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

• US 5,860,953 A
• Filed: 02/09/1996
• Issued: 01/19/1999
• 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): Buiz, Michael
• Assistant Examiner(s): TRUONG, KEVIN THAO
• Application Number:
  US08/598,804
• Time in Patent Office: 1,075 Days
• Field of Search: 604/95, 604/53, 604/96, 128/6, 128/4, 600/182, 600/146, 600/139
• US Class Current: 604/95.04
• CPC Class Codes: A61B 1/00105 characterised by modular construction
• CPC Class Codes: A61B 1/0052 Constructional details of control elements, e.g. handles
• CPC Class Codes: A61M 2025/015 Details of the distal fixation of the movable mechanical means
• 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 end 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, a module interface connected to the proximal end portion of said tube, and deflecting means connected to said tube for deflecting the distal end portion of said elongate 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 first cavity formed within said body and a wall transversely extending across portions of said body and defining distal peripheral portions of said first cavity, and control means connected to said body and detachably connected to said deflecting means of said module through said wall of said body for responsively controlling said deflecting means to thereby manipulate distal portions of said elongate tube, said control means and said deflecting means being connected to define a unitary catheter manipulation means extending from said first cavity, through said wall, and to said elongate tube for manipulating a distal portion of the catheter when positioned within a vessel, cavity, or tissue.

2. A catheter as defined in claim 1, wherein said body and said module interface detachably connect to define a second cavity having peripheries which include an outer surface of said wall and an inner surface of said module interface, said control means and said deflecting means being detachably connected within said second cavity so that said unitary catheter manipulation means extends from said first cavity, through said wall, through said second cavity, and to said elongate tube for manipulating said distal portion of the catheter when positioned within a vessel, cavity, or tissue.

3. A catheter as defined in claim 1, wherein at least proximal portions of said module interface coextensively overlie distal portions of said body of said handle such that said body and said module interface define a unitary catheter body having sufficient stability for easily manipulating of said unitary catheter body by a user thereof.

4. A catheter as defined in claim 1, wherein said module interface further comprises proximal, non-uniform peripheries, and wherein said body of said handle further comprises distal, non-uniform peripheries positionally aligning with said non-uniform peripheries of said module interface, said non-uniform peripheries of said module interface being detachably connected to said non-uniform peripheries of said distal portion of said body so as to define a non-uniform contiguous boundary between said module and said handle whereby said module is stabilized relative to said handle during manipulation of said tube within a human body.

5. A catheter as defined in claim 1, wherein said handle further comprises an imaging interface positioned in a proximal portion of said body, said imaging interface extending from within said first cavity through said wall, and image capturing means positioned within said first cavity and being connected to said imaging interface for capturing images, and wherein said catheter further comprises a fiber optic scope detachably connected to said imaging interface of said handle and positioned in said at least one lumen of said tube and extending from the proximal end portion of said tube to the distal end portion thereof for receiving images within a human body and for providing light into the vessel, cavity, or tissue of a human body.

6. A catheter as defined in claim 1, wherein said elongate tube of said module further comprises a plurality of lumens and wherein said module interface surface comprises a plurality of access ports formed in an outer surface of said module interface being positionally aligned with said plurality of lumens for accessing said plurality of lumens therefrom to insert fluids and instruments into a cavity, vessel, or tissue of a human body.

7. A catheter as defined in claim 6 wherein said module interface further includes a manifold including a piping connector having a plurality of openings therein, said piping connector connecting at least two of said plurality of said access ports to one of said plurality of lumens of said elongate tube, said access ports and said one of said plurality of lumens being positionally aligned on opposite ends of said openings of said piping connector defining a relatively straight channel whereby medical instruments and fluids can be inserted through said access ports, into said one of said plurality of lumens, and extend through said one of said plurality of lumens along a substantially straight path from a user toward a distal end of said tube.

8. A catheter as defined in claim 1, wherein said body of said handle includes a proximal portion, a medial portion integrally connected to said proximal portion, and a distal portion integrally connected to said medial portion, said module being detachably connected to at least distal portions of said body of said handle, said at least distal portions of said body being positioned at a predetermined angle from said proximal portion, and from said module interface further includes at least one access port positionally aligned with said at least one lumen so as to define a relatively straight channel whereby medical instruments and fluids can be inserted through said access port and into said at least one lumen, and extend through said at least one lumen along a substantially straight path from a user toward a distal end of said tube.

9. A catheter as defined in claim 1, wherein said body includes a recess portion formed in a medical portion thereof, and wherein said control means comprises a control wheel rotatably mounted to said recess portion of said body for controlling said deflecting means to thereby manipulate said distal portions of said elongate tube within a human body and control connector means responsively connected to said control wheel and responsively and detachably connected to said deflecting means for connecting said control wheel to said deflecting means to thereby manipulate said distal end portions of said elongate tube when positioned within a human body.

10. A catheter as defined in claim 9, wherein said control connector means comprises at least one deflection linkage wire fixedly connected to said control wheel and extending from said control wheel toward a distal portion of said body within said first cavity, a deflection control pin fixedly connected to said at least one deflection linkage wire in a proximal portion of said deflection control pin, said deflection control pin extending from said first cavity through said wall, said deflection control pin being detachably connected to said deflecting means of said module so that said control wheel thereby responsively actuates said deflection linkage wire and said deflection control pin to control said deflecting means for manipulating said distal end portion of said elongate tube when positioned within a human body.

11. A catheter as defined in claim 1, wherein said deflecting means comprises a pair of steering wires having distal portions positioned in said distal portion of said elongate tube and proximal portions positioned in said module interface, said proximal end portions being operatively and detachably connected to said control means to thereby responsively manipulate said distal end portions of said elongate tube when positioned within a human body.

