CN116782812A - Real-time sampling system - Google Patents

Real-time sampling system Download PDF

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Publication number
CN116782812A
CN116782812A CN202180090028.7A CN202180090028A CN116782812A CN 116782812 A CN116782812 A CN 116782812A CN 202180090028 A CN202180090028 A CN 202180090028A CN 116782812 A CN116782812 A CN 116782812A
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CN
China
Prior art keywords
needle
release
actuator
guide tube
distal end
Prior art date
Legal status (The legal status is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the status listed.)
Pending
Application number
CN202180090028.7A
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Chinese (zh)
Inventor
大卫·A·赫林
吉恩-马丁·巴亚尔容
贾森·T·潘岑贝克
约瑟夫·肯内利·乌尔曼
克里斯多佛·R·拉尔夫
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Olympus Medical Systems Corp
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Olympus Medical Systems Corp
Priority date (The priority date is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the date listed.)
Filing date
Publication date
Priority claimed from US17/546,788 external-priority patent/US20220183666A1/en
Application filed by Olympus Medical Systems Corp filed Critical Olympus Medical Systems Corp
Priority claimed from PCT/IB2021/000851 external-priority patent/WO2022123306A2/en
Publication of CN116782812A publication Critical patent/CN116782812A/en
Pending legal-status Critical Current

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Abstract

The disclosed embodiments include apparatus, systems, and methods for securing a control device of an elongate instrument to an insertion device. In an illustrative embodiment, an apparatus includes a coupling configured to couple a control device with a port of an insertion device for delivering an elongate instrument to a target location. A bushing extends from the coupling and is configured to be inserted within an opening in a port of the insertion device. The elongate instrument may be movably extendable through the bushing. A first sealing member is disposed on an outer surface of the bushing to seal the outer surface of the bushing against an inner surface of the opening in the port. A second sealing member is disposed on the outer surface of the elongated instrument for movably sealing the outer surface of the elongated instrument.

Description

Real-time sampling system
Priority claim
The present application claims the priority and benefits of all U.S. provisional patent applications entitled "REAL-TIME SAMPLING SYSTEM (REAL time sampling System)" and having serial numbers 63/123,571, 63/123,601, 63/123,623, 63/123,641, 63/123,696, and 63/123,731, and all U.S. non-provisional patent applications entitled "REAL-TIME SAMPLING SYSTEM (REAL time sampling System)" and having serial numbers 17/546,685, 17/546,757, 17/546,774, 17/546,788, 17/546,804, and 17/546,818, filed on day 12, 2021, 10.
Technical Field
The present disclosure relates to an interface for controlling a device for collecting samples from within a body.
Background
The statements in this section merely provide background information related to the present disclosure and may not constitute prior art.
Insertion and manipulation of thin and elongated instruments within living beings or other objects allows for the continuous improvement of various types of analysis, diagnosis and treatment of those living beings or objects in minimally invasive techniques. For example, non-invasive biopsy, endoscopic imaging, and catheterization treatments have enabled the assessment and treatment of many internal lesions without invasive surgery.
Correspondingly, the elongate instrument may also be used to collect samples from within the body in a relatively non-invasive manner. For example, when a biopsy from the lung is required to determine whether a detected lesion is cancerous, an insertion device, such as a bronchoscope, may be used to guide one or more elongate instruments to a location near the lesion to obtain a sample, rather than cutting into the chest of the patient to obtain the sample. However, merely delivering the elongate instrument to a location near the lesion may only provide a portion of what is needed to sample the lesion itself.
BRIEF SUMMARY OF THE PRESENT DISCLOSURE
The disclosed embodiments include devices, systems, and methods for controlling sampling of tissue using one or more elongate instruments insertable into a body.
In an illustrative embodiment, an apparatus includes a coupling configured to couple a control device with a port of an insertion device configured to deliver an elongate instrument to a target location. A bushing extends from the coupling and is configured to be inserted within an opening in a port of the insertion device. An elongate instrument may be movably extendable through the bushing. The first sealing member is disposed on an outer surface of the bushing and is configured to seal the outer surface of the bushing against an inner surface of the opening in the port. A second sealing member is disposed on the outer surface of the elongated instrument and is configured to movably seal the outer surface of the elongated instrument.
In another illustrative embodiment, a system includes an elongate instrument. A control device is movably coupled with the elongate instrument and configured to extend and retract the elongate instrument. The coupling is configured to removably secure the insertion device with the control device. The insertion device is configured to deliver an elongate instrument to a target site and includes a port to receive the elongate instrument therethrough. A bushing extends from the coupling and is configured to be inserted within an opening in a port of the insertion device through which the elongate instrument can movably extend. The first sealing member is disposed on an outer surface of the bushing and is configured to seal the outer surface of the bushing against an inner surface of the opening in the port. A second sealing member is disposed on the outer surface of the elongated instrument and is configured to movably seal the outer surface of the elongated instrument.
In another illustrative embodiment, a method includes providing a coupler adjacent to an opening in a port of an insertion device, wherein the coupler supports an elongate instrument to be delivered by the insertion device to a target location. A bushing through which the elongate instrument is inserted movably extends into the opening. The outer surface of the liner seals against the opening to prevent fluid from passing between the inner surface of the opening and the outer surface of the liner. The outer surface of the elongate instrument is moveably sealed to prevent the passage of fluid between the outer surface of the elongate instrument and the coupling. Fluid is prevented from entering the coupling in a sealable manner around the outer surface of the bushing and around the outer surface of the elongated instrument.
In another illustrative embodiment, an apparatus includes a control device configured to facilitate extension of an elongate instrument to a target location. A port in the end of the control device is configured to press against a side of the elongate instrument to secure the elongate instrument for movement with the control device.
In another illustrative embodiment, a system includes an elongate instrument configured to deliver a sampling needle and an imaging probe to a target location. The control device is configured to facilitate extension of the elongate instrument to a target location. A securing mechanism within the end of the control device is configured to press against a side of the elongate instrument to secure the elongate instrument for movement with the control device.
In another illustrative embodiment, a method includes receiving an elongate instrument into an instrument port of a control device configured to facilitate extension of the elongate instrument to a target location. The sides of the elongate instrument are compressibly secured by the control device such that the elongate instrument moves with the control device.
In another illustrative embodiment, an apparatus includes a stylet configured to be insertable into a lumen of a needle via a proximal port secured to a needle actuator secured to the needle. An end cap fixably coupled to the stylet and configured to cover a proximal end of the needle actuator is movable relative to the needle actuator to enable an operator to withdraw the stylet from the lumen.
In another illustrative embodiment, a system includes a needle defining a lumen. The stylet is configured to be insertable into a lumen of a needle via a proximal port secured to a needle actuator secured to the needle. An end cap fixably coupled to the stylet and configured to cover a proximal end of the needle actuator is movable relative to the needle actuator to enable an operator to withdraw the stylet from the lumen.
In another illustrative embodiment, a method includes inserting a distal end of a stylet into a lumen of a needle secured with a needle actuator. The stylet is inserted into the lumen until an end cap fixably engaged with the proximal end of the stylet covers the proximal end of the needle actuator. The end cap is withdrawn from the proximal end of the needle actuator until the stylet is withdrawn from the lumen. A vacuum source is coupled to the lumen.
In another illustrative embodiment, a system includes a needle defining a lumen. The stylet is configured to be insertable into a lumen of a needle secured with the needle actuator. The end cap is fixably coupled to the stylet. The end cap is configured to be secured to the proximal end of the needle actuator when the stylet is fully inserted into the lumen. The end cap is also configured to cooperate with the proximal end of the needle actuator to prevent removal of the stylet from the lumen in response to manipulation of the needle actuator to facilitate extraction of a tissue sample with the distal end of the needle.
In another illustrative embodiment, a method includes inserting a distal end of a stylet into a lumen of a needle secured with a needle actuator. The stylet extends into the lumen until an end cap, which is fixably engaged with the proximal end of the stylet, engages the distal end of the needle actuator. The end cap is secured to the proximal end of the needle actuator such that the end cap prevents the stylet from being removed from the lumen when the needle actuator is manipulated to facilitate extraction of a tissue sample with the distal end of the needle.
In another illustrative embodiment, an apparatus includes a guide tube defining a lumen through which a needle can extend. The needle actuator is configured to be fixably coupled to the proximal end of the needle. The first release device is movably coupled to the needle actuator and is configured to be engaged to release the needle actuator to move the needle actuator from a retracted position at the end of the guide tube, in which the distal end of the needle is retracted within a distal end of the sheath positionable adjacent tissue to be sampled, to a ready position, in which the distal end of the needle is adjacent the distal end of the sheath. The second release device is movably coupled to the needle actuator and is configured to be engaged to release the needle actuator to move the needle actuator from the ready position to the sampling position at which the distal end of the needle is advanceable into tissue to be sampled.
In another illustrative embodiment, a system includes a needle defining a first lumen. The sampling device is configured to be coupled to an insertion device configured to deliver a needle to tissue to be sampled. The guide tube extends from the sampling device and defines a second lumen through which the needle can extend. The needle actuator is configured to be fixably coupled to the proximal end of the needle. The first release device is movably coupled to the needle actuator and is configured to be engaged to release the needle actuator to move the needle actuator from a retracted position at the end of the guide tube, in which the distal end of the needle is retracted within a distal end of the sheath insertable via the insertion device and positionable adjacent tissue to be sampled, to a ready position, in which the distal end of the needle is adjacent the distal end of the sheath. The second release device is movably coupled to the needle actuator and is configured to be engaged to release the needle actuator to move the needle actuator from the ready position to the sampling position at which the distal end of the needle is advanceable into tissue to be sampled.
In another illustrative embodiment, a method includes engaging a first release device to release a needle actuator from a retracted position at an end of a guide tube in which a distal end of a needle is retracted within a distal end of a sheath positionable adjacent tissue to be sampled. The needle actuator is advanced to the ready position to advance the distal end of the needle adjacent the distal end of the sheath. The second release means is engaged to release the needle actuator from the ready position. The needle actuator is advanced to advance the distal end of the needle into the tissue to be sampled.
In another illustrative embodiment, an apparatus includes a guide tube defining a lumen configured to slidably transfer a needle from a proximal end of the guide tube to a distal end of the guide tube, wherein the proximal end of the guide tube includes an asymmetric outer cross-section. The needle actuator is configured to be coupled to the proximal end of the needle, wherein the needle actuator includes an asymmetric distal opening configured to receive the guide tube in response to the needle actuator being oriented such that the distal end of the needle faces a desired direction.
In another illustrative embodiment, a system includes a needle defining a first lumen. The sampling device is configured to be coupled to an insertion device configured to deliver a needle to tissue to be sampled. A guide tube defining a lumen is configured to slidably transfer a needle from a proximal end of the guide tube to a distal end of the guide tube, wherein the proximal end of the guide tube includes an asymmetric outer cross-section. The needle actuator is configured to be coupled to the proximal end of the needle, wherein the needle actuator includes an asymmetric distal opening configured to receive the guide tube in response to the needle actuator being oriented such that the distal end of the needle faces a desired direction.
