Guidewire introduction system

Abstract

A guidewire introduction system includes a housing having, a thumbwheel assembly, a wire guide assembly, a movable bracket, a needle assembly including a needle and a needle hub at least partially received in the housing and longitudinally movable between a needle extension position and a needle retraction position in the housing, where the needle extends from the housing through a distal opening in the needle extension position and at least partially retracts into the housing through the distal opening in the needle retraction position. The system includes a biasing element disposed to bias the needle assembly to the needle retraction position, a needle holder configured to releaseably hold the needle assembly in the needle extension position and against the biasing element, and a release button configured to release the needle assembly from the needle extension position to the needle retraction position.

Description

GUIDEWIRE INTRODUCTION SYSTEMCROSS-REFERENCE TO RELATED APPLICATIONS

[0001] This application claims the benefit of U.S. Provisional Application Serial No. 63 / 674,997, filed July 24, 2024. The disclosure of the prior application is considered part of (and is incorporated by reference in) the disclosure of this applicationTECHNICAL FIELD

[0002] This disclosure describes systems, devices, and methods for the introduction of elongate instruments including catheters, guidewires, and other instruments and more particularly to the introduction of catheters, guidewires, and other instruments into small diameter blood vessels, deep vessels, central veins, arteries, and those visualized by ultrasound.BACKGROUND

[0003] Catheter introduction systems can be used to insert and guidewires, catheters, and other instruments into vessels of a subject. Catheter introduction sets can involve the use of two hands (e g., both of the user’s hands) to operate the device. One hand is utilized to insert a needle and catheter, and a second hand to feed the guidewire. In imaging implementations such as ultrasonic imaging, the user removes one hand from the imaging probe to feed the guidewire. Consequently, a single user cannot visualize the guidewire directly while advancing and guiding a guidewire or other instrument, which increases the possibility of misplacement of the guidewire or other instrument. A procedure can include insertion and navigation of a guidewire to a target area, and subsequent treatment at that area involving one or more additional instruments that can be exchanged over the wire.SUMMARY

[0004] This disclosure describes systems, devices, and methods for the introduction of elongate instruments including catheters, guidewires, and other instruments. In particular implementations, the systems, devices, and methods described herein can include the introduction of catheters / needles into small diameter blood vessels, deep vessels, central veins, arteries, and those visualized by ultrasound. The systems, devices, and methods described hereinprovide a needle / catheter introduction apparatus that is reliable and can be easily operated with one hand.

[0005] Some embodiments described herein include a guidewire introduction apparatus including: a housing having a distal opening; a thumbwheel assembly; a wire guide assembly configured to route a guidewire behind the thumbwheel assembly; a movable bracket supporting the wire guide assembly and longitudinally movable in the housing; a needle assembly including a needle and a needle hub at least partially received in the housing and longitudinally movable between a needle extension position and a needle retraction position in the housing, wherein the needle extends from the housing through the distal opening in the needle extension position and at least partially retracts into the housing through the distal opening in the needle retraction position; a biasing element disposed to bias the needle assembly to the needle retraction position; a needle holder configured to releaseably hold the needle assembly in the needle extension position and against the biasing element; and a release button configured to release the needle assembly from the needle extension position to the needle retraction position.

