DETAILED ACTION
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 .
Information Disclosure Statement
The Information Disclosure Statement (IDS) filed 01/09/2026 has been considered by the Examiner.
Claim Rejections - 35 USC § 102
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 (i.e., changing from AIA to pre-AIA ) 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.
The following is a quotation of the appropriate paragraphs of 35 U.S.C. 102 that form the basis for the rejections under this section made in this Office action:
A person shall be entitled to a patent unless –
(a)(1) the claimed invention was patented, described in a printed publication, or in public use, on sale, or otherwise available to the public before the effective filing date of the claimed invention.
(a)(2) the claimed invention was described in a patent issued under section 151, or in an application for patent published or deemed published under section 122(b), in which the patent or application, as the case may be, names another inventor and was effectively filed before the effective filing date of the claimed invention.
Claims 21, 23-25, 27, 28, 32, and 34-38 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Rodger et al (US 20180325373 A1).
Regarding claim 1, Rodger teaches a manometric catheter probe, comprising:
a flexible circuit (560); and
at least one pressure sensor (540) including:
a body having a cavity configured to receive at least a portion of the flexible circuit (see annotated Fig. 5 below);
a microelectromechanical systems (MEMS) sensor electrically coupled to the flexible circuit (see Abstract; microelectromechanical systems pressure sensitive membrane, [0063]; pressure sensor 540 measures resistance readings and outputs them to IC 558 with a communications coil via flexible PCB 560); and
a flexible sleeve (546) disposed over the body for containing a fluid (see Fig. 5, [0064]; pressure sensitive silicon membrane 542 is encapsulated by oil chamber 554 comprising a pliable membrane 546 on its top side),
the fluid configured to communicate pressure to the MEMS sensor (see [0063-0064]; pressure sensitive silicon membrane 542 is encapsulated by oil chamber 554).
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Regarding claims 23 and 24, Rodger teaches the manometric catheter probe according to claim 21, wherein the at least one pressure sensor includes an electrical connector for electrically coupling the MEMS sensor to the flexible circuit, wherein the electrical connector includes a spring contact configured to electrically couple the MEMS sensor to the flexible circuit (see [0063]; pressure sensor 150 measures resistance readings and outputs them to IC 558 with a communications coil via flexible PCB 560).
Regarding claim 25, Rodger teaches the manometric catheter probe according to claim 21, wherein the flexible circuit is a flexible printed circuit (see [0063]; flexible polyamide PCB 560)).
Regarding claim 27, Rodger teaches the manometric catheter probe according to claim 21, wherein the at least one pressure sensor includes a fluid injection port configured to receive the fluid into the flexible sleeve (see Fig. 13, [0085]; a cover of an electronic pressure sensor is removed to expose a pressure sensitive silicon or other material membrane within a recess, the recess around the pressure sensitive membrane is filled with oil, [0087]; some miniaturized pressure sensors can be opened from the top, and silicone oil is deposited into the plastic package, and the oil is contained like a bowl).
Regarding claim 28, Rodger teaches the manometric catheter probe according to claim 21, further comprising a second flexible sleeve disposed over the at least one pressure sensor (see [0046]; semi rigid housing 107 surrounding the pressure sensor assembly and integrated circuits made of a shape fitting silicone rubber material).
Regarding claim 32, Rodger teaches a manometric catheter sensor assembly, comprising:
a body (540);
a microelectromechanical systems (MEMS) sensor coupled to the body (see Abstract; microelectromechanical systems pressure sensitive membrane, [0063]; pressure sensor 540 measures resistance readings and outputs them to IC 558 with a communications coil via flexible PCB 560);
a flexible sleeve (546) disposed over the body for containing a fluid configured to communicate pressure to the MEMS sensor (see Fig. 5, [0064]; pressure sensitive silicon membrane 542 is encapsulated by oil chamber 554 comprising a pliable membrane 546 on its top side); and
a sealing channel formed in the body and configured to seal the flexible sleeve to the body to contain the fluid (see annotated Fig. 5 below).
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Regarding claims 34 and 35, Rodger teaches the manometric catheter sensor assembly according to claim 32, further comprising an electrical connector configured to electrically couple the MEMS sensor to a flexible circuit, wherein the electrical connector includes a spring contact configured to electrically couple the MEMS sensor to the flexible circuit (see [0063]; pressure sensor 150 measures resistance readings and outputs them to IC 558 with a communications coil via flexible PCB 560).
