CN113079287B

CN113079287B - Interventional medical device system

Info

Publication number: CN113079287B
Application number: CN202110322254.5A
Authority: CN
Inventors: 王林辉; 杨波; 刘冰; 张超; 吴震杰; 张宗勤; 徐红; 鲍一; 何屹; 徐凯
Original assignee: Beijing Surgerii Technology Co Ltd; Shanghai Changzheng Hospital; First Hospital of Jiaxing; First Affiliated Hospital of Naval Military Medical University of PLA
Current assignee: Shanghai Changzheng Hospital; First Hospital of Jiaxing; First Affiliated Hospital of Naval Military Medical University of PLA; Beijing Surgerii Robot Co Ltd
Priority date: 2021-02-09
Filing date: 2021-03-25
Publication date: 2022-08-30
Anticipated expiration: 2041-03-25
Also published as: CN113079287A

Abstract

The present disclosure relates to the field of medical devices, and discloses an interventional medical device system, comprising: the device comprises a bendable and extensible tubular medical instrument, an image acquisition device and a processor. The instrument comprises an extensible tube, a bendable element, a driving wire and a medical instrument, wherein the extensible tube comprises an inner layer, an outer layer and a fluid cavity positioned between the inner layer and the outer layer, the inner layer and the outer layer are connected in an invertible area positioned at the far end and can be inverted, the bendable element comprises a flexible tube and a wrist joint, the driving wire is fixedly connected with the wrist joint, and the medical instrument is arranged at the far end of the wrist joint. The image acquisition device is used for acquiring images of a cavity where the extendable tube is located, and the processor is configured to receive the images, process the images, determine an actual navigation path, and generate a tube control signal and a bending member control signal for controlling the movement of the extendable tube and the bending member. The interventional medical device system can better adapt to the gradually narrowed curved complex cavity channel so as to reduce or avoid touch and friction with the cavity channel.

Description

Interventional medical device system

Technical Field

The present disclosure relates to the field of medical devices, and more particularly, to an interventional medical device system.

Background

The intracavitary interventional operation gradually becomes a research hotspot of the industry, and compared with the traditional open operation which mainly depends on a doctor to carry out manual operation, the intracavitary interventional operation has the advantages of small wound, safety, quick postoperative recovery, few complications and the like, and can eliminate the danger caused by misoperation during physical trembling and fatigue of the doctor in the manual operation process. The doctor can adopt teleoperation mode to control the intracavity interventional instrument to implement operation, the motion is stable and reliable, the precision is high, and the operation quality is favorably improved.

However, the flexibility of the currently adopted interventional instrument is relatively poor, the interventional instrument cannot adapt to a bent and complex human body cavity, the cavity can be damaged, and the interventional instrument has a large volume, so that the further popularization of the instrument for assisting the intracavity interventional diagnosis or operation is limited.

Disclosure of Invention

Based on the above problems, the present disclosure provides an interventional medical device system, which has better flexibility, can realize controllable extension, and can be well adapted to a curved and complex lumen that gradually narrows.

In some embodiments, the present disclosure provides an interventional medical device system comprising: a rotatably extendable tubular medical device comprising: an extendable tube comprising an inner layer, an outer layer, and a fluid chamber between the inner and outer layers for containing a fluid; the extendable pipe comprises an invertible area positioned at the distal end, the inner layer and the outer layer are connected in the invertible area and can be inverted, and the radial sizes of the inner layer and the outer layer are respectively reduced in a step-like manner from the proximal end to the distal end; a deflectable member disposed in the channel surrounded by the inner layer of the extendable tube, the deflectable member including a flexible tube and a wrist joint disposed at a distal end of the flexible tube; the drive wire penetrates through the hose, the distal end of the drive wire is fixedly connected with the wrist joint, and the drive wire is used for driving the wrist joint to bend under the driving of the wrist joint driving mechanism so as to drive the extensible pipe to bend; and a medical instrument disposed at a distal end of the wrist joint; the image acquisition equipment is used for acquiring an image of a cavity where the extensible pipe is located; and a processor configured to receive an image captured by the image capture device, process the received image, determine an actual navigation path, and generate a tube control signal for controlling the extendable tube to extend distally or withdraw proximally along the lumen based on the actual navigation path and a flexure control signal for controlling the flexible tube to move distally or withdraw proximally along the lumen and for controlling the wrist to flex.

Drawings

In order to more clearly illustrate the technical solutions in the embodiments of the present disclosure, the drawings used in the description of the embodiments of the present disclosure will be briefly introduced, and it is apparent that the drawings in the description below only illustrate some embodiments of the present disclosure, and those skilled in the art can obtain other embodiments according to the contents of the embodiments of the present disclosure and the drawings without creative efforts.

Fig. 1 shows a schematic view of a distal portion of an extendable tube according to some embodiments of the present disclosure;

fig. 2 shows a schematic view of a distal portion of another extendable tube, according to some embodiments of the present disclosure;

fig. 3 shows a schematic view of a distal portion of another extendable tube, according to some embodiments of the present disclosure;

fig. 4(a) shows a cross-sectional view of an extendable tube according to some embodiments of the present disclosure;

fig. 4(b) shows another cross-sectional view of an extendable tube according to some embodiments of the present disclosure;

FIG. 5(a) shows a partial schematic structural view of a tube drive mechanism according to some embodiments of the present disclosure;

FIG. 5(b) shows a cross-sectional schematic view of a tube drive mechanism according to some embodiments of the present disclosure;

fig. 6 illustrates a structural schematic of a bendable extending tubular medical device according to some embodiments of the present disclosure;

FIG. 7 illustrates a schematic structural view of a deflectable member according to some embodiments of the present disclosure;

FIG. 8 illustrates a schematic structural view of a wrist joint of a deflectable member according to some embodiments of the present disclosure;

FIG. 9 shows a schematic structural view of a flexible tube of a bendable element according to some embodiments of the present disclosure;

FIG. 10 shows a schematic structural view of a slit unit according to some embodiments of the present disclosure;

fig. 11 illustrates a structural schematic of an interventional medical device system according to some embodiments of the present disclosure;

fig. 12 illustrates a flow chart of a method of driving a bendable extending tubular medical instrument according to some embodiments of the present disclosure.

