Image guided surgery system guide wire and methods of manufacturing and use thereof

Abstract

To provide: improved guide wire systems for use in placement of nasal treatment devices; methods of manufacture thereof; and methods of use thereof.SOLUTION: A guide wire system comprises: a guide wire 102 having a distal end 104 and a proximal end 106, where the guide wire comprises a superelastic material; a first connector 108 coupled to the proximal end of the guide wire; a second connector 110 coupled to the guide wire between the distal end and the proximal end; an electromagnetic sensor 112 coupled to the distal end of the guide wire; and a polymeric tube 114 surrounding at least a portion of the guide wire and at least a portion of the electromagnetic sensor.SELECTED DRAWING: Figure 2

Description

[Technical Field]

[0001] The present invention relates generally to guidewire systems, and more particularly to guidewire systems and methods of manufacture and use that can be used in conjunction with image-guided surgical systems to facilitate the insertion and positioning of various other devices at desired locations within the body, particularly sinus cavities.

[0002] [Priority Claim] 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 September 13, 2019, which is incorporated herein by reference in its entirety. [Background technology]

[0003] Unless otherwise indicated herein, the material described in this section is not prior art to the claims in this application, nor is it admitted to be prior art by inclusion in this section.

[0004] Sinusitis is a condition that affects more than 35 million Americans and many others in other developed countries. Sinusitis occurs when one or more of the four sinus cavities (i.e., maxillary, ethmoid, frontal, and sphenoid sinuses) are blocked or otherwise have impaired drainage. Normally, each sinus, lined with a mucous membrane, produces mucus, which is transported by cilia out of the sinus, into the nasal cavity, and down the throat. The sinuses collectively produce approximately one liter of mucus per day, and effective transport of this mucus is important for sinus health.

[0005] Each sinus has a drainage passageway or outlet that opens into the nasal passageway. This drainage passageway has an ostium along with a "transition space" in 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 in one or more openings or the area near the opening becomes inflamed, mucus release is obstructed, and the sinus enters an infected and / or inflammatory stage, i.e., sinusitis. While many cases of sinusitis can be treated with appropriate medication, in some cases, sinusitis may persist for months or longer, a condition called chronic sinusitis, and may become ineffective against medical treatment. Some patients are also prone to frequent attacks of sinusitis over a period of time, called recurrent acute sinusitis.

[0006] Balloon dilation has been applied to treat narrowed sinus passages to treat sinusitis. These balloon dilation devices generally involve the use of an inflatable balloon mounted on the distal end of a catheter, such as a balloon catheter. The inflatable balloon is inserted into the narrowed sinus passage in a deflated state, typically using a guidewire that is positioned in the desired sinus cavity using an image-guided surgery system. The balloon is then inflated, opening or reducing the narrowing of the treated sinus passage and promoting good sinus drainage and ventilation. At the same time, functional mucosal tissue of most, if not all, of the sinus lining and its drainage passages is preserved. Summary of the Invention [Problem to be solved by the invention]

[0007] Although guidewire systems for use in the placement of nasal treatment devices exist, improvements in guidewire systems, methods of manufacture, and methods of use may be desirable. [Means for solving the problem]

[0008] The present disclosure relates to guidewire systems, methods of manufacture, and methods of use. More particularly, the present disclosure relates to guidewire systems used in conjunction with image-guided surgery systems to treat nasal conditions such as sinusitis.

[0009] In one example, the present disclosure provides a guidewire system. The guidewire system includes 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. The guidewire system also includes a first connector coupled to the proximal end of the guidewire. The guidewire system also includes a second connector coupled between the distal and proximal ends of the guidewire. The guidewire system also includes an electromagnetic sensor coupled to the distal end of the guidewire. The guidewire system also includes 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 of manufacturing a guidewire system. The method includes positioning a first connector on a proximal end of a guidewire, the first connector 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. The method also includes positioning a second connector on the guidewire between a distal end of the guidewire and a proximal end of the guidewire. The method also includes positioning an electromagnetic sensor on 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 applying a heat source to at least a portion of the polymer tube.