Regarding claim 36, Rodger teaches the manometric catheter sensor assembly according to claim 34, wherein the flexible circuit is a flexible printed circuit (see [0063]; flexible polyamide PCB 560).
Regarding claim 37, Rodger teaches the manometric catheter sensor according to claim 32, further comprising a fluid injection port configured to receive the fluid into the flexible sleeve (see Fig. 13, [0085]; a cover of an electronic pressure sensor is removed to expose a pressure sensitive silicon or other material membrane within a recess, the recess around the pressure sensitive membrane is filled with oil, [0087]; some miniaturized pressure sensors can be opened from the top, and silicone oil is deposited into the plastic package, and the oil is contained like a bowl).
Regarding claim 38, Rodger teaches the manometric catheter sensor assembly according to claim 32, further comprising a second flexible sleeve disposed over the MEMS sensor (see [0046]; semi rigid housing 107 surrounding the pressure sensor assembly and integrated circuits made of a shape fitting silicone rubber material).
Claims 21, 25, and 29 are rejected under 35 U.S.C. 102(a)(2) as being anticipated by Damaser et al (US 20210196203 A1).
Regarding claim 21, Damaser teaches a manometric catheter probe, comprising:
a flexible circuit (24); and
at least one pressure sensor (25) including:
a body having a cavity configured to receive at least a portion of the flexible circuit (see [0032]; [0032]; the pressure sensor 25 can be mounted in any position on the PCB 24);
a microelectromechanical systems (MEMS) sensor electrically coupled to the flexible circuit (see [0032]; pressure sensor 25, comprising a diaphragm to collect pressure data, and mounted on the PCB 24); and
a flexible sleeve (12) disposed over the body for containing a fluid (see [0031]; at least a portion of the outer housing 12 can be filled with a non-compressible fluid 22),
the fluid configured to communicate pressure to the MEMS sensor (see [0035]; displacement of the flexible material of the elongated outer housing can be transmitted through the non-compressible fluid to the pressure sensor on the PCB 24).
Regarding claim 25, Damaser teaches the manometric catheter probe according to claim 21, wherein the flexible circuit is a flexible printed circuit (see [0032]; flexible printed circuit board 24).
Regarding claim 29, Damaser teaches the manometric catheter probe according to claim 21, wherein the manometric catheter probe comprises a plurality of pressure sensors that are evenly spaced along a length of the manometric catheter probe (see [0032]; flexible PCB 24 can include a pressure sensor 25, or multiple similarly-configured pressure sensors, the pressure sensor 25 can be amounted in any position on the PCB 24).
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 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.
This application currently names joint inventors. In considering patentability of the claims the examiner presumes that the subject matter of the various claims was commonly owned as of the effective filing date of the claimed invention(s) absent any evidence to the contrary. Applicant is advised of the obligation under 37 CFR 1.56 to point out the inventor and effective filing dates of each claim that was not commonly owned as of the effective filing date of the later invention in order for the examiner to consider the applicability of 35 U.S.C. 102(b)(2)(C) for any potential 35 U.S.C. 102(a)(2) prior art against the later invention.
Claims 21-23, 26, 31-34, and 39 are rejected under 35 U.S.C. 103 as being unpatentable over Dirksen et al (US 20210298617 A1), optionally in view of Rodger et al (US 20180325373 A1).
Regarding claim 21, Dirksen teaches a manometric catheter probe, comprising:
a circuit (200); and
at least one pressure sensor (150) including:
a body (151) having a cavity configured to receive at least a portion of the circuit (see Fig. 5, [0048]; integrated circuit 200 disposed in the substrate 151);
a microelectromechanical systems (MEMS) sensor electrically coupled to the circuit (see [0048]; the pressure sensor 150 can be references as a microelectromechanical system); and
a flexible sleeve (168) disposed over the body for containing a fluid (see [0058]; membrane 168 is disposed over cavity 161 and moves in response to the external pressures applied to pressure sensor 150),
the fluid configured to communicate pressure to the MEMS sensor (see Fig. 5, [0061-0064]; cavity 161 is created by sacrificial etching in substrate 151, and then sealed by membrane 168 wherein the cavity forms a space for the membrane 168 to deform into; it can be appreciated that while the cavity 161 is not filled with a liquid fluid, the assumed gaseous fluid that fills sealed cavity 161 fulfills the limitations as it communicates pressure to the MEMS pressure sensor by means of changing capacitances and oscillation frequencies).