Detailed Description

In order to make the technical problems solved, technical solutions adopted and technical effects achieved by the present disclosure clearer, the technical solutions of the embodiments of the present disclosure will be described in further detail below with reference to the accompanying drawings, and it is obvious that the described embodiments are only some embodiments of the present disclosure, but not all embodiments. All other embodiments, which can be derived by a person skilled in the art from the embodiments disclosed herein without making any inventive step, fall within the scope of protection of the present disclosure.

In the description of the present disclosure, it should be noted that the terms "center", "upper", "lower", "left", "right", "vertical", "horizontal", "inner", "outer", and the like indicate orientations or positional relationships based on orientations or positional relationships shown in the drawings, only for convenience of description and simplification of description, but do not indicate or imply that the device or element referred to must have a particular orientation, be constructed in a particular orientation, and operate, and thus, should not be construed as limiting the present disclosure. Furthermore, the terms "first," "second," and the like are used for descriptive purposes only and are not to be construed as indicating or implying relative importance. In the description of the present disclosure, it should be noted that, unless explicitly stated or limited otherwise, the terms "mounted," "connected," and "coupled" are to be construed broadly and may include, for example, fixed and removable connections; can be mechanically or electrically connected; they may be connected directly or indirectly through intervening media, or they may be interconnected between two elements. The specific meaning of the above terms in the present disclosure can be understood in a specific case to those of ordinary skill in the art. In the present disclosure, the end close to the operator (e.g., doctor) is defined as proximal, proximal or posterior, and the end close to the surgical patient is defined as distal, distal or anterior, anterior.

Fig. 1 illustrates a schematic view of a distal end portion of a bendable extending tubular medical instrument 100 according to some embodiments of the present disclosure. The flexible elongate tubular medical device 100 can be passed through an opening (e.g., an incision or natural opening) into a lumen (which can include, for example, a blood vessel, trachea, esophagus, vagina, intestine, etc., in a human or animal). As shown in fig. 1, the bendable elongate tubular medical device 100 may include an elongate tube 110, and the elongate tube 110 may include a flexible material. The extendable tube 110 comprises an inner layer 111, an outer layer 112, and a fluid chamber 113 located between the inner layer 111 and the outer layer 112. The fluid chamber 113 is for containing a fluid 140. The extendable tube 110 further comprises an invertible region 114 at the distal end, the inner layer 111 and the outer layer 112 being joined together and invertible in the invertible region 114. In some embodiments, the radial dimensions of the inner layer 111 and the outer layer 112 may decrease stepwise in a direction extending from the proximal end to the distal end, respectively. In this way, the bendable elongate tubular medical device 100 can accommodate a narrowing lumen to reduce or avoid contact and friction with the lumen. In some embodiments, the fluid lumen 113 can be uniformly distributed in a step-wise manner from the proximal end to the distal end. The inner layer 111 may be everted in the invertible regions 114 to form the outer layer 112, or the outer layer 112 may be everted in the invertible regions 114 to form the inner layer 111. By everting between the inner layer 111 and the outer layer 112, the extendable tube 110 can be extended or retracted distally to facilitate extension of the steerable extendable tubular medical device 100 within the lumen to a target location or retraction from the lumen. For example, the inner layer 111 is moved distally by a length L, the inner layer 111 of length L is everted in the evertable region 114 to form the outer layer 112, and the fluid 140 fills the fluid chamber 113 extended by everting the inner layer 111 so that the extendable tube 110 may be extended forward. The inner layer 111 is moved proximally by a length L ', and the outer layer 112 of length L' is inverted in the invertible region 114 to form the inner layer 111 so that the extendable tube 110 may be retracted.

Fig. 2 and 3 show schematic distal portion configurations of

extendable tubes

210 and 310, respectively, according to some embodiments of the present disclosure. In some embodiments, as shown in fig. 1, 2 and 3, the radial dimension of the

outer layer

112 and 312 may decrease in a step manner from the proximal end to the distal end, and the radial dimension of the

inner layer

111 and 311 may decrease in a step manner from the proximal end to the distal end. It will be appreciated that the configuration of the

extendable tubes

110, 210 and 310 shown in fig. 1, 2 and 3 may be a configuration during extension or a configuration when extension is stopped. The contours of the outer and inner layers may be straight, curved, or a combination thereof. In this disclosure, step-wise refers to a sharp change in the profile slope of the layer at the step region.

