Patent Description:
The present invention relates generally to a guide wire system and more particularly to guide wire systems and methods of manufacture and use that are useable in conjunction with image guided surgery systems to facilitate insertion and positioning of various other apparatus at desired locations within the body, in particular the sinus cavities.

Sinusitis is a condition affecting over <NUM> million Americans, and similarly large populations in the rest of the developed world. Sinusitis occurs when one or more of the four paired sinus cavities (i.e., maxillary, ethmoid, frontal, sphenoid) becomes obstructed, or otherwise has compromised drainage. Normally the sinus cavities, each of which are lined by mucosa, produce mucous which is then moved by beating cilia from the sinus cavity out to the nasal cavity and down the throat. The combined sinuses produce approximately one liter of mucous daily, so the effective transport of this mucous is important to sinus health.

Each sinus cavity has a drainage pathway or outflow tract opening into the nasal passage. This drainage passageway can include an ostium, as well as a "transition space" in the region of the ostia, such as the "frontal recess," in the case of the frontal sinus, or an "ethmoidal infundibulum," in the case of the maxillary sinus. When the mucosa of one or more of the ostia or regions near the ostia become inflamed, the egress of mucous is interrupted, setting the stage for an infection and/or inflammation of the sinus cavity, i.e., sinusitis. Though many instances of sinusitis may be treatable with appropriate medicates, in some cases sinusitis persists for months or more, a condition called chronic sinusitis, and may not respond to medical therapy. Some patients are also prone to multiple episodes of sinusitis in a given period of time, a condition called recurrent acute sinusitis.

Balloon dilation has been applied to treat constricted sinus passageways for the treatment of sinusitis. These balloon dilation devices typically involve the use of an inflatable balloon located at the distal end of a catheter such as a balloon catheter. Generally, the inflatable balloon is inserted into the constricted sinus passageway in a deflated state via the use of a guide wire that is positioned in the desired nasal cavity using an image guided surgery system. The balloon is then expanded to open or reduce the degree of constriction in the sinus passageway being treated to facilitate 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 passageways are preserved.

<CIT> discloses a navigation guidewire that may be connected to an IGS navigation system. The navigation guidewire comprises an elongate tube and a bent hypotube, which comprise a tubular shape. The bent hypotube is securely fastened to the elongate tube at a solder joint.

<CIT> discloses a guide wire inserted and disposed in the inside of a catheter, wherein a lumen of the catheter and an inner cavity of a balloon are connected by a communication structure provided on the catheter.

<CIT> discloses a further medical guide wire, wherein the guide wire comprises a position sensor.

While guide wire systems exist for use in placement of nasal treatment devices, improved guide wire systems, methods of manufacture, and methods of use may be desirable.

The invention relates to a guide wire system according to claim <NUM> and to a method of manufacturing a guide wire system according to claim <NUM>. The dependent claims represent further embodiments of the invention. Methods for surgery are not claimed.

The present disclosure is related to guide wire systems, methods of manufacture, and methods of use. More specifically, the present disclosure relates to guide wire systems for use in combination with image guided surgery systems for treating nasal afflictions such as sinusitis.

In one example, the present disclosure provides a guide wire system. The guide wire system includes a guide wire having a distal end and a proximal end, wherein the guide wire comprises a superelastic material that is configured to (i) transition from a first configuration to a second configuration responsive to a force applied to the guide wire and (ii) return from the second configuration to the first configuration responsive to the force being removed from the guide wire. The guide wire system also includes a first connector coupled to the proximal end of the guide wire. The guide wire system also includes a second connector coupled to the guide wire between the distal end and the proximal end. The guide wire system also includes an electromagnetic sensor coupled to the distal end of the guide wire. The guide wire system also includes a polymeric tube surrounding at least a portion of the guide wire and at least a portion of the electromagnetic sensor.

In another example, the present disclosure provides a method manufacturing a guide wire system. The method includes positioning a first connector at a proximal end of a guide wire, wherein the guide wire comprises a superelastic material that is configured to (i) transition from a first configuration to a second configuration responsive to a force applied to the guide wire and (ii) return from the second configuration to the first configuration responsive to the force being removed from the guide wire. The method also includes positioning a second connector on the guide wire between a 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 polymeric 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 polymeric tube.

