WO2020142340A1

WO2020142340A1 - Subcutaneous delivery system

Info

Publication number: WO2020142340A1
Application number: PCT/US2019/068532
Authority: WO
Inventors: Andrew COTHREL; Robert Dunki-Jacobs; Jill Embry; Phil NASH
Original assignee: Xact Medical, Inc.
Priority date: 2018-12-31
Filing date: 2019-12-26
Publication date: 2020-07-09

Abstract

A subcutaneous delivery apparatus comprises a body, an arm having a distal end and a proximal end, the arm coupled to the body about the proximal end such that the arm articulates relative to the body in at least one degree of freedom, a track that extends along at least a portion of the arm, and a drive magnetic coupler that traverses along the track. In use, the drive magnetic coupler magnetically couples to a cartridge magnetic coupler through a sterile barrier that forms a physical separation therebetween such that motion of the drive magnetic coupler along the track causes corresponding motion of the cartridge magnetic coupler across the sterile barrier.

Description

SUBCUTANEOUS DELIVERY SYSTEM

TECHNICAL FIELD

Various aspects of the present disclosure relate to percutaneous medical procedures, such as needle insertion into a subcutaneous target. Further aspects relate specifically to delivery systems therefor.

BACKGROUND ART

Needle insertion into a patient can be essential for procedures such as nutrition, medications, anesthesia, chemotherapy, insertion of devices, etc. In this regard, the patient experience during a needle insertion procedure is largely dictated by the training, skill, and experience of a phlebotomist performing needle target selection and needle insertion procedures. Moreover, the accuracy and efficiency with which a needle can be inserted to a specific site within a body has a large impact on the efficiency and efficacy of a corresponding procedure.

DISCLOSURE OF INVENTION

According to aspects of the present disclosure, a subcutaneous delivery system is disclosed. The subcutaneous delivery system includes a body and an arm coupled to the body. The arm has a proximal end adjacent to the body, and a distal end that is extended from the body such that the arm articulates relative to the body in at least one degree of freedom. A track extends along at least a portion of the arm. The subcutaneous delivery system also includes a drive magnetic coupler that traverses along the track.

In use, a cartridge is installed on the subcutaneous delivery system. In particular, a cartridge magnetic coupler of a cartridge is brought into magnetic cooperation with (i.e., magnetically couples to) the drive magnetic coupler of the subcutaneous delivery system over a sterile barrier (e.g., stationary sterile barrier). The sterile barrier thus forms a physical separation between the drive magnetic coupler of the subcutaneous delivery system and the cartridge magnetic coupler of the installed cartridge. However, motion of the drive magnetic coupler along the track causes corresponding motion of the cartridge magnetic coupler (and hence the cartridge) across the sterile barrier (e.g., the sterile barrier remains in between the drive magnetic coupler and cartridge magnetic coupler). According to further aspects of the present disclosure, a subcutaneous delivery system comprises an arm having a track that extends along at least a portion thereof. The system also has a drive magnetic coupler that traverses along the track. In use, a cartridge is installed on, and is operated analogous to that set out above. For instance, a sterile barrier forms a physical separation between the drive magnetic coupler of the subcutaneous delivery system and a cartridge magnetic coupler of the installed cartridge. Moreover, motion of the drive magnetic coupler along the track causes corresponding motion of the cartridge magnetic coupler (and hence the cartridge) across the sterile barrier.

According to yet further aspects of the present disclosure, a cartridge is disclosed. The cartridge includes a body and a cartridge magnetic coupler that is disposed on a portion of the body. When the cartridge is in use, the cartridge magnetic coupler magnetically couples to a drive magnetic coupler of a needle insertion device through a sterile barrier that forms a physical separation therebetween. Once installed, the cartridge magnetic coupler magnetically follows the drive magnetic coupler to traverse along a track, of the needle insertion device.

According to still additional aspects of the present disclosure, a sterile barrier is disclosed. The sterile barrier has a first barrier that couples to a second barrier. In some embodiments, the first barrier is a semi-rigid barrier. Further, in some embodiments, the second barrier is a flexible and/or wipeable barrier. When the sterile barrier is in use, the first barrier and the second barrier are conformable into a channel of a track of a needle insertion device. Moreover, the first barrier and the second barrier form a physical separation between a first set of magnets of a drive magnetic coupler and a second set of magnets of a cartridge magnetic coupler. Accordingly, motion of the drive magnetic coupler along the track causes corresponding motion of the cartridge magnetic coupler across the sterile barrier (e.g., the sterile barrier remains in between the drive magnetic coupler and cartridge magnetic coupler). In some embodiments, the sterile barrier is considered a stationary barrier.

According to further aspects of the present disclosure, a subcutaneous delivery apparatus is disclosed. The apparatus has an articulating arm having a distal end and a proximal end, which articulates in a first degree of freedom. The apparatus also includes a channel that extends along at least a portion of the articulating arm. Further, a cartridge engages with, and travels along the channel. In addition, the apparatus includes a sterile barrier disposed between the cartridge and the track. BRIEF DESCRIPTION OF DRAWINGS

FIG. 1 is an illustration of an example delivery system according to aspects of the present disclosure;

FIG. 2 is an illustration of an example delivery system according to aspects of the present disclosure;

FIG. 3 is a schematic illustration of magnetic forces that can be utilized to couple a cartridge to a track of a needle delivery system, according to aspects herein;

FIG. 4 is another schematic illustration of magnetic forces that can be utilized to couple a cartridge to a track in a needle delivery system, according to additional aspects herein;

FIG. 5 is yet another schematic illustration of magnetic forces that can be utilized to couple a cartridge to a track of an arm in a needle delivery system, according to yet further aspects herein;

FIG. 6 is an illustration of an embodiment of a subcutaneous delivery apparatus according to aspects of the present disclosure;

FIG. 7 is an illustration of a further embodiment of the subcutaneous delivery apparatus of FIG. 6 according to aspects of the present disclosure;

FIG. 8A is an illustration of a magnetic coupler, e.g., a cartridge magnetic coupler according to aspects herein;

FIG. 8B is an illustration of a magnetic receiver, e.g., a drive magnetic coupler according to aspects of the present disclosure and

FIG. 9 is an illustration of an embodiment of a cartridge for a subcutaneous delivery apparatus according to aspects of the present disclosure.

