DETAILED ACTION
This action is in response to amendments received on 08/03/2026. Claims 1-20 were previously pending. Claims 11 and 20 have been amended. A complete action on the merits of claims 1-20 follows below.
Notice of Pre-AIA or AIA Status
The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA .
In the event the determination of the status of the application as subject to AIA 35 U.S.C. 102 and 103 (or as subject to pre-AIA 35 U.S.C. 102 and 103) is incorrect, any correction of the statutory basis for the rejection will not be considered a new ground of rejection if the prior art relied upon, and the rationale supporting the rejection, would be the same under either status.
Response to Arguments
Applicant’s arguments, see pages 2-3, filed 08/03/2026, with respect to the rejection(s) of claims 1 and 18 under 5 U.S.C. 102(a)(1) as being anticipated by Howard have been fully considered and are persuasive. Examiner’s interpretation of Howard was that the signal used to assess contact by measuring impedance would naturally be lower than the treatment energy in order to prevent damage to tissue; however, as applicant pointed out Howard does not specifically state that. Therefore, the rejection has been withdrawn. However, upon further consideration, a new ground(s) of rejection is made in view of Paul, Adnerson and Prutchil.
Claim Rejections - 35 USC § 103
The following is a quotation of 35 U.S.C. 103 which forms the basis for all obviousness rejections set forth in this Office action:
A patent for a claimed invention may not be obtained, notwithstanding that the claimed invention is not identically disclosed as set forth in section 102, if the differences between the claimed invention and the prior art are such that the claimed invention as a whole would have been obvious before the effective filing date of the claimed invention to a person having ordinary skill in the art to which the claimed invention pertains. Patentability shall not be negated by the manner in which the invention was made.
The factual inquiries set forth in Graham v. John Deere Co., 383 U.S. 1, 148 USPQ 459 (1966), that are applied for establishing a background for determining obviousness under 35 U.S.C. 103 are summarized as follows:
1. Determining the scope and contents of the prior art.
2. Ascertaining the differences between the prior art and the claims at issue.
3. Resolving the level of ordinary skill in the pertinent art.
4. Considering objective evidence present in the application indicating obviousness or nonobviousness.
Claims 1-20 are rejected under 35 U.S.C. 103 as being unpatentable over Howard (US Pub. No. 2022/0061909) in view of Paul (US Pub. No. 2010/0274239).
Regarding Claim 1, Howard teaches a radiofrequency generator for use in a tissue puncture system for puncturing a tissue in a body ([0006]), the radiofrequency generator comprising:
a radiofrequency (RF) circuit configured to couple to an active electrode of an RF puncture device and configured to couple to a return electrode ([0061], [0065] and RF generator 354 coupled to at least one of electrodes 320, 322, 324,326, 328 in Fig. 19 in view of the monopolar mode),
the RF circuit configured to generate each of a puncture signal and a test signal (“A battery powered RF generator is configured to deliver RF energy to the electrode tip and also to measure impedance at the tip to provide information about the location of the electrode tip” [0006], “The processor may be configured to send a first signal to the output when the first electrode reaches a predetermined relationship with the tissue plane, and to send a second signal to the output when the second electrode reaches the predetermined relationship with the tissue plane” [0013], “The electrode tip 24 enables delivery of RF energy for piercing tissue, and optionally enables use as an ECG measuring device and/or an impedance measuring device” [0054], “Connector cable 28 may connect to an optional Electro-cardiogram (ECG) interface unit via connector 30. An optional ECG connector cable connects an ECG interface unit to an ECG recorder, which displays and captures ECG signals as a function of time. A generator connector cable may connect the ECG interface unit to an energy source such as a generator (not illustrated). In this embodiment, the ECG interface unit can function as a splitter, permitting connection of the electrosurgical tissue piercing apparatus 102 to both an ECG recorder and generator simultaneously. ECG signals can be continuously monitored and recorded and the filtering circuit within the ECG interface unit and may permit energy, for example RF energy, to be delivered from the generator through electrosurgical apparatus 10 without compromising the ECG recorder” [0057], “The RF generator may include a processor configured to associate a particular electrode in contact with the fossa with a depth of penetration of the needle through the fossa, and display an indicium of that depth. With multiple electrodes, once the tip passes through the fossa, the impedance change is noted. Then as subsequent electrodes are passed through the fossa, each time contact of an electrode with the blood pool or the tissue changes, impedance changes. Each electrode may be in communication with the proximal hub and RF generator by way of a unique electrical conductor, such as a wire or conductive traces embedded between insulator layers in the sidewall” [0067], “Distal segment 107 terminates at functional tip region 110, which comprises an energy delivery component and optionally also functions as an impedance and/or ECG measuring device” [0103] and “The processor 350 is configured to send a first signal to the output when the first electrode reaches a predetermined relationship with the tissue plane, and to send a second signal to the output when the second electrode reaches the predetermined relationship with the tissue plane. The predetermined relationship may be when the electrode first contacts the tissue plane, or when the electrode passes through the tissue plane such as into the left atrium blood pool beyond the tissue plane” [0135]); and
a controller 350 coupled to the RF circuit (Fig. 19, [0010]-[0014], [0067] and [0135]), the controller configured to: measure an impedance of the test signal ([0081]-[0084]); determine a state of the active electrode based on the impedance measurement (“a processor configured to take impedance measurements at the tip to confirm contact with the intra atrial septum and/or confirm entry into the left atrium” abstract, “The processor may be configured to send a first signal to the output when the first electrode reaches a predetermined relationship with the tissue plane, and to send a second signal to the output when the second electrode reaches the predetermined relationship with the tissue plane. The predetermined relationship may be when the electrode first contacts the tissue plane, or when the electrode passes through the tissue plane such as into a blood pool beyond the tissue plane. The output may comprise at least one of an audio output, a visual output, or a tactile output” [0013]-[0014], “generating a first output when the first electrode first contacts or penetrates through the tissue plane; and generating a second output when the second electrode first contacts or penetrates through the tissue plane” [0017], “The RF generator may include a processor configured to associate a particular electrode in contact with the fossa with a depth of penetration of the needle through the fossa, and display an indicium of that depth. With multiple electrodes, once the tip passes through the fossa, the impedance change is noted” [0067], “The impedance detection is also used for identifying contact with tissue and to confirm penetration of the target tissue wall” [0081] and “The impedance measurement enables an automatic power shutoff feature based upon penetration through septum which produces a measurable impedance change. Audible, visual and/or tactile feedback may be provided at milestone events such as when the electrode tip is placed in contact with tissue, and when the electrode tip 24 has penetrated through the fossa and enters the left atrium” [0084]); and display the state on a display device (“Audible, visual and/or tactile feedback may be provided at milestone events such as when the electrode tip is placed in contact with tissue” [0084] and [0014], [0136]);
although Examiner takes the position that naturally the impedance measuring signal must be lower than the treatment/puncture energy delivered to tissue, Howard is silent in specifically stating the test signal having a lower power than the puncture signal.
In the same field of invention, Paul teaches “The RF voltage signal being used to measure the phase angle may be supplied by the same RF power source that provides the ablation energy or may be provided by a separate independent supply. The frequency of the RF energy used to assess the electrical coupling is preferably between about 1 KHz and about 1000 KHz, and more preferably between about 50 KHz and about 500 KHz, and most preferably between about 400 KHz and about 500 KHz. The power of the RF signal needed to assess electrical coupling is much lower than the power levels required for ablation, and preferably is less than about 1 W, and more preferably less than about 0.001 W. The current amperage is also significantly less than is necessary for effective ablation and is preferably less than 10 mA, and more preferably less than about 1 mA” in [0107].
It would have been obvious to one having ordinary skill in the art prior to the effective filing date of the current invention that the power needed to assess electrical contact between any of the electrodes in the invention of Howard must be much less than the power required to ablate/puncture tissue during treatment in view of the teachings of Paul.
Regarding Claim 2, Howard teaches the invention as applied above and determining electrode contact with tissue based on the measured impedance, but does not specifically teach wherein the impedance includes complex impedance having magnitude and phase angle information.
