Patent ID: 12251089

DETAILED DESCRIPTION OF EXAMPLE EMBODIMENTS

Example sealant dispensing systems (e.g., sealant dispenser, hemostatic agent applicator, hemostatic matrix dispenser, etc.) herein provide improved hemostatic fluid application and dispensing features.

FIG.1illustrates an example fluid dispensing system or dispenser100, according to the present disclosure.FIG.2illustrates the example dispenser100in a configuration where the disposable probe unit160is detached from (e.g., not mounted on) the driver unit120. The dispenser100is configured to apply a sealant (e.g., a hemostatic matrix or other flowable hemostatic agent) to a surgical surface (e.g., blood vessel, etc.). The dispensing system100includes a filling syringe102, a reusable driver unit120, and a disposable probe unit160.

The filling syringe102can be used to fill and/or refill a sealant reservoir (not shown) inside the probe unit160. In specific examples, the filling syringe102can be a 5 milliliter (ml) or a 10 ml syringe. Other types of syringes are possible as well. To facilitate this, the probe unit160includes a valve176(shown inFIG.1) shaped to receive the filling syringe102. For example, the luer cap166(shown inFIG.2) can be removably disposed on the probe unit160to expose or cover an inlet or port of the valve176to which the filling syringe can be connected to transport sealant fluid into the probe unit160.

In some examples, the probe unit160is configured as a removable, detachable, and/or disposable device. For example, before or during a surgical procedure, a new disposable probe unit160can be installed on/attached to the driver unit120. Then, in this example, the disposable probe unit160can be removed and disposed of after the surgical procedure. In general, it is desirable to avoid using a same endoscopic applicator (e.g., the probe unit160) to treat multiple patients so as to avoid risks such as contamination or infection. To that end, the present disclosure provides the disposable probe unit160as a relatively low cost component that can be replaced without replacing the entire dispenser100.

FIG.3Ais a perspective view of an embodiment of the example driver unit120, according to the present disclosure.FIG.3Bis an exploded view of the example driver unit120ofFIG.3A.

In some examples, the driver unit120is configured as a reusable device that can receive, mount, and/or operate different disposable probe units similar to probe unit160. As best shown inFIG.3A, the driver unit120is shaped and configured as a hand-held device (e.g., gun shape). As such, the driver unit120(and more generally the dispenser100) can be conveniently held and operated using a single hand during a surgery and/or while performing an endoscopic application of a sealant. In the illustrated example, the driver unit120is shaped to form a handle that can be used to support/grip the driver unit120(and/or the dispenser100) with a single hand.

As shown, the driver unit120includes a display130and a trigger132. In the illustrated example, the display130is disposed at a proximal end122of the driver unit120. With this arrangement, the present disclosure advantageously allows a user to easily view information on the display130while holding the driver unit120, applying sealant on a surgical site, and/or while performing some other surgical task.

In an example, the display130is configured to display a current level and/or amount of sealant (e.g., in milliliters) currently disposed inside the probe unit160(and/or currently available for dispensing). Thus, the dispenser100of the present disclosure can advantageously assist a surgeon when evaluating whether a sufficient amount of sealant is available for adequately sealing a wound.

In an example, the display130is configured to display operation parameters of the dispenser100, such as a value of a fixed amount of sealant that will be dispensed when the trigger132detects a tactile input assigned to an automatic mode of the dispenser100. For instance, a user of the dispenser100can select a value of one milliliter as the fixed amount to be dispensed when the user taps or presses the trigger132for a short period of time (e.g., 100 milliseconds). In this example, the display130may be configured to display the selected value of one millimeter to as a convenient reminder for the user during a surgical procedure.

In an example, the display130is configured to display an identifier (e.g., a number) that identifies which specific probe unit160is currently mounted on the driver unit120. For instance, a given probe unit160can be configured to transmit a message (e.g., radio frequency identifier (RFID) code, etc.) when it is mounted on the driver unit120, and the display130can then display a value representing an identifier that identifies that particular probe unit160.

The display130may include any type of display, such as a light emitting diode (LED) display, a liquid crystal display (LCD), among others. In some examples, the display130is a touch screen display that allows a user to select, adjust, and/or set various operation parameters to control the driver unit120(and/or the dispenser100). As an example, a user can use the touch screen display130to set a value for a particular amount of sealant (e.g., 1 ml, etc.) that the dispenser100should dispense when operating in an automatic mode.

The trigger132is configured to detect a tactile input, such as a touch or press action, from a user of the dispenser100. In a specific example, the trigger132includes a silicon cover (or other cover) and a tactile switch covered by the silicon cover. The driver unit120is configured to control the probe unit160(and/or one or more components of the driver unit120) based on the tactile input detected by the trigger132. In a specific example, a force required to operate the trigger132can be relatively low (e.g., between 3 Newtons (N) and 12 N).

