Microintroducer System

Abstract

A microintroducer system includes an introducer sheath coupled to a handle and an adapter, where the handle and introducer sheath define a channel therethrough. The adapter includes a receiving tube with a predetermined angled portion, which provides a path from the proximal opening to the channel of the microintroducer. The adapter may be integral with the microintroducer or separately attached. A separately attached adapter may include a spin nut or other attachment mechanism for connecting the adapter to the microintroducer. The predetermined angled portion may include multiple bent portions, for example, to form a helical path. The microintroducer system may include a shape-sensing stylet system. The predetermined angled portion of the adapter may provide a reference point for calibrating the shape-sensing stylet. As the stylet passes through the predetermined angled portion, an external device coupled to the stylet calibrates the bend.

Description

[Technical field]

[0001] SUMMARY OF THE DISCLOSURE Embodiments disclosed herein relate to a micro-introducer system that includes a micro-introducer and an adapter. Summary of the Invention

[0002] The microintroducer may include an introducer sheath coupled to the handle, the handle and the introducer sheath defining a channel therethrough. The adapter may include a receiving tube having a predetermined angled portion, the receiving tube defining a path from the proximal opening to the channel of the microintroducer. The adapter may be integral with the microintroducer or separately attached. The predetermined angled portion may include multiple bent portions to form a helical path. The predetermined angled portion may be at any angle relative to the longitudinal axis of the microintroducer system, for example, between 45 degrees and 90 degrees, and in some embodiments, about 70 degrees. If separately attached, the adapter includes an attachment mechanism configured to couple to the proximal connector of the microintroducer. The connecting member may include a spin nut including a break line that allows removal of the spin nut from the inserted medical instrument. The receiving tube of the adapter may include an opening or slit that allows removal of the receiving tube from the inserted medical instrument. The micro-introducer can include an advancement mechanism disposed in a wall of the receiving tube, the advancement mechanism configured to move the medical instrument through the micro-introducer system. The advancement mechanism can be a scroll wheel, and in some embodiments, can be disposed adjacent to a predetermined angled portion of the receiving tube.

[0003] The microintroducer system may further include a shape-sensing stylet system, which may include a shape-sensing stylet and an external device in communication therewith. The predetermined angled portion provides a calibration point for the shape-sensing stylet. In embodiments in which the microintroducer system includes an advancement mechanism, the advancement mechanism may provide a reference point for the external device to begin measuring one of the bend pattern and insertion length of the shape-sensing stylet. A method of shape-sensing a patient's vessel may include advancing a shape-sensing stylet through a receiving tube and the predetermined angled portion, and calibrating a first bend of the shape-sensing stylet relative to an angle formed by the predetermined angled portion. The external device may use the first bend to measure the bend pattern of the shape-sensing stylet, and may use the bend pattern to determine the path of the vessel. The external device may use the bend pattern to determine the shape of the patient's vessel in three-dimensional (3D) space.

[0004] In some embodiments, an adapter can be separately coupled to the proximal end of the microintroducer for receiving the elongated medical instrument. The adapter includes a funnel-shaped opening and defines a channel with an angled portion, the angled portion including a predetermined angle. The angled portion positions the funnel-shaped opening away from the surface of the skin and provides a convenient target for introducing the elongated medical instrument. The adapter can further include a scroll wheel. The scroll wheel can be disposed in the angled portion and can engage a distal tip of the elongated medical instrument. The scroll wheel can be used to draw the elongated medical instrument into the adapter and into the angled portion, thus preventing twisting or tangling of the elongated medical instrument. Additionally, the scroll wheel provides continuous pressure, bending and advancement speed within the adapter.

