Steerable and aimable catheter - Patent Review 4758222

BACKGROUND AND SUMMARY OF THE INVENTION This application is a continuation-in-part of copending application Ser. No. 06/728,634 filed May 3, 1985, now U.S. Pat. No. 4,601,705 which is a continuation-in-part of application Ser. No. 06/547,402 filed Oct. 31, 1983, now U.S. Pat. No. 4,543,090 issued Sept. 24, 1985. The present application relates to catheters, cannulae, and the like and particularly to catheters that are steerable through body cavities and aimable at obstructions, organs, or tissue within the body from a position external to the body. Some attempts have been made in the past to provide catheters having distal ends which, when inserted into a body, are manipulatable to advance the catheter through body cavities. See for example, U.S. Pat. Nos. 3,674,014 and 3,773,034. The catheter disclosed in U.S. Pat. No. 3,674,014 includes permanent magnets and employs a magnetic field to bend the distal end of the catheter. The catheter disclosed in U.S. Pat. No. 3,773,034 includes fluid conduits and employs a fluid to bend the distal end of the catheter. Other controlled devices are disclosed in U.S. Pat. Nos. 3,605,725 and 4,176,662. However, these prior devices are quite difficult to control and manipulate. Some work has previously been done to produce a catheter which is readily insertable while being effectively anchorable in a body cavity. See, for example, U.S. Pat. Nos. 3,729,008 and 3,890,977. In U.S. Pat. No. 3,890,977 to Wilson, the distal end of the catheter is formed into a desired shape by using a material exhibiting mechanical memory that is triggered by heat. By heating the mechanical memory material, the distal end of the catheter is shaped to anchor the catheter within the body. However, the change of the shape or other movement of the distal end in these prior devices is limited to a single direction. Once the memory material has been heated causing the distal end to move in said single direction to assume its characteristic anchoring shape, it becomes necessary to deform the distal end manually at a temperature below the transition temperature of the mechanical memory material in order to change the shape of the distal end. The need for manual manipulation of a catheter once it is inserted into a body limits the steerability and aimability of the catheter. Other devices are known for guiding a catheter to a particular location within the body. See for example U.S. Pat. No. 3,043,309. One object of the present invention is to provide a steerable catheter, cannula, and the like which is easy to operate and steerable in a plurality of different directions within the body. Another object of the present invention is to provide an aimable catheter, cannula, and the like which is easy to operate and which can be aimed at obstructions, organs, or tissues in a plurality of different directions within the body. Yet another object of the present invention is to provide a catheter of improved maneuverability having means for slidably coupling each of a plurality of temperature-activated memory elements to a core member so that each memory element is permitted to slip in relation to the adjacent core member when at least one of the memory elements is heated to assume a predetermined "memorized" shape. Another object of the present invention is to provide a steerable and aimable catheter of very simple design having only one temperature-activated memory element that is movable to a predetermined shape using remote controls to steer and aim the catheter and yet is automatically returnable to an initial shape without manual manipulation by an operator. Still another object of the present invention is to provide a highly maneuverable catheter having at least one resilient element for biasing the distal end of the catheter to assume an initial shape and a separate temperature-activated memory element that is movable under heat to bend the distal end of the catheter to a multiplicity of shapes other than the initial shape. According to the present invention, a catheter includes an elongated tubular member having a distal end for ready insertion into a body and a temperature-activated memory element in the distal end of the tubular member. Control means is also provided for selectively heating the temperature-activated memory element. When heated to a predetermined temperature, the memory element moves in a first direction to assume a first predetermined shape, thereby deflecting the distal end of the tubular member in the first direction. The catheter further includes return means within the distal end of the hollow tubular member for applying a force to move the memory element in a second direction away from the first direction when the temperature of the memory element is less than the predetermined temperature. Thus, the memory element is moved to assume a shape other than the first Predetermined shape and deflect the distal end of the tubular member in the second direction. In the catheter's relaxed state, the memory element is not heated causing the distal end of the catheter to be deflected in the second direction by the return means. Thus, the catheter normally has a curved shape bending in the second direction. During steering and aiming operations, the control means is operable to heat the memory element so that it moves in the first direction to assume its first predetermined shape. The memory element exerts sufficient steering force to overcome the force applied by the return means for the purpose of deflecting the distal end of the tubular member in the first direction. Desirably, the catheter has another curved shape bending in the first direction when the memory element is heated to assume its predetermined shape. Thus, the control means is operable to straighten or bend the distal end of the catheter solely by varying the temperature of the single temperature-activated memory element. In preferred embodiments of the present invention, the catheter includes only one temperature-activated memory element and the return means includes spring means for yieldably biasing the single temperature-activated memory element in the second direction. Such biasing causes the memory element to have a shape other than the first predetermined shape as long as the temperature of the memory element is less than the predetermined temperature. Desirably, the spring means is a resilient material preformed to define a second predetermined shape. The return means further includes a core member within the distal end of the hollow tubular member. Each of the spring means and memory element is attached to the core member so that the spring means moves to assume a shape other than the second predetermined shape in response to movement of the memory element in the first direction. The core member is made of a memory material and moves in the second direction to assume a second predetermined shape defined by the core member in response to cooling the memory element to a temperature that is lower than the predetermined temperature. Thus, the memory feature of the core member aids the spring means in yieldably biasing the memory element in the second direction. A sleeve is provided for coupling both the temperature-activated memory element and spring means to a distal end of the core member so that each "bending means" (e.g. memory element or spring means) is permitted to slip in relation to the adjacent core member when at least one of the bending means moves to assume its predetermined shape. The assistive sleeve permits each bending means to slide in relation to the adjacent core member during operation of the control means. Thus, the memory element and spring means are able to slip in relation to the distal end of the core member so that maneuverability of the tubular member within the body toward a selected deflected position is increased. Additional objects, features, and advantages of the invention will become apparent to those skilled in the art upon consideration of the following detailed description of preferred embodiments exemplifying the best mode of carrying out the invention as presently perceived.