Dirksen is silent regarding wherein the integrated circuit is a flexible circuit. However, it can be appreciated that the prior art discloses all of the claimed limitations except that of a flexible circuit, which is well-known, routine, and conventional in the art, as demonstrated by Rodger, which uses a flexible PCB in communication with a MEMS pressure sensor (Rodger Abstract, [0063]). Therefore, a substitution of the flexible circuit taught by Rodger for the integrated circuit disclosed by Dirksen would have been obvious to one of ordinary skill in the art as they are equivalent components and the use of one over the other would not produce any unexpected or novel result. See MPEP 2144.06.
Regarding claim 22, Dirksen teaches the manometric catheter probe according to claim 21, wherein the body defines an annular recess and the MEMS sensor is disposed in the annular recess (see [0059]; the cavity 161 has an annular recess, [0059]; the basic principles of active cells 160a/b is a parallel-plate capacitor between electrodes provided in the membrane 168 and the substrate 151 at the base 165 of cavity 161).
Regarding claim 23, Dirksen teaches the manometric catheter probe according to claim 21, wherein the at least one pressure sensor includes an electrical connector (174) for electrically coupling the MEMS sensor to the circuit (see [0060]; pressure sensor 150 includes vias 174 providing a communication pathway from electrical signals between the active cells 160a/b and the integrated circuit 200).
Regarding claim 26, Dirksen teaches the manometric catheter probe according to claim 21, wherein the body may be cylindrical (see [0054]; substrate 151 is formed into any suitable size and shape such that the pressure sensor 150 can be implemented in the intraluminal device 110, including a flexible elongate member 116, [0034]; the flexible elongate member 116 can have a generally cylindrical profile).
Regarding claim 31, Dirksen teaches the manometric catheter probe according to claim 21, further comprising a temperature sensor electrically coupled to the circuit (see [0048]; in some embodiments the dummy cell 164 is electrically active, electrically connected, and may be used for temperature sensing).
Regarding claim 32, Dirksen teaches a manometric catheter sensor assembly, comprising:
a body (151);
a microelectromechanical systems (MEMS) sensor coupled to the body (see [0048]; the pressure sensor 150 can be referenced as a microelectromechanical system, pressure sensor 150 includes three capacitive cells formed in substrate 151);
a flexible sleeve (168) disposed over the body for containing a fluid configured to communicate pressure to the MEMS sensor (see [0058]; membrane 168 is disposed over cavity 161 and moves in response to the external pressures applied to pressure sensor 150, [0061-0064]; cavity 161 is created by sacrificial etching in substrate 151, and then sealed by membrane 168 wherein the cavity forms a space for the membrane 168 to deform into; it can be appreciated that while the cavity 161 is not filled with a liquid fluid, the assumed gaseous fluid that fills sealed cavity 161 fulfills the limitations as it communicates pressure to the MEMS pressure sensor by means of changing capacitances and oscillation frequencies); and
a sealing channel formed in the body and configured to seal the flexible sleeve to the body to contain the fluid (see annotated Fig. 5 below which denotes an unlabeled channel in body 151 which creates a surface for membrane 168 to be sealed atop cavity 161).
Regarding claim 33, Dirksen teaches the manometric catheter sensor assembly according to claim 32, wherein the body defines a recess and the MEMS sensor is disposed in the recess (see [0059]; the cavity 161 has an annular recess, [0059]; the basic principles of active cells 160a/b is a parallel-plate capacitor between electrodes provided in the membrane 168 and the substrate 151 at the base 165 of cavity 161).
Regarding claim 34, Dirksen teaches the manometric catheter sensor assembly according to claim 32, further comprising an electrical connector (174) for electrically coupling the MEMS sensor to the circuit (see [0060]; pressure sensor 150 includes vias 174 providing a communication pathway from electrical signals between the active cells 160a/b and the integrated circuit 200).
