Apparatus and methods for positioning a vascular sheath

• US 6,626,918 B1
• Filed: 10/06/2000
• Issued: 09/30/2003
• Est. Priority Date: 10/06/2000
• Status: Expired due to Term

• Current Assignee: Integrated Vascular Systems, Inc. (Abbott Laboratories Incorporated)
• Original Assignee: Medical Technology Incorporated
• Inventors: Belef, W. Martin, Ginn, Richard S.
• Primary Examiner(s): Milano, Michael J.
• Assistant Examiner(s): Baxter, Jessica R
• Application Number:
  US09/680,837
• Time in Patent Office: 1,089 Days
• Field of Search: 606/213, 606/219, 606/220, 606/139, 606/146, 606/142, 606/143, 606/144, 606/148
• US Class Current: 606/148
• CPC Class Codes: A61B 17/0057 Implements for plugging an opening in the wall of a hollow or tubular organ, e.g. for sealing a vessel puncture or closing a cardiac septal defect sutures A61B17/04; closing rectum or urethra near body surface A61F2/0009
• 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 17/3498 Valves therefor, e.g. flapper valves, slide valves haemostasis valves A61M39/06; check valves A61M39/24
• CPC Class Codes: A61B 2017/00672 Locating means therefor, e.g. bleed back lumen
• CPC Class Codes: A61B 2017/3454 Details of tips
• CPC Class Codes: A61B 2090/062 penetration depth
• CPC Class Codes: A61M 2025/0079 Separate user-activated means, e.g. guidewires, guide tubes, balloon catheters or sheaths, for sealing off an orifice, e.g. a lumen or side holes, of a catheter
• CPC Class Codes: A61M 25/0662 Guide tubes
• CPC Class Codes: A61M 25/0693 Flashback chambers

Abstract

An apparatus for positioning an introducer sheath includes a sheath having a distal end including first and second ports, the second port being located distally from the first port. An obturator is slidable within the sheath that includes a distal region that sealingly engages an interior surface of the sheath. The obturator includes first and second openings in the distal region that are alignable with the first and second ports in the sheath. A housing is slidable on the exterior of the sheath that releasably holds a closure element. The sheath may be inserted into an incision communicating with a blood vessel, the first and second ports providing backbleed indication of the depth of the insertion of the sheath into the vessel. The housing is actuated to deploy the closure element to engage and close the incision.

Claims

1. An apparatus for introduction into an opening in a wall of a body lumen, comprising:

a sheath having proximal and distal ends, the distal end having a size and shape for insertion into a body lumen, the distal end including first and second ports therein, the first port being disposed at a more distal location than the second port;

an elongate member disposed within the sheath, the elongate member including a distal region configured for sealingly engaging an inner surface of the sheath, the elongate member including first and second openings in the distal region, the first and second openings being alignable with the first and second ports in the sheath; and

first and second lumens extending distally from the proximal end of at least one of the sheath and the elongate member, the first and second lumens communicating with the first and second openings, respectively.

2. The apparatus of claim 1, further comprising a closure element slidably disposed on an exterior of the sheath, the closure element configured for engaging tissue adjacent the opening for closing the opening.

3. The apparatus of claim 1, further comprising a housing slidably disposed on the exterior of the sheath, the housing configured for releasably holding a closure element, the housing being actuable from a proximal end of the sheath for advancing the closure element distally during deployment of the closure element.

4. The apparatus of claim 1, wherein the first and second ports are axially aligned with one another.

5. The apparatus of claim 4, further comprising a marker on the proximal end of the tubular sheath, the marker having a predetermined peripheral orientation about the sheath for identifying the peripheral location of the first and second ports.

6. The apparatus of claim 1, wherein the elongate member is insertable into the sheath, and wherein the first and second ports are aligned with the first and second openings when the elongate member is fully inserted into the sheath.

7. The apparatus of claim 6, wherein the elongate member and the sheath include cooperating detents for securing the elongate member axially with respect to the sheath when the elongate member is fully inserted into the sheath.

8. The apparatus of claim 6, wherein the first lumen extends axially through the elongate member.

9. The apparatus of claim 6, wherein the second lumen comprises an annular lumen between the elongate member and the sheath.

10. The apparatus of claim 1, wherein the elongate member is insertable into the sheath, and wherein the first port is aligned with the first opening when the elongate member is inserted a first distance into the sheath, and wherein the second port is aligned with the second opening when the elongate member is inserted a second distance into the sheath.

11. The apparatus of claim 1, wherein the elongate member is rotatable within the sheath, and wherein the first port is aligned with the first opening when the elongate member is rotated to a first position within the sheath, and wherein the second port is aligned with the second opening when the elongate member is rotated to a second position within the sheath.

12. The apparatus of claim 1, wherein the first and second lumens extend within the elongate member between its proximal end and the first and second openings, respectively.

13. An apparatus for delivering a vascular closure element into engagement with tissue adjacent an opening into a body lumen, comprising:

a sheath having proximal and distal ends and an exterior surface, the sheath including an interior surface defining a first lumen extending between the proximal and distal ends, and one or more ports in the distal end communicating with the first lumen;

a housing slidably disposed on the exterior of the sheath, the housing being configured for releasably holding a closure element, the housing being actuable from a proximal end of the sheath for advancing the closure element distally during deployment of the closure element; and

an elongate member insertable into the first lumen of the sheath, the elongate member including a distal region configured for sealingly engaging the interior surface of the sheath, thereby defining an annular region between the elongate member and the sheath proximal to the distal region, the annular region communicating with the one or more ports when the elongate member is fully inserted into the sheath.

