# US 10,368,911 B2 · Methods and devices for puncturing tissue > Agents: this data is available as JSON from the patentgrep API and MCP server — see https://patentgrep.com/llms.txt - Number: US 10,368,911 B2 - Document ID: US10368911B2 - Status: Granted - Kind: B2 - Application number: 14/910,525 - Filed: 2013-11-20 - Published: 2016-06-23 - Granted: 2019-08-06 - Earliest claimed: 2013-08-07 - Assignees: Baylis Medical Company Inc. - Applicants: Baylis Medical Company Inc. - Inventors: Gareth Davies; John Paul Urbanski; Ferryl Alley; Bogdan Beca - Web page: https://patentgrep.com/patent/US10368911B2 ## CPC - A61B 17/3478: {Endoscopic needles, e.g. for infusion (biopsy needles A61B10/0233; catheters with injection needles A61M25/0067)} - A61B 18/1492: {having a flexible, catheter-like structure, e.g. for heart ablation (A61B18/1477 takes precedence)} - A61B 90/39: {Markers, e.g. radio-opaque or breast lesions markers} - A61B 2017/00247: {Making holes in the wall of the heart, e.g. laser Myocardial revascularization} - A61B 2017/003: {Steerable} - A61B 2017/22042: {Details of the tip of the guide wire} - A61B 2017/22044: {with a pointed tip} - A61B 2017/3488: {Fixation to inner organ or inner body tissue} - A61B 2018/00351: {Heart} - A61B 2018/00363: {Epicardium} - A61B 2018/00601: {Cutting} - A61B 2018/144: {Wire} - A61B 2090/3966: {Radiopaque markers visible in an X-ray image} - A61M 25/0041: {pre-formed, e.g. specially adapted to fit with the anatomy of body channels (urethral catheters A61F2/04)} - A61M 25/09: Guide wires - A61B: DIAGNOSIS; SURGERY; IDENTIFICATION (usefulness limited to only animals A61D) - 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 Novel and unique medical devices and associated methods are disclosed, for facilitating efficient and repeatable puncture of a tissue site while allowing vascular access from various access sites of a patient's body. Disclosed medical devices include dilators and wires usable alone or in combination and configured to facilitate tissue access and puncture at various anatomical locations from desired access sites. The medical devices each include one or more sections having sufficient flexibility for accessing the tissue site from the access site while retaining sufficient stiffness to perform one or more additional functions. ## Claims ### Claim 1 A passive dilator configured for use with an ancillary device to access tissue at a puncture site within a patient's heart by a superior access approach the ancillary device comprising a curvature-imparting region for defining a curvature, the dilator comprising: a substantially rigid distal end region; a substantially flexible intermediate region terminating at the distal end region; the substantially flexible intermediate region of the dilator being configured to allow the ancillary device to achieve a desired curvature by providing minimal resistance to the curvature of the curvature-imparting region of the ancillary device; the substantially rigid distal end region having a rigidity greater than the flexible intermediate region for dilating tissue at the puncture site and to facilitate advancement of the dilator there-through while substantially preventing deformation of the substantially rigid distal end region; the passive dilator substantially lacking a curve; and a location of the substantially flexible intermediate region of the passive dilator being configured to correspond to a location of the curvature-imparting region of the ancillary device; Wherein the lack of the curve, in conjunction with the substantially flexible intermediate region, ensures that the dilator does not substantially interfere with the curvature of the ancillary device enabling the ancillary device to attain the desired curvature to position the dilator distal end portion at the puncture site via the superior access approach. ### Claim 2 (depends on 1) The dilator of claim 1, wherein the substantially rigid distal end region has a length of between about 2.5% to about 60% of a length of said substantially flexible intermediate region. ### Claim 3 (depends on 1) The dilator of claim 1, wherein the dilator further comprises a proximal region extending proximally from the substantially flexible intermediate region, the proximal region having a rigidity greater than the flexible intermediate region. ### Claim 4 (depends on 3) The dilator of claim 3, wherein the distal end region and the proximal region have a rigidity that is substantially equal. ### Claim 5 (depends on 4) The dilator of claim 4, wherein the rigidity of each of the distal end region and the proximal region is equal to about 0.8 GPa and wherein the rigidity of the flexible intermediate region is equal to about 0.3 GPa. ### Claim 6 (depends on 5) The dilator of claim 5, wherein the distal end region and the proximal region are formed from High Density Polyethylene, and wherein the flexible intermediate region is formed from Low Density Polyethylene. ### Claim 7 (depends on 1) The dilator of claim 1, wherein the substantially rigid distal end region defines a taper. ### Claim 8 (depends on 1) The dilator of claim 1, wherein the substantially rigid distal end region defines a dual taper. ### Claim 9 (depends on 1) The dilator of claim 1, wherein the substantially rigid distal end region defines a shape-retaining tip section of the dilator. ### Claim 10 A method of accessing a chamber of a patient's heart using a superior access approach, the method using a dilator with an ancillary device to access a tissue of the patient's heart, the ancillary device comprising a steerable device having a curvature-imparting region operable to guide the dilator by directing the dilator along a curve, the dilator comprising a passive dilator comprising a substantially rigid distal end region, and a substantially flexible intermediate region terminating at the distal end region, the passive dilator substantially lacking a curve, the method comprising the steps of: (a) advancing the steerable device through a patient's vasculature, from a superior approach access site into the patient's heart, the steerable device defining a lumen and containing the passive dilator within the lumen, where a location of the substantially flexible intermediate region of the dilator corresponds