Regarding claim 39, Dirksen teaches the manometric catheter sensor assembly according to claim 32, further comprising a temperature sensor (see [0048]; in some embodiments the dummy cell 164 is electrically active, electrically connected, and may be used for temperature sensing).
Claims 29, 30, and 40 are rejected under 35 U.S.C. 103 as being unpatentable over Dirksen et al (US 20210298617 A1), in view of Rodger et al (US 20180325373 A1), and in view of Stuebe et al (US 20050065450 A1).
Regarding claim 29, Dirksen in view of Rodger teaches the manometric catheter probe according to claim 21. Dirksen is silent regarding wherein the manometric catheter probe comprises a plurality of pressure sensors that are evenly spaced along a length of the manometric catheter probe.
Stuebe teaches a manometric catheter probe (110) including a plurality of pressure sensors (111a-111e) that are evenly spaced along a length of the manometric catheter probe (see Stuebe Fig. 1, [0025]; pressure sensors 111a-e are spaced apart in about 5 cm increments along the length of the esophageal probe 110).
It would have been obvious for one of ordinary skill in the art prior to the effective filing date of the claimed invention to modify Dirksen’s probe with a plurality of evenly spaced pressure sensor assemblies as taught by Stuebe. One of ordinary skill in the art would have been motivated to make this modification in order to track a peristaltic wave and track a bolus transit through the length of the esophagus (Stuebe [0026]).
Regarding claim 30, Dirksen in view of Rodger teaches the manometric catheter prove according to claim 21. Dirksen is silent regarding an impedance sensor electrically coupled to the circuit.
Stuebe teaches a manometric catheter probe (110) including at least one of each of an electrically coupled pressure sensor (111) and impedance sensor (112).
It would have been obvious for one of ordinary skill in the art prior to the effective filing date of the claimed invention to modify Dirksen’s manometry probe with an impedance sensor as taught by Stuebe. One of ordinary skill in the art would have been motivated to make this modification in order to utilize impedance data to make several determinations of the function/motility of an esophagus including that of bolus transmit time (Stuebe [0029]).
Regarding claim 40, Dirksen teaches a manometry system, comprising: a manometric catheter probe, comprising:
a circuit (200); and
at least one pressure sensor (150) assembly coupled to the flexible circuit (Fig. 4), the at least one pressure sensor assembly including:
a body (151) having a cavity configured to receive at least a portion of the circuit (see Fig. 5, [0048]; integrated circuit 200 disposed in the substrate 151);
a microelectromechanical systems (MEMS) sensor electrically coupled to the circuit (see [0048]; the pressure sensor 150 can be references as a microelectromechanical system); and
a flexible sleeve (168) disposed over the body for containing a fluid (see [0058]; membrane 168 is disposed over cavity 161 and moves in response to the external pressures applied to pressure sensor 150),
the fluid configured to communicate pressure to the MEMS sensor (see Fig. 5, [0061-0064]; cavity 161 is created by sacrificial etching in substrate 151, and then sealed by membrane 168 wherein the cavity forms a space for the membrane 168 to deform into; it can be appreciated that while the cavity 161 is not filled with a liquid fluid, the assumed gaseous fluid that fills sealed cavity 161 fulfills the limitations as it communicates pressure to the MEMS pressure sensor by means of changing capacitances and oscillation frequencies);
a processor (122); and
a memory storing instructions (124), which, when executed by the processor, cause the manometry system to: acquire a pressure measurement from the at least one pressure sensor assembly (see [0046]; any steps related to data acquisition, data processing, instrument control, and/or other processing or control aspects of the present disclosure may be implemented by the computer 120 using corresponding instructions stored on or in the memory 124 and executed by the processor 122).
Dirksen is silent regarding wherein the integrated circuit is a flexible circuit. However, it can be appreciated that the prior art discloses all of the claimed limitations except that of a flexible circuit, which is well-known, routine, and conventional in the art, as demonstrated by Rodger, which uses a flexible PCB in communication with a MEMS pressure sensor (Rodger Abstract, [0063]). Therefore, a substitution of the flexible circuit taught by Rodger for the integrated circuit disclosed by Dirksen would have been obvious to one of ordinary skill in the art as they are equivalent components and the use of one over the other would not produce any unexpected or novel result. See MPEP 2144.06.
