JP2008502433A - Steerable vascular sheath - Google Patents

Abstract

A maneuver that is durable enough to provide sufficient strength and rigidity to be guided through body cavities and tissues, and at the same time flexible enough to perform complex operations through body cavities and tissues. Provide a possible access sheath.
A steering device for accessing a blood vessel includes an elongated body (81) and a steerable portion. The access sheath (80) has a sufficiently small outer diameter that can be inserted into a blood vessel and a sufficient length to extend into the patient's circulatory system. The access sheath has two internal lumens, the first lumen is configured to be sized to access the surgical site, and the second lumen is a tension that deflects the steerable portion upon actuation. It is configured to be sized to accommodate the device (86). The tensioning device is directly or remotely attached to the actuating device and operates to control the tension and slack applied to the tensioning device.
[Selection] Figure 1

Description

(Related application)
This application is a continuation-in-part of US patent application Ser. No. 10 / 832,867 filed on Apr. 26, 2004, and is a US provisional patent application No. 60/579 filed Jun. 14, 2004. , 500, and these applications are hereby incorporated by reference. US patent application Ser. No. 10 / 832,867 is filed on U.S. patent application Ser. No. 10 / 766,138 filed on Jan. 28, 2004 and U.S. patent application Ser. , 116, which is a continuation-in-part application and claims benefit based on US Provisional Patent Application No. 60 / 465,310, filed April 25, 2003, which is hereby incorporated by reference. Quote.

  The present invention relates generally to surgical access devices and, more particularly, to a sheath that is steerable and can be used in a vascular procedure.

  Sheaths and catheters are used to access body vessels such as arterial and venous branches and urinary tracts in the circulatory system, body cavities such as the chest and abdomen, and hollow viscous organs such as the stomach, intestine and bladder Have been used for many years. More particularly, sheaths and catheters have been used for fluid delivery, fluid collection, implant delivery, and providing access paths to instruments such as endoscopes. However, many endoscopes, for example, are flexible enough to bend, but cannot be steered or deflected in a controlled and / or dynamic manner. Thus, there is a need in the art for a steerable access sheath that can perform complex manipulations through blood vessels, body cavities, and / or tissues.

  In some instruments, the maneuvering objective has been achieved, for example, by “pre-bending” the distal tip of the surgical device prior to insertion and rotating the instrument after the instrument has been inserted. So it reaches the arterial branch in the body. If the angle of bending has to be adjusted, the device must be removed, bent again and reinserted. For this reason, a long time is spent in the body, and the operation time becomes long. In addition, since these sheaths and catheters are navigated in many difficult to reach areas, it is desirable that these devices be stiff but as flexible as possible. Also, if the sheath and catheter are constructed from thin walls, the diameter of the device can be minimized and the radius of the internal lumen can be maximized.

  If the access sheath is composed of a thin wall made of a material such as plastic or rubber, the sheath will bend and twist during use. This complicates the surgical procedure with endoscopes and other devices due to the sharp edges of the kinked sheath, resulting in potential damage. In addition, bent or kinked sheaths are not useful because they do not communicate and do not become instrument passages. Thus, the industry is durable enough to provide sufficient strength and rigidity to guide through body cavities and tissues, and at the same time flexible enough to perform complex operations through body cavities and tissues. There is a need for such a steerable access sheath.

  There is provided a surgical access device or a surgical device for accessing a blood vessel, wherein the elongate body comprises at least one steerable region. The elongate body has a proximal end, a distal end, and a lumen extending through the body and is sized and configured to be inserted into a blood vessel. The apparatus also includes a tensioning device extending into the elongate body, the tensioning device coupled to at least one steerable region of the elongate body, and a distal side from the proximal end of the elongate body. An actuator coupled to a tensioning device extending to the actuator for controlling the tension of the tensioning device to navigate the elongate body through the circulatory system. The tensioning device is made from a material that can withstand kinking, such as Nitinol, braided cable, or any flexible strand or wire. The actuator includes a control knob for controlling the tension or slack applied to the tensioning device.

  A surgical device for accessing a blood vessel according to one aspect includes a tube, the tube having a proximal end, a distal end, a steerable region, and an enlarged inlet, the tube being a primary side. A lumen and first and second secondary lumens are both provided extending to the tube. The device also includes a first tensioning device coupled to the steerable region and extending to the first secondary lumen, and a device coupled to the steerable region and extending to the secondary lumen. A second tensioning device passing therethrough. The device also includes an enlarged inlet extending from the distal end of the tube, the enlarged inlet configured to form a transition from the exterior of the tube into the primary lumen of the tube, and enlarged A movable actuator disposed around an inlet and coupled to a first tensioning device and a second tensioning device that rotates in one direction moves the first tensioning device and rotates in the opposite direction And a movable actuator for moving the second tensioning device. The steerable area is deflected or steered by the action of the tensioning device so that the steerable area deflects when the puller wire applies a pulling force to the steerable area in the tube.

  Another aspect of a surgical device for accessing a blood vessel comprises an elongated tube having a proximal end, a distal end, a steerable region, and an enlarged inlet. The elongate tube has a lumen extending through the elongate tube and is configured to be manipulated through the femoral artery, iliac artery, and uterine artery. For example, a tensioning device such as a tension wire is coupled to the steerable region and extends through the lumen, for example, an actuator means such as a handpiece is coupled to the tensioning means to move and steer the tensioning means. It is configured to move the area.

  In order that the features of the present invention may be better understood, the following detailed description is made with reference to the accompanying drawings. In the drawings, corresponding elements are denoted by the same reference numerals.

  As shown in FIGS. 1-4, the steerable access sheath 80 includes an elongate body 81 and, in one embodiment, a funnel-shaped or tapered inlet 83. The elongate body 81 is substantially or completely steerable and has varying stiffness or flexibility, or is fully compliant. The outer diameter of the elongated body is sufficiently small so that it can be inserted into a conduit or body cavity such as a vein or an artery.

  The access sheath 80 further includes a primary lumen 84 and a secondary lumen 85, both extending from the elongated body 81. The primary lumen 84 is sized and configured to provide a path to access a surgical site or target site for a surgical procedure. For example, the primary lumen 84 provides a conduit for advancing surgical instruments such as dilators and diagnostic and therapeutic elements such as contrast agents to a surgical site or target site. The secondary lumen 85 is sized and configured to accommodate a tensioning device, such as a control wire or tension wire, that, when operated, deflects the elongated body 81 of the access sheath 80. In one embodiment, the secondary lumen is not utilized, and therefore the tensioning device 86 is included directly within the access sheath 80. For example, the tensioning device 86 is attached to the access sheath or primary lumen and extends along the length of the access sheath or primary lumen, via the tensioning device, to the elongated body 81 in the access sheath 80. Provide sufficient deflection. In one aspect, the tensioning device 86 may be embedded in the wall of the access sheath 80 and / or the primary lumen 84.

  The tensioning device 86 extends through the secondary lumen 85 with one end attached to the actuator 87 and the other end attached to the distal portion of the elongate body 81. The actuator 87 includes a knob operated by a thumb, a ring as shown in the figure, or other type of device to control the tension device 86. As shown, tension is applied to tensioning device 86 by pulling the ring coupled to the puller wire proximally. When the ring is released, the puller wire moves distally to loosen the tension or the tensioning device 86 is loosened and the access sheath is straightened or restored to its previous or original form. .

  Thus, by manipulating the actuator 87, the user navigates the access sheath 80 and passes through the body's detours, curved path conduits and cavities to access surgical sites and points of interest. In addition, the access sheath provides a conduit or channel from outside the body to the site of interest via the primary lumen to insert and retrieve instruments, tissues and other items used in connection with surgical procedures. To do.

  Actuator 87 is similar to, comparable to, embodied, or otherwise incorporated into the manipulation handpiece described above or in the following embodiments, and is linear with respect to the access sheath , Offset, or remote. In addition, the access sheath attaches a plurality of pull wires to a plurality of thumbwheels, shafts, knobs, or other types of movable elements of an actuator or operating handpiece to move the access sheath in one or more different directions. To deflect.

  In one particular embodiment, the funnel shaped inlet 83 is sized and configured to guide dilators, obturators, and / or other devices into the working channel, and is the primary side of the access sheath 80. It forms the transition to the lumen. The funnel shaped inlet also includes or is coupled to the connector to provide a conduit that couples the secondary lumen and tensioning device 86 to the actuator 87. In one embodiment, the inlet 83 includes or is coupled to a valve, such as a fixed or floating zero valve and / or a diaphragm valve. The valve may also comprise a deformable material, structure, gel, or any combination thereof to form a seal around the instrument inserted into the inlet, or the instrument may be inserted into or removed from the inlet 83. Before and after being sealed, the inlet is sealed.