[0011] In yet another example, the present disclosure provides a method of treating a paranasal sinus in a subject. The method includes inserting a distal portion of a guidewire system into a lumen of a balloon dilatation catheter, the guidewire system comprising: (i) a guidewire having a distal end and a proximal end, the guidewire comprising a superelastic material configured to (1) transition from a first configuration to a second configuration in response to a force applied to the guidewire and (2) return from the second configuration to the first configuration in response to the force being removed from the guidewire; (ii) a first connector coupled to the proximal end of the guidewire; (iii) a second connector coupled between the distal and proximal ends of the guidewire; (iv) an electromagnetic sensor coupled 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 dilatation catheter comprising: (i) an inner guiding member including a lumen; and (ii) a movable shaft coupled to the balloon and attached to the inner guiding member, the movable shaft configured to allow the movable shaft to move along the inner guiding member while preventing the movable shaft from rotating about the inner guiding member. The method also includes coupling a second connector of the guidewire system to the balloon dilatation catheter such that the distal end of the guidewire is fixed relative to the distal end of the balloon dilatation catheter. The method also includes simultaneously directing the distal end of the guidewire and the distal end of the balloon dilatation catheter into a sinus drainage passageway using data received from the electromagnetic sensor. The method also includes inflating the balloon.

[0012] These and other aspects, advantages and alternatives will become apparent to those skilled in the art from a reading of the following detailed description, where appropriate with reference to the accompanying drawings. [Brief explanation of the drawings]

[0013] [Figure 1] FIG. 1 is a side view of an example guidewire. [Figure 2]2 is a cross-sectional view of the guidewire system of FIG. 1 taken along line AA, according to an example. [Figure 3] 3 is a detailed cross-sectional view of the distal end of the guidewire system of FIG. 2, according to an example. [Figure 4] FIG. 2 is a perspective view of the guidewire system of FIG. 1, according to an example. [Figure 5] FIG. 5 is a perspective view of a distal portion of the guidewire system of FIG. 4, according to an example. DETAILED DESCRIPTION OF THE INVENTION

[0014] Exemplary methods and systems are described herein. It should be understood that the words "exemplary," "exemplary," and "illustrative" are used herein to mean "serving as an example, instance, or illustration." Any example or feature described herein as being "exemplary," "typical," or "illustrative" is not necessarily to be construed as preferred or advantageous over other examples or features. The examples described herein are not intended to be limiting. It will be readily understood that aspects of the present disclosure, as generally described and illustrated herein, can be arranged, substituted, combined, separated, and designed in a wide variety of different configurations, all of which are expressly contemplated herein.

[0015] Furthermore, the particular 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 figure. Furthermore, some of the elements shown may be combined or omitted. Still further, an example may include elements not shown.

[0016] In the following description, numerous specific details are set forth to provide a thorough understanding of the concepts of the present disclosure; however, the concepts of the present disclosure may be practiced without some or all of these specific details. In other instances, details of well-known devices and / or processes are omitted so as not to unnecessarily obscure the disclosure. While some concepts will be described in conjunction with specific examples, it will be understood that these examples are not intended to be limiting.

[0017] Unless otherwise indicated, terms such as "first," "second," etc. are used herein merely as identifiers and are not intended to impose any order, position, or hierarchical requirements on the items to which they refer. Furthermore, reference to, for example, a "second" item does not require or exclude the presence of, for example, a "first" or lower-numerical item, and / or, for example, a "third" or higher-numerical item.

[0018] As used herein, a system, device, structure, article, element, component, or hardware that is "configured" to perform a specified function is in fact capable of performing the specified function without any modification, rather than potentially requiring further modification to perform the specified function. In other words, a system, device, structure, article, element, component, or hardware that is "configured" to perform a specified function is specifically selected, made, implemented, utilized, programmed, and / or designed for the purpose of performing the specified function. As used herein, "configured to" refers to existing characteristics of a system, device, structure, article, element, component, or hardware that enable the system, device, structure, article, element, component, or hardware to perform the specified function without further modification. With respect to the present disclosure, a system, device, structure, article, element, component, or hardware described herein as being "configured" to perform a particular function may additionally or alternatively be described as being "adapted" and / or "operable" to perform that function.

