Image guided surgical system guidewire and method of manufacture and use

Abstract

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

Description

[0001] Related Applications

[0002] This application claims priority to U.S. Provisional Application No. 62 / 899,999, filed on September 13, 2019, entitled “Image Guided Surgery System Guide Wire and Methods of Manufacture and Use,” the contents of which are incorporated herein by reference in their entirety. Technical Field

[0003] The present invention relates generally to a guidewire system, and more particularly to a guidewire system and methods of manufacture and use that can be used in conjunction with an image-guided surgical system to facilitate insertion and positioning of a variety of other devices at desired locations within the body, particularly sinus cavities. Background Art

[0004] 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.

[0005] Sinusitis is a disease that affects more than 35 million Americans and is present in large numbers in other developed countries as well. Sinusitis occurs when one or more of the four paired sinus cavities (i.e., maxillary, ethmoid, frontal, and sphenoid) become blocked or otherwise have compromised drainage. Normally, each sinus cavity, which is lined by mucous membranes, produces mucus, which is then moved from the sinus cavity out of the nose and down the throat by the beating cilia. Sinusitis combined produces about a liter of mucus per day, so efficient transport of this mucus is important to sinus health.

[0006] Each sinus cavity has a drainage pathway or outflow tract that leads to the nasal passage. The drainage pathway may include an orifice and a "transition space" in the area of ​​the orifice, such as the "frontal recess" in the case of the frontal sinus, or the "ethmoid infundibulum" in the case of the maxillary sinus. When the mucous membranes of one or more of the orifices or areas near the orifices become inflamed, the outflow of mucus is interrupted, thereby providing conditions for infection and / or inflammation of the sinus cavity (i.e., sinusitis). Although many cases of sinusitis can be treated with appropriate medications, in some cases, sinusitis persists for months or longer, a condition known as chronic sinusitis, and may not respond to medical treatment. Some patients are also prone to multiple episodes of sinusitis in a given period of time, a condition known as recurrent acute sinusitis.

[0007] Balloon dilatation has been applied to treat narrow sinus passages to treat sinusitis. These balloon dilatation devices generally involve the use of an inflatable balloon located at the distal end of a catheter (e.g., a balloon catheter). Typically, the inflatable balloon is inserted into the narrow sinus passage in a contracted state using an image-guided surgical system via a guidewire positioned in the intended nasal cavity. The balloon is then inflated to open or reduce the degree of narrowing of the sinus passage being treated to promote better sinus drainage and ventilation. At the same time, most (if not all) of the functional mucosal tissue lining of the sinuses and their drainage channels are retained.

[0008]

[0006] While guidewire systems for placement of nasal therapeutic devices exist, there may be a need for improved guidewire systems, methods of manufacture, and methods of use. Summary of the invention

[0009] The present disclosure relates to guidewire systems, methods of manufacture, and methods of use. More particularly, the present disclosure relates to guidewire systems for use in conjunction with image-guided surgical systems to treat nasal ailments such as sinusitis.

[0010] In one example, the present disclosure provides a guide wire system. The guide wire system includes a guide wire with a distal end and a proximal end, wherein the guide wire includes a superelastic material, and the superelastic material is configured to (i) change from a first configuration to a second configuration in response to a force applied to the guide wire and (ii) return to the first configuration from the second configuration in response to removing force from the guide wire. The guide wire system also includes a first connector connected to the proximal end of the guide wire. The guide wire system also includes a second connector connected to the guide wire between the distal end and the proximal end. The guide wire system also includes an electromagnetic sensor connected to the distal end of the guide wire. The guide wire system also includes a polymer tube surrounding at least a portion of the guide wire and at least a portion of the electromagnetic sensor.