In the same field of invention, Paul teaches determining the degree of contact between the electrode and tissue based on “a coupling index indicative of a degree of contact between an electrode and a tissue can be used. The coupling index can be calculated from the components of complex impedance, such as resistance, reactance, impedance magnitude, and impedance phase angle” in [0016].
It would have been obvious to one having ordinary skill in the art prior to the effective filing date of the current invention to detect the degree of contact between the electrode and tissue based on complex impedance having magnitude and phase angle information as Paul teaches since it is a known method of determining the contact.
Regarding Claim 3, Howard in view of Paul teaches wherein the test signal includes a frequency above 100 kHz (Paul teaches the “frequency of the RF energy used to assess the electrical coupling is preferably between about 1 KHz and about 1000 KHz, and more preferably between about 50 KHz and about 500 KHz, and most preferably between about 400 KHz and about 500 KHz” in [0107]).
It would have been obvious to one having ordinary skill in the art prior to the effective filing date of the current invention to use a frequency above 100 KHz applied in the test signal to determine contact between the electrode and tissue in view of the teachings of Paul as it is known in the art.
Regarding Claim 4, Howard in view of Paul teaches wherein the test signal includes a first frequency, and the puncture signal includes a second frequency (Howard teaches applying multiple signals, Paul teaches the test signal having a “frequency of the RF energy used to assess the electrical coupling is preferably between about 1 KHz and about 1000 KHz, and more preferably between about 50 KHz and about 500 KHz, and most preferably between about 400 KHz and about 500 KHz” in [0107] and Howard teaches “the energy is delivered as a continuous wave at a frequency between about 400 kHz and about 550 kHz, such as about 460 kHz” in [0061]).
Regarding Claim 5, Howard in view of Paul teaches wherein the first frequency is the same as the second frequency (Paul teaches the test signal having a “frequency of the RF energy used to assess the electrical coupling is preferably between about 1 KHz and about 1000 KHz, and more preferably between about 50 KHz and about 500 KHz, and most preferably between about 400 KHz and about 500 KHz” in [0107] and Howard teaches “the energy is delivered as a continuous wave at a frequency between about 400 kHz and about 550 kHz, such as about 460 kHz” in [0061]; therefore, there exist a range of first and second frequencies that are the same).
Regarding Claim 6, Howard in view of Paul teaches wherein the state of the active electrode is based on data loaded into a memory device of the controller ([0060] of Paul).
Regarding Claim 7, Howard in view of Paul teaches wherein the data is stored on a non-transitory memory device coupled to the RF puncture device ([0060] and Figs. 1, 3 of Paul).
Regarding Claim 8, Howard in view of Paul teaches wherein the state of the active electrode is determined from a lookup table ([0032], [0141] and [0169] of Paul).
Regarding Claim 9, Howard in view of Paul teaches wherein the lookup table is a multidimensional lookup table having impedance magnitude and phase angle as inputs ([0060] of Paul).
Regarding Claim 10, Howard in view of Paul teaches wherein the lookup table includes test signal frequency as an input (various frequencies-[0060]).
Regarding Claim 11, Howard teaches wherein the RF puncture device includes adilator/sheath assembly (flexible needle body 12/tubular body 104 shown in various figures), and wherein the state of the active electrode based on the impedance measurement is selected from one of open circuit state, the active electrode positioned proximally in the dilator/sheath assembly, the active electrode positioned distally in the dilator/sheath assembly, the active electrode at adilator tip of the dilator/sheath assembly, the active electrode extended from the dilator tip of the dilator/sheath assembly and in contact with a target tissue to be punctured, and the active electrode extended from the dilator tip of the dilator/sheath assembly and in contact with a fluid interposed between the active electrode and the target tissue (“a processor configured to take impedance measurements at the tip to confirm contact with the intra atrial septum and/or confirm entry into the left atrium” abstract, also see [0010]-[0014], [0067], [0081] and [0084]).
Regarding Claim 12, Howard teaches a tissue puncture system for puncturing a tissue in body, the tissue puncture system ([0006]) comprising: a puncture device having an active electrode (various figures 1A-14C and 17A-19 show different embodiments of a puncture device having an active electrode); and a radiofrequency (RF) generator coupled to the puncture device, the RF generator comprising: an RF circuit configured to couple to the active electrode of the puncture device and configured to couple to a return electrode ([0061], [0065] and RF generator 354 coupled to at least one of electrodes 320, 322, 324,326, 328 in Fig. 19 in view of the monopolar mode), the RF circuit configured to generate each of a puncture signal and a test signal (“A battery powered RF generator is configured to deliver RF energy to the electrode tip and also to measure impedance at the tip to provide information about the location of the electrode tip” [0006], “The processor may be configured to send a first signal to the output when the first electrode reaches a predetermined relationship with the tissue plane, and to send a second signal to the output when the second electrode reaches the predetermined relationship with the tissue plane” [0013], “The electrode tip 24 enables delivery of RF energy for piercing tissue, and optionally enables use as an ECG measuring device and/or an impedance measuring device” [0054], “Connector cable 28 may connect to an optional Electro-cardiogram (ECG) interface unit via connector 30. An optional ECG connector cable connects an ECG interface unit to an ECG recorder, which displays and captures ECG signals as a function of time. A generator connector cable may connect the ECG interface unit to an energy source such as a generator (not illustrated). In this embodiment, the ECG interface unit can function as a splitter, permitting connection of the electrosurgical tissue piercing apparatus 102 to both an ECG recorder and generator simultaneously. ECG signals can be continuously monitored and recorded and the filtering circuit within the ECG interface unit and may permit energy, for example RF energy, to be delivered from the generator through electrosurgical apparatus 10 without compromising the ECG recorder” [0057], “The RF generator may include a processor configured to associate a particular electrode in contact with the fossa with a depth of penetration of the needle through the fossa, and display an indicium of that depth. With multiple electrodes, once the tip passes through the fossa, the impedance change is noted. Then as subsequent electrodes are passed through the fossa, each time contact of an electrode with the blood pool or the tissue changes, impedance changes. Each electrode may be in communication with the proximal hub and RF generator by way of a unique electrical conductor, such as a wire or conductive traces embedded between insulator layers in the sidewall” [0067], “Distal segment 107 terminates at functional tip region 110, which comprises an energy delivery component and optionally also functions as an impedance and/or ECG measuring device” [0103] and “The processor 350 is configured to send a first signal to the output when the first electrode reaches a predetermined relationship with the tissue plane, and to send a second signal to the output when the second electrode reaches the predetermined relationship with the tissue plane. The predetermined relationship may be when the electrode first contacts the tissue plane, or when the electrode passes through the tissue plane such as into the left atrium blood pool beyond the tissue plane” [0135]); and
a controller coupled to the RF circuit (such as controller 350 in Fig. 19, [0010]-[0014], [0067] and [0135]), the controller configured to: measure an impedance of the test signal ([0081]-[0084]); determine a state of the active electrode based on the impedance measurement (“a processor configured to take impedance measurements at the tip to confirm contact with the intra atrial septum and/or confirm entry into the left atrium” abstract, “The processor may be configured to send a first signal to the output when the first electrode reaches a predetermined relationship with the tissue plane, and to send a second signal to the output when the second electrode reaches the predetermined relationship with the tissue plane. The predetermined relationship may be when the electrode first contacts the tissue plane, or when the electrode passes through the tissue plane such as into a blood pool beyond the tissue plane. The output may comprise at least one of an audio output, a visual output, or a tactile output” [0013]-[0014], “generating a first output when the first electrode first contacts or penetrates through the tissue plane; and generating a second output when the second electrode first contacts or penetrates through the tissue plane” [0017], “The RF generator may include a processor configured to associate a particular electrode in contact with the fossa with a depth of penetration of the needle through the fossa, and display an indicium of that depth. With multiple electrodes, once the tip passes through the fossa, the impedance change is noted” [0067], “The impedance detection is also used for identifying contact with tissue and to confirm penetration of the target tissue wall” [0081] and “The impedance measurement enables an automatic power shutoff feature based upon penetration through septum which produces a measurable impedance change. Audible, visual and/or tactile feedback may be provided at milestone events such as when the electrode tip is placed in contact with tissue, and when the electrode tip 24 has penetrated through the fossa and enters the left atrium” [0084]); and display the state on a display device (“Audible, visual and/or tactile feedback may be provided at milestone events such as when the electrode tip is placed in contact with tissue” [0084] and [0014], [0136]).
although Examiner takes the position that naturally the impedance measuring signal must be lower than the treatment/puncture energy delivered to tissue, Howard is silent in specifically stating the test signal having a lower power than the puncture signal.
