WO2023078168A1 - 一种医用光纤导向结构及导向方法 - Google Patents
一种医用光纤导向结构及导向方法 Download PDFInfo
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- WO2023078168A1 WO2023078168A1 PCT/CN2022/128191 CN2022128191W WO2023078168A1 WO 2023078168 A1 WO2023078168 A1 WO 2023078168A1 CN 2022128191 W CN2022128191 W CN 2022128191W WO 2023078168 A1 WO2023078168 A1 WO 2023078168A1
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- optical fiber
- guide tube
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Classifications
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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
- A61B18/00—Surgical instruments, devices or methods for transferring non-mechanical forms of energy to or from the body
- A61B18/18—Surgical instruments, devices or methods for transferring non-mechanical forms of energy to or from the body by applying electromagnetic radiation, e.g. microwaves
- A61B18/20—Surgical instruments, devices or methods for transferring non-mechanical forms of energy to or from the body by applying electromagnetic radiation, e.g. microwaves using laser
- A61B18/22—Surgical instruments, devices or methods for transferring non-mechanical forms of energy to or from the body by applying electromagnetic radiation, e.g. microwaves using laser the beam being directed along or through a flexible conduit, e.g. an optical fibre; Couplings or hand-pieces therefor
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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
- A61B18/00—Surgical instruments, devices or methods for transferring non-mechanical forms of energy to or from the body
- A61B2018/00571—Surgical instruments, devices or methods for transferring non-mechanical forms of energy to or from the body for achieving a particular surgical effect
- A61B2018/00577—Ablation
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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
- A61B18/00—Surgical instruments, devices or methods for transferring non-mechanical forms of energy to or from the body
- A61B18/18—Surgical instruments, devices or methods for transferring non-mechanical forms of energy to or from the body by applying electromagnetic radiation, e.g. microwaves
- A61B18/20—Surgical instruments, devices or methods for transferring non-mechanical forms of energy to or from the body by applying electromagnetic radiation, e.g. microwaves using laser
- A61B18/22—Surgical instruments, devices or methods for transferring non-mechanical forms of energy to or from the body by applying electromagnetic radiation, e.g. microwaves using laser the beam being directed along or through a flexible conduit, e.g. an optical fibre; Couplings or hand-pieces therefor
- A61B2018/2205—Characteristics of fibres
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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
- A61B18/00—Surgical instruments, devices or methods for transferring non-mechanical forms of energy to or from the body
- A61B18/18—Surgical instruments, devices or methods for transferring non-mechanical forms of energy to or from the body by applying electromagnetic radiation, e.g. microwaves
- A61B18/20—Surgical instruments, devices or methods for transferring non-mechanical forms of energy to or from the body by applying electromagnetic radiation, e.g. microwaves using laser
- A61B18/22—Surgical instruments, devices or methods for transferring non-mechanical forms of energy to or from the body by applying electromagnetic radiation, e.g. microwaves using laser the beam being directed along or through a flexible conduit, e.g. an optical fibre; Couplings or hand-pieces therefor
- A61B2018/2205—Characteristics of fibres
- A61B2018/2222—Fibre material or composition
Definitions
- the invention relates to the technical field of medical devices, in particular to a medical optical fiber guiding structure and guiding method.
- laser ablation As a new technology, compared with traditional treatment methods, laser ablation has the advantages of precise and controllable ablation range, little damage to normal structures around the lesion, small surgical trauma, short operation time, and fast postoperative recovery. There is hope for patients with lesions located deep in the brain who cannot tolerate conventional craniotomy.
- the ablation catheter used to transmit laser energy to achieve tissue damage restricts the internal optical fiber to a straight surgical channel. Due to the influence of the microenvironment, the plan of the non-linear surgical channel is what the surgical operator wants.
- the treatment strategy of "curve to save the country" for better conformal ablation and global ablation, avoiding important brain tissues .
- the medical optical fiber installed inside it can only realize tissue ablation in a linear channel and a limited area, that is, it can only ablate the lesion tissue in the axial direction of the linear channel and in a limited area nearby. For ablation of larger lesions, multiple linear ablation channels need to be considered.
- sampling before ablation is required, sampling must be performed before the ablation catheter is inserted; if sampling is required after ablation, sampling must be performed after the ablation catheter is pulled out, and the operation is difficult.
- the risk of injury and infection to the patient is also extremely high.
- the embodiment of the present invention aims to provide a medical optical fiber guiding structure and guiding method to solve the problem that the existing optical fiber can only pass through the lesions in the limited area around it in the straight ablation channel established by the ablation catheter.
- the problem of tissue ablation has achieved the therapeutic purpose of "curve to save the country”.
- the present invention provides a medical optical fiber guiding structure, which includes an optical fiber guiding tube, and the optical fiber guiding tube includes a first tube section and a second tube section;
- the first pipe section has a lumen extending in the axial direction
- the second tube section has an opening communicating with the lumen
- An extension direction in which the opening communicates with the lumen and an extension direction of the lumen form a set angle, and the set angle is an obtuse angle.
- a medical optical fiber is detachably connected in the fiber guide tube;
- the medical optical fiber can pass through the opening for guiding bending.
- first pipe section is the straight pipe part of the fiber guide tube
- second pipe section is the bent part of the fiber guide tube; the medical optical fiber passes through the bent part to realize guiding and bending.
- it also includes a guide tube base, a fixing cover and a skull nail, one end of the guide tube base is arranged in the end of the skull nail, and the other end is screwed to the fixing cover.
- a sealing plug is also included, and the sealing plug is arranged in the through hole where the guide tube base is connected with the fixed cover.
- the guide tube base includes a first threaded part and an optical axis part, the first threaded part and the optical axis part are respectively located at both ends of the guide tube base, and the first threaded part is provided with external threads.
- the center of the guide tube base is provided with a coaxial and communicating first through hole, a second through hole and a third through hole, the first through hole and the second through hole are respectively located in the guide tube
- the two ends of the base and the rear end of the fiber guide tube are arranged in the second through hole.
- the diameter of the second through hole is smaller than the diameter of the first through hole and larger than the diameter of the third through hole; the diameter of the third through hole is larger than the diameter of the medical optical fiber, the The diameter of the second through hole is equal to the outer diameter of the fiber guide tube.
- the center of the fixed cover is provided with a coaxial and communicating threaded hole and a fourth through hole, the diameter of the fourth through hole is greater than or equal to the diameter of the medical optical fiber, and the first threaded part is arranged on the inside the threaded hole.
- the sealing plug is arranged in the first through hole, the outer wall of the sealing plug is attached to the inner wall of the first through hole, and the central hole of the sealing plug is sleeved with the medical optical fiber and is in contact with the first through hole.
- the outer wall of the medical optical fiber is bonded.
- the skull nail includes a first connecting part, a second connecting part and a second threaded part connected in sequence, the first connecting part is connected to the optical axis part, and the second threaded part is provided with an external thread , and connected to the skull.
- the present invention provides a medical optical fiber guiding method, using the above-mentioned medical optical fiber guiding structure, the steps include:
- Step 1 Fix the cranial nail to the skull
- Step 2 Insert the medical optical fiber into the optical fiber guide tube. At this time, the front end of the medical optical fiber does not exceed the bending part of the optical fiber guide tube; one end of the guide tube base is connected to the optical fiber guide tube, and the other end is installed with a sealing plug and the fixed cover is tightened;
- Step 3 Insert the fiber optic guide tube to the designated position through the skull nail;
- Step 4 Loosen the fixed cover and pull the medical fiber backward so that the front end of the medical fiber does not exceed the bending part, rotate the base of the guide tube to adjust the direction of the bend, and then extend the medical fiber out of the fiber guide tube, and the other The area is ablated.
- the present invention can achieve at least one of the following beneficial effects:
- the front end of the optical fiber guide tube of the present invention is a curved part, and the front end of the curved part is provided with an arc-shaped incision.
- the important tissue of the target lesion area can be conformally ablated without re-planning a new channel, which improves the efficiency of the operation.
- the front end of the optical fiber guide tube of the present invention presents a sharp arc edge, which can easily penetrate through the brain tissue.
- the projection of the entire curved part towards the straight tube part is located in the cross section of the straight tube part, so only It is necessary to open a small circular hole in the skull, and through the guidance and positioning of the skull nail, the guide tube can be extended into the brain.
- only a cylindrical channel is established in the brain, and it will not pull the tissue when it is pulled out. Injury, achieve minimally invasive treatment.
- the present invention realizes the self-bending deformation of the medical optical fiber through the optical fiber guide tube, which can avoid important areas that are not suitable for puncture; by adjusting the opening orientation of the optical fiber guide tube, the range of the ablation area can be further expanded, and the originally required The ablation can only be completed by opening two or more channels, which improves the efficiency.
- the present invention cooperates with different medical optical fibers, such as side-firing optical fibers, and by changing the opening orientation of the optical fiber guide tube, it can more conveniently match lesions of different shapes, complete conformal ablation, and realize multi-regional ablation in the same channel .
- the limiting portion of the present invention is provided with a scale line, and the skull nail is provided with a marking line.
- the rotation angle of the optical fiber guide tube can be quantitatively changed to ablate other areas, expanding the ablation area without The operation path is re-planned to improve the operation efficiency; at the same time, by loosening the fixed cover, the medical optical fiber can be advanced or retreated along the axial direction of the optical fiber guide tube, and the ablation area can be expanded.
- the optical fiber guide tube of the present invention is not only suitable for optical fiber ablation surgery, but also can be used with a soft tube sampling needle to realize bending sampling or suction of damaged tissue after ablation.
- the materials used in parts of the present invention are all made of nuclear magnetic compatible materials, such as glass, polytetrafluoroethylene or PC (Polycarbonate, polycarbonate), etc., which can be carried out in MR (Magnetic Resonance, magnetic resonance) Operations, whether it is ablation surgery or residual sampling, can be performed under MR scanning, and the surgical process can be monitored in real time, which is safer.
- nuclear magnetic compatible materials such as glass, polytetrafluoroethylene or PC (Polycarbonate, polycarbonate), etc.
- the guide structure of the present invention can not only realize laser ablation operation, but also realize sampling operation according to the different appliances (such as medical optical fiber, sampling needle or sampler) used inside; the sampling and laser ablation can be reasonably arranged according to actual needs Sequence, as well as the sampling devices used, do not need to establish additional sampling channels in the brain, and do not need to replace the guide structure with other auxiliary devices, which expands the range of use of the device, improves surgical efficiency, and reduces damage to patients and infection risk.
- the different appliances such as medical optical fiber, sampling needle or sampler
- the front end of the optical fiber guide tube of the present invention is a curved portion with a lateral opening, and the medical optical fiber can pass through the lateral opening of the curved portion, which is more flexible in puncturing angle and puncturing direction.
- it increases the flexibility and diversity of path options to avoid important tissues, and on the other hand, it also provides an ablation solution that can realize large lesion tissue from a single channel, which not only improves the efficiency of the operation, but also greatly improves the operation efficiency. It can be said that the minimally invasive and effective treatment of "overtaking on a curve" has been realized.