[0006] Such an apparatus can include one or more of the following optional features. The needle assembly is configured and arranged to engage with the movable bracket and longitudinally move the movable bracket in the housing as the needle assembly is released from the needle extension position to the needle retraction position. The wire guide assembly includes a guide wheel and a contact peg arranged adjacent the guide wheel and configured to route the guidewire between the guide wheel and the contact peg. The housing includes a longitudinal slide track configured to guide movement of the movable bracket. The movable bracket includes a longitudinal groove configured to engage with the slide track of the housing. The guidewire extends through the needle. The thumbwheel assembly is at least partially exposed at the housing and rotatable by a user to advance or retract the guidewire through the distal opening of the housing. The thumbwheel assembly includes: a pair of drive wheels configured to permit for a user to contact and rotate the thumbwheel assembly; and a spacer plate engaged between the drive wheels and configured to frictionally grip the guidewire within the housing to cause the spacer plate to advance or retract the guidewire as the thumbwheel assembly is rotated. The drive wheels are spaced apart at a distance configured to permit for the needle assembly to move between the drive wheels when the needle assembly is released from the needle extensionposition to the needle retraction position. The drive wheels include teeth arranged along their circumferences and configured to provide a tactile response and friction for a user to rotate the thumbwheel assembly. The needle holder includes: a stopper wall movable relative to the housing and connected to the release button; a first opening provided in the stopper wall and having a first diameter, the first opening configured to engage with a portion of the needle assembly and hold the needle assembly in the needle extension position; and a second opening provided in the stopper wall and partially overlapping the first opening, the second opening having a second diameter larger than the first diameter, and configured to permit the portion of the needle assembly to pass through against the biasing element as the needle assemble is released from the needle extension position to the needle retraction position, wherein the portion of the needle assembly is aligned with the first opening when the needle assembly is in the needle extension position, and when the release button is connected to the stopper wall such that when actuated, the release button moves the stopper wall in the housing to align the second opening with the portion of the needle assembly so that the portion of the needle assembly passes through the second opening and the needle assembly is released from the needle extension position to the needle retraction position.

[0007] Some embodiments described herein include a guidewire introduction apparatus including: a housing; a wire guide assembly; a needle assembly including a needle; and a retraction mechanism configured to retract the needle assembly from a needle extension position to a needle retraction position.

[0008] Some embodiments described herein include a guidewire introduction apparatus including: a housing; a wire guide assembly; a needle assembly including a needle; and a retraction mechanism configured to retract the needle assembly into the housing.

[0009] Such an apparatus can include one or more of the following optional features. The apparatus includes a guidewire extending through at least part of the housing and the needle. The apparatus includes one or more wheels configured to advance a guidewire through the needle.

[0010] Particular implementations can, in certain instances, realize one or more of the following advantages. The systems, devices, and methods described herein can be operated by one hand to advance a guidewire, a catheter, and other instruments. The single-handed use of the device facilitates user comfort and flexibility to perform other operations with a free other hand.The systems, devices, and methods herein can facilitate improved patient outcomes and medical treatment by making IV placement more efficient and more accurate, and reducing pain.DESCRIPTION OF THE DRAWINGS

[0011] FIG. 1 is a perspective view of an example introducer apparatus.

[0012] FIG. 2 is a perspective view of the apparatus of FIG. 1 with a center strip being transparent.

[0013] FIG. 3 is a perspective view of the apparatus of FIG. 1 with a housing being transparent.

[0014] FIG. 4 is an enlarged perspective view of a forward end portion of the apparatus of FIG. 1 with a front portion being transparent to illustrate an example needle assembly housed therein.

[0015] FIG. 5 illustrates an example center strip with some components associated therewith.

[0016] FIG. 6 is a side view of the apparatus of FIG. 1 (below), in comparison with an example housing of another apparatus (above).

[0017] FIG. 7 is an enlarged cross sectional side view of example engagement of a needle hub and a carriage.

[0018] FIG. 8 illustrates a side view (above) and a side cross sectional view (below) of the apparatus in a needle extended position.

[0019] FIG. 9 illustrates a side view of the apparatus in a guidewire extended position.

[0020] FIG. 10 illustrates a side view (above) and a side cross sectional view (below) of the apparatus in a needle retracted position.

[0021] FIG. 11 is a side cross sectional view of the apparatus of FIG. 1.

[0022] FIG. 12 illustrates an example principle of retracting a needle and wheel assemblies.

[0023] FIG. 13 illustrates an example drive wheel assembly.

[0024] FIG. 14 illustrates an example principle of retracting a needle and a carriage supporting a lower pulley and a conveyer pin.DETAILED DESCRIPTION

[0025] The technology disclosed herein generally relates to a system, device and method for the introduction of catheters / needles, and more particularly to the introduction of catheters / needles into small diameter blood vessels, deep vessels, central veins, arteries, and those visualized by ultrasound. The technology provides a needle / catheter introduction apparatus that is reliable and can be easily operated with one hand.

