초록 ▼

Systems and methods for penetrating a tissue membrane to gain access to a target site are disclosed. In some examples, systems and methods for accessing the left atrium from the right atrium of a patient's heart are carried out by puncturing the intra-atrial septal wall. One embodiment provides a sy

Systems and methods for penetrating a tissue membrane to gain access to a target site are disclosed. In some examples, systems and methods for accessing the left atrium from the right atrium of a patient's heart are carried out by puncturing the intra-atrial septal wall. One embodiment provides a system for transseptal cardiac access that includes a guiding catheter, an access catheter and a guidewire. The access catheter may include a tissue penetration member disposed within a housing wherein the tissue penetration member is substantially contained within the housing when in a retracted configuration. When the distal end of the access catheter is disposed adjacent the septal wall, the user can initiate an actuator switch, which may be in a proximal portion of the system, to cause the tissue penetration member to extend through the septal wall. Alternatively, the tissue penetration member can be actuated automatically by a contact trigger mechanism, without initiation by the user, upon contact with the septal wall by a distal contact member which is coupled to the contact trigger mechanism. Such a system may also include an interlock mechanism to prevent triggering of the tissue penetration member at undesirable times during a procedure.

대표청구항 ▼

We claim: 1. A transseptal access system, comprising: an elongate guiding catheter having a proximal end, a distal end and an inner lumen extending from the proximal end to the distal end thereof; an access catheter which is configured to advance through the guiding catheter and which has an elonga

We claim: 1. A transseptal access system, comprising: an elongate guiding catheter having a proximal end, a distal end and an inner lumen extending from the proximal end to the distal end thereof; an access catheter which is configured to advance through the guiding catheter and which has an elongate catheter body section with an actuation lumen, a proximal end, a distal end and a distal section including a housing having a translation chamber in communication with the actuation lumen and bounded at least partially by an inner bore, a body section guidewire lumen separate from the actuation lumen and extending from the proximal end of the elongate catheter body section and disposed along the elongate catheter body section, and a hollow tissue penetration member having a sharpened tissue penetrating tip, a piston slidably sealed against the inner bore of the translation chamber of the housing and an outside surface of a distal section of a tubular element of the body section guidewire lumen and a guidewire lumen in fluid communication and aligned with the body section guidewire lumen to allow a guidewire to be advanced from the body section guidewire lumen into the tissue penetration member guidewire lumen, the tissue penetration member being disposed at the distal section of the elongate catheter body section and axially displaceable in a distal direction with respect to the distal section of the elongate catheter body section and distal section of the tubular element from a retracted state with the sharpened distal tip disposed within the distal section of the catheter body section to a distally extended state with the sharpened distal tip extending distally beyond a distal end of the catheter body section; and a tissue penetration actuator which includes a pressurized fluid actuator having a syringe actuated by a compressed spring, which is in fluid communication with the actuation lumen and which is configured to impinge fluid on the piston to impart high velocity translation in a distal direction on the tissue penetration member relative to the distal section of the elongate catheter body section. 2. A transseptal access system, comprising: an elongate guiding catheter having a proximal end, a distal end and an inner lumen extending from the proximal end to the distal end thereof; an access catheter which is configured to advance through the guiding catheter and which has an elongate catheter body section with an actuation lumen, a proximal end, a distal end and a distal section including a housing having a translation chamber in communication with the actuation lumen and bounded at least partially by an inner bore, a body section guidewire lumen separate from the actuation lumen and extending from the proximal end of the elongate catheter body section and disposed along the elongate catheter body section, and a hollow tissue penetration member having a sharpened tissue penetrating tip, a piston slidably sealed against the inner bore of the translation chamber of the housing and an outside surface of a distal section of a tubular element of the body section guidewire lumen and a guidewire lumen in fluid communication and aligned with the body section guidewire lumen to allow a guidewire to be advanced from the body section guidewire lumen into the tissue penetration member guidewire lumen, the tissue penetration member being disposed at the distal section of the elongate catheter body section and axially displaceable in a distal direction with respect to the distal section of the elongate catheter body section and distal section of the tubular element from a retracted state with the sharpened distal tip disposed within the distal section of the catheter body section to a distally extended state with the sharpened distal tip extending distally beyond a distal end of the catheter body section; and a tissue penetration actuator including a pressurized fluid actuator in fluid communication with the actuation lumen and configured to impinge fluid on the piston to impart high velocity translation in a distal direction on the tissue penetration member relative to the distal section of the elongate catheter body section. 