Transport component and pushing device using the same

Abstract

The present disclosure relates to a transport assembly and a pushing device using the transport assembly. The pushing device is used to push medical devices. The transport assembly is configured to be movable between a first position and a second position within a housing of the pushing device. The first position is a proximal position within the housing of the pushing device, away from a distal surface, and the second position is a distal position close to the distal surface. The distal surface is a surface of the housing close to the skin surface. The transport assembly includes at least two elastic arms, a restraining member, and a coupling member. The at least two elastic arms are disposed on the coupling member and extend in a direction from the first position to the second position. The restraining member is used to restrain and gather the at least two elastic arms. The coupling member is engaged with the medical device. The transport assembly provided by the present disclosure can make the pushing device simple to use.

Description

[0001] This application is a divisional application of a patent application filed on December 30, 2019, with application number 2019114026669 and invention name: Pushing device for medical devices. Technical Field

[0002] The present disclosure relates to a conveying assembly and a pushing device using the conveying assembly. Background Art

[0003] For the purpose of clinical diagnosis or personal health monitoring, it is sometimes necessary to insert a medical device containing an analyte sensor under the skin to detect the concentration of a specific component (such as glucose, salt, lactate, oxygen) in interstitial fluid.

[0004] In particular, for diabetic patients, daily, real-time, and continuous monitoring of interstitial fluid glucose concentration is essential to reduce and mitigate the incidence of complications such as hypoglycemia and hyperglycemia in insulin-dependent diabetics. Typically, when blood glucose concentration begins to decrease, the interstitial fluid glucose concentration decreases before the blood glucose concentration, indicating that a decrease in interstitial fluid glucose concentration can predict impending hypoglycemia. Analyte monitoring devices that allow users to monitor the concentration of a specific component in interstitial fluid in real time on a daily basis typically include an analyte sensor inserted beneath the skin, in contact with the interstitial fluid, and a sensor control device applied to the skin. Analyte monitoring devices are typically placed on the upper arm. To position the analyte monitoring device in the appropriate operating position, a push mechanism is typically required. Specifically, the push mechanism inserts the analyte sensor beneath the skin while simultaneously applying the sensor control device to the skin. Such push mechanisms typically require single-handed operation, requiring the push mechanism to be simple, safe, and reliable in insertion and application. Furthermore, a needle tip is typically used to insert the analyte sensor beneath the skin. However, such push devices currently on the market are often complicated to operate, the pushing force is uncontrollable, the position is offset during the insertion process, and the analyte monitoring device is not properly inserted and applied, resulting in poor user experience and unreliable monitoring results. Summary of the Invention

[0005] The present disclosure is made in view of the above-mentioned prior art conditions, and its purpose is to provide a pushing device for medical devices that is simple to operate, safe, and reliable in insertion and application.

[0006] To this end, the present disclosure provides a pushing device for a medical device, which includes: a shell having a distal surface close to the skin surface; a transport assembly, which is configured to be movable between a proximal position away from the distal surface and a distal position close to the distal surface in the shell, and the transport assembly includes a coupling member that is engaged with the medical device; and a needle tip support portion, which is configured to be movable between the proximal position and the distal position in the shell, wherein the transport assembly has at least two elastic arms engaged with the needle tip support portion and a restraining member that restrains the elastic arms, and a biasing member is provided in the shell to hinder the restraining member when the transport assembly moves from the proximal position to the distal position.

[0007] In the present disclosure, a restraining member restrains the elastic arm, so that the needle tip support portion is confined within the transport assembly. When the transport assembly moves from a proximal position to a distal position, the biasing member hinders the movement of the restraining member, thereby releasing the restraint on the elastic arm by the restraining member, thereby further releasing the engagement of the elastic arm with the needle tip support portion, allowing the needle tip support portion to retract from the distal position to the proximal position. In this case, after the medical device is applied to the skin surface, the needle tip support portion can automatically retract to the proximal position. This can reduce damage to human tissue caused by the push device and improve the safety of the push device.

[0008] Additionally, in the push device of the present disclosure, the medical device optionally includes an analyte sensor disposed beneath the skin surface in contact with tissue fluid and a sensor control device disposed on the skin. In this case, the analyte sensor can monitor the concentration of a specific component in the tissue fluid, and the sensor control device transmits the monitoring data to a user-friendly display device, thereby enabling the user to monitor their health status in real time on a daily basis.