[0005] A more detailed description of the present disclosure will now be given with reference to certain embodiments illustrated in the accompanying drawings. It will be understood that these drawings represent only typical embodiments of the present invention and therefore should not be considered limiting of its scope. Exemplary embodiments of the present invention will be described and explained with additional features and details using the following accompanying drawings. [Brief description of the drawings]

[0006] [Figure 1A] FIG. 1A shows a micro-introducer system that includes a micro-introducer and an integrated adapter that includes an angled portion. [Figure 1B] FIG. 1B shows a micro-introducer system that includes a micro-introducer and a separate adapter that includes an angled portion. [Diagram 2] FIG. 2 shows the adaptor of FIG. 1B coupled to a microintroducer. [Figure 3A] FIG. 3A illustrates one embodiment of an adapter. [Figure 3B] FIG. 3B illustrates another embodiment of the adapter. [Figure 4A] FIG. 4A illustrates a micro-introducer system including a shape-sensing stylet system in a first position. [Figure 4B] FIG. 4B shows the micro-introducer system of FIG. 4A with the shape-sensing stylet system in a second position. [Figure 5A] FIG. 5A illustrates a micro-introducer system including a scroll wheel according to some embodiments. [Figure 5B] FIG. 5B shows the scroll wheel separated from the stylet. DETAILED DESCRIPTION OF THE PREFERRED EMBODIMENTS

[0007] Reference is now made to the drawings, in which like structures are numbered likewise, and it is understood that the drawings are illustrative and schematic representations of exemplary embodiments of the invention and are not limiting and are not necessarily drawn to scale.

[0008] To aid in describing the fixed system, the following coordinate terminology is used (see FIG. 1A): A "longitudinal axis" is generally parallel to the axis of the introducer sheath of the instrument. A "lateral axis" is perpendicular to the longitudinal axis. A "transverse axis" extends perpendicular to both the longitudinal and lateral axes. Additionally, as used herein, "longitudinal" refers to a direction substantially parallel to the longitudinal axis, "lateral" refers to a direction substantially parallel to the lateral axis, and "transverse" refers to a direction substantially parallel to the transverse axis. The term "axis" as used herein refers to the axis of the introducer sheath, and is therefore substantially synonymous with the term "longitudinal" as used herein.

[0009] For clarity, the term "proximal" refers to a direction relatively closer to a clinician using the devices described herein, and the term "distal" refers to a direction relatively farther from the clinician. For example, the tip of an introducer sheath located inside a patient's body is considered to be the distal end of the device, and the connector that remains outside the body is toward the proximal end of the device. Additionally, the terms "including," "having," and "having" have the same meaning as the term "comprising" when used herein, including the claims.

[0010] The terms "upper," "lower," "top," "bottom," "lower," "upper," and the like, used to describe this fixed system, are used in relation to the illustrated orientation of the embodiment. For example, the term "upper" is used to describe the portion of the instrument that is above a lateral axis passing through the axis of the introducer sheath. The term "lower" is used to describe the portion of the instrument that is below a lateral axis passing through the axis of the introducer sheath. The terms "left" and "right" are used consistently throughout this disclosure and are used to describe structures from the perspective of a clinician using the instrument.

[0011] Briefly summarized, the embodiments disclosed herein relate to a microintroducer system and method thereof. Although the description relates to a microintroducer for a vascular access system, it is understood that the embodiments disclosed herein are also applicable to the introduction of gastric feeding tubes, catheters, guidewires, and similar systems for introducing instruments to map regions within a human or animal body. The embodiments disclosed herein include an adapter coupled to a proximal end of the microintroducer to receive an elongated medical instrument, such as a shape-sensing stylet. The adapter defines a channel including a funnel-shaped opening and an angled portion including a predetermined angle. The angled portion positions the funnel-shaped opening away from the surface of the skin and provides a convenient target for introducing the elongated medical instrument. Additionally, the predetermined angle provides a reference point for a medical instrument, such as a shape-sensing stylet, to be inserted through the microintroducer. As the stylet passes through the angled portion, an external device coupled to the shape-sensing stylet calibrates the bend of the stylet relative to the predetermined angle. Additionally, the reference points indicate starting points for measuring the shape-sensing stylet bending pattern and insertion length, which can be used by an external device to determine the shape of the shape-sensing stylet path and therefore the shape of the patient's vasculature in three-dimensional (3D) space.