3. A transseptal access system, comprising: an elongate guiding catheter having a proximal end, a distal end and an inner lumen extending from the proximal end to the distal end thereof; an access catheter which is configured to advance through the guiding catheter and which has an elongate catheter body section with an actuation lumen, a proximal end, a distal end and a distal section including a housing having a translation chamber in communication with the actuation lumen and bounded at least partially by an inner bore with a resilient rebound member disposed in the translation chamber proximally of a distal boundary of the translation chamber, a body section guidewire lumen separate from the actuation lumen and extending from the proximal end of the elongate catheter body section and disposed along the elongate catheter body section, and a hollow tissue penetration member having a sharpened tissue penetrating tip, a piston disposed proximally of the rebound member and slidably sealed against the inner bore of the translation chamber of the housing and an outside surface of a distal section of a tubular element of the body section guidewire lumen and a guidewire lumen in fluid communication and aligned with the body section guidewire lumen to allow a guidewire to be advanced from the body section guidewire lumen into the tissue penetration member guidewire lumen, the tissue penetration member being disposed at the distal section of the elongate catheter body section and axially displaceable in a distal direction with respect to the distal section of the elongate catheter body section and distal section of the tubular element from a retracted state with the sharpened distal tip disposed within the distal section of the catheter body section to a distally extended state with the sharpened distal tip extending distally beyond a distal end of the catheter body section; and a tissue penetration actuator including a pressurized fluid actuator in fluid communication with the actuation lumen and configured to impinge fluid on the piston to impart high velocity translation in a distal direction on the tissue penetration member relative to the distal section of the elongate catheter body section. 4. The access system of claim 3 wherein the resilient rebound member extends from the piston to the distal boundary of the translation chamber and exerts a proximally directed force on the piston when the tissue penetration member is in a fully retracted state so as to fully retract the tissue penetration member when the tissue penetration actuator is not actuated. 5. A transseptal access system, comprising: an elongate guiding catheter having a proximal end, a distal end and an inner lumen extending from the proximal end to the distal end thereof; an access catheter which is configured to advance through the guiding catheter and which has an elongate catheter body section with a proximal end, a distal end and a distal section, a body section guidewire lumen extending from the proximal end of the elongate catheter body section and disposed along the elongate catheter body section, and a hollow tissue penetration member having a sharpened tissue penetrating tip, a piston slidably sealed against an outside surface of a distal section of a tubular element of the body section guidewire lumen and a guidewire lumen in fluid communication and aligned with the body section guidewire lumen to allow a guidewire to be advanced from the body section guidewire lumen into the tissue penetration member guidewire lumen, the tissue penetration member being disposed at the distal section of the elongate catheter body section and axially displaceable in a distal direction with respect to the distal section of the elongate catheter body section and distal section of the tubular element from a retracted state with the sharpened distal tip disposed within the distal section of the catheter body section to a distally extended state with the sharpened distal tip extending distally beyond a distal end of the catheter body section; a tissue penetration actuator configured to impart high velocity translation in a distal direction on the tissue penetration member relative to the distal section of the elongate catheter body section; an interlock mechanism coupled to an interlock switch at the proximal end of the elongate catheter body section and configured to prevent distal translation of the tissue penetration member when in a locked state and allow distal translation of the tissue penetration member when in an unlocked state; and a distal contact member extending from the distal end of the access catheter and coupled to a contact trigger mechanism which is configured to prevent distal translation of the tissue penetration member when in a locked state and allow distal translation of the tissue penetration member when in an unlocked state when the interlock mechanism is also in an unlocked state whereby the contact trigger mechanism is unlocked upon contact with target tissue of the septum by the distal contact member. 