Sealing occlusion catheter and method of using same

• US 6,461,346 B1
• Filed: 12/09/1994
• Issued: 10/08/2002
• Est. Priority Date: 08/29/1990
• Status: Expired due to Fees

• Current Assignee: Applied Medical Resources Corporation (Applied Medical Corporation)
• Original Assignee: Applied Medical Resources Corporation (Applied Medical Corporation)
• Inventors: Buelna, Terrence J.
• Primary Examiner(s): Thaler, Michael H.
• Application Number:
  US08/352,432
• Time in Patent Office: 2,860 Days
• Field of Search: 604/104, 604/105, 604/54, 604/55, 604/500, 604/514, 604/515, 604/516, 604/517, 606/198
• US Class Current: 604/500
• CPC Class Codes: A61M 2025/0681 Systems with catheter and outer tubing, e.g. sheath, sleeve or guide tube
• CPC Class Codes: A61M 2025/1052 for temporarily occluding a vessel for isolating a sector
• CPC Class Codes: A61M 2025/1086 having a special balloon surface topography, e.g. pores, protuberances, spikes or grooves
• CPC Class Codes: A61M 2210/1089 Urethra
• CPC Class Codes: A61M 25/10 Balloon catheters A61M25/0125 takes precedence; embolectomy A61B17/22032; retractors A61B17/02; inflatable balloons for placing stents or stent-grafts A61F2/958 ; stomach balloons for treatment of obesity A61F5/0003; oesophagal tubes A61J15/00

Abstract

A medical instrument adapted for disposition a relative to an orifice defined in a body wall or for disposition in a passage in a body is provided. The medical instrument includes an elongate tube portion having a handle disposed at one end thereof, and an expandable section disposed near the other end thereof. The expansion member is expandable to form a seal between the expansion member and a surface of the body wall orifice or the body passage around substantially an entire circumference of the expansion member.

Claims

1. A method for sealing an orifice defined through a body wall and into a body region on the other side of the orifice comprising the steps of:

providing an instrument comprising;

an elongate tube portion having a proximal end, a distal end, and a lumen extending therebetween,

an expansion member having a distal end and a proximal end and a peripheral wall extending therebetween, the peripheral wall being formed of a material impervious to liquid and sufficiently flexible to permit the distal end and the proximal end of the expansion member to be moved relative to each other between an expanded state of the peripheral wall wherein the distal end and the proximal end are spaced from each other by a first distance, and a contracted state of the peripheral wall wherein the distal end and the proximal end are spaced from each other by a second distance greater than the first distance, said expansion member extending axially from said distal end of said elongate tube, the expansion member in the expanded state including a portion having the general configuration of a cone with an apex at the distal end of said expansion member, a base proximal of said apex, and an inclined outer surface extending between the apex and the base and facing generally distally, and

an operating member fixedly coupled to the expansion member adjacent the distal end of said expansion member, so as to be substantially immovable axially relative to said expansion member distal end, and extending proximally therefrom through at least a portion of said lumen, displacement of said operating member and expansion member distal end coupled thereto proximally relative to said elongate tube portion so as to reduce a distance between said distal end of said expansion member and said distal end of said elongate tube portion forcibly displacing said peripheral wall toward the expanded state;

and performing a procedure including;

introducing the distal end of the expansion member into the body orifice; and

displacing said operating member and expansion member distal end fixedly coupled thereto relative to said elongate tube portion so as to reduce a distance between said distal end of said expansion member and said distal end of said elongate tube portion and thereby expand said expansion member with said operating member remaining fixedly coupled thereto and

engaging said inclined outer surface with said body wall to form a radial seal between the inclined outer surface and the body wall to inhibit fluid from flowing proximally through the orifice;

said operating member being fixedly coupled to said expandable structure throughout said procedure.

2. The method recited in claim 1 wherein said step of providing an instrument comprises providing an expansion member having a distal orifice and the method further comprises the steps of orienting the distal end of the expansion member within the region so that the seal is formed in proximity to the orifice and injecting an injectate through said distal orifice, distally of the seal.

