Multi-conduit balloon catheter

• US 10,639,457 B2
• Filed: 05/04/2018
• Issued: 05/05/2020
• Est. Priority Date: 09/23/2005
• Status: Active Grant

• Current Assignee: Acclarent Incorporated (Johnson & Johnson)
• Original Assignee: Acclarent Incorporated (Johnson & Johnson)
• Inventors: Becker, Bruce B.
• Primary Examiner(s): Bouchelle, Laura A
• Application Number:
  US15/971,389
• Publication Number:
  US 20180318559A1
• Time in Patent Office: 732 Days
• CPC Class Codes: A61B 90/30 Devices for illuminating a surgical field, the devices having an interrelation with other surgical devices or with a surgical procedure
• CPC Class Codes: A61M 1/85 with gas or fluid supply means, e.g. for supplying rinsing fluids or anticoagulants for negative pressure wound therapy A61M1/92, A61M1/94; combined with tracheal tubes A61M16/0463; dental instruments with combined rinsing and aspirating A61C17/0208
• 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 2025/1061 having separate inflations tubes, e.g. coaxial tubes or tubes otherwise arranged apart from the catheter tube
• CPC Class Codes: A61M 2210/0618 Nose
• 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 25/10 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 25/1002 characterised by balloon shape A61M25/1006, A61M25/1009 take precedence
• CPC Class Codes: A61M 3/0283 with at least two inner passageways, a first one for irrigating and a second for evacuating suction-irrigation systems A61M1/77; aspiration tips with fluid supply means A61M1/85; for negative pressure wound therapy A61M1/92
• CPC Class Codes: A61M 3/0295 with inflatable balloon

Abstract

A suctioning and irrigating sinus balloon catheter is provided for treating a patient'"'"'s paranasal sinus system, including dilating prepared openings, and natural ostia and ducts and excising sinus cavities and choana. The catheter has a number of fluid carrying conduits to provide irrigation, suction and inflation/deflation to the distally mounted balloon. The catheters have sufficient stiffness and column strength that the balloon carrying distal segment of the catheter can be pushed into the prepared opening, natural ostium or duct, choana or sinus to be excised. Some catheters can be hand bendable by the surgeon. Some catheters provide the capability of threading an endoscope through one of the conduits. The methods use the balloon catheters to dilate prepared openings to selected parts of the sinus system, to dilate natural ostia and ducts of the sinus system, choana, and/or to dilate sinus cavities to remove them.

Claims

1. A method of treating a paranasal sinus of a patient using an elongate member, wherein the elongate member comprises a shaft and a treatment feature disposed on the shaft, wherein at least a distal portion of the elongate member is configured to be laterally bendable and inserted into a nostril of the patient, the method comprising:

(a) identifying an anatomical structure associated with the paranasal sinus of the patient;

(b) using a bending tool to laterally bend at least the distal portion of the elongate member relative to a proximal portion of the elongate member during a medical procedure, with the bending being performed according to the identified anatomical structure such that the distal portion is disposed relative to the proximal portion of the elongate member at a bend angle;

(c) inserting the distal portion of the elongate member into a nostril of the patient;

(d) directing the distal portion of the elongate member via the bend angle such that at least the distal portion is within or adjacent to one of the paranasal sinuses, wherein the distal portion maintains the formed bend angle during the act of directing; and

(e) treating the paranasal sinus using the treatment feature.

2. The method of claim 1, wherein using the bending tool further comprises:

(i) placing at least the distal portion of the elongate member in contact with the bending tool, the bending tool having a bending surface with a predetermined curvature and/or bend angle, and

(ii) manipulating the elongate member relative to the bending surface such that a curvature of at least the distal portion corresponds to the predetermined curvature and/or bend angle of the bending surface.

3. The method of claim 2, wherein the bending tool further comprises an engagement feature, and the method further comprises engaging at least the distal portion of the elongate member with the engagement feature to maintain contact between the bending surface and at least the distal portion of the elongate member while manipulating the elongate member.

4. The method of claim 3, wherein the distal portion comprises a tip, wherein the engagement feature further comprises a recess having a shape and size corresponding to at least a portion of the tip, wherein the engaging step further comprises directing at least a portion of the tip into the recess.

5. The method of claim 1, wherein the act of using the bending tool is performed before the act of inserting, wherein the distal portion maintains the formed bend angle during the act of inserting.

