DEVICE, SYSTEM, AND METHOD OF VENOUS ACCESS

A catheter deployment device including a housing; and a panel coupled to the housing. The panel extends from the housing at an angle and the panel includes an aperture. The deployment device further includes a deployment assembly coupled to the housing. The deployment assembly is aligned with the aperture along an insertion axis.

BACKGROUND

Central venous access is a common medical procedure where catheters are placed in a vein of a patient. Central venous access is a form of venous access, more generally, that focuses on the placement of catheters in centrally located veins and is typical used as a more reliable vascular access for prolonged intravenous therapies or critically ill patients.

Conventional central venous access procedures follow the Seldinger technique, which is generally illustrated in FIG. 1. SeeAn Introduction to Clinical Emergency Medicine, Cambridge University Press, 2012. However, conventional procedures have a considerable rate of variation in terms of complication rates. For example, one review described an overall complication rate with conventional central venous access procedures of 15 percent. The rate of mechanical or procedure-related complications, is mainly operator dependent. Published rates of cannulation success and complications vary according to the anatomic site, the use of ultrasound guidance, and operator experience. Mechanical complications can occur in up to 33 percent of cannulation attempts with inexperienced operators. Examples of mechanical complications include bleeding, arterial puncture, arrhythmia, air embolism, thoracic duct injury, nerve injury, catheter malposition, and pneumothorax or hemothorax.

SUMMARY

The present disclosure provides in one aspect, a deployment device including a housing and a panel coupled to the housing. The panel extends from the housing at an angle and the panel includes an aperture. The deployment device further includes a deployment assembly coupled to the housing. The deployment assembly is aligned with the aperture along an insertion axis.

In some embodiments, the deployment device further includes an actuator configured to move a portion of the deployment assembly relative to the housing.

In some embodiments, the actuator is configured to move the portion along the insertion axis.

In some embodiments, the actuator is configured to move the portion along a transverse axis that intersects the insertion axis.

In some embodiments, the transverse axis is perpendicular to the insertion axis.

In some embodiments, the actuator is a first actuator and the portion is a first portion, and wherein the device further includes a second actuator configured to move a second portion of the deployment assembly along a transverse axis that is perpendicular to the insertion axis.

In some embodiments, the actuator is a first actuator and the portion is a first portion, and wherein the device further includes a second actuator configured to move a second portion of the deployment assembly relative to the housing.

In some embodiments, the actuator is an electric motor and the device further includes a power supply positioned within the housing.

In some embodiments, the housing includes a surface with an opening, and wherein the panel extends from the surface and the opening is aligned with the aperture.

In some embodiments, the angle is within a range of 30 degree to 90 degrees.

In some embodiments, the angle is 90 degrees.

In some embodiments, the deployment assembly is a peripheral venous access deployment module.

In some embodiments, the deployment assembly is a central venous access deployment module.

In some embodiments, the central venous access deployment module includes a needle, a dilator, a guidewire, and a catheter.

In some embodiments, the central venous access deployment module includes a retractable knife.

In some embodiments, the deployment device further includes a processor and a memory, wherein the memory includes instructions that when executed by the processor position the catheter within a vein of a patient.

In some embodiments, the deployment assembly is a first deployment assembly and the first deployment assembly is removable from the housing and replaceable with a second deployment assembly.

In some embodiments, the actuator is coupled to the deployment assembly by a detachable interface.

In some embodiments, the deployment device further includes an ultrasound module coupled to the panel.

In some embodiments, the deployment device further includes a handle coupled to the housing.

The present disclosure provides, in one aspect, an assembly including a base with a frame and a carrier movable with respect to the frame. The assembly further includes a guidewire extending along an insertion axis and movable with respect to the frame along the insertion axis. The assembly further includes a needle module coupled to the carrier, and a catheter movable with respect to the frame along the insertion axis.

In some embodiments, the needle module is movable with the carrier, and movable with respect to the carrier along the insertion axis.

In some embodiments, the needle module includes a slide, a needle coupled to the slide, an actuator, and a transmission positioned between the actuator and the slide, and wherein the actuator is activated to move the needle along the insertion axis.

In some embodiments, the actuator is activated to move the needle relative to the carrier along the insertion axis.

In some embodiments, the needle module further includes a cover movable between a closed configuration and an open configuration.

In some embodiments, the assembly further includes a cover actuator coupled to the cover, wherein the cover actuator is activated to move the cover between the closed configuration and the open configuration.

In some embodiments, the needle includes a slot. The cover is spaced from the slot when the needle is in the open configuration.

In some embodiments, the carriage moves relative to the frame in a direction transverse to the insertion axis.

In some embodiments, the needle module includes a knife movable along the insertion axis.

In some embodiments, the knife is movable with respect to the guidewire.

In some embodiments, the needle module further includes a dilator.

In some embodiments, the dilator is movable with respect to the guidewire along the insertion axis.

In some embodiments, the needle module includes a needle, a dilator, and a knife.

In some embodiments, the needle is independently movable with respect to the dilator and the knife, and the knife is independently movable with respect to the needle and the dilator.

In some embodiments, the needle is at least partially positioned within the dilator, and the knife is at least partially positioned within the dilator.

In some embodiments, the dilator includes a dilator slot aligned with a slot formed in the needle.

In some embodiments, the assembly further includes a guidewire drive, wherein actuation of the guidewire drive moves the guidewire along the insertion axis.

In some embodiments, the assembly further includes a catheter drive, wherein actuation of the catheter drive moves the catheter along the insertion axis.

In some embodiments, the assembly further includes a second carrier movable with respect to the frame along the insertion axis. The guidewire drive and the catheter drive are coupled to the second carrier.

In some embodiments, the guidewire is positioned within the catheter.

The present disclosure provides in one aspect, a device including a cylindrical member with a cylindrical wall extending along a longitudinal axis. A slot is formed in the cylindrical wall and the slot extends along the longitudinal axis. The device further includes a blocking member movable with respect to the cylindrical member between a closed configuration in which the slot is blocked by the blocking member and an open configuration in which the slot is open to the longitudinal axis.

In some embodiments, the cylindrical member is a first cylindrical member and the cylindrical wall is a first cylindrical wall. The blocking member is a second cylindrical member with a second cylindrical wall extending along the longitudinal axis.

In some embodiments, the second cylindrical wall is positioned within the first cylindrical wall.

