Eustachian tube dilation balloon with ventilation path

• US 10,206,821 B2
• Filed: 03/31/2015
• Issued: 02/19/2019
• Est. Priority Date: 12/20/2007
• Status: Active Grant

• Current Assignee: Acclarent Incorporated (Johnson & Johnson)
• Original Assignee: Acclarent Incorporated (Johnson & Johnson)
• Inventors: Campbell, Peter F., Harfe, Daniel T., Ha, Hung V., Muni, Ketan P., Nguyen, Andy, Lam, Sivette, Chang, John Y., Goldfarb, Eric
• Primary Examiner(s): Louis, Richard
• Application Number:
  US14/674,639
• Publication Number:
  US 20150202089A1
• Time in Patent Office: 1,421 Days
• CPC Class Codes: A61B 1/07 using light-conductive means, e.g. optical fibres
• CPC Class Codes: A61B 1/227 for ears, i.e. otoscopes
• CPC Class Codes: A61B 1/233 for the nose, i.e. nasoscopes , e.g. testing of patency of Eustachian tubes
• CPC Class Codes: A61B 17/00234 for minimally invasive surgery A61B17/0218, A61B17/0469, A61B17/12013, A61B17/1285, A61B17/29, A61B17/320016 take precedence
• CPC Class Codes: A61B 17/12104 in an air passage
• CPC Class Codes: A61B 17/12131 characterised by the type of occluding device
• CPC Class Codes: A61B 18/20 using laser
• CPC Class Codes: A61B 2017/00296 mounted on an endoscope
• CPC Class Codes: A61B 2017/00787 Surgery of the ear
• CPC Class Codes: A61B 2018/00327 Ear, nose or throat
• CPC Class Codes: A61B 2018/144 Wire
• CPC Class Codes: A61B 5/036 by means introduced into body tracts A61B5/032 and A61B5/035 take precedence
• CPC Class Codes: A61B 5/411 Detecting or monitoring allergy or intolerance reactions to an allergenic agent or substance
• CPC Class Codes: A61B 5/415 the glands, e.g. tonsils, adenoids or thymus
• CPC Class Codes: A61B 5/6852 Catheters
• CPC Class Codes: A61B 8/12 in body cavities or body tracts, e.g. by using catheters catheters per se A61M25/00
• CPC Class Codes: A61F 11/20 Ear surgery
• CPC Class Codes: A61F 11/202 Surgical middle-ear ventilation or drainage, e.g. permanent; Implants therefor
• CPC Class Codes: A61F 2250/0067 Means for introducing or releasing pharmaceutical products into the body
• CPC Class Codes: A61M 2025/0008 having visible markings on its surface, i.e. visible to the naked eye, for any purpose, e.g. insertion depth markers, rotational markers or identification of type
• CPC Class Codes: A61M 2025/0166 : Sensors, electrodes or the like for guiding the catheter to a target zone, e.g. image guided or magnetically guided
• CPC Class Codes: A61M 2025/09008 : having a balloon
• CPC Class Codes: A61M 2025/09183 : having tools at the distal tip
• CPC Class Codes: A61M 2025/105 : having a balloon suitable for drug delivery, e.g. by using holes for delivery, drug coating or membranes
• CPC Class Codes: A61M 2025/1075 : having a balloon composed of several layers, e.g. by coating or embedding
• CPC Class Codes: A61M 2210/0681 : Sinus (maxillaris)
• CPC Class Codes: A61M 25/0032 : characterized by at least one unconventionally shaped lumen, e.g. polygons, ellipsoids, wedges or shapes comprising concave and convex parts
• CPC Class Codes: A61M 25/0041 : pre-formed, e.g. specially adapted to fit with the anatomy of body channels urethral catheters A61F2/04
• CPC Class Codes: A61M 25/0054 : with regions for increasing flexibility
• CPC Class Codes: A61M 25/0068 : Static characteristics of the catheter tip, e.g. shape, atraumatic tip, curved tip or tip structure
• CPC Class Codes: A61M 25/007 : Side holes, e.g. their profiles or arrangements; Provisions to keep side holes unblocked
• CPC Class Codes: A61M 25/01 : Introducing, guiding, advancing, emplacing or holding catheters A61M25/10 takes precedence
• CPC Class Codes: A61M 25/0102 : Insertion or introduction using an inner stiffening member, e.g. stylet or push-rod
• CPC Class Codes: A61M 25/0105 : Steering means as part of the catheter or advancing means; Markers for positioning systems for detection of markers A61B
• CPC Class Codes: A61M 25/0147 : with movable mechanical means, e.g. pull wires
• CPC Class Codes: A61M 25/09 : Guide wires
• CPC Class Codes: 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
• CPC Class Codes: A61M 29/02 : Dilators made of swellable material balloon catheters for angioplasty A61M25/104
• CPC Class Codes: A61M 31/00 : Devices for introducing or retaining media, e.g. remedies, in cavities of the body A61M25/00 takes precedence ; introducing or retaining ophthalmic products into the ocular cavities A61F9/0008
• CPC Class Codes: A61M 31/002 : Devices for releasing a drug at a continuous and controlled rate for a prolonged period of time artificial gland structures or devices A61F2/022; intra-uterine contraceptive devices A61F6/14; tampons for introducing into the vagina A61F13/20, A61L15/00; suppositories or bougies for intra-vaginal or intra-uterine application A61K9/02; physical forms of medicinal preparations for sustained or differential drug release A61K9/20, A61K9/50
• CPC Class Codes: A61N 1/30 : Apparatus for iontophoresis, i.e. transfer of media in ionic state by an electromotoric force into the body, or cataphoresis
• CPC Class Codes: A61N 7/02 : Localised ultrasound hyperthermia hyperthermia in general A61F7/00

Abstract

An apparatus comprises a shaft, an expandable dilator, and at least one ventilation pathway. The shaft defines a longitudinal axis and comprises a distal and proximal ends with at least one shaft lumen. The expandable dilator comprises body with its own proximal and distal ends. The body is configured to transition between a contracted state and an expanded state. The body is configured to dilate a Eustachian tube of a patient in the expanded state. The at least one ventilation pathway is configured to provide ventilation from the distal end of the body to the proximal end of the body when the body is in the expanded state. In some examples, the ventilation pathway comprises a set of transversely oriented vent openings formed through the shaft. In some other examples, the ventilation pathway comprises a space defined between one or more radially outwardly protruding features of the expandable dilator.

