Guidewire for image-guided surgery system and methods of making and using it

Abstract

The present disclosure provides a guidewire system comprising: (a) a guidewire having a distal end and a proximal end, the guidewire comprising a superelastic material; (b) a first connector 108 coupled to the proximal end of the guidewire; (c) a second connector 110 coupled between the distal and proximal ends of the guidewire; (d) an electromagnetic sensor 112 coupled to the distal end of the guidewire; and (e) a polymer tube surrounding at least a portion of the guidewire and at least a portion of the electromagnetic sensor.

Description

Technical Field

[0001] The present invention generally relates to a guide wire system, and more particularly to a guide wire system that can be used in conjunction with an image-guided surgery system to facilitate the insertion and positioning of various other devices at a desired location within the body, particularly in the sinus cavity, as well as methods of manufacture and use.

[0002] [Claims of Priority] This patent application claims priority to U.S. Provisional Patent Application No. 62 / 899,999, entitled "Image Guided Surgery System Guide Wire and Methods of Manufacture and Use," filed on September 13, 2019, which is hereby incorporated by reference in its entirety.

Background Art

[0003] Unless otherwise indicated herein, the materials described in this section are not prior art to the claims in this application and are not admitted to be prior art by inclusion in this section.

[0004] Sinusitis is a disease that affects more than 35 million Americans and a large number of people in other developed countries as well. Sinusitis occurs when one or more of the four sinus cavities (i.e., maxillary, ethmoid, frontal, sphenoid) become blocked or, alternatively, when there is a drainage disorder. Normally, the sinus cavities, each covered by a mucous membrane, produce mucus, which is moved by cilia out of the sinus cavities and reaches the nasal cavity and then falls into the throat. Since the sinus cavities together produce approximately one liter of mucus per day, the effective transport of this mucus is important for the health of the sinus cavities.

[0005] Each sinus has an ostium, which is an opening that extends into the nasal passage. This opening has an ostium, along with a transition space, which is the area of ​​the opening, such as the frontal recess in the case of the frontal sinus, or the ethmoidal infundibulum in the case of the maxillary sinus. When the mucous membrane of one or more openings or areas near openings becomes inflamed, the release of mucus is obstructed, and the sinuses enter an infected and / or inflammatory phase, which is sinusitis. Many cases of sinusitis are treatable with appropriate medication, but in some cases, sinusitis can persist for several months or more, becoming a condition called chronic sinusitis, where medical treatment may become ineffective. Also, some patients tend to experience frequent attacks of sinusitis over a period of time, known as recurrent acute sinusitis.

[0006] Balloon dilation is used to treat narrowed sinus passages in the treatment of sinusitis. These balloon dilation devices generally involve the use of an inflatable balloon attached to the distal end of a catheter, such as a balloon catheter. Typically, an image-guided surgery system is used to position a guidewire in the desired nasal cavity, and the inflatable balloon is inserted into the narrowed sinus passage in a deflated state. The balloon then inflates, opening the sinus passage being treated or reducing the narrowing, thereby promoting good sinus drainage and airflow. At the same time, most, if not all, of the functional mucosal tissue of the sinus lining and its drainage passages is preserved. [Overview of the project] [Problems that the invention aims to solve]

[0007] While guidewire systems exist for positioning nasal treatment devices, improvements to the guidewire system, manufacturing methods, and usage methods may be desirable. [Means for solving the problem]

[0008] This disclosure relates to a guidewire system, a method of manufacturing it, and a method of using it. More specifically, this disclosure relates to a guidewire system used in conjunction with an image-guided surgical system to treat nasal diseases such as sinusitis.

[0009] In one example, the present disclosure provides a guidewire system. The guidewire system comprises a guidewire having a distal end and a proximal end, and comprising a guidewire made of a superelastic material configured to (i) transition from a first form to a second form in response to a force applied to the guidewire, and (ii) return from the second form to the first form in response to the removal of the force from the guidewire. The guidewire system also comprises a first connector connected to the proximal end of the guidewire. The guidewire system also comprises a second connector connected between the distal and proximal ends of the guidewire. The guidewire system also comprises an electromagnetic sensor connected to the distal end of the guidewire. The guidewire system also comprises a polymer tube surrounding at least a portion of the guidewire and at least a portion of the electromagnetic sensor.