In another illustrative embodiment, a method includes inserting a distal end of a needle into a guide tube defining a lumen and configured to deliver the distal end of the needle to tissue to be sampled, wherein the needle is fixably coupled with a needle actuator. Providing a distal opening in the needle actuator to the proximal end of the guide tube, wherein the distal opening in the needle actuator is configured to slidably receive the proximal end of the guide tube in response to the needle actuator being oriented in a desired direction to direct the distal end of the needle to face the desired direction. When the needle actuator is oriented in the desired direction, the distal opening of the needle actuator slides over the outer surface of the guide tube.
In another illustrative embodiment, an apparatus includes an anti-buckling device including at least one movable support bracket. At least one of the brackets includes a generally planar member having an inner aperture and an outer edge configured to movably engage an inner surface of the channel, wherein the planar member is configured to provide lateral support to an elongate instrument selected from one of a needle and a probe that is extendable through the inner aperture in response to the elongate instrument being driven through the channel by an actuator that is receivable within the channel. The at least one bracket further includes a positioning member extending from the planar member, wherein the positioning member is configured to resist torsion of the planar member relative to the axis of the channel and is configured to move relative to the distal end of the actuator so as not to impede movement of the actuator toward the distal end of the channel.
In another illustrative embodiment, a system includes an elongate instrument selected from one of a needle and a probe. A control device is movably coupled with the elongate instrument and configured to extend and retract the elongate instrument, the control device including an anti-buckling device including at least one movable support bracket. At least the bracket includes a generally planar member having an inner aperture and an outer edge configured to movably engage an inner surface of the channel. The planar member is configured to provide lateral support to an elongate instrument that is extendable through the inner aperture in response to the elongate instrument being driven through the channel by an actuator that is receivable within the channel. The at least one bracket further includes a positioning member extending from the planar member, wherein the positioning member is configured to resist torsion of the planar member relative to the axis of the channel and is configured to move relative to the distal end of the actuator so as not to impede movement of the actuator toward the distal end of the channel.
In another illustrative embodiment, a method includes engaging an actuator slidably received within a channel, wherein the actuator is configured to move from a proximal end of the channel toward a distal end of the channel to advance an elongate instrument selected from one of a needle and a probe through a distal opening at the distal end of the channel. The elongate instrument is movably supported away from the inner surface of the channel at a point between the distal end of the actuator and the distal end of the channel. As the distal end of the actuator advances toward the distal end of the channel, at least a portion of the stent moves past the distal end of the actuator such that the portion of the stent does not obstruct the movement of the distal end of the actuator toward the distal end of the channel.
Other features, advantages, and areas of applicability will become apparent from the description provided herein. It should be understood that the description and specific examples are intended for purposes of illustration only and are not intended to limit the scope of the present disclosure.
Drawings
The drawings described herein are for illustration purposes only and are not intended to limit the scope of the present disclosure in any way. The components in the drawings are not necessarily to scale, emphasis instead being placed upon illustrating the principles of the disclosed embodiments, wherein:
FIG. 1 is a side view of an illustrative sampling system;
FIGS. 2 and 3 are exploded views of the coupling of the system of FIG. 1;
FIG. 4 is a cross-sectional view of the coupling of FIGS. 2 and 3;
FIG. 5 is a perspective view of a port for securing an elongate instrument in an actuator of the system of FIG. 1;
FIG. 6 is a cross-sectional view of a port in the actuator of FIG. 5;
fig. 7 and 10 are side views of a needle actuator and a side view of an end cap, respectively, of the system of fig. 1;
FIGS. 8 and 9 are a cross-sectional view of the needle actuator and a cross-sectional view of the end cap of FIGS. 7 and 10, respectively;
FIGS. 11A, 12A and 13A are cross-sectional views of the needle actuator and release mechanism of FIG. 7 configured to control the position of a sampling needle;
11B, 12B and 13B are partial schematic side plan views of a distal end of a sampling needle positioned adjacent tissue to be sampled and corresponding to the configuration of the needle actuator and release mechanism of FIGS. 11A, 12A and 13A, respectively;
FIG. 14 is a perspective view of the needle actuator of FIG. 7 mounted on a guide tube of the system of FIG. 1;
FIGS. 15A and 15B are schematic views of the distal end of a sampling needle having a directional orientation;
FIGS. 16 and 17 are partial schematic plan views of an asymmetric opening in the distal end of the needle actuator and the guide tube;
FIGS. 18, 20 and 21 are perspective views, partially in section, of the system of FIG. 1 showing the anti-buckling device;
FIG. 19 is a side view of the representative anti-buckling device of FIGS. 18, 20 and 21;
FIG. 22 is a flow chart of an illustrative method of coupling the system of FIG. 1 to an insertion device;
FIG. 23 is a flow chart of an illustrative method of securing an elongate instrument within a port of the system of FIG. 1;
FIG. 24 is a flow chart of an illustrative method of securing a stylet within a needle of the system of FIG. 1;
FIG. 25 is a flow chart of an illustrative method of controlling advancement of a needle of the system of FIG. 1;
FIG. 26 is a flow chart of an illustrative method of controlling the orientation of a needle actuator of the system of FIG. 1; and
fig. 27 is a flow chart of an illustrative method of supporting an elongate instrument of the system of fig. 1.
Detailed Description
The following description is merely illustrative in nature and is not intended to limit the present disclosure, application, or uses. It will be noted that the first digit of the three-digit reference number and the first two digits of the four-digit reference number correspond to the first digit of the one-digit reference number and the first two digits of the reference number, respectively, in which the element first appears.
The following description illustrates various embodiments of a control system for sampling tissue using an elongate instrument capable of insertion into a body by way of illustration only and not limitation.
It will be appreciated that various embodiments of the control system described herein may facilitate deployment and control of the procedure of the elongate instrument. In various embodiments, the elongate instrument may include a sheath that encloses the imaging probe and the sampling needle. The sheath is insertable into the body to reach a target tissue to be sampled. The imaging probe may be used to locate tissue to be sampled or a portion of tissue of interest. A sampling needle may be used to obtain a sample of the tissue.
In various embodiments, the control system may be coupled with an insertion device, such as an endoscope or bronchoscope, that includes an insertion catheter that is insertable into the body via an orifice or other opening. The control system may be coupled directly to the insertion device or to a replaceable valve, such as a biopsy valve connected to the endoscopic device. The insertion device enables the insertion catheter to be inserted into the body and guided to a desired location within the body. The insertion catheter may be configured to receive an elongate instrument that is extendable through the insertion catheter. The elongate instrument is insertable into the body via the insertion device to obtain a tissue sample at a desired location within the body. The elongate instrument may be operably coupled with a control system that enables an operator to manipulate the elongate instrument to obtain a tissue sample. An illustrative control system is described below.
Referring to fig. 1, an illustrative control system 100 operates in conjunction with an insertion device 190 (only a portion of the insertion device 190 is shown in fig. 1), such as an endoscope or bronchoscope. The endoscopic device may include a replaceable valve, such as a biopsy valve (not shown), through which the elongate instrument 102 may be inserted. As previously described, the insertion device includes an insertion catheter that is insertable into the body via an orifice or other opening (neither shown in fig. 1). The insertion device 190 receives the elongate instrument 102, which elongate instrument 102 may be extended to a desired position by an insertion catheter. Also as previously described, in various embodiments, the elongate instrument 102 is a sampling probe that may include an imaging probe and a sampling needle (neither shown separately in fig. 1) contained within a sheath. The elongate instrument 102 is insertable via the insertion device 190 to obtain a tissue sample at a desired location within the body. The elongate instrument 102 may also include a stylet (not shown in fig. 1) that may be removably inserted into and/or through the needle, as described further below.
The control system 100 described herein is coupled to the insertion device 190 using a coupling 110 at a distal end 111 of the control system 100. The elongate instrument 102, which is manipulated by the control system 100, extends through the coupling 110 and is inserted into an insertion catheter (not shown) of the insertion device 190. The elongate instrument 102 may be fixed to an actuator 112, the actuator 112 being movably coupled to a housing 114. The actuator 112 may be movable along the housing 114 between a proximal end 113 and a distal end 111 of the control system 100 (the proximal end 113 and the distal end 111 of the control system 100 corresponding to the proximal end and the distal end of the housing 114) to extend and retract the elongate instrument 102 relative to the insertion device 190. An anti-buckling device (not shown in fig. 1) may be received within housing 114 to provide lateral support to elongate instrument 102 as actuator 112 drives elongate instrument 102 through housing 114.
In various embodiments, the sheath of the elongate instrument 102 is fixably secured to the actuator 112 with the imaging probe and needle received into the sheath via the actuator 112. Proximal port 120 is configured to receive and secure the imaging probe. The guide tube 130 is configured to receive and engage a needle actuator 140 secured to the sampling needle. The guide tube 130 and the needle actuator 140 may be movably coupled at the directional interface 150. The orientation interface 150 is configured to maintain the orientation of the needle actuator 140 relative to the guide tube 130 to control the orientation of the sampling needle, as described further below. The needle actuator 140 may removably receive an end cap 160, the end cap 160 being coupled with a stylet and the end cap 160 may be used to releasably secure the stylet within the sampling needle. The needle actuator may also include a release mechanism 170 that is positively engaged by an operator to allow the sampling needle to be advanced into a sampling position, also as described further below.
Referring to fig. 2, the coupling 110 may be used to secure the control system 100 to a port 290 of the insertion device 190. As previously described, the insertion device 190 may include a replaceable valve, such as a biopsy valve. In this case, the coupling 110 may be directly coupled to a biopsy valve coupled to the insertion device 190. In various embodiments, the coupling 110 includes a sealing system 210, a housing 250, and a locking mechanism 270. The components of the coupling 110 are configured to sealably secure the control system 100 to the insertion device 190.
In various embodiments, the sealing system 210 includes a bushing 212 extending from the distal end 111 of the control system 100 (fig. 1). The bushing 212 is configured to be slidably received within an opening 292 in a flange at the end of a connector 294 of the port 290. The bushing 212 is sized to slide within the opening 292 and support the first and second seal members 214, 224.
In various embodiments, the first sealing member 214 may have the nature of an O-ring configured to form a fluid seal between the outer surface 211 of the elongate instrument 102 (which may be the outer surface of the sheath) and the inner surface 216 of the bushing 212. The first sealing member 214 may thus help prevent fluid from flowing out of the insertion device 190 between the outer surface 211 of the elongate instrument 102 and the liner 212. When the elongate instrument 102 is inserted into the port 290, the first sealing member 21 is able to slide and move over the elongate instrument 102.
The second sealing member 224 is configured to fluidly seal the outer surface 223 of the bushing 212 to the opening 292 of the connector 294 of the insertion instrument 190. In various embodiments, the second sealing member 224 is a gasket configured to sealably engage the outer surface 223 of the bushing 212 and sealably engage the opening 292 in the connector 294 of the port 290. To this end, in various embodiments, the first sealing member 224 includes an angled surface 225, the surface 225 being configured to sealably engage the opening 292. The second sealing member 224 may thus prevent fluid from flowing out of the insertion device 190 between the opening 292 and the liner 212.
In various embodiments, the two sealing members 214 and 224 may replace a single gasket or membrane for sealing the opening 292. The use of a single gasket or membrane may require that the elongate instrument 102 be forced through a restrictive opening or through the surface of the membrane. As mentioned previously, the elongate instrument 102 may include an imaging probe, a sampling needle, and/or other potentially fragile devices that may be damaged in response to being forced through a restrictive opening or surface of a membrane. By using bushings 212 that support the first and second sealing members 214, 224, a seal between the elongate instrument 102 and the opening 292 may be provided without risking potential damage to the elongate instrument 102.
