# US 5,707,354 A · Compliant catheter lumen and methods > Agents: this data is available as JSON from the patentgrep API and MCP server — see https://patentgrep.com/llms.txt - Number: US 5,707,354 A - Document ID: US5707354A - Status: Granted - Kind: A - Application number: 08/423,589 - Filed: 1995-04-17 - Granted: 1998-01-13 - Earliest claimed: 1995-04-17 - Assignees: Cardiovascular Imaging Systems, Inc. - Inventors: Stephen Salmon; Ronald J. Jabba - Web page: https://patentgrep.com/patent/US5707354A ## CPC - A61F 2/958: Inflatable balloons for placing stents or stent-grafts - A61M 25/00: Catheters; Hollow probes (dilators A61M29/00; {peritoneal catheters A61M1/285; tracheal tubes A61M16/04; for drainage A61M27/00; for uterus, vagina or rectum A61M31/00} ; for measuring or testing A61B; {materials for catheters A61L29/00}) - A61M 25/0043: {characterised by structural features} - A61B 8/12: in body cavities or body tracts, e.g. by using catheters - A61B 8/4461: {Features of the scanning mechanism, e.g. for moving the transducer within the housing of the probe} - A61F 2250/0067: Means for introducing or releasing pharmaceutical products into the body - A61M 25/0029: {characterized by features relating to least one lumen located at the middle part of the catheter, e.g. slots, flaps, valves, cuffs, apertures, notches, grooves or rapid exchange ports (catheter shaft surface irregularities A61M2025/006)} - A61M 2025/0025: {having a collapsible lumen} - A61M 2025/0035: {characterized by a variable lumen cross-section by means of a resilient flexible septum or outer wall} - A61F: FILTERS IMPLANTABLE INTO BLOOD VESSELS; PROSTHESES; DEVICES PROVIDING PATENCY TO, OR PREVENTING COLLAPSING OF, TUBULAR STRUCTURES OF THE BODY, e.g. STENTS; ORTHOPAEDIC, NURSING OR CONTRACEPTIVE DEVICES; FOMENTATION; TREATMENT OR PROTECTION OF EYES OR EARS; BANDAGES, DRESSINGS OR ABSORBENT PADS; FIRST-AID KITS (dental prosthetics A61C) - 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)} - A61B: DIAGNOSIS; SURGERY; IDENTIFICATION (usefulness limited to only animals A61D) ## Abstract In one aspect, the invention provides a vascular catheter sheath for use with a therapeutic catheter having a radially expandable member. The catheter sheath includes a catheter body having a proximal end, a distal end, and at least one lumen adapted to receive the therapeutic catheter. The catheter body further includes a compliant portion near the distal end, with the compliant portion being adaptable to conform to the shape of the expandable member when the expandable member is radially expanded in the lumen. ## Claims ### Claim 1 A vascular catheter sheath for use with a therapeutic catheter having a radially expandable member, said vascular catheter sheath comprising: a catheter body having a proximal end, a distal end, and at least one lumen adapted to receive the therapeutic catheter, wherein the catheter body includes a compliant portion near the distal end, said complaint portion being adaptable to conform to the shape of the expandable member when the expandable member is radially expanded in the lumen wherein the compliant portion is radially expandable from within the lumen when subjected to a threshold pressure of at least 5 psi. ### Claim 2 (depends on 1) The vascular catheter of claim 1, wherein the compliant portion is integrally formed as part of the catheter body. ### Claim 3 (depends on 1) The vascular catheter of claim 1, wherein the compliant portion has a length in the range from about 10 mm to 200 mm. ### Claim 4 (depends on 1) The vascular catheter of claim 1, wherein the compliant portion is constructed of a resilient material that conforms to the shape of the catheter body until radially expanded. ### Claim 5 (depends on 4) The vascular catheter of claim 4, wherein the compliant portion has a diameter in the range from 0.5 mm to 2.0 mm when conforming to the shape of the catheter body and a diameter in the range from 1.5 mm to 5.0 mm when radially expanded. ### Claim 6 (depends on 1) The vascular catheter of claim 1, wherein the compliant portion is constructed of an elastomeric polymer. ### Claim 7 (depends on 1) The vascular catheter of claim 1, further comprising a radially expandable stent disposed around the compliant portion. ### Claim 8 An improved vascular catheter of the type having a catheter body with a proximal end and a distal end, wherein the catheter body includes a proximal region having at least two lumens and a distal region having a common lumen connected to and in communication with both of the lumens of the proximal region and having a cross-sectional area which is less than the combined cross-sectional areas of the two lumens of the proximal region, wherein the improvement comprises a compliant portion in the distal region of the catheter body that can be radially expanded upon application of an internal pressure applied within the common lumen, and wherein the complaint portion is radially expandable from within the common lumen when being subjected to an internal threshold pressure of at least 5 psi. ### Claim 9 (depends on 8) The vascular catheter of claim 8, wherein the distal end of the catheter