[0012] The adapter may further include a scroll wheel. The scroll wheel may be disposed in the angled portion and may engage a distal tip of the elongated medical instrument. The scroll wheel may be used to draw the elongated medical instrument into the adapter and into the angled portion, thus preventing twisting or tangling of the elongated medical instrument. Additionally, the scroll wheel provides continuous pressure, bending and advancement speed within the adapter. Embodiments herein further describe additional aspects of the system and methods of use thereof.

[0013] FIG. 1A shows a perspective view of a microintroducer system 100 including a microintroducer 110 and an adapter 150, according to one embodiment of the present disclosure. The microintroducer 110 includes an introducer sheath 112 that defines a channel 122 extending from a proximal end to a distal end, within which a dilator 114 or similar device may be disposed. In FIG. 1A, the distal tip of the dilator 114 is shown extending beyond the distal tip of the introducer sheath 112. The proximal end of the sheath 112 is shown coupled to a handle 116 (or a pair of handles 116, e.g., left and right handles 116A, 116B). The handle may be attached to a side of the proximal end of the sheath, i.e., the handle may form the proximal end of the channel. For example, the handle may be insert molded onto the proximal end of the sheath. Additionally, the handle may include a valve. Examples of introducer sheaths, including sheath and handle configurations, are disclosed in U.S. Patent Nos. 7,637,893, 8,403,890, and 8,932,260, each of which is incorporated herein by reference in its entirety. The sheath 112 includes split lines 118A, 118B that extend longitudinally along opposing walls of the sheath 112. The split lines 118A, 118B can be score lines, perforations, laser cut lines, or similar lines of weakness that allow the sheath 112 to be split along the longitudinal axis. The split lines 118A, 118B are disposed along opposing walls of the sheath 112 such that the sheath 112 is split into two substantially equal portions. 1A, parting line 118A is located on the upper side of sheath 112 and parting line 118B is located on the lower side thereof, thus defining sheath 112 splittable into left and right portions 112A, 112B. Left sheath portion 112A is attached to left handle 116A and right sheath portion 112B is attached to right handle 116B. Alternatively, the sheath material (e.g., PTFE) can be formed (e.g., extruded) with molecular alignment such that the sheath can be peeled away at the same or similar circumferential locations without parting lines.

[0014] The adapter 150 may be integral with or incorporated within the microintroducer, as shown in Figure 1 A, or may be separately attached, as shown in Figure 1 B. When integral with the microintroducer 110, the adapter 150 includes a distal portion that is splittable into halves 150A and 150B that are aligned with the split lines of the sheath 112 and / or handle 116.

[0015] In embodiments in which the adapter 150 is separately attached as shown in FIG. 1B, the microintroducer 110 further includes a connector 120 disposed at the proximal end. As described below, the connector 120 may include a threaded portion for receiving a corresponding spin nut 152 from the adapter 150. However, it is understood that other types of connectors are contemplated, such as luer lock, slip fit, bayonet connectors, etc. The connector 120 may be defined by left and right portions 120A, 120B that mate with proximal portions of the left and right handles 116A, 116B, respectively. When attached as shown in FIG. 2, the left and right portions 120A, 120B of the connector define a continuous periphery on whose exterior a corresponding spin nut 152 or similar connector can be engaged.

[0016] As discussed above, the adapter 150 may include an attachment mechanism that couples to a connector. The attachment mechanism in one embodiment includes a splittable or breakable portion that allows separation of the adapter 150 after a medical device has been passed through the adapter 150 and inserted through the microintroducer into the patient's vasculature. In one embodiment shown in FIG. 1B, the adapter 150 includes a spin nut 152 configured to engage a threaded connector 120. In other embodiments, the attachment mechanism corresponds to a different type of connector as described above. In the illustrated embodiment, the spin nut includes a break line 166 that extends axially along the longitudinal axis. The break line 166 may include a score line, perforation, laser cut line, or similar line of weakness as described herein. In one embodiment, the spin nut 152 includes one or more break lines 166 that allow the spin nut to be removed while an elongated medical device passing therethrough maintains its position.

