Methods for positioning a medical device in a respiratory system

• US 10,065,009 B2
• Filed: 04/18/2014
• Issued: 09/04/2018
• Est. Priority Date: 12/02/2000
• Status: Expired due to Fees

• Current Assignee: P TECH, LLC
• Original Assignee: P TECH, LLC
• Inventors: Bonutti, Peter M.
• Primary Examiner(s): Cwern, Jonathan
• Application Number:
  US14/256,629
• Publication Number:
  US 20140228679A1
• Time in Patent Office: 1,600 Days
• CPC Class Codes: A61B 1/00082 Balloons
• CPC Class Codes: A61B 1/00124 electrical, e.g. electrical plug-and-socket connection
• CPC Class Codes: A61B 1/005 Flexible endoscopes
• CPC Class Codes: A61B 1/015 Control of fluid supply or evacuation
• CPC Class Codes: A61B 1/0676 at distal tip of an endoscope
• CPC Class Codes: A61B 1/0684 using light emitting diodes [LED]
• CPC Class Codes: A61B 1/07 using light-conductive means, e.g. optical fibres
• CPC Class Codes: A61B 5/065 Determining position of the probe employing exclusively positioning means located on or in the probe, e.g. using position sensors arranged on the probe
• CPC Class Codes: A61B 8/0841 for locating instruments
• 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: A61B 8/4254 using sensors mounted on the probe
• CPC Class Codes: A61B 8/4263 using sensors not mounted on the probe, e.g. mounted on an external reference frame
• CPC Class Codes: A61B 8/445 Details of catheter construction
• CPC Class Codes: A61B 8/461 Displaying means of special interest
• CPC Class Codes: A61M 16/0411 with means for differentiating between oesophageal and tracheal intubation
• CPC Class Codes: A61M 16/0434 Cuffs
• CPC Class Codes: A61M 16/0488 Mouthpieces; Means for guiding, securing or introducing the tubes guiding or introducing with laryngoscopes A61B1/267; holding devices on the body A61M25/02
• CPC Class Codes: A61M 16/0495 with tongue depressors
• CPC Class Codes: A61M 16/0497 Tube stabilizer
• 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 2025/022 : specifically adapted for the mouth
• CPC Class Codes: A61M 2025/09008 : having a balloon
• CPC Class Codes: A61M 2025/091 : having a lumen for drug delivery or suction
• CPC Class Codes: A61M 2205/0272 : Electro-active or magneto-active materials
• CPC Class Codes: A61M 2205/587 : Lighting arrangements
• CPC Class Codes: A61M 25/0102 : Insertion or introduction using an inner stiffening member, e.g. stylet or push-rod
• CPC Class Codes: A61M 25/0108 : using radio-opaque or ultrasound markers
• CPC Class Codes: A61M 25/09 : Guide wires

Abstract

A method for positioning a medical device in a respiratory system is provided. The method includes providing a medical device system including a positioning apparatus having a body section and an upper section, the upper section slidably coupled to the body section, a flexible guide rod, a visible light source, and a medical device for treating the patient slidably receivable on the flexible guide rod. The method also includes inserting the flexible guide rod into a treatment portion of a respiratory system, emitting visible light from the visible light source, visually observing, outside the patient'"'"'s body, the emitted visible light, and slidably moving the medical device distally along the flexible guide rod toward the distal end of the flexible guide rod to a selected position relative to the distal end of the flexible guide rod and within said treatment portion of the respiratory system of the patient'"'"'s body.

Claims

1. A method for positioning a medical device in a respiratory system of a patient, the method comprising:

providing a medical device system including a positioning apparatus configured to enable the insertion of a flexible guide rod into a passage of the patient'"'"'s respiratory system and a guide tube in which the flexible guide rod is slidably received, the positioning apparatus having a body section and an upper section, the body section having a cylindrical central passage, the upper section slidably coupled to the body section such that the upper section slidably moves relative to the body section, and the upper section having a cylindrical passage, such that at least a portion of the cylindrical passage of the upper section and a portion of the cylindrical passage of the body section are parallel, the flexible guide rod having a distal end, a visible light source operatively connected to the flexible guide rod such that visible light from the visible light source can be emitted outward from adjacent the distal end of the flexible guide rod, and a medical device for treating the patient slidably receivable on the flexible guide rod;

inserting the flexible guide rod and the guide tube together along a first respiratory system passage of the patient'"'"'s respiratory system until a distal end of the flexible guide rod is located at a first rod location adjacent an opening to a second respiratory system passage of the patient'"'"'s respiratory system extending transverse to the first respiratory system passage and an open distal end of the guide tube is located at a first tube location adjacent the opening to the second respiratory system passage;