In some embodiments, the slot is a first slot and the second cylindrical member includes a second slot. The first slot and the second slot are aligned in the open configuration, and the first slot and the second slot are misaligned in the closed configuration.

In some embodiments, the first cylindrical wall includes a first outer surface and a first inner surface, and the first slot extends between the first outer surface and the first inner surface. The second cylindrical wall includes a second outer surface and a second inner surface, and the second slot extends between the second outer surface and the second inner surface.

In some embodiments, the first inner surface is positioned between the first outer surface and the second outer surface.

In some embodiments, the second cylindrical member includes an actuator radially extending from the second cylindrical wall.

In some embodiments, the actuator extends through an aperture formed in the first cylindrical wall.

In some embodiments, the device further includes a handle coupled to an end of the first cylindrical member, and the actuator extends through the handle.

In some embodiments, the handle includes a handle slot aligned with the first slot.

In some embodiments, the device further includes a biasing member positioned between the first cylindrical member and the second cylindrical member. The biasing member biases the second cylindrical member toward the closed configuration.

In some embodiments, a first end of the biasing member abuts a stop formed on the first cylindrical member, and a second end of the biasing member abuts a radial wall of the second cylindrical member.

In some embodiments, the device further includes a biasing member positioned between the cylindrical member and the blocking member. The biasing member biases the blocking member toward the closed configuration.

In some embodiments, the first cylindrical member includes a support hub coupled to the second cylindrical member.

In some embodiments, the support hub includes a radial portion extending radially inward from the first cylindrical wall and a bearing portion.

In some embodiments, the radial portion extends through the second cylindrical wall.

In some embodiments, the device is a needle.

In some embodiments, the cylindrical member includes a beveled distal end.

In some embodiments, the device is a dilator.

In some embodiments, the cylindrical member includes a conical distal end.

In some embodiments, the device in the open configuration is configured to radially receive a guidewire through the slot.

DETAILED DESCRIPTION

“About” and “approximately” are used to provide flexibility to a numerical range endpoint by providing that a given value may be “slightly above” or “slightly below” the endpoint without affecting the desired result.

The use herein of the terms “including,” “comprising,” or “having,” and variations thereof, is meant to encompass the elements listed thereafter and equivalents thereof as well as additional elements. As used herein, “and/or” refers to and encompasses any and all possible combinations of one or more of the associated listed items, as well as the lack of combinations when interpreted in the alternative (“or”).

Moreover, the present disclosure also contemplates that in some embodiments, any feature or combination of features set forth herein can be excluded or omitted. To illustrate, if the specification states that an apparatus comprises components A, B, and C, it is specifically intended that any of A, B or C, or a combination thereof, can be omitted and disclaimed singularly or in any combination.

Recitation of ranges of values herein are merely intended to serve as a shorthand method of referring individually to each separate value falling within the range, unless otherwise indicated herein, and each separate value is incorporated into the specification as if it were individually recited herein. For example, if a concentration range is stated as 1% to 50%, it is intended that values such as 2% to 40%, 10% to 30%, or 1% to 3%, etc., are expressly enumerated in this specification. These are only examples of what is specifically intended, and all possible combinations of numerical values between and including the lowest value and the highest value enumerated are to be considered to be expressly stated in this disclosure.

According to one aspect of the present disclosure, a universal deployment device utilizes single-use replaceable deployment assemblies to provide a handheld, battery-powered device that automates central venous access (CVA).

With reference toFIGS.2and3, a deployment device10(i.e., a universal deployment device) is illustrated with a housing14and a panel18coupled to the housing14. The housing14includes a surface22with a first aperture26formed therein. The panel18includes a second aperture30and the panel18extends from the surface22of the housing14at an angle34. In some embodiments, the angle34is within a range of approximately 30 degrees to approximately 50 degrees. In some embodiments, the angle34is approximately 40 degrees. In some embodiments, an ultrasound module38is coupled to the panel18and is utilized to aid positioning of the deployment device10relative to a patient.

In some embodiments, the deployment device10includes a handle42coupled to the housing14. In the illustrated embodiment, the handle14extends from a lower surface46of the housing14. As such, the deployment device10can be considered a hand-held device. In some embodiments, user-activated controls50(FIG.4) are positioned on the handle42. In some embodiments, user-activated controls54(FIG.2) are positioned on a top surface58of the housing14. In the illustrated embodiment, the top surface58is positioned opposite from the lower surface46.

With continued reference toFIGS.2and3, the deployment device10further includes a deployment assembly62coupled to the housing14. In the illustrated embodiment, the deployment assembly62is received within a cutout66formed in the housing14. In the illustrated embodiment, the cutout66is positioned closer to the front surface22than to a rear surface70of the housing14. The deployment assembly62is aligned with the first aperture26and the second aperture30along an insertion axis74(FIG.6). In other words, the insertion axis74passes through the first aperture26, the second aperture30, and the deployment assembly62(FIG.4). As described in greater detail herein, the deployment device10includes an actuator81configured to move a portion of the deployment assembly62relative to the housing14.

With reference toFIG.5, the deployment device10includes a plurality of actuators81,82,83,84,85,86,87,88,89, and90. In some embodiments, the plurality of actuators81-90are configured to move various portions of the deployment assembly62. In the illustrated embodiment, the deployment device10includes ten actuators81-90. In some embodiments, the plurality of actuators81-90is a plurality of electric motors. As explained in greater detail herein, the plurality of actuators81-90is configured to move various portions of the deployment assembly62relative to the housing14. In the illustrated embodiment, the actuator81is configured move a portion of the deployment assembly10along the insertion axis74, whereas the actuators82and83are configured to move portions of the deployment assembly72along a transverse axis (e.g., carrier axis198, carrier axis250) that intersects the insertion axis74. In some embodiments, the transverse axis is perpendicular to the insertion axis74. The housing14includes at least one slot92formed therein. In the illustrated embodiments, a portion of the deployment assembly62is movable relative to the housing14within the slot98.

The deployment assembly62is removable from the housing14and is replaceable with another, different deployment assembly. In the illustrated embodiment, the deployment assembly62is removably coupled to the cutout66in the housing14. In some embodiments, the deployment assembly62is a single-use assembly intended for use in a single procedure. As explained in greater detail herein, a detachable interface102couples the actuators81-90to the removable deployment assembly62. For example, the detachable interface102includes a groove106formed in the actuator81and a drive shaft106in the deployment assembly62at least partially positioned within the groove106. In the illustrated embodiment, the detachable interface102is a key in slot removable rotational coupling.

