Steerable catheter having disposable module and sterilizable handle and method of connecting same

• US 6,007,531 A
• Filed: 01/05/1999
• Issued: 12/28/1999
• Est. Priority Date: 11/21/1995
• Status: Expired due to Fees

• Current Assignee: Catheter Imaging Systems Incorporated
• Original Assignee: Catheter Imaging Systems Incorporated
• Inventors: Mark, Michael J., Snoke, Phillip Jack, Rowley, David Scott
• Primary Examiner(s): Coggins, Wynn Wood
• Assistant Examiner(s): MAYNARD, JENNIFER J
• Application Number:
  US09/225,411
• Time in Patent Office: 357 Days
• Field of Search: 604/20, 604/21, 604/95, 600/160, 600/146, 600/139, 600/182, 606/14-16, 385/53, 385/554, 385/88, 385/92
• US Class Current: 606/15
• CPC Class Codes: A61B 1/0052 Constructional details of control elements, e.g. handles
• CPC Class Codes: A61M 25/0136 Handles therefor
• CPC Class Codes: A61M 25/0147 with movable mechanical means, e.g. pull wires

Abstract

A catheter and methods are provided for inserting at least portions thereof into a vessel, cavity, or tissue of a human body to thereby provide manipulation of a distal portion of the catheter when positioned within a vessel, cavity, or tissue. The catheter preferably has a module which includes an elongate tube having at least one lumen extending from a distal end to a proximal end of the tube, a module interface connected to the proximal end of the tube, and a deflector connected to the tube for deflecting the distal portion of the elongate tube. A handle detachably connects to the module and is configured to be readily held in the hand of a user. The handle has a body which includes a wall positioned in and extending transversely across distal portions of the body. The wall has an outer surface thereof defining an exterior portion of the body and a first cavity formed within the body. Preferably, the body detachably and coextensively connects to the module interface through the outer surface of the wall. A controller is connected to the body and detachably connects to the deflector of the module for responsively controlling the deflector to thereby manipulate distal portions of the elongate tube. The controller and the deflector connect to define a unitary catheter manipulator extending from the first cavity, through the wall, and to the tube for manipulating a distal portion of the catheter when positioned within a vessel, cavity, or tissue.

Claims

1. A catheter for inserting at least portions thereof into a vessel, cavity, or tissue of a human body to thereby provide manipulation of a distal portion of the catheter when positioned within a vessel, cavity, or tissue, the catheter comprising:

a module including an elongate tube having at least one lumen extending from a distal end portion to a proximal end portion of said tube and a module interface connected to the proximal end of said tube;

a handle detachably connected to said module and configured to be readily held in the hand of a user, said handle comprising a body including a wall positioned in and transversely extending across distal portions of said body, said wall having an outer surface thereof defining an exterior portion of said body, and a first cavity formed within said body, said body being detachably and coextensively connected to said module interface through the outer surface of said wall, and an imaging interface located in the proximal portion of said body, said imaging interface extending from within said first cavity through said wall; and

a fiber optic scope detachably connected to said imaging interface of said handle for receiving images within a human body and providing light into the vessel, cavity, or tissue of a human body, said fiber optic scope positioned within said at least one lumen of said tube and extending from the proximal end portion of said tube to the distal end portion thereof.

2. A catheter as defined in claim 1, wherein said handle further comprises an image capturing device positioned within said first cavity and connected to said imaging interface for capturing images from said fiber scope received from within a vessel, cavity, or tissue of the human body.

3. A catheter as defined in claim 1, wherein said module further comprises a deflector connected to said tube for deflecting the distal end portion of said elongate tube, and wherein said handle further comprises a controller connected to said body and detachably connected to said deflector of said module for responsively controlling said deflector means to thereby manipulate distal portions of said elongate tube, said controller and said deflector being connected to define a unitary catheter manipulator extending from said first cavity, through said wall, and to said tube for manipulating a distal portion of the catheter when positioned within a vessel, cavity, or tissue.

4. A catheter as defined in claim 1, wherein said outer surface of said wall and a lower surface of said module interface detachably connect to define a second cavity, said fiber optic scope being connected to said imaging interface of said handle within the second cavity.