MODES FOR CARRYING OUT THE INVENTION

Needle insertion into a subcutaneous target finds many applications in healthcare environments, such as to access a vein, to biopsy a tumor mass, to access a nerve, to access an abscess, etc. In this regard, needle insertion procedures can facilitate extraction, fluid delivery, energy delivery, and other desired tasks.

By way of example, currently, needle insertion into a patient is typically performed manually. While potentially convenient, manual techniques leave open the possibility of“misses” (i.e., the needle misses the target) and other related issues. For instance, a“miss” may occur due to human error. Misses can also occur due to naturally occurring, surgically created, and medicinally created variations in human physiology. As a result, the patient may experience discomfort or a more significant health consequence, which influences patient outcomes, complication rates, and patient experience. Further, complications of“misses” can include pneumothorax, infection, bleeding, arterial puncture, arrhythmia, air embolism, thoracic duct injury, catheter malposition, and hemothorax.

As another example, a manual needle insertion operation may target a vein to administer medications, such as for vaccinations, pain relieving medication, etc. If during administration of the medications, the needle overshoots the target vein (i.e., the needle goes through the vein, thereby exposing a portion of the needle’s distal opening outside of the target vein), medication may be administered into a patient’s body cavity, which may have adverse effects. A similar result may occur if the needle undershoots the target vein (i.e., the needle partially punctures the vein, but still exposes a portion of the needle’s distal opening outside the target vein).

Moreover, manual needle insertion operations can be time consuming. By way of illustration, in example clinical experiences, the time required for central vascular access can range from 15-55 minutes, but up to two hours is also possible where a proper vein is difficult to locate or stick. This results in considerable cost, both directly and indirectly to the healthcare provider.

Aspects of the present disclosure solve these problems by reliably providing needle insertion into subcutaneous target (potentially in 3-5 minutes) for any clinician who needs to perform a needle-based procedure on a patient. Moreover, use of the subcutaneous deliver system, as set out herein, can generate similar results from experienced phlebotomists, as well as from clinicians who are not specialist experts but find that they must obtain subcutaneous access to a target periodically, e.g., 5-15 times per month. Subcutaneous target access is provided by automated and/or semi-automated point of care solutions that accurately allow an operator to attach a needle to a needle insertion device, perform a needle insertion operation, and remove the needle from the needle insertion device without breaching a sterile barrier. Delivery System

Referring now to the figures, and in particular FIG. 1, an example subcutaneous delivery system 100 is illustrated. The subcutaneous delivery system comprises an imaging system 102, a probe 104, and an insertion device 106.

The imaging system 102 generates data (e.g., positional instructions) to send an object (e.g., a needle tip controlled by the insertion device 106) precisely to a point in space (e.g., a subcutaneous position). For purposes of clarity and conciseness, the various disclosures herein are primarily directed toward use of ultrasound (e.g., brightness-mode ultrasound, motion-mode ultrasound, etc.,) as the imaging system 102. Ultrasound provides an ability to show depth perception and establish accurate real-time construction of three- dimensional (3-D) objects from a single image orientation (i.e., does not need multiple views to create a 3-D image). However, aspects of the present disclosure are not strictly reliant on ultrasound technology, and therefore is not limited thereto. For instance, various imaging modalities can be utilized alone or in combination, so long as targeting solutions be calculated in real-time for below-the-skin targets.

In various embodiments, the imaging system 102 includes a processor 112 communicably coupled to related hardware 114 such as a controller 116 (or controllers 116), storage medium(s) 118, network adapter 120 (for communication with various internal external networks), and interface(s) 122 (e.g., to interface with the probe 104), etc.

The controller 116 can be used to interface the processor 112 to one or more physical components of the imaging system.

The storage medium 118 can store program code 124 that can be read out and executed by the processor 112 to carry out imaging functions and/or other functions, e.g., to cooperate with the insertion device 106 as described more fully herein.

In various embodiments, the imaging system 102 may have its own display screen with a graphical user interface (GUI) 126 integral with the imaging system 102, which an operator of the imaging system 102 can interact with during operation thereof. Alternatively, the imaging system 102 can connect to an external display device, e.g., a generic display device such as a stand-alone display (e.g., television, monitor, etc.) or an independent processing device such as a smart device (e.g., smartphone, tablets, laptops, etc.).

The probe 104 is an ultrasound probe in the above example, which interfaces with the imaging system 102 and the insertion device 106. In practical applications, the probe 104 is integrated into the insertion device 106. However, the probe 104 can be a separate device. Moreover, the probe 104 can include one or more sensors, the specific type of which will depend upon the imaging modality.

The insertion device 106 includes a processor 132 communicably coupled to associated hardware 134. Example hardware 134 can include a controller 136 (or controllers 136), storage medium(s) 138, network adapter 140, a cartridge interface 142, and motors and actuators 144 to guide a cartridge (e.g., when the cartridge contains an object, e.g., a needle). Example hardware 134 can also include a frame grabber 146 (which can receive real-time data in either digital or analog formats from the imaging system 102, and forward that data to the processor 132 for processing, etc.), image processor 148, path planning circuitry 150, and one or more optional interfaces 152 (e.g., to support additional sensors, probes, input/output devices, etc.).

In this regard, the processor 132 may be integrated into the insertion device 106, implemented through an independent processing device such as a smart device (e.g., smartphone, tablets, laptops, etc.), combination thereof, etc. The controller 136 of the insertion device 106 interacts with the processor 132 to control an insertion operation, such as by interfacing with mechanical structures to implement one-dimensional (ID) position control, two-dimensional (2D) position control, three-dimensional (3D) position control, rotation, penetration velocity of an object, (e.g., a needle) coupled to a cartridge, combinations thereof, etc., depending upon the specific configuration of the mechanical operation and capability of the insertion device 106.

In other embodiments, a cartridge can support a variety of tools or devices in addition to, or in lieu of a needle, such as biopsy devices, ablation devices (including radiofrequency ablation (RFA) devices), biopsy guns, cryoprobes and microwave probes can be used in conjunction with the insertion device 106.