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 guide wire system into a lumen of a balloon dilation catheter, the guide wire system including: (i) a guide wire having a distal end and a proximal end, wherein the guide wire comprises a superelastic material that is configured to (<NUM>) transition from a first configuration to a second configuration responsive to a force applied to the guide wire and (<NUM>) return from the second configuration to the first configuration responsive to the force being removed from the guide wire, (ii) a first connector coupled to the proximal end of the guide wire, (iii) a second connector coupled to the guide wire between the distal end and the proximal end, (iv) an electromagnetic sensor coupled to the distal end of the guide wire, and (v) a polymeric tube surrounding at least a portion of the guide wire and at least a portion of the electromagnetic sensor, and the balloon dilation catheter including: (i) an inner guide member including the lumen, and (ii) a movable shaft coupled to a balloon and mounted on the inner guide member, wherein the balloon dilation 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. The method also includes coupling the second connector of the guide wire system to the balloon dilation catheter such the distal end of the guide wire is fixed with respect to a distal end of the balloon dilation catheter. The method also includes directing the distal end of the guide wire and the distal end of the balloon dilation catheter simultaneously to a drainage pathway of the sinus cavity using data received from the electromagnetic sensor. The method also includes inflating the balloon.

These as well as other aspects, advantages, and alternatives, will become apparent to those of ordinary skill in the art by reading the following detailed description, with reference where appropriate to the accompanying drawings.

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

Furthermore, the particular arrangements shown in the Figures should not be viewed as limiting. It should be understood that other examples may include more or less of each element shown in a given Figure. Further, some of the illustrated elements may be combined or omitted. Yet further, an example may include elements that are not illustrated in the Figures.

In the following description, numerous specific details are set forth to provide a thorough understanding of the disclosed concepts, which may be practiced without some or all of these particulars. In other instances, details of known devices and/or processes have been omitted to avoid unnecessarily obscuring 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.

The limitations of the following claims are not written in means-plus-function format and are not intended to be interpreted based on <NUM> U. § <NUM>(f), unless and until such claim limitations expressly use the phrase "means for" followed by a statement of function void of further structure.

By the term "about," "approximately," or "substantially" with reference to amounts or measurement values described herein, it is meant that the recited characteristic, parameter, or value need not be achieved exactly, but that deviations or variations, including for example, tolerances, measurement error, measurement accuracy limitations and other factors known to those of skill in the art, may occur in amounts that do not preclude the effect the characteristic was intended to provide.

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

With reference to the Figures, <FIG> is guide wire system <NUM> according to an example, and <FIG> is a cross-sectional view taken along line A-A of the guide wire system of <FIG>. As shown in <FIG>, the guide wire system <NUM> includes a guide wire <NUM> having a distal end <NUM> and a proximal end <NUM>. The guide wire system <NUM> further includes a first connector <NUM> coupled to the proximal end <NUM> of the guide wire <NUM>, and a second connector <NUM> coupled to the guide wire <NUM> between the distal end <NUM> and the proximal end <NUM>. An electromagnetic sensor <NUM> is coupled to the distal end <NUM> of the guide wire <NUM>. The guide wire system <NUM> further includes a polymeric tube <NUM> surrounding at least a portion of the guide wire <NUM> and at least a portion of the electromagnetic sensor <NUM>. In one example, the guide wire system <NUM> is discarded after each procedure. In another example, the guide wire system <NUM> can be sanitized and reused after each procedure.

The guide wire <NUM> comprises a superelastic material. When mechanically loaded, a superelastic material deforms reversibly to high strains (up to <NUM>%) by the creation of a stress-induced phase. When the load is removed, the new phase becomes unstable and the material regains its original shape automatically. As such, the guide wire <NUM> is configured to (i) transition from a first configuration to a second configuration responsive to a force applied to the guide wire <NUM>, and (ii) return from the second configuration to the first configuration responsive to the force being removed from the guide wire <NUM>. In one particular example, the guide wire <NUM> has a straight shape in the first configuration and a bent shape in the second configuration. The superelasticity of the guide wire <NUM> provides kink resistance and tensile strength to the guide wire system <NUM>. In one particular example, the superelastic material comprises a nickel titanium alloy, such as nitinol. Other superelastic materials are possible as well. The guide wire <NUM> can include a lubricious coating that reduces friction between the guide wire <NUM> and other components of the guide wire system <NUM>. A diameter of the guide wire <NUM> ranges from about <NUM> to about <NUM>.