- Fig. 1 is the structural representation of the optical fiber guiding tube of specific embodiment
- Fig. 2 is the cross-sectional view of the fiber guide tube of the specific embodiment
- Fig. 3 is a schematic diagram (1) of the state of the medical optical fiber passing through the bending part of the specific embodiment
- Fig. 4 is the structural representation (1) of the medical optical fiber guiding structure of specific embodiment
- Fig. 5 is the structural representation (two) of the medical optical fiber guiding structure of specific embodiment
- Fig. 6 is a schematic view of the structure of the guide tube base of a specific embodiment (1);
- Fig. 7 is a schematic structural view of a fixed cover of a specific embodiment
- Fig. 8 is a structural schematic diagram of a skull nail in a specific embodiment
- Fig. 9 is a schematic diagram of multiple ablation regions obtained by changing the extension length of the medical optical fiber in a specific embodiment
- Fig. 10 is a structural schematic diagram (3) of the medical optical fiber guiding structure of a specific embodiment
- Fig. 11 is a schematic view of the structure of the guide tube base of a specific embodiment (2);
- Fig. 12 is the structural representation (four) of the medical optical fiber guiding structure of specific embodiment
- Fig. 13 is a sectional view (1) of the medical optical fiber guiding structure of a specific embodiment
- Fig. 14 is a partial structural exploded view of the medical optical fiber guiding structure of a specific embodiment
- Fig. 15 is a schematic diagram of the state where the 0 scale of the guide tube base is aligned with the marking line of the skull nail in a specific embodiment
- Fig. 16 is a schematic diagram of the state where the scale of the guide tube base 60 of the specific embodiment is aligned with the marking line of the skull nail;
- Fig. 17 is a schematic diagram of the ablation in the state where the mark on the light-emitting side of the medical optical fiber corresponds to the 0 scale of the specific embodiment
- Fig. 18 is a schematic diagram of ablation in a state in which the mark on the light-emitting side of the medical optical fiber does not correspond to the 0 scale of the specific embodiment
- Fig. 19 is a schematic cross-sectional view (1) of an optical fiber guide tube of a specific embodiment
- Fig. 20 is a cross-sectional schematic view (2) of an optical fiber guide tube of a specific embodiment
- Fig. 21 is a schematic cross-sectional view of an optical fiber guide tube of a specific embodiment (3)
- Fig. 22 is a cross-sectional schematic view (four) of an optical fiber guide tube of a specific embodiment
- Fig. 23 is a cross-sectional schematic view (five) of an optical fiber guide tube of a specific embodiment
- Fig. 24 is a schematic cross-sectional view of an optical fiber guide tube of a specific embodiment (6);
- Fig. 25 is a cross-sectional schematic view (7) of an optical fiber guide tube of a specific embodiment
- Fig. 26 is a cross-sectional schematic view (eight) of an optical fiber guide tube of a specific embodiment
- Fig. 27 is a sectional view (2) of the medical optical fiber guiding structure of a specific embodiment
- Fig. 28 is a schematic diagram (2) of the state of the medical optical fiber passing through the bending part of the specific embodiment
- Fig. 29 is a schematic structural view of a lateral sampling needle in a specific embodiment
- Fig. 30 is a schematic structural view of the lateral sampling needle in the specific embodiment located in the fiber guide tube;
- Figure 31 is a schematic diagram of sampling with a lateral sampling needle in a specific embodiment
- Fig. 32 is a schematic diagram of the state in which the end surface sampling needle of the specific embodiment is extended out of the fiber guide tube;
- Fig. 33 is a schematic diagram of sampler sampling in a specific embodiment.
- 1-fiber guide tube 11-curved part; 111-arc incision; 12-straight tube part; 13-reflective film; 14-lens structure; 15-opening; Guide tube base; 21-first threaded part; 211-first through hole; 22-optical axis part; 221-second through hole; 23-limiting part; 231-third through hole; 3-fixed cover; 31-threaded hole; 32-fourth through hole; 4-skull nail; 41-first connecting part; 411-fifth through hole; 412-marking line; 42-second connecting part; 421-sixth through hole; 43-second threaded part; 5-sealing plug; 6-sheath locking screw;
- 100-medical optical fiber 101-light-emitting side mark; 200-skull; 300-target lesion area; 301-first ablation area; 302-second ablation area; 400-obstacle; 500-lateral sampling needle; 501-side Sampling port; 502-inclined surface; 600-tissue to be removed; 700-end face incision sampling needle; 701-end face sampling port; 800-sampler.
- connection should be understood in a broad sense, for example, it can be a fixed connection, a detachable connection, or an integral connection , can be mechanically connected, can also be electrically connected, can be directly connected, and can also be indirectly connected through an intermediary.
- connection should be understood in a broad sense, for example, it can be a fixed connection, a detachable connection, or an integral connection , can be mechanically connected, can also be electrically connected, can be directly connected, and can also be indirectly connected through an intermediary.
- top, bottom, above, bottom and “on” are used throughout the description to refer to relative positions of components of the device, such as top and bottom substrates inside the device relative position. It will be appreciated that the devices are multifunctional independent of their orientation in space.
- a specific embodiment of the present invention discloses a kind of medical optical fiber guiding structure, comprises optical fiber guiding tube 1, and medical optical fiber 100 is arranged in described optical fiber guiding tube 1, and described optical fiber guiding tube 1 includes a curved part 11 and a straight tube part 12, the curved part 11 is located at the front end of the straight tube part 12, the front end of the curved part 11 is provided with an incision, preferably, the incision is an arc-shaped incision 111, the medical optical fiber 100 It can pass through the straight tube part 12 and the curved part 11 in sequence, and pass through the arc-shaped incision 111 to realize the guiding and bending of the medical optical fiber 100 .
- the optical fiber guide tube 1 is made of a transparent material, it is preferably an optically transparent material.
- the medical optical fiber 100 can realize laser ablation in the straight tube part 12 , or can realize laser ablation after passing through the curved part 11 . That is to say, during ablation, the laser light path can only pass through the medical optical fiber 100 to achieve damage to the lesion, or can realize laser ablation through the medical optical fiber 100 and the straight tube portion 12 .
- the front end of the optical fiber guide tube is a curved part, and the front end of the curved part is provided with an arc-shaped cutout, and the medical optical fiber will pass through the curved part when passing through the optical fiber guide tube.
- the bending can be realized under the action of the channel, which can avoid the important tissue on the channel, and then can conformally ablate the target lesion area 300 without re-planning a new channel, which improves the efficiency of the operation.
- the front end of the optical fiber guide tube 1 is a curved portion 11 with a lateral opening, and the medical optical fiber 100 can pass through the lateral opening of the curved portion 11, and the puncture angle and direction are more precise. flexibility.
- the projection of the curved portion 11 toward the straight pipe portion 12 is located in the cross section of the straight pipe portion 12 (the interface perpendicular to the axis of the fiber guide tube 1), that is, the outer contour of the curved portion 11 along the axial direction of the straight pipe portion 12 does not exceed the straight pipe portion 12. Axial outer contour of the tube part 12 .
- the front end of the fiber guide tube 1 presents a sharp arc edge, which can easily penetrate through the brain tissue, and at the same time, the entire curved part is also in a circle defined by the outer contour of the straight tube part 12, so only It is necessary to open a small circular hole in the skull, and through the guidance and positioning of the skull nail, the optical fiber guide tube 1 can be extended into the brain. At the same time, only a cylindrical channel is established in the brain without damaging other tissues. It will not cause damage to the tissue by hooking and pulling, and realizes minimally invasive treatment.
- the fiber guide tube 1 is bent at the head end, and this structure can go deep into the brain through the through hole on the skull nail 4 for guiding. At the same time, the medical optical fiber 100 can be guided through the bending structure at the front end.
- the angle between the curved portion 11 and the straight pipe portion 12 should not be too small to avoid breaking the medical optical fiber 100.
- the arrangement of the curved portion 11 and the straight pipe portion 12 is preferably as follows: When the medical optical fiber 100 protrudes from the bending portion 11 for a certain distance, the angle A between the axis of the unbent portion of the medical optical fiber 100 and the axis of the bending portion of the medical optical fiber 100 is between 140° ⁇ 170°.
- the medical optical fiber guiding structure also includes a guide tube base 2, a fixed cover 3, a skull nail 4 and a sealing plug 5, and one end of the guide tube base 2 is located at the end of the skull nail 4. In the through hole, the other end is threadedly connected with the fixed cover 3 , and the sealing plug 5 is arranged in the end of the guide tube base 2 .
- the guide tube base 2 is a structure of revolution, including a first threaded part 21 and an optical axis part 22, the first threaded part 21 and the optical axis part 22 are respectively located at ends.
- the first threaded portion 21 is provided with external threads.
- the center of the first threaded part 21 is provided with a first through hole 211
- the center of the optical axis part 22 is provided with a second through hole 221
- the first through hole 211 and the second through hole 221 communicate
- the The diameter of the first through hole 211 is greater than the diameter of the second through hole 221
- the diameter of the second through hole 221 is equal to the outer diameter of the fiber guide tube 1 .
- the end of the straight tube portion 12 of the fiber guide tube 1 is disposed in the second through hole 221 .
- the first through hole 211 is coaxial with the second through hole 221 .
- the guide tube base 2 is also provided with a third through hole 231 located between the first through hole 211 and the second through hole 221, the third through hole 231 communicates with the first through hole 211 and the second through hole 221, and the diameter of the third through hole 231 is smaller than the diameter of the second through hole 221, and the diameter of the third through hole 231 is slightly larger than the medical
- the diameter of the optical fiber 100 is such that the medical optical fiber 100 can pass through smoothly.
- the third through hole 231 is coaxial with the second through hole 221 .
- the fixed cover 3 is a revolving structure, and is provided with a threaded hole 31 and a fourth through hole 32 , and the threaded hole 31 and the fourth through hole 32 are connected and coaxial.
- the diameter of the fourth through hole 32 is larger than the diameter of the medical optical fiber 100 and smaller than the diameter of the threaded hole 31 .
- the first threaded portion 21 is disposed in the threaded hole 31 .
- the sealing plug 5 is a cylindrical structure, the sealing plug 5 is arranged in the first through hole 211, the outer diameter of the sealing plug 5 is the same as the diameter of the first through hole 211, and the center of the sealing plug 5
- the hole diameter is equal to the diameter of the medical optical fiber 100 .
- the length of the sealing plug 5 is greater than the length of the first through hole 211 , preferably, the length of the sealing plug 5 is 1.3 ⁇ 1.4 times the length of the first through hole 211 .
- the medical optical fiber 100 passes through the fourth through hole 32, the central hole of the sealing plug 5 arranged in the first through hole 211 and the third through hole 231 in sequence, and then enters the second through hole 231.
- the fiber guide tube 1 in the through hole 221 passes through the front end of the fiber guide tube 1 .
- the sealing plug 5 is set in the first through hole 211 for guiding and limiting the medical optical fiber 100.
- the central hole of the sealing plug 5 is an interference fit with the medical optical fiber 100, and the sealing plug 5
- the outer diameter of the first through hole 211 is an interference fit, so that the medical optical fiber 100 can be firmly arranged in the guide tube base 2 .
- the fixing cover 3 is screwed to the first threaded part 21, the medical optical fiber 100 is firmly connected with the guide tube base 2, and the movement of the medical optical fiber 100 in the axial direction and the rotation around its own axis are restricted.
- the skull nail 4 is a structure of revolution, including a first connecting portion 41, a second connecting portion 42 and a second threaded portion 43, the first connecting portion 41, the second connecting portion 42 and the second The two threaded parts 43 are connected in sequence.
- the first connecting portion 41 is connected to the optical axis portion 22 of the guide tube base 2
- the second threaded portion 43 is provided with external threads and connected to the skull 200 .
- the first connecting portion 41 is provided with a fifth through hole 411, the diameter of the fifth through hole 411 is equal to the outer diameter of the optical axis portion 22, and the length of the fifth through hole 411 is greater than the length of the optical axis portion 22, so that The guide tube base 2 has a sufficient moving distance in the axial direction of the fifth through hole 411 .
- the second connecting portion 42 is provided with a sixth through hole 421, the sixth through hole 421 communicates with the fifth through hole 411 and is coaxial, the sixth through hole 421 passes through the second threaded portion 43, and its diameter is equal to that of the optical fiber The outer diameter of the guide tube 1.
- the optical fiber guide tube 1 is installed on the guide tube base 2, and the guide tube base 2 is used to fix the optical fiber guide tube 1 and the medical optical fiber 100, through the sealing plug 5 and the fixed cover 3 cooperate to complete the relative fixing of the medical optical fiber 100.