In various embodiments, once the frame grabber 146 forwards data to the processor 132, the processor 132 can utilize one or more image processors 148 and one or more path planners 150, e.g., to perform calculations necessary for path planning and point placement of an object (e.g., a needle) on the cartridge. The image processor 148 analyzes the information provided by the imaging system 102 and frame grabber(s) 146, detects areas of interest (AOI), and tracks movements of the corresponding cartridge loaded into the insertion device 106. In example embodiments, the path planner 150 searches for an optimal trajectory of an object (e.g., a needle) carried by the cartridge, monitors movement of the cartridge, provides real time adaptation if necessary, combinations thereof, etc., as disclosed in greater detail herein.

Moreover, the insertion device 106 may include various interfaces 152 that work in conjunction with the insertion device 106. Example interfaces link peripherals to the processor 132, such as hand-held controllers, joysticks, and other hardware for interaction with an operator of the insertion device 106.

Further, the insertion device 106 includes program code 154 (e.g., stored in the storage 138) such that when the program code 154 is read out and is implemented by the processor 132, the various components cooperate to effectuate general operation of the insertion device 106. The insertion device 106 may also include its own display with a GUI 156 (hereinafter insertion device-GUI), and/or use an external GUI 126 (e.g., the insertion device 106 can share display screen space with the imaging system display, e.g., via shared/divided screen space, overlays, combinations thereof, etc.).

In various implementations, the imaging system 102 may directly communicate with the insertion device 106. In other implementations, the imaging system 102 may communicate with the insertion device 106 through an external interface 160 (shown as “EX-INTERFACE” in FIG. 1) that has its own processor, storage, program code, GUI, etc., or a combination thereof (e.g., a dedicated smart device).

In operation, the imaging system 102 can function as an autonomous and powered system. Once a user selects a target, the subcutaneous delivery system 100 takes over, calculating the path of the object provided on the attached cartridge (e.g., needle path), actuating object movement, ensuring a path to the correct depth on first attempt. The subcutaneous delivery system 100 can thus minimize tissue damage, typically caused from side-to-side“finding” movements of a needle inherent in manual methods.

Example Delivery System

Now referring to FIG. 2, a side schematic view of an example delivery system 200 is illustrated. The system 200 is analogous in many respects to the system 100 (FIG. 1) and as such, like elements are illustrated with like reference numerals 100 higher in FIG. 2 compared to FIG. 1. Where like elements are illustrated, no additional detail is provided for conciseness, except when necessary to understand differences or aspects disclosed herein. An imaging system 202 with a graphic user interface (GUI) (e.g., analogous to the imaging system 102 - FIG. 1) connects to a probe 204 (e.g., analogous to probe 104 - FIG. 1), which is illustrated as installed in a needle insertion device 206 (e.g., analogous to the insertion device 106 - FIG. 1), e.g., via a connection 208. The connection 208 can also connect electronics of the imaging system 202 to electronics of the needle insertion device 206, and/or form other connections between the components of the system. In some applications, the connection 208 is a physical connection, e.g., a cable bundle, set of separate cables, etc. In other implementations, the connection 208 can be wireless, so as to eliminate a physical tether between the imaging system 202 and the needle insertion device 206.

The needle insertion device 206 has a body 270 that is coupled to an arm 272. The body 270 can form a handle that the user grasps to position the needle insertion device 206 relative to the patient. In this regard, the body 270 may support one or more buttons (e.g., a GO button) and/or other user interface controls to effect operation thereof.

As illustrated, the arm 272 has a proximal end 274 and a distal end 276. Moreover, the arm 272 is coupled to the body 270 about the proximal end 274, such that the arm 272 articulates relative to the body 270 at 278 (e.g., in at least one degree of freedom). In this regard, the body 270 and/or arm 272 can house one or more locomotion mechanism(s), e.g., motors, actuators, gears, cams, pistons, linkages, rack and pinion systems, ratchets, springs, drive belts, drive cables, capstans, other mechanisms, etc.

In multiple implementations, the body 270 is configured to house the probe 204 and orient the probe 204 in a suitable orientation for use in conjunction with the described insertion capabilities. Moreover, the body 270 can house various hardware/electrical components necessary to carry out imaging of an area of interest, calculating a target point for a needle insertion operation, (e.g., via processor 132 in FIG. 1), controlling the positioning of the arm 272 relative to the body 270, providing a housing for various additional sensors, and controlling components necessary for needle delivery.

In various embodiments, the locomotion mechanisms allow the arm 272 to move and/or rotate about at least one pivot point, e.g., about one or more of the X-axis, Y-axis, and Z-axis.

The arm 272 comprises a track 280 that extends along at least a portion of a length thereof. For instance, as illustrated, the track 280 extends from an area near the proximal end 274 of the arm 272 (i.e., generally where the arm 272 couples to the body 270) to an area near the distal end 276 of the arm 272 opposite the proximal end 274. A stage 282 is coupled to the track 280 in such a way that the stage 282 can translate along the arm 272, e.g., in a range from the distal end 276 to the proximal end 278 and back, or other suitable bounded range, which may be dictated by the track 280. For instance, as illustrated, the track 280 extends less than the entirety of the length of the arm 272, e.g., as limited by hardware, need, and other considerations.

Translation of the stage 282 along the track 280 can be accomplished using a variety of mechanisms that enable movement of the stage 282 relative to the arm 272 along the track 280.

The stage 282 carries an attachment object, e.g., a needle 284 or other suitable device as the specific application dictates. In this configuration, the needle 284 can traverse along the length of the arm 272, via the track 280 and corresponding stage 282. In practical applications, it is convenient to mount the needle 284 on a cartridge, which functions as a suitable carrier that releasably and temporarily mates with the stage 282.

In various embodiments, the needle insertion device 206 can include one or more position sensors 286, e.g., linear and/or angular position sensors that are mounted on the arm 272 and/or stage 282 to accurately control the delivery of the object, e.g., to accurately control the delivery of a needle tip to within a predetermined range (e.g., ±50um radius) of a target depth.

Also shown in FIG. 2, a sterile barrier 290 surrounds the insertion device 206 and connection line 208. The sterile barrier 290 physically isolates the needle 284 from the track 280 and other components within the sterile barrier.