[0019] The following claim limitations are not written in means-plus-function form and are not intended to be interpreted under 35 U.S.C. §112(f), unless such claim limitations expressly use language following the phrase "means for" with a recitation of a function and no further structure.

[0020] When the terms "about," "approximately," or "substantially" are used in reference to a quantity or measurement described herein, it means that the characteristic, parameter, or value referred to need not be exactly achieved, but rather that deviations or variations, including, for example, tolerances, measurement errors, limitations in measurement precision, and other factors known to those skilled in the art, may occur to an extent that does not preclude the effect that the characteristic is intended to produce.

[0021] Illustrative, 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, Figure 1 illustrates an example guidewire system 100, and Figure 2 illustrates a cross-sectional view of the guidewire system of Figure 1 taken along line AA. As shown in Figure 2, guidewire system 100 includes a guidewire 102 having a distal end 104 and a proximal end 106. Guidewire system 100 further includes a first connector 108 coupled to proximal end 106 of guidewire 102 and a second connector 110 coupled between distal end 104 and proximal end 106 of guidewire 102. An electromagnetic sensor 112 is coupled to distal end 104 of guidewire 102. Guidewire system 100 also includes a polymer tube 114 surrounding at least a portion of guidewire 102 and at least a portion of electromagnetic sensor 112. In one example, guidewire system 100 is disposed of after each procedure. In another example, guidewire system 100 can be sterilized and reused after each procedure.

[0023] The guidewire 102 comprises a superelastic material. When subjected to a mechanical load, the superelastic material reversibly deforms to high strains (up to 10%) through the creation of a stress-induced phase. When the load is removed, this new phase becomes unstable and the material spontaneously returns to its original shape. Thus, the guidewire 102 is configured to (i) transition from a first configuration to a second configuration in response to a force applied to the guidewire 102, and (ii) return from the second configuration to the first configuration in response to the force being removed from the guidewire 102. In one particular example, the guidewire 102 has a straight shape in the first configuration and a bent shape in the second configuration. The superelastic properties of the guidewire 102 provide kink resistance and tensile strength to the guidewire system 100. In one particular example, the superelastic material comprises a nickel-titanium alloy, such as nitinol. Other superelastic materials are possible. Guidewire 102 may include a lubricious coating that reduces friction between guidewire 102 and other components of guidewire system 100. Guidewire 102 has a diameter ranging from about 0.4 mm to about 1 mm.

[0024] In one example, the hardness of guidewire 102 is constant along the entire length of guidewire 102 from proximal end 106 to distal end 104. In another example, the hardness of the distal portion of guidewire 102 is less than the hardness of the proximal portion of guidewire 102. In such an example, the length of the distal portion of guidewire 102 is less than the length of the proximal portion of guidewire 102. The reduced hardness of the distal portion of guidewire 102 can increase the flexibility of the distal portion of guidewire 102, which can be advantageous in certain use cases.

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

[0026] 1 and described above, guidewire system 100 includes a first connector 108 coupled to the proximal end 106 of guidewire 102. In one example, first connector 108 includes a pin connector, such as, by way of non-limiting example, a 10-pin connector. In another example, polymer tube 114 surrounds at least a portion of first connector 108, and first connector 108 is secured to proximal end 106 of guidewire 102 by thermal bonding between polymer tube 114 and guidewire 102. In another example, guidewire system 100 further includes a second polymer tube positioned around guidewire 102 between first connector 108 and second connector 110.

[0027] The first connector 108 can include a flexible circuit, which includes a memory chip configured to transmit identification information of the guidewire system 100 to an image-guided surgery system when the first connector 108 is coupled to the image-guided surgery system. The flexible circuit includes electronic circuits assembled by attaching electronic devices to a flexible plastic substrate. By way of 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 bend during use.

