe assembly.

[0010] Non-limiting embodiments of the present invention are described for purposes of illustration with reference to the accompanying drawings, which are schematic and not intended to be drawn to scale. In the drawings, the same or substantially the same components shown in the figures are generally each represented by a single number. For clarity, not all components are labeled in all the figures, and not all components of each embodiment are shown where illustration is not necessary for those skilled in the art to understand the disclosure.

Brief Description of the Drawings

[0011]

FIG. 1A

FIG. 1B

FIG. 2A

FIG. 2B

FIG. 3A

FIG. 3B

FIG. 3C

FIG. 3D

Modes for Carrying Out the Invention

[0012] The present invention is not limited to the specific embodiments described herein. The terms used herein are for the purpose of describing only the specific embodiments and are not intended to limit beyond the appended claims. Unless otherwise defined, all technical terms used herein have the same meaning as commonly understood by one of ordinary skill in the technical field to which the present invention belongs.

[0013] Embodiments of the present invention are described with particular reference to a probe assembly, their systems and methods of use, and in particular, a leak prevention assembly including an adjustable ultrasonic port and / or flash port configured to enable lateral and / or axial repositioning of a radial ultrasonic probe and / or flash port while visually imaging peripheral pulmonary nodules. However, it should be understood that such probe assemblies, systems, and methods can be used to visualize and manipulate various tissues within a variety of different body lumens and / or passages within the body.

[0014] As used herein, the singular forms "a", "an", and "the" are intended to include the plural forms as well, unless the context clearly indicates otherwise. As used herein, the terms "comprise" and / or "comprising", or "include" and / or "including" identify the presence of the described features, regions, elements of a step, and / or components, but do not preclude the presence or addition of one or more other features, regions, integers, steps, operations, elements, components, and / or groups thereof.

[0015] As used herein, the term "distal" refers to the end that is furthest from the medical professional or physician when the device is introduced into the patient's body, and the term "proximal" refers to the end that is closest to the medical professional or physician when the device is introduced into the patient's body.

[0016] In various embodiments, the present invention generally relates to an adjustable leak prevention probe assembly configured for use with a bronchial radial ultrasound system and capable of real-time imaging and targeting of pulmonary nodules that are difficult to access. For example, the adjustable probe assembly allows a physician to position / reposition a bronchial radial ultrasound system (e.g., an ultrasound probe, a flush port, and / or the probe assembly) laterally (e.g., along the longitudinal axis) and / or axially (e.g., around or about the longitudinal axis) within a peripheral portion of the lung while maintaining a leak prevention seal and simultaneously flushing fluid through the lumen of the radial ultrasound probe, and includes an adjustable acoustic port and a flush port configured as such.

[0017] Regarding FIGS. 1A - 1B, in one embodiment, the adjustable probe assembly 100 of the present invention includes a housing 110 that defines an internal chamber 111. An ultrasonic port 112 (e.g., a first port) is formed within or extends through the proximal portion of the housing 110. In various embodiments, the ultrasonic port 112 has the same spread (e.g., is substantially aligned) as the internal chamber 111. A flush port 114 (e.g., a second port) that defines a fluid channel 115 passing through the flush port 104 is disposed (e.g., attached, integrally formed) along the central portion of the housing 110. A joint 116 is disposed around the distal portion of the housing 110. In various embodiments, the housing 110 is configured to rotate 360 degrees (e.g., move axially) within the joint 116 to change the position of the flush port 114 relative to the longitudinal axis of the adjustable assembly 100 or to rotate a radial ultrasonic probe extending through the housing 110 (e.g., change the axial position of the radial ultrasonic probe) (described below). The outer surface of the distal portion of the housing includes a surface element 118 configured to frictionally engage the corresponding inner surface of the joint 116. As a non - limiting example, the surface element includes a rubber seal or O - ring configured to maintain or lock the axial position of the housing 110 relative to the joint 116 until a threshold level of rotational force (e.g., a sufficient amount of force applied by a physician's hand) is applied to the housing 110. In various embodiments, the outer surface of the housing 110 and / or the flush port 114 may include a non - slip surface (e.g., overmold, or rubber - coated) to provide sufficient grip for a physician to manipulate the housing 110, such as when wearing wet gloves. An arm, i.e., a protrusion 120, extends from the outer surface of the joint 116 and can fix or lock the housing of the probe assembly within the handle 140 (FIG. 3A) of a catheter having radial ultrasound and needle biopsy functions.

