# US 8,540,674 B2 · Devices, systems, and methods for transeptal atrial puncture using an engagement catheter platform > Agents: this data is available as JSON from the patentgrep API and MCP server — see https://patentgrep.com/llms.txt - Number: US 8,540,674 B2 - Document ID: US8540674B2 - Status: Granted - Kind: B2 - Application number: 13/084,102 - Filed: 2011-04-11 - Published: 2011-10-06 - Granted: 2013-09-24 - Earliest claimed: 2007-04-27 - Assignees: CVDevices, LLC - Applicants: Ghassan S. Kassab; Jose A. Navia, Sr. - Inventors: Ghassan S. Kassab; Jose A. Navia, Sr. - Web page: https://patentgrep.com/patent/US8540674B2 ## CPC - A61B 17/3468: {for implanting or removing devices, e.g. prostheses, implants, seeds, wires (devices for implanting seeds A61M37/0069)} - A61B 17/0057: {Implements for plugging an opening in the wall of a hollow or tubular organ, e.g. for sealing a vessel puncture or closing a cardiac septal defect (sutures A61B17/04; closing rectum or urethra near body surface A61F2/0009)} - A61B 17/3478: {Endoscopic needles, e.g. for infusion (biopsy needles A61B10/0233; catheters with injection needles A61M25/0067)} - A61B 17/3417: {Details of tips or shafts, e.g. grooves, expandable, bendable; Multiple coaxial sliding cannulas, e.g. for dilating (syringe needles A61M5/32; dilators A61M29/00)} - A61B 2017/00247: {Making holes in the wall of the heart, e.g. laser Myocardial revascularization} - A61B 2017/00592: {Elastic or resilient implements} - A61B 2017/00601: {Implements entirely comprised between the two sides of the opening} - A61B 2017/00606: {Implements H-shaped in cross-section, i.e. with occluders on both sides of the opening} - A61B 2017/00876: {magnetic} - A61B 2017/306: {holding by means of suction} - A61B 2017/308: {with suction cups} - A61B 2017/3419: {Sealing means between cannula and body} - A61B 2017/3454: {Details of tips} - A61B 2017/3488: {Fixation to inner organ or inner body tissue} - A61B 2018/00392: {Transmyocardial revascularisation} - A61M 25/003: {characterized by features relating to least one lumen located at the distal part of the catheter, e.g. filters, plugs or valves (catheter tips A61M25/0067)} - A61M 25/007: {Side holes, e.g. their profiles or arrangements; Provisions to keep side holes unblocked} - A61M 25/04: in the body, e.g. expansible {(A61M25/10, A61M16/0488 take precedence)} - A61M 2025/0004: {having two or more concentrically arranged tubes for forming a concentric catheter system} - A61M 2025/0039: {characterized by lumina being arranged coaxially} - A61M 2025/004: {characterized by lumina being arranged circumferentially} - A61M 2025/0089: {Single injection needle protruding axially, i.e. along the longitudinal axis of the catheter, from the distal tip} - 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 Multichannel systems for engaging a bodily tissue and methods of using the same. In at least one embodiment of an exemplary multichannel system for engaging a tissue of the present disclosure, the system comprises an engagement catheter comprising a proximal end, a distal end, and defining a first lumen and second lumen extending between the proximal end and the distal end, an inducer sheath having a proximal portion and a distal portion, and defining a lumen extending therethrough, the inducer sheath configured for insertion into the second lumen of the engagement catheter, and a dilator defining a first channel and a second channel extending therethrough and a tapered tip at the distal end of the dilator, the dilator sized and shaped for inserted into the lumen of the inducer sheath. ## Claims ### Claim 1 A multichannel system for engaging a tissue, the system comprising: an engagement catheter comprising a proximal end and a distal end, and defining a first lumen extending between the proximal end and the distal end; an inducer sheath having a proximal portion and a distal portion, and defining a lumen extending therethrough, the inducer sheath configured for insertion into the first lumen of the engagement catheter; a dilator defining a first channel and a second channel extending therethrough and a tapered tip at a distal end of the dilator, the dilator sized and shaped for insertion into the lumen of the inducer sheath; and a needle device having a needle tip, the needle device capable of insertion into the first channel of the dilator, wherein the needle tip is capable of puncturing a tissue positioned at or near the distal end of the dilator to form a mammalian tissue aperture, wherein the tapered tip of the dilator is configured for insertion of the tapered tip into the mammalian tissue aperture formed using the needle tip. ### Claim 2 (depends on 1) The system of claim 1, wherein the second channel is sized and shaped to allow passage of at least a portion of a first catheter