Medical introducer apparatus

• US 6,562,049 B1
• Filed: 11/09/2000
• Issued: 05/13/2003
• Est. Priority Date: 03/01/2000
• Status: Expired due to Term

• Current Assignee: Cook Medical Technologies, LLC (Cook Group Incorporated)
• Original Assignee: Cook Vascular Incorporated (Cook Group Incorporated)
• Inventors: Norlander, Barry E., Boyle, William J.
• Primary Examiner(s): Calvert, John J.
• Assistant Examiner(s): Hoey, Alissa L.
• Application Number:
  US09/710,112
• Time in Patent Office: 915 Days
• Field of Search: 606/108, 606/192, 606/194, 606/213, 606/1, 606/215, 606/198, 606/191, 606/200, 604/160, 604/161, 604/96, 604/95, 604/283, 604/102, 604/164
• US Class Current: 606/108
• CPC Class Codes: A61B 2017/3484 Anchoring means, e.g. spreading-out umbrella-like structure
• CPC Class Codes: A61B 2017/3488 Fixation to inner organ or inner body tissue
• CPC Class Codes: A61M 2025/0034 characterized by elements which are assembled, connected or fused, e.g. splittable tubes, outer sheaths creating lumina or separate cores
• CPC Class Codes: A61M 2025/0037 characterized by lumina being arranged side-by-side
• CPC Class Codes: A61M 2025/0039 characterized by lumina being arranged coaxially
• CPC Class Codes: A61M 2025/004 characterized by lumina being arranged circumferentially
• CPC Class Codes: A61M 2025/0183 Rapid exchange or monorail catheters
• CPC Class Codes: A61M 2025/0681 Systems with catheter and outer tubing, e.g. sheath, sleeve or guide tube
• CPC Class Codes: A61M 2025/1052 for temporarily occluding a vessel for isolating a sector
• CPC Class Codes: A61M 2210/125 Heart
• CPC Class Codes: A61M 25/003 characterized by features relating to least one lumen located at the distal part of the catheter, e.g. filters, plugs or valves catheter tips A61M25/0067
• 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 25/0067 characterised by the distal end, e.g. tips A61M25/0054, A61M25/04 take precedence; balloon catheters A61M25/10
• CPC Class Codes: A61M 25/0075 Valve means
• CPC Class Codes: A61M 25/0152 with pre-shaped mechanisms, e.g. pre-shaped stylets or pre-shaped outer tubes
• CPC Class Codes: A61M 25/04 in the body, e.g. expansible A61M25/10, A61M16/0488 take precedence
• CPC Class Codes: A61M 25/0662 Guide tubes
• CPC Class Codes: A61M 25/0668 splittable, tear apart
• 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 39/0606 without means for adjusting the seal opening or pressure A61M39/0693 takes precedence

Abstract

An introducer apparatus (10) comprising a pair of co-extending splittable introducer sheaths (11), (12) is disclosed. The unique properties (pushability, torqueability, length, shape, etc.) of the individual introducer sheaths yields an introducer apparatus with the additional navigational flexibility to reach a remote target that whose access would be more difficult or impossible with a single introducer sheath. One embodiment include a coaxial pair of introducer sheaths made of made of molecularly oriented (non-isotropic) polytetrafluoroethylene PTFE which are used for placement of a pacemaker or defibrillator lead into the coronary sinus. In this embodiment, the first introducer sheath (11) is introduced over a wire guide into ostium of the coronary sinus, which represents the first target site. The outer introducer sheath includes preformed bends (20) to facilitate passage through the vasculature. A second introducer sheath (12), which includes a curved distal portion (17), is introduced through the first introducer where it extends from the distal end of the outer introducer sheath to access the second, ultimate target site, such as a coronary artery branching from the coronary sinus. After the pacemaker lead has been placed, both sheaths are split and removed from the patient.