[0026] Referring to FIGS. 1-14, an example introducer apparatus 100 is described. The apparatus 100 generally includes a housing 102 and a drive wheel assembly 110. The housing 102 includes a front end housing 104 and a rear end housing 106. The rear end 106 of the housing 102 has a curved ergonomic shape to be easily grasped and held by a user with the palm about the rear end housing 106 and the finger (such as the index finger) or thumb resting on or about the guide wheel assembly 110. The housing 102 has an internal space that houses the components and protects the user from interfering with the operation of those components or being injured. The front end housing 104 can extends forward from the rear housing 106. The front housing 104 may be generally tubular.

[0027] As best shown in FIGS. 1, 2, and 13, the drive wheel assembly 110 (also referred to herein as a thumbwheel assembly) has two drive wheels I l la, 111b and a spacer plate 113. The drive wheel assembly 110 is positioned at an opening formed at the front end of the housing 102 and extends to a top of the housing 102. The drive wheel assembly 110 is aligned so that it rotates in a direction that is parallel to the longitudinal axis of the apparatus 100. The drive wheel assembly 110 can be centered with respect to the width of the housing 102 so that the drive wheel assembly 110 is aligned with the central longitudinal axis of the apparatus 100. Thus, the drive wheel assembly 110 has two wheels 111 (I l la and 11 lb) that can be rotated by the user in the direction, which is toward the forward end 102 and away from the user. The drive wheels 111 each have a number of teeth 112 positioned along its outer circumference, with channels formed between the teeth 112. The teeth 112 provide a tactile response and friction for the user to better rotate the drive wheels 111. The outer edges of the teeth 112 are slightly rounded so that they are comfortable to push by the user, and can be coated with a rubber or other material that enhances the user's ability to grip the teeth 112 with a finger or thumb.

[0028] The spacer plate 1 13 extends outward from the inward-facing side of a first wheel I l la. The spacing plate 113 defines a space or gap 115 (FIG. 13) between the two wheels I l la, 11 lb having a certain distance sufficient to permit the guidewire 103 and a needle assembly (e.g., needle hub) (FIGS. 11 and 13) to pass between the two wheels I l la, 111b unobstructed. Accordingly, the plate 113 is wider than the diameter of the guidewire 103 and the width of the needle assembly 200. The spacer plate 113 has an outer diameter that is smaller than the outer diameter of the wheels 111, so that the gap 115 is formed and the guidewire 103 and the needle assembly 200 can pass between the two wheels I l la, 11 lb. The two wheels I l la, 111b can be separate from one another, as shown. Alternatively, the wheel assembly 110 can be a single integral piece, whereby the two wheels I l la, 111b are integrally formed with the center spacer plate 113. Still further, the wheel assembly 110 need not have two wheels I l la, 111b and a spacer plate 113, but can have a single wheel and the guidewire 103 can pass to the side of the single wheel. In addition, while the wheel assembly 110 is described as having two wheels 1 I la, 11 lb and a spacer plate 113, it can also be described as a single integral wheel having a central channel 115.

[0029] A wire guide assembly 130 is provided to guide and route a guidewire behind the drive wheel assembly 110. The wire guide assembly 130 can include a guide wheel 116 adjacent to the drive wheel assembly 110. As shown in FIG. 5, the guide wheel 116 can have teeth 118. The teeth 118 interlock with and cooperatively engage the teeth 112 of one or both of the wheels of the drive wheel assembly 110 (e.g., the first wheel I l la). Accordingly, when the user rotates the drive wheel I l la, the wheel teeth 112 of the drive wheel assembly 110 operate the guide wheel teeth 118 to rotate the guide wheel 116. As depicted in FIG. 11, the guide wheel 116 can include a wheel plate 117 having an outer facing surface extending about the outer circumference of the plate 117. A rubber gasket can be provided about the outer surface (or the outer surface can be made of rubber or coated with a rubber material). The outer surface or rubber gasket 119 contacts and thereby engages the guidewire 103. The rubber material of the rubber gasket 119 grips the guidewire 103 so that when the guide wheel 116 moves, the rubber gasket 119 pushes the guidewire 103 forward out of the apparatus 100 and pulls the guidewire back into the apparatus 100.

