Apparatus for treating disorders of the sinuses.

(54) Title: METHODS AND DEVICES TO TREAT BREAST DISORDERS. (54) Title: APPARATUS FOR TREATING DISORDERS OF THE SINUSES.

(57) Summary

A medical device for treating a sinus opening includes a handle, a cleaning sleeve, a rail, a guide wire, a balloon catheter, and a balloon catheter movement mechanism; the handle has a proximal end, a distal end, and a longitudinal axis along the length of the handle; the cleaning sleeve has a distal end and a proximal end; the proximal end of the cleaning sleeve is attached to the distal end of the handle; the rail has a distal end and a proximal end, and is partially disposed within the cleaning sleeve to define an annular lumen that is between the rail and the cleaning sleeve; the guidewire operatively extends from the distal end of the rail, and the balloon catheter is at least partially disposed in the handle and the annular lumen; the balloon catheter movement mechanism is operatively arranged in the handle and configured for the advancement and retraction of the balloon catheter through the handle and the annular lumen, and along the rail and guide wire, which is performed by the user by operation of the balloon catheter movement mechanism; One method of treating a sinus opening includes partially inserting a medical device for treating a sinus opening into a patient's anatomy, and then placing a guidewire that operatively extends from a rail of a medical device into an opening in the patient's breasts; the method further includes advancing a balloon catheter from an annular lumen of the medical device and along the rail of the medical device and the guide wire; the method further includes treating the opening of the sinuses through inflation of the balloon catheter; in the method, the annular lumen is between the rail and a cleaning sheath of the medical device, and advancement is accomplished by the user operating a balloon catheter movement mechanism of the medical device.

(57) Abstract

A medical device for the treatment of a sinus opening ineludes a handle, a grooming sheath, a rail, a guide wire, a balloon catheter and a balloon catheter movement mechanism. The handle has a proximal end, a distal end and a longitudinal axis along the length of the handle. The grooming sheath has a distal end and a proximal end with the proximal end of the grooming sheath being attached to the distal end of the handle. The rail has a distal end and a proximal end and disposed partially within the grooming sheath to define an annular lumen is between the rail and the grooming sheath. The guide wire operatively extends from the distal end of the rail and the balloon catheter is disposed at least partially in the handle and annular lumen. The balloon catheter movement mechanism operatively disposed on the handle and configured for advancement and retraction of the balloon catheter through both the handle and the annular lumen and along both the rail and guide wire by user operation of the balloon catheter movement mechanism. A method for treating a sinus opening ineludes inserting a medical device for the treatment of a sinus opening partially into a patient's anatomy and then positioning a guide wire operatively extending from a rail of a medical device into a sinus opening of the patient. The method further ineludes advancing a balloon catheter from an annular lumen of the medical device and along both the rail of the medical device and the guide wire. The method also ineludes treating the sinus opening via inflation of the balloon catheter. In the method, the annular lumen is between the rail and a grooming sheath of the medical device and the advancing is accomplished via user operation of a balloon catheter movement mechanism of the medical device.

METHODS AND DEVICES TO TREAT BREAST DISORDERS

RELATED REQUESTS

This application claims priority, pursuant to 35 USC

§ 119, on the US provisional patent application. USA no. series 61 / 385,250, entitled "Medical Device for Treatment of a Sinus Opening", filed on September 22, 2010; the US provisional patent application USA no. series 61 / 385,263, entitled “Method for Treating a Sinus

Opening ”, presented on September 22, 2010; the US provisional patent application USA no. series 61 / 385,591, entitled "Meth'ods and Apparatus for Treating Disorders of the Ear, Nose and Throat", filed on September 23, 2010; the US provisional patent application USA no. series 61 / 511,237, entitled “Medical Device and Method for Treatment of a Sinus

I

Opening ”, filed on July 25, 2011, and the US provisional patent application. USA no. Serial No. 61 / 511,290, entitled "Methods and Apparatus for Treating Disorders of the Sinuses" filed on July 25, 2011, all of which are incorporated herein by reference.

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 connected by small openings, known as ostia, to the nasal canal. Each ostium between a paranasal sinus and the nasal cavity is made up of a bone covered by a layer of mucosal tissue. Normally, air enters and exits the paranasal sinuses through the ostia. In addition, the mucosal lining of the sinuses continually forms the mucus, which drains through the ostium into the nasal passage.

Sinusitis is a general term that refers to inflammation

I of one or more of the paranasal sinuses. Acute sinusitis can be associated with upper respiratory infections or allergic conditions, which can cause tissue inflammation and temporarily impede transostial drainage and ventilation of normal sinuses, causing some mucus accumulation and possible infection in the sinus cavities. Chronic sinusitis is a long-term condition characterized by persistent narrowing or obstruction of one or more sinus ostia, leading to chronic sinus infection and inflammation. Frequently, chronic sinusitis is associated with long-term respiratory allergies, nasal polyps, turbinate hypertrophy, 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 pathogen infections. multiple (for example, more than one type of bacteria or more than one genus of microorganisms).

If left untreated, chronic sinusitis can cause irreparable damage to the tissues and / or bone structures of the paranasal anatomy. Initial treatment of chronic sinusitis generally involves the use of medications such as decongestants, nasal steroid sprays, 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 called functional endoscopic sinus surgery (FESS). Normally, FESS is performed using an endoscope and various rigid instruments that are inserted through the patient's nostril. The endoscope is used to visualize the position, and the use of various rigid instruments is aimed at removing tissue from the nasal cavity and the sinus ostia, in an attempt to improve sinus drainage.

Acclarent Inc, of Menlo Park, CA, has developed a technique for treating sinusitis known as the Balloon! Procedure.

I i

Sinuplasty ™, as well as a system to perform the procedure. Many US patents and patent applications. Including the patents of the

I know. USA nos. 7645272, 7654997 and 7803150, and Publications 2008/0097154 and 2008/0281156, each of which is incorporated herein by reference in its entirety, describe various modalities of the Balloon Sinuplasty ™ procedure, as well as,¹ various devices used for the execution of said procedure. At

Item

Balloon Sinuplasty ™ procedure, a guide catheter is inserted into the nose and placed inside or adjacent to the ostium of the affected paranasal sinus.

i,

I

The guide wire is then advanced through the guide catheter to the

I affected paranasal sinus. Subsequently, a dilatation catheter provided i

of an expanded dilator (for example, an infallible balloon) is advanced

I i, through the guide wire to a position where the dilator is located within the ostium of the affected paranasal sinus. The dilator then expands, causing dilation of the ostium and remodeling of the adjacent bone.