Sterile Barrier

According to aspects herein, the sterile barrier 290 can perform one or more functions. For instance, in practical embodiments, the sterile barrier 290 protects the objects on a non-sterile side 291 (within the sterile barrier 290) from fluid contamination originating on a sterile side 292 (outside the sterile barrier 290). The sterile barrier 290 may also prevent fluids and pathogens originating on the non-sterile side 291 from contaminating objects on the sterile side 292. For instance, a needle puncture may cause blood, or other contaminants to contact the needle insertion device 206. However, the sterile barrier 290 protects the needle insertion device 206 such that the hardware of the needle insertion device 206 does not necessarily have to be re-sterilized after every single use.

Due to this requirement, there may not be any direct, physical contact between the track 280, stage 282, and a corresponding cartridge. Rather, the cartridge will reside on one side of the sterile barrier 290, whereas the track 280, stage 282, and other components of the insertion device 106, 206 remain on the opposite side of the sterile barrier 290, physically isolated from the cartridge by the sterile barrier substrate.

Coupling

According to aspects of the present disclosure, magnetic forces are utilized to couple the stage 282 to a cartridge that holds the needle 284 (or other object) through the sterile barrier 290, such that movement of the stage 282 along the track 280 causes movement of the cartridge in a similar (but not necessarily identical) travel path by magnetic forces. Any non-identical travel paths can be attributed for instance, to physical forces that act upon the needle that may resist the magnetic forces involved in coupling the cartridge to the stage. Examples of magnetic coupling, and detailed examples of the sterile barrier are set out in greater detail herein.

Cartridge/Stage Magnetic Coupling

Referring to FIG. 3, a side cross-sectional view of a magnet configuration 300 is illustrated. Although described in terms of magnets for convenience and conciseness of illustration, the magnets are schematically symbolic of magnetic attractions, repulsions, and fields. Thus, any structures that can create the magnetic effects described herein may be used in addition to, or in lieu of the described magnets.

The configuration 300 comprises a cartridge magnet 302, which is mounted on a cartridge component (not shown). This configuration also comprises a pair of coupler magnets 304 and 306, which are mounted on a drive magnetic coupler (also not shown), but which traverses an associated track (e.g., track 280, FIG. 2). The housing for the cartridge and separate drive coupler are not shown for clarity of discussion of magnetic forces utilized herein. Such structures are discussed in greater detail herein. The cartridge magnet 302 has a face FI and a face F2 opposite the face FI. The coupler magnet 304 has a face F3, and the coupler magnet 306 has a face F4. (The coupler magnets 304 and 306 each have an opposite face as well, but these opposite faces are not necessary to understand the aspects herein).

In this configuration 300, the face FI of the cartridge magnet 302 interacts or interfaces with the third face F3 on the coupler magnet 304. Likewise, the face F2 of the cartridge magnet 302 interacts or interfaces with the fourth face F4 on the coupler magnet 306. Face FI of the cartridge magnet 302 can have either a north magnetic polarity (“N”) or a south magnetic polarity (“S”). Regardless, the face F2 will typically be opposite in polarity as the face FI. Here, it may be possible that FI and F2 have the same polarity, e.g., by using a sandwich/magnetic isolating layer, using mechanical forces to overcome magnetic forces, etc. Regardless, the face F3 of the coupler magnet 304 will have a magnetic polarity opposite that of face FI of the cartridge magnet 302. Analogously, the face F4 of the coupler magnet 306 will have a polarity opposite of the face F2 of the cartridge magnet 302.

With respect to magnetic forces generally, opposite polarities will attract to one another, while like polarities will repel one another. In an illustrative example, if the face FI is a“N” polarity, the third face F3 is a“S” polarity, thus the face FI and the face F3 will be attracted to one another. In this example, the second face F2 is thus a“S” polarity, and the face F4 is a“N” polarity. Thus, face F2 and face F4 will be attracted to one another. Here, magnetic attraction can be used to suspend the cartridge magnet 302 between the coupler magnet 304 and coupler magnet 306. This configuration also allows a sterile barrier (not shown) to be positioned between the cartridge magnet 302 and the coupler magnets 304, 306. In some example embodiments, the coupler magnet 306 is not strictly needed. Here, the cartridge magnet 302 will pull into contact with coupler magnet 304 (or into contact with a sterile barrier positioned between the cartridge magnet 302 and coupler magnet 304.

Magnet strength and other considerations may result in different configurations, and thus the above examples are presented by way of illustration, and not by way of limitation.

Referring to FIG. 4, top-down view of a magnet configuration 400 is illustrated. The disclosure relating to FIG. 3 applies to FIG. 4, except that the reference numbers are 100 higher when applicable (e.g., 402 is analogous to 302 in FIG. 3, 404 is analogous to 304 in FIG. 3, 406 is analogous to 306 in FIG. 3, etc.). Thus, all discussion above applies by analogy. Further, primed numbers (‘) are analogous to non-primed counterparts (e.g., 402 is analogous to 402’) in generic structure, but not necessarily analogous with respect to magnetic polarity. While only two sets of magnets (six total magnets) are shown, any number of magnets could be implemented, as schematically represented by the ellipsis.

In the illustrated example, each pair of magnets (402, 402’), (404, 404’) and (406, 406’) defines a“pole pair” that is separated by a pitch. In a working example, FI and F4 are of“N” polarity, and F2 and F3 are of“S” polarity. Further, FI’ and F4’ are of“S” polarity and F2’ and F3’ are of“N” polarity. This strict alternating pattern of polarity need not be implemented, e.g., depending upon how the magnetic attraction and repulsion characteristics of the magnetic fields are to be manipulated to temporarily couple a cartridge to a coupler stage through a sterile barrier.

In an example implementation, assume that the first magnets 402, 402’ comprise a cartridge magnetic assembly, and that the second and third magnets 404, 404’, 406, 406’ comprise the coupler stage magnetic assembly. Under static conditions, magnetic forces should magnetically couple the cartridge to the stage so as to ultimately resolve to a magnetic equilibrium, e.g., a fixed spatial relationship between the cartridge and the stage (as separated by the sterile barrier). However, assume now that the stage starts to move, and thus the magnets 404, 404’, 406, and 406’ start moving in a first direction 408 as indicated by dashed boxes. Under this arrangement, magnetic forces prompt commensurate movement of magnets 402 and 402’. Thus, the magnets 402 and 402’ will begin traveling with the magnets 404, 404’, 406, and 406’ despite a stationary sterile barrier therebetween.

