# US 2010/0168511 A1 · System and method for dilating an airway stenosis > Agents: this data is available as JSON from the patentgrep API and MCP server — see https://patentgrep.com/llms.txt - Number: US 2010/0168511 A1 - Document ID: US20100168511A1 - Status: Published application - Kind: A1 - Application number: 12/566,556 - Filed: 2009-09-24 - Published: 2010-07-01 - Earliest claimed: 2008-12-29 - Assignees: Acclarent, Inc. - Inventors: Ketan P. Muni; Hung V. Ha; Chi Nguyen; Randy S. Chan; John Y. Chang - Web page: https://patentgrep.com/patent/US20100168511A1 ## CPC - A61M 25/0152: {with pre-shaped mechanisms, e.g. pre-shaped stylets or pre-shaped outer tubes} - A61M 25/0102: {Insertion or introduction using an inner stiffening member, e.g. stylet or push-rod} - A61M 25/10: Balloon catheters ({A61M25/0125 takes precedence; embolectomy A61B17/22032; retractors A61B17/02;} inflatable balloons for placing stents or stent-grafts A61F2/958 {; stomach balloons for treatment of obesity A61F5/0003; oesophagal tubes A61J15/00}) - A61M 25/1027: {Making of balloon catheters} - A61M 29/02: Dilators made of swellable material {(balloon catheters for angioplasty A61M25/104)} - A61B 2090/306: {using optical fibres} - A61M 25/0041: {pre-formed, e.g. specially adapted to fit with the anatomy of body channels (urethral catheters A61F2/04)} - A61M 2025/1031: {Surface processing of balloon members, e.g. coating or deposition; Mounting additional parts onto the balloon member's surface} - A61M 2025/1088: {having special surface characteristics depending on material properties or added substances, e.g. for reducing friction} - A61M: DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY (introducing media into or onto the bodies of animals A61D7/00; means for inserting tampons A61F13/26; devices for administering food or medicines orally A61J; containers for collecting, storing or administering blood or medical fluids A61J1/05); DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY (surgery A61B; chemical aspects of surgical articles A61L); DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR {(Electrotherapy, e.g. producing anaesthesia by the use of alternating or intermittent currents A61N1/36021)} - A61B: DIAGNOSIS; SURGERY; IDENTIFICATION (usefulness limited to only animals A61D) ## Abstract A method for dilating a stenotic region in an airway of a patient may include advancing a balloon catheter through the airway of the patient to position an inflatable balloon of the catheter within at least a portion of the stenotic region, maintaining a position of the catheter relative to the patient, and inflating the balloon of the catheter to dilate the stenotic region of the airway. A system for dilating a stenotic region in an airway of a patient may include a catheter shaft having an overall length of less than 70 cm, an inflatable balloon disposed along a distal portion of the catheter shaft, and a stylet. ## Claims ### Claim 1 A method for dilating a stenotic region in an airway of a patient, the method comprising: advancing a balloon catheter having a proximal portion, a distal portion more flexible than the proximal portion, and an overall length less than 70 cm through the airway of the patient to position an inflatable balloon of the catheter within at least a portion of the stenotic region, wherein a stylet disposed in the catheter facilitates the advancing; maintaining a position of the catheter relative to the patient to maintain the position of the balloon within the stenotic region by holding the proximal portion of the balloon catheter; and inflating the balloon of the catheter with the stylet in the catheter to dilate the stenotic region of the airway. ### Claim 2 (depends on 1) The method of claim 1, wherein advancing the balloon catheter comprises advancing a distal portion of the stylet into and through the stenotic region, the stylet having a length allowing the distal portion to protrude beyond a distal end of the catheter. ### Claim 3 (depends on 2) The method of claim 2, further comprising rotating the stylet within the balloon catheter to steer the distal end of the stylet through the stenotic region. ### Claim 4 (depends on 2) The method of claim 2, further comprising: locking the stylet relative to the balloon catheter; and rotating the balloon catheter to steer the stylet through the stenotic region. ### Claim 5 (depends on 1) The method of claim 1, further comprising: advancing a scope into a position within the airway of the patient near the stenotic region; and visualizing placement of the