As shown in fig. 1, the outer layer 112 may include a proximal section 1121 and a distal section 1122 having different radial dimensions, the radial dimensions of the proximal section 1121 and the distal section 1122 are maintained substantially constant in the extending direction from the proximal end to the distal end, the proximal section 1121 and the distal section 1122 may be connected in a sudden or gradual manner at the connection region, and the slope of the profile of the proximal section 1121 at the connection region is different from that of the profile of the distal section 1122 at the connection region, so as to form a step-like profile. The radial dimension of the inner layer 111 of the extendable tube 110 remains substantially constant at the proximal segment 1121 and substantially constant at the distal segment 1122, and may be connected abruptly or gradually at the junction of the proximal segment 1121 and the distal segment 1122, with the slope of the profile of the proximal segment 1121 being different from the slope of the profile of the distal segment 1122 at the junction to form a stepwise profile. The thickness of the fluid lumen 113 remains substantially constant from the proximal to distal extension while the extendable tube 110 is in an everted, stopped state (e.g., fully extended state, or near the lesion site) to form a step of uniform thickness. The inner layer 111 surrounds channels 1111, the radial dimension of the channels 1111 remains substantially constant at the proximal segment 1121 and substantially constant at the distal segment 1122, and may be tapered at the junction of the proximal segment 1121 and the distal segment 1122. the channels 1111 may be adapted to receive a bend to effect steering of the extendable tube 110 by the bend. Either the inner layer 111 or the outer layer 112 may be driven to move distally or proximally so that the inner layer 111 may evert in the invertible regions 114 to form the outer layer 112, or the outer layer 112 may evert in the invertible regions 114 to form the inner layer 111. For example, the inner layer 111 is moved distally by a length L, the inner layer 111 of length L is everted in the evertable region 114 to form the outer layer 112, and the fluid 140 fills the fluid chamber 113 extended by everting the inner layer 111 so that the extendable tube 110 may be extended forward. The inner layer 111 is moved proximally by a length L ', the outer layer 112 of length L' is inverted in the invertible region 114 to form the inner layer 111, so that the extendable tube 110 may be retracted.

In some embodiments, as shown in FIGS. 2 and 3, the

outer layers

212 and 312 may include a stepped profile made up of multiple segments that differ in radial dimension. As shown in fig. 2, the outer layer 212 may sequentially include a proximal segment 2121a, a proximal segment 2121b, a distal segment 2122a and a distal segment 2122b having different radial dimensions, the radial dimensions of the proximal segment 2121a and the distal segment 2122a are substantially constant, the radial dimensions of the proximal segment 2121b and the distal segment 2122b are gradually reduced from the proximal end to the distal end, the proximal segment 2121a and the proximal segment 2121b may be gradually or abruptly connected at a connection region, the proximal segment 2121b and the distal segment 2122a may be gradually or abruptly connected at a connection region, and the distal segment 2122a and the distal segment 2122b may be gradually or abruptly connected at a connection region to form a multi-step profile. The inner layer 211 remains substantially constant at the proximal and

distal portions

2121a, 2122a, tapers in a direction extending proximally to distally at the proximal and

distal portions

2121b, 2122b, and may be joined incrementally at the junction of the proximal and

proximal portions

2121a, 2121b, 2122a, and 2122b to form a stepped profile. As shown in fig. 2, the thickness of the fluid lumen 213 remains substantially constant from the proximal to distal extension in a state where the extendable tube 210 is stopped from everting (e.g., a fully extended state, or near the lesion site) to form a step-like uniform thickness. The inner layer 211 surrounds and defines a channel 2111, the channel 2111 decreasing in extension from the proximal, distal and

distal sections

2121a, 2121b, 2122a, 2122b, the channel 2111 being adapted to receive a steering element for steering the extendable tube 210 by the steering element. Either the inner layer 211 or the outer layer 212 may be driven to move distally or proximally so that the inner layer 211 may evert in the invertible regions 214 to form the outer layer 212, or the outer layer 212 may evert in the invertible regions 214 to form the inner layer 211. The fluid 240 fills the fluid chamber 213 that is extended by the eversion of the inner layer 211 or the eversion of the outer layer 212 so that the extendable tube 210 can extend forward.

As shown in fig. 3, the outer layer 312 may include a proximal segment 3121a, a proximal segment 3121b, a distal segment 3122a, and a distal segment 3122b that differ in radial dimension in order. The radial dimensions of the proximal segment 3121a, the proximal segment 3121b, the distal segment 3122a, and the distal segment 3122b remain substantially constant, the proximal segment 3121a and the proximal segment 3121b may be abruptly connected at a connection region, the proximal segment 3121b and the distal segment 3122a may be abruptly connected at a connection region, and the distal segment 3122a and the distal segment 3122b may be abruptly connected at a connection region to form a multi-step stepwise profile. The inner layer 311 may include a plurality of segments corresponding to the segments of the outer layer 312, and the segments may be abruptly connected at a connection region to form a stepwise profile. As shown in fig. 3, the thickness of the fluid lumen 313 is maintained substantially constant from the proximal to distal direction in a state where the extendable tube 310 stops everting or in a steady state during extension to form a step-like uniform thickness. The inner layer 311 surrounds and forms a channel 3111, the channel 3111 decreasing in extension from the proximal segment 3121a, the proximal segment 3121b, the distal segment 3122a and the distal segment 3122 b. The channel 3111 may be used to accommodate a bend to effect steering of the extendable tube 310 by the bend. Either inner layer 311 or outer layer 312 may be driven to move distally or proximally such that inner layer 311 may evert in invertible region 314 to form outer layer 312, or outer layer 312 may evert in invertible region 314 to form inner layer 311. The fluid 340 fills the fluid chamber 313 extended by the eversion of the inner layer 311 or the eversion of the outer layer 312 so that the extendable tube 310 may extend forward.

Fig. 4(a) and 4(b) illustrate cross-sectional views of the extendable tube 110 (or 210, 310), respectively, according to some embodiments of the present disclosure. In some embodiments, as shown in fig. 4(a), the extendable tube 110 may be circular in cross-section. In some embodiments, as shown in fig. 4(b), the cross-section of the extendable tube 110 may be elliptical. It should be understood that the cross-section of the extendable tube 110 includes, but is not limited to, the configuration of the above embodiments, and may include other shapes, such as rectangular, polygonal, and the like.

In some embodiments, the extendable tube 110 (or 210, 310) may comprise a flexible material, including but not limited to plastic, rubber, etc., such as low density polyethylene, silicon-containing polymers, or fluoropolymers, etc. The flexible, extendable tube 110 may avoid damage to the lumen.