- the guide tube base 2 cooperates with the skull nail 4 to complete the fixation of the optical fiber guide tube 1 .
- the skull nail 4 is fixed on the skull 200 to establish a guiding channel and fix the optical fiber guide tube 1 .
- the medical optical fiber 100 can be a bare optical fiber, or an optical fiber conduit structure with a cooling system or an optical fiber conduit structure without a cooling system. Both the optical fiber conduit with a cooling system and the optical fiber conduit structure without a cooling system are in the prior art, and are not described here. Do repeat.
- the medical optical fiber 100 can also realize laser ablation in the straight tube portion 12 .
- FIG. 1-Fig. 2 discloses a kind of medical optical fiber guiding structure, comprises optical fiber guiding tube 1, and described optical fiber guiding tube 1 is a slender tube, and medical optical fiber 100 is arranged on In the fiber guide tube 1 , the front end of the fiber guide tube 1 is a bending portion 11 , and the medical optical fiber 100 passes through the bending portion 11 to realize the guiding and bending of the medical optical fiber 100 .
- the front end of the optical fiber guiding tube is a curved part.
- the important tissue can be ablated conformally to the target lesion area 300, which improves the efficiency of the operation.
- the fiber optic guide tube 1 is bent at the front end, so that it can pass through the central hole of the skull nail 4 for guidance and go deep into the brain.
- the medical optical fiber 100 can also be guided through the bending structure at the front end.
- the front end of the bending part 11 is provided with an arc-shaped cutout 111 , and the medical optical fiber 100 passes through the arc-shaped cutout 111 of the bending part 11 to realize the guiding and bending of the medical optical fiber 100 .
- the medical optical fiber guiding structure also includes a guide tube base 2, a fixed cover 3, a skull nail 4 and a sealing plug 5, and one end of the guide tube base 2 is connected to one end of the skull nail 4, so that The other end of the skull nail 4 is connected to the skull 200 , the sealing plug 5 is arranged in the other end of the guide tube base 2 , and the other end of the guide tube base 2 is connected to the fixed cover 3 outside.
- the guide tube base 2 is a rotary body structure, including a first threaded part 21, an optical axis part 22 and a limiting part 23, and the first threaded part 21 and the optical axis part 22 are respectively located on the Both ends of the guide tube base 2 , the limiting portion 23 is located between the first threaded portion 21 and the optical axis portion 22 .
- the first threaded portion 21 is provided with an external thread, and the outer diameters of the first threaded portion 21 and the optical axis portion 22 are both smaller than the outer diameter of the limiting portion 23 .
- a scale line is provided on the outer cylindrical surface of the limiting portion 23 , and the scale line equally divides the circumferential angle and is set close to the optical axis portion 22 .
- the center of the guide tube base 2 is provided with a first through hole 211, a second through hole 221 and a third through hole 231, and the first through hole 211 and the second through hole 221 are located at the center of the guide tube base 2 respectively. At both ends, the first through hole 211 , the second through hole 221 and the third through hole 231 communicate and are coaxial.
- the diameter of the second through hole 221 is smaller than the diameter of the first through hole 211 and larger than the diameter of the third through hole 231 , and the diameter of the second through hole 221 is equal to the outer diameter of the fiber guide tube 1 .
- the rear end of the fiber guide tube 1 is disposed in the second through hole 221 .
- the diameter of the third through hole 231 is slightly larger than the diameter of the medical optical fiber 100 so that the medical optical fiber 100 can pass through smoothly.
- the fixing cover 3 is provided with a threaded hole 31 and a fourth through hole 32 , and the threaded hole 31 and the fourth through hole 32 are connected and coaxial.
- the diameter of the fourth through hole 32 is equal to the diameter of the medical optical fiber 100 and smaller than the diameter of the threaded hole 31 .
- the first threaded portion 21 is disposed in the threaded hole 31 .
- the sealing plug 5 is a cylindrical elastic member disposed in the first through hole 211 .
- the outer diameter of the sealing plug 5 is slightly larger than the diameter of the first through hole 211, and the diameter of the central hole of the sealing plug 5 is slightly smaller than the diameter of the medical optical fiber 100, so that the medical optical fiber 100 and the guide tube base connected by the sealing plug 5 2 solid and reliable.
- the length of the sealing plug 5 is greater than the length of the first through hole 211 , preferably, the length of the sealing plug 5 is 1.3 ⁇ 1.4 times the length of the first through hole 211 .
- the sealing plug 5 is set in the first through hole 211 for guiding and limiting the medical optical fiber 100. Since the sealing plug 5 is elastic, its outer diameter is slightly larger than the first through hole 211, and its inner diameter is slightly smaller than the medical optical fiber 100. The outer diameter of the medical optical fiber 100 can be stably arranged in the guide tube base 2 . In addition, after the fixing cover 3 is screwed onto the first threaded part 21 , the medical optical fiber 100 is firmly connected to the guide tube base 2 , and the movement of the medical optical fiber 100 in the axial direction and the rotation around its own axis are restricted.
- the skull nail 4 includes a first connecting portion 41 , a second connecting portion 42 and a second threaded portion 43 connected in sequence.
- the first connecting portion 41 is connected to the optical axis portion 22 of the guide tube base 2
- the second threaded portion 43 is provided with external threads and connected to the skull 200 .
- the center of the skull nail 4 is provided with a coaxial and communicating fifth through hole 411 and a sixth through hole 421, the fifth through hole 411 is located at the end of the first connecting part 41, and the diameter of the fifth through hole 411 is equal to
- the outer diameter of the optical axis portion 22 and the length of the fifth through hole 411 are greater than the length of the optical axis portion 22 , so that the guide tube base 2 has a sufficient moving distance in the axial direction of the fifth through hole 411 .
- the sixth through hole 421 passes through the second threaded portion 43 and has a diameter equal to the outer diameter of the fiber guide tube 1 .
- the medical optical fiber 100 passes through the fourth through hole 32 , the central hole of the sealing plug 5 and the third through hole 231 sequentially, and then enters the fiber guide tube 1 disposed in the second through hole 221 .
- the optical fiber guide tube 1 passes through the fifth through hole 411 and the sixth through hole 421, and then passes through the end of the second threaded part 43 to go deep into the brain, and the medical optical fiber 100 can pass through the fiber guide tube 1
- the bending part 11 is pierced for laser ablation operation.
- the medical optical fiber guide structure also includes a sheath locking screw 6, and the axis of the sheath locking screw 6 is aligned with the optical fiber guide tube 1.
- the axis of the shaft is vertical, and the sheath locking screw 6 can pass through the through hole arranged radially along the first connecting portion 41 and press against the outer wall of the optical shaft portion 22 .
- a marking line 412 is provided on the cylindrical surface of the first connecting portion 41, and the marking line 412 is parallel to the axis of the skull nail 4 and set near the end of the first connecting portion 41, so as to determine the guide tube The angle at which the base 2 rotates relative to the skull nail 4 . Since the skull nail 4 is fixedly connected to the skull 200 through threads, one end of the medical optical fiber 100 and the guide tube base 2 is tightly connected through a sealing plug 5, and the other end of the optical fiber guide tube 1 and the guide tube base 2 Due to the tight fit, the rotation of the guide tube base 2 can change the direction of the arc-shaped incision 111 of the medical optical fiber 100 , so that the target lesion area 300 can be conformally ablated.
- the scale line of the limiting part 23 is provided with a 0 mark point (ie: 0 scale), and the scale line corresponding to the 0 mark point is aligned with the mark line 412.
- the structure is the starting position of the medical fiber optic guiding structure.
- the optical fiber guide tube 1 is installed on the guide tube base 2, and the guide tube base 2 is used to fix the optical fiber guide tube 1 and the medical optical fiber 100, through the sealing plug 5 and the fixed cover 3 cooperate to complete the relative fixing of the medical optical fiber 100.
- the guide tube base 2 cooperates with the skull nail 4 and the sheath locking screw 6 to complete the fixing and guiding structure of the medical optical fiber 100 .
- the skull nail 4 is fixed on the skull 200 to establish a guiding channel and fix the optical fiber guide tube 1 .
- the position and direction of the optical fiber guide tube 1 can be judged by the marking line 412 on the skull nail 4 and the angle scale line on the guide tube base 2 .
- the first area is ablated.
- the medical optical fiber 100 is pulled back by unscrewing the fixing cover 3 so that the front end of the medical optical fiber 100 does not exceed the bending part 11.
- the sheath locking screw 6 rotate the guide tube base 2 to adjust the orientation of the arc-shaped incision 111, and then tighten the sheath locking screw 6, at this time the outlet bending position of the fiber guide tube 1 has been Changes occur, so that the medical optical fiber 100 is extended out of the optical fiber guide tube 1 to ablate the second area.
- the ablation area can be expanded not only in the axial direction where the medical optical fiber 100 protrudes, but also in the radial direction of the guide tube 1 .
- the first area is ablated at 0 scale
- the optical fiber is retracted by loosening the fixing cover 3
- the sheath locking screw 6 is loosened, and the base of the guide tube is rotated 2 to 60 scale, and then tighten the sheath locking screw 6.
- the bending direction of the exit of the fiber guide tube 1 has changed, so that the medical optical fiber 100 can be extended out of the fiber guide tube 1, and the second area can be ablated. Or keep the medical optical fiber 100 still, and directly rotate the guide tube base 2 to 60 scales after loosening the sheath locking screw 6 .
- the medical optical fiber 100 is a medical optical fiber that can emit light from the side (that is, a side-firing optical fiber).
- the medical optical fiber 100 has a light exit side mark 101 to mark the direction of the light exit.
- the ablation area can be further controlled.
- the position and size are easier to conformal ablation.
- Other structures and beneficial effects are the same as those in Embodiment 2, and will not be repeated here.
- the medical optical fiber guiding structure has a certain degree of light transmission and can transmit light paths.
- the front end of the optical fiber guide tube 1 is provided with an optical path adjustment component, and the optical path adjustment component is arranged on the front end side wall of the straight tube part of the optical fiber guide tube 1.
- the optical path adjustment component can change the optical path of the laser light emitted by the medical optical fiber 100 located in the optical fiber guide tube 1 to ablate the target lesion area 300 .
- the optical path adjustment component includes a reflective film 13 and a lens structure 14, the reflective film 13 is used to direct the light emitted by the medical optical fiber 100 to the direction of the target lesion area 300, so as to achieve unidirectional emission; the reflective film 13 and the lens structure 14 can adapt to more tumors of different shapes.
- the lens structure 14 can change the size and/or shape of the ablation zone. Because of the increase of the lens structure 14, the original circular ablation area is transformed into a specific shape ablation area (as shown in Fig. 22 and Fig. 26 ), and more irregular tumors can be adapted.
- the lens structure 14 is located on the fiber guide tube 1. Understandably, the lens structure 14 can be arranged on the inner wall of the fiber guide tube 1 as a separate component, for example, the lens structure 14 is pasted on the inner wall of the fiber guide tube 1, It can also be used as a part of the fiber guide tube 1 .
- the lens structure 14 and the fiber guide tube 1 are integrally structured.
- the lens structure 14 can also be made on the side wall of the fiber guide tube 1 , and the lens structure 14 is embedded in the groove provided on the side wall of the fiber guide tube 1 .
- the lens structure 14 can be a converging lens or a diverging mirror, wherein the concentrating lens is preferably a convex lens, and the diverging mirror is preferably a concave lens.
- the laser light emitted by the medical optical fiber 100 diverges in the circumferential direction, and becomes parallel light after passing through the convex lens, which can locally highlight and/or deepen the focus on the target lesion area 300 where the lens structure 14 is located. ablation.
- the laser light emitted by the medical optical fiber 100 diverges in the circumferential direction, and becomes more divergent after passing through the concave lens, which expands the coverage of the light emitted by the lens structure 14 and enhances the ablation effect.