In the same field of invention, Paul teaches “The RF voltage signal being used to measure the phase angle may be supplied by the same RF power source that provides the ablation energy or may be provided by a separate independent supply. The frequency of the RF energy used to assess the electrical coupling is preferably between about 1 KHz and about 1000 KHz, and more preferably between about 50 KHz and about 500 KHz, and most preferably between about 400 KHz and about 500 KHz. The power of the RF signal needed to assess electrical coupling is much lower than the power levels required for ablation, and preferably is less than about 1 W, and more preferably less than about 0.001 W. The current amperage is also significantly less than is necessary for effective ablation and is preferably less than 10 mA, and more preferably less than about 1 mA” in [0107].
It would have been obvious to one having ordinary skill in the art prior to the effective filing date of the current invention that the power needed to assess electrical contact between any of the electrodes in the invention of Howard must be much less than the power required to ablate/puncture tissue during treatment in view of the teachings of Paul.
Regarding Claim 13, Howard teaches wherein the puncture device is an RF puncture device ([0054] and [0060]-[0064]).
Regarding Claim 14, Howard teaches wherein the return electrode includes a patch electrode, and the tissue puncture system is configured to operate in a monopolar mode ([0061]).
Regarding Claim 15, Howard teaches wherein the RF puncture device includes a transseptal guidewire disposed within a dilator/sheath assembly ([0118]).
Regarding Claim 16, Howard in view of Paul teaches wherein the state of the active electrode is determined from a lookup table ([0060] of Paul).
Regarding Claim 17, Howard in view of Paul teaches wherein the lookup table is stored on a non-transitory memory device coupled to the puncture device ([0060] and Figs. 1, 3 of Paul).
Regarding Claim 18, Howard teaches a method for use in a tissue puncture system ([0010]-[0011]), the tissue puncture system (various figures 1A-14C and 17A-19 show different embodiments of a puncture device having an active electrode) including a radiofrequency energy source coupled to an active electrode of a puncture device and to a return electrode ([0061], [0065] and RF generator 354 coupled to at least one of electrodes 320, 322, 324,326, 328 in Fig. 19 in view of the monopolar mode), the method comprising:
causing the radiofrequency (RF) energy source to generate each of a puncture signal and a test signal (“A battery powered RF generator is configured to deliver RF energy to the electrode tip and also to measure impedance at the tip to provide information about the location of the electrode tip” [0006], “The processor may be configured to send a first signal to the output when the first electrode reaches a predetermined relationship with the tissue plane, and to send a second signal to the output when the second electrode reaches the predetermined relationship with the tissue plane” [0013], “The electrode tip 24 enables delivery of RF energy for piercing tissue, and optionally enables use as an ECG measuring device and/or an impedance measuring device” [0054], “Connector cable 28 may connect to an optional Electro-cardiogram (ECG) interface unit via connector 30. An optional ECG connector cable connects an ECG interface unit to an ECG recorder, which displays and captures ECG signals as a function of time. A generator connector cable may connect the ECG interface unit to an energy source such as a generator (not illustrated). In this embodiment, the ECG interface unit can function as a splitter, permitting connection of the electrosurgical tissue piercing apparatus 102 to both an ECG recorder and generator simultaneously. ECG signals can be continuously monitored and recorded and the filtering circuit within the ECG interface unit and may permit energy, for example RF energy, to be delivered from the generator through electrosurgical apparatus 10 without compromising the ECG recorder” [0057], “The RF generator may include a processor configured to associate a particular electrode in contact with the fossa with a depth of penetration of the needle through the fossa, and display an indicium of that depth. With multiple electrodes, once the tip passes through the fossa, the impedance change is noted. Then as subsequent electrodes are passed through the fossa, each time contact of an electrode with the blood pool or the tissue changes, impedance changes. Each electrode may be in communication with the proximal hub and RF generator by way of a unique electrical conductor, such as a wire or conductive traces embedded between insulator layers in the sidewall” [0067], “Distal segment 107 terminates at functional tip region 110, which comprises an energy delivery component and optionally also functions as an impedance and/or ECG measuring device” [0103] and “The processor 350 is configured to send a first signal to the output when the first electrode reaches a predetermined relationship with the tissue plane, and to send a second signal to the output when the second electrode reaches the predetermined relationship with the tissue plane. The predetermined relationship may be when the electrode first contacts the tissue plane, or when the electrode passes through the tissue plane such as into the left atrium blood pool beyond the tissue plane” [0135]);
measuring an impedance of the test signal (abstract, [0010]-[0014], [0067] and [0081]-[0084]); determining a state of the active electrode based on the impedance measurement (tissue contact is here interpreted to be a state of the electrode based on the impedance measurement, “a processor configured to take impedance measurements at the tip to confirm contact with the intra atrial septum” abstract, also see [0010]-[0014], [0067] and [0081]-[0084]); and
displaying the state on a display device (“Audible, visual and/or tactile feedback may be provided at milestone events such as when the electrode tip is placed in contact with tissue” [0084] and [0014], [0136]);
although Examiner takes the position that naturally the impedance measuring signal must be lower than the treatment/puncture energy delivered to tissue, Howard is silent in specifically stating the test signal having a lower power than the puncture signal.
In the same field of invention, Paul teaches “The RF voltage signal being used to measure the phase angle may be supplied by the same RF power source that provides the ablation energy or may be provided by a separate independent supply. The frequency of the RF energy used to assess the electrical coupling is preferably between about 1 KHz and about 1000 KHz, and more preferably between about 50 KHz and about 500 KHz, and most preferably between about 400 KHz and about 500 KHz. The power of the RF signal needed to assess electrical coupling is much lower than the power levels required for ablation, and preferably is less than about 1 W, and more preferably less than about 0.001 W. The current amperage is also significantly less than is necessary for effective ablation and is preferably less than 10 mA, and more preferably less than about 1 mA” in [0107].
It would have been obvious to one having ordinary skill in the art prior to the effective filing date of the current invention that the power needed to assess electrical contact between any of the electrodes in the invention of Howard must be much less than the power required to ablate/puncture tissue during treatment in view of the teachings of Paul.
Regarding Claim 19, Howard in view of Paul teaches wherein the measuring the impedance of the test signal includes measure a complex impedance having magnitude and phase angle information (Paul teaches determining the degree of contact between the electrode and tissue based on “a coupling index indicative of a degree of contact between an electrode and a tissue can be used. The coupling index can be calculated from the components of complex impedance, such as resistance, reactance, impedance magnitude, and impedance phase angle” in [0016]).
Regarding Claim 20, Howard teaches wherein the RF puncture device includes adilator/sheath assembly (flexible needle body 12/tubular body 104 shown in various figures), and wherein the state of the active electrode based on the impedance measurement is selected from one of open circuit state, the active electrode positioned proximally in the dilator/sheath assembly, the active electrode positioned distally in the dilator/sheath assembly, the active electrode at adilator tip of the dilator/sheath assembly, the active electrode extended from the dilator tip of the dilator/sheath assembly and in contact with a target tissue to be punctured, and the active electrode extended from the dilator tip of the dilator/sheath assembly and in contact with a fluid interposed between the active electrode and the target tissue (“a processor configured to take impedance measurements at the tip to confirm contact with the intra atrial septum and/or confirm entry into the left atrium” abstract, also see [0010]-[0014], [0067], [0081] and [0084]).
Claims 1, 11-15, 18 and 20 are rejected under 35 U.S.C. 103 as being unpatentable over Howard (US Pub. No. 2022/0061909) as applied above in view of Anderson (US Pub. No. 2009/0093864).