[0010] In another example, the present disclosure provides a method for manufacturing a guidewire system. The method includes positioning a first connector at the proximal end of a guidewire, wherein (i) the guidewire comprises a superelastic material configured to transition from a first form to a second form in response to a force applied to the guidewire, and (ii) return from the second form to the first form in response to the removal of the force from the guidewire. The method also includes positioning a second connector on the guidewire between the distal end and the proximal end of the guidewire. The method also includes positioning an electromagnetic sensor at the distal end of the guidewire. The method also includes positioning a polymer tube around at least a portion of the guidewire and at least a portion of the electromagnetic sensor. The method also includes applying or adding a heat source to at least a portion of the polymer tube.

[0011] In yet another example, the present disclosure provides a method for treating the paranasal sinuses of a subject. The method involves inserting the distal portion of a guidewire system into the lumen of a balloon dilation catheter, wherein the guidewire system comprises (i) a guidewire having a distal end and a proximal end, and comprising a superelastic material configured to (1) transition from a first form to a second form in response to a force applied to the guidewire, and (2) return from the second form to the first form in response to the removal of the force from the guidewire; (ii) a first connector connected to the proximal end of the guidewire; (iii) a second connector connected between the distal and proximal ends of the guidewire; (iv) an electromagnetic sensor connected to the distal end of the guidewire; and (v) a polymer tube surrounding at least a portion of the guidewire and at least a portion of the electromagnetic sensor, and the balloon dilation catheter comprises (i) an internal guide member including a lumen; and (ii) a movable shaft connected to a balloon and attached to the internal guide member, wherein the balloon dilation catheter comprises a movable shaft configured to allow the movable shaft to move along the internal guide member and to prevent the movable shaft from rotating around the internal guide member. The method also includes connecting a second connector of the guidewire system to the balloon dilation catheter so that the distal end of the guidewire is fixed to the distal end of the balloon dilation catheter. The method also includes using data received from an electromagnetic sensor to simultaneously direct the distal end of the guidewire and the distal end of the balloon dilation catheter to the drainage passage of the sinus. The method also includes inflating the balloon.

[0012] These embodiments, as well as other embodiments, advantages, and alternative forms, will become apparent to those skilled in the art by referring to the accompanying drawings as appropriate and reading the following detailed description. [Brief explanation of the drawing]

[0013] [Figure 1] This is a side view of a guidewire, one example. [Figure 2]This is a cross-sectional view taken along line AA of the guidewire system in Figure 1, relating to one example. [Figure 3] This is a detailed cross-sectional view of the distal end of the guidewire system shown in Figure 2, which is an example of such a system. [Figure 4] This is a perspective view of the guidewire system shown in Figure 1, which is an example. [Figure 5] This is a perspective view of the distal portion of the guidewire system shown in Figure 4, which is an example of such a system. [Modes for carrying out the invention]

[0014] This specification describes exemplary methods and systems. The terms “example,” “exemplary,” and “illustrative” should be understood to mean “serving as an example, case, or illustration.” An example or feature described herein as “exemplary,” “exemplary,” or “illustrative” is not necessarily construed as being preferable or advantageous to other examples or features. The examples described herein are not intended to be limiting. The aspects of this disclosure, as described and illustrated herein in general, can be arranged, substituted, merged, separated, and designed into a wide variety of configurations, all of which are expressly assumed herein.

[0015] Furthermore, the specific arrangements shown should not be considered limiting. It should be understood that other examples may include more or fewer of each element shown in a given drawing. Moreover, some of the illustrated elements may be merged or omitted. Furthermore, an example may include elements that are not shown.

