Medical device for treatment of a sinus opening.

(54) Title: MEDICAL DEVICE FOR THE TREATMENT OF A BREAST OPENING. (54) Title: MEDICAL DEVICE FOR TREATMENT OF A SINUS OPENING.

(57) Summary

A medical device and method of treating a breast opening includes a handle, a guide catheter, a guide wire, a balloon catheter, a guide wire movement mechanism, and a balloon catheter movement mechanism; the handle has a proximal and a distal end and a longitudinal axis along the handle; the guide catheter is attached to the distal end of the handle and has a lumen of the catheter; the guide wire and balloon catheter are at least partially disposed in the catheter shaft and lumen; the guide wire movement mechanism and the balloon catheter movement mechanism are operatively arranged on the handle; additionally, the guide wire movement mechanism is configured to advance or retract the guide wire through the catheter handle and lumen when the user operates the guide wire movement mechanism; in addition, the guide wire movement mechanism includes an integrated guide wire lock and rotate mechanism configured to rotate the guide wire and to securely lock and unlock the guide wire of the guide wire movement mechanism; In addition, the balloon catheter movement mechanism is configured to advance or retract the balloon catheter through the handle and lumen of the catheter when the user operates the balloon catheter movement mechanism. J&J.

(57) Abstract

A medical device and method for the treatment of a sinus opening ineludes a handle, a guide catheter, a guide wire, a balloon catheter, a guide wire movement mechanism and a balloon catheter movement mechanism. The handle has proximal and distal ends and a longitudinal axis along the length of the handle. The guide catheter is attached to the distal end of the handle and has a catheter lumen. The guide wire and balloon catheter are both disposed at least partially in the handle and catheter lumen. The guide wire movement mechanism and the balloon catheter movement mechanism are both operatively disposed on the handle. In addition, the guide wire movement mechanism is configured for advancement and retraction of the guide wire through the handle and catheter lumen by user operation of the guide wire movement mechanism. Moreover, the guide wire movement mechanism ineludes an integrated guide wire locking and rotation mechanism configured for rotation of the guide wire and for securely locking and unlocking the guide wire to the guide wire movement mechanism. Furthermore, the balloon catheter movement mechanism is configured for advancement and retraction of the balloon catheter through the handle and catheter lumen by user operation of the balloon catheter movement mechanism.

MEDICAL DEVICE FOR THE TREATMENT OF AN OPENING IN

THE BREASTS

RELATED REQUESTS

I

The present application claims priority pursuant to Title 35 of the United States Code, §119 for the United States Provisional Patent Application Serial No. 61 / 385,250, entitled “Medical Device for Treatment of a Sinus Opening”, filed on September 22,

2010, United States Provisional Patent Application Series No.

61 / 385,263, entitled "Method for Treating a Sinus Opening," filed September 22, 2010, and United States Provisional Patent Application Ser. 61 / 511,237, entitled "Medical Device and Method for Treatment of a Sinus Opening", filed on July 25, 2011, which are incorporated herein by reference in their entirety.

FIELD OF THE INVENTION

The present invention relates generally to medical devices, and particularly to related medical devices and methods for the treatment of sinus conditions.

BACKGROUND OF THE INVENTION

The paranasal sinuses are hollow cavities in the skull that connect to the nasal canal through small openings known as ostia. Each ostium between a paranasal sinus and the nasal cavity is formed by a bone covered by a layer of mucous tissue. Normally, air passes into and out of the paranasal sinuses through the ostia. In addition, the mucous lining of the sinuses constantly forms mucus, which drains through the ostia and into the nasal canal.

Sinusitis is a general term that refers to inflammation in one or more of the paranasal sinuses. Acute sinusitis can be associated with infections or allergic conditions of the upper respiratory tract, which can cause tissue swelling and temporarily impede normal trans-ostlal drainage and ventilation of the sinuses, leading to some accumulation of mucus and possibly infection inside the sinus cavities. Chronic sinusitis is a long-term disease characterized by the continuous narrowing or blockage of one or more sinuses of the sinuses that produces a chronic infection and inflammation of the sinuses. Chronic sinusitis is frequently associated with long-term respiratory allergies, nasal polyps, hypertrophic nasal shells, and / or a deviated internal septum. While acute sinusitis is typically caused by infection with a single pathogen (for example, a type of bacteria, a type of virus, a type of fungus, etc.), chronic sinusitis is frequently associated with infections. of multiple pathogens (for example, more than one type of bacteria or more than one genus of microorganisms).

Chronic sinusitis, if left untreated, can cause irreparable damage to the tissues and / or bone structures of the paranasal anatomy. Initial treatment for chronic sinusitis usually includes the use of drugs, such as decongestants, nasal sprays with spheroids, and antibiotics (if the infection is bacterial). In cases where drug treatment alone does not provide permanent relief, surgical intervention may be indicated. ¡

The most common surgical procedure to treat chronic sinusitis is functional endoscopic sinus surgery (FESS). FESS is commonly performed with the use of an endoscope and various rigid instruments inserted through the patient's nostril. Endoscopy is used to visualize post-clonamment and the use of various rigid instruments that are used to remove tissue from the nasal cavity and sinus sinus in an attempt to improve sinus drainage.

Acclarent Inc of Menlo Park, CA has developed a technique known as the Balloon Sinuplasty ™ procedure and a system to perform the procedure for treating sinusitis. Many United States patents and patent applications including United States patents no. 7645272, 7654997 and 7803150 and publications 2008/0097154 and i

2008/0281156, which are incorporated in their entirety by reference in the present description, describe various modalities of the Balloon procedure

Sinuplasty ™, as well as various devices that can be used when performing this procedure. In the Balloon Sinuplasty ™ procedure, a guide catheter is inserted into the nose and positioned within or adjacent to the ostium of the affected paranasal sinus. Next, a guide is advanced through the guide catheter and into the affected paranasal sinus. Next, a dilation catheter having an expanded dilator (eg, an inflatable balloon) is advanced through the guide to a position where the Dilator is positioned within the ostium of the affected paranasal sinus. The dilator then expands, causing dilation of the ostium and restoration of bone adjacent to the ostium, without the need for incision of the mucosa or removal of bone. The catheters and guide wire are then removed, and the dilated ostium facilitates improved drainage and ventilation of the affected paranasal sinus. There is a continuing need for methods and

I improved devices to treat the paranasal sinus.

The novel features of the invention are set forth with particularity in the appended claims. The features and advantages of the present invention will be better understood by referring to the following detailed description that presents illustrative embodiments, in which the principles of the invention and the accompanying figures are used, in which similar numerals indicate similar elements.

BRIEF DESCRIPTION OF THE INVENTION

The present invention provides devices and methods for treating an opening in the sinuses.

In one aspect, a medical device is provided for treating an opening in the breasts. The medical device includes a handle with a proximal end, a distal end, and a longitudinal axis along the handle. The device further includes a guide catheter attached to the distal end of the handle; the guide catheter has a lumen of the catheter. The medical device further includes a guidewire movement mechanism operatively disposed on the handle and a balloon catheter movement mechanism operatively disposed on the handle. The handle and lumen of the catheter are configured to operatively accept a guidewire and balloon catheter. The guidewire movement mechanism is configured to advance or retract a guidewire disposed at least partially in the handle and lumen of the catheter through the handle and lumen of the catheter when the user operates the cable movement mechanism. gluttony. The Guide Wire Movement Mechanism Includes an Integrated Guide Wire Rotation and Locking Mechanism configured to rotate the Guide Wire and to securely lock and unlock the Guide Wire of the Guide Wire Movement Mechanism. The balloon catheter movement mechanism is configured to advance or retract a balloon catheter disposed at least partially in the handle and lumen of the catheter through the handle and lumen of the catheter when the operator operates the movement mechanism. balloon catheter.

