# US 5,257,974 A · Performance enhancement adaptor for intravascular balloon catheter > Agents: this data is available as JSON from the patentgrep API and MCP server — see https://patentgrep.com/llms.txt - Number: US 5,257,974 A - Document ID: US5257974A - Status: Granted - Kind: A - Application number: 07/932,219 - Filed: 1992-08-19 - Granted: 1993-11-02 - Earliest claimed: 1992-08-19 - Assignees: SciMed Life Systems, Inc. - Inventors: James E. Cox - Web page: https://patentgrep.com/patent/US5257974A ## CPC - A61M 25/104: {used for angioplasty} - A61M 2025/1056: {having guide wire lumens outside the main shaft, i.e. the guide wire lumen is within or on the surface of the balloon} - A61M 2025/1079: {having radio-opaque markers in the region of the balloon} - A61M 2025/1095: {with perfusion means for enabling blood circulation while the balloon is in an inflated state or in a deflated state, e.g. permanent by-pass within catheter shaft} - A61M: DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY (introducing media into or onto the bodies of animals A61D7/00; means for inserting tampons A61F13/26; devices for administering food or medicines orally A61J; containers for collecting, storing or administering blood or medical fluids A61J1/05); DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY (surgery A61B; chemical aspects of surgical articles A61L); DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR {(Electrotherapy, e.g. producing anaesthesia by the use of alternating or intermittent currents A61N1/36021)} ## Abstract An adaptor for use with balloons of intravascular balloon catheters commonly used for treating conditions of the vascular system includes a hollow member and an elongated positioning member, which is connected to the hollow member. The hollow member possesses characteristics not possessed by the balloon of the balloon catheter. With a balloon catheter positioned within a blood vessel, the adaptor is capable of longitudinal movement through the blood vessel, between the balloon catheter and a wall of the blood vessel, independent of the balloon catheter. The adaptor is manuevered adjacent to the balloon by manipulating the positioning member until a proximal end and a distal end of the adaptor is generally aligned with a proximal and distal end of the balloon, respectively. Inflation of the balloon secures the hollow member against the balloon in such a manner that the characteristics of the hollow member are imparted to the balloon. ## Claims ### Claim 1 An intravascular balloon catheter system, the balloon catheter system comprising: a catheter shaft having a proximal end, a distal end, an outer surface and at least one lumen extending between the proximal end and the distal end; an inflatable balloon connected to the shaft at the distal end of the shaft; and adaptor means independently movable relative to and operable with the balloon, for modifying a performance of the balloon, when the balloon is inflated within the blood vessel. ### Claim 2 (depends on 1) The balloon catheter system of claim 1 wherein the adaptor means further comprises: a hollow member having a proximal end, a distal end, an outer surface, an inner surface and an opening between the proximal and distal ends; and positioning means connected to the hollow member, for longitudinally moving the hollow member within the blood vessel, between a wall of the blood vessel and the shaft of the catheter, and for positioning the hollow member so as to contact a surface of the balloon and effect the modified performance of the balloon. ### Claim 3 (depends on 2) The balloon catheter system of claim 2 wherein inflating the balloon secures the hollow member between the wall of the blood vessel and an outer surface of the balloon, with the proximal end and the distal end of the hollow member exposed at a proximal end and a distal end of the balloon. ### Claim 4 (depends on 3) The balloon catheter system of claim 3 wherein the opening is positioned between the balloon and the wall of the blood vessel when the balloon is inflated. ### Claim 5 (depends on 4) The balloon catheter system of claim 4 wherein the opening establishes a flow path for blood past the balloon when the balloon is inflated within the blood vessel. ### Claim 6 (depends on 5) The balloon catheter system of claim 5 wherein the opening is defined by the inner surface of the hollow member. ### Claim 7 (depends on 6) The balloon catheter system of claim 6 wherein the outer surface of the hollow member contacts the blood vessel wall and the outer balloon surface