[0016] The following description includes numerous specific details to ensure a full understanding of the concepts of this disclosure, although these concepts can be implemented without some or all of these specific items. Details of known devices and / or processes have been omitted in other instances to avoid unnecessarily obscuring the disclosure. While some concepts are described with specific examples, it should be understood that these examples are not intended to be limiting.

[0017] Unless otherwise indicated, terms such as “first,” “second,” etc., are used solely as identification numbers in this specification and are not intended to impose any order, position, or hierarchical requirements on the items they refer to. Furthermore, referring to an item such as “second” does not require or exclude the existence of, for example, an item such as “first” or an item with a lower number, and / or an item such as “third” or an item with a higher number.

[0018] As used herein, a system, apparatus, structure, article, element, component, or hardware “configured” to perform a specified function is capable of performing the specified function without any modification, rather than having the potential to perform the specified function only after further modification. In other words, a system, apparatus, structure, article, element, component, or hardware “configured” to perform a specified function is specifically selected, manufactured, implemented, used, programmed, and / or designed for the purpose of performing the specified function. As used herein, “configured to ~” refers to an existing characteristic of the system, apparatus, structure, article, element, component, or hardware that enables the system, apparatus, structure, article, element, component, or hardware to perform the specified function without further modification. For the purposes of this disclosure, a system, apparatus, structure, article, element, component, or hardware described herein as “configured” to perform a particular function may additionally or alternatively be described as “adapted” and / or “operable” to perform that function.

[0019] The following limitations of the claims are not described in means-plus-function format and are not intended to be construed under 35 U.S.C. § 112, paragraph (f), unless such claim limitations expressly use language reciting a function after “means for” and without further structure.

[0020] When the terms “about,” “approximately,” or “substantially” are used herein in reference to an amount or measurement, the recited feature, parameter, or value need not be achieved exactly, but rather deviations or variations, including for example, tolerances, measurement errors, limitations of measurement accuracy, and other factors known to those of skill in the art, may occur to the extent not excluding the intended effect resulting from the feature.

[0021] Illustrative and non-exhaustive examples of the subject matter of the present disclosure, which may or may not be claimed, are provided below.

[0022] Referring to the drawings, FIG. 1 is a guidewire system 100 according to one example, and FIG. 2 is a cross-sectional view taken along line A-A of the guidewire system of FIG. 1. As shown in FIG. 2, the guidewire system 100 includes a guidewire 102 having a distal end 104 and a proximal end 106. The guidewire system 100 further includes a first connector 108 coupled to the proximal end 106 of the guidewire 102, and a second connector 110 coupled between the distal end 104 and the proximal end 106 of the guidewire 102. An electromagnetic sensor 112 is coupled to the distal end 104 of the guidewire 102. The guidewire system 100 further includes a polymeric tube 114 surrounding at least a portion of the guidewire 102 and at least a portion of the electromagnetic sensor 112. In one example, the guidewire system 100 is discarded after each procedure. In another example, the guidewire system 100 can be sterilized and reused after each procedure.

[0023] The guide wire 102 includes a superelastic material. When subjected to a mechanical load, the superelastic material reversibly deforms up to a high strain (up to 10%) by the generation of a stress induced phase. When the load is removed, this new phase becomes unstable and the material naturally returns to its original shape. Thus, the guide wire 102 is configured to (i) transition from a first form to a second form in response to a force applied to the guide wire 102, and (ii) return from the second form to the first form in response to the force being removed from the guide wire 102. In one particular example, the guide wire 102 has a straight shape in the first form and a bent shape in the second form. The superelasticity of the guide wire 102 provides the guide wire system 100 with kink resistance and tensile strength. In one particular example, the superelastic material includes a nickel-titanium alloy such as nitinol. Other superelastic materials are possible. The guide wire 102 can include a lubricious coating that reduces friction between the guide wire 102 and other components of the guide wire system 100. The diameter of the guide wire 102 ranges from about 0.4 mm to about 1 mm.