- the sheath structure provided in this embodiment is provided with a lens structure 14 on the optical fiber guide tube 1.
- the medical optical fiber 100 is used for ablation surgery, the medical optical fiber is changed through the lens structure 14 arranged on the optical fiber guide tube 1. 100 laser paths, so the ablation of tumors with irregular shapes becomes more flexible and easy to operate.
- the reflective film 13 and the lens structure 14 are arranged oppositely, and are respectively located on two sides of the medical optical fiber 100 .
- the lens structure 14 is a convex lens, and the laser light emitted circumferentially by the medical optical fiber 100 is returned to the convex lens in parallel when it encounters the reflective film 13 and then focused, and the medical optical fiber 100 directly passes through the convex lens
- the formed parallel light beam can enhance the ablation of a certain area of the target lesion area 300 .
- the lens structure 14 is a concave lens, and the laser light emitted in the circumferential direction of the medical optical fiber 100 is returned to the concave lens in parallel after encountering the reflective film 13, and is refracted by the concave lens at a larger refraction angle. Diffusion, together with the light beam refracted directly through the concave lens by the medical optical fiber 100 , can enhance the ablation of a specific range of the target lesion area 300 .
- an optical path adjustment component is provided at the front end of the optical fiber guide tube 1 , which can expand the types of the medical optical fiber 100 .
- the medical optical fiber 100 may be any one of side-fired optical fiber, diffused optical fiber or ring optical fiber.
- Another specific embodiment of the present invention discloses a medical optical fiber guiding method, using the above-mentioned medical optical fiber guiding structure, the steps include:
- Step 1 Fix the skull nail 4 on the planned path according to the operation plan, and keep it in a fixed state with the skull 200 .
- Step 2 Insert the medical optical fiber 100 into the optical fiber guide tube 1 , at this time, the front end of the medical optical fiber 100 does not exceed the bending portion 11 of the optical fiber guide tube 1 .
- One end of the guide tube base 2 is connected to the fiber guide tube 1 , and the other end is installed with the sealing plug 5 and the fixed cover 3 is screwed tightly.
- the medical optical fiber 100 is kept in a straight state so that when the optical fiber guiding tube 1 is inserted into the brain, other substances will not enter the optical fiber guiding tube 1 and cause subsequent blockage.
- the medical optical fiber 100 can also achieve laser ablation in the straight tube portion 12 , that is, the front end of the medical optical fiber 100 is located in the straight tube portion 12 and does not enter or protrude from the curved portion 11 .
- the medical optical fiber 100 can also be retrofitted.
- Step 3 According to the operation plan, insert the optical fiber guide tube 1 into the designated position through the skull nail 4, avoiding the area that needs to be avoided. There are corresponding graduation marks on the optical fiber guide tube 1, so that the insertion depth can be visually confirmed.
- the uniaxial translation between the medical optical fiber 100 and the optical fiber guide tube 1 can be performed.
- the medical optical fiber 100 can be slowly moved inward. Because the front end of the optical fiber guide tube 1 With a curved structure, the medical optical fiber 100 will bend along with the curved surface. The curved surface should be smooth, otherwise it may be stuck.
- the medical optical fiber 100 passing through the bending part 11 will become straight again due to the influence of its own characteristics.
- the light-emitting part of the front end of the medical optical fiber 100 reaches the target lesion area 300, and skillfully avoids the area with obstacles 400. Tighten the fixed cover 3. Ablation therapy can be further completed.
- Step 4 Loosen the fixing cover 3 and pull the medical optical fiber 100 backward so that the front end of the medical optical fiber 100 does not exceed the bending part 11, then loosen the sheath locking screw 6, and rotate the guide tube base 2 to adjust The orientation of the arc-shaped incision 111, and then tighten the sheath locking screw 6, at this time the outlet bending position of the optical fiber guide tube 1 has changed, so that the medical optical fiber 100 is stretched out of the optical fiber guide tube 1, and the second The area is ablated.
- the ablation area can be expanded not only in the axial direction where the medical optical fiber 100 protrudes, but also in the radial direction of the guide tube 1 .
- the present invention realizes the self-bending deformation of the medical optical fiber through the optical fiber guide tube, which can avoid important areas that are not suitable for puncture; by adjusting the direction of the optical fiber guide tube, the range of the ablation area can be further expanded, realizing the need to open two channels originally.
- the ablation can only be completed, which improves the efficiency; with different medical optical fibers, it can more conveniently match lesions of different shapes and complete conformal ablation.
- the front end of the existing ablation catheter (that is, the end that contacts the lesion tissue for ablation) is closed, and it is only a linear ablation channel, and the medical optical fiber can only move within the axial range of the ablation catheter.
- the tissue ablation range is only limited in the limited area around the ablation catheter.
- the front end of the optical fiber guiding tube 1 is a curved portion 11 with a lateral opening (that is, the arc-shaped incision 111 ), and the medical optical fiber 100 passes through the curved portion 11. Lateral openings allow for guided bending.
- This structural feature expands the range of motion of the medical optical fiber 100, which can not only move in the axial direction, but also realize the movement in the radial direction, and then realize the ablation of large lesion tissues in a single channel.
- the medical optical fiber guiding structure of the present invention also increases the choice of path options that avoid important tissues. Flexibility and variety.
- FIGS. 27-28 discloses a medical optical fiber guiding structure, including an optical fiber guiding tube 1 .
- the front end of the optical fiber guide tube 1 is made into a curved shape to achieve bending when the medical optical fiber 100 passes through.
- the fiber guide tube 1 is a tubular body with a tubular structure as a whole. At this time, to realize the bending of the medical optical fiber 100 when passing out, an opening 15 needs to be opened on the front side wall of the fiber guide tube 1 .
- the fiber guide tube 1 includes a first tube section and a second tube section, the first tube section has a lumen extending in the axial direction, and the side wall of the second tube section has a The communicating opening 15 , so that the passage connecting the opening 15 and the lumen is a curved passage 16 .
- the lumen and the opening 15 are smoothly and excessively connected, and there is a set angle ⁇ between the extension direction of the curved channel 16 and the extension direction of the lumen, and the set angle ⁇ is an obtuse angle .
- the front end of the second pipe section is the puncture head 17 .
- the medical optical fiber 100 or other sampling devices can pass through the opening to achieve guided bending, and the set angle ⁇ is preferably set to be , the angle A between the axis of the unbent portion of the medical optical fiber 100 and the axis of the bent portion of the medical optical fiber 100 is between 140° and 170°.
- first pipe section is the straight pipe part 12 of the fiber guide tube 1
- second pipe section is the bent part 11 of the fiber guide tube 1; the medical optical fiber 100 passes through the bent part 11 Out to achieve guided bending.
- the target tissue can be sampled and tested before and after the ablation operation, so as to facilitate its pathological analysis.
- FIG. 29-Fig. 31 adopts the above-mentioned medical optical fiber guiding structure, and replaces the medical optical fiber 100 with a lateral sampling needle 500, and the lateral sampling needle 500 is connected with the medical optical fiber guiding structure.
- the connection relationship of the structure is the same as the connection relationship between the medical optical fiber 100 and the medical optical fiber guiding structure, and will not be repeated here.
- the side sampling needle 500 is arranged in the fiber guide tube 1, and the front side wall of the side sampling needle 500 is provided with a side sampling port 501, and the front side wall of the side sampling port 501 is an inclined surface 502, preferably Specifically, the inclined surface 502 is inclined towards the rear end of the lateral sampling needle 500, so that when the lateral sampling needle 500 is taken out, the inclined surface 502 can be used to cut off the sample from the tissue to be removed 600, and the lateral sampling needle The front end of the 500 is tapered.
- the lateral sampling needle is a hollow hose as a whole.
- the hose has a certain strength to ensure its own straightness, but it can be bent due to the influence of the structure of the bending part.
- the basic characteristics are consistent with the optical fiber.
- the preferred Teflon tubes are used.
- the head end of the lateral sampling needle is made into a tapered shape for easy puncture, one side is provided with an opening for sampling, and the front end of the opening is made into a sharp incision shape for cutting the sample from the tissue.
- the rear end of the hose can be connected with a negative pressure pump, and the pressure difference in the hollow tube can be adjusted to absorb fluid samples and the like.
- the lateral sampling needle 500 When the lateral sampling needle 500 is used together with the medical optical fiber guide structure, first fix the skull nail 4 and the optical fiber guide tube 1, and confirm the path. After the ablation operation is completed, the medical optical fiber 100 is taken out, and then the lateral sampling needle 500 is inserted from one end of the fiber guide tube 1, and the tip is inserted into the brain to reach the indicated position. At this time, the negative pressure pump at the end of the lateral sampling needle 500 works to absorb the tissue to be sampled to the hollow part of the lateral sampling needle 500 . If it is some fluids such as cerebrospinal fluid and blood, the purpose can be achieved by slowly sucking. If it is some hard tissues, after the adsorption, pull back the lateral sampling needle 500 and use the inclined surface 502 to cut off the tissue to complete the sampling or Clear job.
- some fluids such as cerebrospinal fluid and blood
- the side wall at the rear end of the side sampling port 501 is an inclined surface, and the inclined surface is inclined towards the front end of the lateral sampling needle 500.
- the tissue to be removed 600 can be cut away.
- the sample is stored in the hollow part at the front end of the lateral sampling needle 500, and a negative pressure pump is not needed when the lateral sampling needle 500 is pulled out.
- the lateral sampling needle 500 can also be adjusted radially and axially. Through multiple adjustments and sampling, sampling operations in different regions can be completed, and excessive damage after ablation can be removed. It also facilitates the pathological analysis of the sampled tissue by medical staff. The specific adjustment method will not be repeated.
- the side sampling port 501 of the side sampling needle 500 is coated with a developing coating.
- the position of the sampling needle can be monitored through the MR scanning image, so that the sampling is more accurate and safe. Will not harm other substances in the brain.
- the lateral sampling needle 500 can be used in combination with the aforementioned medical optical fiber 100 , that is, the lateral sampling needle 500 can be used for sampling before or after ablation with the medical optical fiber 100 .
- FIG. 32 adopts the above-mentioned medical optical fiber guiding structure. If the position to be sampled is relatively close to the optical fiber guide tube 1 or the orientation to be sampled is relatively large, the medical optical fiber 100 is replaced with an end face.
- the incision sampling needle 700, the connection relationship between the end surface incision sampling needle 700 and the medical optical fiber guiding structure is the same as the connection relationship between the medical optical fiber 100 and the medical optical fiber guiding structure, and will not be repeated here.
- the end face sampling port 701 (notch) of the end face incision sampling needle 700 is arranged at the front end. During the insertion process, the incision will cut off the tissue and store it in the hollow tube of the end face incision sampling needle 700. , the negative pressure pump connected to the rear end of the end face incision sampling needle 700 ensures that the tissue in the hollow tube will not protrude, and leaves together with the end face incision sampling needle 700 .
- the lateral sampling needle 500 in Example 7 can also be adjusted radially and axially in conjunction with the medical optical fiber guide structure, and can sample in a wider range or remove damaged tissue, with high efficiency and convenient sampling.
- end face incision sampling needle 700 can be used in combination with the above-mentioned medical optical fiber 100 , that is, the end face incision sampling needle 700 can be used for sampling before or after ablation with the medical optical fiber 100 .
- the medical optical fiber guiding structure can also cooperate with a sampler 800 that can meet the requirements for sampling.
- the sampler 800 is a prior art , often used in endoscope tubes, the specific structure will not be repeated, there is a silk thread on the sampler 800 to control the closing and opening of the front-end sampler, after the sampler 800 extends out of the optical fiber guide tube 1, open the front-end sampler 800 , after reaching the position, it is closed by structural pulling, and then exits along the fiber guide tube 1.
- sampler 800 can be used in combination with the above-mentioned medical optical fiber 100 , that is, the sampler 800 can be used for sampling before or after ablation with the medical optical fiber 100 .