In one embodiment the medical device may further include a guidewire at least partially disposed in the catheter handle and lumen and a balloon catheter disposed at least partially in the catheter handle and lumen.

In another embodiment, the movement mechanism of the balloon catheter of the medical device may be configured to advance and retract the balloon catheter through the handle and lumen of the catheter when (

the user operates the balloon catheter movement mechanism, this includes the displacement of the balloon catheter movement mechanism relative to the handle when the user operates the balloon catheter movement mechanism, longitudinal displacement of the balloon catheter movement mechanism along the handle or when the user operates the balloon catheter movement mechanism by rotating at least a portion of the balloon catheter movement mechanism.

In a further embodiment, the guide wire movement mechanism of the medical device is configured to advance or retract the guide wire through the handle and lumen of the catheter when the user i

operates the guide wire movement mechanism, which includes the displacement of the guide wire movement mechanism relative to the handle, or when the user operates the guide wire movement mechanism that includes the longitudinal displacement of the guide wire movement mechanism along the handle.

In another embodiment of the medical device the guide catheter is configured to attach, detach, and reattach to the handle or device.

It also includes a guide tip configured to attach, detach, and reattach to the guide catheter.

In another embodiment of the medical device, a suction route is included to remove material from the paranasal sinus or sinus canal, or an irrigation cartridge is included to irrigate the paranasal sinus or sinus canal.

In a further embodiment the medical device includes a guide wire holder arranged within the handle. The guide wire is at least partially disposed within the guide wire holder and the guide wire holder is configured to prevent the guide wire from bending within the handle while the guide wire is advanced into the handle. The guidewire support may generally be cylindrical in shape and may include a slot-shaped opening configured such that, as the guidewire advances, it enters the guidewire support via the shaped opening. groove.

In another embodiment of the medical device, the guide wire rotation and locking mechanism includes a barrel with an axial opening and a bottleneck shaft disposed at least partially within the axial opening of the barrel.

In a further embodiment of the medical device, the guide wire movement mechanism includes at least one rail configured for sliding movement of the guide wire mechanism along the handle during advancement and retraction of the guide wire.

In yet another embodiment of the medical device, the balloon catheter movement mechanism includes at least one rail configured for sliding movement of the balloon catheter mechanism along

I of the handle during advancement and retraction of the balloon catheter.

In another embodiment, the guidewire movement mechanism and the balloon catheter movement mechanism are arranged on the handle in a configuration for the user to operate both the guidewire movement mechanism and the movement mechanism of the guidewire with one hand. balloon catheter. The guide wire movement mechanism and the balloon catheter movement mechanism may be arranged on the handle in an in-line configuration along the handle or in a side-by-side configuration.

In another embodiment of the medical device the opening in the sinuses for treatment may be at least one of an opening in the frontal sinuses, an opening in the maxillary sinuses, and an opening in the sphenoid sinuses.

In yet another embodiment of the medical device, the guide wire rotation and locking mechanism is configured to operate guide wire rotation with either the thumb or a single finger.

In another aspect, a method of treating an opening in the breasts is provided. The method includes inserting a medical device to treat a sinus opening partially within a patient's anatomy, positioning the medical device into the opening in the sinuses, advancing a guide wire from the medical device into the patient's breast by operation by the user of a mechanism for moving the guide wire of the medical device arranged on the handle of the medical device, rotate the guide wire within the patient's breast by the user operating an integrated locking and rotation mechanism of the guide wire of the guide wire movement mechanism, repeat the steps of advancing and rotating the guide wire to position the Guide wire into breast opening as appropriate for treatment, advancing a medical device balloon catheter along the guidewire by user operation of a medical device balloon catheter movement mechanism disposed on the handle of the medical device, and treating the opening in the sinuses by Inflate the catheter with a balloon.

In one embodiment of the method the step of advancing the guide wire includes the operation by the user of the movement mechanism of the l

guide wire including the displacement of the guide wire movement mechanism relative to the handle or longitudinal displacement of the guide wire movement mechanism along the handle.

In another embodiment of the method, the step of advancing the balloon catheter includes operation by the user of the balloon catheter movement mechanism that includes movement of the balloon catheter movement mechanism relative to the handle, movement longitudinal movement mechanism of the balloon catheter along the handle or rotation i

of at least a portion of the balloon catheter movement mechanism.

I

In a further embodiment, the method may further include i

I deflate the balloon catheter, retract the balloon catheter and guide wire, and i

remove the medical device from the patient's anatomy. 'i

In another embodiment, the method may include joining, before step r

insertion, a detachable guide tip to the medical device, in an i

proper orientation to treat the opening in the breasts or unite, before the i

i insertion stage, a detachable guiding catheter to the medical device in a suitable orientation to treat the opening in the sinuses. '!

In a further embodiment of the method, the step of making t

advancing the guide wire may include advancing the guide wire through a

I guide wire holder arranged on the handle of the medical device and configured to prevent the guide wire from bending on the handle. !

In another embodiment of the method, the guidewire support is practically cylindrical in shape and includes a slot-shaped opening through

i.

I where the guide wire movement mechanism directs the guide wire.

In a further embodiment of the method, the anatomy of the patient f

f is a nostril and the opening in the sinuses can be one of an opening in the frontal sinuses, an opening in the maxillary sinuses and an opening in the sphenoid sinuses.

In another embodiment of the method, the movement mechanism of the

The guidewire and the balloon catheter movement mechanism are arranged on the handle in a configuration for the user to operate both the guidewire movement mechanism and the balloon catheter movement mechanism with one hand and can be in an inline setup along the handle.

In other embodiments of the method, the guide wire rotation and locking mechanism is configured to operate the guide wire rotation with either the thumb or a single finger.

In a further embodiment, the method may include Irrigating the opening in the breasts with the use of the medical device and Irrigation can be accomplished with the use of an Irrigation Cartridge Installed in the medical device or an Irrigation Balloon Catheter incorporated into the medical device.

In yet another embodiment, the method may include sucking the opening in the breasts with the use of the medical device.

BRIEF DESCRIPTION OF THE FIGURES

Figure 1 is a simplified perspective view of a medical device for treating a breast opening in accordance with an embodiment of the present invention.

Figure 2 is a simplified side view of the medical device of Figure 1.

Figure 3 is a simplified side view of the medical device of Figure 1 with a guide wire of the medical device in an advanced position.

I

Figure 4 is a simplified side view of the guidewire, balloon catheter, balloon catheter movement mechanism, guidewire movement mechanism, and guidewire support of the medical device of Figure 1; A functional segment of the balloon of the balloon catheter is shown in an inflated state for clarity.

Figure 5 is a simplified perspective view of the gluttony cable, the balloon catheter, the balloon catheter movement mechanism, the guidewire movement mechanism and the guidewire support of the medical device of Figure 4.

Figure 6 is a simplified perspective view of a medical device for treating a breast opening (without a guide wire, guide tip, and balloon catheter) in accordance with another embodiment of the present invention.

Figures 7A and 7B are the simplified sectional and side views, respectively, of the medical device of Figure 6j

Figure 8 is a simplified representation of a portion of a guide catheter and three removable guide tips as can be used in a medical device in accordance with the embodiments of the present invention.

Figure 9 is a simplified sectional representation of a balloon catheter as can be used in medical devices in accordance with the present invention.

