SYRINGE FOR DELIVERING MEDICATIONS TO IMPLANTED DRUG DELIVERY SYSTEMS AND METHODS FOR USE THEREOF

Abstract

The invention provides for ensuring proper transfer of a fluid to a medical device using a syringe by determining a position of a distal end of the needle relative to the medical device and/or a subject using a sensor. If the position of the distal end of the needle relative to a desired point of injection on a medical device and/or the subject is determined to be within predefined parameters transfer of a content of the syringe to the medical device takes place or may be inhibited by a lockout system.

Claims

1. A method of ensuring proper transfer of a fluid to a medical device using a syringe, comprising: inserting a distal end of a needle of a syringe into a medical device; determining a position of a distal end of the needle relative to a fluid receiving area of the medical device using a sensor; and determining if the position of the distal end of the needle relative to the medical device is within predefined parameters relative to the fluid receiving area.

2. The method of claim 1, further comprising: inhibiting transfer of fluid from the syringe to the medical device if the position of the distal end of the needle relative to the medical device is not within the predefined parameters relative to the fluid receiving area.

3. The method of claim 1, further comprising: allowing transfer of fluid from the swinge to the medical device if the position of the distal end of the needle relative to the medical device is within the predefined parameters relative to the fluid receiving area.

4. The method of claim 1, further comprising: continuously determining, during use, if the position of the distal end of the needle relative to the medical device is within predefined parameters; inhibiting transfer of fluid from the syringe to the medical device if the position of the distal end of the needle is within predefined parameters; and resuming transfer of fluid from the syringe to the medical device if the position of the distal end of the needle relative to the medical device is within the predefined parameters.

5. The method of claim 1, wherein inhibiting fluid flow out of the syringe to the medical device comprises physically inhibiting movement of a plunger in the syringe.

6. The method of claim 1, wherein the medical device comprises a container, and wherein the contents of the syringe are transferrable to the container while the medical device is implemented in a patient.

7. The method of claim 1, wherein determining a position of a distal end of the needle further comprises determining electrical resistance to a current applied to at least a portion of the needle.

8. The method of claim 7, wherein the electrical resistance is determined based on electrical signals received from electrodes associated with the syringe.

9. The method of claim 8, wherein three sets of electrodes are associated with the syringe.

10. The method of claim 9, wherein a first set of electrodes is positionable in a subject's tissue, a second set of electrodes is positionable in a container of the medical device, and a third set of electrodes are positionable in a septum of the medical device.

11. The method of claim 8, wherein determining a position of a distal end of the needle further comprises determining a resistance to electrical current applied to at least a portion of the needle using at least two sets of electrodes associated with the syringe, and further comprising identifying a first substance a first set of electrodes is positioned in during use based on a first determined resistance and identifying a second substance a second set of electrodes is positioned in during use based on a second determined resistance.

12. The method of claim 1, wherein the medical device comprises an implanted device at least partially positioned in the subject and further comprising sending and/or receiving at least one packet of electronic information to and/or from the implanted device using an electronic communications system associated with the syringe.

13. The method of claim 1, further comprising transferring at least one packet of electronic information between the medical device and a control system using an electronic communications system associated with the syringe.

14. The method of claim 1, wherein the medical device comprises an implanted device at least partially positioned in the subject and further comprising ending and/or receiving at least one packet of electronic information to and/or from the implanted device using one or more electrodes associated with the syringe.

15. The method of claim 1, wherein determining a position of a distal end of the needle further comprises emitting short ultrasonic pulses from at least a portion of the needle.

16. The method of claim 1, wherein determining a position of a distal end of the needle further comprises emitting short ultrasonic pulses from at least a portion of the needle using an ultrasonic transducer associated with the syringe.

17. The method of claim 1, further comprising: determining a relative amount of material in a container of the medical device using an ultrasonic transducer associated with the syringe.

18. The method of claim 1, wherein the syringe comprises at least one electrode and at least one ultrasonic transducer associated with the syringe.

19. A method of ensuring proper injection of a patient using a syringe, comprising: inserting a distal end of a needle of a syringe into a patient; determining a position of a distal end of the needle relative to a desired injection point using an electronic sensor; and injecting fluid from the syringe into the patient when the sensor indicates that the distal end of the needle has reached the desired injection point.