  The access sheath 80 and the access sheath and actuator or operating handpiece according to the various embodiments described above will hereinafter be referred to as an access sheath according to one aspect of the present invention, which may be used for vascular surgery, and more particularly, Applicable to procedures in cardiology, urology, radiology, electrophysiology, and gastroenterology, and other fields. For example, in the case of interventional radiology or interventional nephrology, where an image guide is utilized, the steerable and appropriately sized access sheath 80 can be used for instruments and solutions used in these procedures. Or help to place drugs.

  In one embodiment, if an instrument or device is used in combination with the access sheath to stretch and expand the opening, such as a dilator, the arteries and veins are gradually atraumatically wound when the access sheath is deployed. Can be extended. Once the access sheath is in the desired location, the dilator is removed and the access sheath is left in the desired location. The access sheath continues to provide access to the desired area so that, for example, surgical and / or therapeutic instruments and drugs can be placed and protection is provided for the blood vessels. Since continuous access is provided by the access sheath, the need for site or vessel repositioning is reduced. Furthermore, by using an access sheath that is deflectable or steerable, the user can navigate an intricate and sometimes large circulatory system effectively and efficiently. In this manner, the instrument can be placed at the surgical site through the primary lumen of the access sheath by dynamically maneuvering and / or continuously maneuvering the access sheath.

  In another embodiment, the steerable access sheath provides direct vascular access to circulatory vessels and certain organs and tissues to deliver therapeutic agents while ensuring healthy blood flow Is maintained. For example, in hemodialysis, the access sheath provides regular vascular access to the circulatory system, and in cancer, the access sheath provides vascular access to the circulatory system to provide chemotherapy.

  The access sheath is also useful in radiographic diagnosis to confirm the presence of vascular occlusion, such as injury or thrombus formation. When performed near an arterial and venous junction such as a hemorrhoid, it is difficult to guide the contrast agent used so that the contrast agent flows downstream of the blood vessel of interest. If the shape of the access sheath is deflected or changed to match the shape of the blood vessel, the access sheath can direct the contrast agent to the forward flow in the artery and / or vein.

  According to one aspect, a long access sheath 80, e.g., greater than 100 cm in length, can be used for specific surgical or surgical procedures for various diseases or conditions, such as emboli, especially fibroid embolism of the uterus. Useful in the procedure. An access sheath that can have a long length does not limit the path to reach tissue, blood vessels, or regions of interest. The steerable access sheath 80 can also be easily navigated along a tortuous path from the femoral artery to the iliac and uterine arteries. For example, by deflecting the access sheath 80, it turns, bends, or goes from one artery to another, eg, from the iliac artery to the femoral artery, or from the femoral artery to the uterine artery. It becomes easy to change. Once the access sheath has been placed in the vicinity of the region of interest, the conduit provided by the primary lumen can be used, for example, for biocompatible occlusive particles and other therapeutic or diagnostic agents, solutions, or devices. Can be inserted.

  Also, the fixed size provided by the primary lumen of the access sheath 80 overcomes or adapts to limitations imposed by the length of the surgical instrument being inserted, the size of the blood vessel relative to the instrument, and / or blood flow around the instrument. To do. In one embodiment, the distal end of the access sheath is tapered and thus has a smaller diameter than the proximal end of the access sheath. However, the diameters of the primary and secondary lumens are substantially constant over the entire length of the access sheath.

  In one embodiment, one or more covered wires can be wrapped around the inner / outer circumference of the access sheath, the primary lumen, and / or any combination thereof to reinforce the access sheath and allow Instruments that are flexible and can be pre-bent, or other instruments that cannot be actively controlled, can be dynamically controllably deflected by controlling the access sheath. Further, the actively deflectable surgical instrument has a complex structure, and includes elements such as an optical system and a clamp for performing the surgical function and an element for performing the active deflection. Thus, such instruments are fragile, and if broken, repairs and replacements are expensive and can still be used as surgical instruments, although they cannot be actively deflected. Also, blood vessels and body conduits that are accessed or where surgical procedures are performed impose sizing limitations that impede surgical instruments including all deflectable elements or mechanisms.

This reduces the cost of replacement, repair, and construction by using an access sheath instead of the elements used in such surgical instruments, or controllably deflecting broken instruments, and wear of such instruments. Reduce the damage and lengthen the life of such instruments. The reinforced access sheath also allows the size and shape of the primary lumen to be kept substantially constant throughout the access sheath, so that the force acting on the instrument placed inside the access sheath Can be reduced, and the life of these instruments can be extended.
The forces or stresses that accumulate along the access sheath that cause kinking of the access sheath are distributed along the access sheath because of the complex structure of the access sheath. Thus, the kinks that occur in the access sheath are reduced. Moreover, according to the wire coil, the wall of the access sheath can be made extremely thin without reducing the durability and strength of the access sheath. Accordingly, the overall diameter or outer diameter of the access sheath is small, and the incision or insertion site for the access sheath can be made small without reducing the size or diameter of the primary lumen.

  Thus, access sheaths according to various embodiments of the present invention have thin wall portions and large lumens, atraumatic ends, kinky structures, and / or combinations thereof. In addition, access sheaths according to various embodiments of the present invention have a wide range of lengths ranging from about 5.5 cm or less to about 100 cm or more, and various between these lengths, such as about 13 cm or 45 cm. Have a long length. The access sheaths according to various embodiments of the present invention are also strong and rigid, yet flexible enough to be intricately guided through body conduits, cavities or tissues.

Referring to FIG. 5, an embodiment of an actuator or operating handpiece 90 that matches the access sheath 80 is shown. The proximal end of the actuator 90 includes a funnel-shaped inlet 91 that is coupled to the interior of the actuator to access the working channel and forms a transition that transitions to the primary lumen of the access sheath 80. . Inlet 91 is sized and configured to receive a surgical instrument such as dilator 82.
A puller wire that extends through the first secondary lumen in the access sheath 80 is attached to a first movable element, such as a threaded cylinder or a ratchet slider. Another puller wire that extends through the second secondary lumen in the access sheath is attached to the second movable element. The first secondary lumen extends through the access sheath and along the first side of the access sheath. The second secondary lumen also extends through the access sheath 80 and along the second side of the access sheath. The first side portion of the access sheath and the second side portion of the access sheath are opposed to each other.

A knob 92 surrounding the movable element is engaged with the element by screwing or other configuration and is movable when the user twists or turns the knob 92 in one direction and moves it clockwise or proximally. One of the elements is moved linearly. For example, when the knob 92 is rotated clockwise or dragged proximally, the first movable element moves proximally, and the tensioning device coupled to the first movable element also causes the access sheath Moving toward the proximal end of the device and applying a tensile force to the access sheath, thereby deflecting the access sheath in the first direction.
The knob 92 can also move in the opposite direction, moving the first movable element in the distal direction to straighten the access sheath. As the knob 92 continues to move in the opposite direction and passes the zero point 93, the knob 92 disengages from the first movable element and engages the second movable element. As the knob 92 moves distally and the tensioning device coupled to the second movable element moves proximally, it exerts a tensile force on the access sheath 80, thereby causing the access sheath to move in different directions or Deflect in the opposite direction. As knob 92 moves in the opposite direction back toward zero point 93, the second movable element moves distally, loosening the tensioning device and causing the access sheath to extend linearly.

The various access devices and their structures described below are applicable to the steerable access sheath described above. For example, the remotely operated handpiece described below can be used in place of the ring shown in FIG.
6-8 illustrate a surgical access device or steerable hard-to-twist access device 100 according to one embodiment of the present invention, which includes, inter alia, cardiology, urology, radiology, Used in electrophysiology and gastrointestinal medicine. Access device 100 includes an access sheath 102 having a longitudinal axis 103 extending from a proximal end to a distal end, and a handle portion 104 coupled to the proximal end of access sheath 102. The access sheath 102 includes an elongated body 105 and a steerable region or steerable portion 106. It should be appreciated that the steerable portion 106 can be formed at any location along the access sheath 102. In addition, the steerable portion 106 and the elongate body 105 have variable stiffness depending on the use of the access sheath 102. The access sheath 102 has a sufficiently small outer diameter so that it can be inserted into a body cavity or conduit. As shown in FIG. 7, the access sheath 102 typically has two lumens, a primary lumen 112 and a secondary lumen 114.