Claims

1. A method of using a dilator assembly, the dilator assembly comprising:

(a) a shaft defining a longitudinal axis, wherein the shaft comprises;

(i) a distal end,

(ii) a proximal end, and

(iii) at least one shaft lumen;

(b) an expandable dilator located on the at shaft, wherein the expandable dilator is positioned between the distal end of the shaft and the proximal end of the shaft, wherein the expandable dilator comprises a body configured to transition between a contracted state and an expanded state, wherein the body is configured to dilate a Eustachian tube of a patient in the expanded state, wherein the body further comprises a distal end and a proximal end; and

(c) at least one ventilation pathway configured to provide ventilation from the distal end of the body to the proximal end of the body when the body is in the expanded state, wherein the at least one ventilation pathway comprises one or both of the following;

(i) a set of transversely oriented vent openings formed through the shaft, wherein at least one vent opening is distal to the distal end of the body and at least one other vent opening is proximal to the proximal end of the body, or

(ii) a space defined by one or more radially outwardly protruding features of the expandable dilator,

the method comprising;

(a) inserting the expandable dilator into a Eustachian tube of a patient

(b) expanding the expandable dilator to dilate the Eustachian tube, wherein the at least one ventilation pathway enables air to travel between the distal end of the body and the proximal end of the body through the at least one ventilation pathway while the expandable dilator dilates the Eustachian tube, thereby ventilating a distal portion of the Eustachian tube while dilating the Eustachian tube.

2. The method of claim 1, wherein the body comprises a conical shape, wherein the conical shape is configured to complement a conical geometry a Eustachian tube.

3. The method of claim 1, wherein the expandable dilator has a stepped shape.

4. The method of claim 1, wherein one or more the outwardly protruding features comprise a plurality of longitudinally extending lobes separated by recesses.

5. The method of claim 4, wherein the lobes are configured to bear against a wall of a Eustachian tube while the recesses are configured to define the space providing the ventilation pathway.

6. The method of claim 5, wherein the lobes are angularly spaced equidistantly from each other about the longitudinal axis of the shaft.

7. The method of claim 1, wherein the one or more outwardly protruding features comprise a plurality of ribs extending angularly about the longitudinal axis of the shaft, wherein the ribs are longitudinally spaced apart from each other.

8. The method of claim 7, wherein the body further includes a plurality of annular recesses positioned between the ribs, such that the annular recesses provide longitudinal spacing of the ribs apart from each other.

9. The method of claim 7, wherein the body further includes a plurality of longitudinal recesses crossing the ribs.

10. The method of claim 1, wherein the one or more outwardly protruding features comprise a plurality of discrete bumps extending radially outwardly from the body.

11. The method of claim 10, wherein the discrete bumps are positioned in arrays positioned angularly about the longitudinal axis of the shaft and along a length of the body.

12. The method of claim 1, wherein the one or more outwardly protruding features comprise a spiral rib extending helically along the body.

13. The method of claim 1, wherein the one or more outwardly protruding features comprise fins extending along the length of the body.

14. The method of claim 1, wherein the dilator assembly further comprises a vent tube, wherein the vent tube is positioned adjacent to an exterior region of the body, wherein the vent tube extends along an axis that is parallel to the longitudinal axis of the shaft.

15. The method of claim 1, wherein the dilator is configured to mechanically expand without inflation.

16. A method of using a dilator assembly, the dilator assembly comprising:

(a) a shaft defining a longitudinal axis, wherein the shaft comprises;

(i) a distal end,

(ii) a proximal end, and (iii) at least one shaft lumen;

(b) an expandable dilator located on the at shaft, wherein the expandable dilator is positioned between the distal end of the shaft and the proximal end of the shaft, wherein the expandable dilator comprises a body configured to transition between a contracted state and an expanded state, wherein the body is configured to dilate a Eustachian tube of a patient in the expanded state, wherein the body further comprises a distal end and a proximal end; and

(c) at least one ventilation pathway configured to provide ventilation from the distal end of the body to the proximal end of the body when the body is in the expanded state, the method comprising;

(a) inserting the expandable dilator into a Eustachi an tube of a patient (b) expanding the expandable dilator to dilate the Eustachian tube, wherein the at least one ventilation pathway releases air to travel between the distal end of the body and the proximal end of the body through the at least one ventilation pathway while the expandable dilator dilates the Eustachian tube due to the expansion of the dilator, thereby ventilating a distal portion of the Eustachian tube while dilating the Eustachian tube.

17. A method of using a dilator assembly, the method comprising:

(a) inserting an expandable dilator into a Eustachian tube of a patient expanding the expandable dilator from a contracted state to an expanded state to thereby dilate the Eustachian tube, wherein at least one ventilation pathway releases air to travel between a distal end of a body of the expandable dilator and a proximal end of the body of the expandable dilator through the at least one ventilation pathway while the expandable dilator dilates the Eustachian tube due to the expansion of the dilator, thereby ventilating a distal portion of the Eustachian tube while dilating the Eustachian tube.