- the lateral sampling needle 500 in Embodiment 7, the end surface incision sampling needle 700 in Embodiment 8, and the sampler 800 in Embodiment 9 can be a hose as a whole, and the hose has a certain strength. It can guarantee its own straightness, but it can be bent due to the influence of the structure of the bending part, and its basic characteristics are consistent with those of optical fibers. It is preferably a polytetrafluoroethylene tube.
- the optical fiber guide tube 1 of the present invention is not only a surgical channel for laser ablation, but also can become a sampling channel for a side sampling needle 500 or an end face incision sampling needle 700 or a sampler 800 when the ablation is completed, which can be completed in the same operation In addition to the damage to the lesion, the sampling of the lesion after the damage can be completed.
- the hardness of the optical fiber guide tube 1 is much greater than that of the medical optical fiber 100 , the lateral sampling needle 500 , the end face incision sampling needle 700 and the sampler 800 .
- the lateral sampling needle 500, the end surface incision sampling needle 700 and the sampler 800 can all be realized by means of existing technologies, and will not be described in detail here.
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Abstract
一种医用光纤导向结构及导向方法,属于医疗器械技术领域,解决了现有技术中光纤在消融导管所建立的直行消融通道内仅能对其所贯穿周围有限区域内的病灶组织进行消融的问题,包括光纤导向管(1),光纤导向管(1)包含第一管段和第二管段;第一管段具有沿轴向方向延伸设置的管腔,第二管段具有一与管腔连通的开口;开口与管腔连通的延伸方向和管腔的延伸方向之间呈一设定夹角,设定夹角为钝角,既增加了避开重要组织的路径方案选择的灵活性和多样性,又提供了从单一通道就可实现大病灶组织的消融方案,不仅提高了手术的效率,还提高了手术的安全性和有效性。
Description
相关申请的交叉引用
本申请要求于2021年11月05日申请的,申请号为202111306280.5,名称为“一种医用光纤导向结构及导向方法”的中国专利申请的优先权。
本发明涉及医疗器械技术领域,尤其涉及一种医用光纤导向结构及导向方法。
作为一种新技术,相比传统的治疗手段,激光消融术具有消融范围精准可控,对病变周围正常结构几乎没有损伤,以及手术创伤小、手术时间短、术后恢复快等优势,尤其为病变位于脑内深部、不能耐受常规开颅手术治疗的患者带来了曙光。目前用以传输激光能量以实现组织损毁的消融导管限制内部的光纤只能走直线型手术通道,但在实际消融手术中,由于受肿瘤位置、形状和大小的影响,同时也受到血管等其他肿瘤微环境的影响,非直线型手术通道的方案是手术操作者所希望的。尤其是,在遇到肿瘤位于脑深部位置,且其周围紧邻重要组织时,为了更好的适形消融和全域消融,避开重要的脑组织,采取“曲线救国”的治疗策略是较为有利的。
在颅内建立非直线型手术通道绝非易事,也会相应增加手术时间和穿刺难度。而现有的消融导管使设置在其内部的医用光纤只能实现直线通道、有限区域的组织消融,即仅能对该直线通道的轴向方向及其附近有限区域的病灶组织进行消融,而对于较大病灶的消融就需要考虑建立多个直线型消融通道。
另外,现有的激光消融手术方案中,如要消融前进行取样则需在未***消融导管前进行取样,若要在消融后取样,则需将消融导管拔出后实行取样,手术的操作难度大,患者受到损伤及感染的风险也极高。
发明内容
鉴于上述的分析,本发明实施例旨在提供一种医用光纤导向结构及导向方法,用以解决现有光纤在消融导管所建立的直行消融通道内仅能对其所贯穿周围有限区域内的病灶组织进行消融的问题,实现了“曲线救国”的治疗目的。
一方面,本发明提供了一种医用光纤导向结构,包含光纤导向管,所述光纤导向管包含第一管段和第二管段;
所述第一管段具有沿轴向方向延伸设置的管腔,
所述第二管段具有一与所述管腔连通的开口;
所述开口与所述管腔连通的延伸方向和所述官管腔的延伸方向之间呈一设定夹角,所述设定夹角为钝角。
进一步地,所述光纤导向管内可拆卸连接有一医用光纤;
所述医用光纤可从所述开口穿出以实现导向弯曲。
进一步地,所述第一管段为所述光纤导向管的直管部,所述第二管段为所述光纤导向管的弯曲部;所述医用光纤从所述弯曲部穿出实现导向弯曲。
进一步地,还包括导向管基座、固定盖和颅骨钉,所述导向管基座的一端设于所述颅骨钉的端部内,另一端与所述固定盖螺纹连接。
进一步地,还包括密封塞,所述密封塞设于所述导向管基座连接有所述固定盖的通孔内。
进一步地,所述导向管基座包括第一螺纹部和光轴部,所述第一螺纹部和光轴部分别 位于所述导向管基座的两端,所述第一螺纹部设有外螺纹。
进一步地,所述导向管基座的中心设有同轴且连通的第一通孔、第二通孔和第三通孔,所述第一通孔和第二通孔分别位于所述导向管基座的两端,所述光纤导向管的后端设于所述第二通孔内。
进一步地,所述第二通孔的直径小于所述第一通孔的直径,且大于所述第三通孔的直径;所述第三通孔的直径大于所述医用光纤的直径,所述第二通孔的直径等于所述光纤导向管的外径。
进一步地,所述固定盖的中心设有同轴且连通的螺纹孔和第四通孔,所述第四通孔的直径大于等于所述医用光纤的直径,所述第一螺纹部设于所述螺纹孔内。
进一步地,所述密封塞设于所述第一通孔内,所述密封塞的外壁与所述第一通孔的内壁贴合,所述密封塞的中心孔套设所述医用光纤且与所述医用光纤的外壁贴合。
进一步地,所述颅骨钉包括依次连接的第一连接部、第二连接部和第二螺纹部,所述第一连接部与所述光轴部连接,所述第二螺纹部设有外螺纹,并与颅骨连接。
另一方面,本发明提供了一种医用光纤导向方法,采用上述医用光纤导向结构,步骤包括:
步骤1:将颅骨钉与颅骨固定连接;
步骤2:将医用光纤***光纤导向管中,此时医用光纤的前端不超过光纤导向管的弯曲部;导向管基座一端与光纤导向管连接,另一端安装密封塞并旋紧固定盖;
步骤3:将光纤导向管通过颅骨钉***到指定的位置;
拧松固定盖,通过外部施加推力,将医用光纤向光纤导向管的前端移动,使医用光纤穿出弯曲部并依靠弯曲部改变方向;然后拧紧固定盖;
步骤4:拧松固定盖将医用光纤向后拉,使医用光纤的前端不超过弯曲部,旋转导向管基座以调整弯曲部的朝向,再将医用光纤伸出光纤导向管,可以对另一区域进行消融。
与现有技术相比,本发明至少可实现如下有益效果之一:
(1)本发明的光纤导向管的前端为弯曲部,且弯曲部的前端设有弧形切口,医用光纤从光纤导向管穿出时会在弯曲部的作用下实现弯曲,可以避开通道上的重要组织,进而可对目标病灶区域适形消融,而不需要重新规划新的通道,提高了手术的效率。
(2)本发明的光纤导向管的最前端是呈现尖锐的弧边,可以较为轻易的穿刺透脑部组织,同时整个弯曲部朝向直管部的投影位于直管部的横截面内,所以只需要在头骨上开一个圆形的小孔,通过颅骨钉导向定位,便可以将导向管伸入脑内,同时在脑内建立的也只是一个圆柱型通道,退出时不会勾拉组织造成附带损伤,实现微创治疗。
(3)本发明通过光纤导向管,实现医用光纤的自弯曲变形,可以避让开不合适穿刺的重要区域;通过调节光纤导向管的开口朝向,可以进一步的扩大消融区域的范围,实现了原本需要开两个或多个通道才能完成的消融,提高了效率。
(4)本发明配合不同的医用光纤,比如侧射光纤,通过改变光纤导向管的开口朝向,可以更加方便的匹配不同形状的病灶,完成适形消融,实现了在同一通道内的多区域消融。
(5)本发明的限位部上设有刻度线,颅骨钉上设置标记线,通过转动导向管基座可以定量改变光纤导向管的转动角度,对其他区域进行消融,扩展了消融面积,无需重新规划手术路径,提高了手术效率;同时,通过松动固定盖,可以将医用光纤沿光纤导向管的轴向推进或后退,能够再扩大消融区域。
(6)本发明的光纤导向管不仅可以适用于光纤的消融手术,也可以配合软管取样针,实现弯曲取样或抽吸消融后的损毁组织。
(7)本发明的零部件采用的材料均由核磁兼容的材料制成,例如玻璃、聚四氟乙烯或PC(Polycarbonate,聚碳酸酯)等,可以在MR(Magnetic Resonance,磁共振)中进行操作,不管是消融手术还是残留取样,都可以在MR扫描下进行,可以实时监测手术过 程,更加的安全。
(8)本发明的导向结构根据内部使用的不同器具(如医用光纤,取样针或取样器),既能实现激光消融操作,又可以实现取样操作;可根据实际需要合理安排取样与激光消融的先后顺序,以及使用的取样器具,不需要额外在脑部建立取样通道,也不需要将导向结构更换为其他辅助装置,扩大了装置的使用范围,提高了手术效率,减少了对患者的损伤和感染风险。
(9)本发明的光纤导向管的前端为具有侧向开口的弯曲部,医用光纤可以从弯曲部的侧向开口穿出,进而在穿刺角度、穿刺方向上更具灵活性。一方面增加了避开重要组织的路径方案选择的灵活性和多样性,另一方面也提供了从单一通道就可实现大病灶组织的消融方案,不仅提高了手术的效率,也大大提高了手术的安全性和有效性,可谓实现了“弯道超车”的微创有效治疗。
本发明中,上述各技术方案之间还可以相互组合,以实现更多的优选组合方案。本发明的其他特征和优点将在随后的说明书中阐述,并且,部分优点可从说明书中变得显而易见,或者通过实施本发明而了解。本发明的目的和其他优点可通过说明书以及附图中所特别指出的内容中来实现和获得。
附图仅用于示出具体实施例的目的,而并不认为是对本发明的限制,在整个附图中,相同的参考符号表示相同的部件。
图1为具体实施例的光纤导向管结构示意图;
图2为具体实施例的光纤导向管剖视图;
图3为具体实施例的医用光纤穿出弯曲部的状态示意图(一);