In some embodiments, the deployment device10is configured to receive different types of deployment assemblies. In some embodiments, the deployment assembly62is a peripheral venous access deployment module. In some embodiments, the deployment assembly62is a central venous access deployment module. In some embodiments, the deployment assembly62is a spinal or epidural anesthesia deployment module. In other words, the same deployment device10can be utilized for deployment assemblies tailored to a variety of medical procedures. As such, in some embodiments, the deployment assembly62is a first deployment assembly and the first deployment assembly is removable from the housing14by a user and replaceable with a second deployment assembly. In some embodiments, the first deployment assembly is used with a first medical procedure and the second deployment assembly is used with a second medical procedure.

With reference toFIG.5, the deployment device10includes a power supply106, a processor110, and a memory114positioned within the housing14. In some embodiments, the power supply106is a removable and rechargeable battery pack. In other embodiments, the power supply106includes a corded AC power cord. In the illustrated embodiment, the power supply106is electrically coupled to the processor110and at least one of the actuators81-90, and the memory114is electrically coupled to the processor110.

The processor110(e.g., a microprocessor, a microcontroller, a processing unit, or other suitable programmable device) can include, among other things, a control unit, an arithmetic logic unit (“ALC”), and a plurality of registers, and can be implemented using a known computer architecture (e.g., a modified Harvard architecture, a von Neumann architecture, etc.). In some embodiments the processor110is a microprocessor that can be configured to communicate in a stand-alone and/or a distributed environment, and can be configured to communicate via wired or wireless communications with other processors, where such one or more processor can be configured to operate on one or more processor-controlled devices that can be similar or different devices.

In some embodiments, the memory114is any memory storage and is a non-transitory computer readable medium. The memory can include, for example, a program storage area and the data storage area. The program storage area and the data storage area can include combinations of different types of memory, such as a ROM, a RAM (e.g., DRAM, SDRAM, etc.), EEPROM, flash memory, a hard disk, a SD card, or other suitable magnetic, optical, physical, or electronic memory devices.

The processor110can be connected to the memory114and execute software instructions that are capable of being stored in a RAM of the memory (e.g., during execution), a ROM of the memory (e.g., on a generally permanent bases), or another non-transitory computer readable medium such as another memory or a disc. In some embodiments, the memory114includes one or more processor-readable and accessible memory elements and/or components that can be internal to the processor-controlled device, external to the processor-controlled device, and can be accessed via a wired or wireless network. Software included in the implementation of the methods disclosed herein can be stored in the memory. The software includes, for example, firmware, one or more applications, program data, filters, rules, one or more program modules, and other executable instructions. For example, the processor110can be configured to retrieve from the memory and execute, among other things, instructions related to the processes and methods described herein. For example, in some embodiments, the memory114includes instructions that when executed by the processor110, activate at least one of the actuators81-90to automatically provide central venous access in a patient (e.g., to position a catheter within a vein of a patient).

The description now turns to the details of the deployment assembly62, illustrated as a central venous access deployment assembly. With reference toFIGS.7A-7G, the deployment assembly62includes a base module118, a guidewire122, a needle module126, a dilator module130, and a catheter134. The guidewire122extends along the insertion axis74and is movable with respect to the base module118along the insertion axis74. Likewise, the catheter134is movable with respect to the base module118along the insertion axis74. In particular, the guidewire122and the catheter134move with respect to a base plate138of the base module118along the insertion axis74. In some embodiments, a portion of the guidewire122is positioned underneath the base plate138. In particular, a portion of the guidewire122is positioned within a storage chamber142formed in the base plate138.

With reference toFIGS.9and10, the base module118includes the base plate138, a first carrier146(e.g., a needle carrier) movable with respect to the base plate138, and a second carrier150(e.g., a dilator carrier) movable with respect to the base plate138. In the illustrated embodiment, the first carrier146is coupled to the needle module126and the second carrier150is coupled to the dilator module130. In some embodiments, the needle module126is movable with the first carrier146and the dilator module130is movable with the second carrier150.

With reference toFIGS.11-14, the needle module126includes a first slide154, a second slide158separable from the first slide154, a needle162coupled to the first slide154, and a rack166coupled to the first slide154. A transmission170is positioned between the actuator81and the rack166. In the illustrated embodiment, the transmission170is removably coupled to the actuator81by the detachable interface102. In the illustrated embodiment, the actuator81is activated to move the needle162(and the slides154,158) along the insertion axis74. In some embodiments, the needle module126is movable with respect to the needle carrier146along the insertion axis74. During operation, the needle module126is driven forward along the insertion axis74(i.e., fromFIG.7AtoFIG.7B) and then the needle module126is driven backwards along the insertion axis74(i.e., fromFIG.7BtoFIG.7C).

With continued reference toFIGS.11-14, the needle162is movable between a closed configuration (FIG.11) and an open configuration (FIG.14). A transmission174is positioned between the actuator84and the needle162. In the illustrated embodiment, the transmission174is coupled to the second slide158. The actuator84is activated to move the needle162between the closed configuration in which the needle162is not laterally separable from the guidewire122and the open configuration in which the needle162is laterally separable from the guidewire122. With reference toFIG.13, the transmission174in the illustrated embodiment includes a bevel gear set178A,178B and a spur gear set182A,182B. The spur gear set182A,182B includes a first gear182A positioned on the first slide154and a second gear182B positioned on the second slide158. In the illustrated embodiment, at least a portion of the needle162is rotatably coupled to the first gear182A. With reference toFIG.13, the first gear182A includes a slot186through which the guidewire122is permitted to move.

As explained in greater detail herein, the needle162is initially positioned around the guidewire122in the closed configuration (throughFIGS.7A-7C). When the needle162is moved to the open configuration (FIG.7D) and the needle162is able to move laterally with respect to the guidewire122and the insertion axis74. In this way, the needle162is advantageously quickly removed from the insertion axis162after use to permit other modules (e.g., the dilator module130) to move along the insertion axis74.