I to the ostium, without requiring incision of the mucosa or the removal of any bone. The catheters and guide wire are then removed and the ostium (dilated allows for better drainage and ventilation of the affected paranasal sinus. 'There is i

a continuing need to improve methods and devices for sinus treatment. ;

t

The novel features of the invention are set forth with

I particularity in the attached claims. You will get a better (

understanding the features and advantages of the present invention by referring to the following detailed description which sets forth illustrative embodiments, in which the principles of the invention are used, and the attached figures, where similar numbers indicate similar elements.

BRIEF DESCRIPTION OF THE FIGURES

Figure 1 is a simplified representation of the side view of a medical device in accordance with an embodiment of the present invention.

Figure 2 is a simplified representation of the cross section 10 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 extended medical device.

Figure 4 is a simplified perspective representation of the guidewire, rail, and cleaning sleeve of the medical device of Figure 3.

Figure 5 is a simplified side view of the medical device of Figure 1, with the guidewire and balloon catheter of the medical device extended and the balloon catheter inflated over the gluttony cable.

Figure 6 is a simplified perspective representation of the guidewire, balloon catheter, and cleaning sleeve of the medical device of Figure 5.

Figure 7 is a flow chart illustrating the steps of a method of treating a paranasal sinus opening in accordance with one embodiment of the present invention.

Figure 8 is a simplified representation of the side view of the medical device of Figure 1, with the guide and balloon catheter of the medical device extended and the inflated balloon catheter on the rail.

Figure 9 is a simplified representation of the lateral cross section 5 of the medical device of Figure 8.

Figure 10 is a simplified representation of the lateral cross section of a portion of the medical device of Figure 8.

Figure 11 is another simplified representation of the section

I lateral cross section of a portion of the medical device of Figure 8.

Figure 12 is a combination of side view and multiple cross-sectional view of the medical device of Figure 3.

Figure 13 is a simplified representation of a balloon catheter subunit as can be used in embodiments of the present invention.

Figures 14A and 14B are simplified lateral and cross-sectional views of the balloon catheter subunit of Figure 13.

Figure 15 is a simplified representation of another subunit of the balloon catheter as can be used in embodiments of the present invention.

Figure 16 is a simplified cross-sectional view of a portion of the balloon catheter subunit of Figure 15.

Figures 17A and 17B are a combination of side view and multiple cross sectional view of balloon catheters as can be used in embodiments of the present invention.

Figure 18 is an embodiment of the device according to the invention, showing a side view of an alternative handle design.

Figure 19 is an embodiment of the device according to the invention, showing a side view of the device with another handle design.

Figure 20 is an embodiment of the device according to the invention, showing a side view of another alternative handle design.

Figure 21 is a side view of the distal end of a cleaning sleeve in accordance with the present invention.

Figure 22 is a side view of the distal end of the rail of the device according to the present invention.

Figures 23A and 23B are the side and perspective views, 15 respectively, and Figures 23C and 23D are front views of the distal portion of the device according to the present invention.

Figure 24 is an enlarged side view of the gluttonous cable movement mechanism in accordance with the present invention.

Figure 25 is a simplified side view of an alternative movement mechanism 20 of the guide wire, as well as the guide wire of the medical device according to the invention.

Figure 26 is a simplified cross-sectional view of the guide wire movement mechanism as well as the guide wire of Figure 25 in a locked position.

Figure 27 is a simplified cross-sectional view 5 of the gluttony movement mechanism and the gluttony cable of Figure 25 in an unlocked position.

Figure 28 is a simplified transparent view of the guide wire movement mechanism, as well as the guide wire of the

Figure 25 in the absence of the barrel of the guide wire movement mechanism. Figure 29 is an enlarged perspective view of the glide cable movement mechanism of Figure 24.

BRIEF DESCRIPTION OF THE INVENTION

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

In one aspect, a medical device is provided for the treatment of a sinus opening. The medical device includes a handle with a proximal end, a distal end, and a longitudinal axis along the length of the handle. The medical device further includes a cleaning sleeve with a distal end and a proximal end; the proximal end of the cleaning sleeve is attached to the distal end of the handle, as well as a rail with a distal end and a proximal end, and is partially disposed within the cleaning sleeve in such a way as to define a

Ring lumen between the rail and the cleaning sleeve; the distal end of the rail has an angular shape with an angle suitable for a particular paranasal sinus and the rail is rotatable with respect to the longitudinal axis. The guide wire extends operationally from the distal end of the rail; a balloon catheter is at least partially disposed in the handle and the annular lumen, and a movement mechanism of the balloon catheter is operatively arranged in the handle. The balloon catheter movement mechanism is configured to advance and retract the balloon catheter through the handle and annular lumen, and along the rail and guidewire, performed by the user through the operation of the movement mechanism. balloon catheter.

In one embodiment, the distal end of the cleaning sleeve is expanded to facilitate advancement and retraction of the balloon catheter. In a further embodiment, the expanded cleaning sleeve includes expandable slits.

In another embodiment, the guide wire is attached to the distal end of the rail and extends a predetermined fixed length beyond the distal end of the rail.

In a further embodiment, the medical device includes a guide wire movement mechanism operatively disposed on the handle. The rail has a lumen of the rail, the guide wire is arranged at least partially in the handle and the lumen of the rail, and wherein the guide wire movement mechanism and the guide wire are configured for the advancement and retraction of the guide wire through the handle and the lumen of the rail, what the user does through the operation of the gluttony cable movement mechanism.

In another embodiment, the guide medical device includes a guide wire rotation and locking mechanism.

In another embodiment, the guide wire has a proximal end, a distal end, and an atraumatic tip attached to the distal end of the guide wire.

In a further embodiment, the cleaning sleeve is configured to collapse a deflated balloon catheter during delivery.

Retraction of the balloon catheter in the annular lumen. ¡

In another embodiment, the balloon catheter has a functional segment. In one embodiment, the functional segment has a distal extension. In another embodiment, the balloon catheter, rail, and gluttony cable are configured such that the balloon catheter can advance from the annular opening so that the functional segment is located entirely on the guidewire, partially on the gluttony cable. and partially on the rail, at least partially extended beyond the end of the guidewire to inflate the balloon catheter.

In a further embodiment, at least a portion of the rail is formed of a malleable material, so that the user can manipulate the shape of the rail.

¡

In another embodiment, the first rail can be removed and replaced with a second rail that has a second angular shape.

In yet another embodiment, the rail includes visible endoscopic marking.

In another embodiment, the distal end of the cleaning sleeve includes an atraumatic tip.

In another aspect, a method is provided for the treatment of a sinus opening; the method includes partially inserting a medical device to treat a sinus opening in a patient's anatomy, placing a guide wire that operatively extends from a rail of a medical device to an opening in the patient's sinuses, advancing a balloon catheter of the medical device from an annular lumen of the medical device and along the rail of the medical device and the guide wire, and treating the opening of the sinuses through inflation of the balloon catheter. The annular lumen is between the rail and a cleaning sleeve of the medical device, and the user advances through the operation of the balloon mechanism of the balloon catheter of the medical device:

In a further embodiment, the method includes deflating the balloon catheter, retracting the balloon catheter into the cleaning sleeve, optionally retracting the guidewire into the lumen of the rail, and removing the medical device from the patient's anatomy.