图4为具体实施例的医用光纤导向结构的结构示意图(一);
图5为具体实施例的医用光纤导向结构的结构示意图(二);
图6为具体实施例的导向管基座结构示意图(一);
图7为具体实施例的固定盖结构示意图;
图8为具体实施例的颅骨钉结构示意图;
图9为具体实施例的改变医用光纤伸出长度获得的多次消融区域示意图;
图10为具体实施例的医用光纤导向结构的结构示意图(三);
图11为具体实施例的导向管基座结构示意图(二);
图12为具体实施例的医用光纤导向结构的结构示意图(四);
图13为具体实施例的医用光纤导向结构的剖视图(一);
图14为具体实施例的医用光纤导向结构的部分结构***图;
图15为具体实施例的导向管基座0刻度与颅骨钉的标记线对齐的状态示意图;
图16为具体实施例的导向管基座60刻度与颅骨钉的标记线对齐的状态示意图;
图17为具体实施例的医用光纤的出光侧标记与0刻度对应状态下的消融示意图;
图18为具体实施例的医用光纤的出光侧标记与0刻度非对应状态下的消融示意图;
图19为具体实施例的光纤导向管横截面示意图(一);
图20为具体实施例的光纤导向管横截面示意图(二);
图21为具体实施例的光纤导向管横截面示意图(三);
图22为具体实施例的光纤导向管横截面示意图(四);
图23为具体实施例的光纤导向管横截面示意图(五);
图24为具体实施例的光纤导向管横截面示意图(六);
图25为具体实施例的光纤导向管横截面示意图(七);
图26为具体实施例的光纤导向管横截面示意图(八);
图27为具体实施例的医用光纤导向结构的剖视图(二);
图28为具体实施例的医用光纤穿出弯曲部的状态示意图(二);
图29为具体实施例的侧向取样针结构示意图;
图30为具体实施例的侧向取样针位于光纤导向管内的结构示意图;
图31为具体实施例的侧向取样针取样示意图;
图32为具体实施例的端面取样针伸出光纤导向管的状态示意图;
图33为具体实施例的取样器取样示意图。
附图标记:
1-光纤导向管;11-弯曲部;111-弧形切口;12-直管部;13-返光膜;14-透镜结构;15-开口;16-弯曲通道;17-穿刺头;2-导向管基座;21-第一螺纹部;211-第一通孔;22-光轴部;221-第二通孔;23-限位部;231-第三通孔;3-固定盖;31-螺纹孔;32-第四通孔;4-颅骨钉;41-第一连接部;411-第五通孔;412-标记线;42-第二连接部;421-第六通孔;43-第二螺纹部;5-密封塞;6-护套锁紧螺钉;
100-医用光纤;101-出光侧标记;200-颅骨;300-目标病灶区域;301-第一消融区域;302-第二消融区域;400-阻碍物;500-侧向取样针;501-侧取样口;502-倾斜面;600-待清除组织;700-端面切口取样针;701-端面取样口;800-取样器。
下面结合附图来具体描述本发明的优选实施例,其中,附图构成本发明一部分,并与本发明的实施例一起用于阐释本发明的原理,并非用于限定本发明的范围。
在本发明实施例的描述中,需要说明的是,除非另有明确的规定和限定,术语“相连”应做广义理解,例如,可以是固定连接,也可以是可拆卸连接,或一体地连接,可以是机械连接,也可以是电连接,可以是直接相连,也可以通过中间媒介间接相连。对于本领域的普通技术人员而言,可以根据具体情况理解上述术语在本发明中的具体含义。
全文中描述使用的术语“顶部”、“底部”、“在……上方”、“下”和“在……上”是相对于装置的部件的相对位置,例如装置内部的顶部和底部衬底的相对位置。可以理解的是装置是多功能的,与它们在空间中的方位无关。
实施例1
本发明的一个具体实施例,如图1-图2所示,公开了一种医用光纤导向结构,包括光纤导向管1,医用光纤100设在所述光纤导向管1内,所述光纤导向管1包括弯曲部11和直管部12,所述弯曲部11位于直管部12的前端,所述弯曲部11的前端设有切口,优选地,切口为弧形切口111,所述医用光纤100可以依次穿过直管部12、弯曲部11,从弧形切口111穿出,实现医用光纤100的导向弯曲。
由于所述光纤导向管1采用透明材质,优选为光学透明材质。所述医用光纤100既可以在所述直管部12内实现激光消融,也可以穿出所述弯曲部11后实现激光消融。也就是说,消融时,激光光路可以仅透过所述医用光纤100实现对病灶的损毁,也可以透过所述医用光纤100和所述直管部12实现激光消融。
与现有技术相比,本实施例提供的医用光纤导向结构,光纤导向管的前端为弯曲部,且弯曲部的前端设有弧形切口,医用光纤从光纤导向管穿出时会在弯曲部的作用下实现弯曲,可以避开通道上的重要组织,进而可对目标病灶区域300适形消融,而不需要重新规划新的通道,提高了手术的效率。
由于使用现有的消融导管进行消融时,如果要获得更大的消融范围或达到适形消融或实现消融完全的目的,手术路径规划和消融通道的建立最好是沿着病灶组织的近中轴线进入。然鉴于肿瘤微环境的影响,这种近中轴线的进入方式不是每次都是可取或理想的。本实施例中,所述光纤导向管1的前端为具有侧向开口的弯曲部11,医用光纤100可以从 所述弯曲部11的侧向开口穿出,进而在穿刺角度、穿刺方向上更具灵活性。一方面增加了避开重要组织的路径方案选择的灵活性和多样性,另一方面也提供了从单一通道就可实现大病灶组织的消融方案,不仅提高了手术的效率,也大大提高了手术的安全性和有效性,可谓实现了“弯道超车”的微创有效治疗。
弯曲部11朝向直管部12的投影位于直管部12的横截面(垂直于光纤导向管1的轴线的界面)内,即弯曲部11沿直管部12的轴向的外轮廓不超过直管部12的轴向外轮廓。
本实施例中,光纤导向管1的最前端是呈现尖锐的弧边,可以较为轻易的穿刺透脑部组织,同时整个弯曲部也都在一个直管部12外轮廓限定的圆中,所以只需要在头骨上开一个圆形的小孔,通过颅骨钉导向定位,便可以将光纤导向管1伸入脑内,同时在脑内建立的也只是一个圆柱型通道,不会损伤其他组织,退出时也不会勾拉组织造成损伤,实现微创治疗。
所述光纤导向管1在头端进行了弯曲,此结构既可以通过导向用的颅骨钉4上的通孔,深入脑内。同时可以通过前端的弯曲结构对医用光纤100进行导向。
值得注意的是,弯曲部11与直管部12的轴线夹角不宜过小,避免折断医用光纤100,优选地,如图3所示,弯曲部11和直管部12的设置方式优选为,当所述医用光纤100伸出所述弯曲部11一定距离时,使得所述医用光纤100的未弯曲部分的轴线与所述医用光纤100的弯曲部分的轴线之间的夹角A介于140°~170°之间。
如图4-图5所示,医用光纤导向结构还包括导向管基座2、固定盖3、颅骨钉4和密封塞5,所述导向管基座2的一端设于所述颅骨钉4的通孔内,另一端与所述固定盖3螺纹连接,所述密封塞5设于所述导向管基座2的端部内。
如图6所示,所述导向管基座2为回转体结构,包括第一螺纹部21和光轴部22,所述第一螺纹部21和光轴部22分别位于所述导向管基座2的两端。所述第一螺纹部21设有外螺纹。
所述第一螺纹部21的中心设有第一通孔211,所述光轴部22的中心设有第二通孔221,所述第一通孔211和第二通孔221连通,且所述第一通孔211的直径大于所述第二通孔221的直径,所述第二通孔221的直径等于光纤导向管1的外径。所述光纤导向管1的直管部12的端部设于第二通孔221内。所述第一通孔211与所述第二通孔221同轴。
为了对光纤导向管1的端部进行限位,导向管基座2还设有位于所述第一通孔211和第二通孔221之间的第三通孔231,所述第三通孔231与所述第一通孔211、第二通孔221连通,且所述第三通孔231的直径小于所述第二通孔221的直径,所述第三通孔231的直径略大于医用光纤100的直径,以便所述医用光纤100能够顺利通过。所述第三通孔231和第二通孔221同轴。
如图7所示,所述固定盖3为回转体结构,设有螺纹孔31和第四通孔32,所述螺纹孔31和第四通孔32连通且同轴。所述第四通孔32的直径大于医用光纤100的直径且小于所述螺纹孔31的直径。所述第一螺纹部21设于所述螺纹孔31内。
所述密封塞5为圆筒状结构,所述密封塞5设于所述第一通孔211内,所述密封塞5的外径与第一通孔211的直径相同,密封塞5的中心孔直径与医用光纤100的直径相等。所述密封塞5的长度大于第一通孔211的长度,优选地,密封塞5的长度为第一通孔211的长度的1.3~1.4倍。
在本实施例中,医用光纤100依次穿过所述第四通孔32、设于所述第一通孔211内的密封塞5的中心孔和第三通孔231后,进入设于第二通孔221内的光纤导向管1内,并从所述光纤导向管1的前端穿出。
所述密封塞5设于第一通孔211内用于对医用光纤100进行导向和限位,当固定盖3拧紧后,密封塞5的中心孔与医用光纤100为过盈配合,密封塞5的外径与第一通孔211为过盈配合,使得医用光纤100能够稳固设在导向管基座2内。所述固定盖3旋紧到第一 螺纹部21后,将医用光纤100与导向管基座2稳固连接,限制所述医用光纤100沿轴向的移动和绕自身轴线转动。
如图8所示,所述颅骨钉4为回转体结构,包括第一连接部41、第二连接部42和第二螺纹部43,所述第一连接部41、第二连接部42和第二螺纹部43依次连接。第一连接部41与所述导向管基座2的光轴部22连接,所述第二螺纹部43设有外螺纹,与颅骨200连接。
所述第一连接部41内设有第五通孔411,第五通孔411的直径等于光轴部22的外径,第五通孔411的长度大于所述光轴部22的长度,使得导向管基座2在第五通孔411的轴线方向上具有足够的移动距离。
所述第二连接部42设有第六通孔421,第六通孔421与第五通孔411连通且同轴,第六通孔421贯通所述第二螺纹部43,且其直径等于光纤导向管1的外径。
本实施例中,所述光纤导向管1安装在导向管基座2上,所述导向管基座2用于固定光纤导向管1和医用光纤100,通过所述密封塞5和固定盖3的配合来完成对医用光纤100的相对固定。同时,所述导向管基座2与颅骨钉4相互配合完成对光纤导向管1的固定。其中所述颅骨钉4固定在颅骨200上,起到建立导向通道和固定所述光纤导向管1的作用。
医用光纤100可以是裸光纤,也可以是含冷却***的光纤导管结构或非冷却***的光纤导管结构,含有冷却***的光纤导管和非冷却***的光纤导管结构均为现有技术,在此不做赘述。
可理解的,如图9所示,通过改变医用光纤100沿光纤导向管1伸出的长度和/或所述弧形切口111的朝向,和/或所述医用光纤100在所述直管部12内的相对位置,可以实现在同一通道内的多区域消融,以治疗较大区域的病灶,示例性地,通过改变医用光纤100沿光纤导向管1的伸出长度获得第一消融区域301和第二消融区域302。当然,如图4、图10所示,所述医用光纤100还可以在所述直管部12内实现激光消融。
实施例2
本发明的另一个具体实施例,如图1-图2所示,公开了一种医用光纤导向结构,包括光纤导向管1,所述光纤导向管1为一细长管,医用光纤100设在所述光纤导向管1内,所述光纤导向管1的前端为弯曲部11,所述医用光纤100从所述弯曲部11穿出,实现医用光纤100的导向弯曲。
与现有技术相比,本实施例提供的医用光纤导向结构,光纤导向管的前端为弯曲部,医用光纤从光纤导向管穿出时会在弯曲部的作用下实现弯曲,可以避开通道上的重要组织,进而可对目标病灶区域300适形消融,提高了手术的效率。
所述光纤导向管1在前端进行了弯曲,既可以通过导向用的颅骨钉4的中心孔,深入脑内。同时也可以通过前端的弯曲结构对医用光纤100进行导向。