Dirksen teaches wherein the device (110) may be used to examine the esophagus (Dirksen [0037]), however, Dirksen is silent regarding determining, based on the pressure measurement, at least one of a motility function of an esophagus or bolus transit dynamics in the esophagus.
Stuebe teaches a manometric esophageal probe (110) having at least one pressure sensor assembly (111) and;
a processor (120); and
a memory storing instructions (121), which, when executed by the processor, cause the manometry system to:
acquire a pressure measurement from the at least one pressure sensor assembly (see Stuebe Fig. 2, [0033]; step 202 receive pressure values), and determine, based on the pressure measurement, at least one of a motility function of an esophagus or bolus transit dynamics in the esophagus (see Stuebe Fig. 2, [0037]; step 205 display pressure values as operational esophagus movement).
It would have been obvious for one of ordinary skill in the art prior to the effective filing date of the claimed invention to modify Dirksen’s pressure sensing probe which may be configured for use in an esophagus with the manometric esophageal probe and motility function/bolus transit dynamics determination in the esophagus as taught by Stuebe. One of ordinary skill in the art would have been motivated to make this modification in order to detect, measure, and diagnose any abnormal operations of the esophagus in order to prevent or treat reflux which may cause pain or other undesirable outcomes to a patient (Stuebe [0004-0005).
Double Patenting
The nonstatutory double patenting rejection is based on a judicially created doctrine grounded in public policy (a policy reflected in the statute) so as to prevent the unjustified or improper timewise extension of the “right to exclude” granted by a patent and to prevent possible harassment by multiple assignees. A nonstatutory double patenting rejection is appropriate where the conflicting claims are not identical, but at least one examined application claim is not patentably distinct from the reference claim(s) because the examined application claim is either anticipated by, or would have been obvious over, the reference claim(s). See, e.g., In re Berg, 140 F.3d 1428, 46 USPQ2d 1226 (Fed. Cir. 1998); In re Goodman, 11 F.3d 1046, 29 USPQ2d 2010 (Fed. Cir. 1993); In re Longi, 759 F.2d 887, 225 USPQ 645 (Fed. Cir. 1985); In re Van Ornum, 686 F.2d 937, 214 USPQ 761 (CCPA 1982); In re Vogel, 422 F.2d 438, 164 USPQ 619 (CCPA 1970); In re Thorington, 418 F.2d 528, 163 USPQ 644 (CCPA 1969).
A timely filed terminal disclaimer in compliance with 37 CFR 1.321(c) or 1.321(d) may be used to overcome an actual or provisional rejection based on nonstatutory double patenting provided the reference application or patent either is shown to be commonly owned with the examined application, or claims an invention made as a result of activities undertaken within the scope of a joint research agreement. See MPEP § 717.02 for applications subject to examination under the first inventor to file provisions of the AIA as explained in MPEP § 2159. See MPEP § 2146 et seq. for applications not subject to examination under the first inventor to file provisions of the AIA . A terminal disclaimer must be signed in compliance with 37 CFR 1.321(b).
The filing of a terminal disclaimer by itself is not a complete reply to a nonstatutory double patenting (NSDP) rejection. A complete reply requires that the terminal disclaimer be accompanied by a reply requesting reconsideration of the prior Office action. Even where the NSDP rejection is provisional the reply must be complete. See MPEP § 804, subsection I.B.1. For a reply to a non-final Office action, see 37 CFR 1.111(a). For a reply to final Office action, see 37 CFR 1.113(c). A request for reconsideration while not provided for in 37 CFR 1.113(c) may be filed after final for consideration. See MPEP §§ 706.07(e) and 714.13.
The USPTO Internet website contains terminal disclaimer forms which may be used. Please visit www.uspto.gov/patent/patents-forms. The actual filing date of the application in which the form is filed determines what form (e.g., PTO/SB/25, PTO/SB/26, PTO/AIA /25, or PTO/AIA /26) should be used. A web-based eTerminal Disclaimer may be filled out completely online using web-screens. An eTerminal Disclaimer that meets all requirements is auto-processed and approved immediately upon submission. For more information about eTerminal Disclaimers, refer to www.uspto.gov/patents/apply/applying-online/eterminal-disclaimer.