[0028] As shown in FIG. 1 and described above, the guidewire system 100 further includes a second connector 110 coupled 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 interface with a complementary bayonet connector on the balloon dilatation catheter to couple the guidewire system 100 to the balloon dilatation catheter. In one particular example, the second connector 110 is coupled to a handpiece of the balloon dilatation catheter. The geometry of the second connector 110 on the handpiece allows a user to set a desired distance between the distal end 104 of the guidewire 102 and the distal end of the balloon dilatation catheter. In one example, when the second connector 110 is coupled to the balloon dilatation catheter, the distal end 104 of the guidewire 102 is aligned with the distal end of the balloon dilatation catheter. In another example, if the second connector 110 is coupled to a balloon dilatation catheter, the distal end 104 of the guidewire 102 extends distally from the distal end of the balloon dilatation catheter.

[0029] Exemplary balloon dilation catheters and methods of use particularly suited for dilating the paranasal sinuses and related anatomical structures, as well as methods of use with guidewire system 100, are disclosed, for example, in U.S. Patent No. 8,282,667, which is incorporated herein by reference.

[0030] 1 and described above, guidewire system 100 includes an electromagnetic sensor 112 positioned at the distal end 104 of guidewire 102. In use, electromagnetic sensor 112 is configured to interact with an image-guided surgery system and transmit data to the image-guided surgery system indicative of the location of electromagnetic sensor 112. Because electromagnetic sensor 112 is positioned at the distal end 104 of guidewire 102, the transmitted location of electromagnetic sensor 112 corresponds to the location of distal end 104 of guidewire 102. As 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 to treat a nasal condition, such as sinusitis.

[0031] In one example, the electromagnetic sensor 112 is potted with epoxy and then coupled to the distal end 104 of the guidewire 102. In another example, the electromagnetic sensor 112 is coupled to the distal end 104 of the guidewire 102 by potting with epoxy. Potting the electromagnetic sensor 112 in epoxy may provide a more robust sensor that can better withstand the rigors of multiple nasal procedures. In yet another example, the electromagnetic sensor 112 may be secured to the distal end 104 of the guidewire 102 with a radio frequency (RF) tipping die. Utilizing an RF tipping die has the advantage of bonding the electromagnetic sensor 112 to the distal end 104 of the guidewire 102 without the use of adhesives. Additionally, because the RF tipping die bonds the electromagnetic sensor 112 to the polymer tube 114, the RF tipping die prevents the electromagnetic sensor 112 from moving.

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

[0033] In another example, a method of manufacturing a guidewire system 100 of any of the above examples is provided. The method may include (a) positioning a first connector 108 on the proximal end 106 of the guidewire 102, the guidewire 102 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 102, and (ii) return from the second configuration to the first configuration in response to the force being removed from the guidewire 102; (b) positioning a second connector 110 on the guidewire 102 between the distal end 104 of the guidewire 102 and the proximal end 106 of the guidewire 102; (c) positioning an electromagnetic sensor 112 on the distal end 104 of the guidewire 102; (d) positioning a polymer tube 114 around at least a portion of the guidewire 102 and at least a portion of the electromagnetic sensor 112; and (e) applying a heat source to at least a portion of the polymer tube 114.

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

[0035] As described above, the electromagnetic sensor 112 is potted in epoxy and then coupled to the distal end 104 of the guidewire 102. In another example, the electromagnetic sensor 112 is coupled to the distal end 104 of the guidewire 102 by being potted in epoxy. In yet another example, the electromagnetic sensor 112 is affixed to the distal end 104 of the guidewire 102 with a radio frequency chipping die.

[0036] In one example, a method for treating a paranasal sinus in a subject is disclosed, comprising: (a) inserting a distal portion of a guidewire system into a lumen of a balloon dilatation catheter, the guidewire system comprising: (i) a guidewire having a distal end and a proximal end, the guidewire comprising a superelastic material configured to (1) transition from a first configuration to a second configuration in response to a force applied to the guidewire, and (2) return from the second configuration to the first configuration in response to the force being removed from the guidewire; (ii) a first connector coupled to the proximal end of the guidewire; (iii) a second connector coupled between the distal and proximal ends of the guidewire; (iv) an electromagnetic sensor coupled 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 method includes inserting a balloon dilation catheter comprising: (i) an inner guiding member including a lumen; and (ii) a movable shaft coupled to the balloon and attached to the inner guiding member, the movable shaft configured to allow the movable shaft to move along the inner guiding member and prevent the movable shaft from rotating about the inner guiding member; (b) coupling a second connector of the guidewire system to the balloon dilation catheter such that the distal end of the guidewire is fixed relative to the distal end of the balloon dilation catheter; (c) using data received from the electromagnetic sensor, simultaneously directing the distal end of the guidewire and the distal end of the balloon dilation catheter into the drainage passage of the sinus; and (d) inflating the balloon.