  The primary lumen 112 is sized and configured for access to the surgical site and the goals of the surgical procedure. In particular, the primary lumen 112 is used to advance diagnostic and therapeutic elements to a surgical site or target. The secondary lumen 114 is sized and configured to accommodate a tensioning device, such as a control wire or tensioning wire, that, when operated, deflects the steerable portion 106 of the access sheath 102. The tensioning device 116 extends through the secondary lumen 114 with one end attached to the actuator or handle portion 104 and the other end attached to the distal portion 107 of the steerable portion 106. The handle portion 104 includes a knob 118 that is operated with the thumb to control the tensioning device 116. For example, pulling the knob 118 in the proximal direction 119 will apply tension to the tensioning device 116 and the tensioning device will be tensioned, and moving in the distal direction 120 will loosen the tension and relax the tensioning device 116.

  18-21 show an actuator or operating handpiece 500 according to another embodiment of the present invention, which includes a proximal facing portion 502 and a distal facing portion. 504, a hand-held extension 506, and at least one thumbwheel member 508a, b. Proximal facing portion 502 has a substantially flat support surface and includes a funnel shaped inlet portion 510. The funnel-shaped inlet portion 510 is sized and configured to guide an obturator or other instrument and insert it into a working channel inside the handpiece 500. Distal facing portion 504 is coupled to access sheath 102. The working channel in handpiece 500 is sized and configured to form a transition in primary lumen 112 of access sheath 102. The hand extension 506 is sized and configured to accommodate two extended human fingers in the hold position. At least one thumbwheel 508 allows the user to deflect the steerable portion 106 of the access sheath 102.

  The steerable portion 106 deflects through the action of a tension device 116, such as a pull wire or control wire, associated with a secondary lumen 114 provided within the access sheath 102. The shaft to which the tensioning device 116 is coupled is disposed between the two thumbwheels 508 a, 508 b or between at least one thumbwheel and the opposite side of the handpiece 500. As the thumbwheels 508a, 508b are rotated, the tensioning device 116 deflects the portion 106 by exerting a tensile force against the steerable portion 106 of the access sheath 102. In accordance with one aspect of the present invention, each hand extension in the handpiece 500 is provided with a direction indicator 512 to indicate the direction in which the distal end of the access sheath 102 is deflected or bent. To do.

  It should be understood that the actuator or operating handpiece in the present invention may be mounted remotely with respect to the associated access sheath to control tension and relaxation of the tensioning device. In this case, the handpiece is coupled to a flexible tube or body coupled to the access sheath. If a remote access point or fixture is provided, for example, the handpiece thumbwheel can be positioned away from the surgical site, preventing or interfering with the insertion of the entire working length of the access sheath. Never do. Further, it should be understood that the access sheath may be provided with a plurality of puller wires attached to a plurality of thumbwheels of the operating handpiece to deflect the steerable portion of the access sheath in different directions. .

In one embodiment of the invention, the access sheath 102 is comprised of an extruded multi-lumen plastic tube. As a modification, the access sheath 102 is molded from a plastic or rubber-like material. Preferred materials include vinyl chloride resins, polyesters, silicone elastomers, natural or synthetic rubbers, polyurethanes, or other similar materials. The hardness of the material ranges from Shore A hardness 40 to Shore D hardness 70. These materials are generally flexible and durable. As shown in FIG. 22, in another embodiment of the present invention, a sheath that is difficult to kink is obtained by molding a structure such as a spring in the tube of the sheath. More specifically, the access sheath 102 is formed by surrounding an inner plastic body 610 with a metal spring coil 612 and further covering it with an outer body 614. The access sheath 102 according to this particular embodiment provides strong kinking resistance. The inner body 610 provides a smooth surface inside the sheath to provide a passage for the instrument. The spring coil 612 provides resistance to kinking of the sheath tube, and the outer body 614 provides a suitable covering for the spring coil 612.
In one aspect of the maneuverability of the present invention, placing a tightly wound spring in the secondary lumen 114 of the access sheath 102 facilitates movement of the tensioning device 116 inserted therein. . The spring is secured to the secondary lumen 114 by gluing or other means. Among other things, the spring is inserted through the spring and serves to isolate the force applied to the tensioning device 116 attached to the distal portion 107 of the steerable portion 106. In particular, the spring adds stability and rigidity to the elongated body 105 when the tensioning device 116 is operated, and only the steerable portion 106 is bent or steered. Further, the spring acts to guide the tensile force applied to the tensioning device 116 to the steerable portion 106, only the portion 106 is deflected and the elongate body 105 is not deflected. That is, the pulling force is isolated to the steerable portion 106 formed at any location along the access sheath 102. If the spring is coated with a lubricious material, the tensioning device 116 can be moved more easily. The spring covers the entire inner surface area of the secondary lumen 114 or only a portion such that the tensile force can be isolated in the secondary lumen 114.

  The spring is closely wound with a 0.005 inch diameter wire to form a tightly wound spring coil with an outer diameter of 0.02 inch. For the 0.5-2 inches on the distal side of the spring, it is stretched to leave the windings open, leaving a gap of approximately 0.02 inches between the windings. This stretched portion spring facilitates isolation of the tensile force applied by the tensioning device 116. The spring is coated, for example, with a plastic jacket and joined to the secondary lumen 114 from the proximal end of the spring to the proximal end of the stretched portion. The stretched portion is then left free to move and / or compressed into a plastic jacket. The distal end of the stretched portion is secured to the distal end of the access sheath 102 along with the tensioning device 116. The distal end of the plastic jacket, together with the tensioning device 116 and the spring, is joined to the distal end of the access sheath 102, but these elements do not require a common joining point or joining method.

  As described above, the proximal end of the access sheath 102 is directly or remotely attached to the handle portion 104 or the actuator or handpiece 500 to maintain the position of the catheter while the operator can control, pull, etc. A tensile force is applied to the tension device 116 of the above. This pulling force causes the stretched portion of the 0.02 inch diameter spring to contract and causes the sheath to bend in the region where the stretched portion of the spring is located. It should be understood that the stretched portion is formed at any location where bending is required in the catheter or surgical access device and is not limited to the distal end of the device. Furthermore, one or more deflection assemblies comprising springs and tension devices may be provided in the access device to cause deflection in different areas or planes. The amount of bending or deflection is proportional to some extent to the force or tension applied to the tensioning device.

  In one embodiment, the tensioning device 116 is a control or tension wire comprised of Nitinol, knitted cable, or any flexible strand or wire. In one embodiment, the control wire is inserted into the spring and extends through the secondary lumen 114, as shown in FIG. The proximal end of tensioning device 116, such as a control wire or tension wire, is coupled to an actuator such as knob 118 of handle portion 104. The distal end of the control or tension wire is attached to the distal portion 107 of the steerable portion 106 as described above. In another aspect of the invention, as shown in FIG. 17, tensioning device 416 is a flattened or flat member that extends through at least steerable portion 106 of access sheath 102. is doing.

  In another aspect of the present invention, as shown in FIGS. 6 and 9-10, the steerable portion 106 faces a plurality of notches 108 and slits 110 spaced apart in the radial and longitudinal directions. The distal portion 107 can be easily deflected in a desired direction or angle. The notch 108 and the slit 110 are cuts provided in the access sheath 102 so as to cross the longitudinal axis 103. The degree of deflection varies greatly based on a number of factors, such as the number of notches 108 and slits 110, size, direction, shape, and spacing. The notch 108 is deeper and wider at the distal end 150 than at the proximal end 152 in the steerable portion 106. The slit 110 is a very shallow notch and reduces resistance to elongation when the steerable portion 106 bends or deflects toward the notch 108.

  As previously described, the notches 108 and slits 110 are of any desired width, length, depth, and shape. The number of notches 108 and slits 110 provided in the steerable portion 106 will vary according to the flexibility requirements required for the access sheath 102. However, in one embodiment, the slit 110 is narrower and shallower than the notch 108 and the steerable portion 106 is configured as a “fragile side / solid side”, Thereby, the access sheath 102 can be pre-treated to bend in the desired direction. That is, as shown in FIG. 11, when the control wire of tensioning device 116 is pulled proximally, the more flexible side of steerable portion 106, that is, the side with notch 108 begins. It bends in the direction of the notch. In addition, the distal end 150 in the steerable portion 106 includes a deeper and wider notch 108 so that after it is first bent, the bend gradually has a shallow and narrow notch. Progress toward the proximal end 152. It should be understood that the notch 108 extends into the wall of the access sheath 102.