Regarding Claim 1, Howard teaches a radiofrequency generator for use in a tissue puncture system for puncturing a tissue in a body ([0006]), the radiofrequency generator comprising:
a radiofrequency (RF) circuit configured to couple to an active electrode of an RF puncture device and configured to couple to a return electrode ([0061], [0065] and RF generator 354 coupled to at least one of electrodes 320, 322, 324,326, 328 in Fig. 19 in view of the monopolar mode),
the RF circuit configured to generate each of a puncture signal and a test signal (“A battery powered RF generator is configured to deliver RF energy to the electrode tip and also to measure impedance at the tip to provide information about the location of the electrode tip” [0006], “The processor may be configured to send a first signal to the output when the first electrode reaches a predetermined relationship with the tissue plane, and to send a second signal to the output when the second electrode reaches the predetermined relationship with the tissue plane” [0013], “The electrode tip 24 enables delivery of RF energy for piercing tissue, and optionally enables use as an ECG measuring device and/or an impedance measuring device” [0054], “Connector cable 28 may connect to an optional Electro-cardiogram (ECG) interface unit via connector 30. An optional ECG connector cable connects an ECG interface unit to an ECG recorder, which displays and captures ECG signals as a function of time. A generator connector cable may connect the ECG interface unit to an energy source such as a generator (not illustrated). In this embodiment, the ECG interface unit can function as a splitter, permitting connection of the electrosurgical tissue piercing apparatus 102 to both an ECG recorder and generator simultaneously. ECG signals can be continuously monitored and recorded and the filtering circuit within the ECG interface unit and may permit energy, for example RF energy, to be delivered from the generator through electrosurgical apparatus 10 without compromising the ECG recorder” [0057], “The RF generator may include a processor configured to associate a particular electrode in contact with the fossa with a depth of penetration of the needle through the fossa, and display an indicium of that depth. With multiple electrodes, once the tip passes through the fossa, the impedance change is noted. Then as subsequent electrodes are passed through the fossa, each time contact of an electrode with the blood pool or the tissue changes, impedance changes. Each electrode may be in communication with the proximal hub and RF generator by way of a unique electrical conductor, such as a wire or conductive traces embedded between insulator layers in the sidewall” [0067], “Distal segment 107 terminates at functional tip region 110, which comprises an energy delivery component and optionally also functions as an impedance and/or ECG measuring device” [0103] and “The processor 350 is configured to send a first signal to the output when the first electrode reaches a predetermined relationship with the tissue plane, and to send a second signal to the output when the second electrode reaches the predetermined relationship with the tissue plane. The predetermined relationship may be when the electrode first contacts the tissue plane, or when the electrode passes through the tissue plane such as into the left atrium blood pool beyond the tissue plane” [0135]); and
a controller 350 coupled to the RF circuit (Fig. 19, [0010]-[0014], [0067] and [0135]), the controller configured to: measure an impedance of the test signal ([0081]-[0084]); determine a state of the active electrode based on the impedance measurement (“a processor configured to take impedance measurements at the tip to confirm contact with the intra atrial septum and/or confirm entry into the left atrium” abstract, “The processor may be configured to send a first signal to the output when the first electrode reaches a predetermined relationship with the tissue plane, and to send a second signal to the output when the second electrode reaches the predetermined relationship with the tissue plane. The predetermined relationship may be when the electrode first contacts the tissue plane, or when the electrode passes through the tissue plane such as into a blood pool beyond the tissue plane. The output may comprise at least one of an audio output, a visual output, or a tactile output” [0013]-[0014], “generating a first output when the first electrode first contacts or penetrates through the tissue plane; and generating a second output when the second electrode first contacts or penetrates through the tissue plane” [0017], “The RF generator may include a processor configured to associate a particular electrode in contact with the fossa with a depth of penetration of the needle through the fossa, and display an indicium of that depth. With multiple electrodes, once the tip passes through the fossa, the impedance change is noted” [0067], “The impedance detection is also used for identifying contact with tissue and to confirm penetration of the target tissue wall” [0081] and “The impedance measurement enables an automatic power shutoff feature based upon penetration through septum which produces a measurable impedance change. Audible, visual and/or tactile feedback may be provided at milestone events such as when the electrode tip is placed in contact with tissue, and when the electrode tip 24 has penetrated through the fossa and enters the left atrium” [0084]); and display the state on a display device (“Audible, visual and/or tactile feedback may be provided at milestone events such as when the electrode tip is placed in contact with tissue” [0084] and [0014], [0136]);
although Examiner takes the position that naturally the impedance measuring signal must be lower than the treatment/puncture energy delivered to tissue, Howard is silent in specifically stating the test signal having a lower power than the puncture signal.
In the same field of invention, Anderson teaches “In module 602 the controller 102 tests the sufficiency of contact with each electrode. The controller may test the impedance level of each electrode circuit to determine if the impedance is low enough for a proper treatment. A low level RF signal or test energy may be applied to determine the impedance values. It has been determined that an impedance value in the range of 10-400 ohms would be an acceptable range of impedance to apply RF energy to tissue. The controller 102 then determines if the impedance value is appropriate to continue treatment in module 604. If the controller 102 determines that the impedance values are too highs then a warning signal may be transmitted to an operator in module 606. If the controller 102 determines that the impedance values are at an appropriate level to continue treatment then the operation may proceed to module 608” [0053].
It would have been obvious to one having ordinary skill in the art prior to the effective filing date of the current invention to test sufficiency of electrode tissue contact with a low level RF energy or test signal prior to applying the treatment energy to tissue in order to reduce or prevent injury to tissue while assessing contact and positioning/state of position of the electrode with respect to the tissue.
Regarding Claim 11, Howard teaches wherein the RF puncture device includes adilator/sheath assembly (flexible needle body 12/tubular body 104 shown in various figures), and wherein the state of the active electrode based on the impedance measurement is selected from one of open circuit state, the active electrode positioned proximally in the dilator/sheath assembly, the active electrode positioned distally in the dilator/sheath assembly, the active electrode at adilator tip of the dilator/sheath assembly, the active electrode extended from the dilator tip of the dilator/sheath assembly and in contact with a target tissue to be punctured, and the active electrode extended from the dilator tip of the dilator/sheath assembly and in contact with a fluid interposed between the active electrode and the target tissue (“a processor configured to take impedance measurements at the tip to confirm contact with the intra atrial septum and/or confirm entry into the left atrium” abstract, also see [0010]-[0014], [0067], [0081] and [0084]).