The bendable elongate tubular medical device 100 may include one of the

extendable tubes

110 and 310. In some embodiments, the bendable extending tubular medical instrument 100 may further include a tube drive mechanism 120. Fig. 5(a) and 5(b) respectively illustrate partial structural schematic views of a tube driving mechanism 120 according to some embodiments of the present disclosure. As shown in fig. 5(a), the pipe driving mechanism 120 is connected to the extendable pipe 110 (or 210, 310), and the pipe driving mechanism 120 is linearly movable for driving the outer layer 112 or the inner layer 111 of the extendable pipe 110 to move. In some embodiments, the tube drive mechanism 120 may be coupled to the outer layer 112 of the extendable tube 110 to drive movement of the outer layer 112 of the extendable tube 110. In some embodiments, the tube drive mechanism 120 may be coupled to the inner layer 111 of the extendable tube 110 to drive the movement of the inner layer 111 of the extendable tube 110.

In some embodiments, as shown in fig. 5(a) and 5(b), the tube drive mechanism 120 may include a motor 121, a coupling sleeve 122, a transmission assembly 123, and a lead screw nut module 124. The lead screw nut module 124 may employ a friction lead screw or a ball screw. The lead screw nut module 124 may include a lead screw 1241, a nut 1242 disposed on the lead screw 1241, and a movable rod 1243 fixedly connected to the nut 1242. The coupling sleeve 122 includes an integrally formed mounting flange 1221 and a mounting case housing 1222, wherein the mounting flange 1221 is coupled to the motor 121 and the mounting case housing 1222 is configured to receive the transmission assembly 123. In some embodiments, as shown in fig. 5(b), the transmission assembly 123 may include a worm 1231 and a worm gear 1232 that are rotationally engaged with each other. The worm 1231 is connected with an output shaft of the motor 121 through a key connection, and the worm gear 1232 is connected with the screw rod 1241 through a key connection. The axial (in the direction of the longitudinal axis a) output torque of the output shaft of the motor 121 is transmitted transversely (in the direction of the axis B) to the lead screw 1241 through the transmission assembly 123. By converting the rotational movement of the motor 121 into a rotational movement of the lead screw 1241, the drive nut 1242 is rotationally moved relative to the lead screw 1241 to drive a movement rod 1243, which is fixedly connected to the nut 1242, to move linearly. The outer layer 112 or the inner layer 111 of the extendable tube 110 (or 210 and 310) is connected with the moving rod 1243 in a sealing manner, so that the outer layer 112 or the inner layer 111 of the extendable tube 110 is driven to move.

It is to be understood that the tube drive mechanism of the present disclosure includes, but is not limited to, the structure of the above-described embodiments, as long as the drive mechanism capable of achieving linear motion does not depart from the scope of the present disclosure.

Fig. 6 illustrates a structural schematic of a bendable extending tubular medical instrument 100 according to some embodiments of the present disclosure. In some embodiments, as shown in fig. 6, the bendable extending tubular medical device 100 may further include a fluid controller 130. The fluid controller 130 may be used to pressurize the fluid 140 (or 240, 340) to drive the fluid 140 to gradually fill the fluid cavity 113 between the outer layer 112 and the inner layer 111. In some embodiments, the fluid 140 may be a liquid fluid, such as saline, or a gaseous fluid, such as air, carbon dioxide gas, or other inert gas. In some embodiments, the fluid controller 130 may include a gas pump or a liquid pump, or the like.

In some embodiments, as shown in fig. 6, the bendable elongate tubular medical instrument 100 may further include a fluid reservoir 150, the fluid reservoir 150 including a fluid outlet passage 151 and a fluid control passage 152, the fluid controller 130 in communication with the fluid reservoir 150 through the fluid control passage 152. At least one sealing ring 153 may be disposed in the fluid chamber 150, and the outer circumference of the sealing ring 153 is in sealing contact with the inner wall of the fluid chamber 150. The fluid outlet passage 151 is annular, the inner layer 111 of the extendable tube 110 (or 210, 310) is sealingly connected to the inner or outer side of the inner annular wall of the fluid outlet passage 151, the outer layer 112 of the extendable tube 110 extends through the fluid outlet passage 151 to the proximal end of the fluid tank 150 and is sealingly connected to the sealing ring 153, and the sealing ring 153 and the movable rod 1243 of the tube driving mechanism 120 are fixedly connected by at least one connecting rod 126. The pipe driving mechanism 120 is disposed in the fluid tank 150, and one end of the moving rod 1243 of the pipe driving mechanism 120 is connected to the sealing ring 153 to drive the sealing ring 153 to linearly move along the length direction of the fluid tank 150. The seal 153 may prevent the fluid 140 within the fluid tank 150 from leaking out of the gap between the outer layer 112 of the extendable pipe 110 and the inner layer of the fluid tank 150. For example, the tube driving mechanism 120 drives the outer layer 112 of the extendable tube 110 distally by a length L, the outer layer 112 of length L is inverted in the invertible region 114 to form the inner layer 111, and the fluid 140 fills the fluid lumen 113 extending from the inversion of the outer layer 112 so that the extendable tube 110 can be extended forward. The outer layer 112 is moved proximally by a length L ', and the inner layer 111 of length L' is everted in the evertable region 114 to form the outer layer 112 so that the extendable tube 110 may be retracted.

In some embodiments, the tube drive mechanism 120 may be disposed inside the fluid enclosure 150, and the inner layer 111 or the outer layer 112 of the extendable tube 110 (or 210, 310) may extend into the fluid enclosure 150 to connect with the tube drive mechanism 120. In some embodiments, as shown in FIG. 6, the tube drive mechanism 120 may be disposed outside the fluid chamber 150, the travel rod 1243 of the tube drive mechanism 120 may be disposed at least partially inside the fluid chamber 150, and the outer layer 112 of the extendable tube 110 (or 210, 310) may extend into the fluid chamber 150 to sealingly engage the travel rod 1243.