With reference toFIG.9, the first carrier146includes a first mount190(i.e., a first carrier portion) coupled to the first slide154and a second mount194(i.e., a second carrier portion) coupled to the second slide158. The first mount190and the second mount194are movable along a carrier axis198(i.e., a transverse axis) between a first configuration (FIG.7C) with the first slide154and the second slide158of the needle module126coupled together and a second configuration (FIG.7D) with the first slide154separated from the second slide158. In other words, in the first configuration (FIG.7C) the mounts190,194are positioned together and in the second configuration (FIG.7D) the mounts190,194are spaced apart. In the illustrated embodiment, the first gear182A and the second gear182B are enmeshed when the mounts190,194are in the first configuration. The needle162is aligned with the insertion axis74when the first mount190and the second mount194are in the first configuration (FIG.7C) and the needle162is separated from the insertion axis74when the first mount190and the second mount194are in the second configuration (FIG.7D). In some embodiments, the insertion axis74is positioned between the mounts190,194when in the second configuration. In some embodiments, the carrier axis198is transverse to the insertion axis74. In some embodiments, the carrier axis198is perpendicular to the insertion axis74. In the illustrated embodiment, the first slide154is movable with respect to the first mount190along the insertion axis74(seeFIG.7B) and the first slide154is movable with the first mount190along the carrier axis198(seeFIG.7D).

With continued reference toFIGS.11-14, the first slide154includes a groove202through which the guidewire122is allowed to pass as the first slide154moves along the carrier axis198to the second configuration. The guidewire122is positioned within the groove202(FIGS.11and12) when the first mount190and the second mount194are in the first configuration. The guidewire122is spaced from the groove202(FIG.14) when the first mount190and the second mount194are in the second configuration and the slides154,158are spaced apart.

Advantageously, moving the needle laterally with respect to the insertion axis allows the needle to be removed more quickly. After a needle is used in conventional processes, the needle is backed up the entire length of the guidewire to remove the needle from the guidewire. When the guidewire length is long, it is difficult for a single operator to remove the needle from the entire length of guidewire. Some conventional processes therefore need more than one operator to remove a needle from a long guidewire.

Guidewires are used to guide other vascular tools into vessels during vascular procedures, for example. The guidewires vary in dimensions and can have a diameter within a range of approximately 0.014 inches to approximately 0.038 inches and a length within a range of approximately 20 inches to approximately 102 inches. The conventional Seldinger technique for central venous access relies upon the sequential exchange of several vascular tools (e.g., a needle, a dilator, etc.) over the guidewire. The sequential exchange of tools creates challenges and disadvantages for the conventional process. The first disadvantage of the conventional manual central venous access procedure is with threading the vascular tools onto the guidewire. Several attempts may be needed before the operator is successful in manually threading the tool onto the guidewire. The second disadvantage of the conventional manual central venous access procedure is that any exchanged tool needs to pass along the entire length of the guidewire, starting from the distal end and moving toward the patient. Because the guidewires can be long, exchanging tools on the guidewire can require assistance from another operator during the procedure. For example, the surgeon will stand near the proximal end of the guidewire while an assistant stands at the distal end, and the assistant inserts the tool from the distal end and slides the tool over the guidewire until the surgeon receives it at the proximal end for the intended use. After use of the tool is complete, the surgeon then returns the tool to the assistant in the reverse direction. Operation time for the conventional process is longer because to use a vascular tool it must be threaded onto the guidewire and passed along the entire length of the guidewire. Likewise, to remove a vascular tool from the guidewire, it must pass along the entire length of the guidewire again, in reverse. As such, the process of exchanging the tools from the guidewire in the conventional procedure increases the operating time, creates potential hazards for injury, tool slippage, kinking, and other complications.

With reference toFIGS.15-17, the dilator module130includes a first slide206, a second slide210, a dilator214coupled to the first slide206, and a rack218coupled to the first slide206. A transmission222is positioned between the actuator85and the rack218. In the illustrated embodiment, the transmission222is removably coupled to the actuator85by the detachable interface102. In the illustrated embodiment, the actuator85is activated to move the dilator214(and the slides206,210) along the insertion axis74. In some embodiments, the dilator module130is movable with respect to the dilator carrier150along the insertion axis74. During operation, the dilator module130is driven forward along the insertion axis74(i.e., fromFIG.7DtoFIG.7E) and then the dilator module130is driven backwards along the insertion axis74(i.e., fromFIG.7EtoFIG.7F).

With continued reference toFIGS.15-17, the dilator214is movable between a closed configuration (FIG.15) and an open configuration (FIG.17). A transmission226is positioned between the actuator88and the dilator214. In the illustrated embodiment, the transmission226is coupled to the second slide210. The actuator88is activated to move the dilator214between the closed configuration in which the dilator214is not laterally separable from the guidewire122and the open configuration in which the dilator214is laterally separable from the guidewire122. With reference toFIG.16, the transmission226in the illustrated embodiment includes a bevel gear set230A,230B and a spur gear set234A,234B. The spur gear set234A,234B includes a first gear234A positioned on the first slide206and a second gear234B positioned on the second slide210. In the illustrated embodiment, at least a portion of the dilator214is rotatably coupled to the first gear234A. With reference toFIG.13, the first gear234A includes a slot238through which the guidewire122is permitted to move.

In the illustrated embodiment, the first carrier146is a needle carrier, and the second carrier150is a dilator carrier. Similar to the first carrier146, the second carrier150is movable with respect to the base plate138and the dilator module130is coupled to the second carrier150. In some embodiments, the dilator module130is movable with respect to the second carrier150along the insertion axis74. The second carrier150includes a first mount242coupled to the first slide206and a second mount246coupled to the second slide210. The first mount242and the second mount246are movable along a dilator carrier axis250(i.e., a transverse axis) between a first configuration (FIG.7F) with the first slide206and the second slide210of the dilator module130coupled together and a second configuration (FIG.7G) with the first slide206separated from the second slide210. In other words, in the first configuration (FIG.7F) the mounts242,246are positioned together and in the second configuration (FIG.7G) the mounts242,246are spaced apart. In the illustrated embodiment, the first gear234A and the second gear234B are enmeshed when the mounts242,246are in the first configuration. The dilator214is aligned with the insertion axis74when the first mount242and the second mount246are in the first configuration (FIG.7F) and the dilator214is separated from the insertion axis74when the first mount242and the second mount246are in the second configuration (FIG.7G). In some embodiments, the insertion axis74is positioned between the mounts242,246when in the second configuration. In some embodiments, the dilator carrier axis250is transverse to the insertion axis74. In some embodiments, the dilator carrier axis250is perpendicular to the insertion axis74. In some embodiments, the dilator carrier axis250is parallel to the needle carrier axis198. In the illustrated embodiment, the first slide206is movable with respect to the first mount242along the insertion axis74(seeFIG.7E) and the first slide206is movable with the first mount242along the carrier axis250(seeFIG.7G).

