Insufflation needle assembly and method of insufflating a body cavity by using same
The insufflation needle assembly with integrated optic fiber and OCT imaging system addresses the challenges of blind needle entry in minimally invasive surgeries by providing real-time visual guidance, enhancing precision and safety during body cavity insufflation.
Patent Information
- Application Number
- PCT/US2024/042400
- Authority / Receiving Office
- WO · WO
- Patent Type
- Applications
- Current Assignee / Owner
- Priority Date
- 2023-08-16
- Filing Date
- 2024-08-15
- Publication Date
- 2025-02-20
AI Technical Summary
Existing minimally invasive surgical techniques, such as laparoscopic procedures, face challenges during insufflation of body cavities due to the blind entry of Veress needles, which can result in accidental injuries to internal organs or blood vessels.
An insufflation needle assembly with visual functionality is provided, featuring a needle with an outer tubular cannula and an inner hollow cannula equipped with an optic fiber. The optic fiber is coupled with a driving mechanism for rotation and an optical coherence tomography (OCT) imaging system, allowing for real-time visual guidance during needle insertion and insufflation.
The needle assembly enables clear visualization of the needle tip's location within the body cavity, reducing the risk of accidental injuries and improving the precision of insufflation procedures.
Smart Images

Figure US2024042400_20022025_PF_FP_ABST
Abstract
Description
[0001] INSUFFLATION NEEDLE ASSEMBLY AND METHOD OF INSUFFLATING A
[0002] BODY CAVITY BY USING SAME
[0003] BACKGROUND
[0004] Technical Field
[0005] This disclosure relates to devices and methods of use in the practice of surgery that involves insufflation of a body cavity and more particularly to such apparatus forming an incision and insufflating the body cavity with visual capability.
[0006] Description of Related Art
[0007] Minimally invasive surgeries such as laparoscopic, thoracoscopic, cystoscopic, and other endoscopic procedures with small incision and minimal tissue damage are now routinely practiced to reduce patient recovery time. However, these minimally invasive surgeries often involve insufflation of a body cavity, in which the target organs or tissues of the surgeries situate, to provide enough space for surgeons to carry out the procedures efficiently and safely. While the minimally invasive surgeries have improved surgery safety in comparison to the traditional surgeries, one of the major risks associated with the minimally invasive surgeries comes from the insufflation of a body cavity.
[0008] Recently, it is estimated that 50% of the severe complications of a laparoscopy is related to establishment of a pneumoperitoneum, which is insufflation of the peritoneal cavity. This is because a pneumoperitoneum is achieved first with a small incision through the skin and underlying tissues of the patient using a Veress needle, which is used to puncture and then pushed blindly into the internal surgical site, followed by insufflation of gas through the punctured site. Very often, the blind entry of the needle results in accidental injury to internal organs or major blood vessels nearby during the puncturing and pushing procedure.
[0009] While attempts have been made to avoid such complication associated with insufflation of body cavity by modifying the Veress needle into a device with remote visual functionality, none of these provides a clear enough image for surgeons to unambiguously identify the location of the tip of the needle. Modified Veress needles with visual functionality in the prior art include a videoscope inside the lumen of a Veress needle at the distal end such that the image in front of the tip of the needle is captured and seen by the surgeon. However, with the videoscope pushed closely against the tissue, the quality and content of the optical image are often insufficient for a surgeon to distinguish the position of the tip of the Veress needle.
[0010] The present disclosure, therefore, provides a solution to problems associated with the use of such Veress needle assemblies by providing a clear and distinguishable visual aid to help surgeons determine the location of the tip of the needle.