Figure 10 is a combined triple sectional and longitudinal representation of a portion of the balloon catheter of Figure 9 along with a portion of a guidewire.

I

Figure 11 is a simplified side view of a guide wire and guide wire movement mechanism of the medical device of Figure 6.

Figure 12 is a simplified sectional view of the guide wire movement mechanism and the guide wire of Figure 11 in the locked position.

Figure 13 is a simplified sectional view of the guide wire movement mechanism and the guide wire of Figure 11 in the unlocked position.

Figure 14 is a simplified transparent view of the guide wire movement mechanism and guide wire of Figure 11 without the barrel of the guide wire movement mechanism.

Figures 15A, 15B and 15C are simplified perspective, top and side views, respectively, of a guide wire holder as can be used in medical devices in accordance with the present invention; Figure 15B further represents a guide wire.

Figure 16 is a simplified perspective view of the guidewire, balloon catheter, balloon catheter movement mechanism, guidewire movement mechanism, and guidewire support of the medical device of Figure 6; the functional segment of the balloon is shown in an Inflated state for clarity.

Figures 17A, 17B, and 17C are a sequence of simplified perspective views of the guidewire, balloon catheter, balloon catheter movement mechanism, guidewire movement mechanism, and guidewire support of Figure 16. representing advancement of the guide wire by movement of the guide wire through a window opening in the guide wire bracket (Figures 17A and 17B) and through a slot in the guide wire bracket (Figure 17C).

Figure 18 is a simplified side view of the medical device of Figure 6, showing the guide wire movement mechanism in the advanced position.

Figure 19 is a simplified side view of the medical device of Figure 6, showing the guide wire movement mechanism in the advanced position; the arrows indicate how the rotary movement of the barrel of the guide wire movement mechanism works to rotate the guide wire.

Figure 20 is a simplified side view of the medical device of Figure 6, depicting the guide wire movement mechanism in the fully advanced position.

Figure 21 is a simplified side view of the medical device 15 of Figure 6, showing the balloon movement mechanism in a fully advanced position.

Figure 22 is a simplified side view of the medical device of Figure 6, depicting the balloon movement mechanism and the guide wire movement mechanism in the retracted position.

Figure 23 is a flow chart depicting the steps in a method of treating an opening in the breasts, in accordance with an embodiment of the present invention.

Figure 24 is a sectional view of a medical device for treating a breast opening in accordance with an alternate embodiment of the present invention.

Figure 25 is a partially detailed view of the device 5 of Figure 24.

Figure 26A shows a group of sinus guide catheters useful for positioning the sinus balloon catheters of the invention.

Figures 26B and 26C show detailed views of portions of the guide catheters, shown in Figure 26A.

Figures 27A and 27B are views of the guide catheter locking mechanism of the device of Figure 24 for 8 different rotational orientations in accordance with the present invention.

Figure 28 is an enlarged perspective view of the device of Figure 24, showing the suction path in accordance with the present invention.

Figure 29 is an enlarged perspective view of the guide wire actuator of the device of Figure 24.

Figures 30A and 30B are top and side views of the balloon catheter of the device of Figure 24 in accordance with the present invention and Figure 30C shows additional details of the side view shown in Figure 30B.

Figures 31 A, 31B and 31C are top views of the device of Figure 24 showing a guide wire locking mechanism in accordance with the present invention. Figure 31D is a side view of the locking lever of the device of Figure 24 for securing the balloon catheter actuator in accordance with the present invention.

FIG. 32 is a perspective view of the balloon catheter actuator of the device of FIG. 24 for manipulating the guide wire without the wire actuator in accordance with an alternate embodiment of the invention.

DETAILED DESCRIPTION OF THE INVENTION

The following detailed description should be read with reference to the figures, in which similar elements in different figures are listed in the same way. The figures, which are not necessarily to scale, represent illustrative embodiments for the sole purpose of explanation and are not intended to limit the scope of the invention. The detailed description illustrates, for the purpose of exemplifying, not for the purpose of limiting, the principles of the invention. This description will train the person skilled in the art to elaborate and use the invention, and describes various modalities, adaptations, variations, alternatives and uses of the invention, including what is currently considered as the best way to carry out the invention.

As used in the present description, the terms "around" or "approximately" for any value or numerical range indicate an adequate dimensional tolerance that allows part or all of the components to function for the intended purpose, as described in the present description. >

Generally, medical devices for treatment (for l

example, Balloon Sinuplasty ™) of a sinus opening (eg, a frontal, maxillary, or sphenoid sinus opening) in accordance with the embodiments of the present invention include a handle, a balloon catheter, a guide catheter, a guidewire, a guidewire movement mechanism, and a balloon catheter movement mechanism. The handle has a proximal and a distal end and a longitudinal axis along the handle. The guide catheter is attached to the distal end of the handle and has a lumen of the catheter. In addition, the catheter handle and lumen are configured to operatively accept a guidewire and balloon catheter. The guide wire movement mechanism and the balloon catheter movement mechanism are arranged i

operatively on the handle. Additionally, the guide wire movement mechanism is configured to advance or retract a guide wire disposed at least partially in the handle and lumen of the catheter through the handle and lumen of the catheter when the user operates the movement mechanism. of the guide wire. In addition, the guide wire movement mechanism includes an integrated guide wire rotation and locking mechanism configured to rotate the guide wire and to securely lock and unlock the guide wire of the guide wire movement mechanism. Furthermore, the balloon catheter movement mechanism is configured to advance or retract a balloon catheter disposed at least partially in the handle and lumen of the catheter through the handle and lumen of the catheter when the user operates the mechanism. movement of the balloon catheter.

Medical devices in accordance with the embodiments of the present invention are favorable in that the location of the guide wire movement mechanism and the balloon catheter movement mechanism on the handle of the medical device, combined in some embodiments with the sliding movement of the mechanism The guide wire movement mechanism and the balloon catheter movement mechanism along the handle provide a particularly easy to use medical device. For example, a physician may, if desired, operate the guidewire movement mechanism and the balloon catheter movement mechanism with one hand. Also, because the guide wire movement mechanism is configured for guide wire rotation, locking and unlocking, in addition to guide wire advancement and retraction, ease of use (including one-handed use) is further increased plus. Furthermore, the configuration of medical devices in accordance with the embodiments of the present invention allows the user to manipulate the guide catheter and the guide wire simultaneously.

FIG. 1 is a simplified perspective view of a medical device 100 for treating a sinus opening (eg, an opening of the frontal, maxillary, or sphenoid sinuses) in accordance with one embodiment of the present invention. Figure 1 includes indicators representing the tip up, tip left, tip down, and right tip orientations of a guide tip included in medical devices in accordance with the modalities of the present invention.

Figure 2 is a simplified side view of the medical device 100. Figure 3 is a simplified side view of the medical device

100 with a guide wire and the guide wire movement mechanism of the medical device in the advanced position. FIG. 4 is a simplified side view of the guidewire, balloon catheter, balloon catheter movement mechanism, guidewire movement mechanism, and guidewire support of medical device 100; a functional balloon segment of the balloon catheter is shown in an inflated state for clarity. Figure 5 is a simplified perspective view of the guidewire, balloon catheter, balloon catheter movement mechanism, guidewire movement mechanism, and guidewire support of Figure 4.

