Device for protecting tip on replaceable needles

Abstract

A needle tip protection device including a protective body, and an opening in the protective body configured to receive a portion of a needle while a distal tip of the needle is located with a lumen of a device such that the protective body surrounds the portion of the needle; wherein, the protective body is configured to slide distally down the needle as the needle is pulled out of the lumen so as to cover the distal tip of the needle before the distal tip of the needle is exposed outside of the lumen of the device.

Description

Olympus Docket No.: GAP25028-RDFO-WO1 SLW Docket No.: 5409.961 WO1DEVICE FOR PROTECTING XTIP ON REPLACEABLE NEEDLESPRIORITY CLAIM

[0001] This application claims the benefit of priority to U.S. Provisional Patent Application Serial No. 63 / 712,619, filed October 28, 2023, the contents of which are incorporated herein by reference.TECHNICAL FIELD

[0002] This document pertains generally, but not by way of limitation, to medical devices that can be used for various medical procedures. More specifically, but not by way of limitation, this document relates to a medical device with a biopsy needle.BACKGROUND

[0003] When a practitioner desires to gather a sample at a target site, such as a tissue sample, the practitioner maneuvers a medical device to the target site and removes the sample. Typically, the medical device includes a biopsy needle, which is delivered to the target site and used to remove the sample. For example, when a biopsy from a lung is needed to determine whether a detected lesion is cancerous, instead of cutting into the chest of the patient to procure a sample, an inserted device such as a bronchoscope can be used to guide one or more elongated instruments, such as needles, to a location near the lesion to procure a sample.

[0004] Typically, expelling a biopsy sample for pathology analysis does not entail removal of the biopsy needle by itself from the inserted device to purge the acquired sample. Instead, a user will retract the distal end of the biopsy needle into a working channel of the inserted device (e.g., such that the biopsy needle remains housed within the inserted device but with the needle tip no longer exposed to patient anatomy) and then remove the inserted device entirely from the patient. By retracting the needle into the device’s protective sheath, the sharp tip is covered preventing unintended contact injuries. The device is then transported by clinicians who deploy the needle from a protective sheath (e.g., by slightly advancing the needle tip out of the distal end of the bronchoscope of other inserted device), purge the sample, retract the needle back into the device and then transport the device back to the scope for reinsertion into the patient to acquire another sample.Olympus Docket No.: GAP25028-RDFO-WO1 SLW Docket No.: 5409.961 WO1

[0005] However, in some situations it is not practical to remove the inserted device entirely from the patient because doing so would result in a loss of anatomical positioning. With a removable needle, the device can remain in position at the sample site, and just the needle itself is removed to purge the sample. However, in this situation a long biopsy needle is removed from and reinserted into the device exposing the sharp needle tip to users and patients creating a potential hazard due to a possible needle stick.SUMMARY

[0006] The present system includes techniques and devices to aid a user in safely removing and reinserting a needle into a sampling device that may remain positioned adjacent to a site of a target tissue site within a patient throughout acquisition and expulsion of multiple biopsy samples from the target tissue. Such techniques and devices represent an improvement to the safety of the health care professionals during sampling procedures such as, for example, Transbronchial Needle Aspiration (TBNA) in which tissue samples are obtained from the lungs and surrounding areas.

[0007] In one example, the present system provides a method to remove a needle from a sampling device while the sampling device remains in place within a body. The method can include the user beginning to pull the needle out of a lumen of the sampling device while the sampling device remains in a first sampling position within a body. The user then positions a protective device over the needle before the tip of the needle is exposed outside of the lumen. The user then continues to pull the needle out of the lumen and through the protective device until the protective device covers a tip of the needle. The needle can then be handled safely to extract the sample and be re-inserted into the sampling device.

[0008] In one example, the present system includes a needle tip protection device. The protection device can include a protective body and an opening in the protective body configured to receive a portion of a needle while a distal tip of the needle is located with a lumen of a device such that the protective body surrounds the portion of the needle. The protective body is configured to slide distally down the needle as the needle is pulled out of the lumen so as to cover the distal tip of the needle before the distal tip of the needle is exposed outside of the lumen of the medical device.

[0009] In another example, a medical device can include an endoscope, a sampling device coupled to the endoscope and configured to extend through a working channel of the endoscope and out of a distal exit port to a sample position with a body that is beyond the distal end of the endoscope, a needle within the sampling device and extending through aOlympus Docket No.: GAP25028-RDFO-WO1 SLW Docket No.: 5409.961 WO1 lumen of the sampling device to extract a tissue sample at a distal end of the sampling device, wherein the needle is configured to be removed from the sampling device without the sampling device being removed from the sample position, and a needle protective device configured to cover a tip of the needle before the tip is exposed external to the lumen of the sampling device.BRIEF DESCRIPTION OF DRAWINGS

[0010] FIG. 1 shows a schematic diagram of an endoscopy system, in accordance with one embodiment.

[0011] FIG. 2 shows a schematic diagram of the endoscopy system of FIG. 1 comprising the endoscope connected to a control unit of the imaging and control system.

[0012] FIG. 3 shows a portion of a sampling device with a needle inserted within the lumen, in accordance with one embodiment.

[0013] FIG. 4 shows a portion of a sampling device with a needle removed from the lumen, in accordance with one embodiment.

[0014] FIG. 5 shows a perspective view of a protective device applied over a needle, in accordance with one embodiment.

[0015] FIG. 6 shows a perspective view of a protective device applied over a needle, in accordance with one embodiment.

[0016] FIG. 7 shows a perspective view of a protective device applied over a needle, in accordance with one embodiment.

[0017] FIG. 8 shows a cross-section perspective view of a sampling device with a protective device applied over a needle, in accordance with one embodiment.

[0018] FIG. 9 shows a side view of the protective device of FIG. 8, in accordance with one embodiment.

[0019] FIG. 10 shows a perspective view of a protective device over a needle, in accordance with one embodiment.

[0020] FIG. 11 shows a perspective view of a protective device over a needle, in accordance with one embodiment.

[0021] FIG. 12 shows a perspective view of a protective device over a needle, in accordance with one embodiment.

[0022] FIG. 13 shows a perspective view of a protective device over a needle, in accordance with one embodiment.Olympus Docket No.: GAP25028-RDFO-WO1 SLW Docket No.: 5409.961 WO1

[0023] FIG. 14 shows a perspective view of a protective device over a needle, in accordance with one embodiment.

[0024] FIG. 15 shows a perspective view of a portion of the protective device of FIG. 14, in accordance with one embodiment.

[0025] FIG. 16 shows a cross-section of a portion of a needle within a protective device, in accordance with one embodiment.

[0026] FIG. 17 shows a cross-section of a portion of a needle within a protective device, in accordance with one embodiment.

[0027] FIG. 18 shows a method for removing a needle from a sampling device, in accordance with one embodiment.DETAILED DESCRIPTION

[0028] In various examples, sampling devices can be inserted into the patient directly or through another device such as an endoscope (e.g., a bronchoscope) such that the bronchoscope and the sampling device form an endoscope-accessory instrument relationship. As such, the endoscope can be inserted into a desired position within the patient. After the endoscope is in the desired position, the sampling device can be inserted into the endoscope (e.g., via a working channel) and out of a distal end of the endoscope. The sampling device can typically have a smaller diameter than the endoscope such that the sampling device can extend into passageways of the patient with smaller diameters than could be reached with the endoscope alone. For example, in some instances a Solitary Pulmonary Nodule (SPN) may be identified as a biopsy target but may be located deep within a patient’s airway where a passageway adjacent the target is less than 3mm or less where even a modem ultrathin bronchoscope won’t fit. The sampling device can then be extended from the distal end of the endoscope to a target area within the patient, and an instrument (e.g., a biopsy needle) of the sampling device can be deployed to extend from the distal end of the device and obtain a tissue sample from the patient. In the context of a lung biopsy, extension of the sampling device (which may have an outer diameter of roughly 1.9 mm or less) beyond a bronchoscope may facilitate TBNA of target nodules unreachable by even the thinnest of modem bronchoscopes. However, under these challenging circumstances aligning the sampling device properly may be rather time consuming and, therefore, removal of the entire sampling device between acquisition of multiple samples from an individual target nodule may be lessOlympus Docket No.: GAP25028-RDFO-WO1 SLW Docket No.: 5409.961 WO1 desirable than removal of the biopsy needle alone while the sampling device remains in place. Based on these and other circumstances, the inventors of the presently claimed subject matter have recognized a need to facilitate removal of the biopsy needle alone while preventing inadvertent needle sticks of health care professionals conducting medical procedures.