[0011] SUMMARY
[0012] In view of the foregoing, the present disclosure provides an insufflation needle assembly with visual functionality, comprising a needle having an outer tubular sharp- ended cannula and an inner hollow blunt-ended cannula with a side opening near the blunt end, an optic fiber removably disposed in the inner hollow blunt-ended cannula, a driving mechanism coupled to the optic fiber and configured to rotate the optic fiber around its longitudinal axis, an optical coherence tomography imaging system coupled to the optic fiber to provide light through the optic fiber and receive an optic signal from the optic fiber, and a gas source configured to provide gas into the inner hollow cannula. The light provided by a light source of the optical coherence tomography imaging system is a light with a frequency that can be received and processed by an optical coherence tomography imaging system. In at least one embodiment, the light is in a near' infra-red spectrum.
[0013] In at least one embodiment of the present disclosure, the needle further comprises a handle and a port at the proximal end of the outer tubular cannula, wherein the port receives the removable optic fiber and / or a tube connected to the gas source. The port can be of any connection mechanism known in the art, such as a Luer connector, a valve, a socket, or a screw thread.
[0014] In at least one embodiment of the present disclosure, the optic fiber is removably disposed in the inner hollow cannula such that the light passing through the optic fiber is directed out of the inner hollow cannula through the side opening near its blunt end and into the body cavity. In another embodiment of the present disclosure, the optic fiber is a single-mode fiber, a multimode fiber, and / or a coreless fiber. In some embodiments of the present disclosure, the optic fiber may be composed of two or more different types of fibers, such as a single-mode fiber, a multimode fiber, and a coreless fiber. As an example, the optic fiber may be composed of a single-mode fiber or a multimode fiber and ended with a coreless fiber as the termination fiber.
[0015] In at least one embodiment of the present disclosure, the distal end of the optic fiber is a beam deflector. In at least one embodiment of the present disclosure, the beam deflector can be formed directly from the material of the optic fiber by controlled heating and melting. In at least one embodiment of the present disclosure, the optic fiber is fused, bonded, or ground with a beam deflector. In at least one embodiment, a fiber polisher is used to grind and / or polish a reflective slope at the distal end of the optic fiber to create a lateral exit for the light beam at total reflection. In other embodiments, the reflective slope is coated with a light reflective material to deflect light traveling in the optic fiber. In at least one embodiment of the present disclosure, the distal end of the optic fiber is coated with a light reflective material to deflect light traveling in the optic fiber. In at least one embodiment of the present disclosure, the beam deflector is ball-shaped. In at least one embodiment of the present disclosure, the beam deflector is a ball lens. In another embodiment of the present disclosure, the optic fiber is fused with a ball-shaped beam deflector. In at least one embodiment of the present disclosure, the beam deflector is a ball-shaped beam deflector formed directly from the material of the optic fiber by controlled heating and melting.
[0016] In at least one embodiment of the present disclosure, the ball-shaped end of the optic fiber is polished to form an oblique face. In at least one embodiment, the angle of the oblique face can range from 30° to 45°, e.g., 30°, 31°, 32°, 33°, 34°, 35°, 36°, 37°, 38°, 39°, 40°, 41°, 42°, 43°, 44°, or 45°.
[0017] In at least one embodiment, the optic fiber of the needle assembly is enclosed in a sheath. In at least one embodiment, the sheath is transparent to allow transmission of light. In at least one embodiment, at least one part of the optic fiber is supported with a scaffold coupled to the driving mechanism to assist in rotating the optic fiber around its longitudinal axis inside the inner hollow cannula.
[0018] The present disclosure also provides a method of insufflating a body cavity in a subject in need thereof, comprising: making an incision on a skin of the subject; providing a needle assembly of the present disclosure, with the optic fiber removably disposed in the inner hollow cannula, such that light passing through the optic fiber is directed out of the inner hollow cannula through the side opening near its blunt end; inserting the needle assembly into the incision on the skin of the subject; identifying a location of the blunt distal end of the inner hollow cannula based on an image shown on the optical coherence tomography imaging system; advancing the sharpened distal end of the outer tubular cannula of the needle assembly until the blunt distal end of the inner hollow cannula reaches a surface of tissue enclosing the body cavity; puncturing through the surface of tissue enclosing the body cavity with the sharpened distal end of the outer tubular cannula; removing the optic fiber from the inner hollow cannula of the needle assembly; connecting the inner hollow cannula to a gas source; and insufflating the body cavity with a gas from the gas source.