[0030] The drive wheel assembly 110 and the guide wheel 1 16 can be rotatably mounted to the interior sides of the housing 102 by pins. The pins are fixed to or formed at the outer-facing side of the wheels I l la, 11 lb, and both outer-facing sides of the drive wheel 116 and extend transversely outward with respect to the outer-facing sides of the wheels I l la, 11 lb, 116. The pins are received in mating circular openings formed in the sides of the housing 102. For instance, the channels can be formed directly in the side of the housing, or formed in a support member that projects outward from the side (inward with respect to the housing). The pins can rotate within the circular openings so that the drive wheel assembly 110 and the guide wheel 116 can freely rotate with respect to the housing 102.

[0031] The wire guide assembly 130 can further include a contact peg 152 configured to hold the guidewire 103 in place against the guide wheel 116 (e.g., the plate 117 thereof). The peg 152 is aligned with the guide wheel 116 (e.g., the plate 117 thereof), so that the guidewire 103 is positioned between the plate 117 and the outer circumferential surface of the peg 152. The outer surface of the peg 152 can be made of or coated with rubber material or have a rubber gasket.

[0032] The wire guide assembly 130 including the guide wheel 116 and the peg 152 can be rotatably mounted to a bracket or carriage 160 so that the guide wheel 116 and the peg 152 rotate as the guidewire 103 moves. The peg 152 and the guide wheel 116 prevent the guidewire 103 from moving up / down in the embodiments shown. Any suitable number of ribs and pegs can be provided, having any suitable shape, to keep the guidewire 103 properly positioned.

[0033] The carriage 160 is configured to longitudinally move within the housing. The carriage 160 can include a guide groove engaged with a slide track 310 of the housing (e.g., provided on the center strap 300). The carriage 160 can move along the slide track 310 with the guide groove being engaged with the track. The carriage 160 can have a portion (e.g., a front end) configured to contact with a portion (e.g., a needle hub) of the needle assembly when the needle assembly is pushed toward the carriage 160 by a spring force of a biasing element 207 when the biasing element compressed against a part of the needle assembly is released (e.g., by pressing a release button 210).

[0034] A needle assembly 200 includes a needle 204, a cannulated housing or flash chamber 201 and a hub 206. The needle assembly 200 is at least partially received in the housing and longitudinally movable between a needle extension position (FIG. 9) and a needle retractionposition (FIG. 10) in the housing. The needle 204 extends from the housing through the distal opening in the needle extension position, as illustrated in FIG. 9. The needle 204 at least partially retracts into the housing through the distal opening in the needle retraction position, as illustrated in FIG. 10.

[0035] As best shown in FIG. 11, a biasing element 207, such as a spring, is provided and disposed to bias the needle assembly to the needle retraction position. As illustrated, the biasing element 207 can be arranged in the front end housing 104, and compressed between the needle hub 206 and a needle holder 220 when the needle holder 220 is held by the release button 210. The needle holder 220 is configured to releasably hold the needle assembly 200 in the needle extension position and against the biasing element 207. The release button 210 can engage with the needle holder 220 to hold the needle assembly 200 in the needle extension position. The release button 210 can be actuated (e.g., pressed) to release the needle assembly 200 from the needle extension position to the needle retraction position.

[0036] As shown, a sheath or end tube 101 is positioned outside the housing 102 and extends into an opening at the rear end housing 106. The sheath 101 protects the guidewire 103. The guidewire 103 extends through the sheath 101 and the housing 102. More specifically, the guidewire 103 extends through the entire housing 102. It enters together with the sheath 101 through an opening in the rear end housing 106. The sheath 101 terminates once inside the housing 102, and the guidewire 103 continues from the rear end housing 106 to the front end housing 104, where it is supported and guided by the drive wheel assembly 110 and the wire guide assembly 130. At the front end housing 104, the guidewire 103 passes through the needle assembly 200.

[0037] The user then places the needle 204 into the patient, such as the vein or artery lumen. Once the needle 204 is placed, the user rotates the guide wheel assembly 110 in the insertion direction. This can be done using a single hand of the user. Since the needle is already positioned in the vein, the user rotates the wheel 110, which is easy to reach because it is at the front end of the housing 102. Thus, the user can hold the rear end housing 104 in the palm of the hand and (without moving his hand) operate the wheel assembly 1120 with a single finger (such as the index finger). In addition, the user holds the device 100 steady (i.e., it does not have to be moved forward, but rather the housing 102 remains stationary while the user rotates the wheelassembly 1 10) and allows the movement of the wheel 110 to advance the guidewire 103, so that single-handed operation is possible. Single-handed operation is further made possible by the contour shape of the hub. Thus, the user can hold an ultrasound probe in the other hand to assist placement of the guidewire 103 and catheter.