Claims

1. A medical introducer apparatus, comprising:

a first introducer sheath having a distal end, a proximal end and at least a first passageway extending therethrough;

a second introducer sheath having a distal end, a distal portion, a proximal end, and at least a first passageway extending therethrough, the first and second introducer sheaths configured to be longitudinally splittable;

the first and second introducer sheaths further configured to co-extend into a bodily passage, whereby the distal portion of the second introducer sheath is at least partly extendable beyond the distal end of the first introducer sheath;

wherein the first introducer sheath includes a preformed bend in a portion of said sheath that extends in said bodily passage.

2. The introducer apparatus of claim 1 wherein the second introducer sheath is coaxially disposed within the first passageway of the first introducer sheath.

3. The introducer apparatus of claim 2 wherein the curvature of the at least one preformed bend has a radius of 10 cm or tighter.

4. The introducer apparatus of claim 2 wherein the first introducer sheath includes a plurality of preformed bends.

5. The introducer apparatus of claim 4 wherein the plurality of preformed bends include a distal bend and proximal bend, the distal and proximal bends formed such that the first introducer sheath generally comprises a serpentine configuration.

6. The introducer apparatus of claim 2 having an overall length of at least 20 cm.

7. The introducer apparatus of claim 6 wherein the first introducer sheath has a length of at least 35 cm, and the second introducer sheath has a length of at least 45 cm.

8. The introducer apparatus of claim 7 wherein the first introducer sheath has a length of at least 45 cm, and the second introducer sheath has a length of at least 55 cm.

9. The introducer apparatus of claim 2 wherein the distal portion of the second introducer sheath includes a preformed bend.

10. The introducer apparatus of claim 1 wherein at least one of the first introducer sheath and the second introducer sheath further includes an expandable member located about the distal end of the at least one of first and second introducer sheaths.

11. The introducer apparatus of claim 10 wherein the expandable member includes one or more inflatable balloons adapted to at least partially occlude a bodily passage.

12. The introducer apparatus of claim 1 wherein at least one of the first introducer sheath and the second introducer sheath further includes at least one retention element adapted for preventing retrograde migration of the at least one of first and second introducer sheaths.

13. The introducer apparatus of claim 1 further includes at least one steerage member adapted for placement within at least one passageway of at least one of the first introducer sheath and the second introducer sheath.

14. The introducer apparatus of claim 13 wherein at least one of the at least one steerage member selected from a group consisting of a dilator and an obturator.

15. The introducer apparatus of claim 13 wherein at least one of the at least one coaxial steerage member comprises a remotely controllable steerable member.

16. The introducer apparatus of claim 1 wherein at leas one of the first introducer sheath and the second introducer includes a plurality of passageways.

17. The introducer apparatus of claim 1 wherein at least one of the first introducer sheath and the second introducer includes a valve adapted to reduce retrograde flow of bodily fluids from within at least the first passageway thereof.

18. The introducer apparatus of claim 17 wherein said valve is longitudinally splittable.

19. The introducer apparatus of claim 1 wherein at least one of the first introducer sheath and the second introducer includes at least one of a radiopaque marker placed thereon or a radiopaque agent incorporated therewithin.

20. The introducer apparatus of claim 1, wherein each of said first and second introducer sheaths has a preformed bend.

21. A medical introducer apparatus, comprising:

a first introducer sheath having a distal end, a proximal end and a first passageway extending therethrough;

a second introducer sheath having a distal end, a distal portion, a proximal end, and a passageway extending therethrough, the second introducer sheath sized and configured for placement within the passageway of the first introducer sheath such that the distal portion of the second introducer sheath is at least partly extendable beyond the distal end of the first introducer sheath;

wherein the first and second introducer sheaths comprise a molecularly oriented, non-isotropic polymer material such that the first and second introducer sheaths can be longitudinally split along at least one predetermined split line and removed from the patient;

wherein at least one of the first introducer sheath and the second introducer sheath includes a preformed bend in a portion of said sheath that extends in said bodily passage.