[0037] In one example, when the second connector 110 is coupled to a balloon dilatation catheter, the distal end 104 of the guidewire 102 is aligned with the distal end of the balloon dilatation catheter. In another example, when the second connector 110 is coupled to a balloon dilatation catheter, the distal end 104 of the guidewire 102 extends distally from the distal end of the balloon dilatation catheter. In one example, the method can further include repositioning the inner guiding member based at least in part on the determined location of the distal end 104 of the guidewire 102 relative to the sinus.

[0038] In another example, another method of treating a sinus in a subject is disclosed. The method includes: (a) inserting a portion of any of the above-described examples of the guidewire system 100 into a nostril of a subject; (b) using data received from the electromagnetic sensor 112, directing the distal end 104 of the guidewire 102 into a drainage passage of the sinus; (c) while the distal end 104 of the guidewire 102 is within the drainage passage, positioning a balloon dilation catheter over the guidewire 102, the balloon dilation catheter comprising: (i) an inner guiding member including a lumen; and (ii) a movable shaft coupled to the balloon and attached to the inner guiding member, the balloon dilation catheter configured to allow the movable shaft to move along the inner guiding member and prevent the movable shaft from rotating about the inner guiding member; (d) directing the inner guiding member over the guidewire to the drainage passage of the sinus; (e) advancing the movable shaft and the balloon dilation catheter while holding the inner guiding member stationary relative to the drainage passage to position the balloon within the drainage passage; and (f) inflating the balloon.

[0039] In one example, when the second connector 110 is coupled to a balloon dilatation catheter, the distal end 104 of the guidewire 102 is aligned with the distal end of the balloon dilatation catheter. In another example, when the second connector 110 is coupled to a balloon dilatation catheter, the distal end 104 of the guidewire 102 extends distally from the distal end of the balloon dilatation catheter. In one example, the method can further include repositioning the inner guiding member based at least in part on the determined location of the distal end 104 of the guidewire 102 relative to the sinus.

[0040] In yet another example, another method of treating a sinus in a subject is disclosed. The method includes: (a) inserting a distal portion of a balloon dilation catheter into a nostril of a subject, the balloon dilation catheter comprising: (i) an inner guiding member including a lumen; and (ii) a movable shaft coupled to the balloon and attached to the inner guiding member, the movable shaft configured to allow the movable shaft to move along the inner guiding member and prevent the movable shaft from rotating about the inner guiding member; (b) orienting the inner guiding member toward a drainage passage of a paranasal sinus; (c) advancing the movable shaft and the balloon dilation catheter to position the balloon within the drainage passage while holding the inner guiding member stationary relative to the drainage passage; (d) inserting a guidewire system 100, such as any of the above-described examples, into the lumen of the inner guiding member while the balloon is within 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 inner guiding member; and (f) inflating the balloon. In one example, the method can further include repositioning the inner guide member based at least in part on the determined location of the distal end 104 of the guidewire 102 relative to the sinus.

[0041] The methods described herein can be effectively utilized with any of the device and system examples or variations described above, as well as with other examples and variations not explicitly described herein. Features of any device or device component described in any of the examples herein can be used in other suitable examples of the device or device component.

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

[0043] While various aspects and examples have been disclosed herein, other aspects and examples will be apparent to those skilled in the art. The various aspects and examples disclosed herein are for illustrative purposes only and are not intended to be limiting, with the true scope being indicated by the following claims, along with the full scope of equivalents to which such claims are entitled. It is also to be understood that the terminology used herein is for the purpose of describing particular examples only and is not intended to be limiting.

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 end and the proximal end of the guidewire; 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. The guidewire system of claim 1 , wherein the superelastic material comprises nitinol.