Referring to Figures 1-5, the medical device 100 for treating a sinus opening Includes a handle 102, a guide catheter 104, a guide wire 106, a balloon catheter 108 with a functional segment of balloon 110 (see, particularly, Figures 4 and 5), a guide wire movement mechanism 112, a balloon catheter movement mechanism 114, a removable guide tip 116 (shown with a curved (angled) tip in a "tip up" orientation) and a guide wire holder 118 (see Figures 4 and 5). Alternate modalities will now be described, wherein the guide catheter is integrated with the guide tip.

Handle 102 Includes a proximal end 120, a distal end 122, and has a longitudinal axis 124 (the extent of which is represented by a dotted line in Figure 1) along handle 102. Handle 102 includes a suction access tab. 126 and the pins to place the fingers

128a and 128b (see Figure 2). The handle 102 has a certain size and a certain shape so that the user (such as a doctor) can manipulate and operate the medical device 100 with one hand, if he wishes, adequately and efficiently. Handle 102 can be formed of any suitable material including, for example, polycarbonate and ABS (acetonitrile butadiene styrene) and can be manufactured using any suitable technique including, for example, injection molding of two closure halves of the handle.

Guide catheter 104 is attached to distal end 122 of handle 102 and has a lumen of the catheter (i.e., an internal gap, not visible in the perspective of Figures 1-3) therein. Guide catheter 104 has a proximal end 130 and a distal end 132 (see Figure 2). Guide catheter 104 can be formed of any suitable material including, for example, stainless steel, polymeric materials, and combinations thereof. A typical, but not limiting, internal diameter for a guide catheter is between approximately 0.178 cm (0.070) and 0.381 cm (0.150 inches).

In the embodiment of Figures 1-5, removable guide tip 116 is configured to be removably attached to, and detached from, distal end 132 of guide catheter 104. However, removable tips used in medical devices in accordance with The present invention can be attached to and detached from the medical device at any suitable point on the medical device. For example, the removable guide tip can be attached at any point on the guide catheter or at the distal end of the handle. Detachable guide tip 116 can be formed of any suitable material including, for example, stainless steel, polymeric materials, and combinations thereof.

The guide wire 106 is arranged at least partially in the handle 102, the guide wire holder 118 and the catheter lumen of the guide catheter 104. The guide wire 106 may be any suitable guide wire known to a person skilled in the art including, for example, an illuminated guide wire configured to confirm user access to the breast. Balloon catheter 108 is at least partially disposed in handle 102 and lumen of guide catheter 104 and may be any suitable balloon catheter known to a person skilled in the art, as well as the balloon catheters described in the present description.

The guidewire movement mechanism 112 is operatively disposed on the handle 102 and is configured for the advancement and retraction of the guidewire 106 through the handle 102, the guidewire support 118 and the lumen of the guidewire catheter 104 by displacement length of the guide wire movement mechanism 112 along the handle. A comparison of Figures 2 and 3 serves to understand how the movement of the guide wire movement mechanism 112 along the handle 102 works to advance the guide wire 106 so that the guide wire 106 extends from the detachable guide tip. 116.

The guide wire movement mechanism 112 includes an integrated guide wire rotation and locking mechanism 134 configured to rotate the guide wire 106 and to securely lock and unlock the guide wire 106 of the guide wire movement mechanism 112. Hereinafter Additional details of such an integrated guide wire rotation and locking mechanism are described with respect to Figures 11 through 14.

Once informed regarding the present description, a person with experience in the matter will recognize that the mechanisms of the

Guide wire movement used in medical devices (and methods) in accordance with the present invention are not limited to the mechanisms

I operated by the user by sliding along the handle. Rather, the operation by the user of the guide wire movement mechanism may be any suitable operation that produces an operable movement of the guide wire by, for example, translation (i.e., motion that changes the position of an object) of the guide wire movement mechanism relative to the handle or rotation of a component of the guide wire movement mechanism. In this sense, the configuration of the guide wire movement mechanism supports the operation by the user by means of a suitable rack and pinion mechanism, gears and / or electromechanical means.

The balloon catheter movement mechanism 114 is operatively disposed on the handle 102 and is configured to advance and retract the balloon catheter 108 through the handle 102 and the guide catheter lumen by longitudinal displacement of the catheter movement mechanism with ball along the handle. However, upon Informed with respect to the present disclosure, a person skilled in the art will recognize that the balloon catheter movement mechanisms used in medical devices (and methods) in accordance with the present invention are not limited to Mechanisms operated by the user by longitudinal displacement along the handle. Rather, the operation by the user of the balloon catheter movement mechanism may be any suitable operation that produces operable movement of the balloon catheter by, for example, translation of the balloon catheter movement mechanism relative to the handle or rotation of a component of the balloon catheter movement mechanism. In this sense, the configuration of the balloon catheter mechanism supports operation by the user by means of a suitable rack and pinion mechanism, gear-based mechanisms and / or electromechanical means.

The guide wire holder 118 of the medical device 100 is operatively disposed within the handle 102 and provides additional column resistance to the guide wire 106 and prevents the guide wire 106 from bending within the handle 102 during the advancing step. The guide wire support 118 includes a slot-shaped opening 136 (see Figure 5), where the guide wire movement mechanism 112 supplies the guide wire 106. Further details of the guide wire supports that can be used in the embodiments of the present invention are described below with respect to, for example, Figures 15A-15C, 16 and 17A through 17C.

Figure 6 is a simplified perspective view of a medical device 200 for treating an opening in the breasts in accordance with an embodiment of the present invention. Figures 7A and 7B are the simplified sectional and side views, respectively, of medical device 200. Figure 8 is a simplified representation of a portion of a guide catheter and three guide tips (also called removable guide tips) as can be used in a medical device in accordance with the embodiments of the present invention.

Figure 9 is a simplified sectional representation of a balloon catheter as can be used in medical devices in accordance with the present invention. Figure 10 is a combined triple sectional and longitudinal representation of a portion of the balloon catheter of Figure 9 along with a portion of a guidewire and a portion of a balloon inflation tube.

Figures 11 to 14 are several simplified representations of a guide wire and guide wire movement mechanism of medical device 200. Figures 15A, 15B and 15C are several simplified views of a guide wire holder used in medical device 200. ; Figure 15B further represents a portion of a guide wire. FIG. 16 is a simplified perspective view of the guidewire, balloon catheter, balloon catheter movement mechanism, guidewire movement mechanism, and guidewire support of medical device 200; the functional segment of the balloon is shown in an inflated state for clarity. The

Figures 17A, 17B and 17C are a sequence of simplified perspective views of the guidewire, the balloon catheter, the balloon catheter movement mechanism, the guide wire movement mechanism and guide wire holder of Figure 16 depicting the advancement of the guide wire including movement of the guide wire through a window opening of the guide wire holder (Figures 17A and 17B) and through a slot-shaped opening in the guide wire bracket (Figure 17C).

Referring to Figures 6 through 17C, medical device 200 for treating a breast opening includes a handle 202, a guide catheter 204, a guide wire 206 (not included in Figure 6 but see, for example, the Figures

7A-7B and 8), a balloon catheter 208 with the functional segment of balloon 209 (see Figures 9 and 16, particularly), a guidewire movement mechanism 210, a balloon catheter movement mechanism 212 and a removable guide tip 214. It should be noted that medical device 200 differs from medical device 100 in that, for example, removable guide tip 214 of medical device 200 is straight (i.e., has an angle of zero (0) degrees), while the guide tip Detachable 114 of medical device 100 has an angle. The benefits of straight and removable removable tips in the efficient treatment of multiple openings in the breasts are described below.

Handle 202 Includes a proximal end 216, a distal end

218 and has a longitudinal axis 220 along the handle 202 which is represented by a dotted line in Figure 7A. Handle 202 includes finger pin 222a and 222b and is of a certain size and shape such that the user (such as a physician) can manipulate and operate medical device 200 with one hand, if desired.