22. The introducer apparatus of claim 21 wherein the polymer material comprises polytetrafluoroethylene.

23. The introducer apparatus of claim 21 wherein the first introducer sheath includes a plurality of preformed bends.

24. The introducer apparatus of claim 23 wherein the plurality of preformed bends includes a distal bend and proximal bend, the first introducer sheath being so configured that when the first introducer sheath is placed within the vascular system of a patient such that the distal end of the first introducer is generally located within the region including the right atrium and coronary sinus of the patient, the proximal bend being generally located within, and generally conforming to the curvature of the right subclavian and innominate veins of the patient, while the distal bend is at least partially located within the right atrium and configured such that the distal end of the first introducer sheath is oriented toward the ostium of the coronary sinus of the patient.

25. The introducer apparatus of claim 23 wherein the first introducer sheath has a length of at least 35 cm, and the second introducer sheath has a length of at least 45 cm.

26. The introducer apparatus of claim 25 wherein the first introducer sheath has a length of at least 45 cm, and the second introducer sheath has a length of at least 55 cm.

27. The introducer apparatus of claim 23 further includes at least one steerage member adapted for placement within the passageway of at least one of the first introducer sheath and the second introducer sheath.

28. The introducer sheath of claim 21, wherein at least one of the first introducer sheath and the second introducer sheath includes a longitudinally splittable valve adapted to reduce retrograde flow of bodily fluids from within at least the first passageway thereof.

29. A medical introducer apparatus, comprising:

a first introducer sheath having a distal end, a proximal end and one or more passageways extending therethrough;

a second introducer sheath having a distal end, a distal portion, a proximal end, and one or more passageways extending therethrough, the first and second introducer sheaths configured to be longitudinally splittable;

the first and second introducer sheaths further configured to co-extend into a bodily passage, whereby the distal portion of the second introducer sheath is at least partly extendable beyond the distal end of the first introducer sheath;

at least one steerage member adapted for placement within at least one of the one or more passageways of at least one of the first introducer sheath and the second introducer sheath, the at least one steerage member being so configured such that placement thereof within a selected one of the one or more passageways permits the at least one of the first introducer sheath and the second introducer sheath to assume a configuration having at least one curve extending therealong during passage thereof through a bodily passage.

30. The introducer apparatus of claim 29 wherein at least one of the at least one steerage member includes one or more preformed bends.

31. The introducer apparatus of claim 29 wherein at least one of the at least one steerage member comprises a remotely controllable steerable member.

33. The introducer sheath of claim 29, wherein at least one of the first introducer sheath and the second introducer sheath includes a longitudinally splittable valve adapted to reduce retrograde flow of bodily fluids from within at least the first passageway thereof.

32. A medical introducer apparatus, comprising:

a first introducer sheath having a distal end, a proximal end and a first passageway extending therethrough, the first introducer measuring 45 to 55 cm in length and further having a proximal bend and a distal bend, the first introducer sheath being so configured that when the first introducer sheath is placed within the vascular system of a patient such that the distal end of the first introducer is located within the right atrium of the patient, the proximal bend is generally located within, and generally conforms along the curvature of the right subclavian and innominate veins of the patient, while the distal bend is at least partially located within the right atrium and configured such that the distal end of the first introducer sheath is oriented toward the ostium of the coronary sinus of the patient;

a second introducer sheath having a distal end, a distal portion comprising a preformed curve, a proximal end, and a first passageway extending therethrough, the second introducer sheaths measuring 55 to 65 cm in length and further sized and configured for placement within the first passageway of the first introducer sheath such that the distal portion of the second introducer sheath is at least partly extendable beyond the distal end of the first introducer sheath;

at least one steerage member adapted for placement within the first passage of at least one of the first introducer sheath and the second introducer sheath, the at least one steerage member so configured such that placement thereof within the first passage of at least one of the first introducer sheath and the second introducer sheath permits the at least one of the first and second introducer sheaths to assume a configuration having at least one curve extending therealong during passage thereof through a bodily passage;

wherein the first and second introducer sheaths comprise molecularly oriented, non-isotropic polytetrafluoroethylene such that the first and second introducer sheaths can be longitudinally split along at least one predetermined split line and removed from the patient.