With continued reference to fig. 3, in various embodiments, the coupling 110 further includes a housing 250, the housing 250 being secured to the insertion device 190 by a locking mechanism 270. Housing 250 includes an outer housing 252, with outer housing 252 configured to cover a base 298 of connector 294 and/or connector 290 extending from insertion device 190. Housing 250 also includes a shroud 260 through which elongate instrument 102 extends and shroud 260 may cover and/or help secure bushing 212 and seal members 214 and 216. In various embodiments, the shroud 260 helps to hold the first sealing member 214 in place against the end of the connector 290 of the insertion device 190. The housing 250 also includes a slot 254, the slot 254 configured to receive a locking mechanism 270, the locking mechanism 270 being slidably received through the slot 254 in various embodiments.
In various embodiments, the locking mechanism 270 includes a base 272, and a locking member 274 extends from the base 272, the locking member 274 being configured to securely engage the connector 294. Referring to fig. 2 and 3, the locking member 274 defines a wave-like groove 276 between the opposing legs 279. The wave groove 276 is configured such that when the locking mechanism 270 is driven through the groove 254, the wave groove 276 passes over the connector 294 of the port 290 of the insertion device 190. In various embodiments, the undulating groove 276 includes a wide portion 278 and a narrow portion 280. The wide portion 278 is configured to be wide enough to pass over the connector 294 and a flange 296 wider than the connector 294. However, the narrow portion 280, while wide enough to pass over the connector 294, is too narrow to pass over the flange 296. When the locking mechanism 270 is in the secured position, the narrow portion 280 of the undulating groove 276 of the locking member 274 engages the connector 294 behind the flange 296. Engagement of the locking member 274 with the flange 296 may prevent the coupling 110 from being withdrawn from the insertion device 190 until the locking mechanism 270 is manipulated to slide the narrow portion 280 of the locking member 274 out behind the flange 296.
Once the locking mechanism 270 is in the secured position, one or more latches 284, such as a barb-shaped hook as shown in fig. 3, engage a notch or similar structure (not shown) in the housing 250 to hold the locking mechanism 270 in place. The one or more latches 284 hold the locking member 274 in place until a removal force is applied to the base 272 to forcibly release the one or more latches 284 to allow the locking mechanism 270 to be at least partially withdrawn from the slot 254 in the housing 250.
Referring to fig. 4, in various embodiments, the control system 100 is coupled to the insertion device 190 via a coupling 110. The bushing 212 extending from the control system 100 is inserted into the opening 292 of the port 290 of the insertion device 190. The first seal member 214 seals the exterior of the elongate instrument 102 against the bushing 212. In various embodiments, the first sealing member 214 is held in place against the end of the bushing 214 by a fitting 412 coupled with the cap 260 of the housing 250 through which the elongate instrument 102 extends 260 of the housing 250. The second sealing member 224 seals the exterior of the bushing 212 against the opening 292 of the port 290 of the insertion device 290.
The locking mechanism 270 extends through the slot 254 in the housing 250. The locking member 274 slides around the connector 294 of the port 290 behind the flange 296 to prevent withdrawal of the control system 110 from the insertion device 190. After the control system 110 has been used to collect a sample (not shown), the locking mechanism 270 may be forcibly disengaged to allow the locking mechanism 270 to be at least partially withdrawn from the slot 254 in the housing 250. When the locking member 274 is moved such that the wide portion 278 (fig. 3) of the undulating groove 276 passes over the flange 296, the housing 250 may be moved away from the port 290 to allow the control system 110 to be withdrawn from the insertion device 190.
Referring to fig. 5, in various embodiments, the actuator 112 includes a proximal port 120, which proximal port 120 may be adapted to securely receive an imaging probe as previously described. The actuator 112 is positioned at the distal end 501 of the housing 114. The actuator 112 is laterally slidable along the housing 114 to advance the elongate instrument 102 (fig. 1). As previously described, the elongate instrument 102 may include a sheath (not shown in FIG. 5) slidably driven by the actuator 112. In various embodiments, as previously described, the sheath may contain an imaging probe and a sampling needle (neither shown in fig. 5). Both the imaging probe and the sampling needle can be secured to the actuator 112 such that the imaging probe and needle advance with the sheath as the actuator 112 advances and retracts along the housing 114. The sampling needle may be separately secured to the actuator 112 and controlled by the needle actuator 140, as described further below. The imaging probe may be received and secured by the proximal port 120 at the proximal end 530 of the actuator 112. The proximal port 120 is configured to press against and thus clamp the side of the imaging probe in a compressible manner, as described further below.
Proximal port 120 includes a rotatable cap 550 at distal end 530 of actuator 112. The rotatable cover 550 includes an opening 552 and an imaging probe can be received in the opening 552. As further described with reference to fig. 6, the imaging probe is clamped by a flexible gasket (not shown in fig. 5) compressed between the rotatable cap 550 and the body of the actuator 112. Compression of the flexible gasket between rotatable cap 550 and the body of actuator 112 operates similarly to a Tuohy-Borst adapter, wherein the flexible gasket acts as a valve. The flexible gasket includes an opening at a central portion of the flexible gasket that can be compressed and thus deformed to close the opening in the flexible gasket. In various embodiments, rotation of the rotatable cap 550 results in compression of the flexible washer, which in turn results in the flexible washer engaging a side of the imaging probe. The rotatable cap of the Tuohy-Borst adapter may be rotated multiple times to control the flow of liquid through the valve. In contrast, in various embodiments, the rotatable cap 550 and the actuator 112 are configured such that only a portion of the rotatable cap 550 is rotated for compressibly securing the sides of the imaging probe.
In various embodiments, the following visual and/or tactile confirmation is provided: the imaging probe is fixed and will therefore move with the actuator 112 as the imaging probe advances along the housing. For example, in various embodiments, the rotatable cover 550 and socket 560 at the distal end 530 of the actuator 112 are shaped such that the rotatable cover 550 can be received into the socket 560 only when the rotatable cover 550 has been rotated to secure the imaging probe. As shown in fig. 5, in various embodiments, the rotatable lid 550 includes at least one planar surface 554, the at least one planar surface 554 corresponding to a planar edge 564 of the receptacle 560. In this configuration, when the rotatable lid 550 is rotated to the closed position, the rotatable lid 550 may be slidably received into the socket 560, thereby providing visual and/or tactile confirmation that the imaging probe has been secured. If the rotatable lid 550 is not rotated to the closed position, the rotatable lid 550 will be blocked from slidably inserting into the receptacle 560 because the flat edge 564 will block the non-flat surface of the rotatable lid 550 from inserting into the receptacle 560.
Referring to fig. 6, a flexible gasket 650 sits in a mounting socket 660 in the body 630 of the actuator 112. The rotatable cap 550 has an externally threaded surface 652 that is threadably received by an internally threaded surface 662 of the socket 560 of the actuator 112. Distal end 621 of flexible washer 650 engages distal end 661 of mounting socket 660. The distal end 653 of the rotatable lid 550 engages the proximal end 623 of the flexible gasket 620. In response to rotation of rotatable cap 550 in the tightening direction, the interaction of externally threaded surface 652 of rotatable cap 550 with internally threaded surface 662 of socket 660 causes flexible washer 620 to be compressed between proximal end 623 of mounting socket 630 and distal end 653 of rotatable cap 550. Compression of the flexible gasket 620 presses it against an elongate body, such as an imaging probe 650, received through the flexible gasket 620.
As previously described with reference to fig. 5, after the rotatable cover 550 has been rotated to compress the flexible washer 620 to secure the imaging probe 650, the rotatable cover 550 may be slidably inserted into the socket 560 at the distal end 530 of the actuator 112. After the sampling operation is completed, the rotatable cap 550 may be slid from the socket 560 and counter rotated to release the imaging probe 650 from the proximal port 120. The rotatable lid 550 can slide relative to the externally threaded surface 652 such that the rotatable lid 550 can be slidably received within the socket 560 when the rotatable lid 550 has been rotated to the tightened position and/or the rotatable lid 550 can be slidably withdrawn from the socket 560 when it is desired to loosen the rotatable lid 550.
With continued reference to fig. 6, it should be noted that once inserted through the proximal port 120, the imaging probe 650 can be received at the sheath 610, the sheath 610 having a proximal end 612 coupled to the actuator 112. In various embodiments, sheath 610 defines a first lumen 614 configured to receive imaging probe 650 and a second lumen 616 configured to receive sampling needle 670. As described further below, the sampling needle 670 is coupled to the needle actuator 140 and the sampling needle 670 is controlled by the needle actuator 140. The needle actuator 140 is slidably mounted on the guide tube 130 (which is also described further below). In various embodiments, the sampling needle 670 extends from the needle actuator 140 through the guide tube 130 and into the second lumen 616 of the sheath 610, and the sampling needle 670 may extend through the second lumen 616 into the body to collect a sample. The guide tube 130 is also coupled to the actuator 112. Thus, when the needle actuator 140 and imaging probe 650 are secured to the actuator 112, movement of the actuator 112 advances the sheath 610 and the imaging probe 650 and sampling needle 680 contained within the sheath 610.
Referring to fig. 7, the sampling needle 670 is held and controlled by the needle actuator 140. The needle actuator 140 includes a housing 710 having a distal end 712, the distal end 712 engaging the guide tube 130 extending from the actuator 112. The needle actuator 140 is movable along the guide tube 130 to enable an operator (not shown) to puncture or otherwise agitate tissue with the distal end of the sampling needle 670 (fig. 6) to retrieve a tissue sample (not shown in fig. 7-10). In various embodiments, the end cap 160 is removably secured to the proximal end 714 of the housing 710 of the needle actuator 140 to secure a stylet (not shown in fig. 7), as described further below.
Referring to fig. 8, in various embodiments, a stylet 810 is movably received within the sampling needle 670 and fixably secured to the end cap 160. The stylet 810 can provide a range of functions including, by way of illustration and not limitation: sealing the end of the sampling needle 670 until the sampling needle 670 is in place to collect a sample; increasing the stiffness of the sampling needle 670 to facilitate insertion into tissue; guiding or guiding the end of the sampling needle 670; and/or other functions. However, once sampling needle 670 has been ready to receive a tissue sample, it may be desirable to withdraw stylet 810 from sampling needle 670 so that the tissue sample may be aspirated into sampling needle 670. To facilitate retrieval of the tissue sample, once stylet 810 is withdrawn from sampling needle 670, it may be desirable to apply a vacuum source, such as a syringe or pump (not shown in fig. 7-10), to the proximal end of sampling needle 670 (via a proximal port, as described below).
As previously described, the operator may move the needle actuator 140 along the guide tube 130 to penetrate or agitate tissue at the distal end (not shown in fig. 8) of the sampling needle 670. When the needle actuator 140 is moved, the end cap 160 covers the proximal end of the needle actuator 140. Further, when the sampling needle 670 is driven, it may be desirable to hold the stylet 810 in place such that agitation of the sampling needle 670 does not cause the stylet 810 to inadvertently and/or undesirably dislodge and slide out of the sampling needle 670 before removal of the stylet 810 is desired. The end cap 160 may help prevent removal of the stylet 810.