With continued reference toFIGS.15-17, the first slide206includes a groove254through which the guidewire122is allowed to pass as the first slide206moves along the dilator carrier axis250to the second configuration. The guidewire122is positioned within the groove254(FIGS.15and16) when the first mount242and the second mount246are in the first configuration. The guidewire122is spaced from the groove254(FIG.17) when the first mount242and the second mount246are in the second configuration and the slides206,210are spaced apart.

With reference toFIGS.7A-7G, the deployment assembly62includes a guidewire drive wheel258that is removably coupled to the actuator89. In the illustrated embodiment, the guidewire122is positioned between the drive wheel258and an idler wheel262. In the illustrated embodiment, the base plate138is positioned between the guidewire drive wheel258and the insertion axis74. In other words, the guidewire drive wheel258(and the actuator89) is positioned beneath the base plate138, and the insertion axis74is above the base plate138in the illustrated embodiment. Actuation of the guidewire drive wheel258by the actuator89moves the guidewire122along the insertion axis74. In the illustrated embodiment, the guidewire122can be moved along the insertion axis74by the guidewire drive wheel258in both directions. As such, the guidewire actuator89is controlled to automatically position the guidewire122appropriately for the medical procedure being performed.

With reference toFIG.8, the deployment assembly62includes a catheter drive wheel266that is removably coupled to the actuator90. In the illustrated embodiment, the catheter134is positioned between the drive wheel266and an idler wheel270. Actuation of the catheter drive wheel266by the actuator90moves the catheter134along the insertion axis74. In the illustrated embodiment, the catheter134can be moved along the insertion axis74by the catheter drive wheel266in both directions. In the illustrated embodiment, the guidewire122is positioned within the catheter134and the guidewire122and the catheter134are independently movable. As such, the catheter actuator90is controlled to automatically position the catheter134appropriately for the medical procedure being performed.

In operation of the illustrated embodiment, the deployment assembly62is inserted into the cutout66of the deployment device10, and the deployment device10is positioned with respect to a patient. At this initial starting point, the guidewire122is threaded inside the needle162, the dilator214, and the catheter134and the modules126,130are in the starting positions shown inFIG.7A. Next, the needle module126and the guidewire122move forward along the insertion axis74toward a blood vessel of a patient (FIG.7B). Then, the needle module126and the guidewire122stop after entering the blood vessel. Next, the needle module126is moved backwards along the insertion axis74back to the starting position (FIG.7C). At this point, the catheter134is still in the starting position. Next, the needle module126moves to an open configuration and splits into two parts, moving to the sides along the needle carrier axis198(FIG.7D). The guidewire122and the catheter134remains in position as the needle module126separates. Next, the dilator module130moves forward along the insertion axis74and enters the blood vessel (FIG.7E). Next, the dilator module130is moved backwards along the insertion axis74bask to the starting position (FIG.7F). At this point, the catheter134is still in the starting position. Next, the dilator module130moves to an open configuration and splits into two parts, moving to the sides along the dilator carrier axis250(FIG.7G). Next, the catheter134is moved forward over the guide wire122along the insertion axis74until the catheter134is inserted into the blood vessel. The drive wheel266moves the catheter134relative to the guidewire122. Next, the guidewire122is retracted from the blood vessel as the catheter134remains in position. The drive wheel138moves the guidewire122relative to the catheter134. At this point, the catheter134is inserted in the blood vessel and the device10can be removed and the deployment assembly62discarded. As such, the disclosure provides a method of automatically performing a medical procedure, for example, a central venous access catheter placement. As such, the deployment device10reduces the operating time required to obtain central venous access.

In some embodiments, a system includes the deployment device10and any number of deployment assemblies62configured for use with the deployment device10. In some embodiments, each of the deployment assemblies is configured for a different medical procedure. In some embodiments, deployment assemblies are single use whereas the deployment device10is reusable.

The present disclosure provides in one aspect, a deployment device including a housing with a surface having a first aperture and a panel coupled to the housing. The panel extends from the surface at an angle and the panel includes a second aperture. The deployment device further includes a deployment assembly coupled to the housing. The deployment assembly is aligned with the first aperture and the second aperture along an insertion axis.

In some embodiments, an actuator is configured to move a portion of the deployment assembly relative to the housing. In some embodiments, the actuator is configured to move the portion along the insertion axis. In some embodiments, the actuator is configured to move the portion along a transverse axis that intersects the insertion axis. In some embodiments, the transverse axis is perpendicular to the insertion axis.

In some embodiments, the actuator is a first actuator and the portion a first portion, and wherein the device further includes a second actuator configured to move a second portion of the deployment assembly along a transverse axis that is perpendicular to the insertion axis.

In some embodiments, the actuator is a first actuator and the portion a first portion, and wherein the device further includes a second actuator configured to move a second portion of the deployment assembly relative to the housing.

In some embodiments, the actuator is an electric motor and the device further includes a power supply positioned within the housing.

In some embodiments, the housing includes a slot, wherein a portion of the deployment assembly is movable relative to the housing within the slot.

In some embodiments, the angle is within a range of 30 degree to 50 degrees. In some embodiments, the angle is 40 degrees.

In some embodiments, the deployment assembly is a peripheral venous access deployment module. In some embodiments, the deployment assembly is a central venous access deployment module. In some embodiments, the central venous access deployment module includes a needle, a dilator, a guidewire, and a catheter.

In some embodiments, the deployment device includes a processor and a memory, wherein the memory includes instructions that when executed by the processor position the catheter within a vein of a patient.

In some embodiments, the deployment assembly is a first deployment assembly and the first deployment assembly is removable from the housing and replaceable with a second deployment assembly. In some embodiments, the actuator is coupled to the deployment assembly by a detachable interface. In some embodiments, the detachable interface includes a groove formed in the actuator and a drive shaft in the deployment assembly at least partially positioned within the groove.

In some embodiments, the deployment device further includes an ultrasound module coupled to the panel. In some embodiments, the deployment device further includes a handle coupled to the housing.