Regarding Claim 12, Howard teaches a tissue puncture system for puncturing a tissue in body, the tissue puncture system ([0006]) comprising: a puncture device having an active electrode (various figures 1A-14C and 17A-19 show different embodiments of a puncture device having an active electrode); and a radiofrequency (RF) generator coupled to the puncture device, the RF generator comprising: an RF circuit configured to couple to the active electrode of the puncture device and configured to couple to a return electrode ([0061], [0065] and RF generator 354 coupled to at least one of electrodes 320, 322, 324,326, 328 in Fig. 19 in view of the monopolar mode), the RF circuit configured to generate each of a puncture signal and a test signal (“A battery powered RF generator is configured to deliver RF energy to the electrode tip and also to measure impedance at the tip to provide information about the location of the electrode tip” [0006], “The processor may be configured to send a first signal to the output when the first electrode reaches a predetermined relationship with the tissue plane, and to send a second signal to the output when the second electrode reaches the predetermined relationship with the tissue plane” [0013], “The electrode tip 24 enables delivery of RF energy for piercing tissue, and optionally enables use as an ECG measuring device and/or an impedance measuring device” [0054], “Connector cable 28 may connect to an optional Electro-cardiogram (ECG) interface unit via connector 30. An optional ECG connector cable connects an ECG interface unit to an ECG recorder, which displays and captures ECG signals as a function of time. A generator connector cable may connect the ECG interface unit to an energy source such as a generator (not illustrated). In this embodiment, the ECG interface unit can function as a splitter, permitting connection of the electrosurgical tissue piercing apparatus 102 to both an ECG recorder and generator simultaneously. ECG signals can be continuously monitored and recorded and the filtering circuit within the ECG interface unit and may permit energy, for example RF energy, to be delivered from the generator through electrosurgical apparatus 10 without compromising the ECG recorder” [0057], “The RF generator may include a processor configured to associate a particular electrode in contact with the fossa with a depth of penetration of the needle through the fossa, and display an indicium of that depth. With multiple electrodes, once the tip passes through the fossa, the impedance change is noted. Then as subsequent electrodes are passed through the fossa, each time contact of an electrode with the blood pool or the tissue changes, impedance changes. Each electrode may be in communication with the proximal hub and RF generator by way of a unique electrical conductor, such as a wire or conductive traces embedded between insulator layers in the sidewall” [0067], “Distal segment 107 terminates at functional tip region 110, which comprises an energy delivery component and optionally also functions as an impedance and/or ECG measuring device” [0103] and “The processor 350 is configured to send a first signal to the output when the first electrode reaches a predetermined relationship with the tissue plane, and to send a second signal to the output when the second electrode reaches the predetermined relationship with the tissue plane. The predetermined relationship may be when the electrode first contacts the tissue plane, or when the electrode passes through the tissue plane such as into the left atrium blood pool beyond the tissue plane” [0135]); and
a controller coupled to the RF circuit (such as controller 350 in Fig. 19, [0010]-[0014], [0067] and [0135]), the controller configured to: measure an impedance of the test signal ([0081]-[0084]); determine a state of the active electrode based on the impedance measurement (“a processor configured to take impedance measurements at the tip to confirm contact with the intra atrial septum and/or confirm entry into the left atrium” abstract, “The processor may be configured to send a first signal to the output when the first electrode reaches a predetermined relationship with the tissue plane, and to send a second signal to the output when the second electrode reaches the predetermined relationship with the tissue plane. The predetermined relationship may be when the electrode first contacts the tissue plane, or when the electrode passes through the tissue plane such as into a blood pool beyond the tissue plane. The output may comprise at least one of an audio output, a visual output, or a tactile output” [0013]-[0014], “generating a first output when the first electrode first contacts or penetrates through the tissue plane; and generating a second output when the second electrode first contacts or penetrates through the tissue plane” [0017], “The RF generator may include a processor configured to associate a particular electrode in contact with the fossa with a depth of penetration of the needle through the fossa, and display an indicium of that depth. With multiple electrodes, once the tip passes through the fossa, the impedance change is noted” [0067], “The impedance detection is also used for identifying contact with tissue and to confirm penetration of the target tissue wall” [0081] and “The impedance measurement enables an automatic power shutoff feature based upon penetration through septum which produces a measurable impedance change. Audible, visual and/or tactile feedback may be provided at milestone events such as when the electrode tip is placed in contact with tissue, and when the electrode tip 24 has penetrated through the fossa and enters the left atrium” [0084]); and display the state on a display device (“Audible, visual and/or tactile feedback may be provided at milestone events such as when the electrode tip is placed in contact with tissue” [0084] and [0014], [0136]);
although Examiner takes the position that naturally the impedance measuring signal must be lower than the treatment/puncture energy delivered to tissue, Howard is silent in specifically stating the test signal having a lower power than the puncture signal.
In the same field of invention, Anderson teaches “In module 602 the controller 102 tests the sufficiency of contact with each electrode. The controller may test the impedance level of each electrode circuit to determine if the impedance is low enough for a proper treatment. A low level RF signal or test energy may be applied to determine the impedance values. It has been determined that an impedance value in the range of 10-400 ohms would be an acceptable range of impedance to apply RF energy to tissue. The controller 102 then determines if the impedance value is appropriate to continue treatment in module 604. If the controller 102 determines that the impedance values are too highs then a warning signal may be transmitted to an operator in module 606. If the controller 102 determines that the impedance values are at an appropriate level to continue treatment then the operation may proceed to module 608” [0053].
It would have been obvious to one having ordinary skill in the art prior to the effective filing date of the current invention to test sufficiency of electrode tissue contact with a low level RF energy or test signal prior to applying the treatment energy to tissue in order to reduce or prevent injury to tissue while assessing contact and positioning/state of position of the electrode with respect to the tissue.
Regarding Claim 13, Howard teaches wherein the puncture device is an RF puncture device ([0054] and [0060]-[0064]).
Regarding Claim 14, Howard teaches wherein the return electrode includes a patch electrode, and the tissue puncture system is configured to operate in a monopolar mode ([0061]).
Regarding Claim 15, Howard teaches wherein the RF puncture device includes a transseptal guidewire disposed within a dilator/sheath assembly ([0118]).
Regarding Claim 18, Howard teaches a method for use in a tissue puncture system ([0010]-[0011]), the tissue puncture system (various figures 1A-14C and 17A-19 show different embodiments of a puncture device having an active electrode) including a radiofrequency energy source coupled to an active electrode of a puncture device and to a return electrode ([0061], [0065] and RF generator 354 coupled to at least one of electrodes 320, 322, 324,326, 328 in Fig. 19 in view of the monopolar mode), the method comprising:
causing the radiofrequency (RF) energy source to generate each of a puncture signal and a test signal (“A battery powered RF generator is configured to deliver RF energy to the electrode tip and also to measure impedance at the tip to provide information about the location of the electrode tip” [0006], “The processor may be configured to send a first signal to the output when the first electrode reaches a predetermined relationship with the tissue plane, and to send a second signal to the output when the second electrode reaches the predetermined relationship with the tissue plane” [0013], “The electrode tip 24 enables delivery of RF energy for piercing tissue, and optionally enables use as an ECG measuring device and/or an impedance measuring device” [0054], “Connector cable 28 may connect to an optional Electro-cardiogram (ECG) interface unit via connector 30. An optional ECG connector cable connects an ECG interface unit to an ECG recorder, which displays and captures ECG signals as a function of time. A generator connector cable may connect the ECG interface unit to an energy source such as a generator (not illustrated). In this embodiment, the ECG interface unit can function as a splitter, permitting connection of the electrosurgical tissue piercing apparatus 102 to both an ECG recorder and generator simultaneously. ECG signals can be continuously monitored and recorded and the filtering circuit within the ECG interface unit and may permit energy, for example RF energy, to be delivered from the generator through electrosurgical apparatus 10 without compromising the ECG recorder” [0057], “The RF generator may include a processor configured to associate a particular electrode in contact with the fossa with a depth of penetration of the needle through the fossa, and display an indicium of that depth. With multiple electrodes, once the tip passes through the fossa, the impedance change is noted. Then as subsequent electrodes are passed through the fossa, each time contact of an electrode with the blood pool or the tissue changes, impedance changes. Each electrode may be in communication with the proximal hub and RF generator by way of a unique electrical conductor, such as a wire or conductive traces embedded between insulator layers in the sidewall” [0067], “Distal segment 107 terminates at functional tip region 110, which comprises an energy delivery component and optionally also functions as an impedance and/or ECG measuring device” [0103] and “The processor 350 is configured to send a first signal to the output when the first electrode reaches a predetermined relationship with the tissue plane, and to send a second signal to the output when the second electrode reaches the predetermined relationship with the tissue plane. The predetermined relationship may be when the electrode first contacts the tissue plane, or when the electrode passes through the tissue plane such as into the left atrium blood pool beyond the tissue plane” [0135]);
measuring an impedance of the test signal (abstract, [0010]-[0014], [0067] and [0081]-[0084]); determining a state of the active electrode based on the impedance measurement (tissue contact is here interpreted to be a state of the electrode based on the impedance measurement, “a processor configured to take impedance measurements at the tip to confirm contact with the intra atrial septum” abstract, also see [0010]-[0014], [0067] and [0081]-[0084]); and
displaying the state on a display device (“Audible, visual and/or tactile feedback may be provided at milestone events such as when the electrode tip is placed in contact with tissue” [0084] and [0014], [0136]);
although Examiner takes the position that naturally the impedance measuring signal must be lower than the treatment/puncture energy delivered to tissue, Howard is silent in specifically stating the test signal having a lower power than the puncture signal.