3. The method recited in claim 1 wherein:

the displacing step includes the step of expanding the peripheral wall of the expansion member, and moving the tube axially to bring the expanded peripheral wall into sealing engagement with the body wall.

4. A method as in claim 1, wherein at least said contracted state is a relaxed state of said expansion member.

5. A method as in claim 1, wherein the distal facing surface of the expansion member is engaged with the body wall at the orifice.

6. A method for introducing an injectate into a body region, comprising the steps of:

inserting an endoscope up to a body wall defining an orifice into the body region, the orifice having a first diameter and the endoscope having a working channel with a second diameter,

providing a medical instrument comprising;

an elongate tube portion having a proximal end, a distal end, and a lumen extending therebetween,

an expansion structure having a distal end and a proximal end and a peripheral wall extending therebetween, the peripheral wall being formed of a material impervious to liquid and sufficiently flexible to permit the distal end and the proximal end of the expansion structure to be moved relative to each other between an expanded state of the peripheral wall wherein the distal end and the proximal end are spaced from each other by a first distance, and a contracted state of the peripheral wall wherein the distal end and the proximal end are spaced from each other by a second distance greater than the first distance, said expansion structure extending axially from said distal end of said elongate tube portion, and

an operating member fixedly coupled to the expansion structure adjacent the distal end of said expansion structure, so as to be substantially immovable axially relative to said expansion structure distal end, and extending proximally therefrom through at least a portion of said lumen, so that displacement of said operating member and expansion structure distal end coupled thereto proximally relative to said elongate tube portion so as to reduce a distance between said distal end of said expansion structure and said distal end of said elongate tube portion displaces said peripheral wall toward the expanded state;

and performing a procedure including;

introducing said medical instrument through the working channel of the endoscope, the instrument being operable between an expanded state characterized by said expansion structure expanded to a third diameter larger than the first diameter of the orifice and larger than the second diameter of the working channel, and a contracted state characterized by said expansion structure contracted to a fourth diameter smaller than the second diameter of the working channel, the outer surface of the expandable structure in its expanded state being non-cylindrical along substantially its entire length and including a portion having a generally conical shape having an apex adjacent the distal end thereof and a base proximal of said apex, and an inclined outer surface extending between the apex and the base and facing generally distally, with the third diameter being defined at a point of maximum expansion along the length of the outer surface;

operating the expandable structure to the non-cylindrical expanded state;

moving the inclined outer surface of the expandable structure in the expanded state into contact with the body wall to form a seal with the body wall;

injecting the injectate through the tube and into the body conduit or cavity while the seal inhibits flow of the injectate through the orifice;

operating the expandable structure to the contracted state; and

withdrawing the tube through the working channel of the endoscope;

said operating member being fixedly coupled to said expandable structure throughout said procedure.

7. A method as in claim 6, wherein at least said contracted state is a relaxed state of said expansion member.

8. A method as in claim 6, wherein the distal facing surface of the expansion member is engaged with the body wall at the orifice.

9. A medical instrument adapted for disposition relative to an orifice defined in a body wall, comprising:

an elongate tube portion having a proximal end, a distal end, and a lumen extending therebetween;

an expansion member having a distal end and a proximal end and a peripheral wall extending therebetween, the peripheral wall being formed of a material impervious to liquid and sufficiently flexible to permit the distal end and the proximal end of the expansion member to be moved relative to each other between an expanded state of the peripheral wall wherein the distal end and the proximal end are spaced from each other by a first distance, and a contracted state of the peripheral wall wherein the distal end and the proximal end are spaced from each other by a second distance greater than the first distance and vice versa, said expansion member extending axially from said distal end of said elongate tube, the peripheral wall comprising a circumferential living hinge having a wall thickness less than adjacent portions of the peripheral wall, said living hinge thereby facilitating expansion of said peripheral wall;

the expansion member in the expanded state including a portion having the general configuration of a cone with an apex at the proximal end of said expansion member, a base proximal of said apex, and an inclined outer surface extending between the apex and the base and facing generally outwardly;

