JP4832763B2 - Access medical device and medical procedure execution method - Google Patents

Description

  The present invention relates to medical devices and methods, and more particularly to medical devices and methods useful for performing decompression-assisted surgery such as laparoscopic surgery without gas injection.

  Conventional minimally invasive procedures perform the above procedure by lifting a tissue wall or body wall from the internal organ, thereby separating the body wall from the internal organ and creating a surgical space for introducing various surgical instruments. Therefore, the use of gas (carbon dioxide, etc.) injection is indispensable.

  Next Patent Literature: Patent Literature 1, Patent Literature 2, Patent Literature 3, Patent Literature 4, Patent Literature 5, Patent Literature 6, Patent Literature 7, Patent Literature 8, Patent Literature 9, Patent Literature 10, Patent Literature 11, Patent Document 12 discloses various instruments used in medical or surgical applications.

  Next Patent Literature: Patent Literature 13, Patent Literature 14, Patent Literature 15, Patent Literature 16, Patent Literature 17, Patent Literature 18, Patent Literature 19, Patent Literature 20, Patent Literature 21, Patent Literature 22, Patent Literature 23, Patent Document 24, Patent Document 25, and Patent Document 26 disclose examples of medical devices including trocars and instrument assemblies.

  Gas injection is commonly used, but non-gas based methods have been proposed. For example, such a method can use a mechanical device in which the tissue is lifted externally or the tissue lifts the tissue without using gas and the surgical space. And is lifted by a support similar to a stirrup provided inside. One method uses a reduced pressure driven tissue lift device. The following U.S. Patents: US Pat. Nos. 5,028,028, and 3,029, relating to disclosure relating to lifting devices and methods, including vacuum lifting devices and methods, are incorporated herein by reference.

  The method described in U.S. Patent No. 6,057,031 describes a decompression shell and provides a "dome" shaped surgical area within a patient. An optical trocar having an obturator and a cannula sleeve may be used with such a vacuum shell. However, there are challenges associated with the use of the trocar in decompression-assisted surgery and / or surgery without gas injection.

  For example, a conventional trocar may have a working length that is insufficient for such applications (the working length is defined as the substantial length of the tubular portion of the trocar below the sealing surface of the trocar) There). On the other hand, increased length trocars are difficult to manipulate and can restrict movement during surgical procedures.

  In addition, using a conventional bladed trocar with a decompression shell or other decompression lift device may accidentally contact internal organs during the first “invisible” entry into the body cavity. Probably not desirable. Even if an optical obturator is used, further skills are required to simultaneously introduce and position the trocar tip. Also, introducing the camera assembly into the trocar obturator may result in a bulky (difficult to handle) assembly during the step of drilling into body tissue.

  Furthermore, conventional trocars with a fixed length may not be suitable for all patients. Another patient may have different thicknesses of the abdominal wall and / or the fat layer corresponding to this abdominal wall. For example, lightweight or normal weight patients require a trocar having a specific length, while relatively fertile patients require a longer trocar.

Another problem in using a conventional trocar for decompression-assisted surgery is that when the trocar is inserted after the decompression shell has been placed over the tissue, the trocar first removes the piercable membrane of the case. It is at the point where it is perforated and then enters the patient's tissue. If the user tries to pierce the body wall without applying a vacuum to the decompression shell, the body wall should try to twist under the piercing force and the internal organs will be damaged there is a possibility. On the other hand, if a conventional trocar is inserted after applying reduced pressure and lifting part or all of the abdominal wall from the internal organ, the body lumen and the organ below the abdominal wall may also “lift” . Peristaltic bowel movement becomes dull due to anesthetic action, leading to the formation of trapped gas pockets. These trapped gases expand under reduced pressure, resulting in a reduction in surgical space and an increase in gas pressure within the lumen of the intestinal tract. In the case of abdominal surgery, during the period in which the abdominal cavity is under reduced pressure, the diaphragm may be drawn into the abdominal cavity, and the thoracic cavity may be negatively pressured.
US Patent Application No. 20030065358 A1 US Patent Application No. 20003120437 A1 US Patent Application No. 20036099550 A1 U.S. Patent Application No. 2003003586802 A1 US Patent Application No. 200303823947 A1 US Patent Application No. 20030379939 A1 US Patent Application No. 20030376169A1 US Patent Application No. 20035456684 A1 US Patent Application No. 200303336220 A1 US Patent Application No. 200303186714 A1 European Patent Application No. 0614646 B1 International Patent Application No. WO0193742 A2 US Patent Application No. 200303628A1 US Patent Application No. 20030603770 A1 US Patent Application No. 20030023257 A1 US Patent Application No. 20030004529 A1 US Patent Application No. 20030004528 A1 US Patent Application No. 200303582441 B1 US Patent Application No. 20020198554 A1 US Patent Application No. 20020183775 A1 International Patent Application No. WO9410898 A1 Japanese Patent Application No. 11089851A Japanese Patent Application No. 07047076A Japanese Patent Application No. 05228160A Japanese Patent Application No. 04263849A Japanese Patent Application No. 04253852A US Pat. No. 6,042,539 US Pat. No. 5,938,626 US Pat. No. 5,893,368

  An object of the present invention is to provide a medical device that improves workability in medical treatment and is excellent in safety, and a method for executing the medical treatment.

  According to a first aspect of the present invention, there is provided a medical device for accessing an internal space of a patient, the first elongate member having a proximal end, a distal end and an internal lumen, an open proximal end, A second elongate member having an inner lumen with an open distal end and a passage extending between the ends, wherein the second elongate member is attached to the first elongate member when the second elongate member is attached. The first elongate member is removable from the second elongate member so that the distal end of the elongate member is positioned at an intermediate position between the proximal end and the distal end of the second elongate member. To provide a generally continuous fluid path.

  The invention according to claim 11 is a medical device comprising a hollow first elongate member, a second hollow elongate member removably attached to a proximal end of the hollow first elongate member, A cap detachably attached to at least one of the hollow first long member and the hollow second long member, and positioning along the outer surface of the hollow first long member The sleeve is included.