[0009] In addition, in the push device of the present disclosure, optionally, the analyte sensor monitors glucose, thereby facilitating the user to monitor the glucose concentration in the body in real time on a daily basis.

[0010] In addition, in the pushing device of the present disclosure, the pushing device may optionally further include a first spring disposed between the housing and the transport assembly. In this case, when the housing is released from the transport assembly, the transport assembly can be moved from a proximal position to a distal position under the pushing force of the first spring, thereby applying the medical device to the skin surface.

[0011] In the push device of the present disclosure, the transport assembly may optionally include a protrusion, and the housing may include a contact member that engages the protrusion and a shoulder that can be disengaged from the protrusion. In this case, a user presses the contact member to disengage the protrusion from the shoulder. This allows the transport assembly to be pushed from a proximal position to a distal position.

[0012] Additionally, in the pusher device of the present disclosure, the needle tip support portion optionally supports the needle tip so that the needle tip is completely covered by the housing when the needle tip support portion is in the proximal position. In this case, the housing protects the needle tip from contact with foreign objects that could cause deformation or contamination, and the needle tip is invisible to the user, thereby improving the safety and comfort of the pusher device.

[0013] In addition, the pushing device of the present disclosure may optionally further include a second spring disposed between the transport assembly and the needle tip support portion. In this case, after the insertion and application actions are completed, the needle tip support portion can be pushed by the second spring to return from the distal position to the proximal position, thereby allowing the needle tip to be removed from the body.

[0014] In addition, in the push device of the present disclosure, the engaging member is optionally configured to release the engagement of the engaging member with the medical device when the transport assembly moves from the proximal position to the distal position. In this case, the medical device can be separated from the transport assembly, thereby remaining in a state of application on the skin.

[0015] In addition, in the push device of the present disclosure, the needle tip may optionally have a needle groove extending along its length, with the analyte sensor positioned within the needle groove. In this case, the needle tip can penetrate the skin and subcutaneous tissue, and position the analyte sensor within the subcutaneous tissue, thereby enabling more complete contact between the analyte sensor and tissue fluid.

[0016] Additionally, in the push device of the present disclosure, optionally, when the needle tip support portion moves from the proximal position to the distal position, the needle tip is inserted below the skin surface and the analyte sensor is positioned in contact with tissue fluid. In this case, the analyte sensor can monitor the concentration of a specific component in the tissue fluid, thereby enabling the user to monitor their health status in real time on a daily basis.

[0017] Furthermore, in the push device of the present disclosure, the sensor control device can optionally be applied to the skin surface. In this case, the analyte sensor can monitor the concentration of a specific component in the tissue fluid, and the sensor control device can transmit the monitoring data to a user-friendly display device, thereby enabling the user to monitor their health status in real time on a daily basis. BRIEF DESCRIPTION OF THE DRAWINGS

[0018] Figure 1 Schematic diagram showing a pushing device according to an embodiment of the present invention.

[0019] Figure 2 1 is an exploded view showing the pushing device according to the present embodiment.

[0020] Figure 3 Schematic diagram showing a medical device according to this embodiment.

[0021] Figure 4 Schematic diagram showing the joint according to this embodiment.

[0022] Figure 5 Schematic diagram showing the needle tip according to this embodiment.

[0023] Figure 6 It is a cross-sectional view showing an initial state of the pushing device according to this embodiment.

[0024] Figure 7 1 is a cross-sectional view showing the pushing device according to this embodiment when pushing is completed.

[0025] Figure 8 This is a cross-sectional view showing the needle tip of the pusher according to this embodiment after retraction.

[0026] Description of labels:

[0027] 1…pushing device, 9…medical device, 91…analyte sensor, 92…sensor control device, 921…hole, 922…engaging groove, 10…housing, 101…distal surface, 11…touch member, 12…shoulder, 13…biasing member, 20…transportation assembly, 21…elastic arm, 22…constraint member, 23…protrusion, 24…engaging member, 241…protrusion, 30…first spring, 40…needle tip support, 50…needle tip, 51…needle groove, 60…second spring. DETAILED DESCRIPTION

[0028] Hereinafter, preferred embodiments of the present invention will be described in detail with reference to the accompanying drawings. In the following description, identical components will be assigned identical reference numerals, and duplicate descriptions will be omitted. Furthermore, the accompanying drawings are merely schematic, and the proportions of the dimensions of the components and the shapes of the components may differ from the actual ones.