maintaining the guide tube in position so that the distal end of the guide tube is located generally at the first tube location;

while performing the step of maintaining the guide tube in position, advancing the flexible guide rod through the guide tube so that the distal end of the flexible guide rod moves in a distal direction relative to the open distal end of the guide tube from the first rod location, to a second rod location in the second respiratory system passage;

emitting visible light from the visible light source outward from adjacent the distal end of the flexible guide rod while performing the step of advancing the flexible guide rod such that the emitted visible light is transmitted outward from within the patient'"'"'s respiratory system and through the patient'"'"'s body as the flexible guide rod is advanced;

visually observing, outside the patient'"'"'s body, the emitted visible light that is transmitted outward through the patient'"'"'s body to determine the location of the distal end of the flexible guide rod as the flexible guide rod is advanced; and

slidably moving, after said performing the step of visually observing the emitted visible light that is transmitted outward through the patient'"'"'s body, the medical device distally along the flexible guide rod toward the distal end of the flexible guide rod to a selected position relative to the distal end of the flexible guide rod and within the second respiratory system passage.

2. The method for positioning a medical device in a respiratory system of a patient as set forth in claim 1, wherein the step of inserting the flexible guide rod and the guide tube together comprises inserting the flexible guide rod and the guide tube together into a body orifice of the patient'"'"'s body in communication with the first respiratory system passage, wherein a distal end section of the guide tube encompassing the open distal end of the guide tube has an arcuate shape such that the guide tube extends from adjacent the body orifice to the open distal end of the guide tube and the open distal end of the guide tube generally faces the opening to the second respiratory system passage after performing the step of inserting the flexible guide rod and the flexible guide tube together.

3. The method for positioning a medical device in a respiratory system of a patient as set forth in claim 2, wherein the step of advancing the flexible guide rod through the guide tube includes bending a section of the flexible guide rod into an arcuate shape corresponding to the arcuate shape of the distal end section of the guide tube as the section of the flexible guide rod moves along the distal end section of the guide tube.

4. The method for positioning a medical device in a respiratory system of a patient as set forth in claim 1, wherein both the guide tube and the positioning apparatus have at least one matching colored indicium.

5. The method for positioning a medical device in a respiratory system of a patient as set forth in claim 1, wherein the flexible guide rod comprises an optical fiber having a distal end adjacent the distal end of the flexible guide rod, and a proximal end configured to remain outside the patient'"'"'s body during said method for positioning a medical device, wherein the visible light source is adjacent the proximal end of the optical fiber, wherein said emitting visible light from the visible light source comprises transmitting visible light from the visible light source located outside the body through the optical fiber of the flexible guide rod.

6. The method for positioning a medical device in a respiratory system of a patient as set forth in claim 1, wherein the flexible guide rod includes a plurality of markers spaced predetermined distances from the distal end of the flexible guide rod, the method further comprising:

visibly observing, after said inserting the flexible guide rod, one or more of the markers outside the patient to determine a position of the distal end of the flexible guide rod in the treatment portion of the respiratory system of the patient'"'"'s body.

7. The method for positioning a medical device in a respiratory system of a patient as set forth in claim 1, further comprising:

endoscopically observing the flexible guide rod in the respiratory system of the patient'"'"'s body during said inserting the flexible guide rod.

8. The method for positioning a medical device in a respiratory system of a patient as set forth in claim 1, wherein the opening to the second respiratory system passage is formed in a wall of the first respiratory system passage.

9. The method for positioning a medical device in a respiratory system of a patient as set forth in claim 1, wherein the step of advancing the flexible guide rod relative through the guide tube comprises moving the distal end of the flexible guide rod in an inferior direction of the patient.

10. The method for positioning a medical device in a respiratory system of a patient as set forth in claim 9, wherein the step of moving the distal end of the flexible guide rod in the inferior direction comprises moving the distal end of the flexible guide rod in the inferior direction along the second respiratory system passage.

11. The method for positioning a medical device in a respiratory system of a patient as set forth in claim 1, wherein the upper section of the positioning apparatus comprises a single piece of monolithic material that extends seamlessly about the cylindrical passage of the upper section.

12. The method for positioning a medical device in a respiratory system of a patient as set forth in claim 1, wherein the cylindrical passage of the upper section of the positioning apparatus has a length and the cylindrical central passage of the body section of the positioning apparatus has a length that is greater than the length of the cylindrical passage of the upper section of the positioning apparatus.