Guide catheter 204 is attached to distal end 218 of handle 202 and has a lumen of the catheter (i.e., an internal gap) 224 therein (see Figure 7B). Guide catheter 204 has a proximal end 226 and a distal end 228.

Detachable guide tip 214 of medical device 200 is configured to be removably attached to, and detached from, distal end 228 of guide catheter 204. Figure 8 depicts three guide tips 214a,

214b and 214c illustrative, but not limiting, a portion of guide catheter 204 and guide wire 206. Attachment and separation of guide tips to medical devices in accordance with the embodiments of the present invention can be accomplished using any Suitable media including a clip, button, and bayonet mechanism.

Each of the guide tips 214a, 214b, and 214c in Figure 8 is configured to include angles (from 0 degrees to 110 degrees) which makes them particularly suitable for treating various openings in the sinuses. Furthermore, the removable configuration of the guide catheter and guide tips is such that the guide tips can be attached to the medical device (eg, attached to the guide catheter) in a certain orientation relative to the rest of the medical device or attached in one orientation. and then rotate in another orientation. For example, to treat an opening in the frontal sinuses, a guide tip with an angle of 70 to 90 degrees may be used with the guide tip attached or rotated in a "tip clockwise" configuration for a right-handed user operating the medical device with the thumb of the right hand. This orientation ensures more accessible control for the user's dominant finger when the user operates the guide wire movement mechanism and / or the balloon catheter movement mechanism of the medical device.

For treatment of the maxillary sinuses, a preferred orientation of the guide tip depends on the side (i.e., right or left maxilla) of the opening in the treated sinus, in addition to the user's dominant hand and the finger finger. For the treatment of an opening in the right maxillary sinus, a guide tip with an angle of 90 to 110 degrees with a "tip up" orientation can be used for a skilled user operating the medical device with the thumb. For the treatment of an opening in the left maxillary sinus, a guide tip with an angle of 90 to 110 degrees with a "tip down" orientation can be used for a skilled user operating the medical device with the thumb. For treatment of an opening in the right sphenoid sinus, a 0-30 degree angle guide tip with a "tip up" orientation (if the guide tip is angled) can be used for a skilled user operating the device doctor with thumb. For the treatment of an opening in the Left sphenoid sinus, a guide tip with an angle of 0 to 30 degrees with a "tip down" orientation can be used for a skilled user operating the medical device with the thumb. Table 1 summarizes a preferred angle for the guide tip and orientation of the guide tip for a right-handed user who operates (operates) the controls of the medical device (i.e., the guide wire movement mechanism and the catheter movement mechanism. with the ball). The orientations are as indicated in Figure 1.

Table 1- Orientation of the tip according to the user and the type of breast

<td colspan="2"></td><td>Preferred angle of guide tips (in degrees)</td><td>Right-handed user who operates the controls with the thumb</td><td>Right-handed user who operates the controls with the index</td>

<td rowspan="3">Breast type</td><td>Frontal</td><td> 70-90</td><td>Tip to the right</td><td>Tip up</td>

<td>Right maxilla</td><td> 90-110</td><td>Tip up</td><td>Tip to the left</td>

<td>Left jaw</td><td> 90-110</td><td>Tip down</td><td>Tip to the right</td>

<td></td><td>Right sphenoid (assuming an angled tip)</td><td> 0-30</td><td>Tip up</td><td>Tip to the left,</td>

<td></td><td>Left sphenoid (assuming an angled tip)</td><td> 0-30</td><td>Tip down</td><td>Tip to the right</td>

Guide wire 206 is disposed at least partially in handle 202 and lumen of catheter 224. Guide wire 106 may be any suitable guide wire known to a person skilled in the art, Including, for example, a wire Illuminated guide.

The balloon catheter 208 is further arranged at least partially in the handle 202 and the lumen of the catheter 224. With respect to the

Figures 9 and 10, the balloon catheter 208 includes an external shaft 230, an internal shaft 232 and a proximal shaft 234. The balloon catheter 208 further includes

I a guide wire access opening 236.

Balloon catheter 208 includes a section (shown as A in Figure 9) with a coaxial lumen design and a section (shown as B in Figure 9), where the external horn, internal horn, and proximal horn are They join in such a way as to facilitate a transition between a coaxial configuration, a dual lumen configuration and a single lumen proximal shaft. FIG. 10 (an illustrative, but not limiting, representation in a manner in which guidewire 206 and balloon catheter 208 can interact i

within handle 202 of medical device 200) includes three simplified sectional representations. Sectional illustration “C” represents a coaxial arrangement of the outer shaft and the inner shaft along line CC of Figure 10. Sectional illustration “D” represents a double lumen configuration (ie, the access opening to the guide wire 236 and the catheter inflation lumen

I with balloon 238) along line DD in Figure 10. Sectional illustration “E” (along line EE in Figure 10) represents a single lumen configuration (ie, the lumen of balloon catheter inflation).

The coaxial design of segment A provides a beneficially small profile to fit the guide rod of medical device 200. Furthermore, because there is only a single double lumen segment (ie segment B) in addition to the coaxial segment, medical devices Incorporating the configuration of Figures 9 and 10 require a relatively low complexity manufacturing. However, once informed with respect to the present disclosure, a person skilled in the art will recognize that balloon catheters used in medical devices and methods in accordance with the embodiments of the present invention may have any suitable configuration and are not limited to the configuration of Figures 9 and 10. For example, a balloon catheter used in medical devices and methods in accordance with the embodiments of the present invention may include a double lumen segment that extends to the distal end of the balloon catheter instead of the coaxial segment depicted in the Figures. 9 and 10. In such a configuration, the guide wire access lumen has an opening at the distal end of the balloon catheter through which the guide wire advances and the balloon catheter inflation lumen has an opening in the functional segment of the balloon to inflate the segment functional ball.

Furthermore, the construction of the balloon catheter shafts can be such that the detrimental effects of the forces (friction or other) between the catheter shaft and the guide wire are minimized during operation of the medical device. For example, a lubricating coating can be used on the catheter stem to minimize friction forces between the guide wire and the balloon catheter stem. Additionally, the stem of the balloon catheter may be of interlocking construction to prevent collapse of the internal horn of the balloon catheter in the guidewire. Such a collapse is of particular interest when the balloon catheter travels through the curve of a curved guide tip.

Balloon catheter 208 can be formed of any suitable material known to a person skilled in the art including, for example, nylon, Pebax, or PET. The balloon catheter can be a catheter of any size that includes, but is not limited to, 3.5mm to 7mm diameter (when inflated) and 12mm to 24mm functional length (eg 3.5mm x 12mm .5mm x 16mm, 5mm x 24mm, 6mm x 16mm, 6mm x 20mm, 6mm x 24mm, 7mm x 16mm and 7mm x 24mm. In addition, balloon catheter 208, glutton catheter 204, and handle 202 may be configured such that the

The balloon catheter 208 is removable from guide catheter 204 and handle 202.

The guide wire movement mechanism 210 is operatively disposed on the handle 202 (see, for example, Figures 6, 7A, and 7B) and is configured to advance and retract the guide wire 206 through the handle 202 and the lumen of the catheter 224 by operation of the guide wire movement mechanism 210 by the user. In medical device 200 such an operation by the user includes longitudinal displacement of the guide wire movement mechanism 210 along the handle 202.