Claims

What is claimed is:

1. An apparatus comprising

an elongated tubular member having a proximal end and a distal end for insertion into the body,

a temperature-activated memory element in the distal end of the tubular member, the memory element moving in a first direction to assume a first predetermined shape and deflect the distal end of the tubular member in the first direction when heated to a predetermined temperature,

resilient means within the distal end of the tubular member providing a predetermined bias for applying a force to move the distal end of the tubular member in a second direction away from the first direction to assume a predetermined curved shape when the temperature of the memory element is less than the predetermined temperature so that the memory element is moved to assume a shape other than the first predetermined shape in response to movement of the distal end of the tubular member to assume the predetermined curved shape, the resilient means being coupled to the temperature-activated memory element so that when the memory element moves in the first direction to assume its first predetermined shape a force is applied to move the resilient means in the first direction and when the resilient means moves in the second direction upon cooling of the memory element to a temperature less than the predetermined temperature a force is applied to move the memory element in the second direction, and

control means for selectively heating the memory element so that the memory element is moved in the first direction to overcome the force applied by the resilient means and deflect the distal end of the tubular member in the first direction so that the distal end of the tubular member is moved to assume a selected shape other than its predetermined curved shape.

2. The apparatus of claim 1, wherein the control means includes a power supply source, means for coupling the power supply source to the memory element, and a control device for steering the distal end of the tubular member through cavities of the body, the control device including means for selectively varying the power applied to heat the memory element and means for selectively disabling the coupling means to decouple the power supply source and the memory element so that the resilient means acts to move the distal end of the tubular member in the second direction away from the first direction to assume the predetermined curved shape causing the memory element to move to assume a shape other than the first predetermined shape.

3. The apparatus of claim 1, wherein the resilient means includes spring means for yieldably biasing the memory element in the second direction and the spring means has a predetermined spring constant causing the spring means to apply a primary return force of a magnitude sufficient to move the memory element to assume a shape other than the first predetermined shape while the temperature of the memory element is less than the predetermined temperature.

4. The apparatus of claim 3, wherein the memory element and the spring means are located in diameterically opposed relationship to each other in the distal end of the tubular member.

5. The apparatus of claim 3, wherein the spring means is made of a resilient material preformed to define a second predetermined shape and the spring means moves to assume a shape other than the second predetermined shape in response to movement of the memory element in the first direction.