body is tapered, with the distal end having an outer dimension that is smaller than an outer dimension of the distal region. ### Claim 10 (depends on 8) The vascular catheter as in claim 8, wherein the compliant portion is integrally formed as part of the catheter body. ### Claim 11 (depends on 10) The vascular catheter of claim 10, wherein the compliant portion has a diameter in the range from 0.5 mm to 2.0 mm when conforming to the shape of the catheter body and a diameter in the range from 1.5 mm to 5.0 mm when radially expanded. ### Claim 12 (depends on 8) The vascular catheter of claim 8, wherein the compliant portion is constructed of an elastomeric polymer. ### Claim 13 (depends on 8) The vascular catheter of claim 8, wherein the compliant portion has a length in the range from about 10 mm to 200 mm. ### Claim 14 (depends on 8) The vascular catheter of claim 8, wherein the distal region has a length in the range from about 10 mm to 200 mm. ### Claim 15 (depends on 8) The vascular catheter of claim 8, further comprising a radially expandable stent disposed around the compliant portion. ### Claim 16 A vascular catheter system comprising: a catheter sheath having a catheter body with a proximal end, a distal end and at least one lumen, wherein the catheter body includes a compliant portion near the distal end that is radially expandable; and a balloon angioplasty catheter having a proximal end, a distal end, and a balloon near the distal end, wherein the catheter can be passed through the lumen of the catheter sheath, and wherein the balloon can be expanded to radially expand the compliant portion. ### Claim 17 (depends on 16) The vascular catheter system of claim 16, wherein the catheter body further includes a proximal region having at least two lumens and a distal region having a common lumen connected to and in communication with both of the lumens of the proximal region and having a cross-sectional area which is less than the combined cross-sectional areas of the two lumens of the proximal region. ### Claim 18 (depends on 17) The vascular catheter system of claim 17, wherein the distal end of the catheter body is tapered, with the distal end having an outer dimension that is smaller than an outer dimension of the distal region. ### Claim 19 (depends on 16) The vascular catheter system of claim 16, wherein the compliant portion is integrally formed as part of the catheter body. ### Claim 20 (depends on 16) The vascular catheter system of claim 16, further comprising an ultrasonic imaging element for insertion into the lumen of the catheter sheath. ### Claim 21 (depends on 16) The vascular catheter system of claim 16, further comprising a radially expandable stent disposed around the compliant portion. ### Claim 22 A vascular catheter sheath for use with a therapeutic catheter having a radially expandable member, said vascular catheter sheath comprising: a catheter body having a proximal end, a distal end, and at least one lumen adapted to receive the therapeutic catheter, wherein the catheter body includes a compliant portion near the distal end, said complaint portion being adaptable to conform to the shape of the expandable member when the expandable member is radially expanded in the lumen, wherein the compliant portion is constructed of a resilient material that conforms to the shape of the catheter body until radially expanded, and wherein the compliant portion has a diameter in the range from 0.5 mm to 2.0 mm when conforming to the shape of the catheter body and a diameter in the range from 1.5 mm to 5.0 mm when radially expanded. ### Claim 23 (depends on 22) The vascular catheter of claim 22, wherein the compliant portion is radially expandable from within the lumen when subjected to a threshold pressure of at least 5 psi. ### Claim 24 A vascular catheter sheath for use with a therapeutic catheter having a radially expandable member, said vascular catheter sheath comprising: a catheter body having a proximal end, a distal end, and at least one lumen adapted to receive the therapeutic catheter, wherein the catheter body includes a compliant portion near the distal end, said complaint portion being adaptable to conform to the shape of the expandable member when the expandable member is radially expanded in the lumen, and wherein a radially expandable stent is disposed around the compliant portion. ### Claim 25 An improved vascular catheter of the type having a catheter body with a proximal end and a distal end, wherein the catheter body includes a proximal region having at least two lumens and a distal region having a common lumen connected to and in communication with both of the lumens of the proximal region and having a cross-sectional area which is less than the combined cross-sectional areas of the two lumens of the proximal region, wherein the improvement comprises a compliant portion in the distal region of the catheter body that can be radially expanded upon application of an internal pressure applied within the common lumen, and wherein the distal end of the catheter body is tapered, with the distal end having an outer dimension that is smaller than an outer dimension of