In-vivo introducible antenna for detecting an RF tag

Abstract

The present invention relates to an in-vivo introducible antenna for detecting RF tags and provides an interrogation and detection system for detecting surgical instruments within a patient's body, the system comprising: one or more RFID tags attached to surgical instruments within the patient's body. Each RFID tag is configured to emit a return signal upon energization, and a remote signal generator is configured to generate an energization signal for the one or more RFID tags. The signal generator is operably coupled to an in-vivo introducible antenna via a communication cable. The system further comprises an in-vivo introducible antenna configured to be inserted into a surgical site within the patient's body through a trocar-cannula assembly. Wherein the tubular channel defines a shape having a dimension "D1" such that the dimension "D1" of the tubular channel is less than a dimension "D2" of the in-vivo introducible antenna.

Description

[0001] Cross-reference to related applications

[0002] This application claims the benefit and priority of U.S. Provisional Patent Application No. 63 / 002,487, filed March 31, 2020, the entire contents of which are incorporated herein by reference. Technical Field

[0003] This disclosure generally relates to interrogation and detection systems for detecting radio frequency (RF) tags, and more specifically, to insertable antennas used within surgical sites. Background Technology

[0004] Before performing surgery, it is often useful or important to determine the presence of surgically related objects in the patient's body. Such objects can take various forms. For example, objects can take the form of instruments such as scalpels, scissors, forceps, hemostatic forceps, and / or clamps. And, for example, objects can take the form of related accessories and / or disposable items such as surgical sponges, gauze, and / or cotton wool. Failure to locate objects before suturing the patient may require additional surgical procedures and, in some cases, may have serious adverse medical consequences.

[0005] Some hospitals have developed procedures that include checklists or require multiple counts to track the use and return of items during surgical procedures. This manual method is inefficient, time-consuming for trained personnel, and prone to errors.

[0006] Another approach employs transponders and a wireless interrogation and detection system. This approach uses wireless transponders (e.g., RFID tags) attached to various objects used during surgical procedures. The interrogation and detection system comprises a transmitter that emits pulsed broadband wireless signals (e.g., radio frequency or microwave frequencies) and a detector for detecting the wireless signals returned by the transponder in response to the emitted pulsed broadband signals. This automated system can advantageously improve accuracy while reducing the amount of time required by highly trained and paid personnel. Examples of this approach are discussed in U.S. Patent No. 6,026,818, published February 22, 2000, and U.S. Patent Publication No. 2004 / 0250819, published December 16, 2004.

[0007] Commercial implementation of such an automated system requires the entire system to be cost-competitive and highly accurate. Specifically, false negatives must be avoided to ensure that no objects are mistakenly left inside the patient. Directly interrogating the surgical site by transmitting a probe signal from within the open surgical site is a straightforward way to reduce signal interference caused by external factors. However, the size of the transmitting antenna limits the utility of this option. Modern minimally invasive surgical methods discourage clinicians from making large open wounds inside the patient. Instead of large incisions to access the treatment site, small orifices provide access points for surgical instruments used internally. These orifices are often too small to conveniently insert the transmitting antenna into the treatment site for direct interrogation.

[0008] Furthermore, when attempting to locate RFID-tagged items within a surgical site, it is important that the antenna transmits a probe signal and receives a return signal to occupy as much physical space as possible, as a larger antenna has a wider detection range for the return signal within the surgical site. Therefore, it is desirable to bypass external signal interference sources by directly interrogating the surgical site with a relatively large, adjustable antenna capable of passing through the small openings commonly used in modern surgical practice. Summary of the Invention

[0009] This disclosure relates to a system for detecting surgical objects and devices used in body cavities during surgical procedures, and more specifically, to an antenna that is directly inserted into the surgical site.

[0010] One aspect of this disclosure relates to an interrogation and detection system for detecting surgical instruments within a patient's body. The interrogation and detection system includes: one or more RFID tags configured to emit one or more return signals upon energization, each RFID tag being attached to a surgical instrument within the patient's body; a remote signal generator configured to generate an energizing signal for the one or more RFID tags; and an in-body insertable antenna operatively coupled to the signal generator, the in-body insertable antenna being configured to receive the one or more return signals emitted by the one or more RFID tags in an extended state. The in-body insertable antenna is configured to be in a folded state smaller than the extended state for insertion into the patient's body.