所述弯曲部11的前端设有弧形切口111,所述医用光纤100从所述弯曲部11的弧形切口111穿出,实现医用光纤100的导向弯曲。
如图10所示,医用光纤导向结构还包括导向管基座2、固定盖3、颅骨钉4和密封塞5,所述导向管基座2的一端与所述颅骨钉4的一端连接,所述颅骨钉4的另一端与颅骨200连接,所述密封塞5设于所述导向管基座2的另一端内,且导向管基座2的另一端外侧连接所述固定盖3。
如图11所示,所述导向管基座2为回转体结构,包括第一螺纹部21、光轴部22和限位部23,所述第一螺纹部21和光轴部22分别位于所述导向管基座2的两端,所述限位部23位于第一螺纹部21和光轴部22的之间。所述第一螺纹部21设有外螺纹,所述第一螺纹部21、光轴部22的外径均小于所述限位部23的外径。
所述限位部23的外圆柱面上设有刻度线,刻度线等分圆周角,且靠近所述光轴部22设置。
所述导向管基座2的中心设有第一通孔211、第二通孔221和第三通孔231,所述第一通孔211和第二通孔221分别位于导向管基座2的两端,所述第一通孔211、第二通孔221和第三通孔231连通且同轴。
所述第二通孔221的直径小于所述第一通孔211的直径,且大于所述第三通孔231的直径,所述第二通孔221的直径等于光纤导向管1的外径。所述光纤导向管1的后端设于第二通孔221内。所述第三通孔231的直径略大于医用光纤100的直径,以便所述医用光纤100能够顺利通过。
如图7所示,所述固定盖3设有螺纹孔31和第四通孔32,所述螺纹孔31和第四通孔32连通且同轴。所述第四通孔32的直径等于医用光纤100的直径且小于所述螺纹孔31的直径。所述第一螺纹部21设于所述螺纹孔31内。
所述密封塞5为圆筒状结构的弹性件,其设于所述第一通孔211内。所述密封塞5的外径略大于第一通孔211的直径,密封塞5的中心孔直径略小于医用光纤100的直径,使得通过所述密封塞5连接的医用光纤100和导向管基座2稳固可靠。所述密封塞5的长度大于第一通孔211的长度,优选地,密封塞5的长度为第一通孔211的长度的1.3~1.4倍。
所述密封塞5设于第一通孔211内用于对医用光纤100进行导向和限位,由于密封塞5具有弹性,且外径略大于第一通孔211,其内径略小于医用光纤100的外径,使得医用光纤100能够稳固设在导向管基座2内。此外,所述固定盖3旋紧到第一螺纹部21后,将医用光纤100与导向管基座2稳固连接,限制所述医用光纤100沿轴向的移动和绕自身轴线转动。
如图8所示,所述颅骨钉4包括依次连接的第一连接部41、第二连接部42和第二螺纹部43。第一连接部41与所述导向管基座2的光轴部22连接,所述第二螺纹部43设有外螺纹,与颅骨200连接。
所述颅骨钉4的中心设有同轴且连通的第五通孔411和第六通孔421,所述第五通孔411设在第一连接部41端,第五通孔411的直径等于光轴部22的外径,第五通孔411的长度大于所述光轴部22的长度,使得导向管基座2在第五通孔411的轴线方向上具有足够的移动距离。所述第六通孔421贯通所述第二螺纹部43,且其直径等于光纤导向管1的外径。
在本实施例中,医用光纤100依次穿过所述第四通孔32、密封塞5的中心孔和第三通孔231后,进入设于第二通孔221内的光纤导向管1内。所述光纤导向管1穿过第五通孔411和第六通孔421,再从第二螺纹部43的端部穿出深入脑中,所述医用光纤100可从所述光纤导向管1的弯曲部11穿出进行激光消融操作。
为了对光纤导向管1进一步限位,如图12、图13、图14所示,医用光纤导向结构还包括护套锁紧螺钉6,所述护套锁紧螺钉6的轴线与光纤导向管1的轴线垂直,护套锁紧螺钉6能够穿过沿所述第一连接部41径向设置的通孔抵压在光轴部22的外壁上。
值得注意的是,所述第一连接部41的圆柱面上设有标记线412,标记线412与所述颅骨钉4的轴线平行且靠近第一连接部41的端部设置,以便确定导向管基座2相对于颅骨钉4转动的角度。由于所述颅骨钉4通过螺纹与颅骨200固定连接,所述医用光纤100与导向管基座2的一端通过密封塞5紧密配合连接,所述光纤导向管1与导向管基座2的另一端紧密配合,因而旋转导向管基座2能够改变医用光纤100的弧形切口111的朝向,进而可以目标病灶区域300适形消融。
可理解地,为了便于更好地操作医用光纤导向结构,所述限位部23的刻度线设有0标记点(即:0刻度),0标记点对应的刻度线与标记线412对齐,此结构为医用光纤导向结构的起始位置。
本实施例中,所述光纤导向管1安装在导向管基座2上,所述导向管基座2用于固 定光纤导向管1和医用光纤100,通过所述密封塞5和固定盖3的配合来完成对医用光纤100的相对固定。同时,所述导向管基座2与颅骨钉4、护套锁紧螺钉6相互配合完成对医用光纤100的固定及导向的结构。其中所述颅骨钉4固定在颅骨200上,起到建立导向通道和固定所述光纤导向管1的作用。通过所述颅骨钉4上标记线412和导向管基座2上的角度刻度线来判断光纤导向管1的位置方向。
在实际操作过程中,按上述说明中的在0°刻度是消融了第一区域,此时通过拧松所述固定盖3将医用光纤100向后拉使医用光纤100的前端不超过弯曲部11,再拧松所述护套锁紧螺钉6,旋转导向管基座2以调整弧形切口111的朝向,再拧紧护套锁紧螺钉6,此时所述光纤导向管1的出口弯曲位置已经发生变化,以此再将医用光纤100伸出光纤导向管1,可以对第二区域进行消融。不仅可以在医用光纤100伸出的轴向方向上扩展消融面积,同时可以沿导向管1的径向方向上扩展消融面积。
示例性地,如图15、图16所示,在0刻度时消融了第一区域,此时通过拧松固定盖3将光纤缩回来,拧松护套锁紧螺钉6,旋转导向管基座2到60刻度,再拧紧护套锁紧螺钉6,此时光纤导向管1的出口弯曲朝向已经发生变化,以此再将医用光纤100伸出光纤导向管1,可以对第二区域进行消融。或者保持医用光纤100不动,在拧松护套锁紧螺钉6后直接旋转导向管基座2到60刻度。
实施例3
本发明的另一个具体实施例,公开了一种医用光纤导向结构,所述医用光纤100是可以侧边出光的医用光纤(即侧射光纤),在实施例2的基础上,如图17、图18所示,所述医用光纤100上有出光侧标记101,标识出光口的方向,此时,通过拧松所述固定盖3后调节医用光纤100出光口的方向,可以进一步的控制消融区域的位置和大小,更加容易适形消融。其他结构与有益效果与实施例2相同,在此不再一一赘述。
实施例4
本发明的另一个具体实施例,公开了一种医用光纤导向结构,所述医用光纤导向结构具有一定的透光性,可进行光路的传输。进一步的,所述光纤导向管1的前端设有光路调节组件,所述光路调节组件设于所述光纤导向管1的直管部的前端侧壁,当所述医用光纤100的前端位于直管部内时,所述光路调节组件能够改变位于所述光纤导向管1内的医用光纤100发出的激光的光路以对目标病灶区域300进行消融。
所述光路调节组件包括反光膜13和透镜结构14,所述反光膜13用于将所述医用光纤100出射的光线都导向目标病灶区域300的方向,以实现单方向的发射;所述反光膜13和所述透镜结构14配合可以适配更多不同形状的肿瘤。
所述透镜结构14可以改变消融范围的大小和/或形状。因为所述透镜结构14的增加,把原来呈圆环状的消融区域转变为特定形状的消融区(如图22、图26所示),进而可以适配更多的不规则肿瘤。
所述透镜结构14位于光纤导向管1上,可理解地,透镜结构14既可以作为单独的部件设于光纤导向管1的内壁上,比如将透镜结构14粘贴在光纤导向管1的内壁上,也可以作为所述光纤导向管1的一部分。
本实施例中,为了减小护套结构的体积,所述透镜结构14和所述光纤导向管1是一体结构。当然也可以在所述光纤导向管1的侧壁上制作透镜结构14,所述透镜结构14嵌设在光纤导向管1的侧壁设置的槽内。
所述透镜结构14可以为聚光镜或发散镜,其中聚光镜优选为凸透镜,发散镜优选为凹透镜。
当所述透镜结构14为凸透镜时,所述医用光纤100发出的激光周向发散,经过凸透镜后变为平行光出射,可以局部突出和/或加深对透镜结构14所在部位的目标病灶区域300的消融。
当所述透镜结构14为凹透镜时,所述医用光纤100发出的激光周向发散,经过凹透镜后变的更加发散,扩大透镜结构14所在位置出光的覆盖范围,增强消融效果。
本实施例提供的护套结构,在所述光纤导向管1上设有透镜结构14,当医用光纤100用于消融手术时,通过设置于所述光纤导向管1上的透镜结构14改变医用光纤100发出的激光的路径,因此对形状不规则肿瘤的消融变得更为灵活和易于操作。
所述反光膜13和透镜结构14相对设置,分别位于所述医用光纤100的两侧。如图19-图22所示,所述透镜结构14为凸透镜,医用光纤100周向发射的激光在遇到反光膜13时被平行返回至凸透镜后进行聚焦,加上医用光纤100直接透过凸透镜形成的平行光束,能够增强对目标病灶区域300某一区域的消融。
如图23-图26所示,所述透镜结构14为凹透镜,医用光纤100周向发射的激光在遇到所述反光膜13后被平行返回至凹透镜,经过凹透镜折射后以更大的折射角散发,加上医用光纤100直接透过凹透镜折射的光束,能够增强对目标病灶区域300特定范围的消融。
可理解地,本实施例中,也可以通过改变反光膜13沿光纤导向管1的径向的覆盖面积和/或改变设有反光膜13处的弧形面的结构来获得不同的出光范围,在此不再赘述。
相较于实施例1至实施例4,在所述光纤导向管1的前端设有光路调节组件,可以扩大所述医用光纤100的类型。在本实施例4中,所述医用光纤100可为侧射光纤、弥散光纤或环形光纤中的任意一种。
实施例5
本发明的另一个具体实施例,公开了一种医用光纤导向方法,采用上述医用光纤导向结构,步骤包括:
步骤1:将所述颅骨钉4按手术计划固定在规划路径上,并与颅骨200保持固定状态。
步骤2:将所述医用光纤100***所述光纤导向管1中,此时医用光纤100的前端不超过光纤导向管1的弯曲部11。所述导向管基座2一端与光纤导向管1连接,另一端安装所述密封塞5并旋紧固定盖3。
所述医用光纤100保持一个笔直的状态,是为了在所述光纤导向管1在***脑内时不会有其他物质进入光纤导向管1内引起后续堵塞。所述医用光纤100还可以在所述直管部12内实现激光消融,即所述医用光纤100的前端位于直管部12中,并不进入弯曲部11或伸出弯曲部11。
可理解地,所述医用光纤100也可以后装。
步骤3:依据手术计划,把所述光纤导向管1通过颅骨钉4***指定的位置,避让开需要避让的区域,光纤导向管1上有相应的刻度线,可以直观确认***的深度。
此时,通过拧松固定盖3来让医用光纤100与光纤导向管1之间可以单轴向平移,通过外部施加推力,可以缓慢的将医用光纤100继续往内移动,由于光纤导向管1前端的弯曲结构,医用光纤100会随着弯曲的面也跟着一起弯曲。其中弯曲的面最好是光滑的,否则可能出现卡死状态。而经过弯曲部11的医用光纤100由于自身特性的影响,又会变直,此时医用光纤100前端的发光部位到达目标病灶区域300,并巧妙的避开有阻碍物400的区域,拧紧固定盖3,可以进一步完成消融治疗。
步骤4:拧松所述固定盖3将医用光纤100向后拉,使医用光纤100的前端不超过弯曲部11,再拧松所述护套锁紧螺钉6,旋转导向管基座2以调整弧形切口111的朝向,再拧紧护套锁紧螺钉6,此时所述光纤导向管1的出口弯曲位置已经发生变化,以此再将医用光纤100伸出光纤导向管1,可以对第二区域进行消融。不仅可以在医用光纤100伸出的轴向方向上扩展消融面积,同时可以沿导向管1的径向方向上扩展消融面积。