  Referring now to FIGS. 12 and 13, a series of opposed notches 108 and slits 110 are further shown. As described above, notching 108 closes when bent, so that notch 108 provides a “fragile side” or preferred bending path. The notch 108 has a wedge shape, and material is removed from the notch portion. Accordingly, there is sufficient margin in the material adjacent to each notch, and the length of the steerable portion 106 can be shortened at the fragile side. In contrast, the slit 110 is a shallow, radial cut directly opposite the notch 108 with little or no material removed. The slit 110 mechanically has the same effect as increasing the elasticity of plastic. That is, due to the slit 110, the material of the steerable portion 106 is stretched beyond the essential properties of the material itself. As a result of this configuration, the primary lumen 112 in the steerable portion 106 will not collapse when deformed or bent into a tightly curved round profile as shown in FIG. In other words, the slit 110 simply opens to extend the “strong side”, and does not collapse and lead to shortening of the “strong side”. The material on the side where the notches 108 and slits 110 are provided generally maintains an elongated dimension and forms the continuity of the access sheath 102.

  In another embodiment of the invention, as shown in FIG. 14, the distal end 200 of the steerable portion 106 has a rounded wall portion 205 to provide an atraumatic insertion tip. Yes. Such an access sheath with a steerable distal portion requires less pushing force to advance the access sheath, since the access sheath has a tortuous path This is because it is not pushed through, but passes around an irregular or irregular body cavity or duct, and it is deflected so that it can get over and get through. As shown in FIGS. 11 and 16, a surgical instrument such as a ureteroscope 300 is guided through a steerable access sheath. For example, as shown in FIG. 16, the ureteroscope 300 is inserted into the upper and lower poles of the renal cup using a steerable access sheath. Other flexible endoscopes, including flexible ureteroscopes and fully passive examination mirrors, can be accurately positioned with the aid of the steerable access sheath of the present invention.

  As shown in FIGS. 23-24, in another embodiment of the present invention, an operating handpiece or actuator 510 is aligned with the access sheath 102. The proximal end of the actuator 510 includes a funnel-shaped inlet portion 516 that is sized and configured to transfer obturators, dilators, ureteroscopes, and other instruments to the working channel inside the actuator 510. Can be inserted into. The working channel 518 of the actuator 510 is sized and configured to form a transition into the primary lumen 112 of the access sheath 102.

  A tensioning device 116 extending through the secondary lumen 114 is attached to the bracket 512. The proximal end of tensioning device 116 is ball-shaped, crimped, or otherwise sized or deformed to secure tensioning device 116 to bracket 512. Bracket 512 is further coupled to slider 514. A lever 511 coupled to the slider 514 causes the user to move the slider 514 and thereby control the tensioning device 116. In FIG. 23B, handpiece 510 includes a pivotable lever 519 coupled to lever 511. Pivotable lever 519 provides a reaction point for lever 511. In other words, when the lever 519 moves distally, the lever 511 moves proximally, and conversely, when the lever 519 moves proximally, the lever 511 moves distally.

  As the slider 514 is moved proximally, the tensioning device 116 applies a tensile force against the steerable portion 106 (see FIG. 6) of the access sheath 102 and thereby deflects the steerable portion 106. The slider 514 also includes a plurality of teeth 515 that engage corresponding teeth 517 provided along the inside of the handpiece 510. Thus, when the slider 514 is moved in the proximal and distal directions, such engagement allows the steerable region or portion 106 of the access sheath 102 to be incrementally controlled to be deflected or straightened.

Referring now to FIGS. 25 and 26, an operating handpiece 520 according to an embodiment that is consistent with the access sheath 102 is shown. The proximal end of the handpiece 520 includes a funnel-shaped inlet portion 522 that is coupled to access the working channel 524 within the handpiece 520 and forms a transition into the primary lumen 112 of the access sheath 102. is doing.
A tensioning device 116 extending through the secondary lumen 114 is attached to the threaded cylinder 526. The knob 527 surrounding the cylinder 526 is provided with a corresponding screw to be engaged with the cylinder 526. When the user twists or turns the knob 527 in one direction such as clockwise, the cylinder 526 moves linearly. Thus, for example, it is moved in the proximal direction. As a result, the tensioning device 116 also moves toward the proximal end of the handpiece 520, applying a tensile force to the steerable portion 106, thereby deflecting the steerable portion 106 in the access sheath 102. Also, moving knob 527 in the opposite direction causes threaded cylinder 526 to move distally and steerable portion 106 of access sheath 102 to be straightened. Accordingly, the handpiece 520 provides a rotary or pivoting control to deflect and / or straighten the steerable portion 106 of the access sheath 102.

  As shown in FIGS. 27-29, in another embodiment of the present invention, an actuator or operating handpiece 530 is harmonized with the access sheath 102, and the handpiece 530 includes a funnel shaped inlet portion 531. is doing. A shaft 532 disposed within the handpiece 530 is coupled to a tensioning device that extends from the access sheath 102 and is coupled to two dials or wheels 533 and 534 that are operated with the thumb. In one embodiment, the wheels 533 and 534 are partially disposed within the handpiece 530. Wheel 533 and / or wheel 534 controls the tensioning device. For example, when the wheel 533 is turned clockwise, the tensioning device is pulled in the proximal direction, applying tension to the tensioning device, such as one or more tensioning wires or control wires. The control wire pulled in the proximal direction is wound around a shaft 532 provided inside the handpiece 530.

  The wheels 533, 534 comprise ratchet wheels or comprise a number of radially extending teeth 535 coupled or integrated with the wheels 533, 534. Teeth 535 engage a corresponding lever or pawl 536 that is coupled to trigger 537. The pawl 536 engaged with the tooth 535 allows the wheels 533, 534 to rotate in one direction, eg, clockwise, but prevents it from rotating in the opposite direction, and causes the wheels 533, 534 to rotate clockwise. , As the shaft 532 inside the handpiece 530 pulls the tensioning device 116 proximally, an incremental control of deflection is provided for the steerable portion 106 of the access sheath 102. When the trigger 537 is operated, the claw 536 pivots and the claw 536 is disengaged from the teeth 535. As a result, the control wire is unwound and moves distally from the shaft 532, and the steerable portion 106 of the access sheath 102 is straightened.

  Referring now to FIGS. 29 and 30, the actuator or operating handpiece 610 is shown offset and coupled from the access sheath 102. FIG. The offset handpiece reduces the working length used in the access sheath and is added to the access sheath along with a handpiece that matches the access sheath. In addition, the user manipulates the handpiece proximate to the access sheath to know tactile and visual feedback and the remainder of the steerable portion 106 of the access sheath 102. A handpiece 610 according to one embodiment includes or is connector-coupled with a connector 611 with a funnel-shaped inlet portion 612 and is sized and configured to receive and guide instruments to and from the access sheath 102. Yes. Secondary lumen 114 is separately coupled to handpiece 610. In one aspect of the invention, a conduit through connector 611 couples secondary lumen 114 and tensioning device 116 to handpiece 610.

  A tensioning device 116 extending through the secondary lumen 114 is attached to the slider 614. A lever 613 coupled to the slider 614 causes the user to move the slider 614 to apply a tensile force to the steerable portion 106 to deflect the steerable portion 106 or to apply a tension to the steerable portion 106. Loosen and straightens the steerable portion 106 of the access sheath 102. The slider 614 according to one aspect of the present invention comprises a plurality of teeth that engage correspondingly provided teeth along the interior of the handpiece and that are steerable in the access sheath 102. Incremental control is provided to deflect and / or straighten out.

  FIG. 31 illustrates an actuator or operating handpiece 620 according to another embodiment of the present invention that is offset relative to the access sheath 102. The handpiece 620 includes a funnel-shaped inlet portion 621 and provides access to the primary lumen in the access sheath 102. The secondary lumen and tensioning device in access sheath 102 are coupled to handpiece 620. The tensioning device 116 is attached to a movable handle member 622 that is pivotally coupled to a stationary handle member 623, for example. In one embodiment, the tensioning device is coupled to a semi-disc or disc that rotates or pivots upon manipulation of the handle member. By manipulating the movable handle member 622, the user pulls or releases the tensioning device 116 to deflect or straighten the steerable portion 106 of the access sheath 102. According to one aspect of the present invention, the ratchet mechanism is disposed within the handpiece 620 or between the movable handle member 622 and the stationary handle member 623 so that the tension device 116 is incrementally controlled. Thereby deflecting the steerable portion 106 of the access sheath 102.