The magnetic fields should be configured to overcome any anticipated shear force resisting the movement of magnets 402, 402’ with the magnets 404, 404’, 406, and 406’. For example, where the magnets 404, 404’, 406, and 406’ are moving in direction 408, the magnetic forces should overcome anticipated shear forces acting in direction 410.

As a few examples, when a needle carried by the cartridge strikes tissue, the physical resistance caused by the tissue will cause shear forces acting in the direction 410. The magnetic fields should overcome such physical resistance so that the cartridge continues to move with the stage of the insertion device. Yet further, shear forces acting in the direction 410 can be generated from the cartridge physically contacting the sterile barrier.

In this regard, strong magnetic coupling in the directions 408 and 410 is desired. However, the cartridge should be easy for the user to separate from the stage. Thus, the magnetic fields should be configured such that resistance to a pull force, e.g., in the direction of arrow 414 (e.g., out of the page as shown) is relatively weak. An example way of achieving a relatively weak resistance to pull force is to control vertical shear force by alternating magnetic polarities in each magnet row. As a specific example, if FI has a S magnetic orientation, then F2’, F3’ and F4 also have a S magnetic orientation. As such, FI’, F2, F3, and F4’ each have a N magnetic orientation. In an example configuration, each row of magnets in the stage have the same number of magnets, and the magnets are aligned such that each magnet of one row directly opposes a corresponding magnet in the other row. That is, 404 is directly across from 406, 404’ is directly across from 406’, etc. Other configurations are also possible, and any combination can be utilized, depending upon the desired magnetic characteristics. In an example embodiment, magnetic orientation can be varied so long as once the cartridge is mechanically coupled to the stage, the combination yields resistance to shear forces, and limited resistance to a pull force.

As noted above, contributing factors to the rebound between the magnets include shear force (or moving force), distance between magnets, and pitch of the pole pairs. Moreover, a distance between magnets also influences the magnetic forces attracting the magnets to one another. As a distance between the magnets increases, the weaker the magnetic forces attracting the magnets to one another becomes. Conversely, as the distance between the magnets decreases, the stronger the magnetic forces attracting the magnets to one another becomes. Thus, for example, the shear forces can be compensated for by establishing the spacing of the magnets to achieve a desired performance.

As another example, if magnets 402 402’ are raised vertically away from magnets 404, 404’ and 406, 406’ as indicated by direction 414, then the magnetic forces between F1/F3, F2/F4, F1’F3’ and F27F4’ become weaker. Thus, geometry can be used to influence a pull force required to separate the cartridge from the stage.

Example Cartridge Magnetic Coupler and Drive Magnetic Coupler

Referring to FIG. 5, an example implementation of a magnetic configuration 500 is illustrated. In this configuration 500, a stage 502 traverses along a track extending into and out of the page as illustrated. A cartridge 504 releasably and temporarily magnetically couples to the stage 502. In the illustrated embodiment, the cartridge 504 has a needle 506 mounted thereto. Moreover, as illustrated, the cartridge 504 magnetically couples to the stage 502 through a sterile barrier 508. As illustrated, the track and stage 502 reside on a first side of the sterile barrier 508, whereas the cartridge 504 is on an opposite side of the sterile barrier 508. In practice, the system may include a guide 510 that can be positioned opposite the track to assist in guiding the cartridge 504 on the cartridge-side of the sterile barrier 508. Notably, the cartridge includes a cartridge magnetic coupler 512 that includes a row of cartridge magnets (e.g., analogous to 402, 402’ described with reference to FIG. 4). In the illustrated view, the row of magnets is projecting out of the page. The cartridge magnet in the view of FIG. 5 has an“S” polarity to the left as shown, and an“N” polarity to the right as shown. Further, the stage 502 comprises a drive magnetic coupler 514 that is defined by first magnetic structure 516 (including a row of magnets coming out of the page as shown) and a second magnetic structure 518 (including a row of magnets coming out of the page, as shown). The first magnetic structure 516 is analogous to the magnets 404, 404’ and the second magnetic structure 518 is analogous the magnets 406, 406’ described with reference to FIG. 4.

The first magnetic structure 516 illustrates a magnet having a“N” polarity facing the cartridge magnet 512. Correspondingly, the second magnetic structure illustrates a magnet having a“S” magnetic polarity facing the cartridge magnet 512. In practice, these magnetic structures can be single magnets, rows of magnets, etc. as described more fully herein, e.g., with regard to FIG. 3 and FIG. 4.

In this configuration, the cartridge 504 is magnetically coupled to the stage 502 via the magnetic coupling between the cartridge magnetic coupler 512 and the drive magnetic coupler 514. As noted more fully herein, magnetic attraction between the cartridge magnetic coupler 512 and the drive magnetic coupler 514 can be increased and/or decreased based upon the number of magnets, magnet polarity and orientation, strength of the magnets, distance between magnets, etc., as described more fully herein.

In various embodiments, the track may optionally comprise a third magnetic structure 520, which may itself have any number of different magnetic configurations. In this example, the third magnetic structure 520 (e.g., a magnet or row of magnets, etc.) is positioned only in select places along the track, e.g., towards a proximal end of the track (FIG. 2). In this particular configuration, the third magnetic structure 518 has a“N” polarity half and a“S” polarity oriented as shown in FIG. 5. By moving the third magnetic structure 520 toward the cartridge magnetic coupler 512, as“assist” is provided to reduce the pulling force necessary to remove the cartridge 504 from the stage 502. Needle Cartridge

Now referring to FIG. 6, an example embodiment for a subcutaneous delivery apparatus 600 is illustrated. The apparatus 600 comprises an arm 602 (e.g., the arm 272 in FIG. 2) having a proximal end 604 and a distal end 606. In an example implementation, the proximal end 604 can couple to a body such as the body 270 - FIG. 2).

Further, the apparatus 600 comprises a track 608 that extends from an area at/near the distal end 606 of the arm 602, to/near the proximal end 604 of the arm 602. In some embodiments, the track 608 may not fully extend to the entire length of the arm 602. Instead, the track may stop short (shown as a dashed circle 609) of the distal end 606 of the arm 602 to function as a loading area for various implements etc. Likewise, articulating hardware or other structure(s) may limit the extent of the track to stop short of the proximal end 604 of the arm 602.