The present disclosure provides in one aspect, an assembly including a base module with a base plate and a carrier movable with respect to the base plate. The assembly further includes a guidewire extending along an insertion axis and movable with respect to the base plate along the insertion axis. The assembly further includes a needle module coupled to the carrier, and a catheter movable with respect to the base plate along the insertion axis.

In some embodiments, the needle module is movable with the carrier, and movable with respect to the carrier along the insertion axis. In some embodiments, the needle module includes a slide, a needle coupled to the slide, and a rack coupled to the slide.

In some embodiments, the assembly further includes an actuator and a transmission positioned between the actuator and the rack, and wherein the actuator is activated to move the needle along the insertion axis.

In some embodiments, the needle is movable between a closed configuration and an open configuration. In some embodiments, the assembly further includes an actuator and a transmission positioned between the actuator and the needle, wherein the actuator is activated to move the needle between the closed configuration and the open configuration. In some embodiments, the needle includes an outer cylindrical member with a first slot and an inner cylindrical member with a second slot, and wherein the first slot and the second slot are aligned when the needle is in the open configuration.

In some embodiments, the slide includes a first slide and a second slide separable from the first slide, and wherein the needle is coupled to the first slide and the transmission is coupled to the second slide. In some embodiments, the carrier includes a first carrier portion coupled to the first slide and a second carrier portion coupled to the second slide, wherein the first carrier portion and the second carrier portion are movable along a carrier axis between a first configuration with the first slide and the second slide coupled together and a second configuration with the first slide separated from the second slide. In some embodiments, the carrier axis is transverse to the insertion axis.

In some embodiments, the needle includes an outer cylindrical member and an inner cylindrical member positioned within the outer cylindrical member. The outer cylindrical member and the inner cylindrical member are aligned with the insertion axis when the first carrier portion and the second carrier portion are in the first configuration, and the outer cylindrical member and the inner cylindrical member are separated from the insertion axis when the first carrier portion and the second carrier portion are in the second configuration.

In some embodiments, the outer cylindrical member includes a first slot and the inner cylindrical member includes a second slot, and wherein the first slot and the second slot are aligned when the needle is in the open configuration. In some embodiments, the first slide includes a groove and wherein the guidewire is positioned within the groove when the first carrier portion and the second carrier portion are in the first configuration.

In some embodiments, the carrier is a needle carrier, and the assembly further includes a dilator carrier movable with respect to the base plate and a dilator module coupled to the dilator carrier. In some embodiments, the dilator carrier defines a dilator carrier axis and the dilator module is movable along the insertion axis and movable along the dilator carrier axis. In some embodiments, the dilator module includes a dilator with an outer cylindrical member and an inner cylindrical member positioned within the outer cylindrical member. The dilator is movable between a closed configuration and an open configuration.

In some embodiments, the assembly further includes a guidewire drive wheel.

Actuation of the guidewire drive wheel moves the guidewire along the insertion axis. In some embodiments, the base plate is positioned between the guidewire drive wheel and the insertion axis. In some embodiments, the assembly further includes a catheter drive wheel. Actuation of the catheter drive wheel moves the catheter along the insertion axis. In some embodiments, the guidewire is positioned within the catheter.

With reference toFIG.18, a needle300is illustrated as a stand-alone device. The needle300is similar to the needle162described in relation to the needle module126and details herein apply to both the needle300and the needle162. The needle300includes a cylindrical member304, a handle308coupled to a proximal end312of the cylindrical member304, and a blocking member316movable with respect to the cylindrical member304between a closed configuration and an open configuration.

The cylindrical member304includes a cylindrical wall320extending along a longitudinal axis324. In the illustrated embodiment, the cylindrical member304includes a beveled distal end328. A first slot332is formed in the cylindrical wall320and the first slot332extends along the longitudinal axis324. In the closed configuration, the first slot332is blocked by the blocking member316and in the open configuration the first slot332is open to the longitudinal axis324. In other words, the needle300can be positioned around a guidewire (e.g., the guidewire122) in the open configuration and the needle300is secured around the guidewire in the closed configuration. Similar to the needle162of deployment assembly62, the needle300is advantageously laterally positioned around the guidewire as opposed to threading the needle300along the length of the guidewire.

With reference toFIGS.20A-20C, in the illustrated embodiment, the cylindrical member304is a first cylindrical member and the cylindrical wall320is a first cylindrical wall, and the blocking member316is a second cylindrical member with a second cylindrical wall336extending along the longitudinal axis324. In the illustrated embodiment, the two cylindrical members304,316of the needle300are concentric. In some embodiments, the blocking member316is any suitable shape to at least partially block the slot332in the first cylindrical member304.

In the illustrated embodiment, the second cylindrical wall336is positioned within the first cylindrical wall320. The second cylindrical member316includes a second slot340. In the illustrated embodiment, the needle300includes an outer cylindrical member304with a first slot332and an inner cylindrical member316with a second slot340. The first cylindrical wall320includes a first outer surface344and a first inner surface348. The first slot332extends between the first outer surface344and the first inner surface348. The second cylindrical wall336includes a second outer surface352and a second inner surface356. In the illustrated embodiment, the second slot340extends between the second outer surface352and the second inner surface356. In the illustrated embodiment, the first inner surface348is positioned radially between the first outer surface344and the second outer surface352.

The first slot332and the second slot340are aligned in the open configuration of the needle300(FIGS.20B,20C) and the first slot332and the second slot340are misaligned in the closed configuration of the needle300(FIG.20A). In other words, a portion of the second slot340overlaps the first slot332in the open configuration, and a portion of the cylindrical wall336overlaps the first slot332in the closed configuration. The handle308includes a handle slot310aligned with the first slot332of the first cylindrical member304.

With continued reference toFIG.18, the needle300includes an actuator360. In the illustrated embodiment, the actuator360is integrally formed with the second cylindrical member316and the actuator360radially extends from the second cylindrical wall336. The actuator360extends through an aperture364formed in the first cylindrical wall320. In the illustrated embodiment, the actuator360extends through the handle308and is graspable and actuated by a user.