  The invention according to claim 12 includes a decompression device for providing a surgical space in a patient body, and a composite part system device for providing access from one location outside the decompression device to one location in the patient, The composite part system includes a removable first member and a second member, the first member providing a first portion of the access passage, and the second member providing a second portion of the access passage. Is.

  The invention according to claim 13 is a method for performing a medical procedure, wherein a part of a patient's body is separated from other parts of the patient's body to provide a surgical space in the patient's body, and a composite part Accessing the surgical space via a system passageway.

  The invention according to claim 14 is a method of performing a medical procedure, the step of forming an incision in a patient, a proximal portion of the cannula positioned outside the patient, and a distal portion of the cannula being the patient. Inserting a cannula into the incision to be positioned therein, positioning a reduced pressure shell across the incision and the cannula, and an extension extending through and in communication with the reduced pressure shell Providing a cannula.

  According to the present invention, there is an effect that it is possible to provide a medical device that improves workability in medical treatment and is excellent in safety, and a method for executing this medical treatment.

Summary of the Invention

  Applicants have recognized the disadvantages of using a conventional trocar with a vacuum lift device and there is a need for an improved device for accessing the body when the vacuum lift device is used. Applicants have recognized the need for a composite part system passage to be used as a fluid (eg, air) conduit with a vacuum shell. In addition to the gap between the outer surface of the tissue and the decompression shell (from about 75 mm to 100 mm) prior to application of reduced pressure, Applicant also determines the thickness of the tissue wall penetrated to access the internal surgical space. Has also recognized that an assembly having a sufficient length is desirable.

  In one embodiment, the present invention provides a medical device including a composite part passage for accessing a patient's interior space, the device comprising a proximal end, a distal end, and an inner tube. A hollow first elongated member having an inner lumen with a hollow first elongated member having a cavity, an open proximal end, an opened distal end, and a passage extending between the two ends, The first elongate member is removably attached to the second elongate member to provide a generally continuous internal lumen. The distal end of the first elongate member can be positioned at an intermediate position between the proximal end and the distal end of the second elongate member when the second elongate member is attached to the first elongate member. .

  In another embodiment, the present invention provides an assembly including a decompression device for providing a surgical space in a patient body, and a composite component system device for accessing a location within the patient from a location outside the decompression device. provide. The composite component system device may include a detachable first member and a second member, the first member providing a first portion of the access passage and the second member providing a second portion of the access passage. is there.

  In another embodiment, the present invention provides a method for performing a medical procedure. The method includes the steps of separating a portion of the patient's body from other portions of the patient's body to provide a surgical space within the patient, and accessing the surgical space via a composite part system passage. Can do.

  A multi-functional composite part system passage device can impart air movement in two directions. This device and its method of use is such as to allow placement and access to the body cavity under the body wall prior to the application of reduced pressure using the reduced pressure lift device, thereby causing problems with the body cavity under reduced pressure, That is, intestinal tract dilation can be avoided. The design of the composite member can give the freedom to change the length of the device. The apparatus and method of the present invention avoids potentially difficult "invisible" initial entry by not requiring forced penetration or the use of sharp or pointed tips that penetrate tissue. be able to.

  The composite part system passage device according to the present invention can be used to ensure that the surgical space formed by lifting is maintained in an outside air condition (for example, an atmospheric pressure condition). The device can also be used in a camera and / or instrument passage during the procedure due to its internal lumen, including but not limited to laparoscopic manual instruments. A bi-directional air passage for maintaining an outside air condition in the body cavity may be maintained even when the instrument passes through the device. The device of the present invention is an ultrasonic probe for laparoscopic examination or a catheter system probe that penetrates the internal lumen of the above-mentioned device, and is useful for insertion of a diagnostic probe that is not limited thereto. Can be achieved. The device also allows for the loss of surgical space during a surgical procedure (when providing an unobstructed passage lacking any valves or flow control assemblies such as are typically present in conventional trocars). Allows removal of tissue resected or removed via the internal lumen of the device. The device according to the present invention may also ventilate odors that may occur during the use of an electrosurgical instrument for incision or coagulation of internal tissue due to its open communication with the outside air environment. .

  In addition, the composite part system passage device of the present invention provides a conduit for easily releasing any air trapped in the pocket of the inner lumen when the decompression of the decompression lift case is released and eliminated. it can. After releasing and eliminating the case vacuum, the device can provide a conduit for placing a waste catheter that drains body fluid after surgery. Also, if desired, the cannula component can be left in the incision and surgically provided to give a hole into the internal lumen used for visualization for possible bleeding or any post-surgical complications Later it can be closed with a substantially rigid cap.

  The multi-functional composite member-based conduit device provided by the present invention is not limited by theory, but is a minimally invasive procedure that does not use gas by using an external decompression-driven tissue lift device. It can be used in medical procedures that are not limited thereto. This medical procedure is used for incision or coagulation, etc. to introduce instruments and medical cameras that can be used during surgical or diagnostic procedures, therapeutic procedures or surgeries to remove the excised / excised tissue In order to remove odors generated during use of electrosurgical devices and to drain fluids during or after surgery, a surgical area in ambient conditions of temperature and pressure, providing a passage for moving air in two directions Is to maintain.

  The term “long” or “long” means that a part or member has a length that is at least three times its width (eg, a cylinder that has a length that is at least three times the outer diameter). Means.

  The term “procedure” or “surgical procedure” refers to diagnostic, diagnostic, therapeutic, surgical, outpatient or mobile procedures that are either open or laparoscopic or laparoscopically assisted. , Means medical treatment, including but not limited to first aid and post-mortem treatment.

  The term “surgical space” is formed under any tissue or inside a body, such as an organ, by relative separation, such as partially or completely lifting one body structure relative to another body structure. Means any workspace that was made.

  The term “distal” is used to refer to a part, part, end, or tip of a part or member that is remote from the user, whereas the term “proximal” refers to the part closer to the user of the device. Used to describe part, end or tip.