[0029] Figure 1 Schematic diagram showing a pushing device 1 according to an embodiment of the present invention. Figure 2 It is an exploded view showing the pushing device 1 according to the present embodiment.

[0030] like Figure 1 、 Figure 2 As shown, in this embodiment, the pushing device 1 may include a shell 10, which has a distal surface 101 close to the skin surface; a transport component 20, which is configured to be movable between a proximal position away from the distal surface 101 and a distal position close to the distal surface 101 in the shell 10, and the transport component 20 includes a coupling member 24 that is engaged with the medical device 9; and a needle tip support portion 40, which is configured to be movable between a proximal position and a distal position in the shell 10, wherein the transport component 20 has at least two elastic arms 21 engaged with the needle tip support portion 40 and a restraining member 22 that restrains the elastic arm 21, and a biasing member 13 is provided in the shell 10 to hinder the restraining member 22 when the transport component 20 moves from the proximal position to the distal position.

[0031] In the push device 1 of this embodiment, the restraining member 22 restrains the elastic arm 21, so that the needle tip support portion 40 is confined within the transport assembly 20. When the transport assembly 20 moves from the proximal position to the distal position, the biasing member 13 hinders the movement of the restraining member 22, thereby releasing the restraint of the restraining member 22 on the elastic arm 21, thereby further releasing the engagement of the elastic arm 21 with the needle tip support portion 40, allowing the needle tip support portion 40 to retract from the distal position to the proximal position. In this case, after the medical device 9 is applied to the skin surface, the needle tip support portion 40 can automatically retract to the proximal position. This can reduce damage to human tissue caused by the push device 1 and improve the safety of the push device 1.

[0032] (Medical Devices)

[0033] Figure 3 Schematic diagram showing a medical device 9 according to this embodiment. Figure 3 (a) is an oblique plan view showing a medical device 9 according to this embodiment. Figure 3 (b) is an oblique bottom view showing the medical device 9 according to this embodiment.

[0034] like Figure 3As shown, in this embodiment, medical device 9 may include an analyte sensor 91 located below the skin surface in contact with tissue fluid, and a sensor control device 92 placed on the skin. In this case, analyte sensor 91 can monitor the concentration of a specific component in the tissue fluid, and the sensor control device 92 transmits the monitoring data to a user-friendly display device, thereby enabling users to monitor their health status in real time on a daily basis.

[0035] In this embodiment, the monitoring target of the analyte sensor 91 may be glucose, thereby enabling the user to conveniently monitor the glucose concentration in the body in real time on a daily basis.

[0036] In some examples, the sensor control device 92 may include a hole 921 through which the needle tip 50 passes and an engagement groove 922 engaged with the engagement member 24. Thus, the medical device 9 can be engaged to the transport assembly 20 via the engagement groove 922.

[0037] In some examples, the surface of the sensor control device 92 that contacts the skin may have adhesive, thereby facilitating the medical device 9 to be attached to the skin surface by adhesion.

[0038] In some examples, the portion of the analyte sensor 91 exposed outside the sensor control device 92 may be in the shape of a thin strip, thereby facilitating easier insertion of the analyte sensor 91 beneath the skin and more complete contact with the tissue fluid.

[0039] In some examples, the sensor control device 92 may be elliptical in shape, thereby more conveniently fitting into the elliptical inner cavity of the coupling member 24. However, the shape of the sensor control device 92 is not limited thereto and may also be square, disc, triangular, or irregular in shape.

[0040] (case)

[0041] In this embodiment, an elastically deformable contact member 11 may be provided on the housing 10. In this case, the user can release the engagement of the housing 10 with the conveying assembly 20 by squeezing the contact member 11. This makes it convenient for the user to operate the pushing device 1 with one hand.

[0042] In this embodiment, the housing 10 can accommodate the transport assembly 20 and provide a motion track for the transport assembly 20. Thus, the transport assembly 20 can be easily moved between the proximal position and the distal position in the housing 10.

[0043] In this embodiment, the housing 10 may further include a distal surface 101 that contacts the skin surface, thereby helping to define the position where the medical device 9 is placed on the skin surface.