[0011] In another example, the present disclosure provides a method for manufacturing a guide wire system. The method includes positioning a first connector at the proximal end of the guide wire, wherein the guide wire includes a superelastic material, and the superelastic material is configured to (i) change from a first configuration to a second configuration in response to a force applied to the guide wire, and (ii) return to the first configuration from the second configuration in response to removing the force from the guide wire. The method also includes positioning a second connector on the guide wire, between the distal end of the guide wire and the proximal end of the guide wire. The method also includes positioning an electromagnetic sensor at the distal end of the guide wire. The method also includes positioning a polymer tube around at least a portion of the guide wire and at least a portion of the electromagnetic sensor. The method also includes applying a heat source to at least a portion of the polymer tube.

[0012] In yet another example, the present disclosure provides a method of treating a sinus cavity of 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, wherein the guidewire comprises 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 removal of the force from the guidewire, (ii) a first connector coupled to the proximal end of the guidewire, (iii) a second connector coupled to the guidewire and disposed between the distal end and the proximal end, (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 internal guide member comprising a lumen, and (ii) a movable shaft coupled to a balloon and mounted on the internal guide member, wherein the balloon dilatation catheter is configured to allow the movable shaft to move along the internal guide member and prevent the movable shaft from rotating around the internal guide member. The method also includes coupling a second connector of the guidewire system to the balloon dilatation catheter so that the distal end of the guidewire is fixed relative to the distal end of the balloon dilatation catheter. The method also includes using data received from the electromagnetic sensor to simultaneously guide the distal end of the guidewire and the distal end of the balloon dilatation catheter to the drainage passage of the sinus cavity. The method also includes inflating the balloon.

[0013] These and other aspects, advantages and alternatives will become apparent to those skilled in the art by reading the following detailed description and, where appropriate, referring to the accompanying drawings. BRIEF DESCRIPTION OF THE DRAWINGS

[0014] Figure 1 is a side view of a guidewire according to an example.

[0015] Figure 2 According to the example along Figure 1 Cross-sectional view of the guidewire system taken along line AA.

[0016] Figure 3 Based on the example Figure 2 Cross-sectional detail of the distal end of the guidewire system.

[0017] Figure 4 Based on the example Figure 1 Perspective view of the guidewire system.

[0018] Figure 5 Based on the example Figure 4 Perspective view of the distal portion of the guidewire system. DETAILED DESCRIPTION

[0019] Example methods and systems are described herein. It should be understood that the words "example," "exemplary," and "illustrative" as used herein mean "serving as an example, instance, or illustration." Any example or feature described herein as "example," "exemplary," or "illustrative" is not necessarily to be construed as being preferred or superior to other examples or features. The examples described herein are not meant to be limiting. It will be readily understood that the various aspects of the present disclosure as primarily described herein and shown in the figures may be arranged, substituted, combined, separated, and designed in a variety of different configurations, all of which are expressly contemplated herein.

[0020] In addition, the specific arrangements shown in the figures should not be considered as limiting. It should be understood that other examples may include more or fewer elements than each element shown in a given figure. In addition, some illustrated elements may be combined or omitted. In addition, examples may include elements not shown in the figures.

[0021] In the following description, numerous specific details are set forth to provide a thorough understanding of the disclosed concepts, which may be implemented without some or all of these details. In other cases, details of known devices and / or processes have been omitted to avoid unnecessarily obscuring the present disclosure. Although some concepts will be described in conjunction with specific examples, it should be understood that these examples are not intended to be limiting.

[0022] Unless otherwise indicated, the terms "first", "second", etc. are used herein merely as labels and are not intended to impose order, position, or hierarchy requirements on the items to which these terms refer. In addition, reference to an item, such as "second", does not require or preclude the presence of an item, such as "first" or lower-numbered, and / or an item, such as "third" or higher-numbered.

[0023] As used herein, a system, device, structure, article, element, component, or hardware that is "configured to" perform a specified function is indeed capable of performing the specified function without any changes, rather than merely having the possibility of performing the specified function after further modifications are made. In other words, a system, device, structure, article, element, component, or hardware that is "configured to" perform a specified function is specifically selected, created, implemented, utilized, programmed, and / or designed for the purpose of performing the specified function. As used herein, "configured to" represents existing features 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 modifications. For the purposes of this disclosure, a system, device, structure, article, element, component, or hardware that is described as "configured to" perform a particular function may be additionally or alternatively described as "suitable for" and / or "operable" to perform that function.