  The terms “removable attachment” and “can be removably attached” refer to two or more that can be repeatedly combined and separated without destroying, deforming, damaging or diminishing the function or form. Means a part.

  For purposes of illustration, the drawings and descriptions are given for an example procedure using abdominal wall lift, but it should be understood that the invention can be applied to other parts of the patient's body. In particular, the present invention can be applied to a treatment in which the outside of the body is lifted with respect to the inside of the body to form a surgical space, but is not limited thereto.

  While the reduced pressure shell and reduced pressure are described as examples of means for lifting body tissue, it should be understood that the appended claims are not limited to applications including the reduced pressure shell disclosed and illustrated below. It is. Other lifting methods including, for example, mechanical, electromechanical, gas-based or non-gas-based can be used with the apparatus of the present invention.

  While the description and drawings depict threading aspects for removably attached parts, other suitable including, but not limited to, friction fit, snap fit, press fit aspects and electrical or electromechanical attachment means It should be understood that the use of various engagement aspects is possible.

  1 and 2 show an assembled medical device 30 according to one embodiment of the present invention. The medical device 30 can include a hollow first elongate member and a hollow second elongate member that can be removably attached to each other. The first elongate member can include an extension cannula 132. The second elongate member can include a cannula 233. The medical device 30 can also include a third member that can be removably attached to one or both of the extension cannula 132 and cannula 233. 1 and 2, a third member cap 331 can be included. The medical device 30 can also include a sleeve 434 for sealing.

  Extension cannula 132, cannula 233, and cap 331 can all be formed of any suitable biocompatible material. In one embodiment, the extension cannula 132, cannula 233, and cap 331 can be formed of a non-shrinkable biocompatible material that is translucent, transparent or opaque and has a relatively rigid or somewhat rigid configuration. . In one embodiment, extension cannula 132, cannula 233 and cap 331 can all be transparent. Each of these members can be manufactured by extrusion or injection molding or any suitable plastic processing method or other suitable manufacturing method. In one embodiment, the extension cannula 132, cannula 233 and cap 331 are all polycarbonate, impact modified acrylic, ABS (acrylonitrile butadiene styrene copolymer) resin, or polyether ether ketone (PEEK). Can be formed.

  In addition, the medical device 30 can include the sealing sleeve 434 as the fourth member. The sealing sleeve 434 can be formed of a relatively flexible material such as flexible polyurethane, silicon, polypropylene, polyisoprene, or elastic rubber. The sealing sleeve 434 can be placed around the outer surface of the cannula 233 such that the sealing sleeve 434 slides around the outer diameter of the cannula 233.

  With reference to FIGS. 3-6 and FIGS. 11-14, the extension cannula 132 may have any suitable cross section including circular and non-circular cross sections. The extension cannula 132 can have an open proximal end 142 and a distal end 144 that can be open or closed. The extension cannula 132 can include an internal lumen 140 that extends from the proximal end 142 to the distal end 144 of the extension cannula 132. Both extension cannula 132 and inner lumen 140 may have a circular cross-section as shown in FIGS. 3-6 or a generally oval cross-section as shown in FIGS. 11-14. it can. Alternatively, the extension cannula 132 can have a generally cylindrical outer surface and the inner lumen 140 can have a non-circular cross section. Although the extension cannula 132 is shown as a single unit piece, the extension cannula 132 can be formed of multiple pieces if desired.

  The extension cannula 132 can have a length of at least about 100 mm (as measured from the proximal end to the pointed tip 138), and in one embodiment the length of the extension cannula 132 is , Between about 100 mm and about 175 mm, and at least about 6 times the outer diameter of the extension cannula 132. The outer diameter of the extension cannula 132 is about 15 mm, and the inner diameter of the inner lumen 140 is about 12.75 mm to accommodate a 10 mm hand instrument. If a 10 mm size instrument is to be used, without being limited by theory, an inner diameter of at least about 12.75 mm to provide a flow region around the instrument introduced via the internal lumen 140 It is believed that it may be desirable to have If a non-circular cross-section internal lumen is used, an internal lumen having an inner diameter of at least 12.75 mm can be used to provide flow around the introduced instrument (eg, If an oval or elliptical cross section is used, it may be desirable to have a major axis of at least about 12.75 mm and a minor axis of at least about 11 mm). It should be understood that the outer diameter and inner diameter may be altered for other applications (eg, reduced to the size of smaller diameter 5 mm or 3 mm minimally invasive instruments).

  The extension cannula 132 can include a pointed tip 138 corresponding to the distal end 144. Pointed tip 138 is provided for drilling through a portion of the vacuum shell membrane. The body of the extension cannula 132 has a generally cylindrical outer surface, and the distal portion of the extension cannula 132 is tapered and has a generally conical outer surface, as shown in FIGS. Can have. One or more side openings (or windows) 137 extend through the wall of the tapered distal portion of the extension cannula 132 so that it extends from the inner lumen 140 to the outer surface of the extension cannula 132. Through communication can be provided. The opening 137 is positionable immediately above the pointed tip 138 on the proximal side of the pointed tip 138 at the distal end 144. In FIG. 3, two openings 137 are positioned about 180 degrees apart on the outer surface of the tapered distal portion of extension cannula 132.

The opening 137 can have any suitable shape. The openings 137 desirably have a total surface area of at least 30 mm ² to provide sufficient air passages to prevent the generation of negative pressure (decompression) within the body cavity.

  The extension cannula 132 can also include an attachment portion 139 for removably attaching the extension cannula 132 to the cannula 233. The attachment portion 139 can take the form of an external screw to allow the extension cannula 132 to be removably attached to the cannula 233 by screwing, but other attachment means ( For example, latch mechanisms, press fits, snap fits and other removable fixation devices) can be used. The attachment 139 can be provided to prevent air leakage at the junction of the extension cannula 132 and cannula 233. The extension cannula 132 can also include an attachment 141 positioned at the proximal end 142 of the extension cannula 132. An attachment portion 141 can be provided for removably attaching the cap 331 to the proximal end 142 of the extension cannula 132. The mounting portion 141 can take the form of an internal screw as shown in FIG.