In an example, the driver unit120is configured to switch on or off the driver unit120(and/or the display130) in response to trigger132detecting a first type of tactile input (e.g., a long press).

In an example, the driver unit120is configured to operate the dispenser100in a priming mode in response to the trigger132detecting a second type of tactile input (e.g., a certain pattern of presses). When operating in the priming mode for instance, the driver unit120can automatically operate the probe unit160to actuate a particular amount of sealant through a cannula of the probe unit160so as to prime the cannula.

In an example, the driver unit120is configured to operate the dispenser100in an automatic mode in response to the trigger132detecting a third type of tactile input (e.g., a soft press, short press, etc.). In the automatic mode, the driver unit120causes the probe unit160to dispense a fixed amount of sealant (e.g., one milliliter, half a milliliter, etc.)

In an example, the driver unit120is configured to operate the dispenser100in a manual mode in response to the trigger132detecting a fourth type of tactile input (e.g., a continuous or long press, a hard press, etc.). In the manual mode for instance, the driver unit120may cause the probe unit to continuously dispense sealant until a user of the dispenser100stops pressing the trigger132.

Accordingly, the present disclosure advantageously enables a user of the dispenser100to conveniently and efficiently operate the dispenser100and/or dispense sealant fluid (e.g., hemostatic matrix) in a particular controlled manner with less effort as compared to traditional hemostatic agent dispensers.

As shown, the driver unit120also includes a rail134and a pusher136disposed at a top side124of the driver unit120. The rail134is configured to provide a track for receiving and/or retaining the probe unit160when the probe unit160is mounted on the driver unit120. The pusher or rack136is configured to actuate (e.g., by pushing or pulling a syringe plunger, etc.) the sealant out of the probe unit160when the trigger132is pressed by a user of the dispenser100.

As best shown inFIG.3B, the driver unit120includes a right cover126, a left cover127, a plurality of screws128, and a plurality of inserts129. During assembly, the right cover126and the left cover127are coupled (e.g., by aligning the screws128with the inserts129) to form a frame that supports the various components of the driver unit120in a particular arrangement.

The driver unit120also includes a chassis138, which can be formed from steel or other solid material. The rail134and the pusher136are disposed on a first side of the chassis138. The driver unit120also includes a motor140and a worm shaft142is disposed on another side of the chassis138opposite the side where the rail134and the pusher136are disposed. The motor140is configured to actuate the pusher136(via the worm shaft142) to move the pusher136forward or backward inside the rail or track134.

In an example, the motor140actuates the pusher136to cause the probe unit160to dispense a sealant. The amount of sealant dispensed by the probe unit160(as well as the remaining amount of sealant) can be measured using an encoder (not shown) that measures the amount of actuation by the motor140. As such, in line with the discussion above, the driver unit120can display the remaining amount of sealant in the probe unit160via the display130.

The driver unit120also includes a battery144, which can be a lithium polymer (LIPO) battery or any other battery. The battery144provides power for various components of the driver unit120(e.g., the display130, the trigger132, the motor140, etc.).

The driver unit120also includes a hall sensor146disposed adjacent to the display130at the proximal end122of the driver unit120. The hall sensor146is configured to detect a magnet (not shown) inside the probe unit160. The driver unit120is configured to detect that the probe unit160is mounted on/attached to the driver unit120based on a signal from the hall sensor146.

The driver unit120also includes circuitry148(e.g., one or more printed circuit boards (PCBs)) wired to perform the various functions and operations of the driver unit120as described above. For example, the driver unit120includes a controller150that receives and provides electrical signals to control various components of the driver unit120(e.g., the display130, the trigger132, the motor140, the hall sensor146, the battery144, etc.) and thus cause the driver unit120(and/or each of the components thereof) to operate in accordance with the description above.

In an example, the controller150receives a signal from the hall sensor146indicating that a probe unit146is mounted on the driver unit120. In response, the controller150operates a near field communication (NFC) reader (e.g., a component of the circuitry148, etc.) to communicate with an NFC tag (not shown) of the probe unit160to retrieve identification information (e.g., NFC tag identifier, etc.) from the probe unit160. The controller150then operates the display130to display an indication of the identifier of the probe unit160received from the NFC tag.