3. The guidewire system of claim 1 or 2, wherein the first connector comprises a pin connector.

4. The guidewire system of claim 3 , wherein the first connector comprises a 10-pin connector.

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

6. The guidewire of any one of claims 1 to 5, wherein the guidewire comprises a lubricious coating.

7. The guidewire system according to any one of claims 1 to 6, wherein the hardness of the guidewire is constant over the entire length of the guidewire from the proximal end to the distal end.

8. The guidewire system according to any one of claims 1 to 6, wherein the hardness of the distal portion of the guidewire is less than the hardness of the proximal portion of the guidewire.

9. The guidewire system of claim 8 , wherein the length of the distal portion of the guidewire is less than the length of the proximal portion of the guidewire.

10. The guidewire system of any one of claims 1 to 9, wherein the diameter of the guidewire is constant along the entire length of the guidewire from the proximal end to the distal end.

11. The guidewire system of any one of claims 1 to 9, wherein the diameter of the distal portion of the guidewire is less than the diameter of the proximal portion of the guidewire.

12. The guidewire system according to any one of claims 1 to 11, wherein the guidewire has a diameter of about 0.4 mm to about 1 mm.

13. 13. The guidewire system of claim 1, wherein the first connector includes a flexible circuit, the flexible circuit including a memory chip configured to transmit identification information of the guidewire system to the image-guided surgical system when the first connector is coupled to the image-guided surgical system.

14. 14. The guidewire system of claim 1, wherein 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.

15. A guidewire system according to any preceding claim, wherein the electromagnetic sensor is potted with epoxy.

16. The guidewire system of any one of claims 1 to 15, wherein the electromagnetic sensor is fixed to the distal end of the guidewire by a radio frequency tipping die.

17. 17. The guidewire system of claim 1, wherein the second connector is coupled to a handpiece of a balloon dilatation catheter, and the geometry of the second connector to the handpiece allows a user to set a desired distance between the distal end of the guidewire and the distal end of the balloon dilatation catheter.

18. The guidewire system of any preceding claim, further comprising a camera positioned at the distal end of the guidewire.

19. The guidewire system according to any one of claims 1 to 18, wherein the guidewire has a straight shape in the first configuration and a bent shape in the second configuration.

20. The guidewire system of any one of claims 1 to 19, wherein the guidewire system is reusable.

21. 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 the distal end of the guidewire and the proximal end of the guidewire; 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; 1. A method of manufacturing a guidewire system, comprising:

22. 22. The method of claim 21, 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.

23. 23. The method of claim 21 or 22, wherein 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.

24. The method of any one of claims 21 to 23, wherein the electromagnetic sensor is potted in epoxy.

25. The method according to any one of claims 21 to 24, wherein the electromagnetic sensor is fixed to the distal end of the guidewire by a radio frequency tipping die.

26. (a) inserting a distal portion of a guidewire system into a lumen of a balloon dilatation catheter, the guidewire system comprising: (i) a guidewire having a distal end and a proximal end, the guidewire comprising a superelastic material configured to (1) transition from a first configuration to a second configuration in response to a force applied to the guidewire, and (2) return from the second configuration to the first configuration in response to the force being removed from the guidewire; (ii) a first connector coupled to the proximal end of the guidewire; and (iii) a second connector coupled between the distal end and the proximal end of the guidewire. (iv) an electromagnetic sensor coupled 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, wherein the balloon dilatation catheter comprises: (i) an inner guiding member including the lumen; and (ii) a movable shaft coupled to the balloon and attached to the inner guiding member, the movable shaft configured to allow the movable shaft to move along the inner guiding member and to prevent the movable shaft from rotating about the inner guiding member. (b) coupling the second connector of the guidewire system to the balloon dilatation catheter such that the distal end of the guidewire is fixed relative to the distal end of the balloon dilatation catheter; (c) simultaneously directing the distal end of the guidewire and the distal end of the balloon dilation catheter into a drainage passage of the sinus using data received from the electromagnetic sensor; (d) inflating the balloon; 1. A method for treating a paranasal sinus in a subject, comprising:

27. 27. The method of claim 26, further comprising repositioning the distal end of the balloon dilatation catheter based at least in part on the determined location of the distal end of the guidewire relative to the sinus.

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