In one example, a stiffness of the guide wire <NUM> is constant along an entire length of the guide wire <NUM> from the proximal end <NUM> to the distal end <NUM>. In another example, a stiffness of a distal portion of the guide wire <NUM> is less than a stiffness of a proximal portion of the guide wire <NUM>. In such an example, a length of the distal portion of the guide wire <NUM> is less than a length of the proximal portion of the guide wire <NUM>. The reduced stiffness of the distal portion of the guide wire <NUM> may provide increased flexibility of the distal portion of the guide wire <NUM>, which may be advantageous in certain use cases.

In one example, a diameter of the guide wire <NUM> is constant along an entire length of the guide wire <NUM> from the proximal end <NUM> to the distal end <NUM>. In another example, a diameter of a distal portion of the guide wire <NUM> is less than a diameter of a proximal portion of the guide wire <NUM>. In such an example, a length of the distal portion of the guide wire <NUM> is less than a length of the proximal portion of the guide wire <NUM>. The reduced diameter at the distal portion of the guide wire <NUM> may provide increased flexibility of the distal portion of the guide wire <NUM>, which may be advantageous in certain use cases.

As shown in <FIG> and as described above, the guide wire system <NUM> includes the first connector <NUM> coupled to the proximal end <NUM> of the guide wire <NUM>. In one example, the first connector <NUM> comprises a pin connector, such as a <NUM>-pin connector as a non-limiting example. In another example, the polymeric tube <NUM> surrounds at least a portion of the first connector <NUM>, and the first connector <NUM> is secured to the proximal end <NUM> of the guide wire <NUM> via a heat bond between the polymeric tube <NUM> and the guide wire <NUM>. In another example, the guide wire system <NUM> further includes a second polymeric tube positioned around the guide wire <NUM> between the first connector <NUM> and the second connector <NUM>.

The first connector <NUM> can include a flexible circuit that includes a memory chip configured to transmit an identification of the guide wire system <NUM> to an image guided surgery system when the first connector <NUM> is coupled to the image guided surgery system. The flexible circuit comprises an electronic circuit that is assembled by mounting electronic devices on flexible plastic substrates. As examples, the flexible plastic substrate can be formed from at least one material chosen from polyimide, Polyether ether ketone, and transparent conductive polyester film. Such a design enables the circuit board to conform to a desired shape, or to flex during its use.

As shown in <FIG> and as described above, the guide wire system <NUM> includes the second connector <NUM> coupled to the guide wire <NUM> between the distal end <NUM> and the proximal end <NUM>. In one example, the second connector <NUM> comprises a bayonet connector configured to interact with a complementary bayonet connector of balloon dilation catheter to thereby couple the guide wire system <NUM> to the balloon dilation catheter. In one particular example, the second connector <NUM> is coupled to a handpiece of balloon dilation catheter. A geometry of the second connector <NUM> with respect to the balloon dilation catheter allows a user to set a desired distance between the distal end <NUM> of the guide wire <NUM> and a distal end of the balloon dilation catheter. In one example, when the second connector <NUM> is coupled to the balloon dilation catheter, the distal end <NUM> of the guide wire <NUM> is aligned with a distal end of the balloon dilation catheter. In another example, when the second connector <NUM> is coupled to the balloon dilation catheter, the distal end <NUM> of the guide wire <NUM> extends distally from a distal end of the balloon dilation catheter.

Exemplary balloon dilation catheters and methods of use particularly suited for the dilation of anatomic structures associated with the sinuses and use with the guide wire system <NUM> are disclosed, for example, in <CIT> which is incorporated by reference herein.

As shown in <FIG> and as described above, the guide wire system <NUM> includes an electromagnetic sensor <NUM> positioned at the distal end <NUM> of the guide wire <NUM>. When in use, the electromagnetic sensor <NUM> is configured to interact with an image guided surgery system to transmit data to the image guided surgery system indicating a location of the electromagnetic sensor <NUM>. Since the electromagnetic sensor <NUM> is positioned at the distal end <NUM> of the guide wire <NUM>, the transmitted location of the electromagnetic sensor <NUM> corresponds to a location of the distal end <NUM> of the guide wire <NUM>. As discussed in additional detail below, this information can be used to ensure a device (such as a balloon dilation catheter) is properly positioned in a desired nasal cavity to thereby treat nasal afflictions such as sinusitis.