6. The method of claim 5, wherein the strap has a number of button holes configured to engage a button on the tool to accommodate a range of catheter body outer diameter.

7. The method of claim 1, wherein the elongate member comprises a balloon catheter, wherein the treatment feature comprises an expandable balloon disposed on the shaft, wherein the act of treating comprises expanding the balloon to dilate an anatomical feature associated with the paranasal sinus.

8. The method of claim 7, wherein the anatomical feature associated with the paranasal sinus comprises a sinus ostium.

9. The method of claim 7, further comprising adjusting a position of the expandable balloon relative to a distal end of the shaft.

10. The method of claim 1, wherein the elongate member comprises a lumen, wherein the method further comprises inserting an illumination device having a light emitting feature into the lumen.

11. The method of claim 10, further comprising confirming a position of the elongate member via transillumination provided by illumination from the light emitting feature.

12. The method of claim 1, further comprising:

(a) removing the elongate member from the patient;

(b) manipulating at least the distal portion of the elongate member according to an anatomical characteristic of another one of the paranasal sinuses;

(c) re-inserting the distal portion of the elongate member into a nostril of the patient;

(d) directing the distal portion of the elongate member such that at least the distal portion is within or adjacent to the other one of the paranasal sinuses; and

(e) treating the other one of the paranasal sinuses using the treatment feature.

13. The method of claim 1, wherein the act of treating the paranasal sinus comprises irrigating the paranasal sinus with a liquid, wherein the lumen is in communication with a port at a proximal portion of the shaft, wherein the method further comprises:

(a) fluidly coupling a source of liquid to the port to perform the act of irrigating the tissue;

(b) decoupling the source of liquid from the port; and

(c) coupling a suction device to the port to perform the act of suctioning the liquid and other material.

14. A method of treating a paranasal sinus of a patient using a balloon catheter, wherein the balloon catheter comprises an elongate shaft including an expandable balloon disposed thereon, wherein at least a distal portion of the balloon catheter is configured to be inserted into a nostril of the patient, the method comprising:

(a) identifying an anatomical structure associated with the paranasal sinus of the patient;

(b) deforming at least the distal portion of the shaft manually by using a bending tool, according to the identified anatomical structure;

(c) inserting the distal portion of the shaft into a nostril of the patient;

(d) directing the distal portion of the shaft to the target treatment area, wherein the distal portion maintains the deformation during the act of directing; and

(e) dilating the target treatment area with the expandable balloon.

15. The method of claim 14, wherein the act of deforming at least the distal portion further comprises bending at least the distal portion to a predetermined radius of curvature or bend angle.

16. The method of claim 14, wherein the act of deforming at least the distal portion further comprises:

(i) placing at least the distal portion of the elongate member in contact with the bending tool, the bending tool having at least one bending surface, and

(ii) manipulating the elongate member relative to the bending surface such that a curvature of at least the distal portion corresponds to a curvature of the bending surface.

17. The method of claim 16, wherein the method further comprises selecting the bending tool from a plurality of bending tools having different radii of curvature and/or different bend angles.

18. The method of claim 16, wherein the bending tool comprises a plurality of bending surfaces, wherein each of the bending surfaces includes a different radius of curvature and/or bend angle.

19. The method of claim 16, wherein the bending tool has a rigid, arcuate contact plate in a generally half-pipe shape.

20. A method of treating a paranasal sinus of a patient using an elongate member, wherein the elongate member comprises a shaft and a treatment feature disposed on the shaft, wherein at least a distal portion of the elongate member is configured to be inserted into a nostril of the patient, the method comprising:

(a) identifying an anatomical structure associated with the paranasal sinus of the patient;

(b) manipulating at least the distal portion of the elongate member according to the identified anatomical structure to form a bend in the elongate member according to the identified anatomical structure, wherein the act of manipulating comprises using a bending tool;

(c) inserting the distal portion of the elongate member into a nostril of the patient;

(d) directing the distal portion of the elongate member such that at least the distal portion is within or adjacent to one of the paranasal sinuses, wherein the bend is retained along the distal portion during the act of directing;

(e) irrigating the paranasal sinus with a liquid delivered through the shaft to the treatment feature; and

(f) suctioning the liquid and other material in or adjacent to the paranasal sinus at the treatment feature through the shaft.