In an example, the controller150operates the trigger132, in accordance with the description of the trigger132above, and receives a signal indicating detection of a tactile input by the trigger132. Depending on the detected tactile input, the controller150then operates the motor140, in accordance with the discussion above, to actuate the pusher136thereby causing the probe unit160to dispense sealant according to one of a plurality of operation modes. The controller150may also keep track of the amount of sealant dispensed and/or remaining in the probe unit160based on a measurement (e.g., via an encoder, etc.) of the actuation caused by the motor140. The controller150may then operate the display130to update and/or display the current remaining amount of sealant inside the probe unit160. More generally, the controller150is configured to operate the various components of the driver unit120to cause the driver unit120to perform the various functions and operations described above.

In an example, the controller150includes one or more processors and a memory storing instructions that, when executed by the one or more processors, cause the driver unit120(and/or components thereof) to perform the functions and operations described above. Alternatively or additionally, the controller150includes digital and/or analog circuitry wired to cause the driver unit120(and/or components thereof) to perform the functions and operations described above.

The driver unit120also includes a universal serial bus (USB) connector152coupled to the circuitry148. The USB connector152is configured as an electrical interface between the driver unit120and an external device (e.g., battery charger, etc.). In an example, the USB connector152is configured to removably connect with a battery charger to receive power for charging the battery144. In an example, the USB connector152is configured to connect with another USB-enabled external device (e.g., computer, etc.) to communicate with and/or receive instructions from the external device. For instance, the external device can communicate with the controller150(via the USB connector152) to update software and/or firmware used to operate the driver unit120(and/or one or more components thereof).

FIG.3Cis a perspective view of a portion of the driver unit120(e.g., bottom side). As best shown inFIG.3C, the USB connector152is exposed to an external environment of the driver120when the driver unit120is assembled (i.e., when the right cover126and the left cover127are connected).

FIG.4Ais a perspective view of an example embodiment of the probe unit160.FIG.4Bis an exploded view of the probe unit ofFIG.4A. The probe unit160extends lengthwise from a proximal end162to a distal end164. The probe unit160includes a housing170and a cannula164. The housing170is configured to store a sealant (e.g., hemostatic matrix) received via a port (e.g., valve176) covered by the luer cap166.

The probe unit160also includes an identification tag168disposed at the proximal end162of the housing170/the probe unit160. The identification tag168is an electronic device that includes a data store storing identification information (e.g., a number or other identifier) and includes a wireless communication device (e.g., transponder, transceiver, etc.) configured to wirelessly transmit the identification information or identifier to the driver unit120when the probe unit160is mounted on/attached to the driver unit120. In an example, the tag168is a passive device (e.g., radio frequency identification (RFID) tag, near field communication (NFC) tag) that is powered (e.g., via induction, etc.) by a wireless signal from the driver unit120when the probe unit160is mounted on/attached to the driver unit120.

The probe unit160also includes a cannula extending away from a distal end163of the housing170to the distal end164of the probe unit160. The cannula defines a fluid channel for transporting a sealant (e.g., hemostatic agent) from the housing170and out of the cannula172(at the distal end164), so that the sealant can be dispensed and/or applied to a biological tissue.

As best shown inFIG.4B, the housing170is formed from a top cover170aand a bottom cover170b. When the probe unit160is mounted on/attached to the driver unit120, bottom cover170bis at a bottom side of the probe unit160(adjacent to the driver unit120) and the top cover170ais at a top side of the probe unit160(opposite the bottom side).

The probe unit160also includes a window174disposed on the top side of the housing170(i.e., at the top cover170a). In an example, the window174includes a transparent substrate (e.g., transparent glass) configured to allow a user to view a portion of an interior of the housing170.

The probe unit160also includes a valve176, a reservoir178, and a plunger180disposed inside the housing170(i.e., between the top cover170aand the bottom cover170b). In an example, the valve176is a dual check valve that controls flow of a sealant from the filling syringe102(shown inFIG.1) through the top side of the housing (e.g., through a port of the valve176that is covered by the luer cap166in the illustration ofFIG.4A) and into the reservoir178. Thus, when filling or refilling the probe unit160with sealant fluid, the syringe102and the reservoir178are in fluid communication via the valve176. To facilitate dispensing the sealant, the dual check valve176controls flow of the sealant from the reservoir178to the cannula172. Thus, the cannula172is in fluid communication with the reservoir178via the valve176. When assembled, the cannula172and the reservoir178are connected to the valve176.

The plunger180is configured to move the sealant out of the reservoir178(and/or into the reservoir178) in response to the plunger180being actuated by the driver unit120. To facilitate this, the plunger180includes a snap feature or connector180awhich connects the plunger180with the pusher136(shown inFIG.3B) of the driver unit120.