20. A syringe system, comprising: a tubular body open at its proximal end and opening to a hollow needle at the distal end; an electrical sensor positioned on the needle; a signal detector for receiving and interpreting signals from the sensor.

Description

BRIEF DESCRIPTION OF THE DRAWINGS

[0031] The invention is best understood from the following detailed description when read in conjunction with the accompanying drawings. It is emphasized that, according to common practice, the various features of the drawings are not to-scale. On the contrary, the dimensions of the various features are arbitrarily expanded or reduced for clarity. Included in the drawings are the following figures:

[0032] FIG. 1 depicts an embodiment of a smart needle device and pre-filled syringe being used to refill an implanted drug pump placed in the abdomen of a patient.

[0033] FIG. 2 depicts an embodiment of the proposed smart needle system attached to a syringe. The smart needle system contains a battery, microprocessor, and valve.

[0034] FIG. 3 depicts an embodiment of the proposed smart needle system connected to a separate system containing the electronics to drive the electrical contacts on the smart needle.

[0035] FIG. 4 depicts an embodiment of the proposed smart needle system inserted into an implantable pump.

[0036] FIG. 5 depicts an embodiment of a smart needle device used with an external infusion pump and an ommaya reservoir electrically coupled wirelessly.

[0037] FIG. 6 depicts an embodiment of a smart needle device used with an external infusion pump and an ommaya reservoir.

[0038] FIG. 7 depicts an embodiment of a representation of a smart acoustic syringe

[0039] FIG. 8 depicts an embodiment of a representation of a smart acoustic syringe.

[0040] FIG. 9 depicts an embodiment of a detail of the needle tip of the smart acoustic needle.

[0041] FIG. 10 depicts an embodiment of a flow chart of the method of use of the smart needle system with an implantable pump.

[0042] FIG. 11 depicts an embodiment of a flow chart of the method of use of the smart needle system with an external infusion pump.

[0043] FIG. 12 depicts an embodiment of a flow chart of the method of use of the smart needle system with an ultrasonic transducer at the tip.

[0044] While the invention is susceptible to various modifications and alternative forms, specific embodiments thereof are shown by way of example in the drawings and may herein be described in detail. The drawings may not be to scale. It should be understood, however, that the drawings and detailed description thereto are not intended to limit the invention to the particular form disclosed, but on the contrary, the intention is to cover all modifications, equivalents and alternatives falling within the spirit and scope of the present invention as defined by the appended claims.

[0045] The headings used herein are for organizational purposes only and are not meant to be used to limit the scope of the description. As used throughout this application, the word may is used in a permissive sense (i.e., meaning having the potential to), rather than the mandatory sense (i.e., meaning must). The words include, including, and includes indicate open-ended relationships and therefore mean including, but not limited to. Similarly, the words have, having, and has also indicated open-ended relationships, and thus mean having, but not limited to. The terms first, second, third, and so forth as used herein are used as labels for nouns that they precede, and do not imply any type of ordering (e.g., spatial, temporal, logical, etc.) unless such an ordering is otherwise explicitly indicated. For example, a third die electrically connected to the module substrate does not preclude scenarios in which a fourth die electrically connected to the module substrate is connected prior to the third die, unless otherwise specified. Similarly, a second feature does not require that a first feature be implemented prior to the second feature, unless otherwise specified.

[0046] Various components may be described as configured to perform a task or tasks. In such contexts, configured to is a broad recitation generally meaning having structure that performs the task or tasks during operation. As such, the component can be configured to perform the task even when the component is not currently performing that task (e.g., a set of electrical conductors may be configured to electrically connect a module to another module, even when the two modules are not connected). In some contexts, configured to may be a broad recitation of structure generally meaning having circuitry that performs the task or tasks during operation. As such, the component can be configured to perform the task even when the component is not currently on. In general, the circuitry that forms the structure corresponding to configured to may include hardware circuits.

[0047] Various components may be described as performing a task or tasks, for convenience in the description. Such descriptions should be interpreted as including the phrase configured to. Reciting a component that is configured to perform one or more tasks is expressly intended not to invoke 35 U.S.C. 112 paragraph (f), interpretation for that component.