[0019] The present disclosure also provides a method of establishing a pneumoperitoneum in a subject in need thereof, comprising: making an incision on a skin of the subject; providing a needle assembly of the present disclosure with the optic fiber removably disposed in the inner hollow cannula such that the light passing through the optic fiber is directed out of the inner hollow cannula through the side opening near the blunt distal end of the inner hollow cannula; inserting the needle assembly into the incision on the skin of the subject; identifying a location of the blunt distal end of the inner hollow cannula based on an image shown on the optical coherence tomography imaging system; advancing the sharpened distal end of the outer tubular cannula of the needle assembly until the blunt distal end of the inner hollow cannula reaches a surface of peritoneum; puncturing through the peritoneum with the sharpened distal end of the outer tubular cannula; removing the optic fiber from the inner hollow cannula of the needle assembly; connecting the inner hollow cannula to a gas source; and insufflating the peritoneum with a gas from the gas source. In at least one embodiment, the optical coherence tomography imaging system of the needle assembly in the method transmits an optic signal into the optic fiber. In at least one embodiment, the optic fiber of the needle assembly in the method rotates around the longitudinal axis thereof in the inner hollow cannula and transmits reflected light received at a distal end of the optic fiber to the optical coherence tomography imaging system to obtain a series of images of the location of the blunt distal end of the inner hollow cannula.
[0020] When the needle assembly of the present disclosure is used to puncture tissue in conjunction with an optic fiber and an optical coherence tomography imaging system, an optical image is instantaneously displayed to identify the location of the needle’s tip. This disclosure relates to devices and methods of use in the practice of surgery that involves insufflation of a body cavity, e.g., to such apparatus forming an incision and insufflating the body cavity with visual-assisted information capability.
[0021] It should be understood that the summary above is provided to introduce, in simplified form, a selection of concepts that are further described in the detailed description below. It is not meant to identify key or essential features of the claimed subject matter, the scope of which is defined by the claims that follow the detailed description. Furthermore, the claimed subject matter is not limited to implementations that solve any disadvantages noted above or in any part of this specification. The above advantages and other advantages and features of the present disclosure will be readily apparent from the following detailed description when taken alone or in combination with the accompanying drawings. The disclosure extends to any combination of features disclosed herein, whether or not such a combination is mentioned explicitly herein. Further, where two or more features are mentioned in combination, for example in the same paragraph, it is intended that such features may be claimed separately without extending the scope of the disclosure. Features from different embodiments described below may also be brought together in any claim.
[0022] BRIEF DESCRIPTION OF DRAWINGS
[0023] The present disclosure can be put into effect in numerous ways, illustrative nonlimiting embodiments of which are described below with reference to the accompanying drawings.
[0024] FIG. 1 shows a schematic embodiment of a needle assembly of the present disclosure.
[0025] FIG. 2 shows a detailed view of the tip of a needle assembly in an embodiment of the present disclosure.
[0026] FIG. 3 shows a diagram illustrating exemplary components of a needle assembly in an embodiment of the present disclosure.
[0027] FIG. 4 shows a flowchart depicting the steps of an insufflation procedure using the needle assembly of the present disclosure.
[0028] FIGs. 5 A and 5B show different tissue layers of abdomen to be traversed by a needle assembly of the present disclosure.
[0029] FIGs. 6 A to 6E show the characteristic optical coherence tomography images obtained in real time with a needle assembly of the present disclosure.
[0030] DETAILED DESCRIPTION
[0031] The following examples are used for illustrating the present disclosure. A person skilled in the art can easily conceive other effects of the present disclosure, based on the disclosure of the specification. It will be apparent that one or more embodiments may be practiced without specific details. The present disclosure can also be implemented or applied as described in different examples. It is possible to modify or alter the following examples for carrying out this disclosure without contravening its scope for different applications.