[0024] The following claim limitations are not drafted in means-plus-function format and are not intended to be interpreted pursuant to 35 U.S.C. § 112(f) unless and until such claim limitations expressly use the phrase "means for..." followed by a claim of functionality without other structure.

[0025] The terms "about," "approximately," or "substantially" with respect to quantities or measurements described herein mean that the recited feature, parameter, or value need not be precisely obtained, but rather that there may be deviations or variations in the quantity (which include, for example, tolerances, measurement errors, measurement precision limitations, and other factors known to those skilled in the art), which may not preclude the effect that the characteristic is intended to provide.

[0026] The following provides illustrative, non-exhaustive examples of subject matter in accordance with the present disclosure, which may or may not be claimed.

[0027] With reference to the accompanying drawings, Figure 1 is a guidewire system 100 according to an example, and Figure 2 is along Figure 1 A cross-sectional view of the guidewire system taken along line AA. Figure 2 As shown, the guide wire system 100 includes a guide wire 102 having a distal end 104 and a proximal end 106. The guide wire system 100 also includes a first connector 108 connected to the proximal end 106 of the guide wire 102 and a second connector 110 connected to the guide wire 102 and between the distal end 104 and the proximal end 106. An electromagnetic sensor 112 is connected to the distal end 104 of the guide wire 102. The guide wire system 100 also includes a polymer tube 114 surrounding at least a portion of the guide wire 102 and at least a portion of the electromagnetic sensor 112. In one example, the guide wire system 100 is discarded after each operation. In another example, the guide wire system 100 can be sterilized and reused after each operation.

[0028] Guidewire 102 includes superelastic material. When mechanically loaded, superelastic material reversibly deforms to high strain (up to 10%) by generating stress-induced phase. When the load is removed, the new phase becomes unstable, and the material automatically recovers its original shape. Therefore, guidewire 102 is configured to (i) change from a first configuration to a second configuration in response to a force applied to guidewire 102, and (ii) return from the second configuration to the first configuration in response to the force being removed from guidewire 102. In a specific example, guidewire 102 has a straight shape in the first configuration and a curved shape in the second configuration. The superelasticity of guidewire 102 provides longitudinal bending resistance and tensile strength for guidewire system 100. In a specific example, superelastic material includes nickel-titanium alloy, such as nitinol. Other superelastic materials are also possible. Guidewire 102 may include a lubricating coating that reduces the friction between guidewire 102 and other components of guidewire system 100. The diameter of guidewire 102 is in the range of about 0.4mm to about 1mm.

[0029] In one example, the stiffness of the guidewire 102 is constant along the entire length of the guidewire 102 from the proximal end 106 to the distal end 104. In another example, the stiffness of the distal portion of the guidewire 102 is less than the stiffness of the proximal portion of the guidewire 102. In such an example, the length of the distal portion of the guidewire 102 is less than the length of the proximal portion of the guidewire 102. The reduced stiffness of the distal portion of the guidewire 102 may provide increased flexibility of the distal portion of the guidewire 102, which may be advantageous in certain use cases.

[0030] In one example, the diameter of the guidewire 102 is constant along the entire length of the guidewire 102 from the proximal end 106 to the distal end 104. In another example, the diameter of the distal portion of the guidewire 102 is smaller than the diameter of the proximal portion of the guidewire 102. In such an example, the length of the distal portion of the guidewire 102 is smaller than the length of the proximal portion of the guidewire 102. The reduced diameter of the distal portion of the guidewire 102 may provide increased flexibility of the distal portion of the guidewire 102, which may be advantageous in certain use cases.

[0031] like Figure 1 As shown and as described above, the guidewire system 100 includes a first connector 108 coupled 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 a non-limiting example. 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 via a thermal bond between the polymer tube 114 and the guidewire 102. In another example, the guidewire system 100 also includes a second polymer tube positioned around the guidewire 102 between the first connector 108 and the second connector 110.