  Referring now to FIGS. 32 and 33, the actuator or operating handpiece 630, 630 ′ is shown offset from the access sheath 102. The operating handpiece 630, 630 'has a funnel-shaped inlet portion 631 and is coupled to a tensioning device attached to a shaft disposed within the handpiece 630, 630'. The shaft is coupled to two knobs or wheels 632 and 633 that are operated with the thumb. As shown in FIGS. 33A and 33B, the wheels 632 and 633 are partially disposed inside the handpiece 630 '. The wheels 632 and 633 control the tension device 116. For example, the wheel 632 and / or the wheel 633 are rotated to apply tension to the tensioning device 116, i.e., the control wire, and to relax the tension of the control wire. In one embodiment, the wheels 632, 633 are coupled to separate and independent control wires to deflect the access sheath in the opposite direction and / or deflect different portions of the access sheath.

  In one aspect of the present invention, manipulating the trigger 634 locks the wheel 632 and / or the wheel 633, thus preventing the tensioning device 116 from moving further, and thus the steerable portion 106 in the access sheath 102. Furthermore, it prevents deflection or stretching in a straight line. Alternatively, the trigger 634 may release or disengage control from the tensioning device 116 from the wheel 632 or 633 so that the tensioning device can return to its original position.

  The actuator or operating handpiece 710 according to the embodiment of the present invention shown in FIGS. 34 to 36 is remotely attached to the access sheath and applies a tensile force to the tensioning device coupled to the access sheath. Loosen. Since the actuator is located away from the surgical site and path or region of operation, the handpiece will not interfere with or interfere with the insertion of instruments along the working length of the access sheath. Absent. In addition, remote actuators do not occupy additional work space or access sheath length. Further, if another user remotely operates the actuator, the other user can concentrate on the surgical procedure, for example, on the operation of the instrument to be inserted into the access sheath or an instrument already inserted. The increase in operation time and the occurrence of confusion caused by switching between the actuator and other devices or using many devices simultaneously can be reduced.

  An actuator 710 according to one embodiment is coupled to a flexible body or conduit 711 that is further coupled to the access sheath 102 via a Y-shaped connector 712. The Y-shaped connector 712 includes a funnel-shaped inlet portion 713 and is sized and configured to guide the instrument into the primary lumen 112 in the access sheath 102. The Y-shaped connector 712 also includes a channel 714 for coupling to a flexible conduit 711. The tensioning device 116 extends through the secondary lumen 114, the channel 714, and the flexible conduit 711 and is attached to a shaft 715 disposed within the actuator 710. The shaft 715 is coupled to a dial or knob 716, a portion of which extends laterally of the handpiece 710, and a finger-held portion is radially disposed throughout the knob 716. The other end of the shaft 715 is rotatably coupled to the handpiece 710.

  Knob 716 controls the tensioning device 116 by the user. For example, when rotated in one direction, such as clockwise, the tensioning device 116 is pulled proximally and wound or wound around the shaft 715. Within the handpiece 710, a plurality of radially disposed teeth 717 of the knob 716, or a separate or embedded ratchet wheel engages a corresponding lever or pawl 718. The pawl 718 pivots about a post coupled to the handpiece 710 and is engaged with the teeth by being biased by a leaf spring 719, allowing the knob 716 to rotate in one direction, for example, clockwise. While preventing rotational movement in the opposite direction. Then, as the knob 716 rotates, the shaft inside the handpiece 710 pulls the tensioning device 116 proximally so that the deflection of the steerable portion 106 in the access sheath 102 can be incrementally controlled. When the trigger 720 is operated, the claw 718 is pivoted so that the claw 718 is disengaged from the tooth 717. As a result, the tensioning device 116 is unwound and can move distally from the shaft 715. Accordingly, the steerable portion 106 of the access sheath 102 is straightened.

37-39, an actuator or operating handpiece 730 according to another embodiment of the present invention is shown remotely attached to the access sheath. A shaft 731 disposed inside the handpiece 730 is attached to the tension device 116. The shaft 731 is coupled to a rotatable key or airfoil lever 732 extending laterally from one side of the handpiece 730.
The user controls the tension device 116 by lever 732. For example, when rotated in one direction, such as clockwise, the tensioning device 116 is pulled in the proximal direction and wound or wound around the shaft 731 in the handpiece 730. A plurality of teeth 733 disposed radially about the shaft 731 or on a ratchet wheel surrounding the shaft engage a corresponding pawl or cantilever arm 734. Arm 734 attached to handpiece 730 and engaging teeth 733 allows lever 732 and shaft 731 to rotate in one direction but prevents rotational movement in the opposite direction. This engagement provides incremental control to the tensioning device 116 and thus to the steerable portion 106 of the access sheath 102.

  The handpiece 730 includes a trigger lever 735 that is pivotally coupled to a post provided within the handpiece 730, a portion of the lever extending through a slot provided in the handpiece 730. ing. When lever 735 is manipulated, i.e. pulled proximally, cantilever arm 734 is moved to disengage from tooth 733 and shaft 731 can freely rotate. Accordingly, the tensioning device 116 coupled to the shaft 731 is unwound and / or moved distally from the shaft 731 to linearly extend the steerable portion 106 of the access sheath 102.

  FIGS. 40-43 illustrate an actuator or operating handpiece 740 according to another embodiment of the present invention that is remotely attached to the access sheath 102 and controls the tension and relaxation of the tensioning device 116. . A shaft 741 is provided inside the handpiece 740, and a tension device 116 is attached to the shaft. The shaft 741 is coupled to the slotted wheel 742 and is partially rotatable inside the handpiece 740. The generally opposed slots 743, 744 are located within the slotted wheel, each extending with a dowel or pin 745, 746, coupled to the distal ends of the button arms 747, 748, respectively. Yes. The proximal ends of the button arms 747 and 748 extend through the opening of the handpiece 740.

  In operation, when the button arm 748 is pulled down, the button arm 747 is raised and the slotted wheel 742 rotates clockwise. As a result, the tensioning device 116 coupled to the shaft 741 is not attracted to the handpiece 740 and the steerable portion 106 of the access sheath 102 remains substantially straight. When the button arm 747 is lowered, the button arm 748 is raised and rotation of the slotted wheel 742 pulls the tensioning device 116 by rotation of the shaft 741 to deflect the steerable portion 106 of the access sheath 102. According to one aspect of the present invention, the handpiece 740 includes a guide 749 that guides the movement of the button arms 747 and 748 and a slot (not shown) in alignment, and the pin moves when the button arm moves. Help 745,746 move linearly. Slotted wheel 742 includes one or more openings along the circumference of the wheel to allow the wheel to rotate without interfering with guide 749. According to another aspect of the present invention, the shaft 741 is coupled to a screw knob and is used to adjust tension and pre-wound the tensioning device 116 about the shaft 741.

  Referring now to FIG. 44, a remotely mounted actuator or operating handpiece 750 is shown according to another embodiment. According to one aspect of the present invention, the handpiece 750 fits into the user's hand and grips and closes the fist, causing the t-shaped bar 753 to move proximally to deflect the access sheath 102. At the same time, when the fist is opened, the t-shaped bar 753 moves distally, causing the access sheath 102 to stretch linearly. For example, the handpiece 750 includes a finger extension member 754 and one or more fingers can be placed on each member 754 so that the t-shaped bar 753 can be gripped. A flare-shaped end 756 provided on the distal side of the tube 751 is placed on the palm.

  A tensioning device 116 extends from the distal end of the tube 751 and is attached to a plate inside the tube 751. Plate 752 is coupled to a t-shaped bar 753, which is slidably coupled to tube 751. In one embodiment, an adjustment screw is coupled to the t-shaped bar 753 to adjust the position of the plate 752 relative to the t-shaped bar 753 within the tube 751. A set of teeth 755 provided inside the tube 751 engages a stop provided on the t-shaped bar 753 as the t-shaped bar 753 moves.

  Moving the t-shaped bar 753 in the proximal direction also moves the plate 751 in the proximal direction, causing the tensioning device 116 to be pulled and deflect the steerable portion 106 of the access sheath 102. Similarly, as the t-shaped bar 753 and plate 751 move distally, the tensioning device 116 is loosened and the steerable portion 106 is straightened. Thus, such engagement provides incremental control in deflecting and / or straightening the steerable portion 106 in the access sheath 102. When a spring-loaded button 757 provided at one end of the t-shaped bar 753 is operated, the teeth of the t-shaped bar 753 are disengaged from the teeth 755 in the tube 751, and the t-shaped bar 753 can move freely.