With continued reference to fig. 8, in various embodiments, the stylet 810 is secured in the stylet mount 812 of the end cap 160. In various embodiments, at least a portion of the stylet 810 and stylet mount 812 can both be received within a proximal port 820 located at the proximal end 714 of the needle actuator 140. In various embodiments, the inner surface 814 of the end cap 160 is configured to engage with the outer surface 824 of the proximal port 820 of the needle actuator 140 to secure the end cap 160 to the needle actuator 140 and, thus, hold the stylet 810 in place until withdrawal of the stylet 810 is desired.
Referring to fig. 9, in various embodiments, the inner surface 814 of the end cap 160 may include grooves or other recesses 916 configured to engage with ridges or other protrusions 926 on the proximal port 820 of the needle actuator 140. The grooves 916 may frictionally engage the ridge 926 such that an operator (not shown) may require a degree of force to manually remove the end cap 160 when needed, wherein the degree of force is greater than the amount of force that may be applied to the stylet during movement or agitation of the sampling needle 670. In various embodiments, the grooves 916 and/or ridges 926 may have a curved or other undulating cross-section to facilitate engagement and disengagement of the grooves 916 with the edges 926 when the end cap 160 is installed and removed from the proximal port 820, respectively.
Referring to fig. 10, in various embodiments, the inner surface of the end cap 103 (not shown in fig. 10) may further include one or more inwardly facing threads 1016 (indicated by dashed lines) configured to engage one or more outwardly facing threads 1026 located on the outer surface 824 of the proximal port 820. Threads 1016 and 1026 enable end cap 160 to be threadably engaged with proximal port 820 to alternately secure or remove end cap 160 by rotating end cap 160 relative to housing 710 of needle actuator 140. Once the end cap 160 is unsecured from the needle actuator 1401153, the stylet 810 can be withdrawn.
Although the examples of fig. 8-10 show the end cap 160 engaging the proximal port 820 to secure the end cap 160 to the needle actuator 140, it will be appreciated that the end cap 160 may engage other portions of the housing 710 of the needle actuator 140 to secure the stylet 810 in place during manipulation of the needle actuator 140.
Referring to fig. 11A, the needle actuator 140 may further include a release mechanism 170, the release mechanism 170 configured to assist an operator (not shown) in selectively advancing the sampling needle 670 using the needle actuator 140. In various embodiments, the release mechanism 170 includes a first release 1050 and a second release 1060. First release device 1050 enables an operator to advance sampling needle 670 from a retracted position within sheath 610 (fig. 6) to a ready position where the sampling needle is adjacent the distal end of an insertion device (not shown) in preparation for engaging tissue to collect a tissue sample. Engaging the second release device 1060 then enables the operator to advance the sampling needle 670 beyond the distal end of the sheath 610 and the insertion device to penetrate or otherwise engage the tissue to be sampled.
Referring to fig. 11B, the distal end 1171 of the sampling needle 670 is in a retracted position removed from the distal end 1111 of the sheath 610. In various embodiments, the distal end 1181 of the stylet 810 is positioned at the distal end 1171 of the sampling needle 670 to, for example, plug the distal end 1170 of the sampling needle 670 and/or increase the stiffness of the sampling needle 670. The distal end 1111 of the sheath 610 has been positioned near a target site which may include the tissue 1101 to be sampled using the sampling needle 670.
Referring again to fig. 11A, the needle actuator 140 is in a retracted position corresponding to the retracted position of the sampling needle 670 of fig. 11B. The release mechanism 170 is configured to prevent the needle actuator 140 from slidably moving relative to the guide tube 130 to move the sampling needle 670 from the retracted position of fig. 11B until the first release device 1050 is engaged by the operator.
In various embodiments, first release 1050 and second release 1060 selectively engage guide tube 130 to limit movement of needle actuator 140 relative to guide tube 130. The first release mechanism 1050 includes a first release interlock 1152. The first release interlock 1152 is slidably received in a first release channel 1153 defined by the housing 710 of the needle actuator 140. The first release interlock 1152 includes a first interface 1154 that is engageable by an operator (not shown). In various embodiments, the first interface 1154 is in the nature of a button that can be pressed by an operator. The first release interlock 1152 and/or the first release groove 1153 may include a spring 1155 or similar temporary deformable structure, the spring 1155 or similar temporary deformable structure applying an opposing force to drive the first release interlock 1152 toward a starting position (as shown in fig. 11A) when the operator is not depressing the first release interlock 1154. The first release interlock 1154 further defines a first channel 1156 through which the guide tube 130 can extend 1156 in response to an operator engaging the first interface 1154 to release the first release interlock 1152.
In various embodiments, the first release interlock 1152 includes a protrusion 1158, which protrusion 1158 is configured to alternately engage a locking recess 1172 adjacent the proximal end 1177 of the guide tube 130 and a channel 1174 formed in the guide tube 130. Ramp 1176 in channel 1174 facilitates guiding protrusion 1158 back into locking recess 1172 after needle actuator 140 has been manipulated to obtain a sample and needle actuator 140 has returned to the starting position of fig. 11A.
In a starting position before the first release interlock 1152 is released by engagement of the operator with the first interface 1154, the protrusion 1158 is received in the locking recess 1172. Engagement of the projection 1158 with the locking recess 1172 prevents lateral movement of the needle actuator 140 along the guide tube 130.
In response to the operator depressing the first release interlock 1154, the first release interlock 1152 can deform the spring 1155 to move the first release interlock 1152 further into the first release slot 1153, thereby removing the protrusion 1158 from the locking recess 1174. Removal of the tab 1158 from the locking recess 1172 thereby enables the guide tube 130 to slide within the channel 1156 of the first release interlock 1152 and allows the needle actuator 140 to move relative to the guide tube 130 to advance the sampling needle 670.
Referring to fig. 12A, the needle actuator 140 is in a ready position corresponding to the ready position of the sampling needle 670 of fig. 12B. In response to first release device 1050 being engaged by the operator, distal end 712 of needle actuator 140 can be advanced along guide tube 130 until guide tube 130 is engaged by second release device 1060. It will be appreciated that the tab 1158 of the first release interlock 1152 has been pierced from the locking notification 172 of the guide tube 130 and has traveled within the channel 1174 on the side of the guide tube 130.
In various embodiments, the second release device 1060 includes a second release interlock 1262. The second release interlock 1262 is slidably received in a second release slot 1263 defined by the housing 710 of the needle actuator 140. The second release interlock 1262 includes a second interface 1264 that is engageable by an operator (not shown). In various embodiments, similar to the first interface 1154 (fig. 11A), the second interface 1264 has the nature of a button that can be pressed by an operator. The second release interlock 1262 and/or the second release slot 1263 may include a spring 1265 or similar temporary deformable structure that applies an opposing force to drive the second release interlock 1262 toward the starting position (as shown in fig. 12A) when the operator is not pressing the second release 1264. The second release interlock 1262 defines a second passage 1266 through which the guide tube 130 may extend 1266 in response to an operator engaging the second interface 1264 to release the second release interlock 1262.
In various embodiments, the second release interlock 1262 blocks access to the distal end 1177 of the guide tube 130 until the second release interlock 1262 is displaced by the operator engaging the second interface 1264. Engaging or depressing the second interface 1264 moves the second release interlock 1262 further into the second release slot 1263 such that the second release interlock 1262 no longer blocks the distal end 1177 of the guide tube 130. The guide tube 130 may then pass through the second channel 1266 of the second release interlock 1262. In various embodiments, as long as the operator continues to engage the second release device 1264, the operator may move the needle actuator 140 along the guide tube 130 to penetrate and/or agitate the tissue 1101 to facilitate retrieval of the tissue sample.
Referring to fig. 12B, after first release device 1050 is activated and needle actuator 140 is advanced along guide tube 130, distal end 1171 of sampling needle 670 and distal end 1181 of stylet 680 are moved in unison to a ready position adjacent distal end 111 of sheath 610. With the distal end 1171 of the sampling needle 670 in place at the distal end 1111 of the sheath 610 adjacent the tissue 1101 to be sampled, the second release device 1060 can be activated to allow the sampling needle 670 to be advanced to sample the tissue 1101.
Referring to fig. 13A, the needle actuator 140 is in a sampling position corresponding to the sampling position of the sampling needle 670 of fig. 13B. With the first and second release devices 1050, 1060 released, the guide tube 130 is able to pass through the first channel 1156 of the first release interlock device 1152 and the second channel 1266 of the second release interlock device 1262. Thus, the needle actuator 140 can be slid along the guide tube 130 to enable the sampling needle 370 to be moved into the tissue 1101 as needed to penetrate and/or agitate the tissue. The end cap 160 (fig. 11A and 12A) has been removed to withdraw the stylet 810 from the sampling needle 670. Thus, a vacuum source 1310, such as a syringe or pump, may be applied to the proximal port 820 to aspirate the tissue sample 1301 into the sampling needle 670 to facilitate capture of the tissue sample 1310.
Referring to fig. 13B, after first release 1050 and second release 1060 have been released, needle actuator 140 can be advanced into tissue 1101 to be sampled. The needle actuator 140 may be moved along the guide tube 130 to puncture and/or agitate the tissue 1101 to disengage the tissue sample 1301. At this point, the stylet 810 (not shown in fig. 13B) may be withdrawn to facilitate receipt of the tissue sample 1301 into the distal end 1171 of the sampling needle 670.
Referring to fig. 14, in various embodiments, the needle actuator 140 includes an asymmetric distal opening 1410, which asymmetric distal opening 1410 is configured to receive an asymmetric guide tube 1430 having an asymmetric cross section, as described further below with reference to fig. 16 and 17. In various embodiments, the asymmetric guide tube 1430 may include one or more protruding structures 1440 that are capable of being received into the groove 1450 in the asymmetric distal opening 1410 at the distal end 712 of the needle actuator. The asymmetric distal opening 1410 may be used to ensure that the needle actuator 140 rotates to a particular orientation when moved onto the guide tube 130, as the distal end of the sampling needle (not shown in fig. 14) may be oriented or capable of being oriented in a particular orientation, as described further below.
By way of non-limiting example and with reference to fig. 15A, the sampling needle 1570 may have a deflectable distal end 1572. The deflectable distal end 1572 may conform to the shape of the sheath 1574 when contained within the sheath 1574. However, the deflectable distal end 1572 may deflect in direction 1578 when extending beyond the distal end 1576 of the sheath 1574. Thus, when the orientation of the deflectable distal end 1572 may be set relative to the orientation of the needle actuator 140, it may be desirable to orient the needle actuator 140 relative to the guide tube 130 such that the deflectable distal end 1572 deflects in a desired direction as the deflectable distal end 1572 extends.
By way of another non-limiting example and referring to fig. 15B, the sampling needle 1571 may have an asymmetric distal end 1573 with a sampling aperture 1575 on a side 1577 of the asymmetric distal end 1573. Thus, when the orientation of the deflectable distal end 1573 may be set relative to the orientation of the needle actuator 140, it may be desirable to orient the needle actuator 140 relative to the guide tube 130 such that the asymmetric distal end 1573 is provided with a sampling aperture 1575 facing a desired direction.