  FIG. 3A shows another embodiment of an extension cannula 132 having an open distal end. 3A shows an extension cannula 132 having a distal portion 160 that includes a first tip portion 162 and a second tip portion 164 and bifurcated. The bifurcated distal portion 160 can be constructed by cutting or otherwise forming the distal end of the extension cannula 132. For example, the distal end of the extension cannula 132 can be cut or formed to have a slit 167 that extends generally parallel to the axis of the extension cannula 132 and that bisects the distal end of the extension cannula 132. It is. The distal portion 160 may be a flexible material such as elastic rubber, silicone rubber, or other suitable material so that the tip portion 162 and tip portion 164 can be easily separated apart (shown in phantom in FIG. 3A). It can be made of a flexible polymer material. FIG. 3A shows how the bifurcated distal portion 160 separates to allow the introduction of a laparoscope 1012 (shown in phantom) therethrough.

  Referring to FIG. 3B, the proximal portion of the extension cannula 132 can be constructed from a generally cylindrical, relatively rigid, generally transparent polycarbonate tube 180, and the distal portion 160 can be made of elastic rubber or other relative Can be constructed of a flexible material and is coupled to the tube 180 by a flexible hinge portion 170. The hinge portion 170 has a corrugated or bellows-like wall structure to bend the distal portion 160 with respect to the polycarbonate tube 180. The hinge portion 170 can be attached to the tube 180 by any suitable method, including but not limited to an interference fit, press fit, snap fit, adhesive, or threaded engagement. If desired, one or more surfaces on the distal portion 160 can be used to sealingly engage a surface on the cannula 233 that contacts it. For example, one of the inclined surfaces on the hinge portion 170 can be used to construct a seal against the contact surface on the cannula 233. Also, in other embodiments, the groove in the hinge portion 170 is used to removably attach the extension cannula 132 and cannula 233 by engaging a complementary groove that can be provided on the extension cannula 132. Is possible.

  2 and 7-10 show a cannula 233 according to one embodiment of the present invention. Cannula 233 can have any suitable cross-sectional shape (eg, circular or non-circular, such as an oval), and the cross-sectional shape can be the same as or different from the cross-sectional shape of extension cannula 132. . The cannula 233 can have a proximal end 238, a distal end 236, and an internal lumen 242 that extends from the proximal end 238 to the distal end 236. The cannula 233 has any suitable cross-sectional shape, including circular and non-circular (eg, oval), as shown in FIGS. 7-10 and FIGS. 15 and 17 Can do. The distal end 236 can be cut obliquely to form an inclined tip for ease of introduction via any incision, as shown in FIGS. The wall thickness of the cannula 132 can be uniform or can vary along the length of the cannula. For example, the wall thickness at the distal end 236 may be changed to facilitate penetrating the incision.

  The cannula 233 can have a length of at least 100 mm, and in one embodiment has a length between about 100 mm and about 175 mm. The length of the cannula 233 can be longer, shorter, or substantially equal to the length of the extension cannula 132. If a 10 mm sized instrument is introduced via cannula 233, the outer diameter of cannula 233 can be about 15 mm and the inner diameter of inner lumen 242 can be at least 12.75 mm. The dimensions of the cannula 233 can be changed, such as by being reduced to use a smaller diameter 5 mm or 3 mm instrument set. In general, it is desirable that the outer diameter and shape of the cannula and extension cannula be substantially the same to avoid leakage through the membrane of the vacuum shell. In one embodiment, the minimum inner diameter of the cannula and extension cannula is at least 12.75 mm to provide a continuous air passage that is not blocked with or without instruments extending through the cannula and extension cannula. can do.

  The cannula 233 can include one or more openings, such as a circular eyelet 235 that penetrates the wall of the cannula 233 laterally. For example, two or more circular eyelets 235 can be spaced approximately equally angularly around the outer surface of cannula 233. If desired, the relatively large eyelet 235A can be positioned along the longest side of the inclined tip (distal end) 236, as shown in FIG. The small hole extends through the wall of the cannula 233 and allows fluid (eg, a gas such as air) to communicate from the inner lumen 242 to the outside of the cannula 233. The eyelet is positioned near the angled tip, and in one embodiment, the eyelet is maximized from about 5 mm to about 10 mm when measured parallel from the edge of the angled tip to the axis of the cannula 233. Can be spaced apart. The eyelet may extend the cannula 132 if the distal end 236 of the cannula 233 is blocked for any reason (eg, the distal end 236 is positioned relative to a tissue or organ mass). An air passageway can be provided from the via cannula 233 to the internal body cavity.

  The cannula 233 can also include an attachment portion 243 such as an internal groove or internal thread for removably attaching the proximal end of the cannula 233 to the extension cannula 132. The attachment portion 243 can have a threaded portion, a groove, or an external surface aspect (such as an external threaded portion) or other aspect for releasably engaging the extension cannula 132. Also, the attachment 243 can be used to removably attach the cap 331 to the proximal end of the cannula 233.

  18 to 20 show the cap 331. FIG. The cap 331 can include a main body 357 and a mounting portion 356 such as an external screw portion. The outer diameter of the relatively large body 357 is provided with a handle for the user to grip. The external threaded portion 356 is formed to threadably engage the threaded portions of the extension cannula 132 and cannula 233 so that the cap 331 is removably attached to the proximal end of either the extension cannula 132 or cannula 233. Can do. The cap 331 can have an inner central hole 358 that can have dimensions (eg, the same diameter) that are substantially equal to the inner lumen 140 and the inner lumen 242. Central hole 358, along with inner lumen 140 and inner lumen 242, can provide a continuous air path from outside the patient to the surgical space within the patient.