[0017] The adapter 150 includes a distal tube 154 that extends along the longitudinal axis of the micro-introducer system 100 and communicates with the channel 122. The distal tube 154 extends to a pre-formed angled section 156 that smoothly bends at an angle relative to the distal tube 154 toward a proximal tube 158. The proximal tube 158 extends away from the distal tube 154 at an angle relative to the longitudinal axis of the micro-introducer system 100. The angled section 156 is angled "at" an angle between 5 degrees and 175 degrees relative to the longitudinal axis. 180 degrees - In one embodiment, an angle "θ" may be defined. "180 degrees- θ 」The angle of the distal tube 154 is between 45 degrees and 90 degrees, and in a preferred embodiment is 70 degrees. The elongate tube includes a plurality of curved sections that together define a helical path, in some embodiments along the angled section, and in some embodiments along the proximal tube section. Other curved paths, such as sinusoidal, are also contemplated. The distal tube section 154, the angled section 156, and the proximal tube section 158 together define a continuous receiving tube 160 of the adapter 150. The receiving tube 160 defines a passageway 162 therethrough, and in the illustrated embodiment is fluidly connected to the sheath channel 122 via the connector 120. The proximal end of the receiving tube 160 includes a funnel 164. The funnel 164 defines a tapered section, such that the proximal end of the funnel 164 defines a diameter that is larger than the diameter of the receiving passageway 162.

[0018] The receiving tube 160 further includes a split line 168. The split line 168 extends axially along the receiving tube 160 from the funnel 164 at the proximal end to the spin nut 152 at the distal end. The split line may include a score line, perforation, laser cut line, or similar line of weakness as described herein that allows the receiving tube 160 to be split along the axis of the receiving channel 162. The split line 168 allows the adapter 150 to be removed while allowing an elongate medical device extending through the adapter 150 to remain in place. In one embodiment, the receiving tube 160 includes one or more split lines, e.g., 168A, 168B, such that the adapter 150 may be split into substantially equal portions. More split lines 168 defining more portions of the adapter 150 are also contemplated.

[0019] In one embodiment shown in FIG. 3A, the receiving tube 160 may include an elongated aperture 170 instead of a parting line 168. The aperture 170 in the embodiment shown in FIG. 3B is a slit such that opposing sides of the receiving tube 160 meet each other. The aperture 170 extends longitudinally along at least one side of the receiving tube 160 along its entire length, for example from the funnel 164 at the proximal end to the spin nut 152 at the distal end. The aperture 170 allows the adapter to be removed while allowing any elongated medical device extending through the adapter to remain in place. It is understood that the aperture 170 may be located at any circumferential location of the receiving tube. In the embodiment shown in FIG. 3A, the aperture is shown as an equidistant gap between the sides of the receiving tube 160. However, it should be understood that the gap may be tapered and may be narrower or wider than shown.

[0020] In an exemplary method of use, the microintroducer 110 with the dilator 114 disposed therein is used to access a vasculature or similar area of ​​a patient. The microintroducer 110 and dilator 114 are advanced distally until the distal tip 124 of the sheath 112 accesses the vasculature or similar area of ​​the patient. The dilator 114 is then removed and the sheath 112 of the introducer 110 defines an access pathway through which other elongated medical devices may be introduced. Such elongated medical devices may include catheters such as stylets, guidewires, integrated shape sensing catheters, peripheral venous catheters, midline catheters, peripherally inserted central catheters (PICCs), acute or chronic central venous catheters (CVCs), and other elongated medical devices introduced into a patient.

[0021] In embodiments in which the adapter is separate from or not integrated with the sheath / handle, the adapter 150 is coupled to the connector 120 using a spin nut 152 or similar connecting member. The receiving passage 162 is fluidly connected to the sheath channel 122 and provides an access channel extending from a funnel 164 located at the proximal end to the sheath tip 124 located at the distal end. An elongated medical instrument is then introduced into the vessel by introducing the instrument through the funnel 164 and traveling along the receiving passage 162 / sheath channel 122 to extend beyond the distal tip 124 of the sheath 112. When the elongated medical instrument is in place, the microintroducer system 100 may be removed without disturbing the position of the elongated medical instrument.