[0048] The scope of the present disclosure includes any feature or combination of features disclosed herein (either explicitly or implicitly), or any generalization thereof, whether or not it any or all of the problems addressed herein. Accordingly, new claims may be formulated during prosecution of this application (or an application claiming priority thereto) to any such combination of features. In particular with reference to the appended claims, features from dependent claims may be combined with those of the independent claims and features from respective independent claims may be combined in any appropriate manner and not merely in the specific combinations enumerated in the appended claims.

[0049] It is to be understood the present invention is not limited to particular devices or biological systems, which may, of course, vary. It is also to be understood that the terminology used herein is for the purpose of describing particular embodiments only and is not intended to be limiting. As used in this specification and the appended claims, the singular forms a, an, and the include singular and plural referents unless the content clearly dictates otherwise. Thus, for example, reference to a linker includes one or more linkers.

DETAILED DESCRIPTION OF THE INVENTION

[0050] Before the present device, system and methodology are described, it is to be understood that this invention is not limited to particular embodiment described, as such may, of course, vary. It is also to be understood that the terminology used herein is for the purpose of describing particular embodiments only, and is not intended to be limiting, since the scope of the present invention will be limited only by the appended claims.

[0051] Where a range of values is provided, it is understood that each intervening value, to the tenth of the unit of the lower limit unless the context clearly dictates otherwise, between the upper and lower limits of that range is also specifically disclosed. Each smaller range between any stated value or intervening value in a stated range and any other stated or intervening value in that stated range is encompassed within the invention. The upper and lower limits of these smaller ranges may independently be included or excluded in the range, and each range where either, neither or both limits are included in the smaller ranges is also encompassed within the invention, subject to any specifically excluded limit in the stated range. Where the stated range includes one or both of the limits, ranges excluding either or both of those included limits are also included in the invention.

[0052] Unless defined otherwise, all technical and scientific terms used herein have the same meaning as commonly understood by one of ordinary skill in the art to which this invention belongs. Although any methods and materials similar or equivalent to those described herein can be used in the practice or testing of the present invention, some potential and preferred methods and materials are now described. All publications mentioned herein are incorporated herein by reference to disclose and describe the methods and/or materials in connection with which the publications are cited. It is understood that the present disclosure supercedes any disclosure of an incorporated publication to the extent there is a contradiction.

[0053] It must be noted that as used herein and in the appended claims, the singular forms a, an, and the include plural referents unless the context clearly dictates otherwise. Thus, for example, reference to a needle includes a plurality of such needles and reference to the predefined parameter includes reference to one or more parameters and equivalents thereof known to those skilled in the art, and so forth.

[0054] The publications discussed herein are provided solely for their disclosure prior to the filing date of the present application. Nothing herein is to be construed as an admission that the present invention is not entitled to antedate such publication by virtue of prior invention. Further, the dates of publication provided may be different from the actual publication dates which may need to be independently confirmed.

Definitions

[0055] Unless defined otherwise, all technical and scientific terms used herein have the same meaning as commonly understood by one of ordinary skill in the art.

[0056] The term catheter as used herein generally refers to medical devices that can be inserted in the body to treat diseases or perform a surgical procedure.

[0057] The term connected as used herein generally refers to pieces which may be joined or linked together.

[0058] The term coupled as used herein generally refers to pieces which may be used operatively with each other, or joined or linked together, with or without one or more intervening members.

[0059] The term directly as used herein generally refers to one structure in physical contact with another structure, or, when used in reference to a procedure, means that one process effects another process or structure without the involvement of an intermediate step or component.

[0060] The present disclosure relates to a smart needle device that can sense when it is properly positioned into an implanted access port in a pump or port using a sensor that is integrated into the refill tool. FIG. 1 depicts an embodiment of a smart needle device 100 and pre-filled syringe 110 being used to refill an implanted drug pump 120 placed in the abdomen of a patient 130. The implanted drug pump can be connected to a catheter line to deliver drugs to the spinal region, the brain, or other regions in the body. In some embodiments, the smart needle device includes a lockout system to prevent injection of medication unless the refill needle is properly positioned in the access port. In some embodiments, the smart needle device may be used in combination with an existing syringe.