14. The apparatus of claim 13, wherein the distal region of the elongate member is expandable between a contracted configuration and an enlarged configuration, the distal region sealingly engaging the interior surface of the sheath in the enlarged condition.

15. The apparatus of claim 13, further comprising a closure element releasably held by the housing, the closure element configured for engaging tissue adjacent-the opening for closing the opening.

16. The apparatus of claim 13, further comprising a backbleed port on the proximal end of the sheath, the backbleed port communicating with the first lumen.

17. The apparatus of claim 13, wherein the elongate member comprises a substantially flexible distal tip that extends from the distal end of the sheath when the elongate member is fully inserted into the sheath.

18. The apparatus of claim 13, wherein the one or more ports comprise a first port in the exterior surface of the sheath, and the sheath further comprises a second port located at a location distal from the first port.

19. The apparatus of claim 18, wherein the elongate member comprises a second lumen extending distally from its proximal end, the second lumen communicating with the second port when the elongate member is fully inserted into the sheath.

20. The apparatus of claim 19, wherein the elongate member includes a third lumen therein extending distally from its proximal end, the third lumen communicating with the first port when the elongate member is fully inserted into the sheath.

21. The apparatus of claim 13, further comprising a seal on the proximal end of the sheath, the seal slidably engaging the elongate member when it is inserted into the lumen, thereby sealing the lumen from proximal flow of fluid.

22. A method for positioning an introducer sheath in an opening in a wall of a body passage, the introducer sheath including a plurality of lumens extending distally from its proximal end and communicating with respective ports in its distal end, each port being disposed at a different distal location on the distal end, the method comprising:

inserting the distal end of the introducer sheath through a patient'"'"'s skin towards the body passage via the opening; and

positioning the distal end with respect to the body passage until one or more of the ports enter the body passage, whereupon fluid pressure within the body passage causes fluid from within the body passage to enter the respective one or more lumens communicating with the one or more ports in the body passage, thereby providing a visual indication of depth of insertion of the introducer sheath.

23. The method of claim 22, wherein the one or more ports are disposed in axial alignment with one another along the distal end, and wherein the step of positioning the distal end comprises rotating the introducer sheath about its longitudinal axis until the ports are in a predetermined orientation with respect to the body passage.

24. The method of claim 23, wherein the introducer sheath extends at a substantially lateral angle between the patient'"'"'s skin and the body passage, and wherein the introducer sheath is rotated to position the ports in a desired rotational orientation.

25. The method of claim 22, further comprising advancing a closure element slidable on the introducer sheath distally to engage tissue within the opening adjacent the body passage.

26. An apparatus for introduction into an opening in a wall of a body lumen, comprising:

a sheath having proximal and distal ends, the distal end having a size and shape for insertion into a body lumen, the distal end including first and second ports therein, the second port being disposed at a more distal location than the first port; and

an elongate member disposed within the sheath, the elongate member including a distal region having a size for sealingly engaging an inner surface of the sheath, the elongate member being movable with respect to the sheath for selectively opening and closing the first and second side ports to permit fluid flow therethrough to the proximal end of the sheath.

27. The apparatus of claim 26, wherein the elongate member at least partially defining a lumen extending from the proximal end of the sheath towards the distal region of the elongate member, and wherein the elongate member includes a region for selectively sealing the first and second ports in the sheath, whereby only one of the first and second ports communicates with the lumen.

28. The apparatus of claim 27, wherein the lumen is located within the elongate member.

29. The apparatus of claim 27, wherein the lumen is defined between the elongate member and the inner surface of the sheath.

30. The apparatus of claim 29, wherein the elongate member further comprises a second lumen therein having an inlet proximal to the distal region of the elongate member and a piston for sealingly engaging the inner surface of the sheath, the piston being located proximal to the inlet, whereby the second lumen communicates with the second side port when the elongate member is disposed at a first position, and the lumen between the elongate member and the inner surface of the sheath communicates with the first side port when the elongate member is disposed at a second position.

31. The apparatus of claim 30, wherein the elongate member is movable axially with respect to the sheath between the first and second positions.

32. The apparatus of claim 30, wherein the elongate member is rotatable with respect to the sheath between the first and second positions.

33. The apparatus of claim 26, further comprising a closure element slidably disposed on an exterior of the sheath, the closure element configured for engaging tissue adjacent the opening for closing the opening.

34. The apparatus of claim 26, further comprising a housing slidably disposed on the exterior of the sheath, the housing configured for releasably holding a closure element, the housing being actuable from a proximal end of the sheath for advancing the closure element distally during deployment of the closure element.

35. The apparatus of claim 26, wherein the first and second ports are axially aligned with one another.

36. The apparatus of claim 35, further comprising a marker on the proximal end of the tubular sheath, the marker having a predetermined peripheral orientation about the sheath for identifying the peripheral location of the first and second ports.

37. The apparatus of claim 26, wherein the elongate member and the sheath include cooperating detents for securing the elongate member with respect to the sheath at one or more desired positions.