[0022] First, the adapter 150 is removed from the connector by loosening the spin nut 152, after which the spin nut 152 is broken along break line 166 and the receiving tube 160 is separated along parting line 168. In one embodiment, the spin nut 152 includes two break lines 166 located along opposing walls of the spin nut 152 such that the spin nut 152 breaks into two substantially equal pieces that can be separated and removed. Next, the user grasps the handles 116A, 116B and separates them proximally and laterally outward. This causes separation of the connector 120 and sheath 112 along parting lines 118A, 118B (or along aligned molecules). This allows the microintroducer 110 to be removed while leaving the elongated medical device in place.

[0023] In one embodiment, the receiving tube 160 is attached to the connector 120 using adhesives, bonding, welding, or a similar suitable method. In one embodiment, the receiving tube 160 and the connector 120 are integrally formed as a single structure. Thus, removal of the adapter 150 and the micro-introducer 110 occurs simultaneously. The receiving tube 160 and the connector 120 separate distally along parting line 118 and proximally along parting line 168 as the handles are pulled away from one another. This allows for removal of the micro-introducer system 100 while leaving the elongated medical device in place.

[0024] In an embodiment having a separate adapter 150, as shown in FIG. 3A, the adapter 150 includes an elongated aperture 170. With the spin nut 152 removed, the adapter 150 is removed from the elongated medical instrument by allowing the elongated medical instrument to pass laterally or sideways through the aperture 170 depending on the location of the aperture 170, as disclosed herein. It is understood that the aperture may be located on the upper, lower or side of the receiving tube 160 without departing from the scope of the present invention. The microintroducer 110 may then be removed by separating the handle 116, as disclosed herein.

[0025] Advantageously, the adapter 150, including the funnel 164, provides a wider opening and a larger target area for introducing a long medical instrument. Additionally, when the microintroducer 110 is introduced into a patient, the microintroducer 110 lies substantially flat against the patient's skin surface. The angled portion 156 allows the proximal tube 158 and funnel 164 to extend away from the surface of the skin, providing a more convenient, open target area for introducing a medical instrument.

[0026] In one embodiment, the angle θ provides a fixed reference angle that can be used as a reference point or starting point for the fiber optic stylet 200. As shown in FIGS. 4A and 4B, with the microintroducer system 100 positioned in the patient and the dilator 114 removed, providing an access channel for the receiving pathway 162 and the sheath channel 122. The fiber optic stylet 200 is advanced through the adapter until it is received within the angled portion 156. The angled portion 156 then bends the distal end 224 of the fiber optic stylet 200 to a predetermined angle to align the distal tip with the longitudinal axis of the microintroducer 110. The fiber optic stylet 200 is communicatively coupled to an external device 250 that detects and records the bend along the length of the stylet 200. By passing the fiber optic stylet 200 through a known angle θ, the external device 250 can automatically calibrate the bend of the fiber optic stylet 200 to the known angle θ. The fiber optic stylet 200 may also use a bend at a known angle θ as a starting point in a shape sensing procedure such that bends detected along the stylet 200 distal to the bend angle θ are recorded and used to map the path of the stylet 200 through the patient's vasculature. The fiber optic stylet 200 may also use a bend at a known angle θ as a starting point for tracking the length of the stylet inserted into the patient's vasculature.

[0027] A fiber optic stylet system such as stylet 200 and external device 250 uses the pattern of bends along the length of the stylet, along with the length of the stylet inserted, to determine a 3D map of the patient's vasculature. Using the angled portion 156 of the adapter 150 as a reference point allows the stylet 200 and external device 250 to calibrate the stylet to a reference plane and automatically activate the mapping software. The external device 250 causes an isometric view of the stylet 200 to be displayed in the user interface along with additional patient images.