[0029] FIG. 1 is a schematic diagram of an endoscopy system 100 that can include an imaging and control system 102 and an endobronchial ultrasound sampling arrangement including an endoscope 104 and a sampling device 136 that is attachable to the endoscope 104 and which includes a distal end 144 that adjustably extends from the distal end of the endoscope 104 via a distal working channel port. The system of FIG. 1 is an illustrative example of an endoscopy system suitable for use with the systems, devices and methods described herein.

[0030] The endoscope 104 can be insertable into an anatomical region for imaging or attached with (e.g., via tethering) one or more sampling devices for biopsies, or one or more therapeutic devices for treatment of a disease state associated with the anatomical region. The endoscope 104 can interface or connect to imaging and control system 102. The endoscope 104 is described in the present example as being a bronchoscope, though other types of endoscopes contemplated for use with the features and teachings of the present disclosure. The imaging and control system 102 can include a control unit 106, a display unit 108, an input unit 110, a light source 112, a fluid source 114, and a suction pump 116.

[0031] The imaging and control system 102 can include various ports for coupling with the endoscopy system 100. For example, the control unit 106 can include a data input / output port for receiving data from and communicating data to the endoscope 104 or attachments. The light source 112 can include an output port for transmitting light to the endoscope 104, such as via a fiber optic link. The fluid source 114 can include a port for transmitting fluid to the endoscope 104. The fluid source 114 can include, for example, a pump and a tank of fluid or can be connected to an external tank, vessel, or storage unit. The suction pump 116 can include a port used to draw a vacuum from the endoscope 104 to generate suction, such as for withdrawing fluid from the anatomical region into which the endoscope 104 is inserted. The display unit 108 and the input unit 110 can be used by an operator of the endoscopy system 100 to control functions of the endoscopy system 100 and view output of the endoscope 104. The control unit 106 can additionally be used to generate signals or other outputs from treating the anatomical region into which the endoscope 104 and / or attachment is inserted. In examples, the control unit 106 can generate electrical output, acoustic output, fluid output, orOlympus Docket No.: GAP25028-RDFO-WO1 SLW Docket No.: 5409.961 WO1 the like for treating the anatomical region with, for example, cauterizing, cutting, freezing, or the like.

[0032] The endoscope 104 can include an insertion section 118, a functional section 120, and a handle section 122, which can be coupled to a cable section 124 and a coupler section 126. The insertion section 118 extends distally from the handle section 122, and the cable section 124 extends proximally from the handle section 122. The insertion section 118 can be elongated and include a bending section, and a distal end to which the functional section 120 can be attached. The bending section can be controllable (e.g., by a steering control 128 on the handle section 122) to maneuver the distal end through tortuous anatomical passageways (e.g., stomach, duodenum, kidney, ureter, trachea, lungs, or the like). The insertion section 118 can also include one or more working channels (e.g., an internal lumen) that can be elongated and can support the insertion of one or more therapeutic tools of the functional section 120, such as a bronchoscope. The working channel can extend between the handle section 122 and the functional section 120. Additional functionalities, such as fluid passages, guide wires, and pull wires, can also be provided by the insertion section 118 (e.g., via suction or irrigation passageways, or the like).

[0033] A coupler section 126 can be connected to the control unit 106 to connect the endoscope 104 to multiple features of the control unit 106, such as the input unit 110, the light source 112, the fluid source 114, and the suction pump 116.

[0034] The handle section 122 can include the steering control 128 as well as a cable attachment portion 130, which may include a stress relief boot to shield the endoscope cable from mechanical stress (e.g., bending and / or twisting). The steering control 128 can be a knob, lever, or other actuation mechanism or the like, which can be used to navigate the endoscope 104 within the patient (e.g., by articulating a bending portion near the distal end of the insertion section 118). The steering control 128 can be connected to a pull wire, or other actuation mechanisms, extending through the insertion section 118. The endoscope 104 may further include a proximal working channel port 132 configured to facilitate delivery of components into the proximal working channel port 132 and through a working channel that extends through the insertion section 118 and out of a distal working channel port. As illustrated in FIGS. 1 and 2, the proximal working channel port 140 may be configured to facilitate attachment of the sampling device 136 to the handle section 122 of the endoscope 104, thereby facilitating delivery of a biopsy needle into a patient’s anatomy.

[0035] According to examples, the imaging and control system 102 can be provided on a mobile platform (e.g., a cart 134) with shelves for housing the light source 112, the suctionOlympus Docket No.: GAP25028-RDFO-WO1 SLW Docket No.: 5409.961 WO1 pump 116, an image processing unit 202 (FIG. 2), or the like. Alternatively, components of the imaging and control system 102, shown in FIG. 1 and FIG. 2, can be provided directly on the endoscope 104 to make the endoscope “self-contained.”

[0036] The functional section 120 can include components for treating and diagnosing the anatomy of a patient. The functional section 120 can include an imaging device (e.g., a complementary metal oxide semiconductor (CMOS) based Chip-on-the-Tip image sensor), an illumination device (e.g., a light emitting diode), and other functional features.

[0037] As shown in FIG. 1, a distal end of the sampling device 136 can extend from a distal end of the functional section (e.g., the insertion section 118 or the cable section 124) of the endoscope 104. The sampling device 136 can be configured to be attached to the proximal working channel port 132 such that the sampling device 136 extends through a working channel of the endoscope 104 and out the distal end of the endoscope 104 (e.g., via a distal working channel port). The sampling device 136 can include a sheath extension mechanism 138, an instrument actuator 142, and a distal end 144. The sheath extension mechanism 138 can be configured to extend the sampling device 136 beyond a distal end of the endoscope 104 such as to navigate the sampling device 136 to the target area within the patient. The sheath extension mechanism 138 can slide along a housing 140 of the sampling device 136 to extend it beyond the distal end of the endoscope 104. The housing 140 can include indicia, which can indicate an amount of extension of the sampling device 136 beyond a distal end of the endoscope 104. The instrument actuator 142 can be configured to extend an instrument (e.g. a needle 146) from the sampling device 136 to obtain a sample of tissue from the patient. As illustrated in FIG. 1, in some embodiments, advancement (e.g., proximal-to-distal movement) of the instrument actuator 142 may cause the instrument to extend from a side exit ramp located within the distal end of the sampling device 136, and into a field of view of an ultrasound transducer element (e.g., a linear ultrasound transducer which may be a Piezoelectric Micromachined Ultrasonic Transducer “pMUT”, a Capacitive Micromachined Ultrasonic Transducer “cMUT”, or other suitable transducer type). In this way, the sampling device 136 may facilitate real-time imaging of both a biopsy needle and target nodule during a live ultrasound image stream throughout a biopsy procedure.

[0038] FIG. 2 is a schematic diagram of the endoscopy system 100 of FIG. 1 including the imaging and control system 102 and the endobronchial ultrasound arrangement, which includes an endoscope and a sampling device 136 extendable via a distal working channel port of the endoscope. FIG. 2 schematically illustrates components of the imaging and control system 102 coupled to the endoscope 104. The imaging and control system 102 can includeOlympus Docket No.: GAP25028-RDFO-WO1 SLW Docket No.: 5409.961 WO1 the control unit 106, which can include or be coupled to an image processing unit 202, a treatment generator 206, and a drive unit 208, as well as the light source 112, the input unit 110, and the display unit 108. The control unit 106 can include, or can be in communication with, an endoscope, a surgical instrument, and an endoscopy system, which can include a device configured to engage tissue and collect and store a portion of that tissue and through which imaging equipment (e.g., a camera) can view target tissue via the inclusion of optically enhanced materials and components. The control unit 106 can be configured to activate a camera to view target tissues distal of the endoscopy system. Likewise, the control unit 106 can be configured to activate the light source 112 to shine a light on the surgical instrument, which can include select components configured to reflect light in a particular manner, such as tissue cutters being enhanced with reflective particles.