The guide wire movement mechanism 210 includes an integrated guide wire rotation and locking mechanism 240 configured to rotate the guide wire 206 and to securely lock and unlock the guide wire of the guide wire movement mechanism, a rail 242 and a front portion 244. Rail 242 is configured to slidably attach guide wire movement mechanism 210 to handle 202. The front part 244 is configured to direct the guide wire 206 towards the handle 202 and the guide wire access opening 236 of the balloon catheter 208 and, in the medical device mode 200, towards the guide wire holder 260 of the medical device 200 as further described below with respect to Figures 11-17C.

The integrated guide wire rotation and locking mechanism 240 t

includes a barrel 246 and a bottleneck shaft 248 (see Figures 11-14, 5 particularly). The lock / unlock capability of the integrated guide wire lock and rotate mechanism 240 allows the user to adjust the length of the guide wire that extends (dlstally) beyond the guide wire movement mechanism 210.

Bottleneck shaft 248 is configured to function as a bottleneck and shaft and has a longitudinal opening through which guide wire 206 passes (see Figure 13, particularly). In the embodiment of Figures 11 to 14, the bottleneck shaft 248 has a generally practically cylindrical shape, and when attached to the c guide wire 206 (see Figure 12, where the represented overlap of the barrel and the bottleneck shaft serves to illustrate that the barrel compresses the bottleneck shaft onto the guide wire), rotates, and moves with the guide wire. Bottleneck shaft 248 rotates within load surfaces 250 of guide wire movement mechanism 210 (see Figure 13). The bottleneck shaft has a plurality of alternate projections 252 and grooves 254 (see Figure 14) configured to secure (close) on the guide wire to link the rotation of the guide wire with the rotation of the bottleneck shaft. The bottleneck shaft 248 exerts strong closing pressure on the guide wire, where the bottleneck shaft is tensioned by the longitudinal movement of barrel 246 (as is evident from a comparison of Figure 12, in where the bottleneck shaft is secured to the guide wire, and Figure 13, where the bottleneck shaft is released from the guide wire).

Barrel 246 has a practically cylindrical section and an opening therein, where the bottleneck shaft 248 is arranged. The contour of the barrel opening is designed to receive the bottleneck shaft and has at least one point Focal configured to collapse the bottleneck shaft onto the guide wire (see Figure 12, particularly). The exterior of barrel 246 has grip characteristics shown in the embodiment of Figures 11-13 as a macroscopic surface feature (i.e. grooves). However, such gripping characteristics may alternatively be microscopic in nature or may be based on properties of friction materials, such as a rubberized surface. Such gripping features provide traction for the user to rotate or move the barrel by operation, for example, with his thumb or finger rotating the cable by rotation of the shaft on which the cable is secured. The distal and proximal ends of the barrel have a raised annular feature 256 that provides traction for the user to move the guide wire movement mechanism when the bottleneck shaft is in the locked position or to provide a grip feature for moving the barrel relative to the rest of the guide wire movement mechanism to lock or unlock the shaft.

Having been informed in connection with the present disclosure, a person skilled in the art will recognize that the guide wire rotation and locking mechanisms used in medical devices in accordance with the present invention may take any suitable form in addition to the barrel configurations. and the bottleneck axle shown in, for example, Figures 11 through 14. For example, the barrel may be practically spherical, cylindrical, or other suitable shape.

The balloon catheter movement mechanism 212 is operatively disposed on the handle 202 and is configured to advance and retract the balloon catheter 208 through the handle 202 and the guide catheter lumen by longitudinal displacement of the catheter movement mechanism with a ball along the handle.

Now, referring to Figures 15A through 17C, particularly, the medical device 200 includes an additional guide wire bracket 260 operatively disposed within the handle 202 of the medical device 200. The guide wire bracket 260 provides additional column resistance to the guide wire 206 and is configured to prevent guidewire 206 from bending within handle 202.

The guidewire bracket 260 is configured as a thin-walled tube having four sections, particularly, a proximal junction section 262, a window section 264, a groove section 266, and a distal junction section 268. In addition, the Guide wire bracket 200 has a slot-shaped opening 270 in slot section 266 and a surface window opening 272 in window section 264 (see Figure 15C). Guidewire support 260 can be formed of any suitable material including, for example, polymeric materials, stainless steel materials, titanium alloys, and combinations thereof.

It is noted that the inclusion of a support for the guide wire in medical devices in accordance with the modalities of the present invention is optional. For example, the guide wire bracket can be removed if another means is provided to prevent or minimize the guide wire from bending (for example, a gear control system to advance the guide wire) or if the guide wire does not bends in no other way during normal use of the medical device.

The sequence depicted in Figures 17A, 17B and 17C represents the movement of the guide wire 210 in an advanced position by the user. In Figures 17A and 17B the guide wire 206 leaves the guide wire movement mechanism 210 and enters the surface window opening 272. In Figure 17C the user has advanced the guide wire movement mechanism 210 further, such that guide wire 206 enters slot-shaped opening 270. The slot-shaped opening 270 is configured so that it opens as the guide wire 206 advances. The slot-shaped opening 270 extends laterally from the surface window opening 272. The opening in the form

Slot I 270 prevents guidewire 206 from bending and surface window opening 272 provides a less friction region to facilitate movement of guidewire 206 within the nasal anatomy.

Having been informed with respect to the present disclosure, a person skilled in the art will recognize that the guide wire holders used in medical devices in accordance with the embodiments of the present invention may have any suitable configuration and are not limited to the configuration represented in Figures 15A to 17C. For example, a suitable guide wire support may be a cylinder with a lumen and a surface window opening (where the lumen and the surface window opening are configured to accept a guide wire) and a coil or interlace (for example, a metallic or polymeric coil) around a portion of the cylinder including at least a portion of the surface window opening or a spiral shaped surface window opening on a rotating coil or tube. In such a guide wire holder, the coil or interlock is configured to prevent the guide wire from bending through the surface window opening while the guide wire is advanced through the handle. Alternatively, the guidewire bracket may include a cylinder with a lumen and a surface window opening (where the lumen and the surface window opening are configured to accept a guidewire) and a reducer casing around a portion of the cylinder that includes at least a portion of the surface window opening. In the

In the present alternative, the reducer casing is configured to prevent the guide wire from bending through the surface window opening while the guide wire is advanced through the handle.

The operation of the medical device 200 including the operation of the guidewire movement mechanism 210 and the balloon catheter movement mechanism 212 are further described below with respect to Figures 18 through 22. Figure 18 is a side view Simplified of the medical device 200 representing the guide wire movement mechanism 210 in the advanced position. The arrow in Figure 18 indicates the directions in which the guide wire movement mechanism 210 can be moved. In the advanced position of Figure 18 the guide wire movement mechanism

210 it has slipped, for example, from about 2.0 to 4.0 cm: from the position shown in Figures 7A-7B.

FIG. 19 is a simplified side view of the medical device 200 showing the guide wire movement mechanism 210 in the advanced position and the arrows indicate how the rotary movement of barrel 246 and bottleneck shaft 248 of the cable movement mechanism Guide 210 operates to rotate guide wire 206.

Figure 20 is a simplified side view of the medical device.

200, representing the guide wire movement mechanism 210 in a fully advanced position, eg, approximately 6.0 - 8.0 cm from the position of Figures 7A-7B. Because the guide wire movement mechanism 210 is shown in a more advanced position in Figure 20 than in Figure 19, the length of the guide wire 206 extending from the detachable guide tip 214 is greater in Figure 20 than in Figure 19.