[0032] In this disclosure, all terms including descriptive or technical terms which are used herein should be construed as having meanings that are obvious to one of ordinary skill in the art. However, the terms may have different meanings according to an intention of one of ordinary skill in the art, case precedents, or the appearance of new technologies. Also, some terms may be arbitrarily selected by the applicant, and in this case, the meaning of the selected terms will be described in detail in the descriptions of the present disclosure. Thus, the terms used herein are defined based on the meaning of the terms together with the descriptions throughout the specification.
[0033] As used in this disclosure, the singular forms “a,” “an,” and “the” include plural referents unless expressly and unequivocally limited to one referent. The term “or” is used interchangeably with the term “and / or” unless the context clearly indicates otherwise.
[0034] Also, when a part “includes” or “comprises” a component or a step, unless there is a particular description contrary thereto, the part can further include other components or other steps, not excluding the others.
[0035] Throughout this disclosure, ordinal numbers (e.g., first, second, third, etc.) may be used as an adjective for an element (i.e., any noun in this disclosure). The use of ordinal numbers is not to imply or create an ordering of the elements nor to limit any element to be only a single element unless expressly disclosed, such as by the use of the terms “before,”
[0036] “after,” “single,” and other such terminology. Rather, the use of ordinal numbers is to distinguish between the elements. By way of an example, a first element is distinct from a second element, and the first element may encompass more than one element and succeed (or precede) the second element in an ordering of elements.
[0037] Notwithstanding that the numerical ranges and parameters setting forth the broad scope of the disclosure are approximations, the numerical values set forth in the examples are reported as precisely as possible. Any numerical value, however, inherently contains certain errors resulting from the standard deviation found in the respective testing measurements. Accordingly, unless indicated to the contrary, the numerical parameters set forth in the present disclosure and attached claims are approximations that can be varied. At the very least, each numerical parameter should at least be construed in light of the number of reported digits and by applying ordinary rounding techniques. All given ranges and values may vary by 1% to 5%, unless indicated otherwise or known otherwise by a person skilled in the art. Therefore, the term “about” is usually omitted from the description and claims.
[0038] As used herein, the phrase “at least one,” in reference to a list of one or more elements, should be understood to mean at least one element selected from any one or more of the elements in the list of elements, but not necessarily including at least one of each and every element listed within the list of elements and not excluding any combinations of elements in the list of elements. This definition also allows that elements may optionally be present other than the elements identified within the list of elements to which the phrase “at least one” refers, whether related or unrelated to those elements identified. Thus, as a nonlimiting example, “at least one of A and B” (or, equivalently, “at least one of A or B,” or, equivalently “at least one of A and / or B”) can refer, in one embodiment, to at least one, optionally including more than one, A, with no B present (and optionally including elements other than B); in another embodiment, to at least one, optionally including more than one, B, with no A present (and optionally including elements other than A); in yet another embodiment, to at least one, optionally including more than one, A, and at least one, optionally including more than one, B (and optionally including other elements).
[0039] As used herein, the terms “subject,” “individual,” and “patient” refer to any mammalian subject for whom diagnosis, prognosis, treatment, or therapy is desired, e.g., humans. Other subjects may include cattle, dogs, cats, guinea pigs, rabbits, rats, mice, horses, and so on.
[0040] Conventional Veress needles include a tubular outer cannula with a sharpened distal end and an inner hollow cylindrical needle, or cannula, which terminates in a blunt end. A spring assembly urges the inner hollow cannula forward so that the blunt end of the inner hollow cannula extends beyond the cutting edge of the sharpened distal end of the outer cannula. When the needle is pressed against the skin of a subject, the inner hollow cannula retracts, thereby permitting the outer sharp cannula to contact the skin and advance into the tissue. As soon as a body cavity is entered, the inner hollow cannula springs forward, so that the accidental cutting of underlying organs by the sharpened outer cannula is avoided. However, maneuvering the conventional Veress needles without visual aid depends largely on the experience of the operator to distinguish the exact location of the tip of the Veress needle after entering the skin.