[0011] The system may further include: a cannula-cannula assembly comprising a tubular channel configured to allow passage of the in-body introduceable antenna, wherein the in-body introduceable antenna is defined in a shape having a size “D2”; and wherein the tubular channel is defined in a shape having a size “D1” such that the size “D1” of the tubular channel is smaller than the size “D2” of the in-body introduceable antenna.

[0012] The in vivo-introducible antenna may include a semi-rigid elongated member supporting a flexible ring configured to fold itself when passing through the tubular channel of the cannula-cannula assembly and unfold when exiting the tubular channel of the cannula-cannula assembly and entering a surgical site within the patient's body.

[0013] The flexible ring may be made of a shape memory alloy, which is configured to automatically return to its initial shape in the absence of external force.

[0014] The initial shape of the flexible ring portion of the in-body antenna can be circular.

[0015] The flexible ring can be configured to fold inward so as to form an elongated elliptical shape when translated distally through the tubular channel.

[0016] The flexible ring can be configured to fold backward so as to be placed side by side with the semi-rigid elongated member when translating distally through the tubular channel.

[0017] The flexible ring can be configured to fold along the axis of the semi-rigid elongated member to form a crescent-shaped profile when translated proximally through the tubular channel.

[0018] The flexible ring can be teardrop-shaped.

[0019] The size of the flexible ring can be larger than that of the tubular channel.

[0020] According to another aspect, a method for detecting one or more surgical instruments within a patient's body is provided. The method includes: distally propelling an in-body insertable antenna through a channel of size "D1" defined within a cannula-cannula assembly and into a surgical site within the patient's body, wherein a portion of the in-body insertable antenna automatically returns to its original shape of size "D2," such that the size "D1" of the tubular channel is smaller than the size "D2" of the in-body insertable antenna; generating an energizing signal configured to stimulate the one or more RFID tags to transmit a return signal; transmitting the energizing signal directly to the surgical site within the patient's body through an extension portion of the in-body insertable antenna; scanning for return signals from the one or more RFID tags attached to each surgical instrument placed within the patient's body before the commencement of surgery; and alerting a clinician of the presence of the one or more RFID tags attached to each surgical instrument upon detection of the one or more return signals.

[0021] The in-body introducible antenna may include a semi-rigid elongated member supporting a flexible ring, wherein the flexible ring is a portion of the in-body introducible antenna configured to automatically deploy to occupy an extended region.

[0022] The method may further include pulling the unfolded flexible ring portion of the internally oriented antenna proximally through the orifice and channel of the cannula-needle assembly, causing the unfolded flexible ring to be compressed by the channel and fold itself.

[0023] The compression of the flexible ring portion facilitates the complete extraction of the internally introduced antenna from the cannula-needle assembly.

[0024] The flexible ring portion may be circular and may be configured to fold along the axis of the semi-rigid elongated member to form a crescent-shaped profile when pulled proximally through the channel of the cannula-cannula assembly.

[0025] According to another aspect, there is provided an adjustable-size in vivo-introducible antenna for insertion into a surgical site and detection of surgical instruments with RFID tags within a patient's body. The antenna includes: a semi-rigid elongated member configured to translate through a tubular channel, wherein the tubular channel defines a shape having a size "D1"; and a flexible ring operably coupled to the semi-rigid member, wherein the flexible ring defines a shape having a size "D2" such that the size "D1" of the tubular channel is smaller than the size "D2" of the in vivo-introducible antenna.

[0026] The flexible ring may be made of a shape memory alloy, which is configured to automatically return to its initial shape in the absence of external force.

[0027] The flexible ring is adjustable in size, allowing it to be reshaped to conform to its surrounding environment.

[0028] The initial shape of the flexible ring can be circular.

[0029] The flexible ring can be configured to fold backward so that it is placed side by side with the semi-rigid elongated member when inserted into the surgical site within the patient's body.

[0030] The flexible ring can be configured to fold along the longitudinal axis of the semi-rigid elongated member to form a crescent-shaped profile when withdrawn from the surgical site within the patient's body. Attached Figure Description

[0031] In the accompanying drawings, the same reference numerals denote the same elements or actions. The dimensions and relative positions of the elements in the drawings are not necessarily drawn to scale. For example, the shapes and angles of different elements are not drawn to scale, and some of these elements are arbitrarily enlarged and positioned to improve the readability of the drawings. Furthermore, the specific shapes of the drawn elements are not intended to convey any information about the actual shape of the particular element, but are chosen solely for ease of identification in the accompanying drawings.