Referring to fig. 16, in various embodiments, an asymmetric distal opening 1410 at the distal end 712 of the needle actuator 140 is formed to receive an asymmetric guide tube 1430. The asymmetric distal opening 1410 may have an asymmetric cross-section, for example, including a groove 1450, the groove 1450 being located on a side of the asymmetric distal opening 1410 to accommodate the protruding structure 1440 located on a side of the asymmetric guide tube 1430. It will be appreciated that due to the protruding structures 1440 on the sides of the asymmetric guide tube 1430 and the slots 1450 on the sides of the asymmetric distal opening 1410, the needle actuator 140 can only move over the guide tube 130 when the needle actuator 140 is in a predetermined orientation relative to the asymmetric guide tube 1430. Thus, while the orientation of the distal ends 1571 or 1573 of the sampling needles 1570 and 1572, respectively, may be determined relative to the needle actuator 140, the orientation of the asymmetric distal ends 1571 or 1573 of the sampling needles 1570 and 1572, respectively, may be maintained while moving the needle actuator 140 over the asymmetric guide tube 1430.
It should be appreciated that in various embodiments, the asymmetric distal opening 1410 may have other configurations than that shown in fig. 16 to receive an asymmetric guide tube 1430. For example and referring to fig. 17, in some embodiments, the asymmetric guide tube 1730 may define a channel 1750 that receives the protruding structure 1740 (rather than supporting the protruding structure 1440 (fig. 14 and 16)) extending from the asymmetric distal opening 1710 at the distal end 712 of the needle actuator 140. By comparing fig. 17 and 16, it will be appreciated that the protrusions, protruding structures, grooves, channels, or other features used in the asymmetric distal opening or asymmetric guide tube may have straight, curved, or angled configurations. Embodiments are not limited to any particular configuration to orient the needle actuator 140 relative to the guide tube 130.
Referring to fig. 18, in various embodiments, control system 100 includes one or more anti-buckling devices 1810 and 1812 in the housing to support elongate instrument 102. The elongate instrument may encounter resistance as the actuator 112 moves from the proximal end 113 along the housing 114 toward the distal end 111. For example, if the elongate instrument 102 encounters a curled, rotated, or collapsed portion of an insertion tube (not shown) of the insertion device 190 as it advances, advancement of the elongate instrument 102 may be hindered. If advancement of the elongate instrument 102 is impeded as the operator drives the actuator 112 near the distal end 111, opposing forces on the elongate instrument 102 may cause the elongate instrument 102 to flex within the housing 114.
It is desirable to prevent the elongate instrument 102 from buckling to avoid damage that may result from bending, snapping or otherwise damaging components such as an imaging probe or a sampling needle. Although a telescoping inner housing may be used to support the elongate instrument 102, the length of the telescoping outer housing section may limit the advancement of the actuator 112 and, thus, the elongate instrument 102. Flexion devices 1810 and 1812 are configured to provide lateral support for elongate instrument 102 within housing 114 without impeding advancement of actuator 112 and elongate instrument 102.
Referring to fig. 19, in various embodiments, an exemplary anti-buckling apparatus 1810 includes a planar member 1920 and a locating member 1950. Planar member 1920 includes an inner aperture 1930 and at least one outer edge 1940, the at least one outer edge 1940 configured to movably engage an inner surface 1818 of a channel 1816 defined by housing 114. The elongate instrument 102 is received through the inner aperture 1930. Planar member 1920 is configured to act as a scaffold by providing structural and lateral support between inner orifice 1930 and at least one outer edge 1940. In other words, if opposing forces bend the elongate instrument 102 perpendicular to its length, the elongate instrument 102 may be engaged by the surface of the inner aperture 1930. Any resulting lateral forces are counteracted by opposing forces of planar member 1920 between at least one outer edge 1940 engaged with inner surface 1818 of channel 1816, thereby preventing lateral bending of elongate instrument 102.
In various embodiments, the positioning member 1945 is used to maintain the orientation of the planar member 1920 within the channel 1816. The positioning member 1950 can prevent the planar member 1920 from twisting within the channel 1816 in response to lateral forces that can be applied by the elongate instrument 102. In various embodiments, the positioning member 1950 maintains the planar member 1920 in an orientation substantially perpendicular to the axis 180 of the channel 1816. In various embodiments, the positioning member 1950 is coupled to the planar member 1920 at an end and is generally orthogonal to the planar member 1920. In use, the locating member 1950 extends between the inner surface 1818 of the channel 1816 and another body, such as the actuator 112, or another anti-buckling member 1810, such as the anti-buckling member 1812. With the locating member 1950 being able to be received between the inner surface 1818 of the channel on one side and the actuator 112 or another buckling-resistant member 1812 on the other side, the planar member 1950 is prevented from twisting, and thus the planar member 1920 is able to be prevented from twisting within the channel 1816.
In various embodiments, the positioning member 1950 also supports a linkage 1960 that may engage the actuator 112 or another buckling-resistant member 1812. Thus, as actuator 112 is drawn from distal end 111 of housing 114 toward proximal end 113 of the housing, anti-buckling devices 1810 and 1812 will be drawn back to their original position within housing 114. In various embodiments, one or more stops 1880 may be provided along the inner surface 1818 of the housing 114. The one or more stops 1880 may be configured to engage one or more outer edges 1940 of the planar member 1920 to prevent the planar member 1920, and thus the anti-buckling devices 1810 and 1812, from collapsing into the actuator 112 or alongside the retraction recesses 1850 and 1852. Accordingly, as elongate instrument 102 is advanced by actuator 112, anti-buckling devices 1810 and 1812 will be in place to support elongate instrument 102.
Referring back to fig. 18, it will be appreciated that the anti-buckling devices 1810 and 1812 may be arranged to be angularly offset from one another. In this manner, as described further below, the positioning members 1950 of the anti-buckling devices 1810 and 1812 may slide into opposing retraction recesses 1850 and 1852, respectively, within or beside the actuator 112 so as not to impede advancement of the actuator 112 within the channel 1816 defined by the housing 114. Further, the inner surface 1818 of the housing 114 may include one or more guides 1885 configured to engage the positioning member 1950 to maintain an orientation of the positioning member 1950 of the anti-buckling device 1810 (or the positioning member of the anti-buckling device 1812) relative to the axis 1801 of the channel 1816.
Referring to fig. 20, in various embodiments, actuator 112 is advanced a distance 2000 toward distal end 111 of housing 114. As actuator 112 advances toward distal end 111 of housing 114, anti-buckling devices 1810 and anti-buckling 1812 devices provide lateral support to elongate member 102. At the same time, the positioning member 2050 of the anti-buckling specific apparatus 1810 enters the retraction recess 1850 such that the anti-buckling apparatus 1810 does not obstruct movement of the actuator 112.
Referring to fig. 21, actuator 112 is advanced a further distance 2100 toward distal end 111 of housing 114. As actuator 112 advances toward distal end 111 of housing 114, anti-buckling devices 1810 and 1812 provide lateral support to elongate member 102. At the same time, the positioning member 2152 of the anti-buckling device 1812 enters into the retraction recess 1852 such that the anti-buckling device 1812 does not obstruct movement of the actuator 112. The anti-buckling devices 1810 and 1812 are offset from one another such that the positioning members 2050 and 2052 are received in opposing retraction recesses 1850 and 1852, respectively. Thus, as actuator 112 advances, anti-buckling devices 1810 and 1812 do not impede each other or actuator 112.
Referring to fig. 22, an illustrative method 2200 of coupling a control system to an insertion device is provided. Method 2200 begins at block 2205. At block 2210, a coupling is provided adjacent to an opening in a port of an insertion device, wherein the coupling supports an elongate instrument to be delivered to a target location by an insertion device. At box 2220, the bushing is inserted into an opening in the insertion device through which the elongate instrument can extend. At block 2230, an outer surface of the liner is sealed against the opening to prevent fluid from passing between an inner surface of the opening and an outer surface of the liner. At block 2240, an outer surface of the elongated instrument is moveably sealed with the body of the coupling to prevent passage of fluid between the outer surface of the elongated instrument and the coupling such that the fluid is sealably prevented from entering into the coupling around the outer surface of the bushing and around the outer surface of the elongated instrument. The method 2200 ends at block 2245.
Referring to fig. 23, an illustrative method 2300 of securing an elongate instrument into a movable control device is provided. Method 2300 begins at block 2305. At block 2310, the elongate instrument is received into a port of a control device configured to facilitate extension of the elongate instrument to a target location. At block 2320, a side of the elongate instrument is compressibly secured to the control device. Method 2300 ends at block 2325.
Referring to fig. 24, an illustrative method 2400 of securing a stylet within a needle using an end cap is provided. Method 2400 begins at block 2405. At block 2410, the distal end of the stylet is inserted into the lumen of the needle secured with the needle actuator. At block 2420, the stylet is extended into the lumen until the distal end of the needle actuator is covered by an end cap fixably engaged with the proximal end of the stylet. At block 2430, the end cap is withdrawn from the proximal end of the needle actuator until the style is withdrawn from the lumen. At block 2440, a vacuum source is coupled to the lumen. The method 2445 ends at block 2435.
Referring to fig. 25, an illustrative method 2500 of controlling movement of a needle actuator is provided. Method 2500 begins at block 2505. At block 2510, the first release device is engaged to release the needle actuator from a retracted position at the end of the guide tube where the distal end of the needle is retracted within the distal end of the sheath positionable adjacent the tissue to be sampled. At block 2520, the needle actuator is advanced to a ready position to advance the distal end of the needle adjacent the distal end of the sheath. At block 2530, a second release device is engaged to release the needle actuator from the ready position. At block 2540, the needle actuator is advanced to advance the distal end of the needle into the tissue to be sampled. The method 2500 ends at block 2545.
Referring to fig. 26, an illustrative method 2600 of orienting a needle actuator relative to a control system to orient a distal end of an attached needle is provided. The method 2600 begins at block 2605. At block 2610, the distal end of the needle is inserted into a guide tube defining a lumen and configured to deliver the distal end of the needle to tissue to be sampled, wherein the needle is fixably coupled with a needle actuator. At block 2620, a distal opening in the needle actuator is provided to the proximal end of the guide tube, wherein the distal opening in the needle actuator is configured to slidably receive the proximal end of the guide tube in response to the needle actuator being oriented in a desired direction to direct the distal end of the needle to face the desired direction. At block 2630, the distal opening of the needle actuator slides over the outer surface of the guide tube when the needle actuator is oriented in the desired direction. The method 2600 ends at block 2535.
Referring to fig. 27, an illustrative method 2700 of preventing buckling of an elongate instrument as the elongate instrument is advanced through a channel is provided. Method 2700 begins at block 2705. At block 2710, an actuator slidably received within the channel is engaged, wherein the actuator is configured to move from the proximal end of the channel toward the distal end of the channel to advance the elongate instrument through a distal opening at the distal end of the channel. At block 2720, a planar member is employed to support the elongate instrument away from the inner surface of the channel at a point between the distal end of the actuator and the distal end of the channel. At block 2730, a positioning member is employed to prevent the planar member from twisting within the channel. At block 2740, as the distal end of the actuator advances toward the distal end of the channel, at least a portion of the passing positioning member is moved past the distal end of the actuator such that the portion of the positioning member does not obstruct movement of the distal end of the actuator toward the distal end of the channel. The method 2700 ends at block 2745.