In another embodiment, placement includes advancing the guide wire from a rail lumen of the rail by sliding a movement of a guide wire movement mechanism of the medical device along a handle of the medical device.

In another embodiment, the patient's anatomy is a nostril.

In yet another embodiment, the rail is formed of a malleable material and the method further includes configuring the malleable rail in a manner suitable for opening the sinuses to be treated prior to the insertion step.

In another embodiment, the treatment step includes inflating a functional segment of the balloon catheter that is disposed entirely on the guide wire, or partially on the guide wire, and partially on the rail, or extending beyond a distal end of the wire. guide.

In a further embodiment, the method includes vacuuming the breast opening.

In yet another embodiment, the method includes irrigating the breast opening.

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 enable the person skilled in the art to make and use the invention, and describes various embodiments, adaptations, variations, alternatives and uses of the invention, including what is currently considered 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 a portion or the set of components to function for the intended purpose, as described in the present description.

Generally, medical devices for treating a breast opening in accordance with embodiments of the present invention 10 include a handle, a cleaning sleeve, a rail, a guide wire, a balloon catheter, and a catheter movement mechanism. with the ball. The handle has a proximal end, a distal end, and a longitudinal axis along the length of the handle, while the cleaning sleeve has a distal end and a proximal end, where the proximal end of the cleaning sleeve is attached to the distal end of the handle. The medical device rail according to embodiments of the present invention has a distal end and a proximal end, and is partially disposed within the cleaning sleeve to define an annular lumen between the rail and the cleaning sleeve. The guidewire operatively extends from the distal end of the rail, and the balloon catheter of the medical device is at least partially disposed in the handle and the annular lumen. The balloon mechanism of the medical devices balloon is operatively arranged in the handle and configured for the advancement and retraction of the balloon catheter through the handle and the annular lumen, and along the rail and guide wire, which performed by the user by operating the balloon catheter movement mechanism by, for example, longitudinally sliding the balloon catheter movement mechanism along the handle.

I

Medical devices according to embodiments of the present invention are beneficial in the sense that, for example, their configuration provides particularly efficient preparation and treatment of a patient's sinus opening and is mechanically simple. Furthermore, the simplicity of medical devices provides for their manufacturing in a cost-effective manner. Furthermore, the rail of medical devices according to embodiments of the present invention is sufficiently rigid, so that it can be beneficially used to search for and access the anatomy of the

Breasts, followed by convenient advancement and inflation of a balloon catheter where the user uses, for example, a single hand. Medical devices are additionally beneficial in that the balloon catheter advances on the rigid rail, so the balloon catheter is well supported and gently advances (tracks) through the anatomy of the breasts. Although described in connection with sinus opening, the inventions described herein may also be useful for the treatment of the Eustachian tube, repair of endocranial fractures, airway procedures such as dilation of subglottic stenosis, and other ear, nose, or throat procedures.

FIG. 1 is a simplified representation of the side view of a medical device 100 for treating a breast opening in accordance with an embodiment of the present invention. Figure 2 is a simplified representation of the cross section of the medical device.

100. Figure 3 is a simplified side view of the medical device 100, with a guide wire of the medical device extended. Figure 4 is a simplified perspective representation of the guide wire, rail, and cleaning sheath of medical device 100. Figure 5 is a simplified side view of medical device 100, with the guide wire and balloon catheter of medical device extended and inflated balloon catheter. Figure 6 is a simplified perspective representation of the guidewire, the balloon catheter, and the medical device cleaning sleeve 100.

Referring to Figures 1 to 5, medical device 100 includes a handle 102, a cleaning sleeve 104, a rail 106, a gluttonous cable

108, a balloon catheter 110, a catheter movement mechanism with

I balloon 112 and a guide wire movement mechanism 114.

Handle 102 has a proximal end 116, a distal end

118, a longitudinal axis 120 (the extension of which is marked in Figure 2 by dashed lines to avoid masking other components of the medical device) along the length of the handle 102 and pins to place the fingers 122a and 122b. Finger pin 122a and 122b can be stationary or rotatable around the handle for a more comfortable and customizable grip.

The handle 102 can be formed of any suitable material, including, for example, polycarbonate and ABS (acetonitrilobutadiene-styrene), and can be manufactured by any suitable technique including, for example, injection molding of two bivalve halves of the handle. The two bivalve halves of the handle can be closed by any suitable manufacturing technique, including, for example, adhesive bonding, screw fixing, clip fixing using molded clips as integral parts of the handle halves, or pins to pressure installed on the handle halves.

Alternative designs of the t are shown in Figures 18, 19 and 20

handle for the devices of the invention. In these embodiments, the finger placement pins shown in Figures 1 through 5 have been replaced with grips 800, 810, and 820 to hold the device in the hand in the absence of an active grip. The grip 800, shown in Figure 18, comprises a 802 cross strap, designed for i

It fits into the user's hand or fingers and allows the user to relax the hand for periods of time without fear of the device falling out of the hand. The handle 810 shown in Figure 19 comprises an open hook 812 designed for the user to engage the handle 102 with freedom of movement at the distal end 118 of the handle. The handle 820 shown in Figure 20 comprises a T-leg 822 and circular finger sections 824 designed for coupling handle 102. A non-linear drive path 826 would allow movement of movement mechanisms 112 and 114 to move. was more natural along the arc of the user's thumb path. In the embodiments shown in Figures 18 and 19, rounded projections 804 and 814 are added to the handles to facilitate easy finger placement.

Cleaning sleeve 104 has a distal end 124, a proximal end 126, and an atraumatic tip 128 (see Figure 4 in particular) at distal end 124. Proximal end 126 of cleaning sleeve 104 is attached to distal end 118 handle 102 (see Figure 3 in particular). Cleaning sleeve 104 can be attached to handle 102 by any suitable technique, including, for example, mechanical adapters known to the person skilled in the art.

Cleaning sleeve 104 is configured to collapse and otherwise clean a balloon catheter 110 during retraction of the balloon catheter within the cleaning sleeve. If desired, the cleaning sleeve

104 can also be configured to provide additional stiffness to the rail

106. Cleaning sleeves in accordance with embodiments of the present invention are particularly useful in that deflating a balloon catheter by applying a vacuum may be at a sub-optimal level in terms of collapsing the balloon catheter into a beneficial profile. little. However, retracting a deflated balloon catheter into a cleaning sleeve can collapse the balloon catheter into a beneficially small profile. That small profile provides the beneficial ability to re-advance and re-inflate the balloon into another sinus opening, particularly, another sinus opening that the deflated balloon catheter enters through a narrow sinus structure.