12. A catheter as defined in claim 1, wherein said module further comprises engaging means for detachably engaging said deflecting means and said control means, said engaging means being hingedly connected to said module interface, said engaging means being movable between a first disengaged position having said engaging means spaced apart from said deflecting means and a second engaged position having said engaging means contactingly engage said deflection means such that said deflection means is detachably connected to said control means for manipulating the distal portion of said tube within a human body.

13. 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 end 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, a module interface connected to the proximal end portion of said tube, and a deflector connected to said tube for deflecting the distal end portion of said elongate 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 first cavity formed within said body and a wall transversely extending across portions of said body and defining distal peripheral portions of said first cavity, and a controller connected to said body and detachably connected to said deflector of said module through said wall of said body for responsively controlling said deflector 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 elongate tube for manipulating a distal portion of the catheter when positioned within a vessel, cavity, or tissue.

14. A catheter as defined in claim 13, wherein said body and said module interface detachably connect to define a second cavity having peripheries which include an outer surface of said wall and an inner surface of said module interface, said controller and said deflector being detachably connected within said second cavity so that said unitary catheter manipulator extends from said first cavity, through said wall, through said second cavity, and to said elongate tube for manipulating said distal portion of the catheter when positioned within a vessel, cavity, or tissue.

15. A catheter as defined in claim 14, wherein at least proximal portions of said module interface coextensively overlie distal portions of said body of said handle such that said body and said module interface define a unitary catheter body having sufficient stability for easily manipulating of said unitary catheter body by a user thereof.

16. A catheter as defined in claim 15, wherein said module interface further comprises proximal, non-uniform peripheries, and wherein said body of said handle further comprises distal, non-uniform peripheries positionally aligning with said non-uniform peripheries of said module interface, said non-uniform peripheries of said module interface being detachably connected to said non-uniform peripheries of said distal portion of said body so as to define a non-uniform contiguous boundary between said module and said handle whereby said module is stabilized relative to said handle during manipulation of said tube within a human body.

17. A catheter as defined in claim 16, wherein said handle further,,comprises an imaging interface positioned in a proximal portion of said body, said imaging interface extending from within said first cavity through said wall, and an image capture device positioned within said first cavity and being connected to said imaging interface for capturing images, and wherein said catheter further comprises a fiber optic scope detachably connected to said imaging interface of said handle and positioned in said at least one lumen of said tube and extending from the proximal end portion of said tube to the distal end portion thereof for receiving images within a human body and for providing light into the vessel, cavity, or tissue of a human body.

18. A catheter as defined in claim 17, wherein said elongate tube of said module further comprises a plurality of lumens and wherein said module interface surface comprises a plurality of access ports formed in an outer surface of said module interface being positionally aligned with said plurality of lumens for accessing said plurality of lumens therefrom to insert fluids and instruments into a cavity, vessel, or tissue of a human body.

19. A catheter as defined in claim 18, wherein said body of said handle includes a proximal portion, a medial portion integral connected to said proximal portion, and a distal portion integrally connected to said medial portion, said module being detachably connected to at least distal portions of said body of said handle, said at least distal portions of said body being positioned at a predetermined angle from said proximal portion, and from said module interface further includes at least one access port positionally aligned with said at least one lumen so as to define a relatively straight channel whereby medical instruments and fluids can be inserted through said access port and into said at least one lumen, and extend through said at least one lumen along a substantially straight path from a user toward a distal end of said tube.

20. A catheter as defined in claim 19, wherein said module interface further includes a manifold including a piping connector having a plurality of openings therein, said piping connector connecting at least two of said plurality of said access ports to one of said plurality of lumens of said elongate tube, said access ports and said one of said plurality of lumens being positionally aligned on opposite ends of said openings of said piping connector defining a relatively straight channel whereby medical instruments and fluids can be inserted through said access ports, into said one of said plurality of lumens, and extend through said one of said plurality of lumens along a substantially straight path from a user toward a distal end of said tube.

21. A catheter as defined in claim 20, wherein said body includes a recess portion formed in a medical portion thereof, and wherein said controller comprises a control wheel rotatably mounted to said recess portion of said body for controlling said deflector to thereby manipulate said distal portions of said elongate tube within a human body and a controller connector responsively connected to said control wheel and responsively and detachably connected to said deflector for connecting said control wheel to said deflector to thereby manipulate said distal end portions of said elongate tube when positioned within a human body.

22. A catheter as defined in claim 21, wherein said controller connector comprises at least one deflection linkage wire fixedly connected to said control wheel and extending from said control wheel toward a distal portion of said body within said first cavity, a deflection control pin fixedly connected to said at least one deflection linkage wire in a proximal portion of said deflection control pin, said deflection control pin extending from said first cavity through said wall, said deflection control pin being detachably connected to said deflector of said module so that said control wheel thereby responsively actuates said deflection linkage wire and said deflection control pin to control said deflector for manipulating said distal end portion of said elongate tube when positioned within a human body.

23. A catheter as defined in claim 22, wherein said deflector comprises a pair of steering wires having distal portions positioned in said distal portion of said elongate tube and proximal portions positioned in said module interface, said proximal end portions being operatively and detachably connected to said controller to thereby responsively manipulate said distal end portions of said elongate tube when positioned within a human body.

24. A catheter as defined in claim 23, wherein said module further comprises engaging means for detachably engaging said deflector and said controller, said engaging means being hingedly connected to said module interface, said engaging means being operatively movable between a first disengaged position having said engaging means spaced apart from said deflecting means and a second engaged position having said engaging means contactingly engage said deflection means such that said deflector is detachably connected to said controller for manipulating the distal portion of said tube within a human body.