FIG. 21 is a simplified side view of medical device 200 depicting the movement mechanism of balloon catheter 212 in a fully advanced position. The arrow in Figure 21 represents the direction of the sliding movement that the movement mechanism of the balloon catheter 212 took to reach the fully advanced position. Figure 21 depicts balloon catheter 208 in an inflated state, as can be used to treat an opening in the sinuses.

I

Figure 22 is a simplified side view of medical device 200 depicting the movement mechanism of the balloon catheter.

212 and the guide wire movement mechanism 210 in the retracted position, where the arrow indicates its retraction direction.

Generally, methods of treating a sinus opening include inserting a medical device to treat a sinus opening partially in a patient's anatomy, and advancing a guide wire from the medical device into the patient's breast by operation on the part of the patient. of the user of a medical device guide wire movement mechanism arranged in a handle of the medical device. The method further includes rotating the guide wire within the patient's breast by user operation of a rotating component of the guide wire movement mechanism, and repeating the steps of advancing and rotating the guide wire to position the wire. Guide into the opening in the breasts as appropriate for the treatment. The method further includes advancing a medical device balloon catheter along the guidewire by user operation of a medical device balloon catheter movement mechanism that is disposed on the handle of the medical device; and treating the opening in the sinuses by inflating the balloon catheter.

The methods in accordance with the embodiments of the present invention are favorable because they use a relatively easy to fix medical device and the methods themselves are easy to carry out. For example, mounting may include attaching a suitable guide tip that the user selects from a plurality of guide tips of various sizes and angles that are supplied with the medical device (see, eg, Figure 8). The methods are easy to carry out because, for example, the medical device can, if desired, be operated with one hand because both the guidewire movement mechanism and the balloon catheter movement mechanism are arranged on the handle of the medical device. Because the methods are easy to perform, they can be performed in a hospital operating room and doctor's office. Furthermore, in various modalities the rotation and locking mechanism of the guide wire of the medical device used in the methods can be operated with the thumb or can be operated with a single finger as an index finger. Also, if a user wishes to treat more than one opening in the breasts, the amount of preparation between the breasts is reduced by the use of a removable guide tip.

FIG. 23 is a flow diagram depicting the steps of a method 300 for treating a sinus opening (such as an opening in the frontal, maxillary, or sphenoldal sinuses) in accordance with one embodiment of the present invention. Method 300 includes, in step 305, attaching a guide tip at a predetermined angle with a medical device to treat an opening in the sinuses. Attachment of the guide tip may, if desired, be such that the guide tip is properly oriented toward the rest of the medical device to treat the opening in the sinuses. A preferred, but not limiting, orientation is an orientation where the guide wire movement mechanism and the balloon catheter movement mechanism of the medical device are oriented toward the user (eg, a physician) during advancement of the guide wire and the balloon catheter.

Thereafter, the medical device for treating an opening in the 10 sinuses is partially inserted into the anatomy of a patient (see step 310 in Figure 23). At step 310 the medical device is inserted, for example, into a patient's nostril to gain access to the sinus ostia (ducts). If desired, the medical device can be rotated up to 180 degrees (depending on the breast type) in any direction around the longitudinal axis of the medical device after insertion.

Thereafter, a guide wire of the medical device is advanced into the patient's breast by sliding movement of a medical device guide wire movement mechanism along a handle of the medical device, as seen in step 315 of Figure 23.

Rotation of the guidewire into the patient's breast by the operation by the user of an integrated locking and rotation of the guidewire of the guidewire movement mechanism (for example, the barrel and bottleneck axle of the Figures 11 through 14) occurs at step 320. Such rotation can be used to, for example, gain access to a breast opening or during confirmation of such access with the use of an Illuminated guide wire.

In step 325 the steps of advancing and rotating the guide wire (eg, steps 315 and 320 in Figure 23) are repeated as appropriate to position the guide wire in the opening in the sinuses to be treated.

Subsequently, in step 330 a balloon catheter of the medical device is advanced along the guide wire by sliding movement of a balloon mechanism of the balloon catheter of the medical device along the handle of the medical device. At step 335, the opening in the sinuses is treated by inflating the balloon catheter. After treatment of the breast opening, the balloon catheter is deflated as mentioned in step 340 of Figure 23. The balloon catheter and guide wire are then retracted into the medical device (see step 345). and the medical device is removed from the patient's anatomy (see step 350).

If desired, method 300 may include an additional step of

Irrigation of the opening in the breasts with the use of the medical device. For example, after retraction of the balloon catheter and guide wire, the treated opening in the sinuses may be irrigated with the medical device before the medical device is removed from the patient's anatomy. Such Irrigation may Include, as a non-limiting example, Exchanging at least the balloon catheter and guidewire with a suitable Irrigation cartridge, such that the Irrigation cartridge is operatively Installed in the medical device. The operative installation of the irrigation cartridge may include, for example, positioning the Irrigation cartridge in the medical device such that the irrigation cartridge extends through the guide catheter and into the opening in the sinuses with or without a guide wire. In an alternate modality, irrigation can be accomplished through an irrigation balloon catheter built into the medical device.

An alternate embodiment in accordance with the present invention will now be described with respect to Figures 24 through 32. An integrated device 400 is shown with a portion of the handle 402 removed in order to describe the device in detail. The medical device 400 for treating a sinus opening includes a guide catheter 404, a guide wire 406, a balloon catheter 408, a guide wire movement mechanism 410, a balloon catheter movement mechanism 412, and a delivery route. suction 414. Each of the portions of device 400 is shown in greater detail in Figure 25 and Figures 26A-32. The 402 handle (shown separated into two halves

I

402a and 402b in Figure 25) is ergonomically designed so that the finger-pin 416a, 416b and 416c can be placed between the fingers of a user who uses the right or left hand to facilitate support of device 400. If the user uses one hand, the user's thumb can reach suction port 418 to use suction path 414 to remove materials from the sinus or sinus canal, the guidewire movement mechanism 410 for advancement and rotation of guidewire 406 and catheter 412 movement mechanism to advance the balloon catheter along correctly positioned guidewire 406.

I

In the embodiment shown with respect to Figures 24 to 32, the representative guide catheter 404 has a linear (0 degree) configuration, but the guide catheter 404 can have any of the configurations shown in Figure 26A. These guide catheters 404a-404f are virtually rigid and each have a predetermined distal curve of 0 degrees (404a), 30 degrees (404b), 90 degrees (404d), 70 degrees (404c), or 110 degrees (404e and 404f). Different curvatures can be used to access the ostia of different sinuses, as described above with respect to the guide tips 116 of Figure 8; however, the guide catheters 404a-404f described in the present description do not have removable tips. For example, a 70 degree guide is typically used to access the ostium of a frontal sinus, a 90 or 110 degree guide is typically used to access the ostium of a maxillary sinus, etc. Each of these 404a-404f guide catheters has a minimum path length (the longitudinal distance through the guide catheter) of 4 cm, a maximum path length of 25 cm, and often a path length between approximately 10 and 12 cm. As shown in Figures 26B and 26C, each guide catheter 404 has a translucent balloon window 450 and a distal tip 452 that allows endoscopic visualization of guide catheter placement in the anatomy of the breast. A rigid distal portion 454 (in the case of a stainless steel hypotube, but which could be of another similar rigid material) allows easy access in the anatomy of the breast, while the translucent balloon window 450 (in the case of a nylon window (but could be of another similar transparent material) allows easy viewing of the ball. A 452 soft guide tip (which may include 20% Barium Sulfate and other similar radiopaque materials) allows for trauma-free, customizable access to the target sinus.

