Systems and methods for percutaneous removal of objects from an internal body space

• US 10,092,324 B2
• Filed: 09/02/2016
• Issued: 10/09/2018
• Est. Priority Date: 09/04/2015
• Status: Active Grant

• Current Assignee: Children's Hospital of Philadelphia (Children's Hospital of Philadelphia Foundation)
• Original Assignee: Children's Hospital of Philadelphia (Children's Hospital of Philadelphia Foundation), Trustees Of The University Of Pennsylvania (University of Pennsylvania)
• Inventors: Gillespie, Matthew J., Gorman, III, Joseph H., Gorman, Robert C., Piper, Mark
• Primary Examiner(s): TANNER, JOCELIN C
• Application Number:
  US15/256,171
• Publication Number:
  US 20170065299A1
• Time in Patent Office: 767 Days
• CPC Class Codes: A61B 17/22031 Gripping instruments, e.g. forceps, for removing or smashing calculi A61B17/221 takes precedence
• CPC Class Codes: A61B 17/221 Gripping devices in the form of loops or baskets for gripping calculi or similar types of obstructions surgical snare instruments A61B17/32056
• CPC Class Codes: A61B 17/50 Instruments, other than pincettes or toothpicks, for removing foreign bodies from the human body locating otherwise A61B5/06; locating by radiation A61B6/00; removing calculi A61B17/22; from the eyes A61F9/00709
• CPC Class Codes: A61B 2017/00367 Details of actuation of instruments, e.g. relations between pushing buttons, or the like, and activation of the tool, working tip, or the like
• CPC Class Codes: A61B 2017/00778 Operations on blood vessels A61B2017/22097, A61B2017/320741 take precedence
• CPC Class Codes: A61B 2017/22034 for gripping the obstruction or the tissue part from inside
• CPC Class Codes: A61B 2017/22035 for retrieving or repositioning foreign objects
• CPC Class Codes: A61B 2017/2215 having an open distal end
• CPC Class Codes: A61F 2/2427 Devices for manipulating or deploying heart valves during implantation
• CPC Class Codes: A61F 2/962 having an outer sleeve
• CPC Class Codes: A61F 2002/9528 for retrieval of stents
• CPC Class Codes: A61F 2002/9623 the sleeve being reinforced

Abstract

Disclosed are systems, methods, and devices for percutaneous retrieval of objects, such as endovascular devices, from an internal body space. The present inventions have vascular, non-vascular (gastrointestinal), and surgical (laproscopic) applications. The inventions include a retrieval end having one or more compressed states and an expanded state, the retrieval end adopting the expanded state when the retrieval end is deployed into a subject'"'"'s internal body space, the retrieval end having a mouth through which an object can be passed into an interior space within the retrieval end when the retrieval end is in the expanded state, the mouth being adjustable between an opened state and a closed state; wherein when at least a portion of the retrieval end of the inner sheath is transitioned to a compressed state following capture of the object, the retrieval end exerts an inward force that at least partially collapses or compresses the object.

Claims

1. A system for percutaneous retrieval of an endovascular device within a subject'"'"'s internal body space comprising:

an outer sheath having a lumen and being configured for percutaneous insertion into a subject'"'"'s internal body space;

an inner sheath that is configured for percutaneous insertion into the subject'"'"'s internal body space via the lumen of the outer sheath, the inner sheath comprising

a distal retrieval end having one or more compressed states and an expanded state, the retrieval end adopting one of the compressed states when the retrieval end is housed within the lumen of the outer sheath, and adopting the expanded state when the retrieval end is deployed into the subject'"'"'s internal body space by exiting a distal end of the outer sheath,

the retrieval end having a main body portion terminating distally in a mouth through which the endovascular device can be passed into an interior space within the retrieval end when the retrieval end is in the expanded state,

the main body portion being sized to enclose the endovascular device, and the mouth being adjustable between an opened state and a closed state so that the endovascular device can be enclosed within the interior space after passing through the mouth of the retrieval end;

wherein the retrieval end comprises a wire weave formed from wires having a first braiding angle of about 45 degrees to about 85 degrees when the retrieval end is in the expanded state and before withdrawal of any portion of the retrieval end into the outer sheath, the wires of said wire weave having a diameter of about 200 to about 300 μ

m, and the wire weave comprises 12, 24, 48, or 96 wire ends; and

,

wherein when at least a portion of the retrieval end of the inner sheath is withdrawn into the outer sheath following capture of the endovascular device within the interior space of the retrieval end, the retrieval end exerts an inward force that at least partially collapses or compresses the endovascular device to a degree that is sufficient to permit withdrawal of the endovascular device into the outer sheath.