[0044] In this embodiment, the housing 10 can accommodate the medical device 9, thereby helping to protect the medical device 9 from being damaged by foreign objects.

[0045] In some examples, the material of the parts constituting the housing 10 can be selected from at least one of plastic, rubber, and metal. In some examples, the material of the parts constituting the housing 10 can be selected from plastic. In some examples, the material of the parts constituting the housing 10 can be selected from at least one of ABS, POM, and nylon. In some examples, the parts constituting the housing 10 can be injection molded from plastic. This can improve the rigidity of the housing 10 and reduce manufacturing costs.

[0046] (Shipping Components)

[0047] In this embodiment, the transport assembly 20 may have a protrusion 23, and the side of the housing 10 may be provided with a contact member 11 that interacts with the protrusion 23 and a shoulder portion 12 that can be detached from the protrusion 23. In this case, the protrusion 23 can be engaged with the shoulder portion 12, and the user can press the contact member 11 to disengage the protrusion 23 from the shoulder portion 12, thereby releasing the engagement of the housing 10 with the transport assembly 20.

[0048] (First spring)

[0049] In this embodiment, the pushing device 1 may further include a first spring 30 disposed between the housing 10 and the transport assembly 20. In this case, when the engagement of the housing 10 with the transport assembly 20 is released, the transport assembly 20 can move from the proximal position to the distal position under the pushing force of the first spring 30, thereby enabling the medical device 9 to be applied to the skin surface.

[0050] (Joints)

[0051] Figure 4 Schematic diagram showing the joint 24 according to the present embodiment. Figure 4 (a) is an oblique plan view showing a joint member 24 according to this embodiment. Figure 4 (b) is an oblique bottom view showing the joint 24 according to this embodiment.

[0052] like Figure 4 As shown, in this embodiment, the transport assembly 20 may include a coupling member 24 that is engaged with the medical device 9 .

[0053] In this embodiment, the engaging member 24 can be configured to release the engagement of the engaging member 24 with the medical device 9 when the transport assembly 20 moves from the proximal position to the distal position. In this case, the medical device 9 can be separated from the transport assembly 20, so that the medical device 9 can remain in the applied state on the skin.

[0054] In this embodiment, the engaging member 24 may include a protrusion 241 that engages with the engaging groove 922 of the medical device 9. In this case, the protrusion 241 engages with the engaging groove 922, and the engaging member 24 holds the medical device 9 within the housing 10. This helps protect the medical device 9 from being damaged by foreign objects.

[0055] In this embodiment, the number of protrusions 241 and corresponding coupling grooves 922 can be adjusted according to the adhesive force of the sensor control device 92 on the skin surface. On the one hand, the reliability of the coupling is guaranteed to prevent the medical device 9 from accidentally detaching from the coupling member 24 before application. On the other hand, the adhesive force of the sensor control device 92 on the skin surface needs to overcome the coupling force between the protrusion 241 and the coupling groove 922 to keep the sensor control device 92 attached to the skin surface.

[0056] In some examples, there may be four pairs of protrusions 241 and corresponding engagement grooves 922 , thereby improving engagement reliability.

[0057] In some examples, when the transport assembly 20 moves to the distal position and the sensor control device 92 is adhered to the skin surface, the engagement between the protrusion 241 and the engagement groove 922 can be released, thereby enabling the sensor control device 92 to remain adhered to the skin surface.

[0058] In this embodiment, the joint 24 may have an inner cavity that matches the outer shape of the sensor control device 92 , thereby further protecting the medical device 9 from damage caused by contact with foreign objects.

[0059] (Elastic Arm)

[0060] In this embodiment, the transport assembly 20 may include at least two elastic arms 21 engaged with the needle tip supporting portion 40 and a restraining member 22 restraining the elastic arms 21 , thereby confining the needle tip supporting portion 40 within the transport assembly 20 .

[0061] In this embodiment, the elastic arm 21 is elastically deformable. In this case, when the restraining member 22 is released from the elastic arm 21, the elastic arm 21 can be stretched outward. Thus, the needle tip support portion 40 can be released from the transport assembly 20.

[0062] In some examples, the elastic arms 21 may be arranged in a manner uniformly distributed on the circumference, so that the restraining member 22 can facilitate gathering the elastic arms 21 to confine the needle tip supporting portion 40 within the transport assembly 20 .