[0041] The Veress needle typically includes means for introducing pressurized gas, e.g., CO2, into the proximal end of the needle so that the gas is passed on through the incision and inflates the body cavity to allow easy access to the surgical site. After formation of a first incision and insufflation of the body cavity, the Veress needle is typically removed, and a trocar is placed through the same incision.
[0042] The present disclosure adopts the conventional Veress needle and provides further visual aids by use of an optical coherence tomography imaging system well known in the art and an optic fiber removably disposed in the inner hollow cannula and configured such that the light passing through the optic fiber is directed out of the inner hollow cannula through the side opening near its blunt end and into the body cavity. The optic fiber is coupled to a driving mechanism such that it rotates along its longitudinal axis to obtain a series of images through the optical coherence tomography imaging system. The visually guided needle assembly for insufflating a body cavity provided by the present disclosure can be instantly adopted from the commercially available Veress needle and essentially maintains the similar way of usage of a Veress needle.
[0043] The present disclosure can be more understood by reading the following descriptions of the embodiments, with reference made to one or more of the accompanying drawings.
[0044] For purposes of illustration, and not limitation, as embodied herein and as illustrated in FIG. 1 and FIG. 2, an apparatus 100 is provided in the form of a Veress-type needle. The apparatus 100 includes a handle 110 connected to a hollow distally extending needle 120 having an outer tubular cannula 121 with a sharpened distal end 1211 for penetrating tissues. The handle 110 and the hollow distally extending needle 120 cooperate to form a conduit for passing at least one of fluid or instruments therethrough. To the proximal end of the hollow distally extending needle 120, a port 130 is disposed and configured to receive a removable optic fiber or a tube connected to a gas source.
[0045] FIG. 2 shows the detailed view at the sharpened distal end 1211 of the outer tubular cannula 121 of the hollow distally extending needle 120 in FIG. 1. The hollow distally extending needle 120 has an inner hollow cannula 122 with a blunt distal end 1221 and a side opening 1222 near the blunt distal end 1221. The side opening 1222 allows fluid in the lumen of the inner hollow cannula 122 to pass through, such as insufflation gas or optic signals. The apparatus 100 further includes a spring (not shown) housed within the handle 110 for biasing the inner hollow cannula 122 to extend past the sharpened distal end 1211, which can be used as a cutting edge or a puncturing tip, of the outer tubular cannula 121 when there is no resistance against the blunt distal end 1221. Therefore, the blunt distal end 1221 of the inner hollow cannula 122 extends beyond the cutting edge of the outer tubular cannula 121.
[0046] On the other hand, when the hollow distally extending needle 120 is pressed against, e.g., the skin, of a subject, the inner hollow cannula 122 retracts, thereby permitting the outer tubular cannula 121 to contact the skin and advance into the tissue. As soon as a body cavity is entered, the inner hollow cannula 122 springs forward, so that the accidental cutting of underlying organs by the sharpened distal end 1211 of the outer tubular cannula 121 is avoided. Therefore, for example, when the hollow distally extending needle 120 traverses the abdominal wall and enters the abdominal cavity, the blunt distal end 1221 of the inner hollow cannula 122 is urged forward by spring beyond the sharpened distal end 1211 of the outer tubular cannula 121, thereby preventing the hollow distally extending needle 120 from cutting through any additional tissue in the abdominal cavity, including, for example, bowels, blood vessels, and the like.
[0047] Referring to FIGs. 1 and 2 again, an optic fiber 150 is slidably disposed within the inner hollow cannula 122 in the conduit formed by the handle 110 and the hollow distally extending needle 120, and is configured such that the optic signal passing through the optic fiber 150 is directed out of the inner hollow cannula 1 2 through a side opening 1222 and into the body cavity.