[0028] As used herein, an external device may include a handheld device, laptop, computer station, server, networked device, or similar suitable device or communicatively connected devices for receiving information from the stylet 200 and displaying a map of the path taken by the stylet through the patient's vasculature. The external device 250 may further overlay images of the patient, which may include a CAT scan, a PET scan, an MRI, an X-ray, and the like. As used herein, the fiber optic stylet 200 may be used with one or more additional medical devices, such as a catheter or guidewire, associated therewith. Thus, once the path of the stylet 200 is mapped, the path of any associated medical devices is also determined. It is also understood that the fiber optic stylet system may include one or more stylets communicatively coupled to the external device 250 for mapping one or more paths through the patient's vasculature.

[0029] The adapter 150 may further include an advancement mechanism for the medical instrument inserted through the microintroducer 100. The advancement mechanism may be any type of drive mechanism, such as, for example, a slide, a screw, a crank, etc. In one embodiment, the advancement mechanism is a scroll wheel as shown in FIGS. 5A and 5B. The scroll wheel 180 may be disposed in a wall of the adapter 150 such that an end face of the scroll wheel 180 engages an elongated medical instrument, such as a stylet 200. Optionally, the stylet 200 may include a reinforcing member (not shown). The reinforcing member may include an elongated member that extends longitudinally through or with the stylet 200, and in one embodiment, the reinforcing member is extruded integrally with the stylet 200. The reinforcing member may include a material, such as a metal or similar alternative material, that exhibits stronger mechanical properties than the stylet 200 and may further prevent the stylet 200 from twisting or tangling. The scroll wheel 180 rotates about a center point 182. As shown in Figure 5B, the user manipulates an end face of the scroll wheel 180 that extends beyond the outer wall of the adapter 150 and is opposite the end face that engages the stylet 200. As the scroll wheel 180 is rotated, the stylet 200 is moved through the receiving channel 162. As shown in Figure 5A, the scroll wheel 180 is adjacent the angled portion 156, although other positions along the adapter 150 are also contemplated.

[0030] FIG. 5B shows the profile of the scroll wheel 180. In one embodiment, the side defines a concave surface that engages the side of an elongated medical device, such as the stylet 200. Optionally, the scroll wheel 180 may include a gripping portion 184, such as a ridge, either integrally formed with the scroll wheel 180 or formed by a separate material exhibiting a different characteristic. For example, the gripping portion 184 may include a silicone rubber ring disposed around the side to aid in engagement of the stylet 200 as well as engagement for a user manipulating the opposing side. The scroll wheel 180 may further include a ball plunger and detent mechanism, or a ratchet mechanism that provides incremental rotation. This allows the user to rotate the scroll wheel 180 at set intervals and advance or retract the stylet 200 at set distance intervals.

[0031] Advantageously, the scroll wheel 180 allows the user to advance or retract the elongated medical instrument through the adapter 150 at a controlled rate. This prevents the stylet 200 from being advanced / retracted too quickly or at an inconsistent rate. Additionally, the scroll wheel 180 can prevent twisting of the elongated medical instrument by pulling it through the adapter 150. When the elongated medical instrument is introduced into the adapter 150, the distal end engages the gripping portion 184 of the scroll wheel 180 before engaging the angled portion 156. The scroll wheel 180 can maintain tension on the stylet 200 or similar elongated medical instrument and pull the instrument through the adapter 150 and around the known angle θ of the angled portion 156. In contrast, when pushing a long medical device through adapter 150 from the proximal end, the distal tip may abut against the inner wall of angled portion 156, creating friction therebetween and potentially causing the device to twist or tangle at its proximal point.

[0032] The scroll wheel 180 may also apply a known, fixed strain to the elongated medical instrument. As the stylet 200 detects bending and tension applied along its length, the known, fixed tension applied by the scroll wheel 180 may be accounted for and filtered from the results by the external device 250. This prevents non-constant tension and bending of the user acting directly on the stylet 200 from affecting the shape sensing results. The scroll wheel 180 may also provide a reference point of known angle of bend θ for calibration and starting points for the shape sensing stylet 200 as disclosed herein.