an operating member fixedly coupled to the expansion member adjacent the distal end of said expansion member and extending proximally therefrom through at least a portion of said lumen, said operating member being substantially permanently attached to said expansion member distal end whereby said operating member and said expansion member remain coupled throughout an entire procedure in which the medical instrument is used, displacement of said operating member and expansion member distal end coupled thereto relative to said elongate tube portion so as to reduce a distance between said distal end of said expansion member and said distal end of said elongate tube portion forcibly displacing said peripheral wall toward the expanded state,

wherein contact of the inclined outer surface of the expansion member in the expanded state with the body wall to exert a pressure on the body wall forms a seal between the expansion member and the body wall, and

wherein said inclined outer surface comprises a concave surface extending radially outwardly from the apex to a maximum radius at the base of the cone;

whereby fluid is inhibited from flowing through the orifice.

10. The instrument recited in claim 9, wherein:

the inclined outer surface of the cone extends radially outwardly with progressive positions from the apex of the cone to the base of the cone.

11. The instrument recited in claim 9, wherein the seal is formed in proximity to the base of the cone.

12. The instrument recited in claim 9, wherein said expansion member is integral with said elongate tube portion and extends substantially continuously therefrom.

13. The medical instrument of claim 9, wherein at least said contracted state is a relaxed state of said expansion member.

14. A medical instrument adapted for disposition relative to an orifice defined in a body wall, comprising:

an elongate tube portion having a proximal end, a distal end, and a lumen extending therebetween;

an expansion member having a distal end and a proximal end and a peripheral wall extending therebetween, the peripheral wall being formed of a material impervious to liquid and sufficiently flexible to permit the distal end and the proximal end of the expansion member to be moved relative to each other between an expanded state of the peripheral wall wherein the distal end and the proximal end are spaced from each other by a first distance, and a contracted state of the peripheral wall wherein the distal end and the proximal end are spaced from each other by a second distance greater than the first distance and vice versa, said expansion member extending axially from said distal end of said elongate tube, the peripheral wall comprising a circumferential living hinge having a wall thickness less than adjacent portions of the peripheral wall, said living hinge thereby facilitating expansion of said peripheral wall;

the expansion member in the expanded state including a portion having the general configuration of a cone with an apex at the proximal end of said expansion member, a base distal of said apex, and an inclined outer surface extending between the apex and the base and facing generally proximally;

an operating member fixedly coupled to the expansion member adjacent the distal end of said expansion member and extending proximally therefrom through at least a portion of said lumen, said operating member being substantially permanently attached to said expansion member distal end whereby said operating member and said expansion member remain coupled throughout an entire procedure in which the medical instrument is used, displacement of said operating member and expansion member distal end coupled thereto relative to said elongate tube portion so as to reduce a distance between said distal end of said expansion member and said distal end of said elongate tube portion forcibly displacing said peripheral wall toward the expanded state,

wherein contact of the inclined outer surface of the expansion member in the expanded state with the body wall to exert a pressure on the body wall forms a seal between the expansion member and the body wall, and

wherein said inclined outer surface comprises a concave surface extending radially outwardly from the apex to a maximum radius at the base of the cone;

whereby fluid is inhibited from flowing through the orifice.

15. The instrument recited in claim 14, wherein:

the inclined outer surface of the cone extends radially outwardly with progressive positions from the apex of the cone to the base of the cone.

16. The instrument recited in claim 14, wherein the seal is formed in proximity to the base of the cone.

17. The instrument recited in claim 14, wherein said expansion member is integral with said elongate tube portion and extends substantially continuously therefrom.

18. The medical instrument of claim 14, wherein at least said contracted state is a relaxed state of said expansion member.

19. A medical instrument adapted for disposition relative to an orifice defined in a body wall, comprising:

an elongate tube portion having a proximal end, a distal end, and a lumen extending therebetween;

an expansion member having a distal end and a proximal end and a peripheral wall extending therebetween, the peripheral wall comprising a woven mesh material, the peripheral wall also being impervious to liquid and sufficiently flexible to permit the distal end and the proximal end of the expansion member to be moved relative to each other between an expanded state of the peripheral wall wherein the distal end and the proximal end are spaced from each other by a first distance, and a contracted state of the peripheral wall wherein the distal end and the proximal end are spaced from each other by a second distance greater than the first distance and vice versa, said expansion member extending axially from said distal end of said elongate tube;