[0038] That action by the user causes the drive wheel assembly 110 to rotate with respect to the housing 102, which in turn moves the guide wheel 116 by operation of the guide wheel teeth 112 and the drive wheel teeth 118. The guidewire 103 is forced forward, through the housing 102 and into the patient.

[0039] Once the guidewire 103 has entered the user's vein (about 1-2.5 inches depending on catheter length), the catheter 202 is pushed off the needle 204 and into the patient. The catheter can be pushed into the patient further than the needle and / or guidewire 103 since it is more flexible and won't puncture the side of the vein or vessel. The user can then remove the needle 204 and guidewire 103 from the patient, leaving the catheter 202 and hub 206 properly placed in the patient. The user can then connect a syringe, IV device or other medical instrument at the rear end of the hub 206.

[0040] In this example, the user can remove the needle and the guidewire without pulling the apparatus from the patient. Instead, the user can press the release tab 210, and the actuated release tab 210 releases the compressed spring 207 so that the needle hub 206 is pushed backward and engages with a front end of the carriage 160. The spring force further pushes the needle hub 206 and the carriage 160 further back toward the proximate end of the housing so that the apparatus 100 is in the retracted position as shown in FIG. 10.

[0041] Referring again to FIGS. 1-3, the apparatus 100 (e.g., a thumbwheel assembly) can be configured to have a wider width by, for example, adding a center strap or filler component 300 which separates the two existing handle halves 102A, 102B and filled the gap between the thumbwheels. The handle halves 102A, 102B have the distal ends that constitute the front end housing 104 and are configured to provide clearance for the needle hub and to seat the hub spring.

[0042] As depicted in FIG. 5, which is a perspective view of the center strap 300 with a few components, the center strap 300 is configured to provide a primary mount for the needle retract button 210. The central strap 300 can include a slide track 310 for the carriage component 160which provides a retractable mount for the lower pulley and conveyer pin (e.g., the wire guide assembly 140 and the peg 152).

[0043] As depicted in FIG. 6, the housing 102 has a length sufficient to accommodate the longitudinal travel or displacement of the carriage 160 and the components supported thereon along the housing. Compared to other handle designs, the housing 102 can provide some vertical enlargement and lengthening of the handle that are necessary to enclose the assembly in the retracted position.

[0044] As shown in FIG. 7, the carriage 160 is configured to ride upon the slide track 310 and to contain a detent feature 320 which was designed to maintain the carriages distal position but to be overridden by the needle retract spring when the needle is retracted.

[0045] Referring to FIGS. 8-10, an example operation of the apparatus 100 is illustrated.The apparatus 100 is in an extended position where the needle is extended from the distal end of the housing (FIG. 8). The apparatus 100 can be operated to advance the guidewire fully from the distal end of the housing (FIG. 9). The apparatus 100 can be operated to retract the needle into the housing by, e.g., actuating the release button 210 (FIG. 10).

[0046] Referring to FIGS. 12-14, several principles and configurations of the apparatus 100 are illustrated. For example, FIG. 12 schematically depicts an example concept that includes a fully retracting the guidewire drive mechanism (e.g., thumbwheel, lower pulley and conveyer pin) along with the needle. FIG. 13 schematically illustrates that the thumbwheel assembly is widened to allow the needle hub to pass below the axis point, without having to making the handle housing longer or bigger to house all the moving components therein. FIG. 14 schematically illustrates that the thumbwheel assembly is configured to remain axially stationary within the handle while the lower pulley and conveyer pin are retracted along with the needle hub.

[0047] While this specification contains many specific implementation details, these should not be construed as limitations on the scope of the disclosed technology or of what may be claimed, but rather as descriptions of features that may be specific to particular embodiments of particular disclosed technologies. Certain features that are described in this specification in the context of separate embodiments can also be implemented in combination in a single embodiment in part or in whole. Conversely, various features that are described in the context ofa single embodiment can also be implemented in multiple embodiments separately or in any suitable subcombination. Moreover, although features may be described herein as acting in certain combinations and / or initially claimed as such, one or more features from a claimed combination can in some cases be excised from the combination, and the claimed combination may be directed to a subcombination or variation of a subcombination. Similarly, while operations may be described in a particular order, this should not be understood as requiring that such operations be performed in the particular order or in sequential order, or that all operations be performed, to achieve desirable results. Particular embodiments of the subject matter have been described. Other embodiments are within the scope of the following claims.