The disclosed subject matter includes, but is not limited to, the subject matter recited in the following clauses with respect to the various embodiments described herein:
first embodiment
1. An apparatus, comprising:
a coupling configured to couple a control device for an elongated instrument with a port of an insertion device configured to deliver the elongated instrument to a target location;
a bushing extending from the coupling and configured to be inserted into an opening in the port of the insertion device through which the elongate instrument is movably extendable;
a first sealing member disposed on an outer surface of the bushing and configured to seal the outer surface of the bushing against an inner surface of the opening in the port; and
a second sealing member disposed on an outer surface of the elongated instrument and configured to movably seal the outer surface of the elongated instrument.
2. The apparatus of clause 1, wherein the first sealing member comprises a gasket disposed on an outer surface of the bushing.
3. The apparatus of clause 1, wherein the second sealing member comprises an O-ring configured to allow the elongate instrument to slidably move within an inner diameter of the O-ring.
4. The apparatus of clause 1, wherein the elongate instrument comprises a sheath defining at least one lumen through which at least one elongate member is extendable.
5. The apparatus of clause 1, wherein the coupling comprises:
an outer housing configured to extend over an adapter extending from the insertion device; and
a locking mechanism configured to secure the outer housing to the adapter, the locking mechanism configured to prevent removal of the coupling from the insertion device without disengagement of the locking mechanism.
6. The apparatus of clause 5, wherein:
the adapter includes a shaft having a first outer diameter and a distal flange having a second outer diameter greater than the first outer diameter; and is also provided with
The locking mechanism includes a locking member configured to engage the shaft to prevent the outer coupling from moving away from the flange without the locking member being removed from the shaft.
7. The apparatus of clause 6, wherein the locking member is slidably securable to the outer housing between a first position in which the locking member does not engage the shaft and a second position in which the locking member engages the shaft.
8. The apparatus of clause 7, wherein the locking member comprises at least one securing mechanism configured to hold the locking member in the second position until the at least one securing mechanism is released.
9. A system, comprising:
an elongate instrument;
a control device movably coupled with the elongate instrument and configured to extend and retract the elongate instrument;
a coupling configured to removably secure the control device with an insertion device configured to deliver the elongate instrument to a target location, the insertion device including a port to receive the elongate instrument therethrough;
a bushing extending from the coupling and configured to be inserted into an opening in the port of the insertion device through which the elongate instrument is movably extendable;
a first sealing member disposed on an outer surface of the bushing and configured to seal the outer surface of the bushing against an inner surface of the opening in the port; and
A second sealing member disposed on an outer surface of the elongated instrument and configured to movably seal the outer surface of the elongated instrument.
10. The system of clause 9, wherein the first sealing member comprises a gasket disposed on an outer surface of the bushing.
11. The system of clause 9, wherein the second sealing member comprises an O-ring configured to allow the elongated instrument to slidably move within an inner diameter of the O-ring.
12. The system of clause 9, wherein the elongate instrument comprises a sheath defining at least one lumen through which at least one elongate member is extendable.
13. The system of clause 9, wherein the coupling comprises:
an outer housing configured to extend over an adapter extending from the insertion device; and
a locking mechanism configured to secure the outer housing to the adapter, the locking mechanism configured to prevent removal of the coupling from the insertion device without disengagement of the locking mechanism.
14. The system of clause 13, wherein:
the adapter includes a shaft having a first outer diameter and a distal flange having a second outer diameter greater than the first outer diameter; and is also provided with
The locking mechanism includes a locking member configured to engage the shaft to prevent the outer coupling from moving away from the flange without the locking member being removed from the shaft.
15. The system of clause 14, wherein the locking member is slidably securable to the outer housing between a first position in which the locking member does not engage the shaft and a second position in which the locking member engages the shaft.
16. The system of clause 15, wherein the locking member includes at least one securing mechanism configured to hold the locking member in the second position until the at least one securing mechanism is released.
17. A method, comprising:
providing a coupling adjacent to an opening in a port of an insertion device, the coupling supporting an elongate instrument to be delivered by the insertion device to a target location;
inserting a bushing into the opening of the insertion device through which the elongate instrument can extend;
Sealing an outer surface of the bushing against the opening to prevent fluid from passing between an inner surface of the opening and the outer surface of the bushing; and
an outer surface of the elongated instrument is moveably sealed to prevent passage of the fluid between the outer surface of the elongated instrument and the coupling such that fluid is sealably prevented from entering into the coupling around the outer surface of the bushing and around the outer surface of the elongated instrument.
18. The method of clause 17, further comprising moveably sealing the outer surface of the elongated instrument at a location along the surface of the elongated instrument prior to the elongated instrument entering the bushing.
19. The method of clause 17, further comprising:
extending an outer housing of the coupling over an adapter extending from a coupling of the insertion device over a port in the insertion device; and
a locking mechanism is engaged to secure the coupling to the insertion instrument, wherein the coupling is not removable from the insertion device without first disengaging the locking mechanism.
20. The method of clause 19, further comprising securing the locking mechanism in a locked position.
Second embodiment
21. An apparatus, comprising:
a control device configured to facilitate extension of the elongate instrument to a target location; and
a port located within an end of the control device, the port configured to press against a side of the elongate instrument to secure the elongate instrument for movement with the control device.
22. The apparatus of clause 21, further comprising a flexible washer configured to compressibly engage the side of the elongated instrument.
23. The apparatus of clause 22, wherein the flexible washer is coupled to the control device.
24. The apparatus of clause 23, wherein a side of the flexible gasket is configured to be collapsed by compressing the flexible gasket along a length of the flexible gasket transverse to the side of the flexible gasket.
25. The apparatus of clause 24, wherein the flexible gasket is secured between a body coupled with the control device and a rotatable cap threadably movable within the body.
26. The apparatus of clause 25, wherein the flexible gasket is configured to be compressed along the length of the flexible gasket by threadably moving the rotatable cap into the body to pinch opposite ends of the flexible gasket.
27. The apparatus of clause 26, wherein the body, the flexible gasket, and the rotatable cap comprise a Tuohy-Borst adapter.
28. The apparatus of clause 26, wherein the body, the flexible washer, and the rotatable cover are configured to be switched from an open position for receiving the elongated instrument to a closed position for securing the elongated instrument by rotating the rotatable cover in a range between a sixteenth turn and an eighth turn.
29. The apparatus of clause 26, wherein the rotatable cover is configured to be receivable into the housing of the control device only if the flexible washer is compressed to compressibly secure the elongate instrument.
30. A system, comprising:
an elongate instrument sampling probe configured to deliver a sampling needle and an imaging probe to a target location;
A control device configured to facilitate extension of the elongate instrument to a target location; and
a port located within an end of the control device, the port configured to compressibly engage a side of the elongate instrument to secure the elongate instrument for movement with the control device.
31. The system of clause 30, further comprising a flexible washer configured to compressibly engage the side of the elongated instrument.
32. The system of clause 31, wherein the flexible gasket is coupled to the control device.
33. The system of clause 32, wherein the side of the flexible gasket is configured to be collapsed by compressing the flexible gasket along a length of the flexible gasket transverse to the side of the flexible gasket.
34. The system of clause 33, wherein the flexible washer is secured between a body coupled with the control device and a rotatable cap threadably movable within the body.
35. The system of clause 34, wherein the flexible gasket is configured to be compressed along the length of the flexible gasket by threadably moving the rotatable cap into the body to pinch opposite ends of the flexible gasket.
36. The system of clause 35, wherein the body, the flexible gasket, and the rotatable cap comprise a Tuohy-Borst adapter.
37. The system of clause 35, wherein the body, the flexible washer, and the rotatable cover are configured to be switched from an open position for receiving the elongated instrument to a closed position for securing the elongated instrument by rotating the rotatable cover in a range between a sixteenth turn and an eighth turn.
38. The system of clause 35, wherein the rotatable cover is configured to be receivable into the housing of the control device only if the flexible washer is compressed to compressibly secure the elongate instrument.
39. A method, comprising:
receiving an elongate instrument into an instrument port of a control device configured to facilitate extension of the elongate instrument to a target location; and
the side of the elongated instrument is compressibly secured to the control device, wherein the elongated instrument is secured for movement with the control device.
40. The method of clause 39, further comprising collapsing a side portion of a flexible washer movable with the control device against the side portion of the elongated instrument to compressibly secure the elongated instrument to the control device.
Third embodiment
41. An apparatus, comprising:
a stylet configured to be insertable into a lumen of a needle via a proximal port of a needle actuator secured to the needle; and
an end cap fixably coupled to the stylet and configured to cover a proximal end of the needle actuator and movable relative to the needle actuator to enable an operator to withdraw the stylet from the lumen.
42. The apparatus of clause 41, wherein the end cap is configured to be secured to the proximal end of the needle actuator.
43. The apparatus of clause 42, wherein the end cap is configured to be secured to the proximal end of the needle actuator when the stylet is fully inserted into the lumen, wherein the end cap is further configured to cooperate with the proximal end of the needle actuator to prevent the stylet from being moved out of the lumen in response to the needle actuator being maneuvered to facilitate extraction of a tissue sample with the distal end of the needle.
44. The apparatus of clause 43, wherein the end cap includes an inner surface configured to securely engage an outer surface of the proximal end of the needle actuator.
45. The apparatus of clause 44, wherein the inner surface comprises an internally threaded surface configured to threadably engage an externally threaded surface of the outer surface.
46. The apparatus of clause 42, wherein the end cap includes an inner surface configured to securely engage an outer surface of the proximal port.
47. The apparatus of clause 41, wherein the proximal port is fluidly coupled to the lumen.
48. The apparatus of clause 46, wherein the proximal port is configured to receive a vacuum source when the stylet is withdrawn from the lumen.
49. A system, comprising:
a needle defining a lumen;
a stylet configured to be insertable into a lumen of a needle via a proximal port of a needle actuator secured to the needle; and
an end cap fixably coupled to the stylet and configured to cover a proximal end of the needle actuator and movable relative to the needle actuator to enable an operator to withdraw the stylet from the lumen.
50. The system of clause 49, wherein the end cap is configured to be secured to the proximal end of the needle actuator.
51. The system of clause 50, wherein the end cap is configured to be secured to the proximal end of the needle actuator when the stylet is fully inserted into the lumen, wherein the end cap is further configured to cooperate with the proximal end of the needle actuator to prevent the stylet from being moved out of the lumen in response to the needle actuator being maneuvered to facilitate extraction of a tissue sample with the distal end of the needle.
52. The system of clause 51, wherein the end cap includes an inner surface configured to securely engage an outer surface of the proximal end of the needle actuator.
53. The system of clause 52, wherein the inner surface comprises an internally threaded surface configured to threadably engage an externally threaded surface of the outer surface.
54. The system of clause 50, wherein the end cap includes an inner surface configured to securely engage an outer surface of the proximal port.
55. The system of clause 49, wherein the proximal port is fluidly coupled to the lumen.
56. The system of clause 55, wherein the proximal port is configured to receive a vacuum source when the stylet is withdrawn from the lumen, the vacuum source being configured to be in fluid communication with the lumen.
57. A method, comprising:
inserting the distal end of the stylet into the lumen of a needle secured to the needle actuator;
extending the stylet into the lumen until an end cap fixably engaged with the proximal end of the stylet covers the proximal end of the needle actuator;
withdrawing the end cap from the proximal end of the needle actuator until the stylet is withdrawn from the lumen; and
a vacuum source is coupled to the lumen.