2. The system according to claim 1, further comprising at least one manipulation tool that grips, grasps, grapples, ensnares, moves, captures, changes the orientation of, or manipulates the endovascular device, the at least one manipulation tool being deployable into the subject'"'"'s internal body space via a lumen in the inner sheath.

3. The system according to claim 1, further comprising a suture line having a loop portion that is positioned around a circumference of the mouth of the retrieval end and that is used to transition the mouth between the opened state and the closed state.

4. The system according to claim 3 wherein said suture line transitions the mouth between the opened state and the closed state independently of whether the retrieval end has been at least partially withdrawn into the outer sheath.

5. The system according to claim 1, further comprising a control line that is affixed to the retrieval end for changing the position of the mouth of the retrieval end within the subject'"'"'s internal body space.

6. The system according to claim 5, wherein the control line also provides longitudinal support for the retrieval end while the endovascular device is being drawn into the retrieval end.

7. The system according to claim 1, wherein the retrieval end elongates and a braiding angle of said wire weave decreases from the first braiding angle to a second braiding angle in response to withdrawal of at least a portion of the retrieval end of the inner sheath into the outer sheath.

8. The system according to claim 1, wherein when at least a portion of the retrieval end of the inner sheath is withdrawn into the outer sheath following capture of the endovascular device within the interior space of the retrieval end, a longitudinal force that is imposed on the inner sheath by an operator of a system during the withdrawal of the inner sheath through the lumen of the outer sheath translates into a radial compressive force by the retrieval end.

9. The system according to claim 1, wherein the mouth has a diameter of 10-15 mm or the main body portion has an outer diameter of about 25 to about 35 mm.

10. A method for percutaneously retrieving an object within a subject'"'"'s internal body space comprising:

delivering to the subject'"'"'s internal body space an outer sheath having a lumen;

introducing an inner sheath into the lumen of the outer sheath, the inner sheath comprising

a distal retrieval end having one or more compressed states and an expanded state, the retrieval end adopting one of the compressed states when the retrieval end is housed within the lumen of the outer sheath, and adopting the expanded state when the retrieval end is deployed into the subject'"'"'s internal body space by exiting a distal end of the outer sheath,

the retrieval end having a mouth through which the object can be passed into an interior space within the retrieval end when the retrieval end is in the expanded state, the mouth being adjustable between an opened state and a closed state so that the object can be enclosed within the interior space after passing through the mouth of the retrieval end,

wherein the retrieval end comprises a wire weave formed from wires having a first braiding angle of about 45 degrees to about 85 degrees when the retrieval end is in the expanded state and before withdrawal of any portion of the retrieval end into the outer sheath, the wires of said wire weave having a diameter of about 200 to about 300 μ

m, and the wire weave comprises 12, 24, 48, or 96 wire ends;

advancing the inner sheath through the lumen of the outer sheath until the retrieval end is deployed into the subject'"'"'s internal body space by exiting the distal end of the outer sheath;

capturing the object at least partially within the interior space of the retrieval end;

at least partially closing the mouth of the retrieval end in order to enclose the object within the interior space of the retrieval end;

withdrawing the inner sheath through the lumen of the outer sheath until the retrieval end exerts an inward force that at least partially collapses or compresses the object; and

,

withdrawing the retrieval end into the lumen of the outer sheath, thereby removing the object from the subject'"'"'s internal body space.

11. The method according to claim 10, wherein the inner sheath is introduced into the lumen of the outer sheath by

introducing the inner sheath into the lumen of a loader tube via a proximal end of the loader tube;

advancing inner sheath through the lumen of the loader tube to a distal end thereof until the inner sheath exits the distal end of the loader tube and enters the lumen of the outer sheath via a proximal end of the outer sheath; and

,

advancing the inner sheath until the retrieval end thereof approaches, but does not exit, the distal end of the outer sheath.

12. The method according to claim 10, further comprising, following deployment of the retrieval end into the subject'"'"'s internal body space, adjusting a position of the retrieval end relative to the object by use of a control line that is affixed to the retrieval end.

13. The method according to claim 12, comprising using the control line to position the retrieval end so that the object is proximate to the mouth of the retrieval end.

14. The method according to claim 10, further comprising, following deployment of the retrieval end into a subject'"'"'s vasculature, advancing through a lumen of the inner sheath a manipulation tool that grips, grasps, grapples, ensnares, moves, captures, changes the orientation, or manipulates the object in order to assist in the step of capturing the object at least partially within the interior space of the retrieval end.