along a contact zone. ### Claim 8 (depends on 7) The balloon catheter system of claim 7 wherein inflating the balloon further creates spaces adjacent the contact zone, between the outer surface of the hollow member and the wall of the blood vessel, the spaces permitting a flow of blood past the balloon while the balloon is inflated within the blood vessel. ### Claim 9 (depends on 7) The balloon catheter system of claim 7 and further comprising: exposure means through a side wall hollow member for exposing the opening so as to permit a flow of blood transverse to the opening, the flow of blood through the exposure means capable of feeding a side branch of the artery when the balloon and hollow member are positioned across the side branch. ### Claim 10 (depends on 9) The balloon catheter system of claim 9 wherein the exposure means includes a plurality of holes. ### Claim 11 (depends on 9) The balloon catheter system of claim 9 wherein the hollow member comprises a tubular coil of a flat member, and wherein the exposure means comprises spaces between adjacent coils of the hollow member. ### Claim 12 (depends on 11) The balloon catheter system of claim 11 wherein the flat member is a metal member. ### Claim 13 (depends on 12) The balloon catheter system of claim 12 wherein the metal member is radiopaque. ### Claim 14 (depends on 11) The balloon catheter system of claim 11 wherein the flat member is a polymer. ### Claim 15 (depends on 9) The balloon catheter system of claim 9 wherein the hollow member comprises a tubular braid of a wire-like member, and wherein the exposure means comprises gaps between an intersection of the wire like members. ### Claim 16 (depends on 4) The balloon catheter system of claim 4 wherein inflation of the balloon causes the outer surface of the hollow member to contact the wall of the artery, and the inner surface of the hollow member to contact the outer surface of the balloon. ### Claim 17 (depends on 16) The balloon catheter system of claim 16 wherein inflation of the balloon further causes the inner and outer surfaces of the hollow member to expand. ### Claim 18 (depends on 17) The balloon catheter system of claim 17 wherein the opening is defined between the inner surface and the outer surface of the hollow member, and wherein the opening is maintained, when the balloon is inflated within the blood vessel, to permit a flow of blood past the inflated balloon. ### Claim 19 (depends on 18) The balloon catheter system of claim 18 and further comprising: exposure means through the outer surface of the hollow member for exposing the opening so as to permit a flow of blood transverse to the opening, the flow of blood through the exposure means capable of feeding a side branch of the artery when the balloon and adaptor are positioned across the side branch. ### Claim 20 (depends on 19) The balloon catheter system of claim 19 wherein the exposure means includes a plurality of holes. ### Claim 21 (depends on 16) The balloon catheter system of claim 16 wherein the opening is defined by the inner surface of the hollow member. ### Claim 22 (depends on 4) The balloon catheter system of claim 4 wherein the opening of the hollow member has a predetermined diameter larger than the balloon when the balloon is deflated. ### Claim 23 (depends on 22) The balloon catheter system of claim 22 wherein the hollow member is positionable with respect to the balloon so that the balloon can be positioned within the opening of the hollow member. ### Claim 24 (depends on 23) The balloon catheter system of claim 23 wherein the hollow member is made of a material other than a material of the balloon. ### Claim 25 (depends on 24) The balloon catheter system of claim 24 wherein an outward radial expansion of the balloon is restricted to the predetermined diameter of the hollow member when the balloon is inflated. ### Claim 26 (depends on 25) The balloon catheter system of claim 25 wherein the predetermined diameter of the hollow member increases less than about 2.7% when the balloon is inflated. ### Claim 27 (depends on 26) The balloon catheter system of claim 26 wherein the material of the hollow member has a characteristic so that positioning the hollow member over the balloon increases a pressure tolerance of the balloon between about 12.5% and about 33.3%. ### Claim 28 (depends on 27) The balloon catheter system of claim 27 wherein the proximal end and the distal end of the hollow member are angled. ### Claim 29 (depends on 3) The balloon catheter system of claim 3 wherein the balloon includes an inner