[0018] In one embodiment, a first seal 122 (e.g., an O-ring) is disposed within the distal portion of the internal chamber 111 (e.g., proximal to the distal opening of the housing 110), and a second seal 124 is disposed within the proximal portion of the internal chamber 111 (e.g., distal to the proximal opening of the housing 110). The first and second seals 122, 124 are configured to prevent fluid introduced (e.g., flushed) through the fluid channel 115 of the flash port 114 from flowing out (e.g., flowing / leaking distally beyond the first seal 122 or proximally beyond the second seal) from the internal chamber 111. A bearing 126 is disposed within the proximal portion of the internal chamber 111 on the proximal side of the second seal 124. In various embodiments, the housing 110 and the ultrasonic port 112 are configured to receive the proximal portion of a radial ultrasonic probe 130 passing therethrough (FIGS. 2A-2B). The bearing 126 is configured to receive the outer surface of the radial ultrasonic probe 130 and support / facilitate rotation of the radial ultrasonic probe 130 within the housing 110.

[0019] As shown in FIGS. 2A-2B, in one embodiment, the proximal portion of the radial ultrasound probe 130 extends through the ultrasound port 112 and the internal chamber 111 of the housing 110. In various embodiments, the radial ultrasound probe 130 includes a drive cable 132 rotatably disposed within a sheath 134. A radial ultrasound transducer (not shown) is attached to the distal end of the drive cable 132, for example, to provide an ultrasound image within a body lumen. The proximal portion of the drive cable 132 passes through the probe assembly 100, such as the internal chamber 111, and extends beyond the proximal end of the housing 110 to connect to an external motor drive unit (MDU). Further, the proximal end of the sheath 134 extends into the internal chamber 111 such that the open proximal end of the sheath 134 is disposed between the first and second seals 122, 124. The distal portion of the radial ultrasound probe (e.g., the drive cable 132 and the sheath 134) extends through the handle 140 of a catheter having, for example, radial ultrasound and needle biopsy capabilities and through the lumen of a dual lumen shaft (not shown) attached to the catheter handle and beyond the distal end of the housing 110. The MDU rotates the drive cable 132 at the required high speed throughout the internal chamber 111 and the entire length of the sheath 134 to impart the required high speed rotation to the radial ultrasound transducer. In various embodiments, the bearing 126 is configured to attenuate, insulate, or otherwise minimize noise, vibration, or other external forces acting on the housing 110 that could interfere with or corrupt the ultrasound signals propagated through (along / through) the radial ultrasound probe 130 (along the drive cable 132). Additionally or alternatively, for example, the proximal portion of the housing including the ultrasound port 112 includes a support structure configured to eliminate or reduce bending or twisting of the proximal portion of the radial ultrasound probe 130 (e.g., the sheath 134 and / or the drive cable 132) or to weaken external forces that could degrade or otherwise affect the quality of the ultrasound image.