As shown in fig. 6, in some embodiments, the bendable extending tubular medical instrument 100 further includes a pressure sensor 160. A pressure sensor 160 may be disposed on the fluid chamber 150 for sensing the pressure within the fluid chamber 150. The pressure sensor 160 may be connected to the fluid controller 130 to send a fluid pressure signal within the fluid tank 150 to the fluid controller 130. The fluid controller 130 may control the fluid pressure in the fluid chamber 150 and the fluid chamber 113(213 or 313) based on the fluid pressure signal.

In some embodiments, the bendable extending tubular medical device 100 may further include a bendable member bendable in at least one degree of freedom at the distal end. Fig. 7 illustrates a schematic structural view of a deflectable member 170 according to some embodiments of the present disclosure. As shown in fig. 7, the inner layer 111 of the extendable tube 110 (or 210, 310) surrounds and forms a channel 1111, and the bendable element 170 is disposed in the channel 1111, and the distal end of the bendable element 170 can cause the extendable tube 110 to bend when bending.

In some embodiments, as shown in fig. 7, bendable element 170 may include a flexible tube 174 and a wrist joint 172 disposed at a distal end of flexible tube 174. Fig. 8 illustrates a schematic structural view of wrist joint 172 of deflectable member 170 according to some embodiments of the present disclosure. As shown in fig. 8, the wrist joint 172 may include a snake bone structure, the snake bone structure may include a plurality of hollow bamboo-shaped turning units 1721 connected end to end, and a kinematic pair capable of turning radially may be formed between two adjacent turning units 1721 through the mutually nested connecting grooves 1722 and connecting protrusions 1723.

Fig. 9 illustrates a schematic structural view of the hose 174 of the deflectable member 170 according to some embodiments of the present disclosure. In some embodiments, as shown in fig. 9, the flexible tube 174 may be provided with a plurality of slit units 175 at intervals along the extending direction thereof, and each slit unit 175 may include at least one slit 1751 extending along the circumference of the flexible tube 174. Fig. 10 illustrates a schematic structural view of a slit unit 175 according to some embodiments of the present disclosure. In some embodiments, as shown in fig. 10, the slit unit 175 may include a plurality of slits 1751, the plurality of slits 1751 being spaced apart in an axial direction of the hose 174, and the plurality of slits 1751 being sequentially offset in a circumferential direction of the hose 174. By providing the slots 1751, the flexible tube 174 can be passively bent to accommodate the lumen. It should be understood that the flexible tube 174 includes, but is not limited to, the above-described structure, and may be other flexible tubes that can be passively bent.

In some embodiments, as shown in fig. 8, the bendable extending tubular medical instrument 100 may further include a drive wire 173. The driving wire 173 may be disposed through the flexible tube 174 or disposed through the wall of the flexible tube 174, the distal end of the driving wire 173 is fixedly connected to the wrist joint 172, and the driving wire 173 is configured to rotate the wrist joint 172 to rotate the extendable tube 110 (or 210, 310) under the driving of the wrist joint driving mechanism.

In some embodiments, as shown in fig. 8, the distal end of the drive wire 173 may be disposed through each of the deflection units 1721 or through the wall of the tube of each of the deflection units 1721, the distal end of the drive wire 173 is fixedly disposed at the distal end of the serpentine structure, and the wrist driving mechanism pushes or pulls the drive wire 173 to cause the serpentine structure to deflect, thereby driving the extendable tube 110 to deflect. In some embodiments, the number of drive wires 173 may be multiple, circumferentially spaced, and the direction of flexion of the wrist joint 172 may be adjusted by pushing, pulling, or cooperatively pushing and pulling the multiple drive wires 173 to achieve flexion of the extendable tube 110 (or 210, 310) in multiple degrees of freedom. Steering of the extendable tube 110 to accommodate complex curved lumens may be achieved by the steering guidance of the deflectable member 170. Thus, the extendable tube 110 may be extended distally, through the lumen, to a target location.

In some embodiments, the bendable extending tubular medical device 100 further includes a system controller (not shown) by which the distance of movement of the tube driving mechanism 120 and the pressure exerted by the fluid controller 130 within the fluid lumen 113(213 or 313) are controlled such that the bendable extending tubular medical device 100 can be controllably extended. In some embodiments, the system controller may control the fluid controller 130, for example, sending pressurization, depressurization instructions to the fluid controller 130. In some embodiments, as shown in fig. 6, the bendable unit 170 may be disposed in the channel 1111 (or 2111, 3111), the proximal portions of the driving wire 173 and the flexible tube 174 of the bendable unit 170 pass through the inner cavity of the moving rod 1243 of the tube driving mechanism 120, the driving wire 173 is connected to a wrist driving mechanism (not shown), and the wrist 172 of the bendable unit 170 is bent by the wrist driving mechanism, so that the extendable tube 110 (or 210, 310) can be bent to adapt to the complicated curved lumen.

In some embodiments, the system controller can also control the bending of the bendable member 170 in order to control the direction of extension of the bendable extending tubular medical instrument 100. In some embodiments, the medical instrument 171 may be disposed distal to the wrist joint 172 of the bendable member 170, and the medical instrument 171 may include an ultrasound probe, a drug capsule, or an end-effector, among others. The system controller may also control the medical instrument 171 to treat tissue at the lesion site, such as release radioactive particles, release drugs, capture or fragment lesion tissue, etc., as the extendable tube 110 (or 210, 310) approaches the lesion site.