The probe unit160also includes a magnet182. In an example, the magnet182includes any type of permanent magnet disposed at the proximal end162of the probe unit160(e.g., adjacent to and opposite the hall sensor146of the driver unit120when the probe unit160is mounted on the driver unit120). The magnet182is configured to produce a magnetic field that is detected by the hall sensor146when the probe unit160is mounted on or attached to the driver unit120. Referring back toFIG.3Bfor example, an interaction of the magnet182with the hall sensor146enables the controller150of the driver unit120to detect that the probe unit160was attached to and/or mounted on the driver unit120.

FIG.5is a cross section view of a portion of the example dispenser100, in a configuration where the probe unit160is mounted on and/or attached to the driver unit120. As noted above (and as best shown inFIG.5), in some examples, when the probe unit160is mounted on the driver unit120, the magnet182of the probe unit160is disposed adjacent to, within a threshold distance from, and opposite the hall sensor146of the driver unit120. The hall sensor146then transmits a signal (e.g., to the controller150of the driver unit120) indicating that the probe unit160is mounted on the driver unit120. The controller150may then communicate with the tag168to receive an identifier or other identification information identifying the probe unit160. In an example, the controller150then causes the display130to display an indication of the identifier received from the tag168and/or performs the other functions and operations noted above in the description of the driver unit120.

FIG.6is a perspective view of a portion of the example dispenser100. It is noted that some of the components of the dispenser100are omitted from the illustration ofFIG.6for convenience in description.

As best shown inFIG.6, the plunger180(of the probe unit160) is connected to the pusher136(of the driver unit120) via the snap feature or connector180a.

In the illustrated example ofFIG.6, the driver unit120also includes a shaft141, a gear143, and a bearing145. For example, the gear143can be configured to transfer an actuation motion of the worm shaft142(caused by the motor140) to the pusher136by rotating about the shaft141. To facilitate this, the gear143is attached to the chassis138(the chassis shown inFIG.3B) via the bearing145.

Although not shown, in some examples, the driver unit120also includes an encoder. The encoder may be implemented as a hardware component coupled to the motor140, as a software component (e.g., executed by the controller150shown inFIG.3B), or as any other circuitry wired to perform the functions of the encoder. In an example, the encoder outputs a signal that indicates an angular position of the motor140and/or the worm shaft142. For example, the signal output from the encoder can be used by the controller150(shown inFIG.3B) to determine an amount of sealant remaining inside the reservoir178(of the probe unit16) and/or an amount of the sealant flowing out of the reservoir178. For example, the controller150can calculate, based on encoder measurements from the encoder, a volume of sealant dispensed by the probe unit160due to actuation of the plunger180by the motor140(via the worm shaft142, the gear143, the pusher136, etc.).

FIG.7is a cross section view of a portion of the example dispenser100, in a configuration where the probe unit160is mounted on/attached to the driver unit120. It is noted that some of the components of the dispenser100are omitted from the illustration ofFIG.7for convenience in description.

As best shown inFIG.7, the chassis138is shaped to support an actuation assembly (e.g., the motor140, a motor shaft139, the gear shaft141, and the gear143) in a particular arrangement. For example, the driver unit120may include a flanged bearing137configured to couple an end of the worm shaft142with the chassis138such that the chassis138retains and supports the worm shaft142while the motor140/the motor shaft139is rotating the worm shaft142. In turn, the rotation of the worm shaft142causes the gear143to rotate, which in turn causes the pusher or rack136to push (or pull) the plunger180into (or out of) the reservoir178. For example, when the pusher/rack136pushes the plunger180into the reservoir178, a sealant (not shown) in the reservoir may flow from the reservoir178to the cannula172through the valve176.

It should be appreciated that for each component with multiple or alternative embodiments, each or any of the embodiments may include the same or similar features as a previously described or a later described embodiment. Additionally, it should be appreciated that some example embodiments herein may include fewer or more components than other example embodiments. Aspects of the subject matter described herein may be useful alone or in combination with one or more other aspects described herein. To the extent that any of these aspects are mutually exclusive, it should be understood that such mutual exclusivity shall not limit in any way the combination of such aspects with any other aspect whether or not such aspect is explicitly recited. Any of these aspects may be claimed, without limitation, as a system, method, apparatus, device, medium, etc.

The many features and advantages of the present disclosure are apparent from the written description, and thus, the appended claims are intended to cover all such features and advantages of the disclosure. Further, since numerous modifications and changes will readily occur to those skilled in the art, the present disclosure is not limited to the exact construction and operation as illustrated and described. Therefore, the described embodiments should be taken as illustrative and not restrictive, and the disclosure should not be limited to the details given herein but should be defined by the following claims and their full scope of equivalents, whether foreseeable or unforeseeable now or in the future.