[0033] The embodiments of the present invention may be embodied in other specific forms without departing from the spirit of the disclosure. The described embodiments are to be considered in all respects merely as illustrative and not restrictive. The scope of the embodiments is therefore indicated by the appended claims, rather than by the foregoing description. All changes that come within the meaning and range of equivalency of the claims are embraced within their scope.

Claims

1. 1. A micro-introducer system comprising: a microintroducer including an introducer sheath coupled to a handle, the handle and the introducer sheath defining a channel therethrough; an adapter comprising a receiving tube having an angled portion, the receiving tube defining a path from a proximal opening to the channel of the microintroducer; the adapter extends along a longitudinal axis of the microintroducer system and includes a distal tube in communication with the channel, the distal tube extending to the angled portion at an angle to a proximal tube; the distal tube, the angled portion, and the proximal tube together define a continuous receiving tube of the adapter; A micro-introducer system, wherein the adaptor is splittable along a split line extending along the entire length of the adaptor.

2. 1. A micro-introducer system comprising: a microintroducer including an introducer sheath coupled to a handle, the handle and the introducer sheath defining a channel therethrough; an adapter comprising a receiving tube having an angled portion, the receiving tube defining a path from a proximal opening to the channel of the microintroducer; the adapter extends along a longitudinal axis of the microintroducer system and includes a distal tube in communication with the channel, the distal tube extending to the angled portion at an angle to a proximal tube; the distal tube, the angled portion, and the proximal tube together define a continuous receiving tube of the adapter; The adapter includes a longitudinal opening extending along the entire length of the receiving tube.

3. The micro-introducer system of claim 2 , wherein the longitudinal opening comprises a slit.

4. The micro-introducer system of claim 1 , wherein the adapter is integrated with the micro-introducer.

5. The micro-introducer system of claim 1 , wherein the micro-introducer includes a proximal connector and the adapter includes an attachment mechanism configured to couple to the proximal connector.

6. The micro-introducer system of claim 1 , wherein the predetermined angled portion comprises a plurality of bent portions along the predetermined angled portion.

7. The micro-introducer system of claim 6 , wherein the pathway is helical.

8. 8. The microintroducer system of claim 1, wherein the predetermined angled portion is an angle between the proximal tube portion and an extension of the longitudinal axis along which the distal tube portion extends that is between 45 degrees and 90 degrees.

9. The micro-introducer system of claim 8 , wherein the angle is about 70 degrees.

10. 10. The micro-introducer system of claim 1, wherein the adapter includes an advancement mechanism disposed in a wall of the receiving tube, the advancement mechanism configured to move a medical instrument through the micro-introducer system.

11. The micro-introducer system of claim 10 , wherein the advancement mechanism is a scroll wheel.

12. The micro-introducer system of claim 11 , wherein the scroll wheel is disposed adjacent the predetermined angled portion.

13. The micro-introducer system of claim 1 , further comprising a shape-sensing stylet system.

14. The micro-introducer system of claim 13 , wherein the shape-sensing stylet system comprises a shape-sensing stylet and an external device in communication with the shape-sensing stylet.

15. The micro-introducer system of claim 14 , wherein the predetermined angled portion provides a calibration point for the shape-sensing stylet.

16. 15. The micro-introducer system of claim 14, wherein the adapter includes an advancement mechanism that provides a reference point for the external device to begin measuring one of a bend pattern and an insertion length of the shape-sensing stylet.

17. 15. A method of operating a microintroducer system as claimed in claim 14 for use in sensing the geometry of a patient's vessel, comprising: the adapter includes an advancement mechanism; the advancement mechanism advances the shape sensing stylet through the receiving tube and the angled portion; and the external device calibrating a first bend of the shape-sensing stylet relative to an angle formed by the predetermined angled portion.

18. 20. The method of claim 17, wherein the external device uses the first bend to measure a bend pattern of the shape-sensing stylet, and the external device uses the bend pattern to determine a path of the vascular vessel.

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