  45 and 46 illustrate an actuator or operating handpiece 760, 760 ′ according to another embodiment of the present invention, each of which can be remotely attached to the access sheath 102. The handpieces 760, 760 'are coupled to a flexible body or tube 761 through which the tensioning device 116 extends. The first handle member 762 to which the tension device 116 is attached is pivotally coupled to the second handle member 763. By manipulating the first handle member 762, the user pulls or releases the tensioning device 116, thereby deflecting or extending the steerable portion 106 of the access sheath 102, respectively. In accordance with one aspect of the present invention, a ratchet assembly may be provided to provide incremental control to the tensioning device 116 and thus to the steerable portion 106 of the access sheath 102.

  The access sheath includes a plurality of tension wires that can be steered by attaching them to a plurality of thumbwheels, shafts, knobs, or other types of movable handpiece elements. It should be understood that may be deflected in different directions. In addition, the tension device is configured to be hydraulic, pneumatic, or electrical, and the operation handpiece is operated by a foot, finger, or other sensor, and the corresponding foot, finger, or other sensor. It should be understood that other extensions may be provided.

  In various embodiments, for example, the embodiments described above and / or the manipulation handpiece 810 according to the embodiment shown in FIGS. 47A and 47B, the tensioning device 116 is coupled to the belt 811. Belt 811 serves as an intermediary between tensioning device 116 and movable element 818 in handpiece 810. Examples of the movable element include sliders 514 and 614 (FIGS. 23B and 29), cylinder 526 (FIG. 25), movable handle member 622 (FIG. 31), shafts 715 and 731 (FIGS. 36 and 37), And various other movable elements, either wholly or partially disposed within the actuator or handpiece, or otherwise forming part of the actuator or handpiece and capable of being coupled to the tensioning device 116 Is. The resulting stress or force applied by the movable element 818 via the belt 811 is replaced from the tensioning device 116. Therefore, the stress caused by the operation of the handpiece and received by the tension device 116 is reduced.

The belt 811 includes a number of openings 812 for engaging teeth 813 radially disposed on the movable element 818 of the handpiece 810. In one embodiment, the belt 811 includes teeth or protrusions and engages with openings, teeth or protrusions provided corresponding to the movable element 818. In either engagement, an incremental control of tensioning device 116 is provided. Thus, when the knob is rotated in one direction, the belt 811 pulls the tensioning device 116 proximally, while rotating the knob in the opposite direction pulls the tensioning device back from the handpiece 810.
A pin or roller 814 is also provided to assist in the engagement of the belt 811 with the movable element 818 of the handpiece 810. In one aspect of the invention, the belt 811 is compliant. In other embodiments, a plate, bar, or less flexible element is coupled to the belt 811 to pull or release the belt 811 in conjunction or independent of the movable element 818.

A U-shaped lever 815 is coupled to the knob 816 and disposed on one or both sides of the handpiece 810 and coupled to the movable element 818 of the handpiece 810. By manipulating the U-shaped lever 815, the user can control the movement / tension of the tensioning device 116, thus deflecting or straightening the steerable portion 106 of the access sheath 102. In one embodiment, a plate is coupled to U-shaped lever 815 and belt 811 to pull and release tension device 116.
In accordance with one aspect of the present invention, operating the trigger 817 locks the belt 811, the movable element 818, or the U-shaped lever 815, so that the tensioning device 116 moves further and is steerable in the access sheath 102. The portion 106 is prevented from being deflected or straightened. Alternatively, the trigger 817 may release or disengage control of the tensioning device 116 from the belt 811, the movable element 818, or the U-shaped lever 815 so that the tensioning device 116 is in its original or original state. Make it possible to return.

  48-51, various manufacturing steps are shown for an access sheath according to an embodiment. First, the wire 801 is wound around the pointing member or mandrel 802. The size and shape of the primary lumen 112 in the access sheath 102 are determined by the size and shape of the mandrel. In one embodiment, the mandrel is stainless steel and is coated with a low friction material or surface such as Teflon or various mold release agents to facilitate access to the mandrel from the access sheath 102. It can be removed. The wire 801 is wound in an overcounter manner using a fixture and a start and stop point that are substantially orthogonal to each other, and the wire 801 is wound around the mandrel 802 in a diagonal line. Then, the wire 801 is wound so as to cancel the tendency of the wire to unwind. In one embodiment, before using the wire, the mandrel 802 can be coated with plastic or inserted into a tube of PVC material to smooth the instrument in the primary lumen without interfering with the wire 801. To be inserted.

  In one embodiment, the wire 801 is a plastic coated wire, in particular a stainless steel coextruded wire of approximately 0.006 inch diameter, fused with a plastic material and coated. Or otherwise included, the overall diameter of the wire 801 is approximately 0.012 inches. A mandrel 802 including a wire 801 is placed or inserted into the control tube. In one embodiment, the mandrel 802 is assisted by inflating the control tube by supplying air at a pressure of, for example, 100 PSI from the end opposite to the insertion. In one embodiment, the control tube is made from a material having a higher melting point than the plastic coating of silicone or wire 801. The assembly is then heated to melt the plastic coating of wire 801 and weld itself to form a generally continuous tubular structure or main tube 803. Then, the control pipe is removed.

A small tube 804 is placed on or contained in the main tube 803. The small tube 804 is longer than the main tube 803 and thus extends substantially longer along the mandrel 802 than the main tube 803. Extending within the portion of the small tube 804 is a tubular structure or inner tube 805 that is approximately the same length as the main tube 803. In one embodiment, the inner tube 805 is made of polyimide and the small tube 804 is made of carothane and heated to the inner tube 805, the main tube 803, and other parts of the access sheath as described below. Adhere and surround the outer periphery of the small tube 804.
The inner tube 805 inside the small tube 804 is adapted to receive the support wire 806. The size and shape of the support wire 806 and the inner tube 805 define the size and shape of the secondary lumen 114 of the access sheath 102. In one embodiment, the support wire is a stainless steel wire approximately 0.12 inches in diameter. Support wire 806 is secured to the proximal end of mandrel 802, through inner tube 805 and small tube 804, to the distal end of mandrel 802. In one embodiment, the support wire 806 secures the small tube 804 to the main tube 803.

  Small tube 804 extends along mandrel 802 substantially longer than inner tube 805. In other words, the length of the small tube 804 is longer than the inner tube 805. The small tube 804 is more flexible than the inner tube 805. The portion from the end point of the inner tube 805 and / or the main tube 803 to the vicinity of the end point of the small tube 804 will eventually form the steerable portion 106 in the access sheath 102. In one embodiment, the small tube 804 is shorter and less flexible than the inner tube 805. Thus, in this embodiment, the portion from the end point of the small tube 804 and / or the main tube 803 to the vicinity of the end point of the inner tube 805 is ultimately the steerable portion 106 in the access sheath 102. Will be formed.

  In one embodiment, the small tube 804, the inner tube 805, and the main tube 803 are the final tube with the small tube 804 and the inner tube 805 surrounded by the main tube 803 and the final tube. Placed in the tube. The assembly is placed or inserted into the control tube and the control tube is removed after the assemblies are attached or joined together.

In one embodiment, either the small tube 804 or the inner tube 805, whichever extends, is a rigid, eg, stainless steel tube, that assists in deflecting the steerable region 106. Thus, the stiffness of the small tube 804 or the inner tube 804 prevents the other portion of the access sheath 102 from being steerable. The tube then shifts the force generated by the tensioning device 116 to deflect the steerable area toward or in the steerable area 106. In addition, a rigid secondary lumen formed of a rigid tube helps protect the tensioning device and instruments inserted or withdrawn from the primary lumen.
Wire 807 is wrapped around a small tube, inner tube 805 and main tube 803. In one embodiment, if the final tube is utilized, the wire 807 is wrapped around the final tube. In one embodiment, the structure or composition of the wire 807 is similar to the wire 801 and / or extends slightly beyond the distal end of the small tube 804 or the inner tube 805.

  In one embodiment, a support tip is placed at or slightly beyond the distal end of the wire 807 to help secure the wire 807 around the small tube 804 or inner tube 805, And / or providing an atraumatic tip. The support tip is made from a material with a Shore D hardness of 75. Along with the rest of the assembly, the mandrel is inserted into the control tube. As described above, in one embodiment, air is supplied to the end opposite the insertion to expand the control tube and assist in the insertion of the mandrel 802. According to one aspect, the control tube is temporarily surrounded by the support tube, and when the tube is pressurized, the tube is prepared for possible damage. When the control tube is heated with the assembly, the plastic coating of wire 807 melts and welds itself to form a substantially continuous tubular structure or tube 808. Then remove the control tube. In one embodiment, the control tube and assembly are heated for approximately 15 minutes at a temperature of approximately 165 degrees ± 5-10 degrees. In this way, the access sheath 102 having variable flexibility is created.