[0061] In some embodiments, the smart needle device may be used as part of a pre-filled syringe. In some embodiments, the smart needle device may be used with an external infusion pump. The smart needle device may include a single-use device or may be reusable (e.g., may be sterilized using standards known in the industry) and used for multiple refills with different syringes. A lockout device may prevent medication injection. The lockout device may continuously detect that the needle is properly placed into the implanted device/port during medication injection. This feature may be especially beneficial for long and slow infusions, such as when the needle device must be placed in the port for tens of minutes to several hours. The smart needle device can thus block medication injection if the needle is displaced or moved during infusion. FIG. 2 depicts an embodiment of the proposed smart needle system 100 attached to a syringe 110. The smart needle system 100 may include a battery 140, microprocessor 150, and valve 160. The system may be able to deliver low voltage signals to the electrodes on the needle tip and to measure the electrical impedance. By the electrical impedance, the microprocessor can open the micro valve and the practitioner can refill the implanted device. FIG. 3 depicts an embodiment of the proposed smart needle system 100 connected to a separate system 170 containing the electronics to drive the electrical contacts on the smart needle. All of these features, which are beneficial and substantially differentiate from that described previously, are described in detail in the text and figures herein.

[0062] In one embodiment of the device, a needle with electrodes on the outside allows for sensing of the position of the syringe as it is being inserted into an implanted drug port. FIG. 4 depicts an embodiment of the proposed smart needle system 100 inserted into an implantable pump 120. The needle first penetrates the skin and up to several centimeters of body tissue 180 before entering a septum 190 in the center of the implanted pump. Once properly inserted through the septum, the electrodes 200 on the needle tip can sense that they are properly placed within the device and can allow for refill of the device. To operate the device, each pair of electrodes may be connected to a small continuous voltage signal that is safe for the patient (e.g. <1 V).

[0063] By monitoring the current and calculating the impedance when the voltage signal is applied, the system can calculate the resistance. Low values of resistance correspond to the needle's initial insertion into the body (which is conductive), the insertion through the septum (where both electrodes are insulated and no current will pass, thus the resistance will be very high), and finally, the placement of the needle in a proper orientation inside the drug reservoir.

[0064] The voltage signal can be either a continuous low voltage signal or may be a time-varying voltage signal such as a frequency-dependent voltage signal so that a complex impedance is calculated at varying frequency components. FIG. 5 depicts an embodiment of a smart needle device 100 used with an external infusion pump 210 and a reservoir 220 (e.g., an ommaya reservoir) electrically coupled wirelessly. The smart needle device detects when it is properly placed in the reservoir of the subject 130 and opens up the microvalve to allow drug to pass from the external infusion pump to the reservoir. The smart needle may further communicate with the external infusion pump through RFID or other means to notify the pump that infusion of drug can begin.

[0065] FIG. 6 depicts an embodiment of a smart needle device 100 used with an external infusion pump 210 and a reservoir 220. The smart needle device detects when it is properly placed in the reservoir and opens up the microvalve to allow drug to pass from the external infusion pump to the ommaya. The smart needle may be driven by electronics contained in the external infusion pump. The needle connects to the external pump through a separate electrical cable 230.

[0066] The needle may have, for example, three different sets of electrodes on the needle tip so that when the needle is properly placed, one set is in the tissues of the body, one set is in the septum, and the third set is in the drug reservoir. By validating that each of these electrodes has an impedance within a specified range, the user can be certain that the needle is properly positioned. Furthermore, the electrodes at the needle tip, which are inserted into the drug reservoir, may measure if the reservoir is full or empty and could further monitor the level of drug.

[0067] In some embodiments, small electrodes are formed on the tip of a needle in various ways. For an implantable pump system, a 22 gauge needle is typically used for refill of the device. Electrodes, for example in gold or silver, may be patterned on the outside of the needle by using various materials and techniques that are common in the semiconductor industry. Furthermore, since very low voltages will be used, the insulating materials may be very thin (-microns). Thus, by using alternating layers of biocompatible insulating materials such as parylene and copper/gold electrical tracks, multiple electrical contacts may be patterned on the outside of the needle connection device. The tracks used for the electrical transmission of the voltage signals may be very thin (<100 urn) since low voltage signals are used. The outer circumference of a 22 gauge needle is 2 mm, giving space for 10 or more potential tracks for electrical signals on the outer circumference. In some embodiments, electrodes may be formed using alternating insulating/conducting tubes on the interior of the needle.

