Inflatable devices for separating layers of tissue, and methods of using

• US 5,722,986 A
• Filed: 07/24/1996
• Issued: 03/03/1998
• Est. Priority Date: 05/29/1991
• Status: Expired due to Term

• Current Assignee: Covidien AG (Medtronic Plc)
• Original Assignee: Origin Medsystems Inc. (Boston Scientific Corporation)
• Inventors: Smith, Jeffrey A., Moll, Frederic H., Chin, Albert K.
• Primary Examiner(s): Dawson, Glenn K.
• Application Number:
  US08/685,744
• Time in Patent Office: 587 Days
• Field of Search: 606/191-200, 200/201, 200/204, 200/207, 604/96-104
• US Class Current: 606/192
• CPC Class Codes: A61B 1/00082 Balloons
• CPC Class Codes: A61B 1/015 Control of fluid supply or evacuation
• CPC Class Codes: A61B 1/018 for receiving instruments
• CPC Class Codes: A61B 1/3132 for laparoscopy
• CPC Class Codes: A61B 17/0218 for minimally invasive surgery A61B17/0281, A61B17/0469, A61B17/12013, A61B17/1285, A61B17/29, A61B17/320016 take precedence
• CPC Class Codes: A61B 17/0281 Abdominal wall lifters
• CPC Class Codes: A61B 17/22032 having inflatable gripping elements balloon catheters A61M25/10
• CPC Class Codes: A61B 17/3417 Details of tips or shafts, e.g. grooves, expandable, bendable; Multiple coaxial sliding cannulas, e.g. for dilating syringe needles A61M5/32; dilators A61M29/00
• CPC Class Codes: A61B 17/3421 Cannulas
• CPC Class Codes: A61B 17/3462 with means for changing the diameter or the orientation of the entrance port of the cannula, e.g. for use with different-sized instruments, reduction ports, adapter seals expandable cannulas A61B17/3417
• CPC Class Codes: A61B 2017/00261 Discectomy
• CPC Class Codes: A61B 2017/00535 pneumatically or hydraulically operated A61B2017/22051, A61B2090/401 take precedence
• CPC Class Codes: A61B 2017/00557 inflatable A61B2017/22051 takes precedence
• CPC Class Codes: A61B 2017/22059 transparent
• CPC Class Codes: A61B 2017/306 holding by means of suction
• CPC Class Codes: A61B 2017/320048 Balloon dissectors
• CPC Class Codes: A61B 2017/3486 Balloon
• CPC Class Codes: A61B 2090/306 using optical fibres
• CPC Class Codes: A61B 90/361 Image-producing devices, e.g. surgical cameras
• CPC Class Codes: A61B 90/50 Supports for surgical instruments, e.g. articulated arms

Abstract

An apparatus and method for separating tissue layers and providing a working space for performing a medical procedure. A first balloon is inserted between the tissue layers and inflated to dissect the tissue layers. A second balloon is also positioned between the tissue layers and inflated to retract the tissue layers. The first balloon is then deflated and punctured with a sharp instrument to created an opening in the first balloon. The second balloon is positioned to impeded the escape of insufflation fluid from the working space and the working space is then insufflated. An instrument for performing the medical procedure may then be introduced into the working space through the opening in the first balloon.

Claims

1. A method of providing a working space in a patient for performing a medical procedure, comprising the steps of:

providing a first balloon, a second balloon, and a delivery device having a distal end;

cutting an incision in a patient;

inserting the distal end of the delivery device into the patient through the incision;

moving the distal end of the delivery device to a position between tissue layers in the patient;

positioning the first balloon between the tissue layers;

inflating the first balloon;

positioning the second balloon between the tissue layers;

inflating the second balloon;

leaving the distal end of the delivery device in the patient after the delivery device inserting step until the second balloon inflating step so that the tissue layers remain at least partially separated; and

insufflating a working space between the tissue layers with an insufflating fluid.

2. The method of claim 1, wherein:

the providing step is carried out with at least one of the first and second balloons being mounted to the delivery device.

3. The method of claim 1, wherein:

the providing step is carried out with the first and second balloons mounted to the delivery device.

4. The method of claim 1, wherein:

the second balloon inflating step is carried out while the first balloon is at least partially positioned within the patient.

5. The method of claim 1, further comprising the step of:

deflating the first balloon.

6. The method of claim 5, wherein:

the providing step is carried out with the delivery device having a first valve fluidly coupled to the first balloon and the deflating step is carried out by operating the first valve.

7. The method of claim 1, wherein:

the delivery device inserting step and at least one of the first and second balloon positioning steps is carried out substantially at the same time.