Claims 21-28 and 30-40 rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-4, 10-14, 18 and 20 of U.S. Patent No. 12,440,116. Although the claims at issue are not identical, they are not patentably distinct from each other because they are both directed to a manometry system comprising a manometric catheter probe comprising:
a flexible circuit; and
at least one pressure sensor assembly coupled to the flexible circuit, the at least one pressure sensor assembly including:
a body having a cavity configured to receive at least a portion of the flexible circuit;
a microelectromechanical systems (MEMS) sensor electrically coupled to the flexible circuit; and
a flexible sleeve disposed over the body for containing a fluid, the fluid configured to communicate pressure to the MEMS sensor;
a processor; and
a memory storing instructions, which, when executed by the processor, cause the manometry system to:
acquire a pressure measurement from the at least one pressure sensor assembly, and determine, based on the pressure measurement, at least one of a motility function of an esophagus or bolus transit dynamics in the esophagus.
A brief, but non-exhaustive matching of the pending claims and the issued claims is provided below:
Application No. 19/354,875
Pending Claims
U.S. Patent No. 12,440,116
Issued Claims
21. A manometric catheter probe, comprising: a flexible circuit; and at least one pressure sensor including: a body having a cavity configured to receive at least a portion of the flexible circuit; a microelectromechanical systems (MEMS) sensor electrically coupled to the flexible circuit; and a flexible sleeve disposed over the body for containing a fluid, the fluid configured to communicate pressure to the MEMS sensor.
1. A manometric catheter probe, comprising: a flexible printed circuit; at least one pressure sensor assembly disposed along the flexible printed circuit and coupled therewith, the at least one pressure sensor assembly including: a body including a central cavity receiving at least a portion of the flexible printed circuit; an annular recess around the body; a microelectromechanical systems (MEMS) sensor disposed in the annular recess; an electrical connector configured to electrically couple the MEMS sensor and the flexible printed circuit; and a first flexible sleeve disposed over the body in a manner forming a cavity between the first flexible sleeve and the annular recess for containing a fluid, the fluid configured to communicate pressure to the MEMS sensor; and a second sleeve disposed over the at least one pressure sensor assembly.
22. The manometric catheter probe according to claim 21, wherein the body defines an annular recess and the MEMS sensor is disposed in the annular recess.
1. A manometric catheter probe, comprising: a flexible printed circuit; at least one pressure sensor assembly disposed along the flexible printed circuit and coupled therewith, the at least one pressure sensor assembly including: a body including a central cavity receiving at least a portion of the flexible printed circuit; an annular recess around the body; a microelectromechanical systems (MEMS) sensor disposed in the annular recess; an electrical connector configured to electrically couple the MEMS sensor and the flexible printed circuit; and a first flexible sleeve disposed over the body in a manner forming a cavity between the first flexible sleeve and the annular recess for containing a fluid, the fluid configured to communicate pressure to the MEMS sensor; and a second sleeve disposed over the at least one pressure sensor assembly.
23. The manometric catheter probe according to claim 21, wherein the at least one pressure sensor includes an electrical connector for electrically coupling the MEMS sensor to the flexible circuit.
1. A manometric catheter probe, comprising: a flexible printed circuit; at least one pressure sensor assembly disposed along the flexible printed circuit and coupled therewith, the at least one pressure sensor assembly including: a body including a central cavity receiving at least a portion of the flexible printed circuit; an annular recess around the body; a microelectromechanical systems (MEMS) sensor disposed in the annular recess; an electrical connector configured to electrically couple the MEMS sensor and the flexible printed circuit; and a first flexible sleeve disposed over the body in a manner forming a cavity between the first flexible sleeve and the annular recess for containing a fluid, the fluid configured to communicate pressure to the MEMS sensor; and a second sleeve disposed over the at least one pressure sensor assembly.
24. The manometric catheter probe according to claim 23, wherein the electrical connector includes a spring contact configured to electrically couple the MEMS sensor to the flexible circuit.
10. The manometric catheter probe of claim 1, wherein the electrical connector includes a spring contact configured to electrically couple the MEMs sensor and the flexible printed circuit.