[0039] The coupler section 126 can be connected to the control unit 106 to connect to the endoscope 104 to multiple features of the control unit 106, such as the image processing unit 202, the treatment generator 206, or the like. In examples, the port 132 can be used to insert another instrument or device, such as a daughter scope or auxiliary scope, or a sampling needle, biopsy needle, ablation instrument, scalpel, or the like, into the endoscope 104. Such instruments and devices can be independently connected to the control unit 106 via the cable section 124. In examples, the port 132 can be used to connect the coupler section 126 to various inputs and outputs, such as video, air, light and electric.

[0040] The image processing unit 202, the ultrasound image processing unit 204, and the light source 112 can each interface with the endoscope 104 (e.g., at the functional section 120) or the sampling device 136 by wired or wireless electrical connections. The imaging and control system 102 can accordingly illuminate an anatomical region, collect signals representing the anatomical region, process signals representing the anatomical region, and display images representing the anatomical region on the display unit 108. The ultrasound image processing unit 204 can be configured to receive ultrasonic signals from either of the endoscope 104 or the sampling device 136, which can be converted into ultrasonic images and transmitted to the display unit 108 or any other component of the endoscopy system 100. The imaging and control system 102 can include the light source 112 to illuminate the anatomical region using light of a desired spectrum (e.g., broadband white light, narrow-band imaging using preferred electromagnetic wavelengths, and the like). The imaging and control system 102 can connect (e.g., via an endoscope connector) to the endoscope 104 for signal transmission (e.g., light output from the light source, video signals from the imaging system in the distal end, diagnostic and sensor signals from a diagnostic device, and the like).Olympus Docket No.: GAP25028-RDFO-WO1 SLW Docket No.: 5409.961 WO1

[0041] The fluid source 114 (shown in FIG. 1) can be in communication with control unit 106 and can include one or more sources of air, saline, or other fluids, as well as associated fluid pathways (e.g., air channels, irrigation channels, suction channels, and the like) and connectors (barb fittings, fluid seals, valves, and the like). The imaging and control system 102 can also include a drive unit 208, which can include a motorized drive for advancing a distal section of endoscope 104.

[0042] FIGs 3-4 illustrate one problem addressed by the present system. FIG. 3 shows a portion of the sampling device 136 with the needle 146 inserted within a lumen 150 of the sampling device 136, and FIG. 4 shows a portion of the needle 146 removed from the lumen 150, in accordance with one embodiment. For clarity and to reduce visual clutter, in FIGs 3-4 the sampling device 136 is shown in isolation as opposed to being shown attached to the endoscope 104. It should be appreciated based at least on FIGs 1-2 that when in use the sampling device 136 may be attached to an endoscope 104 that is used to deliver the sampling device 136 into the patient anatomy. Additionally, it is contemplated that in some use cases the sampling device 136 may be configured for delivery into a patient’s anatomy adjacent to a target tissue by itself (i.e., without being attached to and delivered through a working channel of an endoscope).

[0043] Here, the sampling device 136 is configured to extend to a sample position with a body, as discussed above. The needle 146 can be coupled with and controlled by the needle actuator 142. The needle 146 includes a proximal base coupled to a fitting 330 which can be attached to the needle actuator 142 during use, and then un-attached when the needle 146 is to be withdrawn from the lumen 150. The needle further includes a distal tip 154. The needle 146 can also include a lumen. The lumen can be used to extract a sample from the patient. The needle actuator 142 can be slidably mounted on a needle extension guide tube 143. The needle 146 can extend from the needle actuator 142 through the needle extension guide tube 143 through the lumen 150 into the endoscope, through which the sampling needle 146 can be extended into a body to collect a sample.

[0044] Depending on the location of the target tissue within the patient’s anatomy, a stylet within the needle lumen may be used to prevent the sampling needle 146 from collecting non-targeted tissue. For example, in a scenario where the operator is targeting tissue several millimeters or centimeters beyond an airway wall, the operator may leave the stylet fully inserted in the sampling needle while the sampling needle is advanced through non-target tissue. Then, once the needle has reached or nearly reached the target tissue, the stylet may be partially or fully withdrawn to permit the target tissue to enter the samplingOlympus Docket No.: GAP25028-RDFO-WO1 SLW Docket No.: 5409.961 WO1 needle core. In some implementations, the operator may visually confirm that the needle has reached or nearly reached the target via a live image stream of the needle tip and target. For example, the operator may watch a live ultrasound image generated by the sampling device 136 (i.e., in embodiments in which the sampling device has ultrasound capabilities).

[0045] In this example, the needle 146 is positioned within the sampling device 136 and extends through the lumen 150 of the sampling device 136 to extract a tissue sample at a distal end of the sampling device 136. In an example, the needle 146 can be a nitinol needle. This material allows the long needle to be kink-resistant and very springy, and allows the needle to be pre-formed, such as with a curved tip 154, as will be discussed below. In some examples, the needle 146 may be a laser cut hypotube such as, a stainless steel hypotube, where the laser cuts may be an interrupted or uninterrupted spiral pattern and the cuts are covered with a heat shrink layer.

[0046] The needle 146 can be pulled out using the fitting 330 to which the proximal end the needle 146 is secured. In some embodiments, the needle can be long, up to approximately 54” long and as seen in FIG 4, when the needle 146 comes out of the sampling device 136, the needle can be hard to control due to both its long length and curved shape of the needle’s distal end 154.

[0047] As noted, in some situations it is not practical to remove the whole device 136 from the body to retrieve the sample from the needle 146 because doing so would result in a loss of anatomical positioning of the sampling device when a plurality of samples are desired. So in this situation, the sampling device remains in place with the body at the sampling position and the needle by itself is removed to purge the sample. In this situation the long biopsy needle 146 can be removed from and then reinserted into the device. However, as shown in FIG. 4, this exposes the sharp needle tip 154 to users and patients creating a potential hazard due to a possible needle stick. This potential hazard may be exacerbated with needles having a pre-curved tip due to the possibility of the needle tip being pre-stressed upon withdrawal from the sampling device due to being held straight within the sampling device, and the internal mechanical stresses causing the needle to quickly spring back into the pre-curved shape immediately upon full withdrawal.

[0048] Accordingly, the present disclosure provides a distal tip protection device to decrease the risk of a needle stick. As will be detailed below, as the needle 146 is withdrawn from the parent device 136, a needle tip protective device can be positioned placed over the needle 146.Olympus Docket No.: GAP25028-RDFO-WO1 SLW Docket No.: 5409.961 WO1

[0049] FIG. 5 shows a perspective view of a protective device 300 applied over a needle 146, in accordance with one embodiment.

[0050] Here, the needle protective device 300 is configured to cover a tip of the needle 146 before the tip is exposed external to the lumen 150 of the sampling device 136. This system is designed to protect a user from a tip 154 of the needle 146 and can be used in any application. For example, with a bronchoscope 104 and sampling device 136 assembly. Otherwise, using the sampling device 136 alone. Or other situations where a needle is removed from a lumen of a device while the device remains in the body.

[0051] The needle tip protection device 300 can include a protective body 302 with an opening 304, such as a slit 304, in the protective body 302 configured to receive a body of a portion of a needle 146 while a distal tip of the needle 146 is located with a lumen 150 of a medical device, such as sampling device 136, such that the protective body 302 surrounds the portion of the needle 146. The protective body 302 can be configured to slide distally down the needle 146 as the needle 146 is being pulled out of the lumen 150 so as to cover the distal tip of the needle 146 before the distal tip 154 of the needle 146 is exposed outside of the lumen 150 of the medical device. Thus, referring also to FIG. 3, the protective device 302 can be configured to be applied to a body of the needle 146 proximal from the needle tip 154 with one hand while a second hand holds the fixture 330 attached to a proximal end 152 of the needle 146 and pulls the needle 146 out of the lumen 150.

[0052] In this example, the protective body 302 can include a soft, compliant body having the slit 304 that extends longitudinally across the body 302 and approximately halfway into the body 302 to receive the portion of the needle 146. In use, the body 302 is slipped over a side of the needle 146 while the tip 154 of the needle 146 is still distal of the body 302 and still located within the lumen 150. The needle 146 is then pulled through the body 302 until the tip 154 has entered into the body 302 and is not exposed exterior to the body 302.