本发明通过光纤导向管,实现医用光纤的自弯曲变形,可以避让开不合适穿刺的重要区域;通过调节光纤导向管的方向,可以进一步的扩大消融区域的范围,实现了原本需要开两个通道才能完成的消融,提高了效率;配合不同的医用光纤,可以更加方便的匹配 不同形状的病灶,完成适形消融。
值得说明的是,现有消融导管的前端(即接触病灶组织进行消融的一端)是封闭的,且只是直线型消融通道,医用光纤仅可以在该消融导管的轴向范围内活动,因此对病灶组织的消融范围只局限在该消融导管的周围的有限区域内。而本发明提供的医用光纤导向结构,所述光纤导向管1的前端为具有侧向开口(即所述的弧形切口111)的弯曲部11,所述医用光纤100从所述弯曲部11的侧向开口穿出可以实现导向弯曲。这种结构特点扩大了所述医用光纤100的活动范围,其既可以有轴向方向上的活动,又可以实现径向方向的活动,进而在单一通道内就可实现对大病灶组织的消融。同时,对于肿瘤微环境不是很理想的情况下,例如肿瘤位于脑深部、肿瘤周围具有很多重要组织、血管等,本发明所述的医用光纤导向结构还增加了避开重要组织的路径方案选择的灵活性和多样性。
实施例6
本发明的一个具体实施例,如图27-图28所示,公开了一种医用光纤导向结构,包括光纤导向管1。上述实施例中光纤导向管1的前端做成弯曲的形状来实现医用光纤100穿出时弯曲。本实施例6中,光纤导向管1是整体为管状结构的管状本体,此时要实现医用光纤100穿出时弯曲,就需要在光纤导向管1的前端侧壁上开设一开口15。
具体地,所述光纤导向管1包含第一管段和第二管段,所述第一管段具有沿轴向方向延伸设置的管腔,所述第二管段的侧壁上具有一与所述管腔连通的开口15,使得所述开口15与所述管腔连通的通道为弯曲通道16。优选地,所述管腔与所述开口15是平滑过度连接,且弯曲通道16的延伸方向和所述管腔的延伸方向之间呈一设定夹角α,设定的夹角α为钝角。
值得注意的是,第二管段的前端为穿刺头17。
所述医用光纤100或者其他取样装置(如取样针、取样器等)可以从所述开口穿出进而实现导向弯曲,且设定的夹角α优选地设置为当所述医用光纤100实现导向弯曲时,所述医用光纤100的未弯曲部分的轴线与所述医用光纤100的弯曲部分的轴线之间的夹角A介于140°~170°之间。
进一步的,所述第一管段为所述光纤导向管1的直管部12,所述第二管段为所述光纤导向管1的弯曲部11;所述医用光纤100从所述弯曲部11穿出实现导向弯曲。
实施例7
消融手术后可能会引起水肿等问题,通过清除一部分损毁的组织,可以降低风险。同时,可以在消融手术操作前和结束后,对目标组织进行取样检测,以方便对其做病理分析。
本发明的另一个具体实施例,如图29-图31所示,采用上述医用光纤导向结构,将所述医用光纤100替换为侧向取样针500,所述侧向取样针500与医用光纤导向结构的连接关系与所述医用光纤100与医用光纤导向结构的连接关系相同,在此不再赘述。
所述侧向取样针500设于所述光纤导向管1中,侧向取样针500的前端侧壁设有侧取样口501,所述侧取样口501的前端侧壁为一倾斜面502,优选地,所述倾斜面502朝向侧向取样针500的后端倾斜,使得取出侧向取样针500时,可利用所述倾斜面502从待清除组织600上割离样品,所述侧向取样针500的前端为锥形。
本实施例中,侧向取样针整体为一中空的软管,软管具有一定的强度可以保证自身的直线度,但又可以受到弯曲部的结构影响而弯曲,基本特性与光纤一致,优选的采用聚四氟乙烯管。将侧向取样针的头端做成锥形便于穿刺,一侧设有开口用于取样,开口的最前端做成锋利的切口形状,用于将样品从组织上割离。软管后端可以与负压泵连接,可以调整中空管内的压差,以吸取流质样品等。
当将侧向取样针500与医用光纤导向结构一起使用时,首先固定颅骨钉4和光纤导向管1,并确认路径,消融手术完成后,将所述医用光纤100取出,然后将侧向取样针500 从所述光纤导向管1一端***,尖端***脑内到达指示位置,此时通过侧向取样针500末端的负压泵工作,可以将待取样的组织吸附到侧向取样针500的中空部位。如果是一些脑脊液,血液等流质,可以通过缓慢吸取以达到目的,如果是一些较硬的组织,在吸附后,通过拉回侧向取样针500,用倾斜面502将组织切离以完成取样或者清除工作。
可理解地,所述侧取样口501的后端侧壁为一倾斜面,倾斜面朝向侧向取样针500的前端倾斜,当侧向取样针500进入时即可割离待清除组织600上割离样品,将其储存在所述侧向取样针500的前端中空部位,拉出侧向取样针500时不需要负压泵。
进一步的,如上述实施例的医用光纤100,侧向取样针500也可以进行径向和轴向的调整,通过多次的调节取样,可以完成不同区域的取样手术,清除消融后过多的损毁组织,也方便了医务人员对取样组织的病理分析。具体调整方式不再赘述。
再进一步的,所述侧向取样针500的侧取样口501上涂覆显影涂层,当在MR环境中进行手术时,可以通过MR扫描图像监控取样针的位置,使取样更加准确、安全,不会伤害大脑其他物质。
值得注意的是,所述侧向取样针500与上述的医用光纤100可结合使用,即在采用医用光纤100进行消融前或消融后,可使用侧向取样针500进行取样操作。
实施例8
本发明的另一个具体实施例,如图32所示,采用上述医用光纤导向结构,如果需要取样的位置比较靠近光纤导向管1或者需要取样的方位比较大,将所述医用光纤100替换为端面切口取样针700,所述端面切口取样针700与医用光纤导向结构的连接关系与所述医用光纤100与医用光纤导向结构的连接关系相同,在此不再赘述。
所述端面切口取样针700的端面取样口701(切口)设置在最前端,在***的过程中,切口便会将组织切离,并储存在所述端面切口取样针700的中空管内,抽出时,通过所述端面切口取样针700后端连接的负压泵保证中空管内的组织不会脱出,随取所述端面切口取样针700一起离开。
可理解地,如实施例7的侧向取样针500,配合医用光纤导向结构也可以径向和轴向的调节,可以较大范围的取样或者清除损毁的组织,效率高,取样方便。
值得注意的是,所述端面切口取样针700与上述的医用光纤100可结合使用,即在采用医用光纤100进行消融前或消融后,可使用端面切口取样针700进行取样操作。
实施例9
本发明的另一个具体实施例,如图33所示,采用上述医用光纤导向结构,可理解地,医用光纤导向结构还可以配合能满足要求的取样器800进行取样,取样器800为现有技术,常用于内窥镜管中,具体结构不做累述,取样器800上有丝线可以控制前端取样机的关闭和开启,在取样器800伸出光纤导向管1后,打开前端的取样器800,到达位置后通过结构拉扯关闭,然后沿着光纤导向管1退出。
值得注意的是,所述取样器800与上述的医用光纤100可结合使用,即在采用医用光纤100进行消融前或消融后,可使用取样器800进行取样操作。
需要说明的是,实施例7中的侧向取样针500、实施例8中的端面切口取样针700、实施例9中的取样器800,整体可为一软管,该软管具有一定的强度可以保证自身的直线度,但又可以受到弯曲部的结构影响而弯曲,基本特性与光纤一致,优选的采用聚四氟乙烯管。
本发明所述的光纤导向管1不仅是激光消融的手术通道,还可以在消融完成时成为侧向取样针500或端面切口取样针700或取样器800的取样通道,在同一台手术中即完成了对病灶的损毁,又可以完成对损毁后病灶的取样。此外,所述光纤导向管1的硬度远远大于所述医用光纤100、所述侧向取样针500、所述端面切口取样针700和所述取样器800的硬度。所述侧向取样针500、所述端面切口取样针700和所述取样器800均可以借助现 有技术实现,在此不做详细赘述。
以上所述,仅为本发明较佳的具体实施方式,但本发明的保护范围并不局限于此,任何熟悉本技术领域的技术人员在本发明揭露的技术范围内,可轻易想到的变化或替换,都应涵盖在本发明的保护范围之内。
Claims (10)
- 一种医用光纤导向结构,其特征在于,包含光纤导向管(1),所述光纤导向管(1)包含第一管段和第二管段;所述第一管段具有沿轴向方向延伸设置的管腔,所述第二管段具有一与所述管腔连通的开口;所述开口与所述管腔连通的延伸方向和所述管腔的延伸方向之间呈一设定夹角,所述设定夹角为钝角。
- 根据权利要求1所述的医用光纤导向结构,其特征在于,所述光纤导向管(1)内可拆卸连接有一医用光纤(100);所述医用光纤(100)可从所述开口穿出以实现导向弯曲。
- 根据权利要求1或2所述的医用光纤导向结构,其特征在于,所述第一管段为所述光纤导向管(1)的直管部(12),所述第二管段为所述光纤导向管(1)的弯曲部;所述医用光纤(100)从所述弯曲部(11)穿出实现导向弯曲。
- 根据权利要求1所述的医用光纤导向结构,其特征在于,还包括导向管基座(2)、固定盖(3)和颅骨钉(4),所述导向管基座(2)的一端设于所述颅骨钉(4)的端部内,另一端与所述固定盖(3)螺纹连接。
- 根据权利要求4所述的医用光纤导向结构,其特征在于,还包括密封塞(5),所述密封塞(5)设于所述导向管基座(2)连接有所述固定盖(3)的通孔内。
- 根据权利要求4所述的医用光纤导向结构,其特征在于,所述导向管基座(2)包括第一螺纹部(21)和光轴部(22),所述第一螺纹部(21)和光轴部(22)分别位于所述导向管基座(2)的两端,所述第一螺纹部(21)设有外螺纹。
- 根据权利要求5所述的医用光纤导向结构,其特征在于,所述导向管基座(2)的中心设有同轴且连通的第一通孔(211)、第二通孔(221)和第三通孔(231),所述第一通孔(211)和第二通孔(221)分别位于所述导向管基座(2)的两端,所述光纤导向管(1)的后端设于所述第二通孔(221)内。
- 根据权利要求7所述的医用光纤导向结构,其特征在于,所述密封塞(5)设于所述第一通孔(211)内,所述密封塞(5)的外壁与所述第一通孔(211)的内壁贴合,所述密封塞(5)的中心孔套设所述医用光纤(100)且与所述医用光纤(100)的外壁贴合。
- 根据权利要求6所述的医用光纤导向结构,其特征在于,所述颅骨钉(4)包括依次连接的第一连接部(41)、第二连接部(42)和第二螺纹部(43),所述第一连接部(41)与所述光轴部(22)连接,所述第二螺纹部(43)设有外螺纹,并与颅骨(200)连接。
- 一种医用光纤导向方法,其特征在于,采用权利要求1-9任一项所述的医用光纤导向结构,步骤包括:步骤1:将颅骨钉(4)与颅骨(200)固定连接;步骤2:将医用光纤(100)***光纤导向管(1)中,此时医用光纤(100)的前端不超过光纤导向管(1)的弯曲部(11);导向管基座(2)一端与光纤导向管(1)连接,另一端安装密封塞(5)并旋紧固定盖(3);步骤3:将光纤导向管(1)通过颅骨钉(4)***到指定的位置;拧松固定盖(3),通过外部施加推力,将医用光纤(100)向光纤导向管(1)的前端移动,使医用光纤(100)穿出弯曲部(11)并依靠弯曲部(11)改变方向;然后拧紧固定盖(3);步骤4:拧松固定盖(3)将医用光纤(100)向后拉,使医用光纤(100)的前端不超过弯曲部(11),旋转导向管基座(2)以调整弯曲部(11)的朝向,再将医用光纤(100)伸出光纤导向管(1),可以对另一区域进行消融。
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