a portion of the expansion member, including a portion of the woven mesh material, when in the expanded state, having the general configuration of a cone with an apex at the distal end of said expansion member, a base proximal of said apex, and an inclined outer surface extending between the apex and the base and facing generally distally;

an operating member fixedly coupled to the expansion member adjacent the distal end of said expansion member and extending proximally therefrom through at least a portion of said lumen, said operating member being substantially permanently attached to said expansion member distal end whereby said operating member and said expansion member remain coupled throughout an entire procedure in which the medical instrument is used, displacement of said operating member and expansion member distal end coupled thereto relative to said elongate tube portion so as to reduce a distance between said distal end of said expansion member and said distal end of said elongate tube portion forcibly displacing said peripheral wall toward the expanded state,

wherein contact of the outer surface of the expansion member in the expanded state with the body wall to exert a pressure on the body wall forms a seal between the expansion member and the body wall around substantially an entire circumference of the expansion member,

wherein said inclined outer surface comprises a concave surface extending radially outwardly from the apex to a maximum radius at the base of the cone;

whereby fluid is inhibited from flowing through the orifice.

20. The instrument recited in claim 19, wherein:

the inclined outer surface of the cone extends radially outwardly with progressive positions from the apex of the cone to the base of the cone.

21. The instrument recited in claim 19, wherein said expansion member is integral with said elongate tube portion and extends substantially continuously therefrom.

22. The medical instrument of claim 19, wherein at least said contracted state is a relaxed state of said expansion member.

23. A medical instrument adapted for disposition in a passage in a body, comprising:

an elongate tube portion having a proximal end, a distal end, and a lumen extending therebetween;

an expansion member having a distal end and a proximal end and a peripheral wall extending therebetween, the peripheral wall comprising a woven mesh material, the peripheral wall also being impervious to liquid and sufficiently flexible to permit the distal end and the proximal end of the expansion member to be moved relative to each other between an expanded state of the peripheral wall wherein the distal end and the proximal end are spaced from each other by a first distance, and a contracted state of the peripheral wall wherein the distal end and the proximal end are spaced from each other by a second distance greater than the first distance and vice versa, said expansion member extending axially from said distal end of said elongate tube;

a portion of the expansion member, including a portion of the woven mesh material, when in the expanded state, having the general configuration of a cone including an apex, a base and an inclined outer surface extending between the apex and the base;

an operating member fixedly coupled to the expansion member adjacent the distal end of said expansion member and extending proximally therefrom through at least a portion of said lumen, said operating member being substantially permanently attached to said expansion member distal end whereby said operating member and said expansion member remain coupled throughout an entire procedure in which the medical instrument is used, displacement of said operating member and expansion member distal end coupled thereto relative to said elongate tube portion so to reduce a distance between said distal end of said expansion member and said distal end of said elongate tube portion forcibly displacing said peripheral wall toward the expanded state,

wherein contact of the outer surface of the expansion member in the expanded state with a surface of the passage to exert a pressure on the surface of the passage forms a seal between the expansion member and the surface of the passage around substantially an entire circumference of the expansion member, and

wherein said inclined outer surface comprises a concave surface extending radially outwardly from the apex to a maximum radius at the base of the cone;

whereby fluid is inhibited flowing through the passage.

24. The instrument recited in claim 23, wherein:

the inclined outer surface of the cone extends radially outwardly with progressive positions from the apex of the cone to the base of the cone.

25. The instrument recited in claim 23, wherein said expansion member is integral with said elongate tube portion and extends substantially continuously therefrom.

26. The medical instrument of claim 23, wherein at least said contracted state is a relaxed state of said expansion member.

27. The instrument recited in claim 23, wherein:

the expansion member in the expanded state includes a second portion having the general configuration of a cone including an apex, a base, and an inclined outer surface extending between the apex and the base, the two bases of the cone-configured portions of the expansion member being positioned adjacent each other in a central portion of the expansion member, one of the apexes being positioned proximal the proximal end of the expansion member and the other of the apexes being positioned proximal the distal end of the expansion member.