[0053] In this example, the compliant body 302 can include a soft compliant foam body so that the needle 146 slips into the slit 304 without damage as the user pushes the body 302 over the side of the needle 146. Again, the needle 146 is side loaded into the body 302 so that the needle is pushed through the slit 304 to a base of the slit 304. In some examples, the device 302 can be any shape, for example, a ball or mass of foam of about 1” to 3” long and ’A” to 1” thick, or any dimensions designed to be easily held and manipulated with one hand with a slit or other opening in the body to receive the needle 146. The body 302 can be formed of any compliant material such as foam, plastic, or cloth, for example.Olympus Docket No.: GAP25028-RDFO-WO1 SLW Docket No.: 5409.961 WO1

[0054] The slit 304 can be formed so as to divide the body 302 into two walls 306, 308 and extend across an entire length of the body 302 so that the slit 304 is exposed on both a distal side 312 and a proximal side 314 of the protective body 302 and is open at an upper outer surface 310 of the body 302. This allows the user to just slide the body 302 over the side of the needle 146.

[0055] In use, while the user is pulling the needle out of the sampling device 136, the protective device 300 can be slipped over the needle 146 with one hand, and does not require any special manipulation other than pushing it over the side of the needle 146 so the needle 146 is positioned in the slit 304 and located within the body of the protective device 300.

[0056] The slit 304 defines the first wall 306 and a second wall 308 which have facing surfaces internal to the body 302. Due to the compliant material of the body 302 the walls 306 and 308 are naturally biased towards each other. In some situations, when the tip of the needle 146 is positioned within the protective body 302, a user may need to push out the tip to remove a sample, but due to the walls 306 and 308 pressing together, the curved portion of the needle 146 may stick to the inner surfaces of the walls 306, 308. Accordingly, in some examples, the protective body 302 can include a stepped feature to help control the needle. For example, both ends of the protective body 302 can have a slight gap 316 between the walls 306, 308 (e.g. a slightly bigger slit than the slit 304) so that when the tip 154 of the needle is loaded into the protective device, and the user pushes the tip out of the end of the device to remove a sample, the needle 146 will not stick to the inner surfaces of the walls 306, 308. Putting the gaps 316 at both ends allows the user to apply the protective device 300 to the needle in either orientation, so that the user does not have properly orientate the protective device 300 when placing the protective device onto the needle 146.

[0057] In one example, the slit 304 can include a beveled entry portion 318. The beveled portion 318 can include inward sloping surfaces extending from the top surface 310 downward into the slit opening 304. This allows for the protective body 302 to be more easily applied over the side of the needle since the beveled surfaces will guide the needle right into the opening of the slit 304.

[0058] Protective body 302 can include a bulbous region 320 which is thicker than the slitted upper section including a central hole 322 extending lengthwise through the bulbous portion. This allows for easier holding and manipulation of the device in applying the body 302 over the side of the needle 146.

[0059] For example, referring to FIG. 5, by sliding the protective device 300 over the needle 146 the withdrawing stops when the tip of the needle 146 is enclosed within the deviceOlympus Docket No.: GAP25028-RDFO-WO1 SLW Docket No.: 5409.961 WO1300. The needle 146 can then be safely handled at both ends; the distal end with tip protective device 300 in place as grabbing point and the proximal end with the fitting 330. After biopsy expulsion, the needle 146 is transported back to the sampling device 136, where the protective device 300 is removed just prior to insertion back into the sampling device 136.

[0060] FIG. 6 shows a perspective view of a protective device applied over a needle, in accordance with one embodiment.

[0061] In this example, the protective device 300 can include a protective body 332. Protective body 332 is similar to protective body 302 and similar signs will be used when applicable. For example, protective body 332 can include a soft compliant body formed of a soft foam material. A slit 304 can extend down into the body 332 to receive the portion of the needle 146. In one option, for both of the embodiments of FIG. 5 and FIG. 6, the slit 304 does not need to be cut straight. The slit cut could have inter-woven / inter-locking undulations to help grip the needle. Such a weaving cut slit would allow for good grip of the needle, with more compliant (softer) material for the device. In use, the body 332 is slipped over a side of the needle 146 while the tip 154 of the needle 146 is still distal of the body 332 and still located within the lumen 150. (For example, like in FIG. 3). The needle 146 is then pulled through the body 332 until the tip 154 has entered into the body 332 and is not exposed exterior to the body 332.

[0062] In use, the needle 146 can be side loaded into the body 332 so that the needle is pushed through the slit 304 to a base of the slit 304. In some examples, the body 332 can be about 1” to 3” long and ’A” to 1” thick or any dimensions designed to be easily held and manipulated with one hand with a slit or other opening in the body to receive the needle 146.

[0063] The slit 304 can be formed so as to divide the body 332 into two walls 306, 308 and extend across an entire length of the body 332 so that the slit 304 is exposed on both a distal side 312 and a proximal side 314 of the protective body 302 and is open at an upper outer surface 310 of the body 332. This allows the user to just slide the body 332 over the side of the needle 146.

[0064] In use, while the user is pulling the needle out of the sampling device 136, the protective device 300 can be slipped over the needle 146 with one hand so the needle 146 is positioned in the slit 304 and located within the body of the protective device 300.

[0065] As in the example above, the protective body 332 can include an internal stepped feature to help to control the needle. For example, both ends of the protective body 332 can have a slight gap 316 at each end between the walls 306, 308 so that when the tip of the needle is loaded into the protective device 332, and the user pushes out the tip to remove aOlympus Docket No.: GAP25028-RDFO-WO1 SLW Docket No.: 5409.961 WO1 sample, the needle 146 will not stick to the inner surfaces of the walls 306, 308. In other examples, the device can include inner grooves or features internal to the slit 304 to help hold the needle 146 in positioned within the body 332 at the base of the slit 304.

[0066] In this example, the slit 304 can include a beveled entry portion 318. The beveled portion 318 can include inward sloping surfaces extending from the top surface 310 downward into the slit opening. This allows for the protective body 332 to be more easily applied over the side of the needle since the beveled surfaces will guide the needle right into the opening of the slit 304.

[0067] In this example, the protective body 332 can include a gap portion 334 opposite of the slit configured to be squeezed to open the slit 304 by separating walls 306, 308. For example, the clip portion 334 can include a pair of legs 336, 338 formed so as to be separated from each other. Thus, the legs 336 and 338 are biased such that when squeezed together (like a clothespin) the legs help open the slit 304 by separating walls 306, 308. This allows the protective body 332 to more easily applied using one hand.

[0068] Again, although FIG. 6 shows the needle tip 154 within the protective device 300, in use when the device 300 is first applied over the needle 146, the tip 154 of the needle 146 will still be distal of the device 300 and be located within the lumen of the sampling device. (See FIG. 3) The needle 146 is then pulled through the lumen and the protective body 332 until the tip 154 has entered into the protective body 332 and is not exposed exterior to the protective body 332.

[0069] FIG. 7 shows a perspective view of the protective device 300 applied over the needle 146, in accordance with one embodiment.

[0070] Here, the needle 146 can include one or more markers to indicate to a user the position of the needle 146 and the tip 154 of the needle within the lumen 150 of the sampling device. Specifically, the needle 146 can include a first marker 350 configured to indicate a location on the needle 146 where the user can first apply the protective device 300 as the needle 146 is being pulled out of the lumen 150. The needle can further include a second marker 352 to indicate to the user that the needle tip 154 is safely positioned within the protective body 302.

[0071] In some examples, the first and second markers 350, 352 can include a colored portion visually exposed on an outer surface of the needle 146. For example, the outer surface of the needle 146 can include a shrink wrap layer and there can be a color change at the points where markers 350 and 352 begin. Thus, as the user is pulling the needle 146 out of the lumen 150, when the first marker 350 is exposed, the user will apply the protective deviceOlympus Docket No.: GAP25028-RDFO-WO1 SLW Docket No.: 5409.961 WO1300 over the side of the needle 146 proximate to the location of the first marker 350. The user then grips the protective device 300 so that the needle 146 slides through the device 300 while the user continues to remove the needle 146 from the lumen 150 until the user sees the second marker 352 exposed on the proximal side of the protective device 300. When the user sees the second marker 352, they know the tip 154 is safely within the protective device 300 and the needle 146 can then be handled with two hands using the fitting 330 and the protective device 300 to deliver the needle 146 to the sample extraction area. In some examples, the markings 350, 352 can be etched onto the needle 146, or the needle 146 can otherwise be marked to show the markings locations 350, 352.