Guide catheter 404 is connected to handle 402 by sheath 420 by snapping guide catheter 404 into place over sheath 420 (see Figure 25). Insertion proximal connector 428 of guide catheter 404 accommodates sheath clamp 430 420 against guide catheter lock 424. Button 422 is spring loaded and predisposes the proximal connector of secured guide catheter 428 to reduce radial movement of guide catheter 404 . As can be seen in Figure 27B, elastomer valve 424 is compressed adlclonally against proximal connector 428 through clamp 430 of sheath 420 to reduce axial movement of guide catheter 404. Guide Catheter 404 can be positioned in several positions, but 8 different positions can be incorporated (in addition to the tip up, tip down, tip to the right and tip to the left orientations described in Table 1 above, the orientations may include tip up and to the right, tip up and to the left, tip down and to the right and tip down and to the left, according to the anatomy of the breast and depending on whether the user can use one or the other hand and his preference). Once properly positioned, the auditory feedback (one click) will ensure that the guide catheter is properly attached. To remove guide catheter 404 from handle 402, or to reposition guide catheter 404, guide catheter release button 422 is depressed and guide catheter 404 can be rotated or slid over sleeve 420, removed and replaced with another guide catheter 404. In an alternate embodiment the guide catheter (or the guide tip described above) can be formed of malleable material that allows the user to configure the shape of the guide catheter before inserting the medical device into a patient's anatomy. In this case, the guide catheter can be formed of any suitable malleable material known to a person skilled in the art. An illustrative, but not limiting, malleable material is heat treated (i.e. hardened) stainless steel. Furthermore, the guide catheter can be steerable so that once in the patient's anatomy, the patient can alter its shape to follow the path of the breast.

Again referring to Figure 25, in addition to handle 402, guide catheter 404, and guide catheter lock 424, suction path 414 facilitates the suction of blood or other matter from the sinus cavity. As shown in greater detail in Figure 28, suction Luer connector 432 can be attached to a suitable source of suction and the sinus cavity can be sucked through guide catheter 404 and suction path 414, while covering thumb suction port 418 to increase suction force across the path.

Figure 25 further shows balloon catheter 408 and balloon catheter movement mechanism 412 and guidewire 406 and guidewire movement mechanism 410. Guidewire movement mechanism 410 is shown in detail in Figure 29 and facilitates the advancement, retraction and rotation of the guide wire 406. Mechanism 410 integrates a guide wire rotation and locking mechanism 434 configured for guide wire 406 rotation and to securely lock and unlock guide wire 406 from guide wire movement mechanism 410 as described above with respect to the mechanism for locking and rotating the guide wire 240. Included in Figure 29 is a snap element 438, a flexible material, in this case, a flexible strip, which interacts with the bottleneck flaps 436 to provide audible and tactile feedback of the rotation of the locking mechanism and rotation 434 and the resulting rotation of guide wire 406. A guide wire t

406 Representative Incorporated in device 400 of the Invention is Relieva Luma Sentry ™ Slnus Illumination System manufactured by Acclarent, Inc., Menlo Park, CA, a guidewire system that can be connected to a light source to illuminate and subsequently transcutaneously visualize the sinus cavity.

Balloon catheter 408, balloon catheter movement mechanism 412, and balloon catheter stem 460 are shown in detail in Figures 30A, 30B, and 30C. FIG. 30A shows the aforementioned balloon catheter stem 460 with dilatation balloon 462 in dlstal portion 464 of body 460 and an inflation Luer connector 466 in proximal portion 468 of body. As shown in Figure 30B, between the i

movement mechanism of the balloon catheter and the median junction of catheter 470 shown in Figure 30C, catheter stem 460 comprises a stem rail 472 (in this case, fabricated from a 304 stainless steel hypotube with a polymeric sheath internal, but that can be of another similar material). The stem rail 472 has a slot 474 (an opening in the hypotube and a cut in the sheath) that facilitates the passage of guide wire 406 from the balloon guide wire movement mechanism 412 and into the guide wire lumen 476 of balloon catheter. Rail 472 and slot 474 allow easy movement of guide wire 406, while preventing bending. As described above with respect to FIG. 10, the median junction of catheter 470 to the balloon catheter stem 460 passes from a balloon catheter stem 460 with a single inflation lumen 478 in its proximal portion 480 to a lumen portion. double the mid section 482 consisting of a guide wire lumen 476 and an inflation lumen 478 and finally to a distal portion 484 of the balloon catheter stem 460 with a coaxial lumen 486 having an internal lumen of the guidewire 488 and an external lumen of inflation 490. Both the lumen of the guidewire and the lumen of the balloon catheter proximal to the Middle catheter junction are manufactured from a stainless steel hypotube. In the proximal section 480 the inflation lumen 478 is round in cross section, in the middle section 482 the inflation lumen 492 is oval in cross section (it is below the guide wire lumen) and the inflation lumen changes to a coaxial configuration .

Before operating the device, the guidewire movement mechanism 410 and the balloon catheter movement mechanism 412 are secured in place, as shown in Figures 31A and 31B. The guide wire lock 500 connects the guide wire movement mechanism 410 and the balloon catheter mechanism 412 and holds the wire 206 fixed, to prevent inadvertent movement of the guide wire 206, preventing the wire from slipping when the barrel 246 is released (see Figure 13). Once the guide wire lock 500 is removed, the guide wire movement mechanism 410 can move independently along the stem rail 472. The brake 502 prevents inadvertent movement of the guide wire 406 unless the guide wire movement mechanism 410 moves or unless the guide wire movement mechanism passes by. As shown in Figure 32, where desired by the user, the guide wire 406 can be manipulated by the user without the use of the guide wire movement mechanism 410 by removing the guide wire 406 from the catheter movement mechanism with balloon 412 and guidewire movement mechanism 410 and by twisting guidewire 406 through opening 510 in balloon catheter mechanism 412 and onto guidewire movement mechanism 410, bypassing it effectively.

Spring locking lever 504 prevents the balloon catheter mechanism 412 from moving proximally when in the up position, but facilitates movement distally (see Figure 31D) when

I is activated with the thumb or finger. When the locking lever 504 is in the down position, the balloon catheter 408 and the guide wire

406 they can be removed so that an irrigation catheter can be inserted into handle 402 and through guide catheter 404.

Once Informed regarding the present description, a person with experience in the matter will recognize that the methods in accordance with the modalities of the present Invention that include method 300 can be easily modified to Incorporate any of the techniques, benefits and characteristics of medical devices in accordance with the embodiments of the present invention and described in the present description. In addition, a person skilled in the art will further recognize that the methods in accordance with the embodiments of the present invention, including method 300, can be modified to incorporate techniques and steps suitable for treating known breast openings. for a person with experience in the field that includes the appropriate techniques and steps described in US Patent Nos. 7,462,175, 7,500,971, and 7,645,272 and in United States Patent Application Publication Nos. 2008/0097154 and 2008/0281156, which are incorporated herein by reference in their entirety. Furthermore, the device and methods according to the present invention can be used in addition to the treatment of the nasal anatomy, for the treatment of an opening or conduit in the ostlum of a paranasal sinus, a paranasal sinus or an opening in the Eustachian tube. .

While the preferred embodiments of the present invention have been shown and described herein, it will be obvious to those skilled in the art that such embodiments are provided by way of example only. Numerous variations, changes, and substitutions will occur to those skilled in the art without departing from the invention. It should be understood that various alternatives to the embodiments of the invention described herein can be employed in the practice of the invention. The following claims are intended to define the scope of the invention and, thus, to support the devices and methods within the scope of these claims and their equivalents.