cylindrical surface and wherein inflation of the balloon secures the hollow member within the inner cylindrical surface of the balloon, the outer surface of the hollow member engaging the inner cylindrical surface of the balloon to restrict an inward radial expansion of the inner cylindrical surface so as to direct an outward radial expansion of an outer surface of the balloon. ### Claim 30 (depends on 29) The balloon catheter system of claim 29 wherein the inner surface of the hollow member defines the opening, and wherein the opening remains open during inflation of the balloon to permit blood to flow past the balloon for as long as the balloon remains inflated within an artery. ### Claim 31 An adaptor for modifying a performance of an inflatable, balloon of an intravascular balloon catheter, the adaptor comprising: a hollow member having a proximal end, a distal end, an outer surface, an inner surface and an opening between the proximal and distal ends; and positioning means connected to the hollow member, for longitudinally moving the hollow member within a blood vessel, between a wall of the blood vessel and the catheter, and for positioning the hollow member so as to contact a surface of the balloon and effect the modified performance of the balloon. ### Claim 32 (depends on 31) The adaptor of claim 31 wherein the opening has a length of at least 10 millimeters. ### Claim 33 (depends on 32) The adaptor of claim 32 wherein the positioning means is made of a shape memory metal alloy. ### Claim 34 (depends on 33) The adaptor of claim 33 wherein the hollow member is noncompliant in a radial direction. ### Claim 35 (depends on 34) The adaptor of claim 34 wherein the opening of the hollow member is defined by the inner surface of the hollow member. ### Claim 36 (depends on 35) The adaptor of claim 35 wherein the hollow member is made of polyethylene. ### Claim 37 (depends on 35) The adaptor of claim 35 wherein the hollow member is made of polyethylene terephthalate (PET). ### Claim 38 (depends on 37) The adaptor of claim 37 wherein the proximal end and the distal end of the hollow member are biased. ### Claim 39 (depends on 36) The adaptor of claim 36 wherein the hollow member further includes geometric support means for maintaining a radial size of the opening of the hollow member when a force is applied to the outer surface of the hollow member. ### Claim 40 (depends on 36) The adaptor of claim 36 wherein the outer surface and the inner surface of the hollow member define a wall of the hollow member, and wherein the wall includes exposure means for exposing the opening through the wall. ### Claim 41 (depends on 40) The adaptor of claim 40 wherein the exposure means comprises a plurality of holes which are circumferentially spaced about the outer surface of the hollow member. ### Claim 42 (depends on 35) The adaptor of claim 35 wherein the hollow member is comprised of a tubular coil of a flat member, and wherein the exposure means comprises spaces between adjacent coils of the hollow member. ### Claim 43 (depends on 42) The adaptor of claim 42 wherein the flat member comprises a length of a metal material. ### Claim 44 (depends on 43) The adaptor of claim 43 wherein the metal material is radiopaque. ### Claim 45 (depends on 42) The adaptor of claim 42 wherein the flat member comprises a length of a polymer material. ### Claim 46 (depends on 35) The adaptor of claim 35 wherein the hollow member is comprised of a tubular braid of wire-like members, and wherein the exposure means comprises gaps between intersections of the wire-like members. ### Claim 47 (depends on 46) The adaptor of claim 46 wherein the wire-like members comprise strands of a metal material. ### Claim 48 (depends on 47) The adaptor of claim 47 wherein the metal material is radiopaque. ### Claim 49 (depends on 33) The adaptor of claim 33 wherein the hollow member is made of a compliant material. ### Claim 50 (depends on 49) The adaptor of claim 49 wherein the opening is defined between the inner surface and the outer surface of the hollow member. ### Claim 51 (depends on 49) The adaptor of claim 49 wherein the compliant material is silicone. ### Claim 52 A method of treating an affected region of a blood vessel, the method comprising: inserting into the blood vessel a catheter comprising a shaft having a proximal end, a distal end and a balloon connected at the distal end of the shaft, the balloon communicating with an inflation lumen of the catheter shaft; positioning the balloon adjacent the affected region of the blood vessel; inserting within