13. The method for positioning a medical device in a respiratory system of a patient as set forth in claim 1, wherein the body section of the positioning apparatus has a length extending parallel to a longitudinal axis of the central cylindrical passage extending therethrough and the upper section of the positioning apparatus has a length extending parallel to the length of the body section, wherein the length of the body section is greater than the length of the upper section.

14. A method for positioning a medical device in a respiratory system of a patient, the method comprising:

providing a medical device system including a positioning apparatus configured to enable the insertion of a flexible guide rod into a passage of a respiratory system of the patient and a guide tube in which the flexible guide rod is slidably received, the positioning apparatus having a body section and an upper section, the body section having a cylindrical central passage, the upper section slidably coupled to the body section such that the upper section slidably moves relative to the body section, and the upper section having a cylindrical passage, such that at least a portion of the cylindrical passage of the upper section and a portion of the cylindrical passage of the body section are parallel, a visible light source operatively connected to the flexible guide rod such that visible light from the visible light source can be emitted outward from adjacent the distal end of the flexible guide rod, wherein the flexible guide rod is slidably receivable in the guide tube;

inserting the flexible guide rod and the guide tube together into a body orifice of the patient'"'"'s body and then along a first respiratory system passage of the respiratory system of the patient'"'"'s body until a distal end of the flexible guide rod and an open distal end of the guide tube are located adjacent an opening to a second respiratory system passage of the respiratory system extending transversely to the first respiratory system passage, wherein a distal end section of the guide tube encompassing the open distal end of the guide tube has an arcuate shape such that the guide tube extends from adjacent the body orifice to the open distal end of the guide tube and the open distal end of the guide tube generally faces the opening to the second respiratory system passage after performing the step of inserting the flexible guide rod and the flexible guide tube together;

after performing the step of inserting the flexible guide rod and the guide tube together until the distal end of the flexible guide rod and the open distal end of the guide tube are located adjacent the opening to the second respiratory system passage, advancing the flexible guide rod relative to the guide tube in a distal direction such that the distal end of the flexible guide rod moves distally away from the open distal end of the guide tube and into the second respiratory system passage, wherein the step of advancing the flexible guide rod relative to the guide tube includes bending a section of the flexible guide rod into an arcuate shape corresponding to the arcuate shape of the distal end section of the guide tube as the section of the flexible guide rod moves along the distal end section of the guide tube;

emitting visible light from the visible light source outward from adjacent the distal end of the flexible guide rod such that the emitted visible light is transmitted from within the second respiratory system passage and outward through the patient'"'"'s body;

visually observing, outside the patient'"'"'s body, the emitted visible light that is transmitted from within the second respiratory system passage and outward through the patient'"'"'s body to determine the location of the distal end of the flexible guide rod within said treatment portion of the respiratory system of the patient'"'"'s body;

wherein the medical device system further includes an inflatable balloon slidably movable relative to the guide tube, the method further comprising;

after performing the step of inserting the flexible guide rod and the guide tube together, slidably moving the inflatable balloon distally relative to the guide tube such that the inflatable balloon moves distally into to the second respiratory system passage; and

after the step of slidably moving the inflatable balloon, inflating the inflatable balloon to apply a force against body tissue in the respiratory system of the patient'"'"'s body.

15. The method for positioning a medical device in a respiratory system of a patient as set forth in claim 14, wherein the opening to the second respiratory system passage is formed in a wall of the first respiratory system passage.

16. The method for positioning a medical device in a respiratory system of a patient as set forth in claim 14, wherein the step of advancing the flexible guide rod relative to the guide tube comprises moving the distal end of the flexible guide rod in an inferior direction of the patient.

17. The method for positioning a medical device in a respiratory system of a patient as set forth in claim 16, wherein the step of moving the distal end of the flexible guide rod in the inferior direction comprises moving the distal end of the flexible guide rod in the inferior direction along the second respiratory system passage.

18. The method for positioning a medical device in a respiratory system of a patient as set forth in claim 14, wherein the upper section of the positioning apparatus comprises a single piece of monolithic material that extends seamlessly about the cylindrical passage of the upper section.

19. The method for positioning a medical device in a respiratory system of a patient as set forth in claim 14, wherein the cylindrical passage of the upper section of the positioning apparatus has a length and the cylindrical central passage of the body section of the positioning apparatus has a length that is greater than the length of the cylindrical passage of the upper section of the positioning apparatus.

20. The method for positioning a medical device in a respiratory system of a patient as set forth in claim 14, wherein the body section of the positioning apparatus has a length extending parallel to a longitudinal axis of the central cylindrical passage extending therethrough and the upper section of the positioning apparatus has a length extending parallel to the length of the body section, wherein the length of the body section is greater than the length of the upper section.