15. The method according to claim 14, further comprising adjusting a position of the retrieval end relative to the object by use of a control line that is affixed to the retrieval end, in order to place the mouth of the retrieval end proximate to the object at the same time that the manipulation tool grips, grasps, grapples, ensnares, moves, captures, changes the orientation, or manipulates the object.

16. The method according to claim 10, wherein the object is an endovascular device.

17. A device for percutaneously retrieving an endovascular device from a subject'"'"'s internal body space comprising:

an elongated tube portion that is configured for percutaneous introduction into a subject and that terminates in a distal retrieval end,

the distal retrieval end comprising a wire weave formed from wires and having one or more compressed states and an expanded state, the retrieval end adopting one of the compressed states when the retrieval end is housed within a lumen of an outer sheath, and adopting the expanded state when the retrieval end is deployed into the subject'"'"'s internal body space by exiting a distal end of the outer sheath,

the wire weave of the retrieval end having a first braiding angle of about 45 degrees to about 85 degrees when the retrieval end is in the expanded state, the wires of said wire weave having a diameter of about 200 to about 300 μ

m, and the wire weave comprises 12, 24, 48, or 96 wire ends,

the retrieval end having a main body portion distally terminating in a mouth through which the endovascular device can be passed into an interior space within the retrieval end when the retrieval end is in the expanded state, the main body portion being sized to enclose the endovascular device, and the mouth being adjustable between an opened state and a closed state so that the endovascular device can be enclosed within the interior space after passing through the mouth of the retrieval end.

18. The device according to claim 17 further comprising a suture line having a loop portion that is positioned around a circumference of the mouth of the retrieval end and that is used to transition the mouth between the opened state and the closed state.

19. The device according to claim 17, further comprising a control line that is affixed to the retrieval end for changing the position of the mouth of the retrieval end within the subject'"'"'s internal body space.

20. The device according to claim 17, wherein the control line also provides longitudinal support for the retrieval end while the endovascular device is being drawn into the retrieval end.

21. The device according to claim 17, wherein the elongated tube portion comprises two or three interior lumens.

22. The device according to claim 17, wherein the mouth can be transitioned into the closed state independently of whether the retrieval end is being withdrawn into the outer sheath.

23. The device according to claim 17 wherein the wire weave of the retrieval end has a first braiding angle when the retrieval end is in the expanded state and before withdrawal of any portion of the retrieval end into the outer sheath.

24. The device according to claim 23, wherein the retrieval end elongates and a braiding angle of said wire weave decreases from the first braiding angle to a second braiding angle in response to withdrawal of at least a portion of the retrieval end into the outer sheath.

25. A device for percutaneously retrieving an endovascular device from a subject'"'"'s internal body space comprising:

an elongated tube configured for percutaneous introduction into a subject that terminates in a retrieval end;

the retrieval end comprising a wire weave formed from wires;

the retrieval end being expandable into an expanded state;

the retrieval end further having a main body portion distally terminating in a mouth through which the endovascular device can be passed into a space within the retrieval end when the retrieval end is in the expanded state;

the main body portion being sized to enclose the endovascular device,

the mouth being adjustable between an opened state and a substantially closed state so that the endovascular device can be retained within the retrieval end after passing through the mouth of the retrieval end,

the wire weave of the retrieval end having a first braiding angle of about 45 degrees to about 85 degrees when the retrieval end is in the expanded state,

the wires of said wire weave having a diameter of about 200 to about 300 μ

m, and,

the wire weave comprises 12, 24, 48, or 96 wire ends.

26. The device according to claim 25, wherein the mouth can be transitioned into the substantially closed state independently of whether the retrieval end is being transitioned from the expanded state to an at least partially collapsed state.

27. The device according to claim 25, wherein the retrieval end elongates and the braiding angle of said wire weave decreases from the first braiding angle to a second braiding angle when the retrieval end is transitioned from the expanded state to an at least partially collapsed state.

28. A system for percutaneous retrieval of an endovascular device within a subject'"'"'s internal body space comprising:

an outer sheath having a lumen and being configured for percutaneous insertion into a subject'"'"'s internal body space;

an inner sheath that is configured for percutaneous insertion into the subject'"'"'s internal body space via the lumen of the outer sheath, the inner sheath comprising

a distal retrieval end having one or more compressed states and an expanded state, the retrieval end adopting one of the compressed states when the retrieval end is housed within the lumen of the outer sheath, and adopting the expanded state when the retrieval end is deployed into the subject'"'"'s internal body space by exiting a distal end of the outer sheath,

the retrieval end having a main body portion terminating distally in a mouth through which the endovascular device can be passed into an interior space within the retrieval end when the retrieval end is in the expanded state,