25. The manometric catheter probe according to claim 21, wherein the flexible circuit is a flexible printed circuit.
4. The manometric catheter probe of claim 1, wherein the electrical connector is comprised of at least one of a flexible circuit or a printed circuit board.
26. The manometric catheter probe according to claim 21, wherein the body is cylindrical.
2. The manometric catheter probe of claim 1, wherein the body of the at least one pressure sensor assembly includes a cylindrical shape.
27. The manometric catheter probe according to claim 21, wherein the at least one pressure sensor includes a fluid injection port configured to receive the fluid into the flexible sleeve.
3. The manometric catheter probe of claim 1, wherein the at least one pressure sensor assembly further includes a fluid injection port configured for filling the fluid into the first flexible sleeve.
28. The manometric catheter probe according to claim 21, further comprising a second flexible sleeve disposed over the at least one pressure sensor.
1. A manometric catheter probe, comprising: a flexible printed circuit; at least one pressure sensor assembly disposed along the flexible printed circuit and coupled therewith, the at least one pressure sensor assembly including: a body including a central cavity receiving at least a portion of the flexible printed circuit; an annular recess around the body; a microelectromechanical systems (MEMS) sensor disposed in the annular recess; an electrical connector configured to electrically couple the MEMS sensor and the flexible printed circuit; and a first flexible sleeve disposed over the body in a manner forming a cavity between the first flexible sleeve and the annular recess for containing a fluid, the fluid configured to communicate pressure to the MEMS sensor; and a second sleeve disposed over the at least one pressure sensor assembly.
30. The manometric catheter probe according to claim 21, further comprising an impedance sensor electrically coupled to the flexible circuit.
18. The system of claim 11, further comprising at least one of a temperature sensor or an impedance sensor.
31. The manometric catheter probe according to claim 21, further comprising a temperature sensor electrically coupled to the flexible circuit.
18. The system of claim 11, further comprising at least one of a temperature sensor or an impedance sensor.
32. A manometric catheter sensor assembly, comprising: a body; a microelectromechanical systems (MEMS) sensor coupled to the body; a flexible sleeve disposed over the body for containing a fluid configured to communicate pressure to the MEMS sensor; and a sealing channel formed in the body and configured to seal the flexible sleeve to the body to contain the fluid.
20. A manometric catheter sensor assembly, comprising: a body including: a central cavity; and an annular recess around the body; a microelectromechanical systems (MEMS) sensor disposed in the annular recess of the body; an electrical connector configured to electrically couple the MEMS sensor and a flexible printed circuit; a first flexible sleeve disposed over the body in a manner forming a cavity between the first flexible sleeve and the annular recess of the body for containing a fluid, the first flexible sleeve includes the fluid configured to communicate pressure to the MEMS sensor; a first sealing channel disposed on a first end of the body and configured to seal the fluid in the first flexible sleeve; a second sealing channel disposed on a second end of the body and configured to seal the fluid in the first flexible sleeve; and a second sleeve disposed over the MEMS sensor.
33. The manometric catheter sensor assembly according to claim 32, wherein the body defines a recess and the MEMS sensor is disposed in the recess.
20. A manometric catheter sensor assembly, comprising: a body including: a central cavity; and an annular recess around the body; a microelectromechanical systems (MEMS) sensor disposed in the annular recess of the body; an electrical connector configured to electrically couple the MEMS sensor and a flexible printed circuit; a first flexible sleeve disposed over the body in a manner forming a cavity between the first flexible sleeve and the annular recess of the body for containing a fluid, the first flexible sleeve includes the fluid configured to communicate pressure to the MEMS sensor; a first sealing channel disposed on a first end of the body and configured to seal the fluid in the first flexible sleeve; a second sealing channel disposed on a second end of the body and configured to seal the fluid in the first flexible sleeve; and a second sleeve disposed over the MEMS sensor.
34. The manometric catheter sensor assembly according to claim 32, further comprising an electrical connector configured to electrically couple the MEMS sensor to a flexible circuit.