[0072] In some examples, the protective device can be made of a clear material so the user can see that the tip 154 is within the protective device 300.

[0073] Accordingly, the above embodiments allow for a protective device to be side- loaded upon the needle while the needle tip is still within the sample device and are configured with a “squeeze to open” design for 1 -handed operation. As noted, additional features can be added to the device 300. For example, to control the needle behavior within the bodies 302, 322, the device can include internal features configured to hold the needle 146 at the base of the slit 304 and / or the internal surfaces of the slit 304 can be stepped to enable the needle to slide forward without sticking into internal surface.

[0074] Referring to FIGs 3-7, in one embodiment, the needle protective devices 300 described above can be applied as follows:

[0075] 1) As the needle 146 is withdrawn from the sampling device 136, the soft, compliant tip protector device 302, 322 is placed over the needle 146 by sliding the device 302, 322 over the side of the needle 146 or squeezing device 302, 322 to open the device up and placing it around the needle 146. For example, the device 302, 322 can be placed on the needle 146 when a user identifies a first mark 350 on the needle. 2) The needle 146 is withdrawn into the protective device 302, 322 and the withdrawing stops when the tip of the needle 146 is enclosed within the device 302, 322. For example, when a user identifies a second mark 352 on the needle at the proximal end 314 of the device 302, 322. 3) The needle 146 can then be safely handled at both ends, the distal end with protective device 302, 322 in place as grabbing point and the proximal end with the fitting 330. 4) The needle 146 can then be transported to the clinician who then removes the protective device from the needle tip to purge the sample. 5) The protective device is then replaced on to the distal end of the needle 146, protecting the tip. 6) The needle 146 is then transported back to the sampling deviceOlympus Docket No.: GAP25028-RDFO-WO1 SLW Docket No.: 5409.961 WO1136, where the protective device 302, 322 is removed just prior to insertion of the needle 146 back into the lumen 150 of the sampling device 136.

[0076] FIG. 8 shows a cross-section perspective view of the sampling device 136 with a protective device 300, such as a sliding tip protector 362 applied over the needle 146, in accordance with one embodiment; and FIG. 9 shows a side view of the sliding tip protector 362, in accordance with one embodiment.

[0077] In this embodiment, the tip protective device 300 can include a cylindrical sliding tip protector 362 that is slidable over a curved needle or a straight needle and that telescopes within the lumen 150 of a receiving hub 370 that is mated to the needle actuator 142 of the sampling device 136 during biopsy collection.

[0078] In one embodiment, the cylindrical sliding tip protector 362 can be configured to slide over the tip 154 of the needle 146 before the needle 146 is removed from the lumen 150. The tip protector 362 can include a hollow tube having openings on both ends to receive the needle 146 which extends through the protective body 362. The tip protector 362 can be positioned within the lumen 150 surrounding the needle 146 while the needle is within the lumen 150. Thus, in this example the needle protector 362 is pre-loaded into the sampling device 136 and is not a separate piece. The tip protector 362 can be about a 2” to 4” plastic tube which is elastically deformable so as to be squeezed with one hand to grip onto the needle 146 when the user desires.

[0079] Thus, when the needle 146 is withdrawn during a biopsy procedure, the sampling device 136 remains at the target site, and the needle 146 is withdrawn until the curved tip of the needle is protected within the slidable tip protector 362. In one example, a proximal grab tab 364 can be located on the proximal end of the tip protector 362 to allow a user to safely manipulate the position of the needle within the slidable tip protector 362. Thus, the needle tip 154 is sufficiently within the needle tip protector 362 such that the tip 154 is covered and can be safely removed from the device 136. In some examples the protective device 362 can be clear to enable the user to see the needle’s position within the device 362.

[0080] Moreover, when using a curved needle, the springiness of the curved needle can help to secure the tip protector 362 sufficiently such that the weight of the tip protector 362 will not cause it to fall off and an intentional force is required to completely remove the tip protector 362 from the needle 146. In particular, as the curved needle tip will be held in a straight configuration by the tip protector 362, the natural tendency of the curved needle tip to return to the curved configuration will cause the needle tip to press slightly against the innerOlympus Docket No.: GAP25028-RDFO-WO1 SLW Docket No.: 5409.961 WO1 wall of the tip protector 362, thereby creating an amount of friction which is great enough to maintain the tip protector 362 on the needle.

[0081] Accordingly, the sliding tip protector 362 facilitates safe removal of the needle 146 from the sampling device 136, expulsion of biopsy sample, and reinsertion into sampling device 136, while sampling device 136 remains at target site.

[0082] In use, as the needle 146 is withdrawn from the sampling device 136, the friction generated by the natural tendency of the curved needle tip to return to the curved configuration causing the needle tip to press slightly against the inner wall of the tip protector 362 may be sufficient to cause the sliding needle protector 362 to eject from the receiving hub fitting 370. The proximal grab tab 364 can be added to facilitate protect or / needle withdrawal by the user.

[0083] The user can grasp onto the needle protector device 362 at the tab 364 to keep the protective device 362 from sliding proximally along the needle 146 and the user continues to withdraw the needle into and through the protector device 362 until the tip of the needle is positioned within the device 362. For example, as discussed above, the markings 350, 352 (FIG. 7) on the needle 146 can be positioned to be seen proximal to the tip protector 362 at a location to indicate that the tip of the needle 146 is safely with in the protective device 136. In another example, the protective device 362 can be clear to allow the user to see the needle’s position within the device.

[0084] The needle can then be handled and separated from the sampling device 136 with less concern for inadvertent contact with the sharp needle tip. The needle 146 can be retracted as needed to purge the contents of the inner lumen of the needle.

[0085] To reinsert the needle 146 into the sampling device 136, the needle protector device 362 can slide forward past the distal tip 154 to provide tip protection to users. In one example, the material of the protector device 362 is stiff enough such that the device 362 straightens the curved needle 146 enabling easier insertion back into the sampling device receiving hub 370.

[0086] In this example the proximal tab 364 can include a cone-shaped structure 366 on a proximal end of the tip protector 362 that mates with an internal surface 372 of a proximal hub 370 of the sampling device 136 handle. This prevents the tip protector 362 from sliding distally down the lumen 150 of the sampling device 136. In various embodiments, the tip protector 362 can include a plastic tube, a metal tube, or a flat coil spring shaped with flare on the proximal end. The protective device can be opaque or translucent.Olympus Docket No.: GAP25028-RDFO-WO1 SLW Docket No.: 5409.961 WO1

[0087] As noted, in various embodiments, the sliding tip protector 362 can be rigid to straighten a curved needle tip during re-insertion into the sampling device 136.

[0088] FIGs 10-13 show examples of the tip protector 362 in use, according to various embodiments. For ease of explanation, the body of the sampling device 136 is not shown and only the proximal hub 370 is shown.

[0089] FIG. 10 shows a perspective view of the protective device 362 over the needle 146; FIG. 11 shows a perspective view of the protective device 362 sliding out of the lumen 150; FIG. 12 shows another embodiment of the protective device 362; and FIG. 13 shows a perspective view of the protective device 362 when the tip 154 of the needle 146 is enclosed with the device 362, in accordance with on embodiment. As described herein, in some embodiments the tendency of a forcibly straightened needle tip to return to its relaxed curved state may generate sufficient friction against the inner wall of the tip protector 362 such that the tip protector 362 remains on the curved portion of the needle absent an external force.

[0090] In FIG. 10, the needle 146 is being pulled out through the tip protector 362 and the lumen 150. As the user continues pulling, at some point the user can grasp the tab 364. For example, if the needle 146 includes one or more of the markings 350, 352 as discussed above for FIG. 7, the user knows when the distal needle tip 154 is getting close. Thus, when the user sees the first marking 350, the user can lightly grasp the tab 364 and let the needle continue to slide through the tip protector 362. In this example, the tab 364 can include a raised section of the body of the protector 362 configured to prevent the protector 362 from sliding distally into the hub 370.