[0048] As illustrated in FIG. 2, the optic fiber 150 has a ball-shaped end with an oblique face
[0049] 151. Light traveling in the optic fiber 150 is deflected by the ball-shaped end and out of the side opening 1222. In an embodiment, FIG. 2 shows the light being deflected in a direction
[0050] 152. In operation, the optic fiber 150 may be supported with a scaffold 153 around the optic fiber 150, which is further coupled to a driving mechanism (not shown), such that the optic fiber 150 rotates around its longitudinal axis in a direction 154 while light traverses along the body of the optic fiber 150. Accordingly, the light is deflected out of the hollow distally extending needle 120 into the tissue next to the side opening 1222 when the oblique face 151 of the ball-shaped end of the optic fiber 150 is aligned with the side opening 1222. The light is then reflected by the tissue, which is received by the optic fiber 150 and processed by an optical coherence tomography imaging system (not shown) in communication to the optic fiber 150.
[0051] In accordance with further implementations, one or more optic fibers can be used to transmit light from a light source through the apparatus 100 to its distal end. The optic fiber 150 can be further enclosed in a protective sheath 155, as shown in FIGs. 1 and 2.
[0052] In addition to the Veress-type needle with an optic fiber 150 as described above, the needle assembly of this embodiment may further comprise an optical coherence tomography imaging system that serves as a light source to provide optic signals through the optic fiber 150, as well as receives reflected optic signals from the tissue, which is further processed and output to display as a real-time image for a surgeon to identify instant location of the tip of the needle.
[0053] As illustrated in FIG. 3, which shows a block diagram of an embodiment of the present disclosure that comprises a Veress-type needle with an optic fiber 301 in communication with an optical coherence tomography imaging system 302, where the optic signals arc processed and converted to electronic signals and displayed on a screen 303.
[0054] In an embodiment, the disclosure may further provide a method of using an apparatus as described herein to implement an insufflation procedure in preparation for a minimally invasive endoscopic surgery, such as a laparoscopic surgical procedure in the abdomen, as illustrated in the flowchart of steps of the method in FIG. 4. The method includes making an incision on a skin of a subject, followed by providing a needle assembly of the present disclosure with the optic fiber removably disposed in the inner hollow cannula such that an optic signal is transmitted into the optic fiber and directed out of the inner hollow cannula through the side opening near the blunt distal end of the inner hollow cannula, and inserting the needle assembly (e.g., the apparatus 100 as illustrated herein above) into the incision, shown as steps 401 to 403.
[0055] The method further includes identifying a location of the blunt distal end of the inner hollow cannula based on an image displayed on the optical coherence tomography imaging system shown as step 404, which is made possible via the optic fiber 150 rotating around its longitudinal axis and the optical coherence tomography imaging system, by receiving and processing signals collected from the reflected light from the tissue next to the side opening 1222 of the inner hollow cannula 122 of the needle assembly as described above. A surgeon can therefore, based on the real-time image showing the location of the blunt distal end of the inner hollow cannula, advance the sharpened distal end of the outer tubular cannula of the needle assembly until the blunt distal end of the inner hollow cannula reaches a surface of peritoneum (step 405). After the surface of peritoneum is identified, the peritoneum is carefully punctured through with the sharpened distal end 1211 of the hollow distally extending needle 120 of the needle assembly (step 406). Before insufflation, the optic fiber 150 is removed from the inner hollow cannula (step 407), and gas (e.g., CO2) can be sent into the peritoneum through the inner hollow cannula to insufflate the peritoneum (step 408).