Support wire 806 is removed from mandrel 802. For example, the support wire 806 at the distal end of the mandrel 802 is cut, and then the mandrel 802 is withdrawn from the access sheath 803. A tensioning device such as a tension wire is attached at or near the distal end of the access sheath, passes through a small tube 804 and an inner tube 805, exits the proximal end of the access sheath 102, and is secured to the actuator. . Thus, the access sheath is deflectable and controllable.
In one embodiment, the tensioning device is tied or looped between the access sheath openings or cuts, the support tip, and / or the wire 807 loop and then returns through itself. . The inner tube 805 and the small tube 804 are threaded with a capture wire to hook or otherwise attach a tensioning device. The capture wire is removed from the proximal end of the access sheath, thereby causing it to exit the proximal end of the access sheath 102 through a tensioning device. The diameter of the support wire 806 is sufficiently large compared to the diameter of the tensioning device so that the capture wire or capture wire loop or hook can easily access these devices through the secondary lumen of the access sheath 102. Can pass through. In one embodiment, a secondary support tip is disposed at the distal end of the access sheath 102 to help secure the tensioning device to the access sheath and / or provide an atraumatic tip. To do.

  As shown in FIGS. 51A-51C, the distal end 809a of the access sheath 102 is tapered and has a smaller diameter than the proximal end 809b of the access sheath 803. However, the diameters of the primary lumen 112 and the secondary lumen 114 are substantially constant throughout the access sheath 102. Further, the taper or reduced diameter of the access sheath, in one embodiment, is due to the inner tube 805 or small tube 804 not interrupting and extending, and the main tube 803 along the length of the mandrel 802. It is a result. As a result, the steerable portion 106 is reduced in material or contains more flexible material so that the steerable portion can easily deflect and bend in response to operation of the attached tensioning device. The shape changes or bends, while the other parts of the access sheath 102 contain substantially more material or less flexible material, for example, substantially linear and substantially the same. The surface is kept fixed and the access sheath is prevented from moving inadvertently or inadvertently.

Further, since the steerable region 106 in the access sheath 102 is reinforced by a wire 807, the steerable region 106 is reinforced to be flexible, pre-bendable, or otherwise actively controlled. Instruments that are not capable can be deflected controllably and dynamically when the steerable region 106 is controlled. In addition, the actively deflectable surgical instrument has a complex structure and includes elements such as optics and clamps to perform its surgical function and elements for performing active deflection. . Thus, such instruments are fragile, and if broken, repairs and replacements are expensive and can still be used as surgical instruments, although they cannot be actively deflected. This reduces replacement, repair, and construction costs by using a reinforced steerable region 106 instead of elements used in such surgical instruments, or controllably deflecting broken instruments, It also reduces wear and breakage of such instruments and extends the life of such instruments. Also, the access sheath 102 reinforced by the wire 807 and / or the wire 801 can keep the size and shape of the primary lumen substantially constant throughout the access sheath 102, so that the access sheath It is possible to reduce the force acting on the devices arranged inside the device, and to extend the life of those devices.
The forces or stresses that accumulate along the access sheath that cause kinking of the access sheath are distributed along the access sheath due to the above-described complex structure of the access sheath, eg, the wires 807, 803 Countered by the coil. Thus, the kinks that occur in the access sheath are reduced. Moreover, according to the wire coil, the wall of the access sheath can be made extremely thin without reducing the durability and strength of the access sheath. Accordingly, the overall diameter or outer diameter of the access sheath is small, and the incision or insertion site for the access sheath can be reduced without reducing the size or diameter of the primary lumen. Thus, an access sheath according to various embodiments of the present invention has a thin wall portion, a large lumen, an atraumatic end, a kink-resistant structure, and a strong and rigid body conduit. And enough flexibility to guide in a complex way through the cavity or tissue. In one embodiment, the wire coil may be wound with a material having alternating durometer hardness.

  Examples of various methods used to manufacture the access sheath 102 or a portion of the access sheath 102 are disclosed in US patent application Ser. Nos. 10 / 766,138 and 10 / 298,116, which are hereby incorporated by reference. Is referenced and quoted here. These steps or portions of the steps can be varied or combined with the steps described above, and vice versa. For example, various ring-shaped elements, such as plastic rings, metal rings, unreinforced plastic rings, and metal reinforced plastic rings, and the like, replace or replace the wires 803 and / or 807. In addition to available. In addition, separate mandrels can be used to form the primary and secondary lumens separately and combine them to make an access sheath.

  In one embodiment of the present invention, access sheaths and actuators according to various embodiments have been described above, hereinafter referred to as access sheaths, combined with an instrument or device such as a dilator used to stretch or enlarge the opening. Thus, when it is deployed, the ureter can be gradually atraumatically expanded. Once the access sheath is in the desired location, the dilator is removed and the access sheath is left in the desired location. The access sheath continues to provide access to the desired area so that, for example, a urinary endoscope or other treatment instrument can be placed and protection is provided for the ureter. For example, the access sheath protects the ureter during placement and retrieval of the device inside the access sheath when removing stone fragments and other tissue and when removing biopsy specimens for potential cancer. To do.

Furthermore, if a deflectable or steerable access sheath is used, the urologist can effectively and efficiently position stones and stone fragments inside the kidney. If a stone is found in one kidney cup of the kidney, especially in the lower pole part of the kidney, it is difficult for the urologist to continue to return to the same kidney cup or place and remove the stone.
If there are many debris inside the kidney cup, go in and out several times to remove the stone. Also, when stones or stone fragments are removed, instruments and tissues such as endoscopes and stone baskets (with stones or stone fragments) are removed as a single unit. The endoscope is then moved back through the sheath and manipulated to find the same kidney cup to remove any remaining stones. However, if the access sheath 102 is used, the access sheath is left deflected in place and faces the same kidney cup or position while the endoscope and stone basket are removed. As a result, the urologist is not required to operate the ureteroscope every time looking for the same kidney cup, so the treatment time by the urologist is shortened. A considerable amount of time is saved, especially if there are large stones in the kidney. In addition, the likelihood of damaging the kidney is reduced due to additional manipulations that are performed each time the ureteroscope is moved back into the kidney. Thus, if an access sheath is used, it is not necessary to find the kidney cup each time the debris is removed, and the stone can be removed while the sheath is deflected and held toward a particular kidney cup.

When a urologist manipulates a ureteroscope, the urologist sometimes uses the inner wall of the kidney to help deflect the ureteroscope to enter certain difficult sites. When using the access sheath 102, an access sheath is used instead of helping to deflect the ureteroscope using the inner wall. Also, as mentioned above, this helps to reduce “wear and breakage” of surgical instruments such as ureteroscopes. If the ureteroscope is provided with a deflection mechanism, this often breaks and the repair is expensive. If an access sheath is used and this helps to manipulate the ureteroscope to the desired location in the kidney, the ureteroscope can be less damaged.
Using the access sheath 102 helps an inexperienced urologist to perform the same difficult treatment procedure that an experienced colleague performs. In performing this procedure, the urologist has access to the lower pole of the kidney to remove the stone. By performing this procedure in a retrograde manner, the patient recovery period is shortened. If the urologist is immature and unfamiliar with removing the stone from the lower pole of the kidney using the ureteroscope in the retrograde direction, the urologist will typically You will approach stones in a way. In this case, since the sheath is placed percutaneously, the recovery period of the patient is increased and the potential morbidity is increased. However, using the access sheath 102 and ureteroscope, the urologist can efficiently and effectively locate and remove the calculus inside the lower pole of the kidney. The access sheath can also be used in a forward manner, if not the preferred way, and provides the same or similar features as described above.

  Thus, according to the present invention, a steerable device for accessing a blood vessel is provided. Although the present invention has been described with respect to certain specific embodiments, many additional variations and applications will be apparent to those skilled in the art. Accordingly, it is to be understood that the invention may be practiced otherwise than as explicitly described and that it be practiced with changes in size, shape, and material, without departing from the spirit and scope of the invention. I want to be. Accordingly, the embodiments of the invention are to be considered in all respects only as illustrative and not restrictive.