  27 to 29 are views showing a sealing sleeve 434 according to one embodiment of the present invention. The sleeve 434 has a generally cylindrical body 436 and a flange portion 468 that extends radially from the distal end of the cylindrical body 436. Central hole 470 extends through sleeve 434. The central hole 470 can be dimensioned such that the sleeve 434 is slip fit over the outer surface of the cannula 233 and slides along the length of the outer surface. Since the sleeve 434 is formed of a relatively flexible material such as elastic rubber, the flange portion 468 can be contoured to the shape of the patient's body. The bottom surface 469 of the flange portion 468 can be attached or otherwise provided with an adhesive such as a pressure sensitive adhesive coating or other suitable adhesive. A release liner (not shown) can be used to cover the adhesive prior to use, and the release liner can be peeled from the surface of the flange portion during use to expose the adhesive coating. Since the adhesive coating provided on the bottom surface 469 can be used to temporarily attach the sleeve 434 to the outer surface of the patient's body, the flange portion 468 allows the cannula 233 to be inserted into the incision in the patient's body. It can help to support the cannula 233 when Further, the bottom surface 469 can be provided with a pharmaceutical substance such as a substance selected from the group consisting of hemostatic substances, antibacterial substances, antimicrobial substances, analgesics, and combinations thereof.

FIGS. 11 to 14 are views showing another embodiment (reference embodiment) of the extension cannula to which reference numeral 1044 is attached. The extension cannula 1044 is shown as having a generally oval cross section, and the inner lumen 1045 has a generally oval cross section. 15, 16 and 17 show another embodiment of a cannula labeled with reference numeral 2049. FIG. Cannula 2049 is shown as having a generally oval cross section and internal lumen 2052 has a generally oval cross section. Extension cannula 1044 can be removably coupled to cannula 2049.

  The use of an internal lumen having an oval or other non-circular cross section may have the advantage of accommodating an insertable instrument having a large width dimension that is aligned with the long axis of the oval cross section. is there. Also, the oval cross-section may be effective to accommodate multiple instruments simultaneously, such as in a parallel relationship. The oval cross-section may also be effective for removing relatively large tissue samples via cannula 2049. The oval cross-section may also help alleviate tissue stretch around the incision in the patient. Referring to FIGS. 16 and 17, the non-circular cross section of cannula 2049 can leave a gap 2055 on both sides of a circular instrument 2050 inserted into the cannula 2049 so that the air channel can be Even when positioned within 2049, it is maintained via cannula 2049. Also, the relatively large cross section provided by the oval shape can provide a high flow rate through cannula 2049 that may be desirable in applications where rapid air passage or large amounts of air are required. For example, if the air passage is not sufficiently large when the tissue is lifted by a decompression shell using a very high power decompression device, a partial decompression effect can be caused in the body cavity in a short time. is there. Non-circular designs such as oval cross-sections avoid the partial decompression effects described above by providing a gap 2055 around the circular instrument 2050 and by providing a large flow area when the circular instrument is not present. can do.

  A non-circular cross section, such as an oval cross section, can be used to accommodate instruments that cannot pass through a circular cross section having an inner diameter comparable to the small diameter of the non-circular cross section. On the other hand, an oval cross section may also be used to simultaneously accommodate multiple instruments having smaller profiles. Oval or non-circular cross-sections may also be effective for removing relatively large ablated tissue via cannula and extension cannula. The non-circular cross section allows the tissue to expand in the other direction while the tissue is pushed in one direction as the tissue passes through the cannula and extension cannula. An oval or similar non-circular cross-section is not limited by theory and may also mitigate tissue stretch around the incision 59 through which the tissue passes. In addition, non-circular cross-sectional shapes can be used to provide a relatively large area of air passages, which desirably requires rapid air passage or large amounts of air (eg, tissue is highly When lifted by a decompression shell using a high power decompression device, if the air passage is not large enough, a partial decompression effect may be triggered in the body cavity in a short time) be able to. A non-circular cross-sectional lumen can be used to avoid the partial depressurization described above by providing a relatively large flow region even when the instrument 2051 is present.

  21 to 26 show how to use the multi-function device 30. In the case of a patient lying on his back during the procedure, as shown in FIG. 21, the incision 59 penetrates the body wall 60 (or other tissue to be lifted) to gain access to the internal body cavity 67. Can be formed. Once the incision 59 is formed, it continues to be opened using hemostatic forceps or a retractor, and the cannula 233 of the multifunction device 30 has the inclined tip 236 and the plurality of small holes 235 all disposed within the body cavity 67. Thus, it can be introduced into the body cavity 67. The markings can be placed on the outer surface of the cannula 233 to assist the surgeon in determining the insertion depth to avoid air leaks or displacement of the extension cannula within the body cavity 67. If desired, the outer surface of the cannula 233 is provided with a groove or ridge to prevent slippage of the cannula 233 at the incision 59 and to assist in sealing between the incision 59 and the outer surface of the cannula 233. (Such as a coaxial ring groove formed along the length of the outer surface of the cannula 233).

  Once the cannula 233 has been inserted to a predetermined depth, the incision may be sutured using a purse string suture technique that airtights around the extension cannula 233. Additional sealing sleeve 434 can slide down across cannula 233 toward incision 59. The protective release liner can be removed from the adhesive-coated surface of the flange 468 on the sealing sleeve 434. The flange 468 can then be pressed against the outer surface of the body wall 60 surrounding the incision 59 to make the incision 59 airtight. In addition to the adhesive coating described above, the bottom surface 469 is coated with other active agents such as antimicrobial agents, wound healing agents, hemostatic agents and the like for additional activity and use of the sealing sleeve. May be. Instead of an adhesive coating, a gel-like coating may be used to make the seal substantially airtight. In addition to sealing the incision, the sleeve 434 can assist in stabilizing the cannula 233 placed in place.