In practical applications, the track 608 is defined by an arm frame in connection to the arm 602. As noted more fully herein, the track is positioned on a first side of a sterile barrier, whereas the cartridge is mounted on an opposite side of the sterile barrier. In this regard, as illustrated, a cartridge 610 is situated on a guide 612 that travels along a path defined by the arm frame. The guide 612 can be positioned in alignment with the track opposite the track and separated therefrom by the sterile barrier. In this regard, magnets or other suitable structures can both register and secure the guide 612 to the arm 602.

In the illustrated embodiment, the cartridge 610 holds a subcutaneous delivery instrument 616 (e.g., needle) and restricts the subcutaneous delivery instrument 616 to a fixed orientation.

Additionally, the apparatus 600 comprises a barrier 620 disposed between the cartridge 610 and the track. The barrier 620 serves as a sterile barrier that prevents potential contamination of the arm and components therein, as described in greater detail herein.

Cartridge. Sterile Barrier and Stage

Now referring to FIG. 7, the example embodiment for a subcutaneous delivery system 600 of FIG. 6 is illustrated in further detail.

As shown, a cross-sectional view is cut across the arm 602 so that select internal features of an example embodiment are illustrated. In this view, the proximal end 604 of the arm extends out of the page, and the distal end 606 of the arm 602 extends into the page. The arm 602 includes a track 608 that comprises an arm frame implemented by a pair of spaced rails 608A, 608B. A stage 622 is positioned between the rails 608A, 608B, and serves as a sled to traverse along the track relative to the arm 602. For instance, the stage 622 can be coupled to a cable via interfaces 624A, 624B. The cable couples to a drive source (e.g., motor) and other optional components (e.g., gearbox, capstan, etc., (not shown). For instance, the stage 622 can be rigidly/fixedly coupled to the cable via the first interface 624A to traverse along the track with the cable. The second interface 624B forms a return for the cable to loop through (e.g., slide through the stage 622), and is decoupled from the cable, thus optional. In this configuration, the stage 622 moves with, and in the direction of travel of the cable via fixed interface 624A, and the cable passes through the interface 624B such that the cable travels in an opposite direction relative to the stage 622 via the second interface 624B, enabling the cable to form a loop.

Regardless, in practical applications, the stage 622 can traverse the track via any suitable drive mechanism, alternative drive structures can include an actuator, gears, belt, linear actuator, or other suitable linear motion technology.

Sterile Barrier

In medical applications, it may be desired and/or required to form a barrier 620, e.g., a sterile barrier, between the cartridge 610 and the arm 602. The use of a sterile barrier 620 allows the subcutaneous delivery system 600 to be used in repeated applications without re-sterilizing the apparatus itself. Rather, by isolating the subcutaneous delivery system 600 in a sterile environment, e.g., via the sterile barrier 620, the cartridge 610 can be kept external to the subcutaneous delivery system 600, e.g., and may be implemented as a disposable cartridge or re-sterilizable cartridge.

The illustrated sterile barrier 620 is comprised of multiple layers including a wipeable barrier 650. The wipeable barrier 650 (shown in thick, equal sized dashed lines) is a sterile barrier layer that may be conformal or otherwise generally follow at least a portion of the shape of the arm 602. Moreover, the wipeable barrier 650 may form a sleeve and/or sock that completely isolates the arm 602 from the cartridge 610. The wipeable barrier 650 may further be integral with barrier material that also covers the body, connector, and other components of the system.

As illustrated, the wipeable barrier 650 is comprised of a rigid material that is disposed adjacently to the arm 602 and the stage 622. For the purposes of this disclosure, “rigid” does not mean inflexible. Rather, rigid means that whichever material is used as the wipeable barrier 650 is resistant to deformation based on relative operation needs as well as other considerations as described herein, and can thus be flexible.

In various embodiments, the wipeable barrier 650 can contact, or be adhered to (e.g., vacuum formed, heat sealed, thread fastened, magnetically fastened, snap-on, etc.), the arm 602. Generally, the wipeable barrier 650 is removable or replaceable if the wipeable barrier 650 becomes damaged or compromised. Further, the wipeable barrier 650 can, and in most circumstances should, be comprised of a sterile material or a material that is conducive to sterilization. In addition, wipeable barrier 650 should be bio-compatible (e.g., compatible with living tissue or a living system by not being toxic, injurious, or physiologically reactive and not causing immunological rejection).

Moreover, a flexible barrier 652 is provided about the arm 602. The flexible barrier 652 extends around the arm 602, except for the area between the cartridge 610 and the arm 602. For instance, in various embodiments, the wipeable barrier 650 surrounds the arm 602 and/or other portions of components described herein (e.g., the sterile layer 290 surrounding the first arm 210, connection cable 208, etc. in FIG. 2). In various embodiments, the flexible barrier 652 is configured to provide closure at the proximal end 604 of the articulating arm 602 and to provide a close fit (not conformal) to all other portions of the device which require a sterile protective barrier (e.g., the first arm 210, connection cable 208, etc. in FIG. 2).

In this regard, in some embodiments, an intermediate, semi-rigid barrier 654 is interposed between the ends of the flexible barrier 652. For instance, as illustrated, the semi rigid barrier 654 is generally conformal or is at least flexible enough to become generally conformal in the area between the arm 602 and the cartridge 610. The semi-rigid barrier 654 mates (or is fastened or bonded) with the flexible barrier 652 to ensure that the sterile barrier meets required and/or desired isolation as required by a particular application. In an example embodiment, the semi-rigid barrier 654 can be made from materials similar to that of the wipeable layer 650 or comprised of a“deformable” film or fabric, which can stretch or redistribute to create pathway for the cartridge 610 to interact with the stage 622. Further, the semi-rigid barrier 654 can, and in most circumstances should, be comprised of a sterile material or a material that is conducive to sterilization. In addition, the semi-rigid barrier 654 layer should be bio-compatible (e.g., compatible with living tissue or a living system by not being toxic, injurious, or physiologically reactive and not causing immunological rejection).