In the same field of invention, Anderson teaches “In module 602 the controller 102 tests the sufficiency of contact with each electrode. The controller may test the impedance level of each electrode circuit to determine if the impedance is low enough for a proper treatment. A low level RF signal or test energy may be applied to determine the impedance values. It has been determined that an impedance value in the range of 10-400 ohms would be an acceptable range of impedance to apply RF energy to tissue. The controller 102 then determines if the impedance value is appropriate to continue treatment in module 604. If the controller 102 determines that the impedance values are too highs then a warning signal may be transmitted to an operator in module 606. If the controller 102 determines that the impedance values are at an appropriate level to continue treatment then the operation may proceed to module 608” [0053].
It would have been obvious to one having ordinary skill in the art prior to the effective filing date of the current invention to test sufficiency of electrode tissue contact with a low level RF energy or test signal prior to applying the treatment energy to tissue in order to reduce or prevent injury to tissue while assessing contact and positioning/state of position of the electrode with respect to the tissue.
Regarding Claim 20, Howard teaches wherein the RF puncture device includes adilator/sheath assembly (flexible needle body 12/tubular body 104 shown in various figures), and wherein the state of the active electrode based on the impedance measurement is selected from one of open circuit state, the active electrode positioned proximally in the dilator/sheath assembly, the active electrode positioned distally in the dilator/sheath assembly, the active electrode at adilator tip of the dilator/sheath assembly, the active electrode extended from the dilator tip of the dilator/sheath assembly and in contact with a target tissue to be punctured, and the active electrode extended from the dilator tip of the dilator/sheath assembly and in contact with a fluid interposed between the active electrode and the target tissue (“a processor configured to take impedance measurements at the tip to confirm contact with the intra atrial septum and/or confirm entry into the left atrium” abstract, also see [0010]-[0014], [0067], [0081] and [0084]).
Claims 1, 11-15, 18 and 20 are rejected under 35 U.S.C. 103 as being unpatentable over Howard (US Pub. No. 2022/0061909) as applied above in view of Prutchi (US Pub. No. 2016/0199127).
Regarding Claim 1, Howard teaches a radiofrequency generator for use in a tissue puncture system for puncturing a tissue in a body ([0006]), the radiofrequency generator comprising:
a radiofrequency (RF) circuit configured to couple to an active electrode of an RF puncture device and configured to couple to a return electrode ([0061], [0065] and RF generator 354 coupled to at least one of electrodes 320, 322, 324,326, 328 in Fig. 19 in view of the monopolar mode),
the RF circuit configured to generate each of a puncture signal and a test signal (“A battery powered RF generator is configured to deliver RF energy to the electrode tip and also to measure impedance at the tip to provide information about the location of the electrode tip” [0006], “The processor may be configured to send a first signal to the output when the first electrode reaches a predetermined relationship with the tissue plane, and to send a second signal to the output when the second electrode reaches the predetermined relationship with the tissue plane” [0013], “The electrode tip 24 enables delivery of RF energy for piercing tissue, and optionally enables use as an ECG measuring device and/or an impedance measuring device” [0054], “Connector cable 28 may connect to an optional Electro-cardiogram (ECG) interface unit via connector 30. An optional ECG connector cable connects an ECG interface unit to an ECG recorder, which displays and captures ECG signals as a function of time. A generator connector cable may connect the ECG interface unit to an energy source such as a generator (not illustrated). In this embodiment, the ECG interface unit can function as a splitter, permitting connection of the electrosurgical tissue piercing apparatus 102 to both an ECG recorder and generator simultaneously. ECG signals can be continuously monitored and recorded and the filtering circuit within the ECG interface unit and may permit energy, for example RF energy, to be delivered from the generator through electrosurgical apparatus 10 without compromising the ECG recorder” [0057], “The RF generator may include a processor configured to associate a particular electrode in contact with the fossa with a depth of penetration of the needle through the fossa, and display an indicium of that depth. With multiple electrodes, once the tip passes through the fossa, the impedance change is noted. Then as subsequent electrodes are passed through the fossa, each time contact of an electrode with the blood pool or the tissue changes, impedance changes. Each electrode may be in communication with the proximal hub and RF generator by way of a unique electrical conductor, such as a wire or conductive traces embedded between insulator layers in the sidewall” [0067], “Distal segment 107 terminates at functional tip region 110, which comprises an energy delivery component and optionally also functions as an impedance and/or ECG measuring device” [0103] and “The processor 350 is configured to send a first signal to the output when the first electrode reaches a predetermined relationship with the tissue plane, and to send a second signal to the output when the second electrode reaches the predetermined relationship with the tissue plane. The predetermined relationship may be when the electrode first contacts the tissue plane, or when the electrode passes through the tissue plane such as into the left atrium blood pool beyond the tissue plane” [0135]); and
a controller 350 coupled to the RF circuit (Fig. 19, [0010]-[0014], [0067] and [0135]), the controller configured to: measure an impedance of the test signal ([0081]-[0084]); determine a state of the active electrode based on the impedance measurement (“a processor configured to take impedance measurements at the tip to confirm contact with the intra atrial septum and/or confirm entry into the left atrium” abstract, “The processor may be configured to send a first signal to the output when the first electrode reaches a predetermined relationship with the tissue plane, and to send a second signal to the output when the second electrode reaches the predetermined relationship with the tissue plane. The predetermined relationship may be when the electrode first contacts the tissue plane, or when the electrode passes through the tissue plane such as into a blood pool beyond the tissue plane. The output may comprise at least one of an audio output, a visual output, or a tactile output” [0013]-[0014], “generating a first output when the first electrode first contacts or penetrates through the tissue plane; and generating a second output when the second electrode first contacts or penetrates through the tissue plane” [0017], “The RF generator may include a processor configured to associate a particular electrode in contact with the fossa with a depth of penetration of the needle through the fossa, and display an indicium of that depth. With multiple electrodes, once the tip passes through the fossa, the impedance change is noted” [0067], “The impedance detection is also used for identifying contact with tissue and to confirm penetration of the target tissue wall” [0081] and “The impedance measurement enables an automatic power shutoff feature based upon penetration through septum which produces a measurable impedance change. Audible, visual and/or tactile feedback may be provided at milestone events such as when the electrode tip is placed in contact with tissue, and when the electrode tip 24 has penetrated through the fossa and enters the left atrium” [0084]); and display the state on a display device (“Audible, visual and/or tactile feedback may be provided at milestone events such as when the electrode tip is placed in contact with tissue” [0084] and [0014], [0136]);
although Examiner takes the position that naturally the impedance measuring signal must be lower than the treatment/puncture energy delivered to tissue, Howard is silent in specifically stating the test signal having a lower power than the puncture signal.
In the same field of invention, Prutchi teaches “The control unit may include, for example, an RF generator. The control unit may have a number of channels that convey an electrical signal bipolarly through a target tissue between electrode pairs (for example, the ablation electrodes may be mounted on the catheter's working [distal] end), and/or unipolarly through a target tissue between an ablation electrode and a dispersive (reference) electrode (e.g., a shaft electrode in contact with lumen fluid (for example blood) and/or an external electrode). The electrodes may be activated in accordance with a switch configuration set by a multiplexer. Multiplexer RF channels may be used to transmit radio frequency (RF) ablation energy to the electrodes. The RF channels may optionally be used to transmit an auxiliary signal. For example an auxiliary signal may be used to measure impedance, slew rate and/or propagation time between pairs of electrodes. When measuring impedance, slew rate and/or propagation time a sensor may optionally include an electrode. In some embodiments a sensor for measuring impedance, slew rate and/or propagation time may include one or more of an ablation electrode and/or a dispersive electrode. For example an auxiliary signal may be similar to an ablation signal but at a lower power (optionally minimizing and/or avoiding tissue damage during measurements). The RF channels may optionally include means to measure electrode/tissue impedance, slew rate and/or propagation time. In some embodiments, measurements may be made with high accuracy and/or repeatability. The RF channels may optionally be controlled by a controller (e.g., a microcontroller and/or single-board computer). The channels may optionally be capable of generating stimulation signals to evoke a response from target tissues and/or measuring an evoked signal from the target tissue. For example, the control unit may transmit a nerve stimulating signal over an electrode (for example an electrode of the ablation catheter). For example, the control unit may evaluate an electrical signal transmitted by the target tissue and/or sensed by an electrode (for example an electrode of the ablation catheter)” [0153] and “electrode impedance, slew rate and/or propagation time measurements may be used to estimate contact (estimated contact) between electrode and tissue as surrogate for thermal contact between electrode interface and target tissue (for example a low impedance of a unipolar signal between an ablation electrode and a dispersive electrode may indicate good contact between the ablation electrode and the target tissue)” [0157].