With reference toFIG.20A, the needle300includes a biasing member368positioned between the first cylindrical member304and the second cylindrical member316. The biasing member368biases the second cylindrical member316toward the closed configuration. In other words, the biasing member368is positioned between the first cylindrical member304and the blocking member316and biases the blocking member316toward the closed configuration. In the illustrated embodiment, the biasing member368is a coil spring. In other embodiments, the biasing member368is a torsion spring or other suitable biasing element. A first end372of the biasing member368abuts a stop376formed on the first cylindrical member304, and a second end380of the biasing member368abuts a radial wall384of the second cylindrical member316. In the illustrated embodiment, the radial wall384at least partially defines the second slot340.

With reference toFIGS.20A-20C, the first cylindrical member304includes a support hub388. In the illustrated embodiment, the support hub388is slidably coupled to the second cylindrical member316. The support hub388includes a radial portion392extending radially inward from the first cylindrical wall320and a bearing portion396. The radial portion392extends through the second cylindrical wall336. In the illustrated embodiment, the bearing portion396includes a cylindrical wall400with a slot404. The bearing portion396rotatably supports the second cylindrical member316to permit the second cylindrical member316to rotate about the axis324with respect to the first cylindrical member304.

With reference toFIG.19, a dilator408is illustrated as a stand-alone device. The dilator408is similar to the needle300ofFIG.18and description relating to the structure and operation of the needle300apply similarly to the dilator408. In addition, the dilator408is similar to the dilator214described in relation to the dilator module130and details herein apply to both the dilator408and the dilator214.

The dilator408includes a cylindrical member412, a handle416coupled to a proximal end420of the cylindrical member412, and a blocking member424movable with respect to the cylindrical member412between a closed configuration and an open configuration. In the illustrated embodiment, an actuator422moves the blocking member424. The cylindrical member412includes a cylindrical wall428extending along a longitudinal axis432. In the illustrated embodiment, the cylindrical member412includes a conical distal end436. A first slot440is formed in the cylindrical wall428and the first slot440extends along the longitudinal axis432. In the closed configuration, the first slot440is blocked by the blocking member424and in the open configuration the first slot440is open to the longitudinal axis432. In other words, the dilator408can be positioned around a guidewire (e.g., the guidewire122) in the open configuration and the dilator408is secured around the guidewire in the closed configuration. Similar to the dilator214, the dilator408is advantageously laterally positioned around the guidewire as opposed to threading the dilator408along the length of the guidewire.

In operation, with reference toFIGS.20A-20C, in the illustrated embodiment, the needle300is biased to the closed configuration (FIG.20A) by the biasing member368. In the closed configuration, the guidewire122is secured within the needle300. The actuator360is actuated by a user to move the needle300to the open configuration (FIG.20B). Specifically, the actuator360rotates the inner cylindrical member316about the longitudinal axis324with respect to the outer cylindrical member304against the bias of biasing member368. In the open configuration, the needle300is configured to radially receive the guidewire122through the slots332,340. Likewise, in the open configuration, the needle300is configured to be laterally separate from the guidewire122though the slots332,340. With reference toFIG.21, advantageous operation of the needle ofFIG.18is shown compared to operation of a conventional needle. With reference toFIG.22, advantageous operation of the dilator ofFIG.19is shown compared to operation of a conventional dilator.

The present disclosure provides in one aspect, a device including a cylindrical member with a cylindrical wall extending along a longitudinal axis. A slot is formed in the cylindrical wall and the slot extends along the longitudinal axis. The device further includes a blocking member movable with respect to the cylindrical member between a closed configuration in which the slot is blocked by the blocking member and an open configuration in which the slot is open to the longitudinal axis.

In some embodiments, the cylindrical member is a first cylindrical member and the cylindrical wall is a first cylindrical wall. The blocking member is a second cylindrical member with a second cylindrical wall extending along the longitudinal axis. In some embodiments, the second cylindrical wall is positioned within the first cylindrical wall.

In some embodiments, the slot is a first slot and the second cylindrical member includes a second slot. The first slot and the second slot are aligned in the open configuration, and the first slot and the second slot are misaligned in the closed configuration.

In some embodiments, the first cylindrical wall includes a first outer surface and a first inner surface, and the first slot extends between the first outer surface and the first inner surface. The second cylindrical wall includes a second outer surface and a second inner surface, and the second slot extends between the second outer surface and the second inner surface. In some embodiments, the first inner surface is positioned between the first outer surface and the second outer surface. In some embodiments, the second cylindrical member includes an actuator radially extending from the second cylindrical wall. In some embodiments, the actuator extends through an aperture formed in the first cylindrical wall.

In some embodiments, the device further includes a handle coupled to an end of the first cylindrical member, and the actuator extends through the handle. In some embodiments, the handle includes a handle slot aligned with the first slot.

In some embodiments, the device further includes a biasing member positioned between the first cylindrical member and the second cylindrical member. The biasing member biases the second cylindrical member toward the closed configuration. In some embodiments, a first end of the biasing member abuts a stop formed on the first cylindrical member, and a second end of the biasing member abuts a radial wall of the second cylindrical member.

In some embodiments, the device further includes a biasing member positioned between the cylindrical member and the blocking member. The biasing member biases the blocking member toward the closed configuration. In some embodiments, the first cylindrical member includes a support hub coupled to the second cylindrical member.

In some embodiments, the support hub includes a radial portion extending radially inward from the first cylindrical wall and a bearing portion. In some embodiments, the radial portion extends through the second cylindrical wall.

In some embodiments, the device is a needle. In some embodiments, the cylindrical member includes a beveled distal end. In some embodiments, the device is a dilator. In some embodiments, the cylindrical member includes a conical distal end. In some embodiments, the device in the open configuration is configured to radially receive a guidewire through the slot.

With reference toFIG.23, a deployment device510including a deployment assembly514is illustrated. The deployment device510includes a housing518and a panel522coupled to the housing518. The panel522includes an aperture526that is aligned with an insertion axis530. The deployment assembly514is removably coupled to the housing518. The deployment assembly514is aligned with the aperture526along the insertion axis530.

With reference toFIG.25, the panel522extends from the housing518at an angle534. In some embodiments, the angle534is within a range of approximately 30 degrees to approximately 90 degrees. In the illustrated embodiment, the angle534is approximately 90 degrees.