In certain embodiments, the sterile barrier can click, slide, or otherwise lock into the track, e.g., bayonet-style such that a bag is only needed about the pivot point of the arm.

The flexible barrier 652 is comprised of a thin sterile material (e.g., plastic) that is coupled to the semi-rigid barrier 654, the track 608, and/or the guide 612. The flexible barrier 652 spatially separates the cartridge 610 from a portion of the arm 602 (or separates the cartridge 610 from the rest of the apparatus 600). Optionally, the semi-rigid barrier 654 and/or the flexible barrier 652 can be attached to the track 608 and/or track guide 612 (visually represented by the solid nail 634) to create a single sterile unit that can be attached and detached from the articulating arm 602 in one piece.

Sterile Guide

Moreover, as noted above, a guide 612 can be positioned in alignment with the track 608 opposite the track 608 and separated therefrom by the sterile barrier 620. In this regard, magnets or other suitable structures can both register and secure the guide 612 to the arm 602.

Correspondingly, the cartridge 610 may further comprise tab guides 630 that correspond to the guide 612, which guide the cartridge 610 along a path in magnetic coupling with the stage 622 as the stage 622 moves along the track 608.

Yet further, the tab guides 630 may utilize offsets 632 that extend from the tab guides 630 to the guide 612. While a variety of shapes, form factors, geometry may be used, a triangular shaped geometry provides a very small surface area to contact the track guide, thus reducing friction, wear/tear, etc. Other shapes can include cylinders, pins, cones, etc.

In some embodiments, the offsets 632 can be made from a crushable material thus providing a smoother transition from the distal end 604 to the proximal end 604. Also, chamfers or bevels on the offsets 632 may further reduce friction. It is also possible to use lubrication to even further reduce friction. Moreover, while only two offsets 632 are shown, in practice one or more can be used.

Under many traditional solutions, it is not possible to have a sterile barrier between the cartridge 610 and the articulating arm 602/stage 622 due to wear and tear from friction caused by the cartridge 610 moving back and forth across the articulating arm 602. However, aspects of the present disclosure (including the apparatus 600) provide for using magnets to guide and drive the cartridge 610 with little to no damage to the barrier.

In this regard, the cartridge 610 comprises a cartridge magnetic coupler 640 that engages a drive magnetic coupler 642 (e.g., magnetic receiver(s) 642a and 642b within the stage 622), the operation of which is analogous to that set out in greater detail herein. For instance, the cartridge magnetic coupler 640 comprises a first set of magnets that alternate polarity (magnetic north designated as “N”, magnetic south designated as “S”) in a predetermined pattern. Correspondingly, the drive magnetic coupler 642 comprises a second set of magnets having an opposing polarity of the first set of magnets.

For further illustration, FIG. 8 A shows an example configuration for a cartridge magnetic coupler and FIG. 8B shows an example configuration for a corresponding drive magnetic coupler. With reference to FIG. 8A and FIG. 8B generally, the cartridge magnetic coupler 800 comprises a first series of magnets 802a-i with an alternating polarity of S-N- S-N-S-N-S-N-S on one side thereof, and correspondingly N-S-N-S-N-S-N-S-N on the opposite side. However, a multitude of polarity combinations may be used.

Correspondingly, the drive magnetic coupler 804 comprises two rows of magnets, including a series of magnets 806a-i, and a series of magnets 806a’ -i’. For example, if the set of magnets 806a-i is oriented such that a face of each magnet is directed into the channel as S-N-S-N-S-N-S-N-S, then the set of magnets 806a’ -i’ are oriented such that a face of each magnet is directed into the channel as N-S-N-S-N-S-N-S-N.

While the cartridge magnetic coupler 800 is illustrated with a single row of magnets (i.e., 802a-i) and the drive magnetic coupler 804 is illustrated with two rows of magnets (i.e., 806a-I, 806a’ -i’), the opposite may be used as well (i.e., the cartridge magnetic coupler 800 has two rows of magnets and the drive magnetic coupler 804 has a single row of magnets).

Advantages

With respect to the apparatuses herein, magnets provide numerous advantages over traditional solutions. For example, by using magnets of opposing polarity between a stage and a cartridge, the cartridge can be retained and driven by the stage without physical contact, thus eliminating violation of the sterile barriers (e.g., the sterile barrier 250 in FIG. 2, the rigid layer 320, semi-rigid layer 322, and flexible layer 324 of FIG. 3). Thus, the apparatuses herein can be used in a sterile environment without a concern of being contaminated in the event of unsterile conditions (e.g., patient bleeds on the apparatus).

Further, by adjusting various dimensions, magnetic properties, etc., of the magnets in relation to one another, adherence and removal forces can be controlled.

Cartridge

Now referring to FIG. 9, another example cartridge 900 for a subcutaneous delivery apparatus is disclosed. The cartridge 900 can incorporate the definitions, embodiments, structures, and figures disclosed herein and can thus be combined in any combination of elements described with reference to any of the preceding figures and/or description. In this regard, not every disclosed element need be incorporated.

The cartridge 900 includes a body 902 (e.g., housing), which comprises first surface 904 such as a planar surface. The body 902 further comprises a second surface 906 that opposes the first surface 904.

Moreover, the body 902 comprises a retention member 908 on the first surface 904 that accepts a subcutaneous delivery apparatus having a length dimension (L) and limits the accepted subcutaneous delivery apparatus 910 to a fixed orientation.

Yet further, the cartridge 900 comprises a cartridge magnetic coupler 912. In various embodiments, the cartridge magnetic coupler 912 comprises a series of independent magnets that alternate polarity in a predetermined pattern such as a single row of magnets as shown in FIG. 8A.

The terminology used herein is for the purpose of describing particular embodiments only and is not intended to be limiting of the disclosure. As used herein, the singular forms "a", "an" and "the" are intended to include the plural forms as well, unless the context clearly indicates otherwise. It will be further understood that the terms "comprises" and/or "comprising," when used in this specification, specify the presence of stated features, integers, steps, operations, elements, and/or components, but do not preclude the presence or addition of one or more other features, integers, steps, operations, elements, components, and/or groups thereof.