[0063] In some examples, there may be three elastic arms 21 , but the number is not limited thereto. The elastic arms 21 may be distributed on the circumference in any number to facilitate gathering of the restraining members 22 .

[0064] In some examples, the restraining member 22 may be in a ring shape, so as to facilitate gathering the elastic arms 21 to confine the needle tip supporting portion 40 within the transport assembly 20 .

[0065] In some examples, the elastic arm 21 may be formed on the coupling member 24 , thereby reducing the number of parts and lowering manufacturing costs.

[0066] (Needle tip support part)

[0067] In this embodiment, the needle tip support portion 40 can support the needle tip 50 so that the needle tip 50 is completely covered by the housing 10 when the needle tip support portion 40 is in the proximal position. In this case, the needle tip 50 can be protected by the housing 10 to avoid contact with foreign objects, which may cause deformation or contamination, and the needle tip 50 can be invisible to the user, thereby improving the safety and comfort of the pushing device 1.

[0068] In some examples, the needle tip support 40 can engage with the needle tip 50 in a claw manner, thereby facilitating the loading of the needle tip 50 onto the needle tip support 40 .

[0069] (Second spring)

[0070] In this embodiment, the pushing device 1 may further include a second spring 60 disposed between the transport assembly 20 and the needle tip support portion 40. In this case, after the insertion and application actions are completed, the needle tip support portion 40 can be pushed by the second spring 60 to return from the distal position to the proximal position, thereby allowing the needle tip 50 to be removed from the body.

[0071] (needle tip)

[0072] Figure 5 Schematic diagram showing the needle tip 50 according to this embodiment.

[0073] like Figure 5 As shown, in this embodiment, the needle tip 50 may have a needle groove 51 provided along the length of the needle tip 50, and the analyte sensor 91 is placed in the needle groove 51. In this case, the needle tip 50 can penetrate the skin and subcutaneous tissue and place the analyte sensor 91 in the subcutaneous tissue, thereby enabling the analyte sensor 91 to more fully contact the tissue fluid.

[0074] In some examples, the material of the needle tip 50 can be selected from stainless steel, thereby helping the needle tip 50 to better penetrate the skin and subcutaneous tissue.

[0075] In this embodiment, when the needle tip support 40 moves from the proximal position to the distal position, the needle tip 50 can be inserted below the skin surface, and the analyte sensor 91 is placed in contact with the tissue fluid. In this case, the analyte sensor 91 can monitor the concentration of a specific component in the tissue fluid, thereby allowing the user to monitor their health status in real time on a daily basis.

[0076] In this embodiment, the sensor control device 92 can be applied to the skin surface. In this case, the sensor control device 92 can transmit the data monitored by the analyte sensor 91 to a display device that is convenient for the user to read, thereby enabling the user to monitor his or her health status in real time on a daily basis.

[0077] (Biasing element)

[0078] In this embodiment, a biasing member 13 may be provided within the housing 10 to obstruct the restraining member 22 when the transport assembly 20 moves from the proximal position to the distal position. In this case, when the transport assembly 20 moves from the proximal position to the distal position, the restraining member 22 is obstructed by the biasing member 13 and disengages from the elastic arm 21. This releases the restraining member 22 from the elastic arm 21, allowing the needle tip support 40 to be released from the transport assembly 20.

[0079] In some examples, the biasing members 13 may be arranged in a manner uniformly distributed around the circumference, thereby improving the uniformity of the contact received by the restraint 22 .

[0080] In some examples, the biasing member 13 may be a protrusion disposed inside the housing 10 , thereby simplifying the parts structure.

[0081] In some examples, the number of the biasing members 13 may be three, but the number is not limited thereto. The biasing members 13 may be distributed on the circumference in any number to hinder the movement of the restraining member 22 .

[0082] In some examples, the biasing member 13 may have a receiving surface that receives one end of the first spring 30 , thereby providing support for the elastic force of the first spring 30 .

[0083] In some examples, the biasing member 13 and the housing 10 may be two connected parts.

[0084] In other examples, the biasing member 13 and the housing 10 may be integrally formed, thereby reducing the number of parts and lowering manufacturing costs.