[0020] Regarding FIGS. 3A - 3D, in one embodiment, the system 200 of the present invention includes an adjustable probe assembly 100 disposed within a handle 140 of a catheter having a radial ultrasound and needle biopsy function. The radial ultrasound probe 130 extends through the housing 110, and the drive cable of the radial ultrasound probe is connected to an external MDU. The distal portion of the radial ultrasound probe extends through the shaft (e.g., a dual - lumen shaft) of a catheter (not shown) attached to the distal end of the handle 140. In various embodiments, the dual - lumen catheter passes through the working channel of an endoscope and extends, for example, into the body lumen of a patient. In various embodiments, the adjustable probe assembly 100 is configured to move (e.g., laterally and / or axially) relative to (e.g., internally) the handle 140. For example, an arm or projection 120 is disposed between first and second surface elements 142, 144 extending from the inner wall of the handle 140. In various embodiments, the first surface element 142 forms an opening configured to receive a corresponding lock button / tab to lock a needle slider corresponding to the handle 140 in a predetermined position, and the surface 144 is the boundary of the handle where the probe assembly disengages from the handle in the proximal direction. The lateral position of the probe assembly 100 within the handle 140 can be changed by moving (e.g., sliding) the housing 110 distally and proximally between the first and second surface elements 142, 144. In various embodiments, the lateral position of the probe assembly within the handle 140 provides (e.g., sets) the desired length of the radial ultrasound probe extending distally through the end of the lumen of the dual - lumen catheter. For example, the lateral position of the probe assembly 100 within the handle 140 can be set or adjusted to change the position of the radial ultrasound transducer at the distal end of the radial ultrasound probe relative to the distal end of the shaft (e.g., a dual - lumen shaft) of the catheter in which the radial ultrasound probe is housed.In one embodiment, the ability to change / adjust the lateral position of the probe assembly 110 within the handle 140 allows the physician to fine-tune the lateral control of the radial ultrasound probe within and extending from the dual-lumen catheter of the catheter without adjusting / changing the position of the catheter handle within the working channel of the endoscope or the position of the endoscope itself through which the dual-lumen catheter of the handle 140 extends. (For example, adjusting the position of the radial ultrasound probe relative to a target pulmonary nodule). In various embodiments, a set screw or another locking member (not shown) can extend through the wall of the handle 140 and engage / contact the outer surface of the joint 116 to lock / fix the housing 110 in a desired lateral position within the handle 140. At the position of the radial ultrasound transducer set (e.g., relative to the distal end of the dual-lumen catheter), the handle 140 and the probe assembly 100 attached thereto can be advanced distally or retracted proximally to advance / retract the dual-lumen catheter into / through the endoscope working channel, for example, to advance the radial ultrasound transducer into the peripheral region of the lung using ultrasound guidance. Further, the housing 110 can be rotated relative to the handle 140 to axially rotate the radial ultrasound probe within the dual-lumen catheter. The proximal portion of the housing (e.g., defining the ultrasound port 112) can also be rotated independently of the remaining portion of the housing 110 (e.g., the flush port 114 and the joint 116, etc.) to rotate the radial ultrasound probe within the dual-lumen catheter. The axial rotation of the flush port 114 relative to the housing 110 can orient the flush port 114 in a position accessible to the physician such that fluid can be flushed through the channel 115 and through the internal chamber 111 and the sheath 134.In one embodiment, the proximal end of the flash port 114 is configured to receive a fluid source 150 (Figs. 3B - 3C) configured to flash fluid through the fluid channel 115 into the internal chamber 111 and into the sheath 134. In various embodiments, the first and second seals 122, 124 prevent fluid from leaking out of the housing 110 when the housing 110 moves laterally and / or axially within the handle 140. Another adjustable ultrasonic port and flash port technology, features, and / or components that can be used herein are disclosed in U.S. Non - Provisional Patent Application, Attorney Docket No. 8150.0581, entitled "Apparatus for Accessing Peripheral Regions of the Lung for Direct Visualization Using an Instrument Mount," filed on the same date as this application and incorporated herein by reference in its entirety, and / or in U.S. Non - Provisional Patent Application, Attorney Docket No. 8150.0746, entitled "Medical Imaging Apparatus, System, and Method," filed on the same date as this application and incorporated herein by reference in its entirety.