6. A transseptal access system, comprising: an elongate guiding catheter having a proximal end, a distal end and an inner lumen extending from the proximal end to the distal end thereof; an access catheter which is configured to advance through the guiding catheter and which has an elongate catheter body section with a proximal end, a distal end and a distal section including a housing with a translation chamber, a body section guidewire lumen extending from the proximal end of the elongate catheter body section and disposed along the elongate catheter body section, and a hollow tissue penetration member having a sharpened tissue penetrating tip, a piston slidably sealed against an outside surface of a distal section of a tubular element of the body section guidewire lumen and a guidewire lumen in fluid communication and aligned with the body section guidewire lumen to allow a guidewire to be advanced from the body section guidewire lumen into the tissue penetration member guidewire lumen, the tissue penetration member being disposed at the distal section of the elongate catheter body section and axially displaceable in a distal direction with respect to the distal section of the elongate catheter body section from a retracted state with the sharpened distal tip disposed within the distal section of the catheter body section to a distally extended state with the sharpened distal tip extending distally beyond a distal end of the catheter body section; a tissue penetration actuator including a spring disposed within the translation chamber and configured to exert a distally directed force on the tissue penetration member when released from a compressed state and impart high velocity translation in a distal direction on the tissue penetration member relative to the distal section of the elongate catheter body section. 7. The access system of claim 6 wherein the spring comprises a compressible spring in a compressed state disposed proximally of the tissue penetration member prior to actuation. 8. An access catheter, comprising: an elongate catheter body section with a proximal end, a distal end, a distal section including a housing having a translation chamber bounded at least partially by an inner bore and an actuation lumen in communication with the translation chamber; a body section guidewire lumen separate from the actuation lumen and extending from the proximal end of the elongate catheter body section and disposed along the elongate catheter body section; a hollow tissue penetration member which has a piston slidably sealed against the inner bore of the translation chamber of the housing and an outside surface of a distal section of a tubular element of the body section guidewire lumen, a sharpened tissue penetrating tip and a guidewire lumen in fluid communication and aligned with the body section guidewire lumen to allow a guidewire to be advanced from the body section guidewire lumen into the tissue penetration member guidewire lumen, the tissue penetration member being disposed at the distal section of the elongate catheter body section and axially displaceable in a distal direction with respect to the distal section of the elongate catheter body section and distal section of the tubular element from a retracted state with the sharpened distal tip disposed within the distal section of the catheter body section to a distally extended state with the sharpened distal tip extending distally beyond a distal end of the catheter body section; and a tissue penetration actuator which includes a pressurized fluid actuator having a syringe actuated by a compressed spring, which is in fluid communication with the actuation lumen of the elongate catheter body section and which is coupled to the tissue penetration member and configured to impinge fluid on the piston to impart high velocity translation in a distal direction on the tissue penetration member relative to the distal section of the elongate catheter body section. 9. An access catheter, comprising an elongate catheter body section with a proximal end, a distal end, a distal section including a housing having a translation chamber bounded at least partially by an inner bore and an actuation lumen in communication with the translation chamber; a body section guidewire lumen extending from the proximal end of the elongate catheter body section and disposed along the elongate catheter body section; a hollow tissue penetration member which has a piston slidably sealed against the inner bore of the translation chamber of the housing and an outside surface of a distal section of a tubular element of the body section guidewire lumen, a sharpened tissue penetrating tip and a guidewire lumen in fluid communication and aligned with the body section guidewire lumen to allow a guidewire to be advanced from the body section guidewire lumen into the tissue penetration member guidewire lumen, the tissue penetration member being disposed at the distal section of the elongate catheter body section and axially displaceable in a distal direction with respect to the distal section of the elongate catheter body section and distal section of the tubular element from a retracted state with the sharpened distal tip disposed within the distal section of the catheter body section to a distally extended state with the sharpened distal tip extending distally beyond a distal end of the catheter body section; and a tissue penetration actuator including a pressurized fluid actuator in fluid communication with the actuation lumen of the elongate catheter body section coupled to the tissue penetration member and configured to impinge fluid on the piston to impart high velocity translation in a distal direction on the tissue penetration member relative to the distal section of the elongate catheter body section. 