therethrough. ### Claim 3 (depends on 1) The system of claim 1, wherein the dilator further defines a third channel extending therethrough, the third channel sized and shaped to allow passage of at least a portion of a second catheter therethrough. ### Claim 4 (depends on 3) The system of claim 3, wherein the dilator further defines a separation member extending therethrough and separating the first channel, second channel and third channel of the dilator. ### Claim 5 (depends on 4) The system of claim 4, wherein the separation member is removable from the dilator, and upon removal merges the first channel, second channel and third channel into a central channel. ### Claim 6 (depends on 1) The system of claim 1, further comprising: a blocking member configured for insertion into the second channel of the dilator to occlude the second channel of the dilator. ### Claim 7 (depends on 1) The system of claim 1, further comprising: a visualization device configured for insertion into the first channel of the dilator, wherein the visualization device is operable to gather location information. ### Claim 8 (depends on 7) The system of claim 7, wherein the visualization device is selected from the group consisting of an endocardial visualization device, an endoscope, and a catheter. ### Claim 9 (depends on 1) The system of claim 1, wherein the engagement catheter further defines a second lumen and further comprises a skirt operatively connected to the distal end of the engagement catheter, the skirt comprising a proximal end having a circumference substantially similar to an outer circumference of the engagement catheter, the skirt further comprising a distal end having a circumference larger than the outer circumference of the engagement catheter; and wherein the system further comprises: a vacuum port located at the proximal end of the engagement catheter, the vacuum port operably connected to the second lumen of the engagement catheter and capable of operative connection to a vacuum source; wherein the second lumen of the engagement catheter includes a suction port located at or near the distal end of the engagement catheter, the suction port configured to allow the distal end of the skirt to removably engage a surface of a bodily tissue such that the skirt is capable of forming a reversible seal with the surface of the tissue when a vacuum source is operatively attached to the vacuum port. ### Claim 10 (depends on 1) The system of claim 1, further comprising: a guide wire configured for insertion into the first channel of the dilator. ### Claim 11 (depends on 10) The system of claim 10, wherein the needle defines a needle lumen therethrough, the needle lumen sized and shaped to receive the guide wire therethrough. ### Claim 12 (depends on 1) The system of claim 1, further comprising: an inflatable balloon at or near the distal portion of the inducer sheath. ### Claim 13 (depends on 12) The system of claim 12, wherein the inflatable balloon is comprised of a radiopaque material. ### Claim 14 (depends on 13) The system of claim 13, wherein the radiopaque material comprises a polyamide elastomer and tungsten. ### Claim 15 (depends on 1) The system of claim 1, wherein the inducer sheath is comprised of polytetrafluoroethylene. ### Claim 16 (depends on 1) The system of claim 1, wherein the inducer sheath has a wall thickness from about 0.2 mm to about 0.3 mm. ### Claim 17 (depends on 1) The system of claim 1, wherein the inducer sheath has a length of within about 5 mm to about 6 mm of a length of the engagement catheter. ### Claim 18 (depends on 1) The system of claim 1, wherein the proximal portion of the inducer sheath is affixed to the proximal end of the engagement catheter. ### Claim 19 (depends on 1) The system of claim 1, wherein the tapered tip of the dilator has a conical shape. ### Claim 20 (depends on 1) The system of claim 1, wherein the dilator is comprised of polyethylene. ### Claim 21 (depends on 1) The system of claim 1, wherein the dilator further comprises a dilator lock capable of preventing the dilator from backward movement after the dilator is inserted into the lumen of the inducer sheath and the dilator lock is locked. ### Claim 22 (depends on 1) The system of claim 1, wherein the tapered tip is comprised of polyurethane. ### Claim 23 (depends on 9) The system of claim 9, wherein the skirt comprises a deformable configuration, and wherein the deformable configuration of the skirt is capable of expanding to an expanded configuration. ### Claim 24 A multichannel system for engaging a tissue, the system comprising: an engagement catheter comprising a proximal end, a distal end, first and second lumens extending between the proximal end and the distal end, and a skirt operatively connected to the distal end, the skirt comprising a