The corresponding structures, materials, acts, and equivalents of all means or step plus function elements in the claims below are intended to include any structure, material, or act for performing the function in combination with other claimed elements as specifically claimed. The description of the present disclosure has been presented for purposes of illustration and description, but is not intended to be exhaustive or limited to the disclosure in the form disclosed. Many modifications and variations will be apparent to those of ordinary skill in the art without departing from the scope and spirit of the disclosure. Aspects of the disclosure were chosen and described in order to best explain the principles of the disclosure and the practical application, and to enable others of ordinary skill in the art to understand the disclosure for various embodiments with various modifications as are suited to the particular use contemplated.

Claims

What is claimed is: 1. A subcutaneous delivery system comprising:

a body;

an arm having a distal end and a proximal end, the arm coupled to the body about the proximal end such that the arm articulates relative to the body in at least one degree of freedom;

a track that extends along at least a portion of the arm; and

a drive magnetic coupler that traverses along the track;

wherein:

in use, the drive magnetic coupler magnetically couples to a cartridge magnetic coupler through a sterile barrier that forms a physical separation therebetween such that motion of the drive magnetic coupler along the track causes corresponding motion of the cartridge magnetic coupler across the sterile barrier.

2. The subcutaneous delivery system of claim 1, wherein:

the drive magnetic coupler generates a first set of magnetic fields that alternate polarity in a predetermined pattern.

3. The subcutaneous delivery system of claim 1, wherein:

the drive magnetic coupler comprises a first set of magnets that alternate polarity in a predetermined pattern.

4. The subcutaneous delivery system of claim 1, wherein:

the drive magnetic coupler comprises:

a receiver having a channel therethrough; and a first set of magnets aligned along a first wall of the channel such that each magnet of the first set of magnets is spaced from adjacent ones of the first set of magnets and alternate in polarity according to a first predetermined pattern; and the cartridge magnetic coupler comprises a row of magnets that alternate in polarity according to a second predetermined pattern;

when the cartridge magnetic coupler is mated with the drive magnetic coupler, the row of magnets of the cartridge magnetic coupler are received in the channel.

5. The subcutaneous delivery system of claim 4, wherein:

the drive magnetic coupler further comprises:

a second set of magnets aligned along a second wall of the channel opposite the first wall such that each magnet of the second set of magnets is spaced from adjacent ones of the second set of magnets and alternate in polarity according to a second predetermined pattern; and

when the cartridge magnetic coupler is mated with the drive magnetic coupler, the row of magnets of the cartridge magnetic coupler are magnetically biased towards a central portion of the channel between the first wall and the second wall.

6. The subcutaneous delivery system of claim 4, wherein:

the sterile barrier comprises:

a first sterile barrier that defines a wipeable barrier that is conformable into the channel between the first set of magnets of the drive magnetic coupler and the row of magnets of the cartridge magnetic coupler.

7. The subcutaneous delivery system of claim 6, wherein:

the sterile barrier further comprises:

a semi-rigid barrier between the wipeable barrier and the row of magnets of the cartridge magnetic coupler; and

a flexible barrier that couples to the semi-rigid barrier.

8. The subcutaneous delivery system of claim 1, wherein:

the magnetic coupling between the drive magnetic coupler and the cartridge magnetic coupler exhibits a larger resistance to shear forces in the direction of travel of the drive magnetic coupler along the track relative to a resistance to a pull force that is orthogonal to the sheer force.

9. A subcutaneous delivery system comprising:

an arm having a track that extends along at least a portion thereof; and

a drive magnetic coupler that traverses along the track;

wherein:

10. A cartridge comprising:

a body; and

a cartridge magnetic coupler disposed on a portion of the body;

wherein:

in use, the cartridge magnetic coupler magnetically couples to a drive magnetic coupler of a needle insertion device through a sterile barrier that forms a physical separation therebetween; and

the cartridge magnetic coupler can then magnetically follow a drive magnetic coupler that traverses along a track, of a needle insertion device.

11. A sterile barrier comprising:

a semi-rigid barrier; and

a flexible barrier that couples to the semi-rigid barrier;

wherein:

in use, the semi-rigid barrier and the flexible barrier are conformable into a channel of a track of a needle insertion device, and the semi-rigid barrier and the flexible barrier form a physical separation between a first set of magnets of a drive magnetic coupler and a row of magnets of a cartridge magnetic coupler. Accordingly, motion of the drive magnetic coupler along a track causes corresponding motion of the cartridge magnetic coupler across the sterile barrier (e.g., the sterile barrier remains in between the drive magnetic coupler and cartridge magnetic coupler).

12. The sterile barrier of claim 11 further comprising:

a rigid barrier disposed between the drive magnetic coupler and the semi-rigid barrier, wherein the rigid barrier is a deformation-resistant material.

13. A subcutaneous delivery apparatus comprising:

an articulating arm having a distal end and a proximal end, which articulates in a first degree of freedom;

a channel that extends along at least a portion of the articulating arm;

a cartridge that engages with, and travels along the channel; and

a barrier disposed between the cartridge and the track.

14. The subcutaneous delivery apparatus of claim 13, wherein:

the cartridge further comprises a magnetic coupler that comprises a first set of magnets that alternate polarity in a predetermined pattern.

15. The subcutaneous delivery system of claim 14, wherein:

the articulating arm further comprises a stage, wherein the stage comprises:

a magnetic receiver that corresponds to the magnetic coupler of the cartridge, the magnetic receiver comprising a second set of magnets having an opposing polarity of the first set of magnets.

16. The subcutaneous delivery system of claim 13, wherein the barrier comprises:

a ridged layer and a semi-rigid layer, wherein:

the rigid layer is adjacent to the articulating arm; and

the semi-rigid layer is adjacent to the cartridge.

17. The subcutaneous delivery system of claim 13 further comprising:

a track guide that is parallel to the channel, wherein the track guide engages corresponding tab guides of the cartridge.

18. The subcutaneous delivery system of claim 17, wherein the track guide is removable from the articulating arm without removing a portion of the barrier.

19. The subcutaneous delivery system of claim 13, wherein the cartridge further comprises:

a retention member accepts a subcutaneous delivery instrument and restricts the subcutaneous delivery instrument to a fixed orientation.

20. The subcutaneous delivery system of claim 13, therein the cartridge further comprises: a grasping member that exerts a clamping force or tension force on the

subcutaneous delivery instrument.