  Once the incision has been made sufficiently airtight, the vacuum shell 61 can be placed on the body wall such that at least one pierceable membrane 62 of the vacuum shell is present on the cannula 233 as shown in FIG. 60 on the outer surface. The pointed tip 138 of the extension cannula 132 can be used to pierce the puncturable membrane 62 of the vacuum shell to form an opening 63 in the membrane 62 (FIG. 23). The cap 331 can be coupled to the extension cannula 132 and can serve as a handle that provides a grip for the extension cannula 132 to advance. The extension cannula 132 can then be pushed distally toward the incision and aligned with the proximal end of the cannula 233. The pointed tip 138 can be inserted into the cannula 233 and the extension cannula 132 can be removably attached to the cannula 233, such as by screwing, friction fitting, or any suitable removable attachment mechanism, This can provide an assembly of cannula 233, extension cannula 132, sleeve 434 and cap 331. In the assembled part, reduced pressure can be supplied to the reduced pressure shell 61.

  The reduced pressure supplied using the reduced pressure shell 61 results in air being drawn from the space 66 as shown by the arrows in FIG. The decompression lifts the incision 59 of the body wall 60 upward toward the decompression shell 61. At the same time, air from the external environment can enter the body cavity 67 via the device 30 by passing through the internal lumens of the hollow cannula 233 and extension cannula 132. Air can enter the device 30 via the cap 331, pass through its internal lumen (center hole) 358, and then pass through the internal lumen 140 of the extension cannula 132. The air can then pass through the distal end of the extension cannula 132 by passing through a fluid passage window (side opening) 137 and into the inner lumen 242 of the cannula 233. The air can then flow into the body cavity via the inclined tip 236 and / or the plurality of eyelets 235 / 235A.

  The amount of air drawn into the body cavity is, to some extent, the size of the internal lumen of the assembled device 30 and the size of the openings of the fluid passage window 137 and the slanted tip 236 and the reduced pressure supplied to the vacuum shell. Depends on speed and level. By providing a continuous fluid path through the assembled device 30, the air drawn into the body cavity 67 balances the effect of the decompression supplied by the decompression shell and maintains the body cavity 67 at ambient pressure conditions. And should be sufficient to avoid any lift or bloating or bloating of the internal organ 65 below the body wall.

  The cap 331 can be used to avoid displacement of the device within the body cavity, i.e., under the decompression shell 61. During the entire procedure, the multi-function, multi-part device 30 can help to provide fluid and / or device communication from the external environment outside the patient to the internal body cavity 67.

  When a full vacuum lift is achieved, the outer surface of the body wall 60 can contact the inner surface of the vacuum shell 61, as shown in FIG. Due to this lift, a surgical space is formed in the body cavity 67. As assembled in FIG. 24, the device 30 is then shown in FIG. 25 until the joint of the cannula 233 and extension cannula 132 is positioned distally of the pierceable membrane 62 of the vacuum shell 61. You can keep it back as it is. The cap 331 can be gripped to pull the device 30 proximally. The depth of marking on the outer surface of cannula 233 can be utilized so that the desired minimum length of cannula 233 remains in the space within body cavity 67.

  The extension cannula 132 can be removed from the cannula 233 and the cap 331 can be removed from the extension cannula 132 and removably attached to the cannula 233. Here, the reconstituted device 30 includes a cap 331 removably coupled to the proximal end of the cannula 233, as shown in FIG. The cannula 233 is provided with a flow passage for external atmospheric pressure in the body cavity 67. Further, various medical devices such as an endoscopic medical device can be introduced into the body cavity 67 via the cap 331 and the cannula 233.

  A cannula 233 positioned as shown in FIG. 26 provides a two-way air passage to maintain the ambient space in the surgical space of the body cavity 67; maintaining good visibility in the surgical space To ventilate odors and odors that may occur with cauterization of internal organs 65; to allow multiple instrument exchanges without losing surgical space; by maintaining an incision in the upper body Continuous access to internal body cavity 67; allowing simultaneous passage of two or more instruments via cannula 233; removal of tissue or fluid from the surgical site via cannula 233 (typical Partly possible removal because the valve required with a simple cannula is not necessary; and the cannula 233 either during or after the procedure. Including the introduction of derived dosing or diagnostic probes, it can be provided with many functions, including but not limited to.

  When the above treatment is completed, the decompression associated with the decompression shell 61 is released, and thereby the body wall 60 is lowered to its original shape. The cap 331 is removed, and the decompression shell 61 is removed while holding the cannula 233 placed at a predetermined position in the incision 59. The cannula 233 can be used to introduce a drainage catheter before it is finally removed or before the incision 59 is closed. Alternatively, the cannula 233 is sealed from ambient conditions and thereafter for post-surgical inspection for any infiltrated bleeding or drainage until the surgeon decides to close the incision, etc. May be secured with a solid, non-hollow cap similar to cap 331 but without an internal lumen 358 to provide an access conduit that can be used to visualize a treatment site within a body cavity .

  While this invention has been described in terms of several embodiments, it is not the intention of the applicants to limit or limit the spirit and scope of the appended rights. Many other changes, modifications, and substitutions should be considered by those skilled in the art without departing from the scope of the invention. For example, but not by way of limitation, a composite part-based access device can be provided in a vacuum shell in the form of a kit. Further, the structure of each part associated with the present invention can alternatively be described as a means for providing the function performed by the part. The foregoing description is given by way of example and other modifications can be considered by one skilled in the art without departing from the scope and spirit of the appended rights.

Specific embodiments of the present invention are as follows.
(1) A medical device for accessing an internal space of a patient, the first elongate member having a proximal end, a distal end, and an internal lumen, an opened proximal end, an opened distal end, and both ends A second elongate member having an internal lumen with a passage extending therebetween, the distal end of the first elongate member when the second elongate member is attached to the first elongate member Is positioned at an intermediate position between the proximal end and the distal end of the second elongate member so that the first elongate member is removably attached to the second elongate member and is generally continuous. A medical device that provides a fluid pathway.
(2) The medical device according to the embodiment (1), wherein the first elongate member has an open distal tip.
(3) The medical device according to embodiment (1), wherein the first elongate member has a closed distal tip.
(4) Embodiment in which the first elongate member has a sharp tip selected from the group consisting of a tip that branches in two directions and a tip that does not branch in two directions ( 1) The medical device described.
(5) The medical device according to the embodiment (1), wherein the first elongate member includes a relatively rigid main body and a relatively flexible distal end portion.