58. The method of clause 57, further comprising securing the end cap to the proximal end of the needle actuator as the stylet extends into the lumen, wherein securing the end cap to the proximal end of the needle actuator prevents the stylet from being removed from the lumen in response to movement of the needle actuator.
59. The method of clause 57, wherein securing the end cap to the proximal end of the needle actuator comprises one of: frictionally engaging the end cap with the needle actuator; and threadably engaging the end cap with the needle actuator.
60. The method of clause 57, wherein coupling the vacuum source to the lumen comprises coupling the vacuum source to a proximal port that is fluidly coupled to the lumen of the needle.
Fourth embodiment
61. An apparatus, comprising:
a guide tube defining a lumen through which a needle can extend;
a needle actuator configured to be fixably coupled to a proximal end of the needle;
a first release device movably coupled to the needle actuator and configured to engage to release the needle actuator, moving the needle actuator from a retracted position at an end of a guide tube, in which a distal end of the needle is retracted within a distal end of a sheath positionable adjacent tissue to be sampled, to a ready position, in which the distal end of the needle is adjacent the distal end of the sheath; and
a second release device movably coupled to the needle actuator and configured to engage to release the needle actuator to move the needle actuator from the ready position to a sampling position at which the distal end of the needle is advanceable into the tissue to be sampled.
62. The apparatus of clause 61, wherein at least one of the first and second release devices comprises a button that is laterally movable transverse to the axis of the guide tube.
63. The apparatus of clause 62, wherein the button comprises a channel through which the guide tube extends, and an inner surface of the channel is configured to frictionally engage an outer surface of the guide tube until the button is engaged to retract the inner surface of the channel from the outer surface of the guide tube.
64. The apparatus of clause 61, wherein the first and second release devices are spring loaded to restore the first and second release devices to a disengaged position when not actively engaged by a user.
65. The apparatus of clause 61, wherein:
the first release means comprises a release interlock; and is also provided with
The guide tube includes a tube interlock, wherein in the retracted position, the release interlock engages the tube interlock to prevent movement of the needle actuator until the first release is engaged.
66. The apparatus of clause 65, wherein the release interlock comprises a protrusion and the tube interlock comprises a recess configured to receive the protrusion.
67. The apparatus of clause 65, wherein the guide tube includes an angled channel configured to guide the release interlock to engage the tube interlock in response to the needle actuator moving to the retracted position.
68. The apparatus of clause 61, wherein the second release device is configured to provide a stop to prevent advancement of the needle actuator from the ready position to the sampling position until the second release device is engaged.
69. A system, comprising:
a needle defining a first lumen;
a sampling device configured to be coupled to an insertion system configured to deliver the needle to tissue to be sampled;
a guide tube extending from the sampling device and defining a second lumen through which the needle can extend;
a needle actuator fixably coupled to the proximal end of the needle and configured to slidably move over the guide tube;
A first release device movably coupled to the needle actuator and configured to engage to release the needle actuator, moving the needle actuator from a retracted position at an end of a guide tube, in which a distal end of the needle is retracted within a distal end of a sheath insertable via the insertion system and positionable adjacent tissue to be sampled, to a ready position, in which the distal end of the needle is adjacent the distal end of the sheath; and
a second release device movably coupled to the needle actuator and configured to engage to release the needle actuator to move the needle actuator from the ready position to a sampling position at which the distal end of the needle is advanceable into the tissue to be sampled.
70. The system of clause 69, wherein at least one of the first and second release devices comprises a button that is laterally movable transverse to the axis of the guide tube.
71. The system of clause 70, wherein the button comprises a channel through which the guide tube extends, and an inner surface of the channel is configured to frictionally engage an outer surface of the guide tube until the button is engaged to retract the inner surface of the channel from the outer surface of the guide tube.
72. The system of clause 69, wherein the first and second release devices are spring loaded to restore the first and second release devices to the disengaged position when not actively engaged by the user.
73. The system of clause 69, wherein:
the first release means comprises a release interlock; and is also provided with
The guide tube includes a tube interlock, wherein in the retracted position, the release interlock engages the tube interlock to prevent movement of the needle actuator until the first release is engaged.
74. The system of clause 73, wherein the release interlock comprises a protrusion and the tube interlock comprises a recess configured to receive the protrusion.
75. The system of clause 73, wherein the guide tube comprises an angled channel configured to guide the release interlock to engage the tube interlock in response to the needle actuator moving to the retracted position without the user engaging the first release.
76. The system of clause 69, wherein the second release is configured to provide a stop to prevent advancement of the needle actuator from the ready position to the sampling position until the second release is engaged.
77. A method, comprising:
engaging a first release device to release the needle actuator from a retracted position at the end of the guide tube, at which the distal end of the needle is retracted within the distal end of the sheath positionable adjacent tissue to be sampled;
advancing the needle actuator to a ready position to advance the distal end of the needle adjacent the distal end of the sheath;
engaging a second release means to release the needle actuator from the ready position; and
the needle actuator is advanced to advance the distal end of the needle into the tissue to be sampled.
78. The method of clause 77, wherein advancing the needle actuator from the retracted position to the ready position comprises advancing the needle actuator until the guide tube engages a ready stop provided by the second release device.
79. The method of clause 77, further comprising continuing to engage the second release device to allow continued movement of the needle actuator.
80. The method of clause 77, further comprising:
re-engaging the second release means;
retracting the needle actuator until the needle actuator reaches the retracted position;
re-engaging the first release means to release the needle actuator from the retracted position; and
the needle actuator is removed from the guide tube.
Fifth embodiment
81. An apparatus, comprising:
a guide tube defining a lumen configured to slidably transfer a needle from a proximal end of the guide tube to a distal end of the guide tube, wherein the proximal end of the guide tube comprises an asymmetric outer cross-section; and
a needle actuator configured to be coupled to the proximal end of the needle, wherein the needle actuator includes an asymmetric distal opening configured to receive the guide tube in response to the needle actuator being oriented such that the distal end of the needle faces a desired direction.
82. The apparatus of clause 81, wherein the guide tube is coupled to an insertion device configured to deliver the needle to a location adjacent to the tissue to be sampled.
83. The apparatus of clause 81, wherein the distal end of the needle is oriented in the desired direction when the distal end of the needle is oriented to move outwardly from a distal opening in the insertion device toward the tissue to be sampled.
84. The apparatus of claim 81, wherein the guide tube comprises a first recess along the asymmetric outer cross-section configured to receive a protrusion extending inwardly from the asymmetric distal opening of the needle actuator, the needle actuator configured to receive the distal end of the guide tube in response to the first protrusion being received within the first recess.
85. The apparatus of clause 84, wherein the first recess is located at the end of a first channel extending longitudinally along the outer surface of the guide tube, the first channel being configured to maintain the orientation of the needle as the needle actuator moves along the guide tube.
86. The apparatus of clause 81, wherein the guide tube includes a second protrusion along the asymmetric outer cross-section configured to engage a second recess in a circumference in the asymmetric distal opening of the needle actuator, the needle actuator configured to receive the distal end of the guide tube in response to the second protrusion being received by the second recess.
87. The apparatus of clause 86, wherein the second recess is located at the end of a second channel extending longitudinally along the inner surface of the needle actuator and is configured to maintain the orientation of the needle as the needle actuator moves along the guide tube.
88. The apparatus of clause 81, wherein the guide tube includes a shaped outer surface configured to engage a shaped inner surface of the needle actuator to maintain the orientation of the needle as the needle actuator moves along the guide tube.
89. The apparatus of claim 88, wherein the contoured outer surface comprises at least one ridge configured to be received in at least one recess in the distal opening of the needle actuator, wherein the needle actuator receives the distal end of the guide tube only when the at least one ridge is received within the at least one recess.
90. A system, comprising:
a needle defining a first lumen;
a sampling device configured to be coupled to an insertion device configured to deliver the needle to tissue to be sampled;
A guide tube defining a second lumen configured to slidably transfer the needle from a proximal end of the guide tube to a distal end of the guide tube, wherein the proximal end of the guide tube comprises an asymmetric outer cross section; and
a needle actuator configured to be coupled to the proximal end of the needle, wherein the needle actuator includes an asymmetric distal opening configured to receive the guide tube in response to the needle actuator being oriented such that the distal end of the needle faces a desired direction.
91. The system of clause 90, wherein the guide tube is coupled to an insertion device configured to deliver the needle to a location adjacent to the tissue to be sampled.
92. The system of clause 90, wherein the distal end of the needle is oriented in the desired direction when the distal end of the needle is oriented to move outwardly from a distal opening in the insertion device toward the tissue to be sampled.
93. The system of clause 90, wherein the guide tube includes a first recess along the asymmetric outer cross-section configured to receive a protrusion extending inwardly from the asymmetric distal opening of the needle actuator, the needle actuator configured to receive the distal end of the guide tube in response to the first protrusion being received within the first recess.
94. The system of clause 93, wherein the first recess is located at the end of a first channel extending longitudinally along the outer surface of the guide tube, the first channel configured to maintain the orientation of the needle as the needle actuator moves along the guide tube.
95. The system of clause 90, wherein the guide tube includes a second protrusion along the asymmetric outer cross-section configured to engage a second recess in a circumference in the asymmetric distal opening of the needle actuator, the needle actuator configured to receive the distal end of the guide tube in response to the second protrusion being received by the second recess.
96. The system of clause 95, wherein the second recess is located at the end of a second channel extending longitudinally along the inner surface of the needle actuator and configured to maintain the orientation of the needle as the needle actuator moves along the guide tube.
97. The system of clause 90, wherein the guide tube includes a shaped outer surface configured to engage a shaped inner surface of the needle actuator to maintain the orientation of the needle as the needle actuator moves along the guide tube.
98. The system of clause 97, wherein the shaped outer surface comprises at least one ridge configured to be received in at least one recess in the distal opening of the needle actuator, wherein the needle actuator receives the distal end of the guide tube only when the at least one ridge is received within the at least one recess.
99. A method, comprising:
inserting a distal end of a needle into a guide tube defining a lumen and configured to deliver the distal end of the needle to tissue to be sampled, the needle being fixably coupled with a needle actuator;
providing a distal opening in the needle actuator to a proximal end of the guide tube, wherein the distal opening in the needle actuator is configured to slidably receive the proximal end of the guide tube in response to the needle actuator being oriented in a desired direction to direct the distal end of the needle to face the desired direction; and
the distal opening of the needle actuator is slid over an outer surface of the guide tube when the needle actuator is oriented in the desired direction.
100. The method of clause 99, further comprising rotating the needle actuator until the distal opening in the needle actuator is configured to slidably receive the proximal end of the guide tube.
Sixth embodiment
101. An apparatus, comprising:
an anti-buckling device comprising at least one moveable support bracket, the at least one bracket comprising:
a generally planar member having an inner aperture and an outer edge configured to movably engage an inner surface of a channel, the planar member configured to provide lateral support to an elongate instrument selected from one of a needle and a probe that is extendable through the inner aperture in response to the elongate instrument being driven through the channel by an actuator that is receivable within the channel; and
a positioning member extending from the planar member, the positioning member configured to prevent twisting of the planar member relative to the axis of the channel, the positioning member configured to move relative to the distal end of the actuator so as not to impede movement of the actuator toward the distal end of the channel.