Cleaning sleeve 104 can be constructed of any suitable material or materials, including, for example, a stainless steel tube with or without a polymeric liner (eg, a Nylon, PTFE or Pebax liner). In the embodiment of Figures 1-6, the polymeric liner includes an extension 104 'that extends slightly from the stainless steel tube at the distal end of the cleaning sleeve (see Figure 4 in particular). The atraumatic tip 128 of the cleaning sleeve 104 may be formed, for example, from a low durometer polymer fused with the polymeric extension 104 'or, in an alternative embodiment, may be formed from a thermally fused and bonded low durometer polymer. to the stainless steel tube with an overlapping joint. The polymer can be colored for endoscopic visualization purposes. The tip of the cleaning sleeve 840 can also be expanded and its diameter can be conical in the distal region (see Figure 21). This tapered tip 840 provides a transition between the outside diameter of the rail 106 and the inside diameter of the cleaning sleeve 104, which provides a ramp to advance through the fabric and then slide. The two slits 842a and 842b, separated by 180 ° (or, alternatively, 4 slits separated by 90 °) are designed to expand when the ball passes through tip 840 and therefore allow the ball to come out and return to enter the cleaning cover

104 with low friction. The most proximal ends of the grooves 842a and 842b (there may be four circular elements if there are four grooves) have the circular elements 844a and 844b, designed to prevent tearing and further proximal propagation of the grooves. As shown in Figure 18, sheath 104 terminates at a distance proximal to the curved section of rail 136, but, in particular embodiments, can be extended to near the curved section of rail 136, so that, when made advance out of the bag, the ball has less travel distance.

As shown in Figure 2, rail 106 has a distal end 130, a proximal end 132, and a lumen of rail 133 (see Figure 12 i

described below) and is partially arranged inside the case

I 104, such that an annular lumen IS is defined between the rail 106 and the cleaning sleeve 104. The proximal end 132 of the rail 106 is attached to the handle 102 (see Figure 2).

The rail 106 is configured to (i) serve as a probe to search for an entry path to the target sinus ostium (also called the sinus opening), (ii) provide a rail suitably to guide the balloon catheter in the sinus ostium and (iii) provide a luminal path (i.e., the lumen of rail 133) for movement of the guide wire. If desired, the lumen of the guide wire of the rail can be made with the appropriate space, so as to apply irrigation or suction through the lumen of the guide wire during the use of the medical device.

Rail 106 may be formed of any suitable material, t

including, for example, 304 stainless steel or 316 stainless steel. In addition, the distal end 130 of rail 106 can be manufactured in a predetermined manner that is appropriate for treating a sinus opening in the range of between about 0 degree and 125 degrees, and you can choose the right 106 rail for treating a particular breast. For example, for entry into the frontal sinus, the default shape may be an angular shape with an angle (curve) in the range of 65 degrees and 85 degrees or approximately 75 degrees. For entry into the sphenoid sinus, the default angular shape can be in the range of about 0 degree to 30 degree, or be approximately horizontal. For maxillary entry, the default angular shape can be in the range of approximately 85 degrees and 125 degrees, or be approximately 100 degrees. For treatment of more than one breast, rail 106 can be removed from handle 102 and replaced with another in a different breast shape.

If desired, the distal end 130 of rail 106 may be formed of a malleable material that allows the user to shape the shape of distal end 130 before inserting medical device 100 into a patient's anatomy. In this circumstance, the distal end 130 may 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 stainless steel (eg tempered). A feature formed in a thermoforming tray would allow a user to configure the distal end 130 directly on the tray, would assist in the correct shaping of the distal end 130, and would prevent the user from using their hands or other instrument with the probable result of damaging the distal end 130.

If desired, the distal end 130 of rail 106 may include visible endoscopic markers (not shown in the figures) and / or an atraumatic tip (also not shown in the figures). This atraumatic tip may be formed, for example, from a soft polymeric material or consist of a suitably polished and sintered distal end. Those visible endoscopic markers can be placed, for example, on the surface of the distal end 130 and configured to indicate the distance from the distal point furthest from the rail. In one embodiment, the visible endoscopic markers are configured as thin circumferential ribbons, where the number of ribbons corresponds to the distance in centimeters at which the marked position is from the furthest distal point. For example, if the marked position is 3 cm from the furthest distal point, the endoscopic visible mark would consist of three thin ribbons. Those visible endoscopic marks beneficially provide a user with a sense of the location of the tip of the rail and thus its extension to a breast.

In the embodiment of Figures 1-6, the distal end 130 of the rail

106 it includes a straight proximal section 134 (such as, for example, a 7 cm straight section), a curved section 136 (eg, a 3 cm curved section), and a relatively short straight distal section 138 (see Figure 1) for example 5mm to 50mm in length. Typical, but not limiting, inner and outer rail diameters are 0.0965 cm (0.038 inch) and 0.132 cm (0.052 inch), respectively. This configuration, together with a gluttonous extension cable, has been determined to provide ease of entry to the breast openings during the treatment of these.

Precise dimensions have been determined for rail 106 to achieve optimal sinus ingress. In order to ensure an adequate range of motion during maxillary sinus probing, a tip 830 range (see Figure 22) of between approximately 0.254 cm (0.10 inch) and 1.27 cm (0.50 inch), or between approximately 0.508 cm (0.20) and 1.02 cm (0.40 inches), and frequently about 0.762 cm (0.30 inches). Furthermore, to ensure easy entry of the glula cord 108 into the maxillary sinus after manipulating the distal end of device 100 into position, a tip path 832 of between about 85 degrees and 125 degrees, or between about 90 degrees and 110 is desirable. degrees and often about 100 degrees. The distal tip can be chamfered to provide support to the distal ball to allow forward directional advancement of the curved guide wire and to facilitate retraction of the ball. To ensure easy entry of the guide wire into the front sinus 108 after manipulating the dlstal end of the device 100 into position, a tip range 830 between approximately 1.02 cm (0.40 inch) and 2.03 cm (0.80 inch) is desirable, or between about 1.27 cm (0.50 inch) and 1.78 cm (0.70 inch) and often about 1.52 cm (0.60 inch), and an 832 tip path between about 55 degrees and 85 degrees is desirable, or between about 60 degrees and 80 degrees and often about 70 degrees. The distal tip can be square or beveled. To ensure easy entry of gluttony cable 108 into the sphenoid sinus after manipulating the distal end of the device

100 in position, a tip path 832 of between about 0 degrees and 30 degrees, or between about 0 degrees and 10 degrees and often approximately horizontal is desirable.