the main body portion being sized to enclose the endovascular device, and the mouth being adjustable between an opened state and a closed state so that the endovascular device can be enclosed within the interior space after passing through the mouth of the retrieval end;

wherein the retrieval end comprises a wire weave formed from wires having a first braiding angle of about 45 degrees to about 85 degrees when the retrieval end is in the expanded state and before withdrawal of any portion of the retrieval end into the outer sheath, the wires of said wire weave having a diameter of about 200 to about 300 μ

m, and the wire weave comprises 11-21 picks per cm; and

,

wherein when at least a portion of the retrieval end of the inner sheath is withdrawn into the outer sheath following capture of the endovascular device within the interior space of the retrieval end, the retrieval end exerts an inward force that at least partially collapses or compresses the endovascular device to a degree that is sufficient to permit withdrawal of the endovascular device into the outer sheath.

29. A device for percutaneously retrieving an endovascular device from a subject'"'"'s internal body space comprising:

an elongated tube portion that is configured for percutaneous introduction into a subject and that terminates in a distal retrieval end,

the distal retrieval end comprising a wire weave formed from wires and having one or more compressed states and an expanded state, the retrieval end adopting one of the compressed states when the retrieval end is housed within a lumen of an outer sheath, and adopting the expanded state when the retrieval end is deployed into the subject'"'"'s internal body space by exiting a distal end of the outer sheath,

the wire weave of the retrieval end having a first braiding angle of about 45 degrees to about 85 degrees when the retrieval end is in the expanded state, the wires of said wire weave having a diameter of about 200 to about 300 μ

m, and the wire weave comprising 11-21 picks per cm,

the retrieval end having a main body portion distally terminating in a mouth through which the endovascular device can be passed into an interior space within the retrieval end when the retrieval end is in the expanded state, the main body portion being sized to enclose the endovascular device, and the mouth being adjustable between an opened state and a closed state so that the endovascular device can be enclosed within the interior space after passing through the mouth of the retrieval end.

30. A device for percutaneously retrieving an endovascular device from a subject'"'"'s internal body space comprising:

an elongated tube configured for percutaneous introduction into a subject that terminates in a retrieval end;

the retrieval end comprising a wire weave formed from wires;

the retrieval end being expandable into an expanded state;

the retrieval end further having a main body portion distally terminating in a mouth through which the endovascular device can be passed into a space within the retrieval end when the retrieval end is in the expanded state;

the main body portion being sized to enclose the endovascular device,

the mouth being adjustable between an opened state and a substantially closed state so that the endovascular device can be retained within the retrieval end after passing through the mouth of the retrieval end,

the wire weave of the retrieval end having a first braiding angle of about 45 degrees to about 85 degrees when the retrieval end is in the expanded state,

the wires of said wire weave having a diameter of about 200 to about 300 μ

m, and,

and the wire weave comprising 11-21 picks per cm.

31. A method for percutaneously retrieving an object within a subject'"'"'s internal body space comprising:

delivering to the subject'"'"'s internal body space an outer sheath having a lumen;

introducing an inner sheath into the lumen of the outer sheath, the inner sheath comprising

a distal retrieval end having one or more compressed states and an expanded state, the retrieval end adopting one of the compressed states when the retrieval end is housed within the lumen of the outer sheath, and adopting the expanded state when the retrieval end is deployed into the subject'"'"'s internal body space by exiting a distal end of the outer sheath,

the retrieval end having a mouth through which the object can be passed into an interior space within the retrieval end when the retrieval end is in the expanded state, the mouth being adjustable between an opened state and a closed state so that the object can be enclosed within the interior space after passing through the mouth of the retrieval end,

wherein the retrieval end comprises a wire weave formed from wires having a first braiding angle of about 45 degrees to about 85 degrees when the retrieval end is in the expanded state and before withdrawal of any portion of the retrieval end into the outer sheath, the wires of said wire weave having a diameter of about 200 to about 300 μ

m, and the wire weave comprises 11-21 picks per cm;

advancing the inner sheath through the lumen of the outer sheath until the retrieval end is deployed into the subject'"'"'s internal body space by exiting the distal end of the outer sheath;

capturing the object at least partially within the interior space of the retrieval end;

at least partially closing the mouth of the retrieval end in order to enclose the object within the interior space of the retrieval end;

withdrawing the inner sheath through the lumen of the outer sheath until the retrieval end exerts an inward force that at least partially collapses or compresses the object; and

,

withdrawing the retrieval end into the lumen of the outer sheath, thereby removing the object from the subject'"'"'s internal body space.