the distal region. ### Claim 26 (depends on 25) The vascular catheter of claim 25, wherein the complaint portion is radially expandable from within the common lumen when being subjected to an internal threshold pressure of at least 5 psi. ### Claim 27 An improved vascular catheter of the type having a catheter body with a proximal end and a distal end, wherein the catheter body includes a proximal region having at least two lumens and a distal region having a common lumen connected to and in communication with both of the lumens of the proximal region and having a cross-sectional area which is less than the combined cross-sectional areas of the two lumens of the proximal region, wherein the improvement comprises a compliant portion in the distal region of the catheter body that can be radially expanded upon application of an internal pressure applied within the common lumen, wherein the distal region has a length in the range from about 10 mm to 200 mm, and wherein the compliant portion has a diameter in the range from 0.5 mm to 2.0 mm when conforming to the shape of the catheter body and a diameter in the range from 1.5 mm to 5.0 mm when radially expanded. ### Claim 28 An improved vascular catheter of the type having a catheter body with a proximal end and a distal end, wherein the catheter body includes a proximal region having at least two lumens and a distal region having a common lumen connected to and in communication with both of the lumens of the proximal region and having a cross-sectional area which is less than the combined cross-sectional areas of the two lumens of the proximal region, wherein the improvement comprises a compliant portion in the distal region of the catheter body that can be radially expanded upon application of an internal pressure applied within the common lumen, and wherein a radially expandable stent is disposed around the compliant portion. ### Claim 29 A method for treating a vascular body lumen, comprising: introducing a catheter sheath having a distal end and a compliant portion near the distal end into the body lumen and positioning the compliant portion near an area of the lumen to be treated; introducing a radially expandable member through the catheter sheath and up to the compliant portion; and radially expanding the expandable member within the compliant portion to radially expand the body lumen at the treatment area. ### Claim 30 (depends on 29) The method of claim 29, further comprising introducing the catheter sheath over a guidewire. ### Claim 31 (depends on 30) The method of claim 30, further comprising removing the guidewire from the compliant portion before introducing the expandable member. ### Claim 32 (depends on 30) The method of claim 30, further comprising advancing the expandable member over the guidewire. ### Claim 33 (depends on 29) The method of claim 29, further comprising ultrasonically imaging the treatment area to obtain an image of the treatment area prior to expanding the expandable member. ### Claim 34 (depends on 33) The method of claim 33, wherein the treatment area is ultrasonically imaged by passing an ultrasonic imaging element through the catheter sheath and rotating the imaging element. ### Claim 35 (depends on 34) The method of claim 34, further comprising maintaining the compliant portion in substantially the same position in the body lumen while both ultrasonically imaging the vessel and radially expanding the expandable member. ### Claim 36 (depends on 29) The method of claim 29, wherein the catheter sheath includes a distal region which is distal to the compliant portion, and further comprising constricting the expandable member until the compliant portion substantially conforms to the shape of the distal region and removing the catheter sheath from the body lumen. ### Claim 37 (depends on 29) The method of claim 29, wherein the expandable member is a balloon, and further comprising inflating the balloon to radially expand the body lumen. ### Claim 38 (depends on 37) The method of claim 37, wherein the catheter sheath further includes a radially expandable stent disposed over the compliant portion, and wherein the method further comprises aligning the stent with the treatment area and inflating the balloon to radially expand the stent at the treatment area. ### Claim 39 (depends on 38) The method of claim 38, further comprising ultrasonically imaging the treatment area to obtain an image of the treatment area prior to expanding the stent. ### Claim 40 A method for treating a vascular body lumen, comprising: introducing a catheter sheath having a distal end and a compliant portion near the distal end and a radially expandable stent over the compliant portion into the body lumen and positioning the stent beyond an area of the lumen to be treated; ultrasonically imaging the body lumen to obtain an image of the treatment area; withdrawing the sheath to align the stent with the treatment area; introducing a radially expandable member through the catheter sheath and up to the stent; and radially expanding the expandable member within the compliant portion to radially expand the stent within the body lumen at the treatment area.