[0091] In one example, as shown in FIG. 12, the tip protector 362 can include a proximal tube extension 365 past the tab 364 to allow the user to grasp the tip protector 362 when the first or second marker is seen.

[0092] In one example, as needle 146 is pulled out, the sliding tip protector 362 may start to come out when the bias of the curved needle tip 154 starts to pull it out via applying a force to a distal end of the tip protector 362. In that case, the user can hold the tab 364 of the tip protector 362 to let the needle 146 continue to slide through the tip protector 362.

[0093] In any case, the user can grab the tab 364 and continue to pull the needle 146 out of the lumen until second marking 352 is seen, when the user then knows that the tip 154 is within the tip protector 362.

[0094] To remove the sample from the needle lumen, the needle tip 154 is pushed out of the distal end of the tip protector and the sample is removed. Then the needle tip is retracted back within the tip protector 362 and the entire assembly of the needle 146 and tip protectorOlympus Docket No.: GAP25028-RDFO-WO1 SLW Docket No.: 5409.961 WO1362 are re-inserted into the lumen 150 of the hub 370. The stiffness of the sliding tip protector 362 helps align with the lumen 150 to reinsert the needle 146.

[0095] As will be further detailed below, in one embodiment, the needle 146 can include a diameter change towards a distal end of the needle 146 proximate the tip 154 which is configured to engage the sliding tip protector 362 at the point when the tip 154 of the needle 146 is within the sliding tip protector 362. For example, there can be a diameter step change or a bump on the needle 146 to grab the tip protector 362. Such a diameter change can be designed to frictionally engage with the inner surface of the tip protector 362 to automatically pull the tip protector out of the lumen 150 when the tip of the needle has been safely positioned within the tip protector 362 as the needle is withdrawn.

[0096] As noted, the needle 146 can include the pre-formed curved tip 154. Accordingly, in some examples, after needle 146 is removed from the sampling device 136, the bias of the curve of the needle 146 holds the sliding tip protector 362 onto body of needle 146.

[0097] FIGs 14 and 15 show another example of a protective device 300, in this example, a sliding tip protector 382. The sliding tip protector 382 is similar in many ways to the sliding tip protector 362 discussed above, and it is understood that certain details given above also apply to the sliding tip protector 382.

[0098] FIG. 14 shows a perspective view of the sliding tip protector 382 over the needle 146, and FIG. 15 shows a perspective view of a portion of the sliding tip protector 382, in accordance with one embodiment.

[0099] In this embodiment, the sliding tip protector 382 is slidable over a curved needle or a straight needle and telescopes within the lumen 150 of the receiving hub 370 that is mated to the needle actuator 142 of the sampling device 136 during biopsy collection.

[0100] In one embodiment, the cylindrical sliding tip protector 382 can be configured to slide over the tip of the needle 146 before the needle 146 is removed from the lumen 150. The tip protector 382 can include a two-part assembly including a hollow tube 384 and a proximal handling member 386. The hollow tube 384 can be a rigid or semi-rigid tube formed of metal or plastic, for example. The tube 384 can include openings on both ends to receive the needle 146 which extends through the protective body 382. The tip protector 382 will be positioned within the lumen 150 and surrounding the needle 146 while the needle is within the lumen 150. Thus, in this example the needle protector 382 is pre-loaded into the hub 370 and lumen 150 of the sampling device 136 and is not a separate piece.

[0101] Thus, when the needle 146 is withdrawn during a biopsy procedure, the sampling device 136 remains at the target site, and the needle 146 is withdrawn until the curved tip ofOlympus Docket No.: GAP25028-RDFO-WO1 SLW Docket No.: 5409.961 WO1 the needle is protected within the slidable tip protector 382. In this example, the proximal handling portion 386 can be located on the proximal end of the tube 384 and be squeezable to allow a user to safely manipulate the position of the needle within the slidable tip protector 382. Thus, the needle tip 154 will be sufficiently within the needle tip protector 382 such that the tip 154 is covered and can be safely removed from the device 136. In some examples the tube 384 can be clear to enable the user to see the needle’s position within the device 382.

[0102] Accordingly, the sliding tip protector 382 facilitates safe removal of the needle 146 from the sampling device 136, expulsion of biopsy sample, and reinsertion into sampling device 136, while sampling device 136 remains at target site.

[0103] In use, as the needle 146 is withdrawn from the sampling device 136, the curve of the needle 146 can contact the distal end of the sliding needle protector 382 and may cause the sliding needle protector 382 to eject from the receiving hub fitting 370.

[0104] The user can grasp onto the sliding tip protector 382 at the handling member 386 to keep the protective device 382 from sliding proximally along the needle 146 and the user continues to withdraw the needle into and through the protector device 382 until the tip of the needle is positioned within the device 382. For example, as discussed above, the marking 350, 352 (FIG. 7) on the needle 146 can be positioned to be seen proximal to the tip protector 382 at a location to indicate that the tip of the needle 146 is safely with in the protective device 382. In another example, the protective device 362 can be clear to allow the user to see the needle’s position within the device.

[0105] The needle can then be handled and separated from the sampling device 136 with less concern for inadvertent contact with the sharp needle tip. By extending the needle 146 from the tip protector, the contents of the inner lumen of the needle can be purged by various methods while keeping the tip protector secured to the needle.

[0106] To reinsert the needle 146 into the sampling device 136, the needle protector device 382 can be slid forward past the distal tip 154 to provide tip protection to users. In one example, the material of the protector device 382 is stiff enough such that the device 382 straightens the needle 146 enabling easier insertion back into the sampling device receiving hub 370.

[0107] In this example the proximal handling member 386 can include a cone-shaped structure 388 that mates with an internal surface of a proximal hub 370 of the sampling device 136 handle. The proximal handling member 386 can further include a lip 390 extending away from an outer surface of the body of the member 386. This lip 390 prevents the tip protector 382 from sliding distally down the lumen 150 of the sampling device 136.Olympus Docket No.: GAP25028-RDFO-WO1 SLW Docket No.: 5409.961 WO1Furthermore, the member 386 can be formed of a rubber material. The tube 384 can be friction fit or otherwise permanently attached to a distal end of the member 386. The rubber material allows the handling member 386 to be easily squeezed down onto the needle 146 by the user to control the movement of the needle 146 as the needle slides through the tip protector 382. Also, friction between the rubber material and the needle will help grip the outer surface of the needle 146 when the tip of the needle is within the tube 384, during handling, sample extraction, and reinsertion into the sampling device 136.

[0108] FIG. 16 shows a cross-section of a portion of a needle 146 within the protective device 382, in accordance with one embodiment. In this example, the needle 146 can include a diameter change towards a distal end of the needle 146 proximate the tip 154 which is configured to engage the sliding tip protector 382 at the point when the tip 154 of the needle 146 is within the sliding tip protector 382. For example, there can be a diameter step change 394 or a bump on the needle 146 such that the distal end of the needle has a larger outer diameter than the proximal end. Likewise, the distal end of the tube 384 has a diameter step change where the inner diameter of the tube is larger towards the distal end, resulting in a shoulder 392. Thus, as the needle 146 is being pulled through the tube 384, the widened portion 394 of the needle will abut against shoulder 392 and hold the protective device 382 in place over the tip of the needle 146. Thus, the diameter change can be designed to engage with the inner surface of the tip protector 382 to automatically apply and pull the tip protector 382 out of the lumen 150 as the needle is withdrawn after the tip of the needle has been safely positioned within the tip protector 382.

[0109] FIG. 17 shows a cross-section of a portion of the needle 146 within the protective device 382, in accordance with one embodiment. This example is the same as FIG. 16, but here, the diameter change of the needle 146 is accomplished using shrink wrap 396 wrapped around the distal end of the needle 146. As above, when the widened diameter of the shrink- wrapped portion 396 of the needle hits the shoulder 392 the protector 382 will then ride along with the needle with the tip of the needle safely within the tube 384. Either of these embodiments is also applicable to the protective device 362, discussed above.