(6) The medical device according to embodiment (1), wherein the first elongate member includes a hollow extension cannula.
(7) The medical device according to embodiment (1), wherein the second elongate member includes a cannula.
(8) The medical device according to the embodiment (1), further including a cap that is detachably attached to a proximal end of at least one of the first elongate member and the second elongate member.
(9) The medical device according to the embodiment (1), further including a cap that is detachably attached to the proximal ends of both the first elongate member and the second elongate member.
(10) The medical device according to the embodiment (1), wherein the first elongate member includes a tip portion suitable for piercing a pierceable membrane.

(11) The first elongate member includes at least one opening that penetrates the wall of the first elongate member and is disposed near the distal end of the first elongate member. The medical device according to the embodiment (1).
(12) The medical device according to the embodiment (1), wherein the first elongate member includes a plurality of openings penetrating the wall.
(13) The medical device according to embodiment (1), wherein the second elongate member includes an inclined distal end.
(14) The second elongate member includes at least one opening that penetrates the wall of the second elongate member and is disposed near the distal end of the second elongate member. The medical device according to the embodiment (1).
(15) The medical device according to the embodiment (1), including a sleeve that can be positioned along an outer surface of the first elongated member.

(16) The medical device according to the embodiment (1), including a sleeve having a sealing surface for sealing between the first elongate member and a part of the patient's body.
(17) The medical device according to the embodiment (1), wherein at least one of the first elongate member and the second elongate member includes a substantially transparent wall.
(18) The medical device according to the embodiment (1), wherein at least one of the first elongate member and the second elongate member includes a non-circular cross section.
(19) The medical device according to embodiment (1), further comprising a cap suitable for removably attaching to at least one of the cannula and the extension cannula.
(20) The medical device according to the embodiment (19), wherein the cap has an opening penetrating the cap.

(21) The medical device according to embodiment (19), wherein the cap is suitable for providing a substantially airtight seal.
(22) The medical device according to embodiment (1), further comprising a sleeve having a sealing surface for assisting in preventing gas leakage due to incision.
(23) The medical device according to embodiment (1), further comprising a sleeve having a coating containing a therapeutic substance.
(24) The medical device according to embodiment (23), wherein the therapeutic substance is selected from the group of substances consisting of hemostatic substances, antibacterial substances, antimicrobial substances, analgesics, and combinations thereof.
(25) A hollow first long member, a second hollow long member that is detachably attached to a proximal end of the hollow first long member, the hollow first long member, and the hollow A medical device comprising a cap detachably attached to at least one of the second elongate members and a sleeve positionable along the outer surface of the hollow first elongate member.

(26) A decompression device for providing a surgical space in a patient body, and a composite component system device for providing access from one place outside the decompression device to one location in the patient. The assembly includes a removable first member and a second member, the first member providing a first portion of the access passage, and the second member providing a second portion of the access passage.
(27) A method for performing a medical procedure, wherein a part of a patient's body is separated from other parts of the patient's body to provide a surgical space in the patient's body, and a passage through a composite part system Accessing the surgical space.
28. The method of embodiment 27, wherein the separating step includes lifting a portion of the patient's body relative to other portions of the patient's body.
(29) A method according to embodiment (27), wherein said separating step comprises using reduced pressure.
(30) The method of embodiment (27), wherein the separating step comprises associating a vacuum shell with a portion of the patient's body.

(31) The method according to embodiment (27), wherein the step of accessing the surgical space includes the step of supplying positive pressure of air to the surgical space via a passage of a composite part system.
(32) The method according to embodiment (27), wherein the step of accessing the surgical space includes the step of supplying outside air to the surgical space via a passage of a composite part system.
33. The method of embodiment 27, comprising placing a first member of the composite part system passageway in an opening in the patient's body.
(34) arranging a first member of the composite part system passage in the opening in the patient's body, and removably attaching the second member of the composite part system passage to the first member; The method according to embodiment (27).
(35) disposing a first member of the passage of the composite part system in an opening in the body of the patient; positioning a decompression device with respect to the body of the patient; The method of embodiment (27), comprising the step of positioning a second member of the passage of the composite part system such that two members extend through the pressure reducing device.

(36) Disposing the first member such that a distal portion of the first member of the passage of the composite part system is disposed within the patient's body and a proximal portion of the first member is disposed outside the patient's body. 28. The method of embodiment (27), comprising the step of placing and placing the second member such that the entire length of the second member of the composite part system passage is located outside the patient's body.
(37) One member of the composite part system passage has a sharp tip selected from the group consisting of a tip branched in two directions and a tip not branched in two directions. A method according to embodiment (27).
Embodiment 38. The method of embodiment 27, wherein one member of the composite part system passage comprises a relatively rigid body and a relatively flexible distal end portion.
(39) A method for performing a medical procedure, the step of forming an incision in a patient, a proximal portion of the cannula positioned outside the patient, and a distal portion of the cannula positioned in the patient Inserting a cannula into the incision, positioning a decompression shell across the incision and the cannula, and providing an extension cannula extending through and in communication with the cannula Including.
40. The method of embodiment 39, comprising removably attaching the extension cannula to the cannula.
(41) The method according to embodiment (39), comprising the step of supplying air from outside the patient to the surgical space inside the patient via the cannula.