6. The apparatus of claim 5, wherein the resilient means further includes interconnecting means for connecting the memory element to the spring means, the interconnecting means transmits a steering force from the memory element to the spring means to overcome the opposing return force generated by the spring means, thereby moving the spring means in the first direction in response to movement of the memory element in the first direction to assume the first predetermined shape during exposure to heating temperature, and the interconnecting means transimits the return force generated by the spring means to the memory element to move the memory element in the second direction in response to movement of the spring means in the second direction to assume the second predetermined shape during exposure to cooliing temperature.

7. The apparatus of claim 6, wherein the interconnecting means is a core member made of a resilient material and preformed to assume a curved shape.

8. An apparatus comprising

an elongated tubular member having a proximal end and a distal end for insertion into the body,

a temperature-activated memory element in the distal end of the tubular member, the memory element moving in a first direction to assume a first predetermined shape and deflect the distal end of the tubular member in the first direction when heated to a predetermined temperature,

resilient means within the distal end of the tubular member having a predetermined bias for applying a force to move the memory element in a second direction away from the first direction when the temperature of the memory element is less than the predetermined temperature so that the memory element is moved to assume a shape other than the first predetermined shape and deflect the distal end of the tubular member in the second direction, and

control means for selectively heating the memory element so that the memory element is moved in the first direction to overcore the force applied by the resilient means and deflect the distal end of the tubular member in the first direction, the resilient means further including a core member within the distal end of the tubular member, and each of the spring means and memory element is attached to the core member.

9. The apparatus of claim 8, wherein the core member and the tubular member are interconnected so that guided movement of the core member in response to operation of at least one of the memory element and the spring means moves the tubular member to a selected deflected position.

10. The apparatus of claim 8, wherein the core member is made of a resilient material preformed to define a second predetermined shape and the core member moves to assume a shape other than the second predetermined shape in response to movement of the memory element in the first direction.

11. The apparatus of claim 8, wherein the core member is made of a memory material having a predetermined spring constant and the core member applies an auxiliary return force of a magnitude sufficient to aid the spring means in yieldably biasing the temperature-activated memory element in the second direction while the temperature of the memory element is less than the predetermined temperature.

12. An apparatus comprising

an elongated tubular member having a proximal end and a distal end for insertion into the body,

a temperature-activated memory element in the distal end of the tubular member, the memory element moving in a first direction to assume a first predetermined shape and deflect the distal end of the tubular member in the first direction when heated to a predetermined temperature,

resilient means within the distal end of the tubular member having a predetermined bias for applying a force to move the memory element in a second direction away from the first direction when the temperature of the memory element is less than the predetermined temperature so that the memory element is moved to assume a shape other than the first predetermined shape and deflect the distal end of the tubular member in the second direction, and

control means for selectively heating the memory element so that the memory element is moved in the first direction to overcome the force applied by the resilient means and deflect the distal end of the tubular member in the first direction, the resilient means including spring means for yieldably biasing the memory element in the second direction and the spring means having a predetermined spring constant causing the spring means to apply a primary return force of a magnitude sufficient to move the memory element to assume a shape other than the first predetermined shape while the temperature of the memory element is less than the predetermined temperature, the resilient means further including a core member within the distal end of the hollow tubular member and sleeve means for slidably coupling the memory element and the spring means to the core member so that each of the memory element and spring means is permitted to slip in relation to the adjacent core member during movement of the memory element to assume the first predetermined shape.

13. The apparatus of claim 12, wherein the sleeve means is a resilient tubular jacket for embracing the core member and the memory element, the tubular jacket having an inner wall defining a slip chamber in which each of the memory element and spring means is able to slip in relation to the core member during selective heating and cooling of the memory element.

14. An apparatus comprising

an elongated tubular member having a proximal end and a distal end for insertion into the body,

a temperature-activated memory element in the distal end of the tubular member, the memory element having an initial curved shape and moving to assume a predetermined shape when heated to a predetermined temperature,

control means for selectively heating the memory element to the predetermined temperature so that the memory element is moved in a first direction to deflect the distal end of the tubular member, and

spring means for yieldably urging the memory element in an opposite second direction to establish said initial curved shape and to aid in returning the memory element to its initial curved shape when the temperature of the memory element is less than the predetermined temperature, the spring means being coupled to the memory element so that when the memory element moves in the first direction to assume its predetermined shape a force is applied to move the spring means in the first direction and when the spring means moves in the second direction upon cooling of the memory element to a temperature less than the predetermined temperature a force is applied to move the memory element in the second direction.