[0110] FIG. 18 shows a method (400) for removing needle 146 from a sampling device 136 while the sampling device 136 remains in place within a body, in accordance with one embodiment.

[0111] Referring also to the Figures above, the method (400) can include first positioning the sampling device into a sampling position within a body. After a sample is procured intoOlympus Docket No.: GAP25028-RDFO-WO1 SLW Docket No.: 5409.961 WO1 the needle, the method includes beginning to pull the needle out of the lumen of the sampling device while the sampling device remains in a first sampling position within a body (410). The method can further include identifying a first marker on the needle (420), and positioning a protective device 300 over the needle proximate the first marker (430), and continuing to pull the needle out of the lumen and through the protective device until the protective device covers a tip of the needle (440).

[0112] Thus, the tip 154 is covered before the needle tip 154 is exposed exterior to a handle of the sample device. Further, the method provides that the user has two hands on the needle 146. One hand on the fitting 330 and second one holding protective device over the tip 154 so that user has manual control of the needle 146 and needle 146 will not whip around the procedure area.

[0113] As discussed above, the first marker can include a colored portion exposed on an outer surface of the needle 146, such as a colored band of shrink-wrap.

[0114] In one example of the method, positioning a protective device over the needle 146 includes positioning the protective device to surround an outer surface of the needle 146 proximate the location of the first marker.

[0115] In one example of the method, continuing to pull the needle 146 out of the lumen 150 includes pulling the needle 146 out until a second marker on the needle 146 is identified on a proximal end of the protector, wherein the second marker is positioned on the needle 146 at a position to indicate that the tip 154 of the needle 146 is enclosed within the protective device.

[0116] In one example of the method, the method further includes exposing the tip 154 of the needle 146 from the protective device to extract a sample from the needle 146 and then reinserting the needle 146 into the lumen 150. For example, the needle just needs to be lightly exposed out of the protective device to allow for easier re-insertion since user has a good grip on the needle 146 by using the protective device.

[0117] Referring to FIG. 5, if the needle 146 is pushed through so just the tip 154 is exposed outside of the protective device 302, the user can more easily manipulate the tip 154 into the lumen 150 and then remove the protective device from the needle 146. Or, in the embodiment of FIG. 8, the user can reinsert the needle 146 / protective device 362 assembly together into the lumen 150. In some examples, a new needle 146 can be inserted into the lumen 150 of the sampling device 136, or re-use needle 146 after sample discharged.

[0118] In summary, the needle protective devices discussed herein are configured to cover a tip of the needle 146 before the tip is exposed external to the lumen 150 of theOlympus Docket No.: GAP25028-RDFO-WO1 SLW Docket No.: 5409.961 WO1 sampling device 136. This allows the needle 146 to be reinserted to the same sample position after a sample is removed from the needle 146 while the distal end 144 of the sampling device 136 remains in place within the body.

[0119] This system is designed to protect a user from the tip of the needle 146 and can be used in any application. For example, as shown with a bronchoscope 104 and sampling device 136. Otherwise using a sampling device 136 alone, or other situations where a needle is removed from a lumen of any device while the device remains in the body.Various Notes & Examples

[0120] Example 1 can include or use subject matter such as a method to remove needle from a sampling device while the sampling device remains in place within a body, the method comprising: beginning to pull a needle out of a lumen of a sampling device while the sampling device remains in a first sampling position within a body; positioning a protective device over the needle before the needle is exposed outside of the lumen; and continuing to pull the needle out of the lumen and through the protective device until the protective device covers a tip of the needle.

[0121] Example 2 can include, or can optionally be combined with the subject matter of Example 1, to optionally include wherein positioning a protective device over the needle includes positioning the protective device to surround an outer surface of the needle proximate a location of a first marker on the needle.

[0122] Example 3 can include, or can optionally be combined with the subject matter of Examples 1 or 2, to optionally include wherein the first marker includes a colored portion exposed on an outer surface of the needle.

[0123] Example 4 can include, or can optionally be combined with the subject matter of one or any combination of Examples 1 through 3 to optionally include continuing to pull the needle out of the lumen includes pulling the needle out until a second marker on the needle is identified on a proximal end of the protective device, wherein the second marker is positioned on the needle at a position to indicate that the tip of the needle is enclosed within the protective device.

[0124] Example 5 can include, or can optionally be combined with the subject matter of one or any combination of Examples 1 through 4 to optionally include exposing the tip of the needle from the protective device to extract a sample from the needle and then reinserting the needle into the lumen.Olympus Docket No.: GAP25028-RDFO-WO1 SLW Docket No.: 5409.961 WO1

[0125] Example 6 can include, or can optionally be combined with the subject matter of one or any combination of Examples 1 through 5 to optionally include wherein the protective device includes a compliant body having a slit in the body to receive the needle.

[0126] Example 7 can include, or can optionally be combined with the subject matter of one or any combination of Examples 1 through 6 to optionally include wherein the protective device includes a clip portion opposite of the slit configured to be squeezed to open the slit.

[0127] Example 8 can include, or can optionally be combined with the subject matter of one or any combination of Examples 1 through 7 to optionally include wherein the protective device includes a cylindrical sliding tip protector configured to slide over the tip of the needle before the needle is removed from the lumen.

[0128] Example 9 can include, or can optionally be combined with the subject matter of one or any combination of Examples 1 through 8 to optionally include wherein the sliding tip protector includes a change in inner diameter proximate a distal end of the sliding tip protector to define a shoulder within the cylindrical sliding tip protector, wherein the shoulder is configured to abut a diameter change of the needle such that the needle abuts the shoulder when the tip of the needle is within the sliding tip protector.

[0129] Example 10 can include or use subject matter such as a needle tip protection device including a protective body; and an opening in the protective body configured to receive a portion of a needle while a distal tip of the needle is located with a lumen of a device such that the protective body surrounds the portion of the needle; wherein, the protective body is configured to slide distally down the needle as the needle is pulled out of the lumen so as to cover the distal tip of the needle before the distal tip of the needle is exposed outside of the lumen of the device.

[0130] Example 11 can include, or can optionally be combined with the subject matter of Example 10 to optionally include wherein the protective body includes a compliant body and the opening includes a slit in the compliant body to receive the portion of the needle.

[0131] Example 12 can include, or can optionally be combined with the subject matter of one or any combination of Examples 10 or 11 to optionally include wherein the slit includes a beveled entry portion.

[0132] Example 13 can include, or can optionally be combined with the subject matter of one or any combination of Examples 10 through 12 to optionally include wherein the protective body includes a clip portion opposite of the slit configured to be squeezed to open the slit.Olympus Docket No.: GAP25028-RDFO-WO1 SLW Docket No.: 5409.961 WO1

[0133] Example 14 can include, or can optionally be combined with the subject matter of one or any combination of Examples 10 through 13 to optionally include wherein the protective body includes a cylindrical sliding tip protector configured to slide over the tip of the needle before the needle is removed from the lumen.

[0134] Example 15 can include, or can optionally be combined with the subject matter of Examples 10 through 14 to optionally include wherein the cylindrical sliding tip protector includes a hollow tube which is positioned with the lumen surrounding the needle while the needle is within the lumen.

[0135] Example 16 can include, or can optionally be combined with the subject matter of Examples 10 through 15 to optionally include wherein the sliding tip protector includes a proximal tab that is held as the needle is withdrawn through the sliding tip protector until the tip is positioned with the body of the sliding tip protector.

[0136] Example 17 can include, or can optionally be combined with the subject matter of Examples 10-16 to optionally include wherein the sliding tip protector includes a change in inner diameter proximate a distal end of the sliding tip protector to define a shoulder within the cylindrical sliding tip protector, wherein the shoulder is configured to abut a diameter change of the needle such that the needle abuts the shoulder when the tip of the needle is within the sliding tip protector.

[0137] Example 18 can include or use subject matter such as a medical device including an endoscope; a sampling device coupled to the endoscope and configured to extend to a sample position with a body; a needle within the sampling device and extending through a lumen of the sampling device to extract a tissue sample at a distal end of the sampling device, wherein the needle is configured to be removed from the sampling device without the sampling device being removed from the sample position; and a needle protective device configured to cover a tip of the needle before the tip is exposed external to the lumen of the sampling device.