[0032] The following description, with reference to the accompanying drawings, illustrates various aspects of the in-body incorporable antenna, RF tag, and article containing said antenna and tag, as disclosed in this invention, wherein:

[0033] Figure 1 This is a schematic diagram illustrating a surgical environment, showing a healthcare provider using an inquiry and detection system to detect RFID-tagged objects inside a patient's body, according to an illustrated aspect.

[0034] Figure 2 This is a schematic diagram of an internally implantable antenna used to detect surgical instruments in use within a patient's body at the surgical site.

[0035] Figure 3A It is an enlarged perspective view of an antenna that can be introduced into the body in a compressed state, the antenna being pushed through a channel toward a surgical site inside the patient's body;

[0036] Figure 3B It was pushed through Figure 3A After the channel enters the surgical site inside the patient's body, an enlarged perspective view of the expanded body through which an antenna can be introduced;

[0037] Figure 3C This is an enlarged perspective view of an internally inserted antenna that has been extracted from a surgical site inside the patient's body.

[0038] Figure 3D It is an enlarged perspective view of an internally inserted antenna that is in a folded state when withdrawn from a surgical site inside the patient's body.

[0039] Figure 3E It is an enlarged perspective view of an internal surgical site where an antenna can be introduced, which is folded backward and pushed through a channel toward the surgical site inside the patient's body.

[0040] Figure 3F It was pushed through Figure 3E After the channel enters the surgical site inside the patient's body, an enlarged perspective view of the partially unfolded and expanded body through which an antenna can be introduced.

[0041] Figure 4A yes Figure 2A front view of the elongated tubular channel and its orifice of the cannula-cannula assembly shown;

[0042] Figure 4B yes Figure 1-3F being in such a state Figure 3B The diagram shows a cross-sectional view of the initial extended state in which an antenna can be introduced.

[0043] Figure 4C Is it like this? Figure 3A The diagram shows a cross-sectional view of an internally oriented antenna that has been compressed to form an elongated elliptical shape under the influence of a slender tubular channel; and

[0044] Figure 4D Is it like this? Figure 3D The diagram shows a cross-sectional view of an internal structure into which an antenna can be introduced, which is folded to form a crescent shape under the influence of a slender tubular channel. Detailed Implementation

[0045] In the following description, certain specific details are set forth in order to provide a thorough understanding of the disclosed aspects. However, those skilled in the art will recognize that the aspects can be practiced without one or more of these specific details, or using other methods, components, and materials. In other instances, well-known structures associated with transmitters, receivers, or transceivers are not shown or described in detail to avoid unnecessarily obscuring the description of the aspects.

[0046] Throughout this specification, the terms "an aspect" or "one aspect" refer to a specific feature, structure, or characteristic described in conjunction with an aspect contained in at least one aspect. Therefore, the phrases "in one aspect" or "in one aspect" appearing in various places throughout this specification do not necessarily refer to the same aspect. Furthermore, in one or more aspects, a specific feature, structure, or characteristic may be combined in any suitable manner.

[0047] Figure 1 A surgical environment "E" is depicted, in which a healthcare provider 12 operates an interrogation and detection system 10 for detecting RFID tags to determine the presence of an object 100a in a patient 18. The interrogation and detection system 10 may include a signal generator 200 and an antenna 300 connected to the signal generator 200 via one or more communication paths (e.g., coaxial cable 250). In one aspect of the interrogation and detection system 10, the antenna 300 may take the form of a handheld stick 300a.

[0048] Item 100a can take various forms, such as instruments, accessories, and / or disposable items useful in the course of a surgical procedure. For example, item 100a can take the form of a scalpel, scissors, forceps, hemostats, and / or clamps. And, for example, item 100a can take the form of surgical sponges, gauze, and / or cotton wool. Item 100a is marked, transported, attached, or otherwise coupled to RFID tag 100. Aspects of the interrogation and detection system 10 disclosed herein are particularly suitable for operation with one or more RFID tags 100 that are not precisely tuned to a selected or chosen resonant frequency. Therefore, RFID tags 100 do not require high manufacturing tolerances or expensive materials, and thus manufacturing costs can be lower.

[0049] In use, the medical provider 12 may position the rod 300a near the patient 18 to detect one or more RFID tags 100 and thus detect the presence of an object 100a. In some aspects, the medical provider 12 may move the rod 300a along and / or across the body of the patient 18. For a detailed description of the exemplary interrogation and detection system, reference may be made to U.S. Patent Application Publication No. 2004 / 0250819, co-owned by Blair et al., filed March 29, 2004, entitled “Apparatus and Method For Detecting Objects Using Tags And Wideband Detection Device,” the entire contents of which are hereby incorporated by reference.