[0032] The first connector 108 may include a flexible circuit including a memory chip configured to transmit an identification of the guidewire system 100 to the image-guided surgery system when the first connector 108 is coupled to the image-guided surgery system. The flexible circuit includes an electronic circuit assembled by mounting electronic devices on a flexible plastic substrate. As an example, the flexible plastic substrate may be formed of at least one material selected from polyimide, polyetheretherketone, and a transparent conductive polyester film. This design enables the circuit board to conform to a desired shape or flex during its use.

[0033] like Figure 1 As shown and as described above, the guidewire system 100 includes a second connector 110 that is coupled to the guidewire 102 between the distal end 104 and the proximal end 106. In one example, the second connector 110 includes a bayonet connector that is configured to interact with a complementary bayonet connector of a balloon dilatation catheter, thereby coupling the guidewire system 100 to the balloon dilatation catheter. In a specific example, the second connector 110 is coupled to the nose of the balloon dilatation catheter. The second connector 110 allows the user to set the desired distance between the distal end 104 of the guidewire 102 and the distal end of the balloon dilatation catheter relative to the geometry 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, when the second connector 110 is coupled to the balloon dilatation catheter, the distal end 104 of the guidewire 102 extends distally from the distal end of the balloon dilatation catheter.

[0034] Exemplary balloon dilatation catheters and methods particularly suitable for dilating anatomical structures associated with the sinuses and for use with the guidewire system 100 are disclosed, for example, in US Pat. No. 8,282,667, which is incorporated herein by reference.

[0035] like Figure 1 As shown 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 surgery system to transmit data indicating the position of the electromagnetic sensor 112 to the image-guided surgery system. Since the electromagnetic sensor 112 is positioned at the distal end 104 of the guidewire 102, the transmitted position of the electromagnetic sensor 112 corresponds to the position of the distal end 104 of the guidewire 102. As discussed in more detail below, this information can be used to ensure that a device (e.g., a balloon dilatation catheter) is correctly positioned in the intended nasal cavity to treat nasal ailments such as sinusitis.

[0036] In one example, the electromagnetic sensor 112 is potted with epoxy before being connected to the distal end 104 of the guide wire 102. In another example, the electromagnetic sensor 112 is potted with epoxy and connected to the distal end 104 of the guide wire 102. Encapsulating the electromagnetic sensor 112 in epoxy can provide a more durable sensor that can better withstand the rigors of multiple nasal surgeries. In yet another example, the electromagnetic sensor 112 can be fixed to the distal end 104 of the guide wire 102 via a radio frequency (RF) dumping mold. Using the RF dumping mold provides the benefit of attaching the electromagnetic sensor 112 to the distal end 104 of the guide wire 102 without using an adhesive. In addition, when the RF dumping mold attaches the electromagnetic sensor 112 to the polymer tube 114, the RF dumping mold prevents the electromagnetic sensor 112 from moving.

[0037] In one example, the guidewire system 100 also 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 the location of the distal end 104 of the guidewire 102 to the medical professional.

[0038] In another example, a method of manufacturing the guidewire system 100 of any of the above examples is provided. The method may include (a) positioning a first connector 108 at the proximal end 106 of a guidewire 102, wherein the guidewire 102 includes 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 removal of the force 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 at 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.

[0039] In one example of the above method, applying a heat source to at least a portion of the polymer tube 114 includes applying a heat source near 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 near the distal end 104 of the guidewire 102 to secure the electromagnetic sensor 112 to the distal end 104 of the guidewire 102.

[0040] As described above, the electromagnetic sensor 112 is encapsulated in epoxy before being 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 encapsulated in epoxy. In yet another example, the electromagnetic sensor 112 is fixed to the distal end 104 of the guidewire 102 via a radio frequency dumping die.