inflatable balloon within the stenotic region using the scope. ### Claim 6 (depends on 5) The method of claim 5, further comprising: viewing at least one shaft marker on a shaft of the balloon catheter using the scope; and approximating a location of the inflatable balloon relative to the stenotic region, based on a location of the shaft marker. ### Claim 7 (depends on 1) The method of claim 1, further comprising inserting a bronchoscope into the airway of the patient before the advancing step, wherein the balloon catheter is advanced through the airway through the bronchoscope. ### Claim 8 (depends on 1) The method of claim 1, further comprising, before the advancing step, forming a bend in the stylet, wherein the bent stylet maintains the balloon catheter in a bent configuration. ### Claim 9 (depends on 1) The method of claim 1, further comprising: removing the balloon catheter and stylet from the airway after the advancing step; forming a bend in the stylet, wherein the bent stylet maintains the balloon shaft in a bent configuration; and reintroducing the balloon catheter and stylet into the airway. ### Claim 10 (depends on 1) The method of claim 1, further comprising: removing the stylet from a stylet lumen of the catheter; and delivering oxygen through the stylet lumen into the airway. ### Claim 11 (depends on 1) The method of claim 1, wherein the method is performed on a pediatric patient. ### Claim 12 A system for dilating a stenotic region in an airway of a patient, the system comprising: a catheter shaft having a proximal portion, a distal portion, a stylet lumen, an inflation lumen and an overall length of less than 70 cm; an inflatable balloon disposed along the distal portion of the catheter shaft and in fluid communication with the inflation lumen; and a stylet having a proximal portion, a distal portion, and a length sufficient to allow the stylet to extend beyond a distal end of the catheter shaft when the stylet is housed within the stylet lumen, wherein the stylet proximal portion is less flexible than the stylet distal portion and the stylet distal portion is bendable and able to retain a bent configuration when disposed within the stylet lumen. ### Claim 13 (depends on 12) The system of claim 12, wherein the catheter shaft distal portion is more flexible than the catheter shaft proximal portion. ### Claim 14 (depends on 13) The system of claim 13, wherein the catheter shaft distal portion has a smaller outer diameter than the catheter shaft proximal portion. ### Claim 15 (depends on 12) The system of claim 12, wherein the catheter shaft comprises: an inner member forming the stylet lumen; and an outer member disposed over part of the inner member, wherein the inner member extends beyond a distal end of the outer member, wherein a proximal end of the balloon is attached to the outer member and a distal end of the balloon is attached to the inner member, and wherein a space between the inner member and the outer member forms the inflation lumen of the catheter shaft. ### Claim 16 (depends on 15) The system of claim 15, further comprising a hub attached to a proximal end of the outer member, the hub comprising: an inflation port in communication with the inflation lumen; and a stylet port in communication with the stylet lumen. ### Claim 17 (depends on 15) The system of claim 15, wherein the inner member includes a distal segment having a larger outer diameter than the remainder of the inner member, wherein the balloon is attached to the inner member at the distal segment. ### Claim 18 (depends on 17) The system of claim 17, wherein the balloon has an outer diameter of at least 12 mm. ### Claim 19 (depends on 15) The system of claim 15, wherein an inner diameter of the inner member is no more than about 1.2 mm and an outer diameter of the inner member is no more than about 1.8 mm. ### Claim 20 (depends on 12) The system of claim 12, wherein the overall length of the catheter shaft is no more than about 50 cm. ### Claim 21 (depends on 12) The system of claim 12, wherein an outer diameter of the catheter shaft immediately proximal to a proximal attachment of the balloon to the shaft is no greater than about 2 mm. ### Claim 22 (depends on 21) The system of claim 21, wherein an outer diameter of the balloon when fully inflated is at least 3 mm, and wherein a working length of the balloon is at least 10 mm. ### Claim 23 (depends on 21) The system of claim 21, wherein the balloon can withstand inflation pressures of up to about 12 atmospheres. ### Claim 24 (depends on 12) The system of claim 