15. The apparatus of claim 14, wherein the spring means includes a resilient member preformed to define a second predetermined shape and the resilient member moves to assure a shape other than the second predetermined shape in response to movement of the memory element in the first direction.

16. The apparatus of claim 15, wherein the spring means further includes interconnecting means for connecting the memory element to the resilient member, the interconnecting means transmits a steering force from the memory element to the resilient member to move the resilient member in the first direction and overcome an opposing return force generated by the resilient member in response to movement of the memory element in the first direction to assume the first predetermined shape during exposure to heating temperature, and the interconnecting means transmits a return force generated by the resilient member to the memory element to move the memory element in the second direction in response to movement of the resilient member in the second direction to assume the second predetermined shape during exposure to cooling temperature.

17. An apparatus comprising

an elongated tubular member having a proximal end and a distal end for insertion into the body,

a temperature-activated memory element in the distal end of the tubular member, the memory element having an initial shape and moving to assume a predetermined shape when heated to a predetermined temperature,

a control means for selectively heating the memory element to the predetermined temperature so that the memory element is moved in a first direction to deflect the distal end of the tubular member, and

spring means for yieldably urging the memory element in an opposing second direction to establish said initial shape and to aid in returning the memory element to its initial shape when the temperature of the memory element is less than the predetermined temperature, the spring means being coupled to the memory elemet so that when the memory element moves in the first direction to asume its predetermined shape a force is applied to move the spring means in the first direction and when the spring means moves in the second direction upon cooling of the memory element to a temperature less than the predetermined temperature a force is applied to move the memory element in the second direction, the spring means including a core member within the distal end of the tubular member, the core member being made of a resilient material preformed to define a second predetermined shape, and the core member moving to assume a shape other than the second predetermined shape in response to movement of the memory element in the first direction.

18. An apparatus comprising

an elongated tubular member having a proximal end and a distal end for insertion into the body,

a temperature-activated memory element in the distal end of the tubular member, the memory element having an initial shape and moving to assume a predetermined shape when heated to a predetermined temperature,

control means for selectively heating the memory element to the predetermined temperature so that the memory element is moved in a first direction to deflect the distal end of the tubular member, and

spring means for yieldably urging the memory element in an opposing second direction to establish said initial shape and to aid in returning the memory element to its initial shape when the temperature of the memory element is less than the predetermined temperature, the spring means being coupled to the memory element so that when the memory element moves in the first direction to assume its predetermined shape a force is applied to move the spring means in the first direction and when the spring means moves in the second direction upon cooling of the memory element to a temperature less than the predetermined temperature a force is applied to mvoe the memory element in the second direction, the proximal end of the elongated tubular member including a central axis, the initial shape established substantially by the spring means being a curved shape bending away from the central axis in the second direction to deflect the distal end of the tubular member in the second direction, and the predetermined shape being another curved shape bending away from the central axis in the first direction to deflect the distal end of the tubular member in the first direction.

19. The apparatus of claim 18, wherein the memory element has a first radius of curvature and the spring means is a resilient member having a second radius of curvature that is less than the first radius of curvature when the memory element moves to assume its initial shape and greater than the first radius of curvature when the memory element moves to assume its predetermined shape.

20. An apparatus comprising

an elongated tubular member having a proximal end and a distal end for insertion into the body,

a core member within the distal end of the hollow tubular member,

first and second memory elements in the distal end of the hollow tubular member, the first memory element being made of a temperature-activated memory material and moving to assume a first predetermined shape and deflect the distal end of the tubular member in one direction when heated to a predetermined temperature, the second memory element being made of a resilient memory material and moving to assume a second predetermined shape and deflect the distal end of the tubular member in another direction when the temperature of the first memory element is less than the predetermined temperature,

sleeve means for slidably coupling each memory element to the core member so that each memory element is permitted to slip in relation to the adjacent core member when at least one of the memory elements moves to assume its predetermined shape, and

control means for selectively heating the first memory element to move the first memory element to assume the first. predetermined shape, thereby exerting a force on the core member sufficient to overcome force exerted on the core member by the second memory element and causing the second memory element to move to assume a shape other than the second predetermined shape, the core member being made of a resilient material preformed to define a third predetermined shape and the core member moving to assume a shape other than the third predetermined shape in response to movement of the first memory element to assume the first predetermined shape.