[0068] In some embodiments, electrodes on the needle may be used to send information to the implanted device. For example, in the case of opiates, the smart needle/syringe may send information to the pump that corresponds to the drug and that can provide for tracking of the medication to ensure that it was properly used for refill of the pump instead of diverted for uses. The interface between the syringe and needle contains electronics that can send low voltage signals to the electrical contacts and that can process them with a microprocessor or the electronics in the hub can be passive and the power supply and other electronics may be located in an external base unit.

[0069] FIG. 10 depicts an embodiment of the method of use of the smart needle system 100 with an implantable pump 120. The user activates the smart needle device prior to insertion in the patient (1002). Activation of the device begins stimulation of the electrical contacts (1004) on the needle tip and measurements of the electrical impedances (1006), which are processed by the microprocessor (1008). When the correct values of impedances are measured, the system activates the micro valve at the needle tip (1010) to allow the user to inject the drug into the device (1012).

[0070] FIG. 11 depicts an embodiment of the method of use of the smart needle system 100 with an external infusion pump 210. The user activates (1102) the smart needle device prior to insertion in the patient. Activation of the device begins stimulation of the electrical contacts on the needle tip (1104) and measurements of the electrical impedances (1106), which are processed by the microprocessor (1108). When the correct values of impedances are measured, the system activates the micro valve at the needle tip (1110) to allow the user to inject the drug into the device (1112). The smart needle may further communicate with the external infusion pump through RFID, direct electrical connection, or other means to notify the pump that injection of drug can proceed.

[0071] In some embodiments, the needle tip contains an ultrasonic transducer. FIGS. 7-8 depict embodiments of a representation of a smart acoustic syringe 100. In some embodiments, an ultrasound element 240 is embedded in the tip or toward the end of the needle and sends and receives ultrasonic pulses 250. Electronics for the system re contained in a separate module coupled through a separate electrical cable 230. FIG. 8 depicts an embodiment of a representation of the smart acoustic syringe 100. Electronics for the system are contained in an external infusion pump 210 coupled through a separate electrical cable 230.

[0072] The device may contain only an ultrasonic transducer or may also contain some embodiment of the electrodes described above and have multiple sensing modalities. In some embodiments, the transducer may include a piezoceramic, piezocomposite, capacitive micromachined ultrasound transducer (CMUT), Polyvinylidene fluoride (PVDF), or other material for sending acoustic signals in response to a voltage stimulus. In some embodiments, the ultrasound transducer may include a ring transducer with a hole in the center that is excited along its thickness mode. FIG. 9 depicts an embodiment of a detail of the needle tip 100a of the smart acoustic needle 100. The acoustic transducer 260 is a circular disk that is embedded in the needle tip. The disk operates at a frequency several times larger than the size of the disk so that the ultrasound energy emanating from the tip is directional. With this configuration, the drug may be injected through the center of the transducer. If a small, 0.7 mm diameter needle or similar size is used, he transducer may include a high frequency ultrasound transducer at a working frequency of 1-20 MHz (preferable 10 MHz) so that the transducer acts as a directional piston source. For example, a transducer in piezoceramic would have a thickness of 200 microns at 10 MHz if it was excited in its thickness mode. In some embodiments, while the electronics for driving the element may be separate from the needle/hub assembly, there may be a small pre-amplifier located in the needle hub that is powered by external electronics. The electronics to the element may include a pulser/receiver or other mode of sending short ultrasound waves at high frequencies (e.g., 10 MHz) and receiving them.

[0073] In some embodiments, when the device sends out short ultrasonic pulses, the ultrasound element may detect when it is in a free tissue space or facing an object that is acoustically reflective. By probing the region around the implantable pump or other device, the location of the septum may be determined. The device may be used to orient the needle tip at 90 degrees to the pump surface to avoid oblique insertion through the pump septum. For example, if the septum material allows for transmission of some of the ultrasonic wave, multiple reflections within the septum may be detected when the transducer is facing the septum material.

[0074] Alternatively, the septum may act as a perfect absorber of ultrasound energy and no reflection may appear when the needle tip is perpendicular to the septum surface. When the transducer is inserted into the septum, the received signal may diminish or disappear (and electrical impedance of the ultrasound element may change) and it will further change once the element is through the septum and inside the pump reservoir or inside the housing of the catheter. Furthermore, the transducer may be used to measure the amount of residual drug in the reservoir by measuring the time of flight of a sent pulse and knowing the sound speed of the drug.

