Establishing access to the body

• US 6,796,976 B1
• Filed: 03/05/1999
• Issued: 09/28/2004
• Est. Priority Date: 03/06/1998
• Status: Expired due to Term

• Current Assignee: Boston Scientific Scimed, Inc. (Boston Scientific Corporation)
• Original Assignee: Scimed Life Systems Incorporated (Boston Scientific Corporation)
• Inventors: Bottcher, Benjamin J., Liu, Clifford M., Adams, John B., Chin, Yem
• Primary Examiner(s): Casler, Brian L.
• Assistant Examiner(s): WILLIAMS, CATHERINE SERKE
• Application Number:
  US09/263,897
• Time in Patent Office: 2,034 Days
• Field of Search: 604/158, 604/160, 604/164.01, 604/533, 604/535, 604/538, 604/539, 604/166.01, 604/164.07, 604/164.13, 604/165.01, 604/165.02, 604/523, 606/108, 128/26
• US Class Current: 604/523
• CPC Class Codes: A61M 25/01 Introducing, guiding, advancing, emplacing or holding catheters A61M25/10 takes precedence
• CPC Class Codes: A61M 25/0108 using radio-opaque or ultrasound markers
• CPC Class Codes: A61M 25/0662 Guide tubes

Abstract

An apparatus and method for access to the inside of a body includes a transparent sheath with a radiopaque marking and fastener for securing a guidewire or catheter. The transparent sheath permits objects located within and near the sheath to be visualized with an external imaging system. Objects located near the sheath can also be observed with an imaging device disposed inside the sheath. The radiopaque marker permits accurate positioning of the sheath in the body. The sheath can be inserted into the body over an interventional device. A fastener prevents migration of a guidewire or catheter during the procedure.

Claims

1. A sheath for maintaining patency of an opening in a human or animal body, the sheath comprising:

an elongated hollow member having sufficient rigidity to maintain patency of a body opening and comprising a transparent material, transparent to visible light, that permits imaging through the wall of the elongated hollow member, a proximal end face, and a radiopaque marking, the elongated hollow member allowing movement of a medical device from a first position where the medical device passes through the proximal end face to a second position where longitudinal motion of the medical device is restricted, the elongated hollow member comprising a clip to engage the medical device when in the second position to restrict longitudinal motion of the medical device.

2. The sheath of claim 1 wherein the clip is structured to secure a guidewire.

3. The sheath of claim 1 wherein the clip is structured to secure a catheter.

10. The sheath of claim 3 wherein the retaining slot further comprises a transverse portion.

4. A sheath for maintaining patency of an opening in a human or animal body, the sheath comprising:

an elongated hollow member having sufficient rigidity to maintain patency of a body opening and comprising a transparent material, transparent to visible light, that permits imaging through the wall of the elongated hollow member, a proximal end face, and a radiopaque marking, the elongated hollow member allowing movement of a medical device from a first position where the medical device passes through the proximal end face to a second position where longitudinal motion of the medical device is restricted, the elongated hollow member defining a retaining slot to engage the medical device when in the second position to restrict longitudinal motion of the medical device.

5. The sheath of claim 4 wherein the elongated hollow member further comprises a distal end face and the radiopaque marking is disposed on the distal end face.

6. The sheath of claim 4 wherein the elongated hollow member defines a longitudinal axis and further comprises a distal end face that, with the longitudinal axis, defines an angle of approximately 90 degrees.

7. The sheath of claim 4 wherein the elongated hollow member defines a longitudinal axis and further comprises a distal end face that, with the longitudinal axis, defines an angle less than 90 degrees.

8. The sheath of claim 4 wherein the elongated hollow member defines a longitudinal axis and comprises

(i) an annular wall defining a lumen to receive the medical device; and

(ii) a distal end face that, with the longitudinal axis, defines an angle less than 90 degrees, the radiopaque marking disposed on the distal end face.

9. The sheath of claim 4 wherein the retaining slot comprises a longitudinal portion.

11. The sheath of claim 4, wherein the elongated hollow member defines a lumen sized to permit passage of an imaging device therethrough.

12. The sheath of claim 11, wherein the imaging device is selected from the group consisting of a forward-viewing endoscope, a side-viewing endoscope, and a viewing catheter.

13. A sheath for maintaining patency of an opening in a human or animal body, the sheath comprising:

an elongated hollow member defining a longitudinal axis and comprised of a transparent material, transparent to visible light, that permits imaging through a wall of the elongated hollow member, the elongated hollow member having sufficient rigidity to maintain patency of a body opening and including a distal end and a proximal end having a proximal end face;

a plurality of radiopaque markings on said elongated hollow member; and

a retaining slot defined by the elongated hollow member at the proximal end, the slot permitting longitudinal movement of a medical device when the medical device passes through the proximal end face and is not engaged in the slot and restricting longitudinal motion of the medical device when the medical device is engaged in the slot.

14. A sheath for maintaining patency of an opening in a human or animal body, the sheath comprising:

an elongated hollow member having sufficient rigidity to maintain patency of a body opening and comprising a transparent material, transparent to visible light, that permits imaging through the wall of the elongated hollow member, a proximal end face, and a radiopaque marking, the elongated hollow member allowing movement of a medical device from a first position where the medical device passes through the proximal end face to a second position where longitudinal motion of the medical device is restricted, the elongated hollow member comprising a band to engage the medical device when in the second position to restrict longitudinal motion of the medical device.