[0041] In one example, a method of treating a sinus cavity of a subject is disclosed. The method includes (a) inserting a distal portion of a guidewire system into a lumen of a balloon dilatation catheter, the guidewire system including: (i) a guidewire having a distal end and a proximal end, wherein the guidewire includes 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 to the guidewire between the distal end and the proximal end, (iv) an electromagnetic sensor coupled to the distal end of the guidewire, and (v) a conductive film surrounding at least a portion of the guidewire and the electromagnetic sensor. at least a portion of a polymer tube, and the balloon dilatation catheter includes: (i) an inner guide member including a lumen, and (ii) a movable shaft connected to the balloon and mounted on the inner guide member, wherein the balloon dilatation catheter is configured to allow the movable shaft to move along the inner guide member and prevent the movable shaft from rotating around the inner guide member, (b) connecting a second connector of the guidewire system to the balloon dilatation catheter so that the distal end of the guidewire is fixed relative to the distal end of the balloon dilatation catheter, (c) using data received from the electromagnetic sensor, simultaneously guiding the distal end of the guidewire and the distal end of the balloon dilatation catheter to the drainage passage of the sinus cavity, and (d) inflating the balloon.

[0042] 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, when the second connector 110 is coupled to the 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 may also include repositioning the internal guide member based at least in part on the determined position of the distal end 104 of the guidewire 102 relative to the sinus cavity.

[0043]

[0011] In another example, another method of treating a sinus cavity of a subject is disclosed. The method includes (a) inserting a portion of the guidewire system 100 of any of the above examples into a nostril of a subject, (b) using data received from the electromagnetic sensor 112, guiding the distal end 104 of the guidewire 102 to a drainage passage of a sinus cavity, (c) while the distal end 104 of the guidewire 102 is in the drainage passage, positioning a balloon dilatation catheter over the guidewire 102, the balloon dilatation catheter comprising: (i) an inner guide member including a lumen, and (ii) a movable shaft coupled to a balloon and mounted on the inner guide member, wherein the balloon dilatation catheter is configured to allow the movable shaft to move along the inner guide member and prevent the movable shaft from rotating about the inner guide member, (d) guiding the inner guide member over the guidewire to the drainage passage of the sinus cavity, (e) advancing the movable shaft and the balloon onto the inner guide member to place the balloon in the drainage passage while maintaining the inner guide member stationary relative to the drainage passage, and (f) inflating the balloon.

[0044] 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, when the second connector 110 is coupled to the 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 may also include repositioning the internal guide member based at least in part on the determined position of the distal end 104 of the guidewire 102 relative to the sinus cavity.

[0045] In yet another example, another method for treating a sinus cavity of a subject is disclosed. The method includes (a) inserting a distal portion of a balloon dilatation catheter into a nostril of the subject, the balloon dilatation catheter including: (i) an inner guide member including a lumen, and (ii) a movable shaft coupled to a balloon and mounted on the inner guide member, wherein the balloon dilatation catheter is configured to allow the movable shaft to move along the inner guide member and prevent the movable shaft from rotating about the inner guide member, (b) guiding the inner guide member to a drainage passage of the sinus cavity, (c) advancing the movable shaft and the balloon onto the inner guide member to place the balloon in the drainage passage while keeping the inner guide member stationary relative to the drainage passage, (d) while the balloon is in the drainage passage, inserting a guidewire system 100 of any of the above examples into the lumen of the inner guide member, (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 guide member, and (f) inflating the balloon. In one example, the method may also include repositioning the inner guide member based at least in part on the determined position of the distal end 104 of the guidewire 102 relative to the sinus cavity.

[0046] The method described herein can be effectively used with any of the examples or variations of the above-mentioned devices and systems and other examples and variations not explicitly described in this document. The features of any device or device component described in any example herein can be used in any other applicable examples of the device or device component.

[0047] It should be understood that the arrangement described herein is for illustrative purposes only. Therefore, those skilled in the art will appreciate that other arrangements and other elements (e.g., machines, interfaces, functions, sequences, and functional groupings, etc.) may be used instead, and some elements may be completely omitted depending on the desired results. In addition, many of the elements described are functional entities that may be implemented as discrete or distributed components or combined with other components, implemented in any applicable combination and position, or may be combined with other structural elements described.