21. The apparatus of claim 20, wherein the first, second, and third predetermined shapes are curved shapes.

22. The apparatus of claim 21, wherein the radius of curvature of the third predetermined shape is greater than the radius of curvature of the second predetermined shape.

23. An apparatus comprising

an elongated tubular member having a proximal end and a distal end for insertion into the body,

a core member within the distal end of the hollow tubular member,

first and second memory element in the distal end of the hollow tubular member, the first memory element being made of a temperature-activated memory material and moving to assume a first predetermined shape and deflect the distal end of the tubular member in one direction when heated to a predetermined temperature, the second memory element being made of a resilient memory material and moving to assume a second predetermined shape and deflect the distal end of the tubular member in another direction when the temperature of the first memory element is less than the predetermined temperature,

sleeve means for slidably coupling each memory element to the core member so that each memory element is permitted to slip in relation to the adjacent core member when at least one of the memory elements moves to assume its predetermined shape, and

control means for selectively heating the first memory element to move the first memory element to assume the first predetermined shape, thereby exerting a force on the core member sufficient to overcome force exerted on the core member by the second memory element and causing the second memory element to move to assume a shape other than the second predetermined shape, the distal end of the tubular member being formed of flexible non-conductive material and the first memory element being formed of a metal having a relatively high electrical resistance.

24. The apparatus of claim 23, wherein the tubular member includes means for providing a passageway therethrough and the first and second memory elements are disposed exterior to the passageway in the distal end of the tubular member.

25. The apparatus of claim 24, wherein the tubular member further includes light-transmitting means in the passageway for transmitting light from the proximal end to the distal end of the tubular member.

26. The apparatus of claim 25, wherein the control means includes a power supply source, means for coupling the power supply source to the first memory element, and a control device for selectively applying power to heat the first memory element to aim the distal end and light-transmitting means to the tubular member at a desired object in the body.

27. The apparatus of claim 26, wherein the first memory element is formed of a nickel titanium alloy.

28. The apparatus of claim 27, wherein the tubular member further includes fluid-transmitting means in the passageway for transmitting fluid from the proximal end to the distal end of the tubular member and vice versa.

29. An apparatus comprising

an elongated tubular member having a proximal end and a distal end for insertion into the body,

a core member within the distal end of the hollow tubular member,

first and second memory elements in the distal end of the hollow tubular member, the first memory element being made of a temperature-activated memory material and moving to assume a first predetermined shape and deflect the distal end of the tubular member in one direction when heated to a predetermined temperature, the second memory element being made of a resilient memory material and moving to assume a second predetermined shape and deflect the distal end of the tubular member in another direction when the temperature of the first memory element is less than the predetermined temperature,

sleeve means for slidably coupling each memory element to the core member so that each memory element is permitted to slip in relation to the adjacent core member when at least one of the memory elements moves to assume its predetermined shape, and

control means for selectively heating the first memory element to move the first memory element to assume the first predetermined shape, thereby exerting a force on the core member sufficient to overcome force exerted on the core member by the second memory element and causing the second memory element to move to assume a shape other than the second predetermined shape, the control means including a power supply source, means for coupling the power supply source to the first memory element, and a control device for selectively applying power to heat the first memory element to steer the distal end of the tubular member through cavities in the body.

30. An apparatus comprising

an elongated tubular member having a proximal end and a distal end for insertion into the body,

a core member within the distal end of the hollow tubular member,

first and second memory elements in the distal end of the hollow tubular member, the first memory element being made of a temperature-activated memory material and moving to assume a first predetermined shape and deflect the distal end of the tubular member in one direction when heated to a predetermined temperature, the second memory element being made of a resilient memory material and moving to assume a second predetermined shape and deflect the distal end of the tubular member in another direction when the temperature of the first memory element is less than the predetermined temperature,

sleeve means for slidably coupling each memory element to the core member so that each memory element is permitted to slip in relation to the adjacent core member when at least one of the memory elements moves to assume its predetermined shape, and

control means for selectively heating the first memory element to move the first memory element to assume the first predetermined shape, thereby exerting a force on the core member sufficient to overcome force exerted on the core member by the second memory element and causing the second memory element to move to assume a shape other than the second predetermined shape, the two memory elements being located in diametrically opposed relationship to each other in the distal end of the tubular member.