[0138] Example 19 can include, or can optionally be combined with the subject matter of Example 18 to optionally include wherein needle includes a first marker configured to indicate a location on the needle to first position the protective device on the needle, and the needle includes a second marker distal from the first marker and configured to indicate a location where the tip of the needle is within the protective device when the second marker is at a proximal end of the protective device.Olympus Docket No.: GAP25028-RDFO-WO1 SLW Docket No.: 5409.961 WO1

[0139] Example 20 can include, or can optionally be combined with the subject matter of one or any combination of Examples 18 through 19 to optionally include wherein the protective device includes a compliant body having a slit in the body to receive the needle.

[0140] Example 21 can include, or can optionally be combined with the subject matter of one or any combination of Examples 18 through 20 to optionally include wherein the protective device includes a cylindrical sliding tip protector configured to slide over the tip of the needle before the needle is removed from the lumen, wherein the cylindrical sliding tip protector includes a hollow tube which is positioned with the lumen surrounding the needle while the needle is within the lumen.

[0141] Example 22 can include, or can optionally be combined with the subject matter of one or any combination of Examples 18 through 21 to optionally include wherein the sliding tip protector includes a shape on a proximal end that mates with an internal portion of a proximal hub of a handle of the sampling device.

[0142] Example 23 can include, or can optionally be combined with the subject matter of one or any combination of Examples 18 through 22 to optionally include wherein the needle include a pre-formed curved tip.

[0143] Each of these non-limiting examples can stand on its own, or can be combined in various permutations or combinations with one or more of the other examples.

[0144] The above detailed description includes references to the accompanying drawings, which form a part of the detailed description. The drawings show, by way of illustration, specific embodiments in which the invention can be practiced. These embodiments are also referred to herein as “examples.” Such examples can include elements in addition to those shown or described. However, the present inventor also contemplates examples in which only those elements shown or described are provided. Moreover, the present inventor also contemplates examples using any combination or permutation of those elements shown or described (or one or more aspects thereof), either with respect to a particular example (or one or more aspects thereof), or with respect to other examples (or one or more aspects thereof) shown or described herein.

[0145] In the event of inconsistent usages between this document and any documents so incorporated by reference, the usage in this document controls.

[0146] In this document, the terms “a” or “an” are used, as is common in patent documents, to include one or more than one, independent of any other instances or usages of “at least one” or “one or more.” In this document, the term “or” is used to refer to a nonexclusive or, such that “A or B” includes “A but not B,” “B but not A,” and “A and B,”Olympus Docket No.: GAP25028-RDFO-WO1 SLW Docket No.: 5409.961 WO1 unless otherwise indicated. In this document, the terms “including” and “in which” are used as the plain-English equivalents of the respective terms “comprising” and “wherein.” Also, in the following claims, the terms “including” and “comprising” are open-ended, that is, a system, device, article, composition, formulation, or process that includes elements in addition to those listed after such a term in a claim are still deemed to fall within the scope of that claim. Moreover, in the following claims, the terms “first,” “second,” and “third,” etc. are used merely as labels, and are not intended to impose numerical requirements on their objects.

[0147] Method examples described herein can be machine or computer-implemented at least in part. Some examples can include a computer-readable medium or machine-readable medium encoded with instructions operable to configure an electronic device to perform methods as described in the above examples. An implementation of such methods can include code, such as microcode, assembly language code, a higher-level language code, or the like. Such code can include computer readable instructions for performing various methods. The code may form portions of computer program products. Further, in an example, the code can be tangibly stored on one or more volatile, non-transitory, or nonvolatile tangible computer-readable media, such as during execution or at other times. Examples of these tangible computer-readable media can include, but are not limited to, hard disks, removable magnetic disks, removable optical disks (e.g., compact disks and digital video disks), magnetic cassettes, memory cards or sticks, random access memories (RAMs), read only memories (ROMs), and the like.

[0148] The above description is intended to be illustrative, and not restrictive. For example, the above-described examples (or one or more aspects thereof) may be used in combination with each other. Other embodiments can be used, such as by one of ordinary skill in the art upon reviewing the above description. The Abstract is provided to comply with 37 C.F.R. § 1.72(b), to allow the reader to quickly ascertain the nature of the technical disclosure. It is submitted with the understanding that it will not be used to interpret or limit the scope or meaning of the claims. Also, in the above Detailed Description, various features may be grouped together to streamline the disclosure. This should not be interpreted as intending that an unclaimed disclosed feature is essential to any claim. Rather, inventive subject matter may lie in less than all features of a particular disclosed embodiment. Thus, the following claims are hereby incorporated into the Detailed Description as examples or embodiments, with each claim standing on its own as a separate embodiment, and it is contemplated that such embodiments can be combined with each other in variousOlympus Docket No.: GAP25028-RDFO-WO1 SLW Docket No.: 5409.961 WO1 combinations or permutations. The scope of the invention should be determined with reference to the appended claims, along with the full scope of equivalents to which such claims are entitled.

Claims

Olympus Docket No.: GAP25028-RDFO-WO1 SLW Docket No.: 5409.961 WO1THE CLAIMED INVENTION IS:

1. A needle tip protection device comprising: a protective body; and an opening in the protective body configured to receive a portion of a needle while a distal tip of the needle is located with a lumen of a device such that the protective body surrounds the portion of the needle; wherein, the protective body is configured to slide distally down the needle as the needle is pulled out of the lumen so as to cover the distal tip of the needle before the distal tip of the needle is exposed outside of the lumen of the device.

2. The device of claim 1, wherein the protective body includes a compliant body and the opening includes a slit in the compliant body to receive the portion of the needle.

3. The device of claim 2, wherein the slit includes a beveled entry portion.

4. The device of any of claims 2-3, wherein the protective body includes a clip portion opposite of the slit configured to be squeezed to open the slit.

5. The device of any of claims 1-4, wherein the protective body includes a cylindrical sliding tip protector configured to slide over the tip of the needle before the needle is removed from the lumen.

6. The device of claim 5, wherein the cylindrical sliding tip protector includes a hollow tube which is positioned within the lumen surrounding the needle while the needle is within the lumen.

7. The device of claim 5-6, wherein the sliding tip protector includes a proximal tab that is held as the needle is withdrawn through the sliding tip protector until the tip is positioned within the body of the sliding tip protector.

8. The device of claim 5-7, wherein the sliding tip protector includes a change in inner diameter proximate a distal end of the sliding tip protector to define a shoulder within the cylindrical sliding tip protector, wherein the shoulder is configured to abut a diameter changeOlympus Docket No.: GAP25028-RDFO-WO1 SLW Docket No.: 5409.961 WO1 of the needle such that the needle abuts the shoulder when the tip of the needle is within the sliding tip protector.

9. A medical device comprising: an endoscope; a sampling device coupled to the endoscope and configured to extend to a sample position with a body; a needle within the sampling device and extending through a lumen of the sampling device to extract a tissue sample at a distal end of the sampling device, wherein the needle is configured to be removed from the sampling device without the sampling device being removed from the sample position; and a needle protective device configured to cover a tip of the needle before the tip is exposed external to the lumen of the sampling device.

10. The medical device of claim 9, wherein the needle includes a first marker configured to indicate a location on the needle to first position the protective device on the needle, and the needle includes a second marker distal from the first marker and configured to indicate a location where the tip of the needle is within the protective device when the second marker is at a proximal end of the protective device.

11. The medical device of any of claims 9-10, wherein the protective device includes a compliant body having a slit in the body to receive the needle.

12. The medical device of any of claim 9-11, wherein the protective device includes a cylindrical sliding tip protector configured to slide over the tip of the needle before the needle is removed from the lumen, wherein the cylindrical sliding tip protector includes a hollow tube which is positioned within the lumen surrounding the needle while the needle is within the lumen.

13. The medical device of claim 12, wherein the sliding tip protector includes a shape on a proximal end that mates with an internal portion of a proximal hub of a handle of the sampling device.Olympus Docket No.: GAP25028-RDFO-WO1 SLW Docket No.: 5409.961 WO114. The medical device of any of claims 9-13, wherein the needle includes a pre-formed curved tip.

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