The distal end 130 of the rail 106 must also be positioned comfortably for the user. A right-handed user will position the rail differently than a left-handed user. Accordingly, the ability to rotate the rail with respect to the longitudinal axis of handle 102 allows the user to orient the geometry of the rail, the balloon catheter movement mechanism 112, and the guidewire movement mechanism 114 of the handle 102. As shown in Figures 23A, 23B, 23C, and 23D, the mechanism for rotating the rail has five key elements: the 920 rail switch, the 922 rail switch terminal, the front clamp 926, the clamp brake 928 and the spring. Referring to Figures 23A and 23B, the distal end 118 of the handle 102 is shown. The first element of the mechanism to rotate rail 106 is rail switch 920, a molded part that provides a bearing surface for rail switch terminal 922. Terminal 922 extends through rail switch 920 and through from the dlstal end 118 of the handle 102 and terminates in a channel 924 defined between the front clamp 926 and the handle 102. The rail switch terminal

922 it is made of a rigid material, in this case Stainless steel, and is welded to rail 106 through rail Switch 920. The front clamp

926 provides a channel 924 for the rail switch terminal 922. When the front clamp 926 is rotated, the rail switch terminal 922 moves to the right or to the left within the keyway 930, depending on the need for proper orientation of the rail. The clamp brake 928 locks the terminal of the Rail Switch 922 in a first slot of the front clamp 932. A spring (not shown) provides the force against the front clamp 926 to hold the 922 rail switch terminal in a forward position. To change position, the clamp 926 is pushed toward the user and rotated so that the terminal of the Rail Switch 922 is pulled out of the first slot 932 of the keyway 930 and rotatable. Once the rail switch terminal 922 reaches a second slot 934 in the keyway 930 (in the case shown, the second slot 934 has an offset of 90 degrees from the original slot, but the slots may have a 45, 90, 135, or 180 degree offset or any Intermediate value, either to the Left or to the right from the first slot 932, and there may be 2, 4, 6, 8 or any number of slots less than or equal to 12), the spring pushes the terminal 922 into the second slot 934. Because the terminal of the Rail Switch 922 rotates around a line that is displaced from the center of the clamp 926, the terminal of the Rail Switch 922 retracts upward and down into slots 932 and 934.

As shown in Figures 1-4, guide wire 108 operatively extends from the distal end of rail 106 and follows the orientation of rail 106 described above. The glutton 108 may be (i) attached to the distal end of the rail and extended a predetermined fixed length beyond the distal end of the rail, or (ii) at least partially disposed on handle 102, while the lumen of the rail with the medical device 100 are configured for the advancement and retraction of the guide wire through the handle and the lumen of the rail by longitudinal sliding of the guide wire movement mechanism 114 along the handle 102 (compare, for example, the figures

2 and 3 that illustrate different extensions of the guide wire). For this latter configuration, the guide wire may be attached to a guide wire movement mechanism, such as element 114 of Figures 1-3 and 5.

In the embodiment of Figures 1-6, guide wire 108 includes an essentially spherical atraumatic tip 140 (see Figures 4 and 6, particularly). That spherical atraumatic tip may, for example, have a diameter in the range of approximately the same diameter as the gluttony cable (for example, 0.0813 cm (0.032 inch)) to 0.203 cm (0.080 inch). The upper limit of the diameter of the spherical atraumatic tip is chosen so that the tip does not unduly prevent the gluttony from finding a narrow path of entry into the sinus. In one embodiment, the rail has a diameter of approximately 0.127 cm (0.050 inch) and the spherical atraumatic tip of the guide wire has a diameter of 0.152 cm (0.060 inch) so that during use of the medical device the spherical tip protects the edge distal furthest from the rail of contact with the breast or other tissue of the patient's anatomy. Alternatively, the spherical tip of the gluttony cable can be of such a size that the balloon catheter can extend beyond the spherical tip.

If desired, the tip of the guide wire 108 can be illuminated in a manner that allows a user to confirm successful entry into a breast opening. That tip may be formed as a molded component that is adhesively bonded to the guide wire 108, but must be translucent to allow all light to pass through the tip.

Guidewire 108 may be formed of any suitable material known to those skilled in the art, including, for example, stainless steel, Nitinol, and combinations thereof, and of any suitable stiffness or graduated stiffness. Also, guide wire 108 can be configured in any suitable way, including, for example, a steel coil t

stainless, a coil wound around a core wire (including a variable diameter core wire that provides varying stiffness along the guide wire), a configuration with an angular distal end (eg, an angular end with angles of 5-30 degrees and a length of 2.0 to 10 mm) and configurations including the incorporation of one or more light transmitting fibers that provide an illuminated distal end of the guidewire and / or a tip formed of a light transmitting material and one or more reinforcing materials (such as a hypotube) that prevent the guide wire of the device from buckling in the patient's anatomy. Other configurations may include a sensor at the tip that allows advancement (for example, an energized coil that originates a magnetic field) or a lens at the tip that allows greater light scattering from the tip. For example, in US Pat. USA no. 2008/0228085, which is incorporated herein by reference in its entirety, describes suitable lighted guide wires which can be incorporated into the current device.

In order for the user to have additional tactile feedback to access the breast, a number of additional features can be incorporated into the handle 102, as will be described later with respect to Figure 24. In this embodiment, in order to avoid buckling of the guide wire 108 between the rail 106 and the distal portion of the guide wire movement mechanism 114, a hypotube 900 may be welded by soldering or ordinary welding to the guide wire 108 and a fin 902 to the hypotube, to connect the guide wire movement mechanism

114 to the hypotube 900. Alternatively, instead of a fin 902, a tube or sleeve can be placed around the hypotube, a terminal with a through hole for the hypotube, a split leg fin welded to either side of the hypotube, or an adhesion connection Directly to the guide wire movement mechanism can be useful to connect the guide wire movement mechanism to the hypotube. In this way, the force applied to the guide wire movement mechanism to advance it along the handle 102 is directly translated into guide wire movement 108 in the anatomy of the sinus. When an obstacle is encountered, the guide wire movement mechanism 114 will stop advancing and the user will know that it is an obstacle. Alternatively, instead of a hypotube, it may be desirable to Increase the diameter of the Inner core cable of the gluttony cable 108 or add a reinforcing element to provide rigidity to the guide wire 108 between the rail 106 and the guide wire movement mechanism 114. Furthermore, when rail 106 is rotated to advance within the right or left maxillary sinus or for the proper orientation of a right-handed or left-handed user, the tube or sleeve placed around hypotube 900 will allow rotation of the glutton 108 with rail 106. , so that it will also be properly located for the breast and / or the manipulation of the user.