8. A method of providing a working space in a patient for performing a medical procedure, comprising the steps of:

providing a first balloon, a second balloon, and a delivery device having a distal end;

cutting an incision in a patient;

inserting the distal end of the delivery device into the patient through the incision;

moving the distal end of the delivery device to a position between tissue layers in the patient;

positioning the first balloon between the tissue layers;

inflating the first balloon;

positioning the second balloon between the tissue layers;

inflating the second balloon;

leaving the distal end of the delivery device in the patient after the delivery device inserting step until the second balloon inflating step so that the tissue layers remain at least partially separated; and

insufflating a working space between the tissue layers with an insufflating fluid, wherein the providing step is carried out with the second balloon being positioned within an interior of the first balloon.

9. A method of providing a working space in a patient for performing a medical procedure, comprising the steps of:

providing a first balloon, a second balloon, and a delivery device having a distal end;

cutting an incision in a patient;

inserting the distal end of the delivery device into the patient through the incision;

moving the distal end of the delivery device to a position between tissue layers in the patient;

positioning the first balloon between the tissue layers;

inflating the first balloon;

positioning the second balloon between the tissue layers;

inflating the second balloon;

leaving the distal end of the delivery device in the patient after the delivery device inserting step until the second balloon inflating step so that the tissue layers remain at least partially separated; and

insufflating a working space between the tissue layers with an insufflating fluid; and

sealing an area in the working space with the second balloon so that the insufflating fluid is impeded from escaping through the incision.

10. A method of providing a working space in a patient for performing a medical procedure, comprising the steps of:

providing a first balloon, a second balloon, and a delivery device having a distal end;

cutting an incision in a patient;

inserting the distal end of the delivery device into the patient through the incision;

moving the distal end of the delivery device to a position between tissue layers in the patient;

positioning the first balloon between the tissue layers;

inflating the first balloon;

positioning the second balloon between the tissue layers;

inflating the second balloon;

leaving the distal end of the delivery device in the patient after the delivery device inserting step until the second balloon inflating step so that the tissue layers remain at least partially separated;

deflating the first balloon, wherein the providing step is carried out with the delivery device having a first valve fluidly coupled to the first balloon and the deflating step includes the step of operating the first valve;

puncturing the first balloon to create an opening in the first balloon; and

insufflating a working space between the tissue layers with an insufflating fluid.

11. A method of providing a working space in a patient for performing a medical procedure, comprising the steps of:

providing a first balloon, a second balloon, and a delivery device having a distal end, the first balloon having an interior and the second balloon being positioned within the interior of the first balloon;

cutting an incision in a patient;

inserting the distal end of the delivery device into the patient through the incision;

moving the distal end of the delivery device to a position between tissue layers;

positioning the first balloon between the tissue layers;

inflating the first balloon;

positioning the second balloon between the tissue layers;

inflating the second balloon; and

insufflating a working space between the tissue layers with an insufflating fluid.

12. The method of claim 11, further comprising the step of:

positioning the second balloon so that the insufflating fluid is impeded from escaping through the incision.

13. The method of claim 11, further comprising the step of:

puncturing the first balloon to create an opening.

14. The method of claim 11, wherein:

the providing step is carried out with at least one of the first and second balloons being mounted to the delivery device.

15. The method of claim 14, wherein:

the delivery device inserting step and at least one of the first and second balloon positioning steps is carried out substantially at the same time.

16. A method of providing a working space in a patient for performing a medical procedure, comprising the steps of:

providing a first balloon, a second balloon, and a delivery device having a distal end;

cutting an incision in a patient;

inserting the distal end of the delivery device into the patient through the incision;

moving the distal end of the delivery device to a position between tissue layers in the patient;

positioning the first balloon between the tissue layers;

inflating the first balloon;

positioning the second balloon between the tissue layers;

inflating the second balloon;

insufflating a working space between the tissue layers with an insufflating fluid;

deflating the first balloon;

creating an opening in the first balloon; and

performing a medical procedure in the working space with an instrument passing through the opening in the first balloon.

17. The method of claim 16, further comprising the step of:

positioning the second balloon so that the insufflating fluid is impeded from escaping through the incision.

18. The method of claim 16, wherein:

the providing step is carried out with at least one of the first and second balloons being mounted to the delivery device.

19. The method of claim 18, wherein:

the delivery device inserting step and at least one of the first and second balloon positioning steps is carried out substantially at the same time.

20. The method of claim 18, wherein:

the opening creating step is carried out by puncturing the first balloon.