It is a top view which shows the medical device by one embodiment of this invention. It is sectional drawing cut | disconnected along the major axis of the said apparatus in FIG. 1 is a plan view showing an extension cannula according to an embodiment of the present invention, in which a distal tip for piercing is closed. FIG. FIG. 6 is a plan view of the distal end of an extension cannula having a flexible distal portion that opens along a slit that provides a passage for the instrument, according to another embodiment of the present invention. 3B is a top view of the flexible distal portion of FIG. 3A coupled to the tubular proximal portion of the extension cannula. FIG. FIG. 4 is a bottom view of the extension cannula of FIG. 3 as viewed from the distal end. FIG. 4 is an elevational view showing the side of the extension cannula shown in FIG. 3 of the device. It is sectional drawing cut | disconnected along the major axis of FIG. 1 is a top view of a cannula according to one embodiment of the present invention viewed from the proximal end. FIG. 1 is an elevational view showing a side portion of a cannula according to one embodiment of the present invention. FIG. FIG. 9 is an elevational view showing the front portion of the cannula of FIG. 8. It is sectional drawing which cut | disconnected the cannula along the long axis. FIG. 6 is a cross-sectional view of another embodiment of a cannula extension member that is non-circular and has a generally oval cross-section according to the present invention. FIG. 12 is a top view of the extension cannula of FIG. 11 as viewed from the proximal end with a generally oval cross section of the extension cannula. FIG. 6 is an elevational view showing the side of an extension cannula having a non-circular cross section. FIG. 14 is a bottom view of the extension cannula of FIG. 13 as viewed from the distal end. FIG. 6 is a cross-sectional view of a cannula that is non-circular and has a generally oval cross-section. FIG. 16 is a view of the cannula of FIG. 15 viewed from the distal end, depicting a laparoscope penetrating the inner lumen of the cannula, resulting in a left and right position of the laparoscope due to a non-circular cross section; FIG. 6 is a bottom view showing a gap providing a conduit allowing air or other instruments to pass through. FIG. 16 is a top view of the cannula of FIG. 15 showing the laparoscope entering the proximal end of the cannula, passing through an internal lumen along the entire length of the body, and exiting the cannulated distal end of the cannula. It is. It is a top view which shows the cap by one Embodiment of this invention. FIG. 19 is an elevational view showing a front portion of the cap of FIG. 18. It is sectional drawing which shows the cap of FIG. FIG. 6 is a perspective view showing a patient lying on a treatment table and an incision performed through a body wall such as the abdominal wall to access a body cavity such as the abdominal cavity where a surgical space is to be provided. A cannula of the present invention, wherein the cannula is positioned to extend through an incision in the body wall and is positioned within the body cavity, and the sloped end is positioned below and within the body cavity. FIG. 5 is a perspective view showing a cannula with an air passage in the form of a small hole arranged in the vicinity of the end. FIG. 7 shows a vacuum shell used to lift a body wall / tissue positioned over a portion of a patient through which a cannula extends, wherein the distal tip for drilling the extension cannula is a vacuum shell The cannula so that the distal tip of the extension cannula is positioned within the cannula and the extension cannula can be removably attached to the cannula FIG. 6 is a perspective view showing a positioning configuration of the distal tip of the extension cannula aligned with the proximal end of the extension cannula. A composite part system of the present invention, with a reduced pressure provided in association with a reduced pressure shell and provided to lift a patient's body wall and to provide a surgical space intermediate the body wall and internal organs. Arrows at various positions depicting the device to be operated, eg, the direction of air flow, such as air entering the body cavity via an air passage provided via the assembled cap, extension cannula and cannula of the present invention It is sectional drawing shown with. FIG. 5 is a drawing showing a surgical space formed by the use of the multifunction access device and reduced pressure shell of the present invention, wherein once lifted, the extension cannula is removed from the cannula and the cannula is partially pulled back proximally. FIG. 6 is a perspective view showing a configuration for positioning an inclined distal end of an extension cannula directly under a wall. FIG. 7 shows a cap removably attached to a cannula, wherein the cannula and patient can be maintained so that the cannula can be used to access a body cavity via the decompression shell and the patient's body wall to maintain a surgical space. FIG. 6 is a perspective view showing a configuration including a sleeve used around the cannula to maintain airtightness with the outside of the body. FIG. 6 is a bottom view of a sealing sleeve showing a flange surface area that can be provided with an adhesive. It is an elevational view showing the front portion of the sealing sleeve. It is sectional drawing which shows the sleeve for sealing.

Explanation of symbols

30 Medical Device 59 Incision 60 Body Wall 61 Depressurized Shell 62 Membrane 63 Opening 65 Internal Organ 66 Space 67 Body Cavity 132 Extension Cannula (First Long Member)
137 Opening 138 Pointed tip 139 Attachment portion 140 Internal lumen 141 Attachment portion 142 Proximal end 144 Distal end 160 Distal portion 162 First tip portion 164 Second tip portion 167 Slit 170 Flexible hinge portion 180 Polycarbonate Tube 233 cannula (second elongated member)
235 Small hole 235A Small hole 236 Distal end 238 Proximal end 242 Internal lumen 243 Attachment portion 331 Cap 356 Attachment portion 357 Main body 358 Central hole 434 Sealing sleeve 436 Main body 468 Flange portion 469 Bottom surface 470 Central hole 1012 Laparoscope 1044 Extension cannula (First long member)
1045 inner lumen 2049 cannula (second elongate member)
2050 circular device 2051 device 2052 internal lumen 2055 gap

Claims (8)

A medical device for accessing a patient's interior space, the first elongate member having a proximal end, a distal end and an inner lumen, an open proximal end, an open distal end, and extending between the ends. A second elongate member having an internal lumen with an existing passage, wherein the distal end of the first elongate member is the first elongate member when the second elongate member is attached to the first elongate member. The first elongate member is removably attached to the second elongate member so as to be positioned at an intermediate position between the proximal end and the distal end of the two elongate members to provide a generally continuous fluid passage. Give,
The first elongate member includes a pointed tip suitable for piercing a pierceable membrane. The medical device of claim 1, wherein the first elongate member has a closed distal tip. The medical device according to claim 1, wherein the first elongate member has a pointed tip selected from the group consisting of a tip branched in two directions and a tip not branched in two directions. apparatus. The medical device of claim 1, wherein the first elongate member includes a relatively rigid body and a relatively flexible distal end portion. It said first elongated member is a hollow cannula extension, the medical apparatus according to claim 1. It said second elongated member is a cannula, the medical device according to claim 1. The medical device according to claim 1, further comprising a cap detachably attached to a proximal end of at least one of the first elongate member and the second elongate member. The medical device according to claim 1, further comprising a cap removably attached to the proximal ends of both the first elongate member and the second elongate member.

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