[0085] Figure 6 It is a cross-sectional view showing an initial state of the pushing device 1 according to this embodiment. Figure 7 1 is a cross-sectional view showing the pushing device 1 according to the present embodiment when pushing is completed. Figure 8 1 is a cross-sectional view showing the needle tip 50 of the pusher device 1 according to the present embodiment after retraction.

[0086] Combine Figure 6 、 Figure 7 、 Figure 8 To further describe the usage process, in this embodiment, the user presses the contact member 11 to push the protrusion 23 away from the shoulder 12, thereby releasing the engagement of the housing 10 with the transport assembly 20. Driven by the first spring 30, the transport assembly 20 moves from the proximal position to the distal position. The analyte sensor 91 is inserted through the needle tip 50 to a position beneath the skin and in contact with tissue fluid, while the sensor control device 92 is applied to the skin surface. When the transport assembly 20 moves from the proximal position to the distal position, the biasing member 13 provided on the housing 10 contacts the restraining member 22 and releases the restraining member 22 from gathering the elastic arm 21, thereby releasing the restraint of the elastic arm 21 on the needle tip support 40. Driven by the second spring 60, the needle tip support 40 moves from the distal position to the proximal position with the needle tip 50, thereby being withdrawn from beneath the skin to the proximal end.

[0087] Although the present invention has been specifically described above in conjunction with the accompanying drawings and embodiments, it will be understood that the above description does not limit the present invention in any form. Those skilled in the art may modify and change the present invention as needed without departing from the spirit and scope of the present invention, and these modifications and changes all fall within the scope of the present invention.

Claims

1. A transport assembly of a pushing device, the pushing device being used to push a medical device, the pushing device comprising a housing, the transport assembly, a needle tip support portion, and a biasing member, characterized in that: The transport assembly is configured to be movable between a first position and a second position in the shell, the first position being a proximal position in the shell away from a distal surface, the second position being a distal position close to the distal surface, and the distal surface being a surface of the shell close to the skin surface; the transport assembly comprises at least two elastic arms, a restraining member and a coupling member; the at least two elastic arms are provided on the coupling member and extend in a direction from the second position to the first position, and the at least two elastic arms are arranged in the transport assembly in a manner uniformly distributed on a circumference; the needle tip support portion is engaged with the at least two elastic arms and is releasably restricted in the transport assembly; the restraining member is annular and is used to restrain and gather the at least two elastic arms, and when the restraint of the at least two elastic arms by the restraining member is released, the at least two elastic arms are stretched outward; the biasing member is provided in the shell and hinders the restraining member when the transport assembly moves from the proximal position to the distal position; the coupling member is engaged with the medical device.

2. The transport assembly according to claim 1, wherein: The medical device includes an analyte sensor placed below the skin surface in contact with tissue fluid and a sensor control device placed on the skin.

3. The transport assembly according to claim 2, wherein: The monitoring object of the analyte sensor is glucose.

4. The transport assembly according to claim 1, wherein: The transport assembly has a protruding portion, and a shoulder portion and a touch piece are provided on the side of the shell. The shoulder portion is used to clamp the protruding portion, and the touch piece is used to release the clamping of the shoulder portion to the protruding portion.

5. A pushing device for medical equipment, characterized in that: It comprises a shell, a transport assembly according to any one of claims 1 to 4, a needle tip support portion and a biasing member; the needle tip support portion is engaged with at least two elastic arms of the transport assembly and is releasably confined within the transport assembly; the biasing member is arranged in the shell and is a restraining member that obstructs the transport assembly when the transport assembly moves from a proximal position to a distal position.

6. The pushing device according to claim 5, wherein: The device further comprises a first spring disposed between the biasing member and the transport assembly, wherein the first spring is configured to push the transport assembly from the proximal position to the distal position after the engagement of the transport assembly by the housing is released; the engagement of the engaging member of the transport assembly with the medical device is released when the transport assembly moves from the proximal position to the distal position; and / or The invention further includes a second spring disposed between the needle tip supporting portion and the transport assembly, wherein the second spring is configured to push the needle tip supporting portion back from the distal position to the proximal position.

7. The pushing device according to claim 5, characterized in that: The needle tip supporting portion supports the needle tip and is coupled to the needle tip in a claw manner.

8. The pushing device according to claim 5, characterized in that: The needle tip support portion supports the needle tip so that the needle tip is completely covered by the housing when the needle tip support portion is located in the proximal position.

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