102. The apparatus of clause 101, wherein the inner aperture of the planar member is sized to allow movement of the elongate instrument along the axis and to limit movement of the elongate instrument transverse to the axis.
103. The apparatus of item 101, wherein the planar member includes an outer edge configured to engage at least a portion of the inner surface of the channel to limit movement of the planar member transverse to the axis.
104. The apparatus of item 101, wherein the bracket is configured to remain in a first position in the channel at least until the actuator is advanced toward the distal end of the channel.
105. The apparatus of item 101, wherein the bracket is configured to stop at a second position in the channel in response to the actuator retracting toward the proximal end of the channel.
106. The apparatus of clause 101, wherein the positioning member is further configured to slidably engage a guide extending parallel to the axis of the channel along the inner surface of the channel, the planar member being held in a direction generally perpendicular to the axis of the channel in response to engagement of the alignment member with the guide.
107. The apparatus of clause 101, wherein the positioning member is configured to be received in a retraction recess between the actuator and a side of the actuator such that the positioning member is slidable past a distal end of the actuator in response to the distal end of the actuator advancing toward the distal end of the channel.
108. The apparatus of clause 107, wherein:
the buckling restrained device comprises a plurality of brackets;
a first positioning member of a first bracket is configured to be received in a first retraction recess between the actuator and a first side of the channel; and is also provided with
The second positioning member of the second bracket is configured to be received in a second retraction recess between the actuator and the second side of the channel.
109. The apparatus of item 101, wherein the positioning member is movably coupled with the actuator.
110. A system, comprising:
an elongate instrument selected from one of a needle and a probe; and
a control device movably coupled with the elongate instrument and configured to extend and retract the elongate instrument, the control device comprising an anti-buckling device comprising at least one movable support bracket, the at least one bracket comprising:
A generally planar member having an inner aperture and an outer edge configured to movably engage an inner surface of a channel, the planar member configured to provide lateral support to the elongate instrument extending through the inner aperture in response to the elongate instrument being driven through the channel by an actuator receivable within the channel; and
a positioning member extending from the planar member, the positioning member configured to prevent twisting of the planar member relative to the axis of the channel, the positioning member configured to move relative to the distal end of the actuator so as not to impede movement of the actuator toward the distal end of the channel.
111. The system of clause 110, wherein the inner aperture of the planar member is sized to allow movement of the elongate instrument along the axis and to limit movement of the elongate instrument transverse to the axis.
112. The system of clause 110, wherein the planar member includes an outer edge configured to engage at least a portion of the inner surface of the channel to limit movement of the planar member transverse to the axis.
113. The system of clause 110, wherein the bracket is configured to remain in a first position in the channel at least until the actuator is advanced toward the distal end of the channel.
114. The system of clause 110, wherein the bracket is configured to stop at the second position in the channel in response to the actuator retracting toward the proximal end of the channel.
115. The system of clause 110, wherein the positioning member comprises an alignment member configured to slidably engage a guide along the inner surface of the channel that extends parallel to the axis of the channel, the planar member being maintained in a direction that is substantially perpendicular to the axis of the channel in response to engagement of the alignment member with the guide.
116. The system of clause 110, wherein the positioning member is configured to be received in a retraction recess between the actuator and a side of the actuator such that the positioning member is slidable past a distal end of the actuator in response to the distal end of the actuator advancing toward the distal end of the channel.
117. The system of entry 116, wherein:
the buckling restrained device comprises a plurality of brackets;
a first positioning member of a first bracket is configured to be received in a first retraction recess between the actuator and a first side of the channel; and is also provided with
The second positioning member of the second bracket is configured to be received in a second retraction recess between the actuator and the second side of the channel.
118. The system of clause 110, wherein the positioning member is movably coupled with the actuator.
119. A method, comprising:
engaging an actuator slidably received within a channel, the actuator configured to move from a proximal end of the channel toward a distal end of the channel to advance an elongate instrument selected from one of a needle and a probe through a distal opening at the distal end of the channel;
employing a planar member to support the elongate instrument away from the inner surface of the channel at a point between the distal end of the actuator and the distal end of the channel;
employing a positioning member to prevent torsion of the planar member within the channel; and
as the distal end of the actuator advances toward the distal end of the channel, at least a portion of the positioning is moved past the distal end of the actuator such that the portion of the positioning does not obstruct movement of the distal end of the actuator toward the distal end of the channel.
120. The method of clause 119, further comprising movably supporting the elongate instrument away from the inner surface of the channel at a plurality of points between the distal end of the actuator and the distal end of the channel.
It will be appreciated that the detailed description set forth above is merely illustrative in nature and that variations that do not depart from the gist and/or spirit of the claimed subject matter are intended to be within the scope of the claims. Such variations are not to be regarded as a departure from the spirit and scope of the claimed subject matter.

Claims (24)

1. An apparatus, comprising:
a coupling configured to couple a control device of an elongate instrument with a port of an insertion device configured to deliver the elongate instrument to a target location;
a bushing extending from the coupling and configured to be inserted into an opening in the port of the insertion device through which the elongate instrument is movably extendable;
a first sealing member disposed on an outer surface of the bushing and configured to seal the outer surface of the bushing against an inner surface of the opening in the port; and
A second sealing member disposed on an outer surface of the elongated instrument and configured to movably seal the outer surface of the elongated instrument.
2. The apparatus of claim 1, wherein the first sealing member comprises a gasket disposed on an outer surface of the bushing.
3. The apparatus of claim 1, wherein the second sealing member comprises an O-ring configured to allow the elongate instrument to slidably move within an inner diameter of the O-ring.
4. The apparatus of claim 1, wherein the elongate instrument comprises a sheath defining at least one lumen through which at least one elongate member is extendable.
5. The apparatus of claim 1, wherein the coupling comprises:
an outer housing configured to extend over an adapter extending from the insertion device; and
a locking mechanism configured to secure the outer housing to the adapter, the locking mechanism configured to prevent removal of the coupling from the insertion device without decoupling the locking mechanism.
6. The apparatus of claim 5, wherein:
the adapter includes a shaft having a first outer diameter and a distal flange having a second outer diameter greater than the first outer diameter; and
the locking mechanism includes a locking member configured to engage the shaft to prevent the outer link from moving away from the shaft without the locking member being removed from the shaft.
7. The apparatus of claim 6, wherein the locking member is slidably secured to the outer housing between a first position in which the locking member does not engage the shaft and a second position in which the locking member engages the shaft.
8. The apparatus of claim 7, wherein the locking member comprises at least one securing mechanism configured to retain the locking member in the second position until the at least one securing mechanism is released.
9. An apparatus, comprising:
a guide tube defining a lumen through which a needle can extend;
a needle actuator configured to be fixably coupled to a proximal end of the needle;
A first release device movably coupled to the needle actuator and configured to engage to release the needle actuator, moving the needle actuator from a retracted position at an end of a guide tube, in which a distal end of the needle is retracted within a distal end of a sheath positionable adjacent tissue to be sampled, to a ready position, in which the distal end of the needle is adjacent the distal end of the sheath; and
a second release device movably coupled to the needle actuator and configured to engage to release the needle actuator to move the needle actuator from the ready position to a sampling position at which the distal end of the needle is advanceable into the tissue to be sampled.
10. The apparatus of claim 9, wherein at least one of the first and second release devices comprises a button that is laterally movable transverse to an axis of the guide tube.
11. The apparatus of claim 10, wherein the button comprises a channel through which the guide tube extends, and an inner surface of the channel is configured to frictionally engage an outer surface of the guide tube until the button is engaged to retract the inner surface of the channel from the outer surface of the guide tube.
12. The apparatus of claim 9, wherein the first and second release devices are spring loaded to restore the first and second release devices to a disengaged position when not actively engaged by a user.
13. The apparatus of claim 9, wherein:
the first release means comprises a release interlock; and is also provided with
The guide tube includes a tube interlock, wherein in the retracted position, the release interlock engages the tube interlock to prevent movement of the needle actuator until the first release is engaged.
14. The apparatus of claim 13, wherein the release interlock comprises a protrusion and the tube interlock comprises a recess configured to receive the protrusion.
15. The apparatus of claim 13, wherein the guide tube comprises an angled channel configured to guide the release interlock to engage the tube interlock in response to the needle actuator moving to the retracted position.
16. The apparatus of claim 9, wherein the second release device is configured to provide a stop to prevent advancement of the needle actuator from the ready position to the sampling position until the second release device is engaged.
17. A system, comprising:
a needle defining a first lumen;
a sampling device configured to be coupled to an insertion system configured to deliver the needle to tissue to be sampled;
a guide tube extending from the sampling device and defining a second lumen through which the needle can extend;
a needle actuator fixably coupled to the proximal end of the needle and configured to slidably move over the guide tube;
a first release device movably coupled to the needle actuator and configured to engage to release the needle actuator, moving the needle actuator from a retracted position at an end of a guide tube, in which a distal end of the needle is retracted within a distal end of a sheath insertable via the insertion system and positionable adjacent tissue to be sampled, to a ready position, in which the distal end of the needle is adjacent the distal end of the sheath; and
a second release device movably coupled to the needle actuator and configured to engage to release the needle actuator to move the needle actuator from the ready position to a sampling position at which the distal end of the needle is advanceable into the tissue to be sampled.
18. The system of claim 17, wherein at least one of the first and second release devices comprises a button that is laterally movable transverse to an axis of the guide tube.
19. The system of claim 18, wherein the button comprises a channel through which the guide tube extends, and an inner surface of the channel is configured to frictionally engage an outer surface of the guide tube until the button is engaged to retract the inner surface of the channel from the outer surface of the guide tube.
20. The system of claim 17, wherein the first and second release devices are spring loaded to restore the first and second release devices to a disengaged position when not actively engaged by a user.
21. The system of claim 17, wherein:
the first release means comprises a release interlock; and
a guide tube comprising a tube interlock, wherein in the retracted position the release interlock engages the tube interlock to prevent movement of the needle actuator until the first release is engaged.
22. The system of claim 21, wherein the release interlock comprises a protrusion and the tube interlock comprises a recess configured to receive the protrusion.
23. The system of claim 21, wherein the guide tube comprises an angled channel configured to guide the release interlock to engage the tube interlock in response to the needle actuator moving to the retracted position without a user engaging the first release.
24. The system of claim 17, wherein the second release device is configured to provide a stop to prevent advancement of the needle actuator from the ready position to the sampling position until the second release device is engaged.
CN202180090028.7A 2020-12-10 2021-12-10 Real-time sampling system Pending CN116782812A (en)

Applications Claiming Priority (14)

Application Number Priority Date Filing Date Title
US63/123,731 2020-12-10
US63/123,641 2020-12-10
US63/123,571 2020-12-10
US63/123,623 2020-12-10
US63/123,601 2020-12-10
US63/123,696 2020-12-10
US17/546,788 US20220183666A1 (en) 2020-12-10 2021-12-09 Real-time sampling system
US17/546,804 2021-12-09
US17/546,685 2021-12-09
US17/546,818 2021-12-09
US17/546,774 2021-12-09
US17/546,757 2021-12-09
US17/546,788 2021-12-09
PCT/IB2021/000851 WO2022123306A2 (en) 2020-12-10 2021-12-10 Real-time sampling system

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