In one example, the electromagnetic sensor <NUM> is potted by an epoxy prior to being coupled to the distal end <NUM> of the guide wire <NUM>. In another example, the electromagnetic sensor <NUM> is coupled to the distal end <NUM> of the guide wire <NUM> by being potted by an epoxy. Potting the electromagnetic sensor <NUM> in an epoxy may provide a more robust sensor that is able to better withstand the rigors of multiple nasal cavity procedures. In yet another example, the electromagnetic sensor <NUM> may be secured to the distal end <NUM> of the guide wire <NUM> via a radio frequency (RF) tipping die. Utilizing an RF tipping die provides a benefit of joining the electromagnetic sensor <NUM> to the distal end <NUM> of the guide wire <NUM> without the use of adhesive. Further, the RF tipping die prevents movement of the electromagnetic sensor <NUM> as the RF tipping die joins the electromagnetic sensor <NUM> to the polymeric tube <NUM>.

In one example, the guide wire system <NUM> further includes a camera positioned at the distal end <NUM> of the guide wire <NUM>. In such an example, the electromagnetic sensor <NUM> may work in combination with the camera to provide a medical professional with the location of the distal end <NUM> of the guide wire <NUM>.

In another example, a method of manufacturing the guide wire system <NUM> of any of the examples described above is provided. The method may include (a) positioning a first connector <NUM> at a proximal end <NUM> of a guide wire <NUM>, wherein the guide wire <NUM> comprises a superelastic material that is configured to (i) transition from a first configuration to a second configuration responsive to a force applied to the guide wire <NUM> and (ii) return from the second configuration to the first configuration responsive to the force being removed from the guide wire <NUM>, (b) positioning a second connector <NUM> on the guide wire <NUM> between a distal end <NUM> of the guide wire <NUM> and the proximal end <NUM> of the guide wire <NUM>, (c) positioning an electromagnetic sensor <NUM> at the distal end <NUM> of the guide wire <NUM>, (d) positioning a polymeric tube <NUM> around at least a portion of the guide wire <NUM> and at least a portion of the electromagnetic sensor <NUM>, and (e) applying a heat source to at least a portion of the polymeric tube <NUM>.

In one example of the method described above, applying the heat source to at least a portion of the polymeric tube <NUM> comprises applying the heat source adjacent the proximal end <NUM> of the guide wire <NUM> to secure the first connector <NUM> to the proximal end <NUM> of the guide wire <NUM>. In another example of the method, applying the heat source to at least a portion of the polymeric tube <NUM> comprises applying the heat source adjacent the distal end <NUM> of the guide wire <NUM> to secure the electromagnetic sensor <NUM> to the distal end <NUM> of the guide wire <NUM>.

As described above, the electromagnetic sensor <NUM> is potted in epoxy prior to being coupled to the distal end <NUM> of the guide wire <NUM>. In another example, the electromagnetic sensor <NUM> is coupled to the distal end <NUM> of the guide wire <NUM> by being potted in epoxy. In yet another example, the electromagnetic sensor <NUM> is secured to the distal end <NUM> of the guide wire <NUM> via a radio frequency tipping die.

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 guide wire system into a lumen of a balloon dilation catheter, the guide wire system including: (i) a guide wire having a distal end and a proximal end, wherein the guide wire comprises a superelastic material that is configured to (<NUM>) transition from a first configuration to a second configuration responsive to a force applied to the guide wire and (<NUM>) return from the second configuration to the first configuration responsive to the force being removed from the guide wire, (ii) a first connector coupled to the proximal end of the guide wire, (iii) a second connector coupled to the guide wire between the distal end and the proximal end, (iv) an electromagnetic sensor coupled to the distal end of the guide wire, and (v) a polymeric tube surrounding at least a portion of the guide wire and at least a portion of the electromagnetic sensor, and the balloon dilation catheter including: (i) an inner guide member including the lumen, and (ii) a movable shaft coupled to a balloon and mounted on the inner guide member, wherein the balloon dilation 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) coupling the second connector of the guide wire system to the balloon dilation catheter such the distal end of the guide wire is fixed with respect to a distal end of the balloon dilation catheter, (c) directing the distal end of the guide wire and the distal end of the balloon dilation catheter simultaneously to a drainage pathway of the sinus cavity using data received from the electromagnetic sensor, and (d) inflating the balloon.