[0048] Although various aspects and examples have been disclosed herein, other aspects and examples will be apparent to those skilled in the art. Various aspects and examples disclosed herein are for illustrative purposes and are not intended to be limiting, with the true scope being indicated by the full scope of the appended claims and the equivalents of these claims. It should also be understood that the terms used herein are only for the purpose of describing specific examples and are not intended to be limiting.

Claims

1. A guidewire system, comprising: A guidewire having a distal end and a proximal end, wherein the guidewire comprises 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 removal of the force from the guidewire; a first connector coupled to a proximal end of the guidewire; a second connector coupled to the guidewire between the distal end and the proximal end and configured for coupling the guidewire to a balloon dilatation catheter; an electromagnetic sensor coupled to the distal end of the guidewire; and A polymer tube surrounds at least a portion of the guidewire and at least a portion of the electromagnetic sensor.

2. The guidewire system according to claim 1, wherein: The superelastic material includes Nitinol.

3. The guidewire system according to any one of claims 1 to 2, wherein: The first connector includes a pin connector.

4. The guidewire system according to claim 3, wherein: The first connector comprises a 10-pin connector.

5. The guidewire system according to any one of claims 1 to 2, wherein: The second connector includes 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.

6. The guidewire system according to any one of claims 1 to 2, wherein: The guidewire includes a lubricious coating.

7. The guidewire system according to any one of claims 1 to 2, wherein: The stiffness of the guidewire is constant along 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 2, wherein: The stiffness of the distal portion of the guidewire is less than the stiffness 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 shorter than the length of the proximal portion of the guidewire.

10. The guidewire system according to any one of claims 1 to 2, 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 according to any one of claims 1 to 2, wherein: The diameter of the distal portion of the guidewire is smaller than the diameter of the proximal portion of the guidewire.

12. The guidewire system according to any one of claims 1 to 2, wherein: The diameter of the guide wire is 0.4 mm to 1 mm.

13. The guidewire system according to any one of claims 1 to 2, wherein: The first connector includes a flexible circuit including a memory chip configured to transmit an identification of the guidewire system to the image-guided surgery system when the first connector is coupled to the image-guided surgery system.

14. The guidewire system according to any one of claims 1 to 2, wherein: The polymer tube surrounds at least a portion of the first connector, and the first connector is secured to a proximal end of the guidewire via a thermal bond between the polymer tube and the guidewire.

15. The guidewire system according to any one of claims 1 to 2, wherein: The electromagnetic sensor is encapsulated by epoxy resin.

16. The guidewire system according to any one of claims 1 to 2, wherein: The electromagnetic sensor is fixed to the distal end of the guidewire via a radio frequency dumping die.

17. The guidewire system according to any one of claims 1 to 2, wherein: The second connector is coupled to a handpiece of a balloon dilatation catheter, and the geometry of the second connector and 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 according to any one of claims 1 to 2, wherein: The guidewire system also includes 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 has a curved shape in the second configuration.

20. The guidewire system according to any one of claims 1 to 2, wherein: The guidewire system is reusable.

21. A method of manufacturing a guidewire system, comprising: Positioning a first connector at a proximal end of a guidewire, wherein the guidewire comprises 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 removal of the force from the guidewire; positioning a second connector on the guidewire between a distal end of the guidewire and a proximal end of the guidewire, wherein the second connector is 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; and A heat source is applied to at least a portion of the polymer tube.

22. The method of claim 21, wherein: Applying the heat source to at least a portion of the polymeric tube includes applying the heat source near a proximal end of the guidewire to secure the first connector to the proximal end of the guidewire.

23. The method according to any one of claims 21 to 22, wherein: Applying the heat source to at least a portion of the polymeric tube includes applying the heat source near a 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 21-22, wherein: The electromagnetic sensor is encapsulated in epoxy resin.

25. The method of any one of claims 21-22, wherein: The electromagnetic sensor is fixed to the distal end of the guide wire via a radio frequency dumping die.

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