[0021] All of the devices and / or methods disclosed and claimed herein can be made and executed without undue experimentation in light of the present disclosure. Although the devices and methods of the present invention are described with respect to preferred embodiments, it will be understood by those skilled in the art that changes can be applied to the devices and / or methods and to the order of steps or the steps themselves disclosed herein without departing from the concept, spirit, and scope of the present invention. All such similar substitutes and modifications apparent to those skilled in the art are deemed to be within the scope of the spirit, scope, and concept of the present invention as defined by the appended claims. The technical idea included in the present disclosure is described below. (Appendix 1) A housing defining an internal chamber, An ultrasonic port formed within a proximal portion of the housing and having the same extent as the internal chamber, A flash port disposed along a central portion of the housing, the flash port forming a fluid channel extending through the flash port, the fluid channel having the same extent as the internal chamber, the flash port, A joint disposed around a distal portion of the housing Comprising, The housing is an adjustable probe assembly that rotates relative to the joint to change the axial position of the flash port relative to the joint. (Appendix 2) The outer surface of the distal portion of the housing includes surface elements that frictionally engage the inner surface of the joint, the adjustable probe assembly according to Appendix 1. (Appendix 3) The joint includes protrusions, the adjustable probe assembly according to Appendix 1 or 2. (Appendix 4) The adjustable probe assembly according to any one of Appendices 1 to 3, further comprising a first seal disposed within a distal portion of the internal chamber and a second seal disposed within a proximal portion of the internal chamber. (Appendix 5) The adjustable probe assembly according to Appendix 4, further comprising a bearing disposed within a proximal portion of the internal chamber and on the proximal side of the second seal. (Appendix 6) The housing and the ultrasonic port receive a radial ultrasonic probe passing through the housing and the ultrasonic port, the adjustable probe assembly according to Appendix 5. (Appendix 7) The bearing supports the rotation of the radial ultrasonic probe, the adjustable probe assembly according to Appendix 6. (Appendix 8) The radial ultrasonic probe includes a drive cable, the drive cable extending through the ultrasonic port and being supported by the bearing, the adjustable probe assembly according to Appendix 7. (Appendix 9) The radial ultrasonic probe includes a sheath, the proximal end of the sheath being disposed within the housing between the first seal and the second seal, the adjustable probe assembly according to Appendix 8. (Appendix 10) The housing is rotated relative to the joint to change the axial position of the radial ultrasonic probe, and a proximal portion of the housing is rotated relative to the remaining portion of the housing to change the axial position of the radial ultrasonic probe, the adjustable probe assembly according to appended claim 9. (Appended claim 11) A catheter handle, An adjustable probe assembly attached to the handle and movable laterally and axially relative to the handle, A radial ultrasonic probe extending through the adjustable probe assembly, the handle, and the shaft of the catheter A system comprising. (Appended claim 12) The adjustable probe assembly includes a housing defining an internal chamber, an ultrasonic port formed within a proximal portion of the housing, and a flush port disposed along a central portion of the housing, the system according to appended claim 11. (Appended claim 13) The radial ultrasonic probe includes a drive cable, the drive cable extending through the ultrasonic port, the system according to appended claim 11 or 12. (Appended claim 14) The flush port includes a fluid channel that conveys fluid through the sheath of the radial ultrasonic probe into the internal chamber, the system according to appended claim 12 or 13. (Appended claim 15) The system further includes a first seal disposed within a distal portion of the internal chamber and a second seal disposed within a proximal portion of the internal chamber, the first and second seals preventing fluid introduced through the flush port from flowing out of the internal chamber, the system according to any one of appended claims 12 to 14.

Claims

1. A system for visualization of pulmonary nodules, the system comprising: a handle comprising first and second surface elements extending from an inner wall of the handle; A housing coupled to the handle, the housing comprising: an interior chamber extending from a proximal portion of the housing to a distal portion of the housing and configured to receive a radial ultrasonic probe therein; a fluid channel in fluid communication with the interior chamber; a radial ultrasound port disposed in a proximal portion of the housing and in fluid communication with a proximal end of the internal chamber; a housing comprising: a fluid port disposed in a portion of the housing distal from the radial ultrasound port and in fluid communication with the fluid channel; a surface element disposed at a distal end of the housing; a fitting disposed about a distal end of the housing and including a protrusion; the coupling is configured to frictionally engage the surface element of the housing, the housing being configured to rotate axially relative to the handle; The system, wherein the protrusion is configured to engage the first and second surface elements of the handle, and the protrusion is configured to allow the housing to move laterally relative to the handle over a longitudinal distance defined by the first and second surface elements.