In one example, when the second connector <NUM> is coupled to the balloon dilation catheter, the distal end <NUM> of the guide wire <NUM> is aligned with a distal end of the balloon dilation catheter. In another example, when the second connector <NUM> is coupled to the balloon dilation catheter, the distal end <NUM> of the guide wire <NUM> extends distally from a distal end of the balloon dilation catheter. In one example, the method can further include re-positioning the inner guide member based at least in part on a determined location of the distal end <NUM> of the guide wire <NUM> with respect to the sinus cavity.

In another example, another method of treating a sinus cavity of a subject is disclosed. The method includes (a) inserting a portion of the guide wire system <NUM> of any of the examples described above into a nostril of the subject, (b) directing the distal end <NUM> of the guide wire <NUM> to a drainage pathway of the sinus cavity using data received from the electromagnetic sensor <NUM>, (c) while the distal end <NUM> of the guide wire <NUM> is in the drainage pathway, positioning a balloon dilation catheter over the guide wire <NUM>, the balloon dilation 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 dilation 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, (d) directing the inner guide member over the guide wire to the drainage pathway of the sinus cavity, (e) advancing the movable shaft and balloon over the inner guide member to place the balloon in the drainage pathway while keeping the inner guide member static relative to the drainage pathway, and (f) inflating the balloon.

In yet another example, another method of treating a sinus cavity of a subject is disclosed. The method includes (a) inserting a distal portion of a balloon dilation catheter into a nostril of the subject, the balloon dilation 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 dilation 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) directing the inner guide member to a drainage pathway of the sinus cavity, (c) advancing the movable shaft and balloon over the inner guide member to place the balloon in the drainage pathway while keeping the inner guide member static relative to the drainage pathway, (d) while the balloon is in the drainage pathway, inserting the guide wire system <NUM> of any of the examples described above into the lumen of the inner guide member, (e) advancing the guide wire system through the lumen until the distal end <NUM> of the guide wire <NUM> is aligned with a distal end of the inner guide member, and (f) inflating the balloon. In one example, the method can further include re-positioning the inner guide member based at least in part on a determined location of the distal end <NUM> of the guide wire <NUM> with respect to the sinus cavity.

The methods described herein can be utilized effectively with any of the examples or variations of the devices and systems described above, as well as with other examples and variations not described explicitly in this document. The features of any of the devices or device components described in any of the examples herein can be used in any other suitable example of a device or device component.

It should be understood that arrangements described herein are for purposes of example only. As such, those skilled in the art will appreciate that other arrangements and other elements (e.g. machines, interfaces, functions, orders, and groupings of functions, etc.) can be used instead, and some elements may be omitted altogether according to the desired results. Further, many of the elements that are described are functional entities that may be implemented as discrete or distributed components or in conjunction with other components, in any suitable combination and location, or other structural elements described as independent structures may be combined.

Claim 1:
A guide wire system (<NUM>) comprising:
a guide wire (<NUM>) having a distal end (<NUM>) and a proximal end (<NUM>), wherein the guide wire (<NUM>) comprises a superelastic material that is configured to (i) transition from a first configuration to a second configuration responsive to a force applied to the guide wire (<NUM>) and (ii) return from the second configuration to the first configuration responsive to the force being removed from the guide wire (<NUM>);
a first connector (<NUM>) coupled to the proximal end (<NUM>) of the guide wire (<NUM>);
a second connector (<NUM>) coupled to the guide wire (<NUM>) between the distal end (<NUM>) and the proximal end (<NUM>);
an electromagnetic sensor (<NUM>) coupled to the distal end (<NUM>) of the guide wire (<NUM>); and
a polymeric tube (<NUM>) surrounding at least a portion of the guide wire (<NUM>) and at least a portion of the electromagnetic sensor (<NUM>).