It would have been obvious to one having ordinary skill in the art prior to the effective filing date of the current invention to use an auxiliary signal which may be similar to an ablation signal but at a lower power to measure impedance and assess electrode/tissue contact in order to minimizing and/or avoiding tissue damage during impedance measurement prior to the actual treatment/puncturing with the higher energy.
Regarding Claim 11, Howard teaches wherein the RF puncture device includes adilator/sheath assembly (flexible needle body 12/tubular body 104 shown in various figures), and wherein the state of the active electrode based on the impedance measurement is selected from one of open circuit state, the active electrode positioned proximally in the dilator/sheath assembly, the active electrode positioned distally in the dilator/sheath assembly, the active electrode at adilator tip of the dilator/sheath assembly, the active electrode extended from the dilator tip of the dilator/sheath assembly and in contact with a target tissue to be punctured, and the active electrode extended from the dilator tip of the dilator/sheath assembly and in contact with a fluid interposed between the active electrode and the target tissue (“a processor configured to take impedance measurements at the tip to confirm contact with the intra atrial septum and/or confirm entry into the left atrium” abstract, also see [0010]-[0014], [0067], [0081] and [0084]).
Regarding Claim 12, Howard teaches a tissue puncture system for puncturing a tissue in body, the tissue puncture system ([0006]) comprising: a puncture device having an active electrode (various figures 1A-14C and 17A-19 show different embodiments of a puncture device having an active electrode); and a radiofrequency (RF) generator coupled to the puncture device, the RF generator comprising: an RF circuit configured to couple to the active electrode of the puncture device and configured to couple to a return electrode ([0061], [0065] and RF generator 354 coupled to at least one of electrodes 320, 322, 324,326, 328 in Fig. 19 in view of the monopolar mode), the RF circuit configured to generate each of a puncture signal and a test signal (“A battery powered RF generator is configured to deliver RF energy to the electrode tip and also to measure impedance at the tip to provide information about the location of the electrode tip” [0006], “The processor may be configured to send a first signal to the output when the first electrode reaches a predetermined relationship with the tissue plane, and to send a second signal to the output when the second electrode reaches the predetermined relationship with the tissue plane” [0013], “The electrode tip 24 enables delivery of RF energy for piercing tissue, and optionally enables use as an ECG measuring device and/or an impedance measuring device” [0054], “Connector cable 28 may connect to an optional Electro-cardiogram (ECG) interface unit via connector 30. An optional ECG connector cable connects an ECG interface unit to an ECG recorder, which displays and captures ECG signals as a function of time. A generator connector cable may connect the ECG interface unit to an energy source such as a generator (not illustrated). In this embodiment, the ECG interface unit can function as a splitter, permitting connection of the electrosurgical tissue piercing apparatus 102 to both an ECG recorder and generator simultaneously. ECG signals can be continuously monitored and recorded and the filtering circuit within the ECG interface unit and may permit energy, for example RF energy, to be delivered from the generator through electrosurgical apparatus 10 without compromising the ECG recorder” [0057], “The RF generator may include a processor configured to associate a particular electrode in contact with the fossa with a depth of penetration of the needle through the fossa, and display an indicium of that depth. With multiple electrodes, once the tip passes through the fossa, the impedance change is noted. Then as subsequent electrodes are passed through the fossa, each time contact of an electrode with the blood pool or the tissue changes, impedance changes. Each electrode may be in communication with the proximal hub and RF generator by way of a unique electrical conductor, such as a wire or conductive traces embedded between insulator layers in the sidewall” [0067], “Distal segment 107 terminates at functional tip region 110, which comprises an energy delivery component and optionally also functions as an impedance and/or ECG measuring device” [0103] and “The processor 350 is configured to send a first signal to the output when the first electrode reaches a predetermined relationship with the tissue plane, and to send a second signal to the output when the second electrode reaches the predetermined relationship with the tissue plane. The predetermined relationship may be when the electrode first contacts the tissue plane, or when the electrode passes through the tissue plane such as into the left atrium blood pool beyond the tissue plane” [0135]); and
a controller coupled to the RF circuit (such as controller 350 in Fig. 19, [0010]-[0014], [0067] and [0135]), the controller configured to: measure an impedance of the test signal ([0081]-[0084]); determine a state of the active electrode based on the impedance measurement (“a processor configured to take impedance measurements at the tip to confirm contact with the intra atrial septum and/or confirm entry into the left atrium” abstract, “The processor may be configured to send a first signal to the output when the first electrode reaches a predetermined relationship with the tissue plane, and to send a second signal to the output when the second electrode reaches the predetermined relationship with the tissue plane. The predetermined relationship may be when the electrode first contacts the tissue plane, or when the electrode passes through the tissue plane such as into a blood pool beyond the tissue plane. The output may comprise at least one of an audio output, a visual output, or a tactile output” [0013]-[0014], “generating a first output when the first electrode first contacts or penetrates through the tissue plane; and generating a second output when the second electrode first contacts or penetrates through the tissue plane” [0017], “The RF generator may include a processor configured to associate a particular electrode in contact with the fossa with a depth of penetration of the needle through the fossa, and display an indicium of that depth. With multiple electrodes, once the tip passes through the fossa, the impedance change is noted” [0067], “The impedance detection is also used for identifying contact with tissue and to confirm penetration of the target tissue wall” [0081] and “The impedance measurement enables an automatic power shutoff feature based upon penetration through septum which produces a measurable impedance change. Audible, visual and/or tactile feedback may be provided at milestone events such as when the electrode tip is placed in contact with tissue, and when the electrode tip 24 has penetrated through the fossa and enters the left atrium” [0084]); and display the state on a display device (“Audible, visual and/or tactile feedback may be provided at milestone events such as when the electrode tip is placed in contact with tissue” [0084] and [0014], [0136]);
although Examiner takes the position that naturally the impedance measuring signal must be lower than the treatment/puncture energy delivered to tissue, Howard is silent in specifically stating the test signal having a lower power than the puncture signal.
In the same field of invention, Prutchi teaches “The control unit may include, for example, an RF generator. The control unit may have a number of channels that convey an electrical signal bipolarly through a target tissue between electrode pairs (for example, the ablation electrodes may be mounted on the catheter's working [distal] end), and/or unipolarly through a target tissue between an ablation electrode and a dispersive (reference) electrode (e.g., a shaft electrode in contact with lumen fluid (for example blood) and/or an external electrode). The electrodes may be activated in accordance with a switch configuration set by a multiplexer. Multiplexer RF channels may be used to transmit radio frequency (RF) ablation energy to the electrodes. The RF channels may optionally be used to transmit an auxiliary signal. For example an auxiliary signal may be used to measure impedance, slew rate and/or propagation time between pairs of electrodes. When measuring impedance, slew rate and/or propagation time a sensor may optionally include an electrode. In some embodiments a sensor for measuring impedance, slew rate and/or propagation time may include one or more of an ablation electrode and/or a dispersive electrode. For example an auxiliary signal may be similar to an ablation signal but at a lower power (optionally minimizing and/or avoiding tissue damage during measurements). The RF channels may optionally include means to measure electrode/tissue impedance, slew rate and/or propagation time. In some embodiments, measurements may be made with high accuracy and/or repeatability. The RF channels may optionally be controlled by a controller (e.g., a microcontroller and/or single-board computer). The channels may optionally be capable of generating stimulation signals to evoke a response from target tissues and/or measuring an evoked signal from the target tissue. For example, the control unit may transmit a nerve stimulating signal over an electrode (for example an electrode of the ablation catheter). For example, the control unit may evaluate an electrical signal transmitted by the target tissue and/or sensed by an electrode (for example an electrode of the ablation catheter)” [0153] and “electrode impedance, slew rate and/or propagation time measurements may be used to estimate contact (estimated contact) between electrode and tissue as surrogate for thermal contact between electrode interface and target tissue (for example a low impedance of a unipolar signal between an ablation electrode and a dispersive electrode may indicate good contact between the ablation electrode and the target tissue)” [0157].