Guide wire 108 serves to safely provide additional reach, beyond the reach of the rail, in the target anatomy. For a predetermined fixed length guide wire, the length may be, for example, in the Range of 5mm to 30mm. For a medical device configured with an extendable guide wire, the configuration may be such that a user can extend the guide wire from the rail at a distance of, for example, 1mm to 50mm.

Balloon catheter 110 is at least partially disposed in handle 102 and the annular lumen between rail 106 and cleaning sheath 104 (see, eg, Figure 12 described below). Furthermore, the balloon catheter 110 is operatively connected to the balloon catheter movement mechanism 112. In this regard, the balloon catheter movement mechanism 112 is configured to advance and retract balloon catheter 110 through handle 102 and annular lumen 135, and along rail 106 and guide wire 108 by Longitudinal sliding of the balloon catheter movement mechanism 112 along the handle 102. However, once informed of the present description, the person skilled in the art will recognize that the movement mechanisms of the balloon catheter used in medical devices (and methods) in accordance with the

The present invention is not limited to those that are actuated by the user by longitudinal sliding along the length of the handle. Rather, the user operation of the balloon catheter movement mechanism may be any suitable operation that results in operable movement of the balloon catheter, 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 regard, the configuration of the balloon catheter mechanism would support such user operation by a suitable rack and pinion mechanism, gear based mechanisms, threaded mechanism and / or electromechanical instruments.

A suitable rack and pinion mechanism can be incorporated into devices in accordance with embodiments of the present invention, for example, using a configuration where a balloon catheter stem disposed within the handle is connected to a rack gear. . That rack gear may be configured for longitudinal movement by coupling with a roller gear that a user operates (i.e. rotates). Between the roller gear and the rack gear there can be a gear train that includes various combinations of gear ratios, which provides a reduction in the necessary force that a user must exert on the roller and / or increases the travel distance of the rack with a small rotation driven on the roller.

A suitable threaded mechanism can be incorporated, for example, by attaching the balloon catheter to a cylindrical component with external threads, where the cylindrical component is restricted to move t

longitudinally without rotation. A roll with internal threads can be configured to mate with the external threads of the cylindrical component. In this configuration, the operation of the user by rotating the roller causes the longitudinal displacement of the cylindrical component and the balloon catheter. The thread design of that modality can be configured with threads of a predetermined pitch or type (for example, a triple entry thread) to provide a greater distance of travel of the catheter to a lesser rotation of the roller.

Balloon catheter 110 may be any suitable balloon catheter known to the person skilled in the art and includes, for example, double-stem balloon catheters with a braided inner stem made of Nylon, PET and Pebax. A braided inner stem provides stiffness to keep the ball in line with the curve of the rail as it advances distally to the rail and inflates. As shown in Figure 9, a smooth conical balloon tip 142 at distal extension 144 to the braided inner stem provides a smooth profile transition to the smaller guide wire 108 and allows the balloon to advance through the curve of the rail and its location in the target anatomy. If desired, the balloon catheter may additionally include a lubrication layer to reduce friction between the catheter rail and balloon. The balloon catheter can be a catheter of any size, including, but not limited to, 3.5mm to 7mm diameter (when inflated) and 12mm to 24mm functional length (eg 3.5mm x 12mm, mm x 16 mm, 5 mm x 24 mm, 6 mm x 16 mm, 6 mm x 20 mm, 6 mm x 24 mm, 7 mm x 16 mm and 7 mm x 24 mm. In a modality for the maxillary sinus, the dimensions of the functional portion of the balloon catheter are mm in diameter (when inflated) and 24 mm in functional length. Balloon catheter 110 may have a conformable distal tip such that, when expanded distally over the distal end of rail 106, it is flush with the outside diameter of guidewire 108. Materials useful for that purpose include, but are not limited to, stainless steel, nitinol, a laser cut coil or tube, of a tip conformation similar to that of the cleaning sheath described above, with two slits 180 degrees apart between yes (or four slits 90 degrees apart).

Before use of the medical device, the balloon catheter 110 retracts into the cleaning sleeve 104 and handle 102. When extended, part or all of the functional length of the balloon of the balloon catheter extends distal to the tip of the rail on the guide wire. In one embodiment, the balloon catheter does not extend beyond the tip of the guidewire. If the tip of the

The guidewire is of sufficient diameter and the guidewire is not fully extended when the balloon catheter is extended, the extension of the balloon catheter may carry the guidewire with it. In another embodiment, the tip of the guidewire is less than one lumen of the balloon catheter. In this modality, the balloon catheter can be extended beyond the tip of the guide wire.

The guide wire movement mechanism 114 is configured to advance and retract the guide wire through handle 102 and the lumen of rail 133 by longitudinally sliding the guide wire movement mechanism 114 along handle 102. However, once informed of the present description, the person skilled in the art will recognize that the guide wire movement mechanisms used in medical devices (and methods) according to the present invention are not limited to those that are operated by the user. by sliding along the length of the handle. Rather, the user's operation of the guide wire movement mechanism may be any suitable operation that results in operable movement of the guide wire, for example, by translation (i.e., motion that changes the position of an object), of the guide wire movement mechanism with respect to the handle or the rotation of a component of the guide wire movement mechanism. In this regard, the configuration of the guide wire movement mechanism would be compatible with user operation by, for example, a suitable rack and pinion mechanism, gears and / or electromechanical instruments.

In an alternative embodiment shown in Figure 25, the guide wire movement mechanism 610 may include an integrated guide wire lock and rotate mechanism 640, configured for guide wire rotation 606 and to lock and unlock the guide wire securely from the guide wire movement mechanism 610, a rail 642 and a nasal bridge 644. The rail 642 is configured to slidably attach the guide wire movement mechanism 610 to the handle 102. Nasal bridge 644 is configured to direct guide wire 606 into handle 102 and lumen of rail 133 of rail 106 as described above.

The integrated guide wire rotation and locking mechanism includes a barrel 646 and a collar type mandrel shaft 648 (see Figures 2529, particularly). The lock / unlock capability of the integrated 640 guide wire lock and rotate mechanism allows a. User adjusts the length of the guide wire that extends (distally) beyond the glide 610 movement mechanism.

Collet chuck shaft 648 is configured to function as a collar chuck and shaft, and has a longitudinal opening through which guide wire 606 passes (see Figure 27, particularly). In the embodiment of Figures 25 to 29, the collar-type mandrel shaft 648 is essentially cylindrical in general, and when locked on the guide wire (see Figure 26, where the overlap shown of the barrel and the axis of Collar type mandrel serves to illustrate that the barrel compresses the collar type mandrel shaft into the guide wire), rotates with the guide wire 606. Collet chuck shaft 648 rotates within support surfaces 650 of guide wire movement mechanism 610 (see Figure 27). The collar type mandrel shaft has a plurality of alternating 652 protrusions and grooves

654 (see Figure 27) configured to lock (close) on the guide wire 5 and thus couple the rotation of the guide wire with the rotation of the collar-type mandrel shaft. Collar-type mandrel shaft 648 exerts a large clamping force on the guide wire when tightened by longitudinal movement of barrel 646 (as is evident from a comparison of Figure 25, where the collar-type mandrel shaft is locked in the gluttony cable, and Figure 26, where the collar-type mandrel shaft is unlocked from the guide wire).