[0050] Now for reference Figure 2 The interrogation and detection system 10 for detecting surgical instruments 100a inside a patient's body includes a signal generator 200 to provide signals to the attached object 100a. Figure 1 One or more RFID tags 100 Figure 1 The antenna 300 provides an energizing signal. Each RFID tag is configured to transmit a return signal when energized, allowing the antenna 300 to detect the return signal and confirm the presence of the object 100a inside the patient 18's body. The antenna 300 is operatively coupled to the signal generator 200 via a communication cable 250. The communication cable 250 may have a variable length to provide a greater range of motion for the clinician operating the antenna 300.

[0051] In one aspect of the interrogation and detection system 10, the antenna 300 is an in vivo insertable antenna 300, which includes a semi-rigid elongated member 310 supporting a flexible ring 320 configured for insertion into a surgical site 15 within the body of the patient 18. Therefore, the interrogation and detection system 10 further includes a cannula-cannula assembly or port 400 to provide an access point for inserting the in vivo insertable antenna 300 into the body of the patient 18. (At least refer to...) Figure 2 The cannula-cannula assembly 400 provides an elongated tubular channel 410 configured to facilitate the passage of an in vivo-introducible antenna 300. Furthermore, the distal end of the elongated tubular channel 410 must provide an opening 420 to allow the in vivo-introducible antenna 300 to enter the surgical site 15 within the patient 18.

[0052] For further reference Figure 3A -F, as described above, the in vivo antenna 300 includes a semi-rigid elongated member 310 supporting a flexible ring 320, and the flexible ring must be inserted into a surgical site 15 within the patient 18. When not under external force, the flexible ring 320 occupies too large a space to be inserted through the elongated tubular channel 410 or orifice 420 of the cannula-cannula assembly 400, see [link to relevant documentation]. Figure 4A and 4B Increasing the size of the flexible ring 320 is necessary to provide a wider range of detection for the antenna 300 that can be introduced into the body for detecting return signals from objects with RFID tags within the surgical site 15.

[0053] To allow insertion through the elongated tubular channel 410 and orifice 420 of the cannula-needle assembly 400 without sacrificing the benefits of increased size, the flexible ring 320 of the in-body insertable antenna 300 is made of a shape memory alloy. This shape memory alloy is sufficiently ductile to be compressed, folded, or otherwise reshaped to conform to its surroundings, while also being configured to automatically return to its original shape without external forces. More specifically, the in-body insertable antenna 300 can be made of materials such as nitinol, spring steel, silver, gold, copper, and various alloys of each of these listed materials. Figure 3A In this process, the flexible ring 320 is initially circular, but is compressed inward to form an elongated elliptical shape, while simultaneously translating distally toward the surgical site in direction "A1" through the elongated tubular channel 410. Upon passing through the opening 420 of the elongated tubular channel 410 and entering the surgical site, the flexible ring 320 automatically returns to its initial circular shape without being affected by external factors of the elongated tubular channel 410, such as... Figure 3B As shown. Note that, in other respects, the initial shape of the flexible ring 320 can be, for example, a teardrop shape or an ellipse, a non-circular shape.

[0054] In some respects, the flexible ring 320 can be folded along the longitudinal axis of the semi-rigid elongated member 310 to form a crescent shape, while simultaneously translating proximally in direction "A2" through the elongated tubular channel 410 away from the surgical site, such as... Figure 3C and 3D As shown. In other aspects, when the flexible ring 320 is translated distally in direction "A1" through the tubular channel 410, in addition to being compressed inward to form an elongated elliptical shape, it can also be folded backward to be placed side by side with the semi-rigid elongated member 310. Without being affected by the external environment of the elongated tubular channel 410, it automatically unfolds and returns to its original circular shape only when passing through the orifice 420 and entering the surgical site, as shown. Figure 3E and 3F As shown.

[0055] Now for reference Figure 4A -D, as described above, the antenna 300 can be introduced into the body and occupy too large a space area without being affected by external forces, so that it cannot be inserted through the elongated tubular channel 410 or orifice 420 of the cannula needle-insertion assembly 400.