the blood vessel, between the shaft of the catheter and a wall of the blood vessel, a hollow member having a proximal end, a distal end, an opening between the proximal end and the distal end, and an elongated member attached to the hollow member for positioning the hollow member in contact with a surface of the balloon; applying a longitudinal force to the elongated member to locate the hollow member within the blood vessel adjacent to the balloon; and inflating the balloon so as to apply a force to the wall of the blood vessel and a surface of the hollow member, the force securing the hollow member against the balloon so as to effect a performance not capable by the balloon alone. ### Claim 53 (depends on 52) The method of claim 52 wherein the step of positioning the balloon includes: inflating the balloon so as to apply a force to the wall of the blood vessel; and deflating the balloon so as to reduce a radial size of the balloon. ### Claim 54 (depends on 52) The method of claim 52 wherein the step of applying the longitudinal force to the elongated member comprises: positioning the proximal end and distal end of the hollow member near a proximal and a distal end of the balloon, respectively. ### Claim 55 (depends on 54) The method of claim 54 wherein the step of positioning further includes positioning the opening between the balloon and the wall of the blood vessel. ### Claim 56 (depends on 55) The method of claim 55 wherein the step of inflating the balloon causes the opening of the hollow member to create a void past the inflated balloon which allows a flow of blood past the inflated balloon. ### Claim 57 (depends on 55) The method of claim 55 wherein the step of inflating the balloon causes an outer surface of the balloon to contact an inner surface of the hollow member, a radial size of the balloon therefore being restricted to a radial size of the hollow member. ### Claim 58 A method of modifying an inflatable balloon of a dilatation balloon catheter, the method comprising: inserting into the blood vessel a catheter comprising a shaft having a proximal end, a distal end and an inflatable balloon connected at the distal end of the shaft, the balloon communicating with an inflation lumen of the catheter shaft; positioning the balloon adjacent the affected region of the blood vessel; inserting within the blood vessel, between the shaft of the catheter and a wall of the blood vessel, a hollow member having a proximal end, a distal end, and an elongated member attached to the hollow member for positioning the hollow member in contact with a surface of the balloon; applying a longitudinal force to the elongated member to locate the hollow member within the blood vessel adjacent to the balloon, with the proximal end and the distal end of the hollow member exposed past a proximal end and a distal end of the balloon; and inflating the balloon so as to cause at least part of the surface of the balloon to exert a force on a surface of the hollow member, the force securing the surface of the hollow member against the surface of the balloon such that the hollow member establishes a fluid pathway past the inflated balloon. ### Claim 59 A method of modifying an inflatable balloon of a dilatation balloon catheter, the method comprising: inserting into the blood vessel a catheter comprising a shaft having a proximal end, a distal end and a compliant, inflatable balloon connected at the distal end of the shaft, the balloon communicating with an inflation lumen of the catheter shaft; positioning the balloon adjacent the affected region of the blood vessel; inserting within the blood vessel, between the shaft of the catheter and a wall of the blood vessel, a hollow member having a proximal end, a distal end, an outer surface, an inner surface, the outer surface defining a predetermined diameter of the hollow member along at least a portion of the hollow member and an elongated member attached to the hollow member for positioning the hollow member in contact with a surface of the balloon; applying a longitudinal force to the elongated member to position the inner surface of the hollow member over the balloon, with the proximal end and the distal end of the hollow member generally aligned with a proximal end and a distal end of the balloon; and inflating the balloon so as to cause an outer surface of the balloon to expand within the hollow member, the hollow member restricting a radial size of the balloon to the predetermined diameter of the hollow member and increasing an inflation pressure tolerance of the balloon.