[0024] In one example, the hardness of the guide wire 102 is constant over the entire length of the guide wire 102 from the proximal end 106 to the distal end 104. In another example, the hardness of the distal portion of the guide wire 102 is less than the hardness of the proximal portion of the guide wire 102. In such an example, the length of the distal portion of the guide wire 102 is less than the length of the proximal portion of the guide wire 102. By reducing the hardness of the distal portion of the guide wire 102, the flexibility of the distal portion of the guide wire 102 can be increased, which can be advantageous in certain use cases.

[0025] In one example, the diameter of the guidewire 102 is constant along its entire length, from the proximal end 106 to the distal end 104. In another example, the diameter of the distal portion of the guidewire 102 is less than the diameter of the proximal portion. In such an example, the length of the distal portion of the guidewire 102 is less than the length of the proximal portion. The reduced diameter of the distal portion of the guidewire 102 can increase its flexibility, which may be advantageous in certain use cases.

[0026] As shown in Figure 1 and described above, the guidewire system 100 includes a first connector 108 connected to the proximal end 106 of the guidewire 102. In one example, the first connector 108 includes a pin connector, such as a 10-pin connector, as an example not limited to this. In another example, a polymer tube 114 surrounds at least a portion of the first connector 108, and the first connector 108 is fixed to the proximal end 106 of the guidewire 102 by thermal bonding between the polymer tube 114 and the guidewire 102. In yet another example, the guidewire system 100 further includes a second polymer tube positioned around the guidewire 102 between the first connector 108 and the second connector 110.

[0027] The first connector 108 may include a flexible circuit, which includes a memory chip configured to transmit identification information of the guidewire system 100 to the image-guided surgery system when the first connector 108 is connected to the image-guided surgery system. The flexible circuit includes electronic circuits assembled by mounting electronic devices onto a flexible plastic substrate. For example, the flexible plastic substrate can be formed from at least one material selected from polyimide, polyetheretherketone, and transparent conductive polyester film. Such a design allows the circuit board to conform to a desired shape or to bend during use.

[0028] As shown in Figure 1 and described above, the guidewire system 100 further comprises a second connector 110 connected between the distal end 104 and the proximal end 106 of the guidewire 102. In one example, the second connector 110 includes a bayonet connector configured to connect the guidewire system 100 to the balloon dilation catheter by interacting with a complementary bayonet connector of the balloon dilation catheter. In one particular example, the second connector 110 is connected to the handpiece of the balloon dilation catheter. The geometry of the second connector 110 to the handpiece allows the user to set a desired distance between the distal end 104 of the guidewire 102 and the distal end of the balloon dilation catheter. In one example, when the second connector 110 is connected to the balloon dilation catheter, the distal end 104 of the guidewire 102 is aligned with the distal end of the balloon dilation catheter. In another example, when the second connector 110 is connected to a balloon inflatable catheter, the distal end 104 of the guidewire 102 extends distally from the distal end of the balloon inflatable catheter.

[0029] A typical balloon dilation catheter and method of use, particularly suitable for dilating the paranasal sinuses and associated anatomical structures, as well as a method of use with a guidewire system 100, are disclosed, for example, in U.S. Patent No. 8,282,667. This U.S. patent is incorporated herein by reference.

[0030] As shown in Figure 1 and described above, the guidewire system 100 includes an electromagnetic sensor 112 positioned at the distal end 104 of the guidewire 102. When in use, the electromagnetic sensor 112 is configured to interact with the image-guided surgical system and transmit data indicating the location of the electromagnetic sensor 112 to the image-guided surgical system. Since the electromagnetic sensor 112 is positioned at the distal end 104 of the guidewire 102, the transmitted location of the electromagnetic sensor 112 corresponds to the location of the distal end 104 of the guidewire 102. As will be discussed in more detail below, this information can be used to ensure that a device (such as a balloon dilation catheter) is properly positioned in the desired nasal cavity and that nasal diseases such as sinusitis are treated.