10. An access catheter, comprising: an elongate catheter body section with a proximal end, a distal end, a distal section including a housing having a translation chamber bounded at least partially by an inner bore and an actuation lumen in communication with the translation chamber; a body section guidewire lumen separate from the actuation lumen and extending from the proximal end of the elongate catheter body section and disposed along the elongate catheter body section; a hollow tissue penetration member which has a piston slidably sealed against the inner bore of the translation chamber of the housing and an outside surface of a distal section of a tubular element of the body section guidewire lumen, a sharpened tissue penetrating tip and a guidewire lumen in fluid communication and aligned with the body section guidewire lumen to allow a guidewire to be advanced from the body section guidewire lumen into the tissue penetration member guidewire lumen, the tissue penetration member being disposed at the distal section of the elongate catheter body section and axially displaceable in a distal direction with respect to the distal section of the elongate catheter body section and a distal section of the tubular element from a retracted state with the sharpened distal tip disposed within the distal section of the catheter body section to a distally extended state with the sharpened distal tip extending distally beyond a distal end of the catheter body section; a resilient rebound member disposed in the translation chamber between a distal end of the piston and a distal boundary of the translation chamber; and a tissue penetration actuator which includes a pressurized fluid actuator in fluid communication with the actuation lumen of the elongate catheter body section, which is coupled to the tissue penetration member and which is configured to impinge fluid on the piston to impart high velocity translation in a distal direction on the tissue penetration member relative to the distal section of the elongate catheter body section. 11. The access catheter of claim 10 wherein the resilient rebound member extends from the piston to the distal boundary of the translation chamber and exerts a proximally directed force on the piston when the tissue penetration member is in a fully retracted state so as to fully retract the tissue penetration member when the tissue penetration actuator is not actuated. 12. An access catheter, comprising: an elongate catheter body section with a proximal end, a distal end and a distal section; a body section guidewire lumen extending from the proximal end of the elongate catheter body section and disposed along the elongate catheter body section; a hollow tissue penetration member which has a sharpened tissue penetrating tip, a piston slidably sealed against an outside surface of a distal section of a tubular element the body section guidewire lumen and a guidewire lumen in fluid communication and aligned with the body section guidewire lumen to allow a guidewire to be advanced from the body section guidewire lumen into the tissue penetration member guidewire lumen, the tissue penetration member being disposed at the distal section of the elongate catheter body section and axially displaceable in a distal direction with respect to the distal section of the elongate catheter body section and a distal section of the tubular element from a retracted state with the sharpened distal tip disposed within the distal section of the catheter body section to a distally extended state with the sharpened distal tip extending distally beyond a distal end of the catheter body section; a tissue penetration actuator coupled to the tissue penetration member and configured to impart high velocity translation in a distal direction on the tissue penetration member relative to the distal section of the elongate catheter body section; an interlock mechanism coupled to an interlock switch at the proximal end of the elongate catheter body section and configured to prevent distal translation of the tissue penetration member when in a locked state and allow distal translation of the tissue penetration member when in an unlocked state; and a distal contact member extending from the distal end of the access catheter and coupled to a contact trigger mechanism which is configured to prevent distal translation of the tissue penetration member when in a locked state and allow distal translation of the tissue penetration member when in an unlocked state when the interlock mechanism is also in an unlocked state whereby the contact trigger mechanism is unlocked upon contact with target tissue of the septum by the distal contact member. 13. An access catheter, comprising: an elongate catheter body section with a proximal end, a distal end and a distal section including a housing with a translation chamber; a body section guidewire lumen extending from the proximal end of the elongate catheter body section and disposed along the elongate catheter body section; a hollow tissue penetration member which has a sharpened tissue penetrating tip, a piston slidably sealed against an outside surface of a distal section of a tubular element of the body section guidewire lumen and a guidewire lumen in fluid communication and aligned with the body section guidewire lumen to allow a guidewire to be advanced from the body section guidewire lumen into the tissue penetration member guidewire lumen, the tissue penetration member being disposed at the distal section of the elongate catheter body section and axially displaceable in a distal direction with respect to the distal section of the elongate catheter body section from a retracted state with the sharpened distal tip disposed within the distal section of the catheter body section to a distally extended state with the sharpened distal tip extending distally beyond a distal end of the catheter body section; and a tissue penetration actuator which includes a spring disposed within the translation chamber and configured to exert a distally directed force on the tissue penetration member when released from a compressed state and which is coupled to the tissue penetration member and configured to impart high velocity translation in a distal direction on the tissue penetration member relative to the distal section of the elongate catheter body section. 14. The access catheter of claim 13 wherein the spring comprises a compressible spring in a compressed state disposed proximally of the tissue penetration member prior to actuation.