to a location-of the curvature-imparting region of the ancillary device; (b) articulating the steerable device to manipulate the flexible intermediate region of the dilator to position the rigid distal end region of the dilator substantially adjacent the tissue of the patient's heart, wherein the lack of the curve, in conjunction with the substantially flexible intermediate region, ensures that the dilator does not substantially interfere with the curvature of the ancillary device enabling the ancillary device to attain the desired curvature to position the dilator distal end portion at the puncture site via the superior access approach; and (c) advancing the substantially rigid distal end region of the dilator through a puncture in the tissue. ### Claim 11 (depends on 10) The method of claim 10, the dilator defining a dilator lumen and containing a medical device within the dilator lumen. ### Claim 12 (depends on 11) The method of claim 11, further comprising a step of advancing the medical device and puncturing the tissue between steps (b) and (c). ### Claim 13 (depends on 10) The method of claim 10, wherein the tissue is a septum of the heart. ### Claim 14 (depends on 10) The method of claim 10, wherein the step of puncturing tissue comprises delivering energy through the medical device to puncture the tissue. ### Claim 15 (depends on 14) The method of claim 14, wherein the step of delivering energy comprises delivering electrical energy. ### Claim 16 (depends on 15) The method of claim 15, wherein the electrical energy is in the radiofrequency range. ### Claim 17 (depends on 10) The method of claim 10, wherein the steerable device is a steerable sheath. ### Claim 18 (depends on 10) The method of claim 10, wherein step (c) comprises dilating the puncture using a shape-retaining tip section of the dilator. ### Claim 19 (depends on 10) The method of claim 10, wherein, between steps (b) and (c), the method further comprises tenting the septum. ### Claim 20 (depends on 10) The method of claim 10, wherein the access site is selected from the group consisting of a left subclavian vein, a right subclavian vein and a jugular vein. ### Claim 21 (depends on 10) The method of claim 10, wherein during the step of advancing the steerable device the substantially flexible intermediate region is positioned to align with the curvature imparting region. ### Claim 22 A kit for accessing a puncture site within a patient's heart by a superior access approach, the kit comprising: a passive dilator comprising a substantially flexible intermediate region terminating at a substantially rigid distal end region; the passive dilator substantially lacking a curve; a steerable sheath comprising a deflectable region and defining a lumen for receiving the dilator therethrough; the sheath and dilator being configured to co-operate such that, in use, the dilator is positionable within the sheath such that a location of the substantially flexible intermediate region of the dilator within the lumen corresponds to a location of the deflectable region of the sheath; and Wherein the lack of the curve, in conjunction with the substantially flexible intermediate region, minimizes resistance of the dilator to deflection of the deflectable region of the steerable sheath enabling the steerable sheath to position the dilator distal end portion at the puncture site via the superior access approach. ### Claim 23 A sheath assembly for accessing a puncture site within a patient's heart by a superior access approach, the sheath assembly comprising: a steerable sheath defining a lumen therethrough and defining a deflectable region; a passive dilator comprising a substantially flexible intermediate region terminating at a substantially rigid distal end region, the passive dilator substantially lacking a curve; the dilator being configured to extend through said lumen such that the deflectable region of the sheath is aligned with the flexible intermediate region of the dilator, the flexible intermediate region having sufficient flexibility to adopt a curvature of the deflectable region upon deflection; and the rigid distal end region having sufficient rigidity to allow the dilator to be advanced across the puncture site for dilating the tissue at the puncture while preventing deformation of the rigid distal end region during advancement; Wherein the lack of the curve, in conjunction with the substantially flexible intermediate region, ensures that the dilator does not substantially interfere with the curvature of the ancillary device enabling the ancillary device to attain the desired curvature to position the dilator distal end portion at the puncture site via the superior access approach. ### Claim 24 A method of using a steerable sheath assembly to access a puncture site within a patient's heart by a superior access approach, the method comprising the steps of: advancing a steerable sheath through vasculature through the superior approach to the puncture site within the patient's heart, the steerable sheath comprising a deflectable region; positioning a dilator within a lumen of the steerable sheath, wherein the passive dilator substantially lacks a curve, said dilator comprising a substantially flexible intermediate region and a substantially rigid distal end region, such that the flexible intermediate region is located within the sheath lumen at a position substantially aligned with the deflectable region of the steerable sheath; actuating the steerable sheath to deflect the steerable sheath to a desired deflection angle thereby deflecting the flexible intermediate region of the dilator for enabling positioning of the dilator distal end region at a desired tissue site within said region of tissue, wherein the passive dilator is configured such the lack of a curve and the flexible intermediate region substantially do not affect the deflection of the steerable sheath while substantially adopting the desired deflection angle; and advancing a portion of the dilator including the distal end region through said desired tissue site, said dilator distal end region having sufficient rigidity to enable advancement of the distal end region through the desired tissue site for dilating said tissue site while preventing deformation of the distal end region.