[0075] FIG. 12 depicts an embodiment of the method of use of the smart needle system 100 with an ultrasonic transducer at the tip. The user activates the smart needle device prior to insertion in the patient (1202). Activation of the device begins stimulation of the ultrasound on the needle tip (1204) and measurements of its electrical impedance, which are processed by the microprocessor (1206). When the device correctly senses that it has been inserted through the septum and into the port, it will allow for the user to refill the device (1208). The smart needle may further communicate with the external infusion pump through RFID, direct electrical connection, or other means to notify the pump that injection of drug can proceed.

[0076] In some embodiments, the proposed device may also consist of a combination of electrical sensors/contacts and acoustic elements and/or be used in combination with other sensors.

[0077] In some embodiments, the interface may contain additional electronics including wireless electronic communication devices (e.g., RFID or Bluetooth). For example, RFID may be used to communicate with the implanted pump system. For example, Bluetooth or another means of electronic transmission can be used to communicate with an external device such as a smartphone. The smartphone may include software for displaying information from the device.

[0078] In some embodiments, the hub may contain a lockout mechanism that prevents the drug from exiting the needle tip if certain criteria are not defined. This lockout mechanism may include a microvalve near the needle tip that does not allow for injection of medications unless the microprocessor/controller validates that the needle/syringe is properly inserted into the correct port in the implanted drug delivery device. These valves may include, for example, solenoid microvalves such as those made by Takasago (http://www.takasago-fluidics.com/pdf/catalog/FVseries.pdf), or may consist of alternative designs such as those listed by Kwang et aL 2006 [A Review ofMicrovalves, J. Micromech. Microeng. 16 (2006) R13-R39] which is incorporated by reference.

[0079] In some embodiments, a security measure may exist within the hub/syringe interface.

[0080] If the smart needle hub is used with a pre-filled syringe, an anti-tamper mechanism may exist in the hub. The anti-tamper mechanism may alter the drug making the drug not useable (e.g., for recreational use). This anti-tamper mechanism may consist of a dye, an emetic drug, or other substance that is released if the user tries to tamper with the needle/hub mechanism.

[0081] In some embodiments, the proposed smart needle may include a single-use device that can be used with a normal syringe full of medication. It can also be part of a pre-filled syringe device.

[0082] In some embodiments, the device may include indicators that notify the user when the device is ready for injection of the drug. These indicators may include colored LEDs, sound, or 20 other indicator that will notify the user when the smart needle is properly inserted into the septum.

[0083] In some embodiments, the device may interact with an external controller through RFID, Bluetooth, or another form of radiofrequency communication. This information may be communicated to another device to indicate the drug information such as: drug type, manufacturer, serial number, concentration, date of re-fill. The smart needle may also communicate directly with the implanted pump system to communicate the drug information so that the pump can store this information for later retrieval. In this patent, certain U.S. patents, U.S. patent applications, and other materials (e.g., articles) have been incorporated by reference. The text of such U.S. patents, U.S. patent applications, and other materials is, however, only incorporated by reference to the extent that no conflict exists between such text and the other statements and drawings set forth herein. In the of such conflict, then any such conflicting text in such incorporated by reference U.S. patents, U.S. patent applications, and other materials is specifically not incorporated by reference in this patent.

[0084] The preceding merely illustrates the principles of the invention. It will be appreciated that those skilled in the art will be able to devise various arrangements which, although not explicitly described or shown herein, embody the principles of the invention and are included within its spirit and scope. Furthermore, all examples and conditional language recited herein are principally intended to aid the reader in understanding the principles of the invention and the concepts contributed by the inventors to furthering the art and are to be construed as being without limitation to such specifically recited examples and conditions. Moreover, all statements herein reciting principles, aspects, and embodiments of the invention as well as specific examples thereof, are intended to encompass both structural and functional equivalents thereof. Additionally, it is intended that such equivalents include both currently known equivalents and equivalents developed in the future, i.e., any elements developed that perform the same function, regardless of structure. The scope of the present invention, therefore, is not intended to be limited to the exemplary embodiments shown and described herein. Rather, the scope and spirit of present invention is embodied by the appended claims.