It would have been obvious to one having ordinary skill in the art prior to the effective filing date of the current invention to use an auxiliary signal which may be similar to an ablation signal but at a lower power to measure impedance and assess electrode/tissue contact in order to minimizing and/or avoiding tissue damage during impedance measurement prior to the actual treatment/puncturing with the higher energy.
Regarding Claim 13, Howard teaches wherein the puncture device is an RF puncture device ([0054] and [0060]-[0064]).
Regarding Claim 14, Howard teaches wherein the return electrode includes a patch electrode, and the tissue puncture system is configured to operate in a monopolar mode ([0061]).
Regarding Claim 15, Howard teaches wherein the RF puncture device includes a transseptal guidewire disposed within a dilator/sheath assembly ([0118]).
Regarding Claim 18, Howard teaches a method for use in a tissue puncture system ([0010]-[0011]), the tissue puncture system (various figures 1A-14C and 17A-19 show different embodiments of a puncture device having an active electrode) including a radiofrequency energy source coupled to an active electrode of a puncture device and to a return electrode ([0061], [0065] and RF generator 354 coupled to at least one of electrodes 320, 322, 324,326, 328 in Fig. 19 in view of the monopolar mode), the method comprising:
causing the radiofrequency (RF) energy source to generate each of a puncture signal and a test signal (“A battery powered RF generator is configured to deliver RF energy to the electrode tip and also to measure impedance at the tip to provide information about the location of the electrode tip” [0006], “The processor may be configured to send a first signal to the output when the first electrode reaches a predetermined relationship with the tissue plane, and to send a second signal to the output when the second electrode reaches the predetermined relationship with the tissue plane” [0013], “The electrode tip 24 enables delivery of RF energy for piercing tissue, and optionally enables use as an ECG measuring device and/or an impedance measuring device” [0054], “Connector cable 28 may connect to an optional Electro-cardiogram (ECG) interface unit via connector 30. An optional ECG connector cable connects an ECG interface unit to an ECG recorder, which displays and captures ECG signals as a function of time. A generator connector cable may connect the ECG interface unit to an energy source such as a generator (not illustrated). In this embodiment, the ECG interface unit can function as a splitter, permitting connection of the electrosurgical tissue piercing apparatus 102 to both an ECG recorder and generator simultaneously. ECG signals can be continuously monitored and recorded and the filtering circuit within the ECG interface unit and may permit energy, for example RF energy, to be delivered from the generator through electrosurgical apparatus 10 without compromising the ECG recorder” [0057], “The RF generator may include a processor configured to associate a particular electrode in contact with the fossa with a depth of penetration of the needle through the fossa, and display an indicium of that depth. With multiple electrodes, once the tip passes through the fossa, the impedance change is noted. Then as subsequent electrodes are passed through the fossa, each time contact of an electrode with the blood pool or the tissue changes, impedance changes. Each electrode may be in communication with the proximal hub and RF generator by way of a unique electrical conductor, such as a wire or conductive traces embedded between insulator layers in the sidewall” [0067], “Distal segment 107 terminates at functional tip region 110, which comprises an energy delivery component and optionally also functions as an impedance and/or ECG measuring device” [0103] and “The processor 350 is configured to send a first signal to the output when the first electrode reaches a predetermined relationship with the tissue plane, and to send a second signal to the output when the second electrode reaches the predetermined relationship with the tissue plane. The predetermined relationship may be when the electrode first contacts the tissue plane, or when the electrode passes through the tissue plane such as into the left atrium blood pool beyond the tissue plane” [0135]);
measuring an impedance of the test signal (abstract, [0010]-[0014], [0067] and [0081]-[0084]); determining a state of the active electrode based on the impedance measurement (tissue contact is here interpreted to be a state of the electrode based on the impedance measurement, “a processor configured to take impedance measurements at the tip to confirm contact with the intra atrial septum” abstract, also see [0010]-[0014], [0067] and [0081]-[0084]); and
displaying the state on a display device (“Audible, visual and/or tactile feedback may be provided at milestone events such as when the electrode tip is placed in contact with tissue” [0084] and [0014], [0136]);
although Examiner takes the position that naturally the impedance measuring signal must be lower than the treatment/puncture energy delivered to tissue, Howard is silent in specifically stating the test signal having a lower power than the puncture signal.
In the same field of invention, Prutchi teaches “The control unit may include, for example, an RF generator. The control unit may have a number of channels that convey an electrical signal bipolarly through a target tissue between electrode pairs (for example, the ablation electrodes may be mounted on the catheter's working [distal] end), and/or unipolarly through a target tissue between an ablation electrode and a dispersive (reference) electrode (e.g., a shaft electrode in contact with lumen fluid (for example blood) and/or an external electrode). The electrodes may be activated in accordance with a switch configuration set by a multiplexer. Multiplexer RF channels may be used to transmit radio frequency (RF) ablation energy to the electrodes. The RF channels may optionally be used to transmit an auxiliary signal. For example an auxiliary signal may be used to measure impedance, slew rate and/or propagation time between pairs of electrodes. When measuring impedance, slew rate and/or propagation time a sensor may optionally include an electrode. In some embodiments a sensor for measuring impedance, slew rate and/or propagation time may include one or more of an ablation electrode and/or a dispersive electrode. For example an auxiliary signal may be similar to an ablation signal but at a lower power (optionally minimizing and/or avoiding tissue damage during measurements). The RF channels may optionally include means to measure electrode/tissue impedance, slew rate and/or propagation time. In some embodiments, measurements may be made with high accuracy and/or repeatability. The RF channels may optionally be controlled by a controller (e.g., a microcontroller and/or single-board computer). The channels may optionally be capable of generating stimulation signals to evoke a response from target tissues and/or measuring an evoked signal from the target tissue. For example, the control unit may transmit a nerve stimulating signal over an electrode (for example an electrode of the ablation catheter). For example, the control unit may evaluate an electrical signal transmitted by the target tissue and/or sensed by an electrode (for example an electrode of the ablation catheter)” [0153] and “electrode impedance, slew rate and/or propagation time measurements may be used to estimate contact (estimated contact) between electrode and tissue as surrogate for thermal contact between electrode interface and target tissue (for example a low impedance of a unipolar signal between an ablation electrode and a dispersive electrode may indicate good contact between the ablation electrode and the target tissue)” [0157].
It would have been obvious to one having ordinary skill in the art prior to the effective filing date of the current invention to use an auxiliary signal which may be similar to an ablation signal but at a lower power to measure impedance and assess electrode/tissue contact in order to minimizing and/or avoiding tissue damage during impedance measurement prior to the actual treatment/puncturing with the higher energy.
Regarding Claim 20, Howard teaches wherein the RF puncture device includes adilator/sheath assembly (flexible needle body 12/tubular body 104 shown in various figures), and wherein the state of the active electrode based on the impedance measurement is selected from one of open circuit state, the active electrode positioned proximally in the dilator/sheath assembly, the active electrode positioned distally in the dilator/sheath assembly, the active electrode at adilator tip of the dilator/sheath assembly, the active electrode extended from the dilator tip of the dilator/sheath assembly and in contact with a target tissue to be punctured, and the active electrode extended from the dilator tip of the dilator/sheath assembly and in contact with a fluid interposed between the active electrode and the target tissue (“a processor configured to take impedance measurements at the tip to confirm contact with the intra atrial septum and/or confirm entry into the left atrium” abstract, also see [0010]-[0014], [0067], [0081] and [0084]).
Conclusion
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/KHADIJEH A VAHDAT/Primary Examiner, Art Unit 3794