Fig. 11 shows a schematic structural view of an interventional medical device system 1 according to some embodiments of the present disclosure. As shown in fig. 11, in some embodiments, the interventional medical device system 1 may include a bendable extending tubular medical device 100, a system processor 101 and an image acquisition device 102. In some embodiments, the image acquisition device 102 may include an endoscope, a fluoroscopic or contrast imaging device, or the like. The medical instrument 171 that is distal to the deflectable member 170 of the bendable elongate tubular medical instrument 100 may include, for example, an end surgical effector, an ultrasound probe, a stylet, and the like. The system processor 101 may be communicatively connected to the bendable extending tubular medical instrument 100 and the image acquisition device 102, respectively, such as by a cable 106 connection or a wireless connection. In some embodiments, as shown in fig. 11, the interventional medical device system 1 may further include a surgical cart 104 and a master cart 105. The bendable extending tubular medical instrument 100 may be disposed on a surgical trolley 104 (e.g., mounted on a robotic arm of the surgical trolley), and the system processor 101 may be disposed on a master trolley 105. In some embodiments, master trolley 105 may include a user interface, such as a master operator, a touch display screen, input buttons, foot pedal buttons, or the like. The system processor 101 may receive input commands from an operator through a user interface or receive instructions stored on a non-volatile storage medium.

Fig. 12 illustrates a flow diagram of a method 1200 for driving a bendable extending tubular medical instrument 100 according to some embodiments of the present disclosure. In some embodiments, the method 1200 may be performed by a system controller of the bendable extending tubular medical instrument 100, by the interventional medical instrument system 1 including the bendable extending tubular medical instrument 100, or by the system processor 101 of the interventional medical instrument system 1. In some embodiments, method 1200 may also be implemented as instructions stored on a non-volatile storage medium. The instructions may be executed to configure a general-purpose processor or a special-purpose processor to perform method 1200.

As shown in fig. 12, at step 1201, a captured image may be received. In some embodiments, the images may be acquired by an endoscope, an X-ray imaging device, a CT (computed tomography) device, or the like. In some embodiments, the images may be captured by a fluoroscopic camera or an endoscope disposed at the distal end of the bendable element 170. For example, the images may include still images, video, X-ray images, CT images, and the like. In some embodiments, the extendable tube 110 (or 210, 310) and the deflectable member 170 of the bendable elongate tubular medical device 100 enter the lumen of the patient 103. The image capturing device 102 located on the patient 103 side sends the captured intraluminal images to the system processor 101 in real time or at regular time, and the system processor 101 may receive the images captured by the image capturing device 102 (refer to fig. 11) in the lumen where the extendable tube 110 is located. The image acquisition device 102 may be a fluoroscopic camera 1021, and the fluoroscopic camera 1021 may include, for example, a CT machine, a Magnetic Resonance Imaging (MRI) machine, a B-ultrasonic machine, or the like. The fluoroscopic camera 1021 can acquire an intra-cavity image by performing fluoroscopy on a human body or an animal body with X-rays or the like. In some embodiments, the system processor 101 may display the acquired image on the display 107. For example, the display 107 may be a screen display or a glasses type image display. The system processor 101 may generate and send display control signals to the display 107 based on the received captured images and display the images on the display 107.

At step 1203, the received image may be processed. For example, the system processor 101 may generate an actual navigation path reflecting the shape of the lumen from the received image (e.g., X-ray image). For example, the actual navigation path may include a lumen path shape from a lumen access to a lesion site. As another example, the actual navigation path may include a lumen centerline of the extendable tube 110 from the current position to the lesion site. In some embodiments, the actual navigation path may be a preset path of the extendable tube in the lumen.

At step 1205, a tube control signal and a turn piece control signal may be generated. For example, the system processor 101 may generate and send a tube control signal and a turn control signal to the system controller according to the actual navigation path, and the system controller may control the movement of the extendable tube 110 (or 210, 310) and the turn 170, either cooperatively or individually, according to the received tube control signal and turn control signal. In some embodiments, the tube control signal may include a tube extension control signal, a tube withdrawal control signal, or a tube stop extension control signal, among others. The turn member control signal may include a turn member advance control signal, a turn member turn control signal, a turn member retract control signal, or a turn member stop motion control signal, etc.

In some embodiments, the system processor 101 may generate the tube extension control signal and the bend steering control signal from the actual navigation path. The system controller may cooperatively control the extension of the extendable tube 110 (or 210, 310) and the advancement of the flexible tube 174 of the bendable element 170 to steer the wrist joint 172 based on the received tube extension control signal and the bending element steering control signal. The tube extension control signals may include signals for controlling the tube drive mechanism, for controlling the advancement of the tube drive mechanism 120, and for controlling fluid controller pressurization, for controlling fluid controller 130 to pressurize within fluid lumen 113 to extend the extendable tube 110 distally. The bend steering control signals may include signals to control the hose drive mechanism for controlling the advancement of the hose drive mechanism and signals to control the wrist joint for controlling the steering of wrist joint 172. In some embodiments, the system controller may control the tube driving mechanism 120 to drive the inner layer 111 or the outer layer 112 of the extendable tube 110 (or 210, 310) to move distally by a length L in response to the received tube extension control signal, the inner layer 111 or the outer layer 112 everts or inverts by the length L in the invertible region 114 such that the fluid cavity 113 extends distally, and control the fluid controller 130 to pressurize (e.g., inject fluid) into the fluid tank 150 in response to a pressurization signal of the tube extension control signal, such that the fluid 140 fills the fluid cavity 113 of the extendable tube 110, thereby filling the fluid cavity 113 extending in the invertible region 114, thereby enabling extension of the extendable tube 110. In some embodiments, the system controller may cooperatively control the hose drive mechanism drive hose 174 to move a length N along the longitudinal axis of the lumen, and cooperatively control the wrist drive mechanism drive wrist 172 to flex an angle α, based on the received steering control signal for the flexure. Wherein the length N may be matched to the length L of movement of the extendable tube 110 to achieve a substantially equal length of movement of the extendable tube 110 and the deflectable member 170 relative to the longitudinal axis of the lumen. The angle α is turned to achieve steering of the bendable member 170 relative to the lumen, and avoid the risk of injury to the lumen due to an excessive offset distance between the wrist joint 172 and the longitudinal axis of the lumen. Thereby changing the moving direction of the extendable tube 110 by the bendable element 170 to realize the movement of the extendable tube 110 and the bendable element 170 along the path of the lumen. In some embodiments, the system controller may also control the amount of pressure exerted by the fluid controller 130 within the fluid chamber 113 in response to a pressurization signal of the tube extension control signal to maintain the pressure within the fluid chamber 113 within a predetermined range during extension of the extendable tube 110 so that the extendable tube 110 may be controllably extended. The preset range may be interpreted as a pressure range that allows the extendable pipe 110 to be normally extended, so as to prevent the extendable pipe 110 from being broken due to an excessive pressure in the fluid chamber 113 or prevent the extendable pipe 110 from being extended due to an insufficient pressure in the fluid chamber 113. In some embodiments, the system controller may independently control extension of the extendable tube 110 (or 210, 310) and advancement of the flexible tube 174 of the pliable component 170 and steering of the wrist joint 172, respectively, based on the received tube extension control signal and the bend steering control signal.