Barrel 646 has an essentially cylindrical cross section and an opening along it, in which the collar type mandrel shaft 648 is located. The contour of the barrel opening is designed to receive the collar type mandrel shaft and has at least one focal point configured to collapse the collar-type mandrel shaft onto the gluttonous cable (see Figure 25, particularly). The exterior of barrel 646 has

I grip characteristics shown in the embodiment of Figures 25-26 as a macroscopic surface characteristic (ie, frames). However, these gripping characteristics could alternatively be microscopic in nature or based on properties of friction materials, such as a rubber surface. Those grip characteristics provide traction for the user to rotate or move the barrel by, for example, thumb operation. The distal and proximal ends of the barrel have a raised ring feature 656, which provides traction for the user to move the guide wire movement mechanism when the collar-type mandrel shaft is in a locked position or provides a grip feature to displace barrel 646 with respect to the rest of the guide wire movement mechanism 610 to lock and unlock shaft 648.

The guide wire movement mechanism 610 is shown in detail in Figure 29 and allows the guide wire 606 to advance, retract and rotate. Mechanism 610 integrates a guide wire rotation and locking mechanism 640 configured for guide wire 606 rotation to lock and unlock guide wire 606 securely to guide wire movement mechanism 610 as further described with respect to Integrated mechanism for locking and rotating the guide wire 640 mentioned above. Included in Figure 29 is a device 658 that interacts with the barrel fins 646 to provide audible and tactile feedback on the rotation of the lockout and rotation mechanism 640 and the resulting rotation of guide wire 606. A representative guide wire 606 incorporated into the Device 100 of the invention is the Relieva Luma Sentry ™ Sinus Illumination System, manufactured by Acclarent, Inc., Menlo Park, CA. It is a guidewire system that can be connected to a light source for transillumination, illumination and posterior transcutaneous visualization of the sinus cavity.

After being informed of the present description, the person skilled in the art will recognize that the guide wire rotation and locking mechanisms used in medical devices according to the present invention can take any suitable form, in addition to the barrel and mandrel axis configurations. necklace type shown, for example, in Figures 25 to 29. For example, the barrel could be in the shape of essentially a sphere, cylinder or other suitable shape.

Generally, methods for treating a sinus opening in accordance with embodiments of the present invention include partially inserting a medical device for treating a sinus opening into a patient's anatomy (eg, the nostril of a patient) and then place a guide wire that operatively extends from a rail of a medical device and penetrates an opening in the patient's sinuses. The methods further include advancing a balloon catheter from an annular lumen of the medical device and along the rail of the medical device and the guide wire. In the methods, the annular lumen is between the rail and a cleaning sheath of the medical device, and advancement is accomplished by the sliding motion of a balloon device of the medical device's balloon catheter along a handle of the device doctor. The method also includes treating the sinus opening by inflating the balloon catheter.

The methods according to embodiments of the present invention are beneficial in that they are, for example, particularly efficient with regard to the placement of the balloon catheter for the treatment of the sinus opening and the retraction of the balloon catheter in the medical device. Furthermore, the methods allow the entire method to be carried out conveniently and efficiently using a single medical device and in a surgical setting or in a medical office.

Referring to Figure 7, method 200 for treating a breast opening in accordance with an embodiment of the present invention includes partially inserting a medical device for treating a breast opening in a patient's anatomy (see step 210 of Figure 7).

In step 220, a guidewire extending operatively from a rail of a medical device is placed in an opening in the patient's sinuses.

Subsequently, and as indicated in step 230 of Figure 7,

I advances a balloon catheter of the medical device from an annular lumen of the medical device along the rail of the medical device and the guide wire!

Alternatively, the balloon catheter can be advanced only on the rail and, at a later stage, inflated only on the rail, as described below. The annular lumen referred to in step 230 is seen to be between the rail and a medical device cleaning sleeve. On the other hand, in step 230 the advance is carried out by a sliding movement of a balloon mechanism of the balloon catheter of the medical device along a handle of the medical device.

Method 200 further includes, at step 240, treating the sinus opening by inflating the balloon catheter. The balloon balloon segment of the balloon catheter (also called the functional portion) can be inflated as needed, depending on the position of the rail and guidewire, only on the rail, partially on the rail, and partially on the guidewire , only on the guide wire or extend beyond the guide wire. After treatment, the balloon catheter is deflated (step 250) and retracted into the cleaning sleeve of the medical device (see step 260). At step 270, the medical device is removed from the patient's anatomy.

Once informed of the present description, the person skilled in the art will recognize that the method 200 can be easily modified to incorporate any of the techniques, benefits and characteristics of medical devices according to the modalities of the present invention and that are described in the present description. For example, methods in accordance with embodiments of the present invention may further include, as a portion of the laying step, the advancement of the guide wire from a

Rail lumen of the rail through a sliding motion of a guide wire movement mechanism of the medical device along a handle of the medical device. That method could further include, after the treatment step, retracting the balloon catheter into the cleaning sleeve and retracting the guidewire into the lumen of the rail. Additionally, the person skilled in the art will further recognize that the methods according to modalities of the present invention, including method 200, can be modified to incorporate techniques and steps suitable for treating the breast opening, known to the expert. in the art, including the appropriate techniques and steps described in US Patents. USA nos. 7,462,175,

7,500,971 and 7,645,272, and in US patent publication applications. USA nos. 2008/0281156 and 2010/0030113, each of which is incorporated herein by reference in its entirety.

Again, with reference to medical device 100, FIG.

8 is a simplified representation of the side view of the medical device

I

100, with the guidewire and balloon catheter of the medical device extended and the balloon catheter inflated on the rail. Figure 9 is a simplified representation of the lateral cross section of medical device 100. Figure 10 is a simplified representation of the lateral cross section of a portion of medical device 100. Figure 11 is a simplified representation of the side cross section of a portion of the medical device 100, and Figure 12 is a combination of a side view and multiple cross section views taken along various lines of the side view of the medical device 100.

Referring to Figures 8 through 12, the handle 102, the cleaning sleeve 104, the rail 106, the guide wire 108, the balloon catheter 110, the balloon catheter movement mechanism 112, and the movement mechanism are shown. of guidewire 114, and lumen of rail 133. Balloon catheter 110 of medical device 100 includes an inner stem 150 and an outer stem

152 (see Figure 12). FIG. 11 shows how the cleaning sleeve 104 is attached to the inside diameter (ID) of a sleeve 190 of handle 102 and how rail 106 is coupled to handle 102 by means of a flap 192. Rail 106 can for example, being soldered by soldering or ordinary solder to fin 192 and fin 192 may be mechanically attached or adhesive bonded to the rest of handle 102.