5. A catheter as defined in claim 2, wherein said handle further comprises an opening positioned in a proximal end portion of said handle and providing access to said first cavity, and an internal interface cable having at least portions thereof positioned in said first cavity, connected to said image capture device, and extending from said first cavity and at least toward said proximal opening of said handle for connecting to an image viewing device so as to readily view images within a human body captured by said image capturing device and for providing a light path into the vessel, cavity, or tissue of a human body.

6. A catheter for inserting at least portions thereof into a vessel, cavity, or tissue of a human body to thereby provide manipulation of a distal portion of the catheter when positioned within a vessel, cavity, or tissue, the catheter comprising:

a module including an elongate tube having at least one lumen extending from a distal end to a proximal end of said tube and a module interface connected to the proximal end portion of said tube; and

a handle detachably connected to said module and configured to be readily held in the hand of a user, said handle comprising a body including a wall positioned in and extending transversely across distal portions of said body, said wall having an outer surface thereof defining an exterior portion of said body, and a first cavity formed within said body, said body being detachably and coextensively connected to said module interface through the outer surface of said wall, an imaging interface connected to said body within said first cavity and extending through said wall, and an image capturing device connected to said imaging interface and positioned within said first cavity for capturing images from within a vessel, cavity, or tissue of the human body.

7. A catheter as defined in claim 6, wherein said imaging means includes sealing means for sealing said imaging means from water and heat for sterilizing said handle with said imaging means positioned within said body of said handle.

8. A catheter according to claim 6, wherein said handle body includes a recess in an upper surface, and said handle further comprises imaging focus means rotatably connected to said body in said recess, said imaging focus means connected to said imaging means within said first cavity for focusing images transmitted from within a vessel, cavity, or tissue of the human body.

9. A catheter according to claim 7, wherein said imaging focus means comprises a focus wheel having a top surface and a bottom surface and a shaft fixedly connected to said focus wheel and extending downwardly into said first cavity of said body, said shaft being rotatably connected to said body in said recess such that said focus wheel is rotatable for focusing images transmitted from within a vessel, cavity, or tissue of a human body.

10. A catheter according to claim 9, wherein said focus wheel further comprises an indentation in said upper surface configured to receive a human finger whereby said focus wheel can be rotated for focusing images transmitted from within a vessel, cavity, or tissue of a human body.

11. A catheter according to claim 6, wherein said module further comprises deflecting means connected to said tube for deflecting the distal portion of said elongate tube and wherein said handle further comprises control means connected to said body and detachably connected to said deflecting means of said module for responsively controlling said deflecting means to thereby manipulate distal portions of said elongate tube, said control means comprises a control wheel including a recessed center portion in the upper surface, said imaging focus wheel is connected to said body in said recess of said control wheel such that said focus wheel and said control wheel define generally concentric circles and are aligned defining a common center portion with said imaging focus wheel having a diameter smaller than said control wheel such that said focus wheel and said control wheel rotate independently and are in proximity for facilitating focusing images and manipulating the distal portion of the tube with the human body by a single medical practitioner.

12. A catheter for inserting at least portions thereof into a vessel, cavity, or tissue of a human body to thereby provide manipulation of a distal portion of the catheter when positioned within a vessel, cavity, or tissue, the catheter comprising:

a module including, an elongate tube having at least one lumen extending from a distal end to a proximal end of said tube, a module interface connected to the proximal end of said tube; and

a handle detachably connected to said module and configured to be readily held in the hand of a user, said handle comprising a body including a proximal portion, a medial portion connected to and integrally formed with said proximal portion, and a distal portion connected to and integrally formed with said medial portion, said distal portion of said body being angularly disposed from said proximal portion of said body so as to define an angle between said distal portion and said proximal portion of said body for facilitating inserting the catheter into a vessel, cavity, or tissue within a human body.

13. A catheter defined in claim 12, wherein said module further comprises deflecting means connected to said tube for deflecting the distal portion of said elongate tube, and said handle further comprises control means connected to said body and detachably connected to said deflecting means of said module for responsively controlling said deflecting means to thereby manipulate distal portions of said elongate tube for manipulating a distal portion of the catheter when positioned within a vessel, cavity, or tissue, and focus means mounted on said body for focusing images received from within the human body such that said focus means and said control means can be actuated using one hand while holding the catheter in the second hand.

14. A catheter as defined in claim 12, wherein a distal portion of said body comprises a bulbous shape.