[0031] In one example, the electromagnetic sensor 112 is potted with epoxy before being connected to the distal end 104 of the guidewire 102. In another example, the electromagnetic sensor 112 is connected to the distal end 104 of the guidewire 102 by being potted with epoxy. Potting the electromagnetic sensor 112 in epoxy can provide a more robust sensor that can withstand the rigors of multiple nasal procedures better. In yet another example, the electromagnetic sensor 112 can be fixed to the distal end 104 of the guidewire 102 by a radio frequency (RF) tipping die. Using an RF tipping die offers the advantage of joining the electromagnetic sensor 112 to the distal end 104 of the guidewire 102 without the use of adhesive. Furthermore, since the RF tipping die joins the electromagnetic sensor 112 to the polymer tube 114, the RF tipping die prevents the electromagnetic sensor 112 from moving.

[0032] In one example, the guidewire system 100 further includes a camera positioned at the distal end 104 of the guidewire 102. In such an example, the electromagnetic sensor 112 can work in conjunction with the camera to provide medical professionals with the location of the distal end 104 of the guidewire 102.

[0033] In another example, a method for manufacturing one of the guidewire systems 100 described above is provided. The method may include (a) positioning a first connector 108 on the proximal end 106 of a guide wire 102, wherein the guide wire 102 is made of a superelastic material configured to (i) transition from a first form to a second form in response to a force applied to the guide wire 102, and (ii) return from the second form to the first form in response to the removal of the force from the guide wire 102; (b) positioning a second connector 110 on the guide wire 102 between the distal end 104 of the guide wire 102 and the proximal end 106 of the guide wire 102; (c) positioning an electromagnetic sensor 112 on the distal end 104 of the guide wire 102; (d) positioning a polymer tube 114 around at least a portion of the guide wire 102 and at least a portion of the electromagnetic sensor 112; and (e) applying or adding a heat source to at least a portion of the polymer tube 114.

[0034] In one example of the method described above, applying a heat source to at least a portion of the polymer tube 114 includes applying the heat source adjacent to the proximal end 106 of the guide wire 102 to fix the first connector 108 to the proximal end 106 of the guide wire 102. In another example of the method, applying a heat source to at least a portion of the polymer tube 114 includes applying the heat source adjacent to the distal end 104 of the guide wire 102 to fix the electromagnetic sensor 112 to the distal end 104 of the guide wire 102.

[0035] As described above, the electromagnetic sensor 112 is potted in epoxy before being connected to the distal end 104 of the guide wire 102. In another example, the electromagnetic sensor 112 is connected to the distal end 104 of the guide wire 102 by being potted in epoxy. In yet another example, the electromagnetic sensor 112 is fixed to the distal end 104 of the guide wire 102 by a radio frequency chipping die.

[0036] In one example, a method for treating a subject's sinuses is disclosed. The method involves (a) inserting the distal portion of a guidewire system into the lumen of a balloon dilation catheter, the guidewire system comprising (i) a guidewire having a distal end and a proximal end, and comprising a superelastic material configured to (1) transition from a first form to a second form in response to a force applied to the guidewire, and (2) return from the second form to the first form in response to the removal of the force from the guidewire; (ii) a first connector connected to the proximal end of the guidewire; (iii) a second connector connected between the distal and proximal ends of the guidewire; (iv) an electromagnetic sensor connected to the distal end of the guidewire; and (v) a polymer tube surrounding at least a portion of the guidewire and at least a portion of the electromagnetic sensor, the balloon dilation catheter The balloon dilation catheter comprises (i) an internal guide member including a lumen, and (ii) a movable shaft connected to and attached to the internal guide member, wherein the balloon dilation catheter is configured to allow the movable shaft to move along the internal guide member and to prevent the movable shaft from rotating around the internal guide member; (b) connecting a second connector of a guidewire system to the balloon dilation catheter so that the distal end of the guidewire is fixed to the distal end of the balloon dilation catheter; (c) using data received from an electromagnetic sensor to simultaneously direct the distal end of the guidewire and the distal end of the balloon dilation catheter to the drainage passage of the sinus sinus; and (d) inflating the balloon.