In some embodiments, the system processor 101 may generate the tube extension control signal and the turnaround control signal based on the actual navigation path. The system controller may cooperatively control the extension of the extendable tube 110 (or 210, 310) and the advancement of the bendable element 170 according to the received tube extension control signal and the bending element advancement control signal. The tube extension control signals may include signals for controlling the tube drive mechanism and signals for controlling the pressurization of the fluid controller. In some embodiments, the system controller may control the tube driving mechanism 120 to drive the inner layer 111 or the outer layer 112 of the extendable tube 110 to move distally by the length L based on the received tube extension control signal, and control the pressure exerted by the fluid controller 130 within the fluid chamber 113 based on the pressurization signal of the tube extension control signal, so as to maintain the pressure within the fluid chamber 113 within a preset range during extension of the extendable tube 110, such that the bendable extendable tubular medical instrument 100 may be controllably extended. The system controller may cooperatively control the hose drive mechanism to drive the hose 174 along the longitudinal axis of the lumen over a length P in response to the received turn-around advancement control signal. Wherein the length P may be matched to the length L of movement of the extendable tube 110 to achieve a substantially equal length of movement of the extendable tube 110 and the deflectable member 170 relative to the longitudinal axis of the lumen. In some embodiments, the system controller may independently control the extension of the extendable tube 110 (or 210, 310) and the advancement of the pliable component 170, respectively, in accordance with the received tube extension control signal and the bend advancement control signal.

In some embodiments, the system processor 101 may generate the tube retraction control signal and the bend retraction control signal according to the actual navigation path, for example when the extendable tube 110 (or 210, 310) is transferred from the current lumen to a different lumen or when the procedure is completed to prepare for retraction of the lumen. The system controller may cooperatively control the retraction of the extendable tube 110 (or 210, 310) and the deflectable member 170 based on the received tube retraction control signal and the deflectable member retraction control signal. In some embodiments, the tube withdrawal control signals may include a withdrawal signal, a reduced pressure signal, the tube withdrawal control signal for controlling withdrawal of the tube drive mechanism 120, and the reduced pressure signal of the tube withdrawal control signal for controlling the fluid controller 130 to reduce pressure from within the fluid cavity 113. In some embodiments, the system controller may control the tube driving mechanism 120 to drive the inner layer 111 or the outer layer 112 of the extendable tube 110 to move proximally by a length L ', based on the received tube withdrawal control signal, to invert or evert the outer layer 112 or the inner layer 111 by the length L' in the invertible region 114 such that the fluid lumen 113 is withdrawn proximally, and control the fluid controller 130 to decompress (e.g., withdraw fluid) based on the decompression signal of the tube withdrawal control signal, to reflow the fluid lumen 150 from the fluid lumen 113 of the extendable tube 110 with the fluid 140, thereby withdrawing the extendable tube 110 proximally. The system controller may cooperatively control the hose drive mechanism to drive the hose 174 to retract along the original path based on the received diverter retraction control signal. In some embodiments, the system controller may independently control the retraction of the flexible tube 174 or wrist joint 172 of the extendable tube 110 (or 210, 310) and deflectable member 170, respectively, in accordance with the received tube retraction control signal and the deflectable member retraction control signal.

In some embodiments, the system processor 101 may generate a tube stop extension control signal and a bend stop motion control signal based on the actual navigation path, for example, when the extendable tube 110 (or 210, 310) reaches the lesion location. The system controller may cooperatively control the extendable tube 110 (or 210, 310) to stop extending and the flexible tube 174 or wrist joint 172 of the deflectable member 170 to stop moving based on the received tube stop extension control signal and the deflectable member stop motion control signal. In some embodiments, the tube extension stop control signals may include a signal to control the tube drive mechanism to stop movement of the tube drive mechanism 120, and a signal to control the fluid controller to stop pressurizing or depressurizing, for controlling the fluid controller 130 to stop pressurizing or depressurizing the fluid chamber 113. In some embodiments, the system controller may control the tube driving mechanism 120 to stop driving the inner layer 111 or the outer layer 112 of the extendable tube 110 to move distally in response to the received tube stop extension control signal, and control the fluid controller 130 to maintain the pressure exerted within the fluid chamber 113 in response to the stop pressurization or depressurization signal of the tube stop extension control signal to keep the extendable tube 110 stopped at the target location. The system controller may cooperatively control the hose drive mechanism or the wrist drive mechanism to stop driving the hose 174 and the wrist 172 in response to the received bending member stop motion control signal so that the bendable member 170 stops at the target position. In some embodiments, the system controller may independently control the extendable pipe 110 (or 210, 310) to stop extending and the deflectable member 170 to stop moving, respectively, based on the received pipe stop extension control signal and the deflectable member stop motion control signal.