[0056] Figure 4A The front view of the tubular channel 410 is shown, emphasizing that the tubular channel 410 defines a generally circular shape with a size or diameter "D1". Similarly, Figure 4B A top view of the in-body antenna 300 is shown, where the flexible ring 320 defines a generally circular shape with a size or diameter "D2" when measured laterally relative to the longitudinal axis "X". The longitudinal axis "X" extends parallel to the direction of movement of the in-body antenna 300 within the tubular channel 410, and therefore, the lateral measurement of the size "D2" of the flexible ring 320 provides a more accurate basis for comparing the relative sizes of the tubular channel 410 and the flexible ring 320. Figure 4A and 4B It can be seen that the dimensions “D1” and “D2” of the tubular channel 410 and the flexible ring 320 indicate that “D2” is greater than “D1”. Accordingly, any measurement results calculated based on dimensions “D1” and “D2” will always indicate that the size of the flexible ring 320 is larger than that of the tubular channel 410, thus highlighting the need for an adjustable size for the antenna 300 that can be introduced into the body to pass through the elongated channel 410 and exit from the aperture 420. Figure 4C This demonstrates that due to, as in Figure 3A The flexible ring 320, with an elongated elliptical shape, is formed by the compressive force applied to the inner surface of the elongated tubular channel 410 when it is translated distally in the direction "A1". Similarly, Figure 4DThe crescent shape of the flexible ring 320 is shown, which is due to its folding along the longitudinal axis "X" of the semi-rigid elongated member 310 as it translates proximally through the elongated tubular channel 410 in the direction "A2". Figure 3D As shown.

[0057] While various aspects of this disclosure have been shown in the accompanying drawings, they are not intended to be limited thereto, as this disclosure is intended to be as broad as permitted in the art and should be read in the same manner. Therefore, the foregoing description should not be construed as restrictive, but rather as an example of particular aspects only. Other modifications will be contemplated by those skilled in the art within the scope and spirit of the appended claims.

Claims

1. A size-adjustable in-vivo introducible antenna for insertion into a surgical site in a patient's body and detecting a surgical implement with an RFID tag in the patient's body, the in-vivo introducible antenna comprising: a semi-rigid elongate member configured to translate through a tubular passageway, wherein the tubular passageway defines a shape having a dimension "Dl"; and a flexible loop operably coupled to the semi-rigid elongate member, wherein the flexible loop defines a shape having a dimension "D2" such that the dimension "Dl" of the tubular passageway is less than the dimension "D2" of the in-vivo introducible antenna, and the flexible loop is configured to fold back to lie alongside the semi-rigid elongate member when inserted into the surgical site in the patient's body.

2. The antenna of claim 1, wherein the flexible loop is comprised of a shape memory alloy configured to automatically return to an initial shape in the absence of an external force.

3. The antenna of claim 2, wherein the flexible loop is size-adjustable such that it can be reshaped to conform to its surroundings.

4. The antenna of claim 3, wherein the initial shape of the flexible loop is circular.

5. An interrogation and detection system for detecting a surgical implement in a patient's body, comprising: one or more RFID tags configured to emit one or more return signals upon energization, each RFID tag attached to a surgical implement in the patient's body; a remote signal generator configured to generate an energization signal for the one or more RFID tags; and the in-vivo introducible antenna of any one of claims 1 to 4 operably coupled to the signal generator, the in-vivo introducible antenna configured to receive the one or more return signals emitted by the one or more RFID tags when in an expanded state, wherein the in-vivo introducible antenna is configured to a collapsed state smaller than the expanded state for insertion into the patient's body.

6. The system of claim 5, further comprising: a trocar-cannula assembly including a tubular passageway configured to facilitate passage of the in-vivo introducible antenna therethrough.

7. The system of claim 6, wherein the in-vivo introducible antenna includes a semi-rigid elongate member supporting a flexible loop, the flexible loop configured to fold itself when passing through the tubular passageway of the trocar-cannula assembly and to unfold when exiting the tubular passageway of the trocar-cannula assembly and entering a surgical site in the patient's body.

8. The system of claim 7, wherein the flexible loop is comprised of a shape memory alloy configured to automatically return to its initial shape in the absence of an external force.

9. The system of claim 8, wherein the initial shape of the flexible loop portion of the in-vivo introducible antenna is circular.

10. The system of claim 9, wherein the flexible ring is configured to fold inward to form an elongated oval shape as it is translated distally through the tubular passageway.

11. The system of claim 9, wherein the flexible ring is configured to fold back to lie alongside the semi-rigid elongated member as it is translated distally through the tubular passageway.

12. The system of claim 9, wherein the flexible ring is configured to fold along the axis of the semi-rigid elongated member to form a crescent shaped profile as it is translated proximally through the tubular passageway.

13. The system of claim 9, wherein the flexible ring is configured to form a teardrop shaped profile as it is translated through the tubular passageway.

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