[0037] In one example, when the second connector 110 is connected to a balloon dilation catheter, the distal end 104 of the guidewire 102 is aligned with the distal end of the balloon dilation catheter. In another example, when the second connector 110 is connected to a balloon dilation catheter, the distal end 104 of the guidewire 102 extends distally from the distal end of the balloon dilation catheter. In one example, the method may further include repositioning the internal guide member based at least in part on the determined location of the distal end 104 of the guidewire 102 relative to the sinuses.

[0038] In another example, a different method for treating a subject's sinuses is disclosed. The method includes (a) inserting a portion of one of the above-described examples of guidewire systems 100 into the nostril of a subject; (b) using data received from an electromagnetic sensor 112 to direct the distal end 104 of the guidewire 102 towards the drainage passage of the sinus; (c) positioning a balloon dilation catheter so as to cover the guidewire 102 while the distal end 104 of the guidewire 102 is in the drainage passage, wherein the balloon dilation catheter comprises (i) an internal guide member including a lumen; and (ii) a movable shaft connected to and attached to the internal guide member, wherein the balloon dilation catheter has a movable shaft configured to allow the movable shaft to move along the internal guide member and to prevent the movable shaft from rotating around the internal guide member; (d) directing the internal guide member across the guidewire to the drainage passage of the sinus; (e) advancing the movable shaft and the balloon dilation catheter to position the balloon in the drainage passage while keeping the internal guide member stationary relative to the drainage passage; and (f) inflating the balloon.

[0039] In one example, when the second connector 110 is connected to a balloon dilation catheter, the distal end 104 of the guidewire 102 is aligned with the distal end of the balloon dilation catheter. In another example, when the second connector 110 is connected to a balloon dilation catheter, the distal end 104 of the guidewire 102 extends distally from the distal end of the balloon dilation catheter. In one example, the method may further include repositioning the internal guide member based at least in part on the determined location of the distal end 104 of the guidewire 102 relative to the sinuses.

[0040] In yet another example, a different method for treating a subject's sinuses is disclosed. The method includes (a) inserting the distal portion of a balloon dilation catheter into the nostril of a subject, wherein the balloon dilation catheter comprises (i) an internal guide member including a lumen, and (ii) a movable shaft connected to a balloon and attached to the internal guide member, wherein the balloon dilation catheter is configured to allow the movable shaft to move along the internal guide member and to prevent the movable shaft from rotating around the internal guide member; (b) directing the internal guide member towards the drainage passage of the paranasal sinus; (c) advancing the movable shaft and balloon dilation catheter to position the balloon in the drainage passage while keeping the internal guide member stationary relative to the drainage passage; (d) inserting one of the above-described guidewire systems 100 into the lumen of the internal guide member while the balloon is in the drainage passage; (e) advancing the guidewire system through the lumen until the distal end 104 of the guidewire 102 is aligned with the distal end of the internal guide member; and (f) inflating the balloon. In one example, the method may further include repositioning the internal guide member based at least in part on the determined location of the distal end 104 of the guidewire 102 relative to the paranasal sinus.

[0041] The methods described herein can be effectively used in conjunction with the examples or variations of the apparatus and systems described above, and with other examples and variations not expressly described herein. Any feature of an apparatus or apparatus component described in any of the examples herein can be used in other suitable examples of the apparatus or apparatus component.

[0042] It should be understood that the arrangements described herein are for illustrative purposes only. Therefore, those skilled in the art will understand that other arrangements and other elements (e.g., machines, interfaces, functions, sequences, groupings of functions, etc.) may be used instead, and that some elements may be omitted entirely depending on the desired result. Furthermore, many of the elements described are functional entities that may be implemented as separate or dispersed components, in any suitable combination and location with other components, or merged with other structural elements described as independent structures.

[0043] While various embodiments and examples have been disclosed herein, other embodiments and examples will be apparent to those skilled in the art. The various embodiments and examples disclosed herein are for illustrative purposes only and are not intended to limit, and the true scope is shown by such claims, along with the entire scope of equivalents to which the following claims are granted. It should also be understood that the terminology used herein is for illustrative purposes only and is not intended to limit.