[0056] FIG. 5 A illustrates different layers of tissues to be traversed by an insufflation needle assembly to establish a pneumoperitoneum for a laparoscopic surgical procedure in the abdomen, including the skin 501, adipose tissue 502, muscle 503, peritoneum 504, and abdominal cavity 505. FIG. 5B illustrates different layers of tissues to be traversed by an insufflation needle assembly to establish a pneumoperitoneum for a laparoscopic surgical procedure in the abdomen in another embodiment, including the skin 501, adipose tissue 502, muscle 503, and abdominal cavity 505, where the peritoneum 504 is presented with peritoneal adhesions. A real-time location of the tip of the needle assembly can be clearly distinguished through the image processed and displayed by the connected optical coherence tomography imaging system.
[0057] For example, the muscle layer of the abdomen, indicated as 503 in FIGs. 5A and 5B, is represented by an optical coherence tomography (OCT) image showing multiple layers of reflected light signals, which is characteristic of muscle fiber bundles (FIG. 6A). The peritoneum, indicated as 504 in FIG. 5A, is shown as a stronger signal (bright white shades) on the optical coherence tomography image (FIG. 6B) due to its denser tissue texture. The abdominal cavity, indicated as 505 in FIGs. 5A and 5B, is shown with no reflection of light from the tissue (no white shades) in the optical coherence tomography image (FIG. 6C). In another embodiment, the peritoneal adhesion, indicated as 504 in FIG. 5B, is detected by the needle assembly of the present disclosure, before a puncture of the peritoneum is made, by an OCT image showing a peritoneum or peritoneal tissue with a denser bright white shade (indicated by # in FIGs. 6D and 6E) following by an adhesion shown as less dense white shade (indicated by * in FIGs. 6D and 6E). Therefore, the optical coherence tomography images shown in such as FIGs. 6 A to 6E provide instant feedback for an operator of the insufflation needle assembly of the present disclosure such that an exact location of the tip of the insufflation needle assembly is recognized by the operator throughout the puncturing procedure to establish a pneumoperitoneum, thereby avoiding puncturing through a peritoneal adhesion by identifying the presence of a peritoneal adhesion before a puncture through the peritoneum is made.
[0058] Therefore, with characteristic optical coherence tomography images obtained in real time by the needle assembly of the present disclosure, a surgeon always knows the location of the needle tip during the puncturing and insufflation procedure. The method further includes stopping advancement of the distal end of the hollow needle when reaching the abdominal cavity. At this point, the optic fiber 150 can be retracted proximally, such as under manual action, and the method can further include commencing insufflation through the hollow needle.
[0059] While some of the embodiments of the present disclosure have been described in detail in the above, it is, however, possible for those of ordinary skill in the art to make various modifications and changes to the embodiments shown without substantially departing from the teaching of the present disclosure. Such modifications and changes are encompassed in the scope of the present disclosure as set forth in the appended claims.
Claims
CLAIMSWhat is claimed is:
1. A needle assembly for insufflating a body cavity inside a subject in need thereof, the needle assembly comprising: a needle having an outer tubular cannula with a sharpened distal end and an inner hollow cannula having a blunt distal end and a side opening near the blunt distal end; an optic fiber removably disposed in the inner hollow cannula and configured for light to pass through the optic fiber and be directed out of the inner hollow cannula through the side opening and into the body cavity; a driving mechanism coupled to the optic fiber and configured to rotate the optic fiber around a longitudinal axis of the optic fiber inside the inner hollow cannula; and an optical coherence tomography imaging system coupled to the optic fiber to provide the light through the optic fiber and receive an optic signal from the optic fiber.
2. The needle assembly of claim 1, further comprising a handle and a port at a proximal end of the outer tubular cannula.
3. The needle assembly of claim 2, wherein the port receives at least one of the optic fiber and a tube connected to a gas source.