The system processor 101 generates an actual navigation path according to the intra-cavity image acquired by the fluoroscopic camera 1021, and continuously updates the movement path of the extendable tube 110 and the bendable piece 170 according to the actual navigation path, so as to realize real-time intra-cavity navigation.

In some embodiments, image acquisition device 102 may also be a contrast imaging device (not shown), which may include, for example, a B-mode ultrasound device, a CT device, an MRI device, a digital subtraction angiography device, and the like. The contrast imaging device is configured to contrast image the target location, such as by using a contrast agent. In operation, the radiography imaging apparatus illuminates a target area and obtains a radiography image of the target area, which may be similar to the fluoroscopic camera 1021.

It is noted that the foregoing is only illustrative of the embodiments of the present disclosure and the technical principles employed. Those skilled in the art will appreciate that the present disclosure is not limited to the specific embodiments illustrated herein and that various obvious changes, adaptations, and substitutions are possible, without departing from the scope of the present disclosure. Therefore, although the present disclosure has been described in greater detail with reference to the above embodiments, the present disclosure is not limited to the above embodiments, and may include other equivalent embodiments without departing from the spirit of the present disclosure, the scope of which is determined by the scope of the appended claims.

Claims

1. An interventional medical device system, comprising:

a bendable elongate tubular medical device comprising an elongate tube comprising an inner layer, an outer layer, and a fluid lumen therebetween for containing a fluid;

the extendable tube comprises an invertible region at a distal end, the inner layer and the outer layer being joined at the invertible region and being invertible; the radial sizes of the inner layer and the outer layer are respectively reduced in a step manner from the proximal end to the distal end;

a deflectable member disposed in a channel surrounded by an inner layer of the extendable tube, the deflectable member comprising a flexible tube and a wrist joint disposed at a distal end of the flexible tube;

the drive wire penetrates through the hose, the distal end of the drive wire is fixedly connected with the wrist joint, and the drive wire is used for driving the wrist joint to bend so as to drive the extensible pipe to bend;

a medical instrument disposed at a distal end of the wrist joint;

the image acquisition equipment is used for acquiring an image of the cavity where the extensible pipe is located; and

a processor configured to receive images acquired by the image acquisition device, process the received images, determine an actual navigation path, and generate a tube control signal and a flexure control signal based on the actual navigation path, the tube control signal for controlling the extendable tube to extend distally or withdraw proximally along the lumen, the flexure control signal for controlling the flexible tube to move distally or withdraw proximally along the lumen and for controlling the wrist to flex;

the bendable extension tubular medical instrument further comprising:

a tube drive mechanism coupled to the extendable tube for driving movement of the outer layer of the extendable tube;

a fluid controller for pressurizing or depressurizing the fluid to drive the fluid to gradually fill or withdraw from the fluid chamber of the invertible region;

the fluid box comprises an annular fluid outlet channel, at least one sealing ring is arranged in the fluid box, the periphery of the sealing ring is in sealing fit with the inner wall of the fluid box, the inner layer of the extensible pipe is in sealing connection with the inner side or the outer side of the inner annular wall of the fluid outlet channel, the outer layer of the extensible pipe penetrates through the fluid outlet channel and extends towards the proximal end of the fluid box and is in sealing connection with the sealing ring, the sealing ring is in fastening connection with a moving rod of the pipe driving mechanism through at least one connecting rod, and the pipe driving mechanism drives the moving rod to drive the sealing ring to linearly move so as to drive the extensible pipe to extend or retract.

2. The interventional medical instrument system of claim 1, the actual navigation path comprising a planned path generated based on the acquired images.

3. The interventional medical device system of claim 2, the planned path comprising a luminal path from the luminal access to a lesion or a luminal path from a current position of the extendable tube to a lesion.

4. The interventional medical device system of claim 2, the processor configured to:

in response to determining the actual navigation path, generating a tube extension control signal for controlling extension of the extendable tube and a diverter advancement control signal for controlling advancement of the flexible tube; or

In response to determining the actual navigation path, generating a tube extension control signal for controlling extension of the extendable tube and a bend steering control signal for controlling advancement of the flexible tube and steering movement of the wrist joint, respectively; or alternatively

In response to determining the actual navigation path, generating a tube withdrawal control signal for controlling withdrawal of the extendable tube and a bend withdrawal control signal for controlling withdrawal of the flexible tube; or alternatively

In response to determining the actual navigation path, generating a tube stop extension control signal for controlling the extendable tube to stop extending and a bend stop motion control signal for controlling the hose or wrist joint to stop moving, respectively.

5. The interventional medical device system of claim 1, wherein the outer layer is turned inwardly at the invertible regions or the inner layer is turned outwardly at the invertible regions.

6. The interventional medical device system of claim 1, wherein the fluid lumens are evenly distributed in a step-wise manner extending from the proximal end to the distal end.

7. The interventional medical instrument system of claim 1, wherein the medical instrument comprises an ultrasound probe, a stylet, a drug capsule, or an end-surgical effector;

the image acquisition device comprises an endoscope, a perspective camera or a radiographic imaging device.

8. The interventional medical device system of any one of claims 1-5, wherein the fluid is a liquid fluid or a gaseous fluid.

9. The interventional medical device system of any one of claims 1-5, wherein the extendable tube is made of a flexible material, the extendable tube having a circular or elliptical cross-section.