Claims

1. a guidewire having a distal end and a proximal end, the guidewire comprising a superelastic material configured to (i) transition from a first configuration to a second configuration in response to a force applied to the guidewire, and (ii) return from the second configuration to the first configuration in response to the force being removed from the guidewire; a first connector coupled to the proximal end of the guidewire; a second connector coupled between the distal and proximal ends of the guidewire and configured to couple the guidewire to a balloon dilatation catheter; an electromagnetic sensor coupled to the distal end of the guidewire; a polymer tube surrounding at least a portion of the guidewire and at least a portion of the electromagnetic sensor; A guidewire system comprising:

2. 10. The guidewire system of claim 1, wherein the superelastic material comprises Nitinol, and / or the guidewire comprises a lubricious coating, and / or the first connector comprises a pin connector or a 10-pin connector.

3. 3. The guidewire system of claim 1, wherein the second connector comprises a bayonet connector configured to interact with a complementary bayonet connector of the balloon dilatation catheter to couple the guidewire system to the balloon dilatation catheter.

4. 4. The guidewire system of claim 1, wherein the hardness of the guidewire is constant along the entire length of the guidewire from the proximal end to the distal end, the diameter of the guidewire is constant along the entire length of the guidewire from the proximal end to the distal end, the hardness of a distal portion of the guidewire is less than the hardness of a proximal portion of the guidewire, the length of the distal portion of the guidewire is less than the length of the proximal portion of the guidewire, and / or the diameter of the distal portion of the guidewire is less than the diameter of the proximal portion of the guidewire, the diameter of the guidewire is between about 0.4 mm and about 1 mm.

5. 5. The guidewire system of claim 1, wherein the first connector comprises a flexible circuit, the flexible circuit comprising a memory chip configured to transmit identification information of the guidewire system to an image-guided surgical system when the first connector is coupled to the image-guided surgical system, and / or the polymer tube surrounds at least a portion of the first connector, and the first connector is secured to the proximal end of the guidewire by thermal bonding between the polymer tube and the guidewire.

6. 6. The guidewire system of claim 1, wherein the electromagnetic sensor is potted with epoxy and / or the electromagnetic sensor is fixed to the distal end of the guidewire by a radio frequency chipping die configured to bond the electromagnetic sensor to the distal end of the guidewire without the use of adhesives.

7. A guidewire system as described in any one of claims 1 to 6, wherein the second connector is connected to a handpiece of the balloon dilation catheter and / or the guidewire system further comprises a camera positioned at the distal end of the guidewire so that a user can set a desired distance between the distal end of the guidewire and the distal end of the balloon dilation catheter.

8. 8. The guidewire system of claim 1, wherein the guidewire has a straight shape in the first configuration and a bent shape in the second configuration, and / or the guidewire system is reusable.

9. positioning a first connector on a proximal end of a guidewire comprising a superelastic material configured to (i) transition from a first configuration to a second configuration in response to a force applied to the guidewire, and (ii) return from the second configuration to the first configuration in response to the force being removed from the guidewire; positioning a second connector on the guidewire between a distal end of the guidewire and the proximal end of the guidewire, the second connector being configured to couple the guidewire to a balloon dilatation catheter; positioning an electromagnetic sensor at the distal end of the guidewire; positioning a polymer tube around at least a portion of the guidewire and at least a portion of the electromagnetic sensor; applying a heat source to at least a portion of the polymer tube; A method of manufacturing a guidewire system, comprising:

10. 10. The method of claim 9, wherein applying the heat source to at least a portion of the polymer tube comprises applying the heat source adjacent the proximal end of the guidewire to secure the first connector to the proximal end of the guidewire; or applying the heat source to at least a portion of the polymer tube comprises applying the heat source adjacent the distal end of the guidewire to secure the electromagnetic sensor to the distal end of the guidewire; and / or the electromagnetic sensor is potted in epoxy; and / or the electromagnetic sensor is secured to the distal end of the guidewire by a radio frequency chipping die configured to bond the electromagnetic sensor to the distal end of the guidewire without the use of an adhesive.