Claims

CLAIMSWHAT IS CLAIMED IS:

1. A guidewire introduction apparatus comprising: a housing having a distal opening; a thumbwheel assembly; a wire guide assembly configured to route a guidewire behind the thumbwheel assembly; a movable bracket supporting the wire guide assembly and longitudinally movable in the housing; a needle assembly including a needle and a needle hub at least partially received in the housing and longitudinally movable between a needle extension position and a needle retraction position in the housing, wherein the needle extends from the housing through the distal opening in the needle extension position and at least partially retracts into the housing through the distal opening in the needle retraction position; a biasing element disposed to bias the needle assembly to the needle retraction position; a needle holder configured to releaseably hold the needle assembly in the needle extension position and against the biasing element; and a release button configured to release the needle assembly from the needle extension position to the needle retraction position.

2. The apparatus of claim 1, wherein the needle assembly is configured and arranged to engage with the movable bracket and longitudinally move the movable bracket in the housing as the needle assembly is released from the needle extension position to the needle retraction position.

3. The apparatus of claim 1, wherein the wire guide assembly includes a guide wheel and a contact peg arranged adjacent the guide wheel and configured to route the guidewire between the guide wheel and the contact peg.

4. The apparatus of claim 1, wherein the housing includes a longitudinal slide track configured to guide movement of the movable bracket.

5. The apparatus of claim 4, wherein the movable bracket includes a longitudinal groove configured to engage with the slide track of the housing.

6. The apparatus of claim 1, wherein the guidewire extends through the needle.

7. The apparatus of claim 1, wherein the thumbwheel assembly is at least partially exposed at the housing and rotatable by a user to advance or retract the guidewire through the distal opening of the housing.

8. The apparatus of claim 1, wherein the thumbwheel assembly comprises: a pair of drive wheels configured to permit for a user to contact and rotate the thumbwheel assembly; and a spacer plate engaged between the drive wheels and configured to frictionally grip the guidewire within the housing to cause the spacer plate to advance or retract the guidewire as the thumbwheel assembly is rotated.

9. The apparatus of claim 8, wherein the drive wheels are spaced apart at a distance configured to permit for the needle assembly to move between the drive wheels when the needle assembly is released from the needle extension position to the needle retraction position.

10. The apparatus of claim 8, wherein the drive wheels include teeth arranged along their circumferences and configured to provide a tactile response and friction for a user to rotate the thumbwheel assembly.

11. The apparatus of claim 1, wherein the needle holder comprises: a stopper wall movable relative to the housing and connected to the release button; a first opening provided in the stopper wall and having a first diameter, the first opening configured to engage with a portion of the needle assembly and hold the needle assembly in the needle extension position; anda second opening provided in the stopper wall and partially overlapping the first opening, the second opening having a second diameter larger than the first diameter, and configured to permit the portion of the needle assembly to pass through against the biasing element as the needle assemble is released from the needle extension position to the needle retraction position, wherein the portion of the needle assembly is aligned with the first opening when the needle assembly is in the needle extension position, and when the release button is connected to the stopper wall such that when actuated, the release button moves the stopper wall in the housing to align the second opening with the portion of the needle assembly so that the portion of the needle assembly passes through the second opening and the needle assembly is released from the needle extension position to the needle retraction position.

12. A guidewire introduction apparatus comprising: a housing; a wire guide assembly; a needle assembly including a needle; and a retraction mechanism configured to retract the needle assembly from a needle extension position to a needle retraction position.

13. A guidewire introduction apparatus comprising: a housing; a wire guide assembly; a needle assembly including a needle; and a retraction mechanism configured to retract the needle assembly into the housing.

14. The apparatus of claim 13, and further comprising a guidewire extending through at least part of the housing and the needle.

15. The apparatus of claim 13, and further comprising one or more wheels configured to advance a guidewire through the needle.

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