4. The needle assembly of claim 1, wherein the optic fiber is a single-mode fiber.
5. The needle assembly of claim 4, wherein the single-mode fiber has one end fused with a coreless fiber.
6. The needle assembly of claim 5, wherein the corclcss fiber has a distal end formed in a ball shape.
7. The needle assembly of claim 6, wherein the distal end of the coreless fiber is formed with an oblique face.
8. The needle assembly of claim 1, wherein the optic fiber is enclosed in a sheath.
9. The needle assembly of claim 8, wherein the sheath is configured to allow transmission of the light.
10. The needle assembly of claim 9, wherein the light is in a near infra-red spectrum.
11. The needle assembly of claim 1, wherein the optic fiber has at least one part supported with a scaffold coupled to the driving mechanism to rotate the optic fiber around the longitudinal axis thereof inside the inner hollow cannula.
12. The needle assembly of claim 1, further comprising a gas source configured to provide gas into the inner hollow cannula.
13. A method of establishing a pneumoperitoneum in a subject in need thereof, the method comprising: making an incision on a skin of the subject; providing the needle assembly of claim 1 with the optic fiber removably disposed in the inner hollow cannula for an optic signal to be transmitted into the optic fiber and directed out of the inner hollow cannula through the side opening near the blunt distal end of the inner hollow cannula; inserting the needle assembly into the incision on the skin of the subject; identifying a location of the blunt distal end of the inner hollow cannula based on an image shown on the optical coherence tomography imaging system; advancing the sharpened distal end of the outer tubular cannula of the needle assembly until the blunt distal end of the inner hollow cannula reaches a surface of peritoneum; puncturing through the peritoneum with the sharpened distal end of the outer tubular cannula; removing the optic fiber from the inner hollow cannula of the needle assembly; connecting the inner hollow cannula to a gas source; and insufflating the peritoneum with a gas from the gas source.
14. The method of claim 13, further comprising rotating the optic fiber around the longitudinal axis of the optic fiber in the inner hollow cannula and transmitting reflected light received at a distal end of the optic fiber to the optical coherence tomography imaging system to obtain a series of images of the location of the blunt distal end of the inner hollow cannula.
15. The method of claim 14, wherein the distal end of the optic fiber is formed in a ball shape with an oblique face for the optic signal to be directed out of the inner hollow cannula through the side opening.
16. A method of insufflating a body cavity in a subject in need thereof, the method comprising: making an incision on a skin of the subject; providing the needle assembly of claim 1 with the optic fiber removably disposed in the inner hollow cannula for an optic signal to be transmitted into the optic fiber and directed out of the inner hollow cannula through the side opening near’ the blunt distal end of the inner hollow cannula; inserting the needle assembly into the incision on the skin of the subject; identifying a location of the blunt distal end of the inner hollow cannula based on an image shown on the optical coherence tomography imaging system; advancing the sharpened distal end of the outer tubular cannula of the needle assembly until the blunt distal end of the inner hollow cannula reaches a surface of tissue enclosing the body cavity; puncturing through the surface of tissue enclosing the body cavity with the sharpened distal end of the outer tubular cannula; removing the optic fiber from the inner hollow cannula of the needle assembly; connecting the inner hollow cannula to a gas source; and insufflating the body cavity with a gas from the gas source.
17. The method of claim 16, further comprising rotating the optic fiber around the longitudinal axis of the optic fiber in the inner hollow cannula and transmitting reflected light received at a distal end of the optic fiber to the optical coherence tomography imaging system to obtain a series of images of the location of the blunt distal end of the inner hollow cannula.
18. The method of claim 17, wherein the distal end of the optic fiber is formed in a ball shape with an oblique face for the optic signal to be directed out of the inner hollow cannula through the side opening.
Citation Information
Patent Citations
Insufflation needle with integrated image sensor
US20120197078A1
Tissue expansion devices, systems and methods
US20150045825A1
Visually Assisted Entry of a Veress Needle with a Tapered Videoscope for Microlaparoscopy
US20170042573A1
Systems and methods for an actively controlled optical imaging device
US20210223026A1
Method and system for image-guided procedures with sensing stylet
US20230181000A1