12, wherein the balloon comprises: a working length of between about 10 mm and about 60 mm; an outer diameter of between about 3 mm and about 24 mm; a proximal tapered portion extending from a proximal end of the working length to a proximal attachment point with the catheter shaft and having a length of between about 1 mm and about 6 mm; and a distal tapered portion extending from a distal end of the working length to a distal attachment point with the catheter shaft and having a length of between about 1 mm and about 6 mm. ### Claim 25 (depends on 12) The system of claim 12, wherein the balloon has an outer surface that is slip-resistant. ### Claim 26 (depends on 12) The system of claim 12, wherein the stylet can extend out of the distal end of the catheter shaft a length of about 1 mm to about 5 cm. ### Claim 27 (depends on 12) The system of claim 12, wherein the stylet comprises: a core wire tapered from the proximal end to the distal end of the stylet; and a coil disposed over at least a distal portion of the core wire. ### Claim 28 (depends on 12) The system of claim 12, wherein the stylet is malleable. ### Claim 29 (depends on 12) The system of claim 12, wherein the flexible portion of the stylet includes a bend relative to a longitudinal axis of the stylet of up to about 20 degrees, wherein the bend causes the distal portion of the balloon catheter to bend when the stylet is disposed therein. ### Claim 30 (depends on 12) The system of claim 12, wherein the stylet includes a locking member coupled with its proximal end for locking the stylet within a hub coupled with the catheter shaft such that rotating the catheter shaft causes the stylet to rotate. ### Claim 31 (depends on 12) The system of claim 12, wherein the stylet includes a light emitting portion at or near its distal end, and wherein a proximal end of the stylet is removably couplable with a light source. ### Claim 32 (depends on 12) The system of claim 12, further comprising an endoscope for viewing the balloon catheter during use. ### Claim 33 (depends on 32) The system of claim 32, wherein the endoscope is removably couplable with the balloon catheter. ### Claim 34 A kit for dilating a stenotic region in an airway of a patient, the kit comprising: a catheter shaft having a proximal portion, a distal portion, a stylet lumen, an inflation lumen and an overall length of less than 70 cm; an inflatable balloon disposed along the distal portion of the catheter shaft and in fluid communication with the inflation lumen; a stylet having a proximal portion, a distal portion, and a length sufficient to allow the stylet to extend beyond a distal end of the catheter shaft when the stylet is housed within the stylet lumen, wherein the stylet proximal portion is less flexible than the stylet distal portion and the stylet distal portion is bendable and able to retain a bent configuration when disposed within the stylet lumen; and user instructions for: advancing the balloon catheter with the stylet disposed therein through the airway to position the inflatable balloon at the stenotic region; maintaining a position of the catheter relative to the patient to maintain the position of the balloon within the stenotic region by holding the proximal portion of the balloon catheter; and inflating the balloon of the catheter with the stylet in the catheter to dilate the stenotic region of the airway. ### Claim 35 (depends on 34) The kit of claim 34, wherein the catheter shaft distal portion is more flexible than the catheter shaft proximal portion. ### Claim 36 (depends on 35) The kit of claim 35, wherein the catheter shaft distal portion has a smaller outer diameter than the catheter shaft proximal portion. ### Claim 37 (depends on 34) The kit of claim 34, wherein the overall length of the catheter shaft is no more than about 50 cm. ### Claim 38 (depends on 34) The kit of claim 34, wherein the balloon comprises: a working length of between about 10 mm and about 60 mm; an outer diameter of between about 3 mm and about 24 mm; a proximal tapered portion extending from a proximal end of the working length to a proximal attachment point with the catheter shaft and having a length of between about 1 mm and about 6 mm; and a distal tapered portion extending from a distal end of the working length to a distal attachment point with the catheter shaft and having a length of between about 1 mm and about 6 mm. ### Claim 39 (depends on 34) The kit of claim 34, wherein the stylet can extend out of the distal end of the catheter shaft a length of about 1 mm to about 5 cm.