Figure 13 is a simplified representation of a subunit of the balloon catheter 300, as can be used in modalities of the

I present invention. Figures 14A and 14B are simplified lateral and cross-sectional views of the balloon catheter subunit 300.

Referring to Figures 13, 14A, and 14B, the balloon catheter subunit 300 includes a balloon catheter 302, a balloon catheter movement mechanism 304, and an inflation tube 306. Balloon catheter 302 includes a functional segment balloon 310, a distal portion of stem 312, a catheter medial joint 314, a flat lumen stem 316, an inner stem 318 and an outer stem 320.

The inner stem 318 and the outer stem 320 are configured t

such that a 322 rail lumen and an annular inflation lumen are formed

326 in the dlstal portion of stem 312 (see cross section 360 of

Figure 14B taken along line BB of Figure 14A). The catheter median junction 314, rail lumen 322 and inflation lumen 328 are in a stacked configuration (see cross section 370 of Figure 14B taken at

along line CC of Figure 14A). Cross section 380 of Figure

14B (taken along line DD of Figure 14A) and cross section

370 they represent a configuration where the flat lumen stem 316 defines the inflation lumen. Cross section 350 of Figure 14B (taken along line AA of Figure 14A) represents the configuration of inner stem 318 and functional segment of balloon 310.

Balloon functional segment 310 can be made of any suitable material, including, for example, polymeric materials such as Pebax, Nylon, and PET. The diameter of the functional segment of the balloon may be, for example, in the range of 3.00 mm to 8.00 mm (inflated) and have a length in the range of, for example, 5 mm to 30 mm, while the typical length is in the range of 20mm to 25mm. The inner and outer stems of the balloon catheter can be made of any suitable material, including, for example, polymers such as Pebax, Nylon, Hytrel, or high-density polyethylene (HDPE). In some embodiments, the inner stem may be braided in construction for increased rigidity so that the balloon remains coaxial with the rail when advanced distal to the rail and inflated. To reduce friction between the balloon catheter and a rail, the inner stem may be formed, for example, from a polymer impregnated with microparticles of PTFE (polytetrafluoroethylene) or have a thin coating of molten PTFE inside the lumen. The balloon can be attached to the inner and outer stems by thermal or laser bonding.

The stem of the inflation lumen 316 may be formed, for example, from a tubular metal material such as a tubular stainless steel material. The inflation lumen stem 316 can be made, for example, by flattening a round stainless steel tube. The inflation lumen stem 316 serves to (i) provide a lumen for inflation and deflation of the balloon functional segment and (i) provide adequate rigidity to advance and retract the balloon catheter while resisting buckling. In one embodiment, the cross section of the inflation lumen stem 316 is flat and can have any suitable ratio of flat height to flat width (depicted in cross section 380), where a particularly beneficial ratio is a 1: 1 ratio.

Figure 15 is a simplified representation of another subunit of balloon catheter 400, as can be used in embodiments of the present invention. Figure 16 is a simplified cross-sectional view of a portion of the balloon catheter subunit of Figure 15.

Referring to Figures 15 and 16, the balloon catheter subunit 400 includes a balloon catheter 402, a balloon catheter movement mechanism 404, and an inflation tube 406. Balloon catheter 402 includes a functional segment of the balloon 410, a distal portion of stem 412, a catheter medial junction 414, and a flat lumen stem 416. The flat lumen stem 416 is assembled into the balloon catheter movement mechanism 404 at a slightly downward angle (see Figure 16). That downward angle serves to prevent buckling, since that angle deflects any buckling in the downward direction (which is a direction that can be reinforced by support from the handle, as shown in the handle of Figure 11).

Figure 16 depicts the joint between the flat lumen stem 416 and the inflation tube 406 within the balloon catheter movement mechanism 404. Figure 16 further depicts a clearance hole 420 for a guidewire, the angular inlet of the flat lumen stem 416 (which forces the flat lumen stem to bend down under any buckling force) and the lap joint between the flat lumen stem 416 and the inflation tube 406.

During fabrication, the flat lumen stem and inflation tube are first joined by techniques such as adhesive or heat bonding. At that heat junction, a polymeric shrink tube is placed over the lap joint segment. The assembly is then placed within a heat source (eg, a hot air, RF energy, or laser energy heat source) to melt the polymeric shrink tube and securely fuse it around a metal stem of the lumen flat. The attached segment is then placed inside the balloon catheter movement mechanism, as shown in Figure 16. Adhesive is then used to bond the flat lumen stem and inflation tube into the balloon catheter movement mechanism.

Figure 17A is a simplified cross-sectional view of a balloon catheter 500, as may be used in embodiments of the present invention. Figure 17A shows an illustrative, but not limiting, balloon catheter 500. At a midline catheter junction. 506 a distal inner balloon stem 502, a distal outer stem are thermally fused

504 and a proximal stem 516. Inner stem 502 comprises a lumen of guidewire 508 and outer stem 504 comprises a distal annular lumen

505 which also serves as an inflated lumen. The middle catheter junction 506 is formed so that the guidewire can exit the catheter and transitions the Inflation lumen from the distal annular lumen 505 (see cross section 510 taken along line AA of Figure 17A) up to a single lumen 507 (see cross section 512 taken along line CC of Figure 17A). As shown in cross section 514 taken along BB in Figure 17A, in order to allow free movement of the balloon catheter mechanism 112 and the guidewire movement mechanism 114 shown in Figures 1 -5, the inflation tube (not shown) and the stem of the attached proximal balloon 516 must be off-center with respect to balloon 518, such that the lumen of gluttony cable 508 and the lumen of inflation 509 are in a configuration of double lumen. In one embodiment, as described above, the materials may be thermally fused at the middle catheter junction 506. In another embodiment, a ring of the hlpotube may be crimped around the middle catheter junction 506. In yet another embodiment shown in Figure 17B, the catheter medial junction 550 may comprise a molded portion to consistently maintain the coaxial dural annular lumens, a distal inflation lumen 552, and a distal glutton lumen 554 (see cross section 556 taken along AA of Figure 17B), a single proximal annular lumen, proximal inflation lumen 558 and a double displacement catheter medial junction 550 (cross section 560 taken along BB of Figure 17B), including a catheter half inflation lumen 562 and a catheter half lumen of the guidewire 564. This molded mid-junction connector allows smooth advancement and retraction of balloon catheter 566 through handle 102 described above.

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 in the present description 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.