2. The system described in claim 1, wherein the surface elements of the housing and the joints are configured to maintain an axial orientation between the housing and the handle until a threshold level of axial force is applied to the handle.

3. The system described in claim 2, wherein the surface element of the housing is a rubber seal or an O-ring.

4. The system described in claim 1, wherein the handle is configured to rotate axially 360 degrees within the joint.

5. The system described in claim 1, wherein the protrusion has an elliptical notch.

6. The system described in claim 1, wherein the radial ultrasonic probe includes a drive cable rotatably disposed within a sheath.

7. The system of claim 6, wherein the housing further comprises a first seal disposed within a distal portion of the internal chamber and a second seal disposed within a proximal portion of the internal chamber.

8. The system described in claim 7, wherein the sheath has an open proximal end disposed between the first seal and the second seal.

9. A system for visualization of pulmonary nodules, comprising: a handle comprising first and second surface elements extending from an inner wall of the handle; A housing coupled to the handle, the housing comprising: an interior chamber extending from a proximal portion of the housing to a distal portion of the housing and configured to receive a radial ultrasonic probe therein; a fluid channel in fluid communication with the interior chamber; a radial ultrasound port disposed in a proximal portion of the housing and in fluid communication with a proximal end of the internal chamber; a housing comprising: a fluid port disposed in a portion of the housing distal from the radial ultrasound port and in fluid communication with the fluid channel; a surface element disposed at a distal end of the housing; a fitting disposed about a distal end of the housing and including a protrusion; The radial ultrasonic probe, the coupling is configured to frictionally engage the surface element of the housing, the housing being configured to rotate axially relative to the handle; The system, wherein the protrusion is configured to engage the first and second surface elements of the handle, and the protrusion is configured to allow the housing to move laterally relative to the handle over a longitudinal distance defined by the first and second surface elements.

10. The system described in claim 9, wherein the surface elements of the housing and the joints are configured to maintain an axial orientation between the housing and the handle until a threshold level of axial force is applied to the handle.

11. The system described in claim 10, wherein the surface element of the housing is a rubber seal or an O-ring.

12. The system described in claim 9, wherein the handle is configured to rotate axially 360 degrees within the joint.

13. The system described in claim 9, wherein the radial ultrasonic probe includes a drive cable rotatably disposed within a sheath.

14. The system of claim 13, wherein the housing further comprises a first seal disposed within a distal portion of the internal chamber and a second seal disposed within a proximal portion of the internal chamber.

15. The system described in claim 14, wherein the sheath has an open proximal end disposed between the first seal and the second seal, and the first and second seals prevent fluid introduced through the fluid port from escaping from the internal chamber.

16. A method for visualization of pulmonary nodules, the method comprising: inserting a radial ultrasonic probe through an interior chamber extending from a proximal portion of the housing to a distal portion of the housing, the housing is coupled to the handle with first and second surface elements extending from an inner wall of the handle; the housing comprises the internal chamber, a fluid channel in fluid communication with the internal chamber, a radial ultrasonic port disposed in a proximal portion of the housing in fluid communication with a proximal end of the internal chamber, a fluid port disposed in a portion of the housing distal from the radial ultrasonic port in fluid communication with the fluid channel, and a surface element disposed at a distal end of the housing; a joint is disposed about a distal end of the housing, the joint including protrusions configured to frictionally engage the surface elements of the housing, the housing configured to rotate axially relative to the handle; The method of claim 1, wherein the protrusion is configured to engage the first and second surface elements of the handle, the protrusion being configured to allow the housing to move laterally relative to the handle over a longitudinal distance defined by the first and second surface elements.

17. The method of claim 16, comprising connecting a fluid source to the fluid port and injecting fluid into the internal chamber.

18. The method of claim 17, comprising axially rotating the housing relative to the handle.

19. The method of claim 17, comprising moving the housing longitudinally relative to the handle.

20. The method of claim 17, comprising capturing a radial ultrasound image using the radial ultrasound probe.

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