Sterility barriers for insertion of non-sterile apparatus into catheters or other medical devices

• US 6,589,164 B1
• Filed: 02/15/2000
• Issued: 07/08/2003
• Est. Priority Date: 02/15/2000
• Status: Expired due to Term

• Current Assignee: Medtronic Vascular, Inc. (Medtronic Plc)
• Original Assignee: TransVascular, Inc. (Medtronic Plc)
• Inventors: Flaherty, J. Christopher
• Primary Examiner(s): Hayes, Michael J.
• Assistant Examiner(s): Thanh, LoAn H.
• Application Number:
  US09/505,149
• Time in Patent Office: 1,239 Days
• Field of Search: 604/171, 604/187, 604/198-199, 604/197, 604/263, 604/20-22, 600/164.01, 600/437, 600/439, 600/459, 600/461-467, 600/101, 600/103, 600/104, 600/106, 600/108, 600/117, 600/118, 600/121, 600/123, 600/129, 600/136, 600/137, 600/139, 600/160
• US Class Current: 600/121
• 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: A61M 25/0017 specially adapted for long-term hygiene care, e.g. urethral or indwelling catheters to prevent infections
• CPC Class Codes: A61M 25/0111 Aseptic insertion devices

Abstract

Methods, apparatus and systems wherein the distal portion of an elongate apparatus (e.g., a catheter or cannula) having a sealed lumen (e.g., a blind lumen) formed therein is insertable into the body of a mammalian patient and a tubular sterility barrier is attached to or formed on the proximal portion of the elongate apparatus. The tubular sterility barrier is arranged so that it extends outside of a sterile field that is being maintained around the proximal portion of the elongate device. A non-sterile working apparatus (e.g., an intravascular ultrasound device or other imaging apparatus, etc.) may then be inserted through the sterility barrier and into the sealed lumen without causing contamination of the sterile field or the patient.

Claims

1. A tissue penetrating catheter device useable, in conjunction with a separate imaging apparatus, to penetrate from the lumen of a patient'"'"'s blood vessel, outwardly through the wall of that blood vessel, and to a target location within the patient'"'"'s body, said tissue penetrating catheter device comprising:

a) a flexible catheter body having i) a proximal end, ii) a distal portion that is insertable into the blood vessel, iii) a penetrator outlet formed in the distal portion, iv) an imaging apparatus inlet located proximal to the distal portion and v) an imaging lumen that extends from the imaging apparatus inlet into the distal portion of the catheter body, at least the portion of the imaging lumen located within the distal portion of the catheter body being sealed such that any microbial contamination introduced thereinto will not escape into the patients body when the distal portion of the catheter body is positioned within a blood vessel, vi) a penetrator passable out of the penetrator outlet, and vii) trajectory determining apparatus useable in conjunction with a separate imaging apparatus to determine the trajectory along which the penetrator will advance from the catheter body; and

b) a generally tubular sterility barrier, one end of said sterility barrier being secured about the imaging apparatus inlet such that an elongate imaging apparatus may be passed through the tubular sterility barrier, through the imaging apparatus inlet and to an operative position within the imaging lumen to permit the imaging apparatus to be used to obtain an image of the penetrator and the target location.

2. A system comprising a catheter device according to claim 1 in combination with an elongate imaging apparatus that is sized for insertion into the imaging lumen of the catheter device.

3. A system according to claim 2 wherein the imaging apparatus comprises an ultrasonic imaging catheter.

4. A system according to claim 2 wherein the imaging apparatus comprises an ultrasonic imaging wire.

5. A system according to claim 2 wherein the catheter device is sterile and the imaging apparatus is non-sterile.

6. A catheter device according to claim 1 wherein the trajectory determining apparatus includes at least one marker formed on the catheter to indicate the direction in which the penetrator will pass from the catheter body.

7. A catheter device according to claim 6 wherein:

the marker comprises an imageable member located at a radial position that is in known alignment with the direction in which the penetrator will extend when deployed from the catheter.

8. A catheter device according to claim 6 wherein:

the marker comprises a plurality of elongate members that extend longitudinally, at circumferentially spaced-apart locations about the catheter;

the imaging lumen extends into a location amidst said elongate members;

a first one of the elongate members is located at a radial position that is in known alignment with the direction in which the penetrator will extend when deployed from the catheter; and

,

the imaging apparatus, when in its operative position, is capable of providing an image of the marker, the image of the marker thereby enabling the operator to ratationally orient the catheter body in the blood vessel such that when the penetrator is subsequently deployed it will pass to the target location.

9. A catheter device according to claim 1 wherein the penetrator comprises a flow of energy.

10. A catheter device according to claim 9 wherein the penetrator is a laser beam.

11. A catheter device according to claim 1 wherein the penetrator comprises an elongate penetrating member.

12. A catheter device according to claim 11 wherein a guidewire lumen extends longitudinally through the tissue penetrating member.

13. A catheter device according to claim 1 wherein the sterility barrier is permanently sealed to the remainder of the catheter device by a microbe-tight seal.

14. A catheter device according to claim 1 wherein the sterility barrier is attachable to and detachable from the remainder of the catheter device by a microbe-tight seal.

15. A catheter device according to claim 1 wherein the penetrator is resilient and has a distal portion, the distal portion of the penetrator being preformed to a curved configuration, said penetrator being longitudinally retractable into the catheter body and longitudinally advanceable out of the catheter body.

16. A catheter device according to claim 1 wherein the sterility barrier is permanently attached to the catheter device.

17. A catheter device according to claim 1 wherein the sterility barrier is detachable from the catheter device.

18. A catheter device according to claim 1 further comprising a hand piece on the proximal end of the catheter body, said imaging apparatus inlet being formed on the hand piece.

19. A catheter device according to claim 1 wherein the sterility barrier is formed of flexible polymer material having a thickness of approximately 1-5 mils.

20. A catheter device according to claim 1 wherein the sterility barrier is substantially transparent.

21. A catheter device according to claim 1 wherein the sterility barrier is sufficiently flexible to allow the operator to grasp the working apparatus through the sterility barrier and to thereby advance the working apparatus into the lumen.