20. A manometric catheter sensor assembly, comprising: a body including: a central cavity; and an annular recess around the body; a microelectromechanical systems (MEMS) sensor disposed in the annular recess of the body; an electrical connector configured to electrically couple the MEMS sensor and a flexible printed circuit; a first flexible sleeve disposed over the body in a manner forming a cavity between the first flexible sleeve and the annular recess of the body for containing a fluid, the first flexible sleeve includes the fluid configured to communicate pressure to the MEMS sensor; a first sealing channel disposed on a first end of the body and configured to seal the fluid in the first flexible sleeve; a second sealing channel disposed on a second end of the body and configured to seal the fluid in the first flexible sleeve; and a second sleeve disposed over the MEMS sensor.
35. The manometric catheter sensor assembly according to claim 34, wherein the electrical connector includes a spring contact configured to electrically couple the MEMS sensor to the flexible circuit.
10. The manometric catheter probe of claim 1, wherein the electrical connector includes a spring contact configured to electrically couple the MEMs sensor and the flexible printed circuit.
36. The manometric catheter sensor assembly according to claim 34, wherein the flexible circuit is a flexible printed circuit.
14. The system of claim 11, wherein the electrical connector is comprised of at least one of a flexible circuit or a printed circuit board.
37. The manometric catheter sensor assembly according to claim 32, further comprising a fluid injection port configured to receive the fluid into the flexible sleeve.
13. The system of claim 11, wherein the at least one pressure sensor assembly further includes a fluid injection port configured for filling the fluid into the flexible sleeve.
38. The manometric catheter sensor assembly according to claim 32, further comprising a second flexible sleeve disposed over the MEMS sensor.
20. A manometric catheter sensor assembly, comprising: a body including: a central cavity; and an annular recess around the body; a microelectromechanical systems (MEMS) sensor disposed in the annular recess of the body; an electrical connector configured to electrically couple the MEMS sensor and a flexible printed circuit; a first flexible sleeve disposed over the body in a manner forming a cavity between the first flexible sleeve and the annular recess of the body for containing a fluid, the first flexible sleeve includes the fluid configured to communicate pressure to the MEMS sensor; a first sealing channel disposed on a first end of the body and configured to seal the fluid in the first flexible sleeve; a second sealing channel disposed on a second end of the body and configured to seal the fluid in the first flexible sleeve; and a second sleeve disposed over the MEMS sensor.
39. The manometric catheter sensor assembly according to claim 32, further comprising at least one of an impedance sensor or a temperature sensor.
18. The system of claim 11, further comprising at least one of a temperature sensor or an impedance sensor.
40. A manometry system, comprising: a manometric catheter probe comprising: a flexible circuit; and at least one pressure sensor assembly coupled to the flexible circuit, the at least one pressure sensor assembly including: a body having a cavity configured to receive at least a portion of the flexible circuit; a microelectromechanical systems (MEMS) sensor electrically coupled to the flexible circuit; and a flexible sleeve disposed over the body for containing a fluid, the fluid configured to communicate pressure to the MEMS sensor; a processor; and a memory storing instructions, which, when executed by the processor, cause the manometry system to: acquire a pressure measurement from the at least one pressure sensor assembly, and determine, based on the pressure measurement, at least one of a motility function of an esophagus or bolus transit dynamics in the esophagus.
11. A manometry system comprising: manometric catheter probe comprising: a flexible printed circuit; at least one pressure sensor assembly coupled with the flexible printed circuit along a length of the flexible printed circuit, the at least one pressure sensor assembly including: a body including an annular recess; a central cavity through the body receiving at least a portion of the flexible printed circuit; a pressure balloon disposed on an outside of the central cavity, including: a fluid configured to communicate pressure to a microelectromechanical systems (MEMS) sensor; and a first flexible sleeve disposed over the body in a manner forming a cavity between the first flexible sleeve and the annular recess for containing the fluid; a MEMS sensor disposed in the pressure balloon, in communication with the fluid; and an electrical connector configured to electrically couple the MEMS sensor and the flexible printed circuit; and a second sleeve disposed over the at least one pressure sensor assembly; a processor; and a memory, including instructions stored thereon, which, when executed, cause the manometry system to: acquire a pressure measurement from the at least one pressure sensor assembly, and determine, based on the measurements, at least one of a motility function of an esophagus or a bolus transit dynamics in the esophagus.
Conclusion
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/A.J.S./Examiner, Art Unit 3792
/Benjamin J Klein/Supervisory Patent Examiner, Art Unit 3792