proximal end having a circumference substantially similar to an outer circumference of the engagement catheter, the skirt further comprising a distal end having a circumference larger than the outer circumference of the engagement catheter; an inducer sheath having a proximal portion, a distal portion, a lumen extending therethrough, and a radiopaque inflatable balloon at or near the distal portion of the inducer sheath, the inducer sheath configured so that it is capable of insertion into the first lumen of the engagement catheter; a dilator comprising a first and second channel extending therethrough and a tapered tip at a distal end of the dilator, the dilator sized and shaped for insertion into the lumen of the inducer sheath; a needle device having a needle tip, the needle device capable of insertion into the first channel of the dilator, wherein the needle tip is capable of puncturing a tissue positioned at or near the distal end of the dilator to form a mammalian tissue aperture, wherein the tapered tip of the dilator is configured for insertion of the tapered tip into the mammalian tissue aperture formed using the needle tip; a vacuum port located at the proximal end of the engagement catheter, the vacuum port being operatively connected to the first lumen of the engagement catheter and capable of operative connection to a vacuum source; and a visualization device capable of insertion into the first channel of the dilator, wherein the visualization device is capable of gathering location information, wherein the first lumen of the engagement catheter includes a suction port located at or near the distal end of the engagement catheter, the suction port configured to allow the distal end of the skirt to removably engage an atrial wall when the atrial wall is adjacent thereto, such that the skirt is capable of forming a reversible seal with the surface of the atrial wall when a vacuum source is operatively attached to the vacuum port. ### Claim 25 A method of engaging a tissue to access a space adjacent thereto, the method comprising the steps of: introducing a multichannel system into a mammalian body so that at least part of the system is adjacent to a targeted tissue, the system comprising: an engagement catheter having a skirt coupled thereto, an inducer sheath positioned within a lumen of the engagement catheter, a dilator positioned within a lumen of the inducer sheath, the dilator having a tapered tip, a needle device having a needle tip positioned within a first channel of the dilator, the needle device capable of insertion into the first channel of the dilator, wherein the needle tip is capable of puncturing a tissue positioned at or near the distal end of the dilator to form a mammalian tissue aperture, wherein the tapered tip of the dilator is configured for insertion of the tapered tip into the mammalian tissue aperture formed using the needle tip, and a catheter positioned within a second channel of the dilator; engaging the targeted tissue using the skirt of the engagement catheter by applying a vacuum to the engagement catheter; piercing the targeted tissue using the needle tip to create the tissue aperture; advancing at least part of the inducer sheath and at least part of the dilator into the tissue aperture and into a space behind the targeted tissue; and inserting at least a portion of the catheter into the space behind the targeted tissue. ### Claim 26 (depends on 25) The method of claim 25, wherein the step of advancing causes a balloon coupled to the inducer sheath to be positioned into the space behind the targeted tissue, and wherein the method further comprises the step of: inflating the balloon to reversibly secure the inducer sheath to the targeted tissue. ### Claim 27 (depends on 25) The method of claim 25, wherein the advancing step further comprises withdrawal of the needle from at least part of the lumen of the dilator. ### Claim 28 (depends on 25) The method of claim 25, further comprising the steps of: removing the dilator from the inducer sheath; and performing a procedure, the procedure selected from the group consisting of introducing a substance into the space, removing a substance from the space, and introducing a device into the space. ### Claim 29 (depends on 25) The method of claim 25, wherein the step of engaging the targeted tissue comprises engaging an atrial wall, and wherein the step of advancing comprises advancing at least part of the inducer sheath and the dilator into and through an atrial wall aperture. ### Claim 30 (depends on 25) The method of claim 25, wherein the step of engaging the targeted tissue comprises engaging an atrial septum, and wherein the step of advancing comprises advancing at least part of the inducer sheath and the dilator into an atrial septum aperture and into a left atrium.