FIG. 1 illustrates a surgical access device or steerable access sheath according to one aspect of the present invention. FIG. 2 is a cross-sectional view showing the access device of FIG. FIG. 3 illustrates a dilator according to one aspect of the present invention. FIG. 4 illustrates a surgical access device or steerable access sheath according to one aspect of the present invention. FIG. 5 illustrates a surgical access device or steerable access sheath according to another aspect of the present invention. FIG. 6 illustrates a surgical access device or a steerable access device according to one embodiment of the present invention. FIG. 7 is a front view of the distal end of the access device of FIG. 8 is a rear view of the proximal end of the access device of FIG. FIG. 9 is an enlarged side view showing the distal portion of the access sheath of FIG. 10 is a cross-sectional side view of the distal portion of the access sheath of FIG. FIG. 11 shows the steerable access device according to the present invention with its distal portion deflected. FIG. 12 is a top view of the distal portion of the access sheath according to the present invention. FIG. 13 is a bottom view of the distal portion of the access sheath according to the present invention. FIG. 14 shows an atraumatic distal end for an access sheath according to the present invention. FIG. 15 shows an actuator in an access device according to the present invention, which is used to control a steerable region or part of an access sheath. FIG. 16 shows a state in which the endoscope is guided to the inside of the kidney pole using the access device according to the present invention. FIG. 17 is a perspective view showing a distal portion of an access sheath having a flat tension member. FIG. 18 is a perspective view showing an actuator or operation handpiece according to another embodiment of the present invention. FIG. 19 is a side view showing the operation handpiece of FIG. FIG. 20 is a perspective view showing an operation handpiece according to the present invention, which includes a direction indicator for indicating a deflection or bending direction of the access sheath. FIG. 21 is another perspective view showing an operation handpiece of the present invention provided with a direction indicator. FIG. 22 is a side elevational view showing an embodiment of a spring for a tube associated with a sheath according to the present invention. FIG. 23A is a side view showing an operation handpiece according to one embodiment of the present invention. FIG. 23B is a perspective view showing an operation handpiece according to an embodiment of the present invention. 24 is a cross-sectional view showing the operation handpiece of FIGS. 23A and 23B. FIG. 25 is a perspective view showing an operation handpiece according to an embodiment of the present invention. FIG. 26A is an exploded view showing the operation handpiece of FIG. FIG. 26B is a cross-sectional view showing the operation handpiece of FIG. FIG. 27 is a perspective view showing an operation handpiece according to an embodiment of the present invention. 28A is a cross-sectional view showing the operation handpiece of FIG. FIG. 28B is a perspective view showing a state where the operation handpiece of FIG. 27 is disassembled. FIG. 29 is a perspective view showing an actuator or operation handpiece according to one embodiment of the present invention. FIG. 30 is a cross-sectional view showing the operation handpiece of FIG. FIG. 31 is a perspective view showing an operation handpiece according to an embodiment of the present invention. FIG. 32 is a perspective view showing an operation handpiece according to an embodiment of the present invention. FIG. 33A is a side view showing an actuator or operation handpiece according to one embodiment of the present invention. FIG. 33B is another side view showing the operation handpiece of FIG. 33A. FIG. 34 is a perspective view showing an operation handpiece according to an embodiment of the present invention. FIG. 35 is a cross-sectional view illustrating a connector according to an embodiment of the present invention. FIG. 36 is a cross-sectional view showing the operation handpiece of FIG. FIG. 37A is an exploded perspective view showing an operation handpiece according to one embodiment of the present invention. FIG. 37B is an exploded perspective view showing an operation handpiece according to one embodiment of the present invention. FIG. 38A is another exploded perspective view showing the operation handpiece of FIG. 36A. FIG. 38B is another exploded perspective view showing the operation handpiece of FIG. 36B. FIG. 39 is a cross-sectional view showing the operation handpiece of FIG. FIG. 40 is a perspective view showing an operation handpiece according to an embodiment of the present invention. 41A is a cross-sectional view showing the operation handpiece of FIG. 41B is a cross-sectional view showing the operation handpiece of FIG. FIG. 42 is a perspective view showing components of the embodiment of the operation handpiece of FIG. FIG. 43 is a perspective view showing components of the embodiment of the operation handpiece of FIG. FIG. 44 is a view showing an operation handpiece according to one embodiment of the present invention. FIG. 45 is a perspective view showing an operation handpiece according to an embodiment of the present invention. FIG. 46 is a perspective view showing an operation handpiece according to an embodiment of the present invention. FIG. 47A is a perspective view showing an operation handpiece according to an embodiment of the present invention. FIG. 47B is a perspective view showing components according to one embodiment of the operating handpiece of FIG. 47A. FIG. 48 illustrates various stages of manufacturing for an access sheath according to an embodiment of the present invention. FIG. 49 illustrates various manufacturing steps for an access sheath according to an embodiment of the present invention. FIG. 50 illustrates various manufacturing steps for an access sheath according to an embodiment of the present invention. 51A-C illustrate various manufacturing steps for an access sheath according to an embodiment of the present invention.

Claims (25)

A surgical device for accessing a blood vessel,
An elongate body having a proximal end, a distal end, at least one steerable region, and a lumen sized and configured to extend into the body and to be inserted into a blood vessel. The elongated body;
A tensioning device extending into the elongate body, the tensioning device being coupled to at least one steerable region of the elongate body;
An actuator coupled to a tensioning device extending distally from the proximal end of the elongate body, wherein the actuator controls the tension of the tensioning device to navigate the elongate body through the circulatory system;
A device characterized by comprising:   The device of claim 1, wherein the outer diameter of the elongate body is sized to be inserted into a blood vessel.   The apparatus of claim 1, wherein the lumen has a path configured to advance one of the dilator and the contrast agent.   The apparatus of claim 1, wherein the tensioning device is at least one tensioning wire.   The device of claim 1, wherein the tensioning device is a flexible flat member.   2. The device of claim 1, further comprising an enlarged inlet at the proximal end of the body and adapted to receive one of a dilator and an obturator.   The apparatus of claim 6, wherein the inlet comprises a valve.   The apparatus of claim 1, wherein the actuator further comprises one of a thumbwheel, knob, lever, button, handle, tee, and dial.   The device of claim 1, wherein the elongated body is deflectable by a tensioning device to conform to the shape of the blood vessel.   The device of claim 1, wherein the elongate body is deflectable by a tensioning device so that the contrast agent flows antegradely into the blood vessel.   The apparatus of claim 1, wherein the elongate body has a length of at least 100 cm.   The apparatus of claim 1 wherein other steerable regions are disposed along non-adjacent portions of the elongate body.   The device of claim 1, wherein the distal end of the elongate body is tapered.   The device further comprises a secondary lumen, a tensioning device is disposed through the secondary lumen, and a spring is secured within the secondary lumen, the tensioning device passing through the spring. The device of claim 1, wherein the device extends.   The apparatus of claim 1, wherein the body comprises an inner plastic body, a spring coil, and an outer plastic body.   The apparatus of claim 15, wherein the inner plastic body is surrounded by a spring coil and is covered by the outer plastic body.   The apparatus of claim 1, wherein the at least one steerable region comprises means for increasing the elasticity of the steerable region.   The apparatus of claim 1, wherein the elongate body is configured to be manipulated through the femoral artery, iliac artery, and uterine artery. A surgical device for accessing a blood vessel,
A tube having a proximal end, a distal end, a steerable region, and an enlarged inlet, the tube comprising a primary lumen and first and second secondary lumens And the above-mentioned pipes, both of which extend to the pipes,
A first tensioning device coupled to the steerable region and extending through the first secondary lumen;
A second tensioning device coupled to the steerable region and extending to the secondary lumen;
An enlarged inlet extending from the distal end of the tube, wherein the enlarged inlet forms a transition from the exterior of the tube into the primary lumen of the tube;
A movable actuator disposed about the enlarged inlet and coupled to the first tension device and the second tension device, rotating in one direction moves the first tension device and in the opposite direction The movable actuator to move the second tensioning device when rotated to
A device characterized by comprising:   20. The device of claim 19, wherein the first secondary lumen and the second secondary lumen are disposed on opposite sides of the tube.   The outer diameter of the tube is sized to be inserted into the blood vessel, and the primary lumen has a path configured to advance one of the dilator and the contrast agent. The apparatus of claim 19.   20. A device according to claim 19, characterized in that the tube is deflectable by a first tensioning device so that the contrast agent flows antegradely into the blood vessel.   20. The apparatus of claim 19, wherein a plurality of steerable areas are disposed along non-adjacent portions of the tube.   20. The device of claim 19, wherein the tube is configured to be manipulated through the femoral artery, iliac artery, and uterine artery. A surgical device for accessing a blood vessel,
An elongate tube having a proximal end, a distal end, a steerable region, and an enlarged inlet, the elongate tube being manipulated through the femoral, iliac, and uterine arteries The elongated tube as configured as described above,
Tension means coupled to the steerable region and extending through the lumen;
Actuator means coupled to tension means for moving the tension means and moving the steerable region;
A device characterized by comprising:

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