With reference toFIGS.24and25, the deployment device510includes an actuator (e.g., actuator606) configured to move a portion of the deployment assembly514relative to the housing518. In some embodiments, the actuator is configured to move the portion along the insertion axis530. In other embodiments, the actuator is configured to move the portion along a transverse axis that intersects the insertion axis530. In some embodiments, the transverse axis is perpendicular to the insertion axis530. In some embodiments, the actuator is one of a plurality of actuators. In some embodiments, the actuator is a first actuator and the portion is a first portion, and the deployment device510further includes a second actuator (e.g., actuator565) configured to move a second portion of the deployment assembly514along a transverse axis that is perpendicular to the insertion axis530. In some embodiments, a second actuator is configured to move a second portion of the deployment assembly relative to the housing518. In some embodiments, the actuator is an electric motor and the deployment device510further includes a power supply positioned within the housing. In some embodiments, the actuator is coupled to the deployment assembly by a detachable interface (e.g., a tongue and groove configuration).

With reference toFIG.23, the housing518includes a surface538(e.g., a front surface) with an opening542. The panel522extends from the surface538and the opening542is aligned with the aperture526. In other words, the insertion axis530extends through the aperture526and the opening542. In the illustrated embodiment, an ultrasound module546is coupled to the panel522. In the illustrated embodiment, the device510further includes a handle550coupled to the housing518.

In some embodiments, the deployment assembly514is a peripheral venous access deployment module. In other embodiments, the deployment assembly514is a central venous access deployment module. The deployment assembly514is a first deployment assembly and is removable from the housing518and replaceable with a second deployment assembly. In other words, the deployment assembly is replaceable. In some embodiments, at least some portions of the deployment assembly are single use disposable components.

With reference toFIG.24, the deployment assembly514includes a base554with a frame558and a carrier562movable with respect to the frame558. The deployment assembly514further includes a guidewire566extending along the insertion axis530and movable with respect to the frame558along the insertion axis530. The deployment device510includes a needle module570coupled to the carrier562, and a catheter574movable with respect to the frame558along the insertion axis530. The needle module570is movable with the carrier562, and movable with respect to the carrier562along the insertion axis530. In the illustrated embodiment, the needle module570is mounted on the carrier562and portions of the needle module570are movable independent of the carrier562.

With reference toFIG.26, the needle module570includes a needle578, a dilator582, and a knife586. In the illustrated embodiment, the needle578and the knife586are at least partially positioned within the dilator582. With reference toFIGS.27and28, the needle module570further includes a knife drive assembly590coupled to the knife586, and a needle drive assembly594coupled to the needle578. In the illustrated embodiment, the knife586and the needle578are independently movable along the insertion axis530with respect to the dilator582. In some embodiment, the knife586and the needle578are independently movable with respect to the guidewire566. In the illustrated embodiment, the knife586is a retractable knife. The needle578is independently movable with respect to the dilator582and the knife586by activation of the needle drive assembly594. Likewise, the knife586is independently movable with respect to the needle578and the dilator582by activation of the knife drive assembly590.

With reference toFIG.24, the needle module570includes a slide598and the needle578, the dilator582, and the knife586are coupled to the slide598. A transmission602positioned between an actuator606and the slide598is configured to move the slide598along the insertion axis530. In the illustrated embodiment, the actuator606is activated to move the slide598, the needle578, the dilator582, and the knife586along the insertion axis530. In other words, the actuator606is activated to move the needle module570relative to the carrier562along the insertion axis530. As detailed herein, the carriage562, and the needle module570coupled to the carriage562, moves relative to the frame558in a direction564transverse to the insertion axis530. Activation of an actuator565moves the carriage562in the transverse direction564. In the illustrated embodiment, the carriage562and the needle module570move perpendicular to the insertion axis530after operation with the needle module570is complete (FIG.32F).

With reference toFIGS.26-28, the needle module570further includes a cover610movable between a closed configuration and an open configuration. With reference toFIG.26, the needle module570further includes a cover actuator614coupled to the cover610. The cover actuator614is activated to move the cover610between the closed configuration and the open configuration. In the illustrated embodiment, the cover actuator614includes a rack portion618engaged with teeth622formed on the cover610to cause the cover610to rotate about the insertion axis530. The needle578includes a needle slot626and the dilator582includes a dilator slot630. The dilator slot630is aligned with the needle slot626. In the open configuration, the cover610is spaced from the needle slot626and the dilator slot630. In other words, the cover610does not block the slots626,630in the open configuration. In the closed configuration, the cover610is positioned to block slots626,630, which prevents the guidewire566from moving through the slots626,630.

With reference toFIG.29, the catheter574is position on a support634with a passageway638that receives the guidewire566. In the illustrated embodiment, the guidewire566is positioned within the catheter574. With reference toFIG.30, the base554further includes a second carrier642movable with respect to the frame558along the insertion axis530. With reference toFIG.31, a guidewire drive assembly646and a catheter drive assembly650are mounted on to the second carrier642. The guidewire drive assembly646is configured to move the guidewire566along the insertion axis530, and the catheter drive assembly650is configured to move the catheter574along the insertion axis530. Actuation of the guidewire drive assembly646moves the guidewire566along the insertion axis530with respect to the frame558. Likewise, actuation of the catheter drive assembly650moves the catheter574and the catheter support634along the insertion axis530with respect to the frame558.

With reference toFIGS.32A-32G, operation of the deployment device510is illustrated.FIG.32Aillustrates positioning the deployment device510with respect to a patient.FIG.32Billustrates the needle578being inserted into the vein.FIG.32Cillustrates the guidewire566being inserted into the vein.FIG.32Dillustrates the knife586cutting the skin.FIG.32Eillustrates the dilator582being inserted into through the cut skin.FIG.32Fillustrates the needle module570moving from the closed configuration to the open configuration.FIG.32Falso illustrates the needle module570moving on the carrier562to the side, away from the insertion axis530, once the needle module570is in the open configuration.FIG.32Gillustrates the catheter574being inserted into the vein over the guidewire566. As detailed herein, the deployment device includes a processor and a memory. The memory includes instructions that when executed by the processor, position the catheter within a vein of a patient.

One skilled in the art will readily appreciate that the present disclosure is well adapted to carry out the objects and obtain the ends and advantages mentioned, as well as those inherent herein. The present disclosure described herein are exemplary embodiments and are not intended as limitations on the scope of the present disclosure. Changes therein and other uses will occur to those skilled in the art which are encompassed within the spirit of the present disclosure as defined by the scope of the claims.

Various features and advantages are set forth in the following claims.