Disclosure of Invention
The invention aims to provide a medical sheath, a ureter guiding sheath and a ureter operation system, which are used for solving the problem that the design scheme of the perfusion channel on the existing sheath cannot meet clinical requirements, namely the sheath has the smallest outer diameter and the sheath has the largest inner diameter.
In order to achieve the above object, the present invention provides the following solutions:
The invention provides a medical sheath tube, which comprises a sheath tube main body, wherein the sheath tube main body is provided with:
The main channel is arranged in the sheath tube main body and is used for allowing fluid or surgical instruments to pass through;
The secondary channel comprises a free part which is easy to deform and a connecting part which is contacted with the sheath body, the secondary channel is provided with a channel inlet and a channel outlet, when the initial state of the secondary channel is in a closed state, fluid or surgical instruments are filled into the secondary channel to deform the free part so as to prop up the secondary channel to an open state, and when the initial state of the secondary channel is in the open state, the free part is pressed by external force so as to deform the secondary channel to be extruded to the closed state.
Optionally, the main channel extends along an axial direction of the sheath body and penetrates through two axial ends of the sheath body.
Optionally, the secondary channel is formed by connecting at least one long sheet-shaped secondary channel component with the tube wall of the sheath tube main body, the connecting part is formed at the connecting part of the secondary channel component and the sheath tube main body, the free part is formed at the rest part of the secondary channel component, the channel inlet is formed at the position of the secondary channel, which is close to the axial first end of the sheath tube main body, and the channel outlet is formed at the position of the secondary channel, which is close to the axial second end of the sheath tube main body.
Optionally, the secondary channel is formed by sleeving or sleeving a long thin-wall tubular secondary channel part in the sheath body, the connecting part is formed at the connecting part of the secondary channel part and the tube wall of the sheath body, the free part is formed at the rest part of the secondary channel part, the channel inlet is formed at the position of the secondary channel, which is close to the axial first end of the sheath body, and the channel outlet is formed at the position of the secondary channel, which is close to the axial second end of the sheath body.
Optionally, the secondary channel is formed by connecting at least one thin-wall fire-fighting water ribbon-shaped secondary channel component with the tube wall of the sheath tube main body, the connecting part is formed at the connecting part of the secondary channel component and the sheath tube main body, the tube wall of the secondary channel component forms the free part, the channel inlet is formed at the position of the secondary channel, which is close to the axial first end of the sheath tube main body, and the channel outlet is formed at the position of the secondary channel, which is close to the axial second end of the sheath tube main body.
Optionally, the secondary channel member is integrally formed with the sheath body.
Optionally, the secondary channel is formed by a thin-wall protruding part formed by co-extrusion with the sheath body, and the thin-wall protruding part serves as the free part and protrudes into or out of the cavity of the sheath body.
Optionally, the secondary channel extends along the axial direction of the sheath body, and the secondary channel is disposed on the outer wall or the inner wall of the sheath body, or is disposed on the outer wall and the inner wall of the sheath body at the same time.
Optionally, the secondary channel member is integrally formed with the sheath body.
Optionally, the secondary channel component is folded at the axial second end of the sheath body to form a folded part, the folded part wraps the axial second end of the sheath body from the inner side and the outer side, and the channel outlet is opened at the folded part.
Optionally, the channel outlets are distributed at least one of a first position, a second position and a third position of the turnup, wherein the first position is located on a part of the turnup located on the outer wall of the sheath body, the second position is located on a part of the turnup located on the inner wall of the sheath body, and the third position is located on a turnup of the turnup.
Optionally, the two ends of the secondary channel part extend to the two axial ends of the sheath body respectively, and are not longer than the two axial ends of the sheath body.
Optionally, the connection portion is formed by combining one or more of a point connection portion, a sheet connection portion and a linear connection portion.
Optionally, a temperature sensor and/or a pressure sensor are further arranged on the sheath tube main body.
Optionally, one secondary channel is arranged on the sheath tube main body, or a plurality of secondary channels are arranged on the sheath tube main body along the circumferential direction of the sheath tube main body.
Optionally, the sheath body is uniformly distributed with a plurality of secondary channels along the circumferential direction of the sheath body.
Optionally, one end of the sheath body for extending into the body cavity is provided as a bendable section.
Optionally, the medical sheath is a vascular sheath, an airway sheath, a lacrimal sheath, an ear canal sheath, a digestive tract sheath or a ureteral sheath.
Optionally, a hydrophilic coating is attached to the inner wall surface and/or the outer wall surface of the sheath body.
The invention also provides a ureteral guiding sheath, which comprises a connector and the medical sheath tube, wherein the connector is provided with a guiding channel, one end of the guiding channel is sleeved on one axial end of the sheath tube main body through a tube connecting structure, the tube connecting structure is provided with a buffer cavity in sealing butt joint with the channel inlet, and the connector is also provided with a filling port communicated with the buffer cavity and a fluid outlet communicated with the main channel.
Optionally, the fluid outlet is provided with a pressure regulating structure.
Optionally, the buffer cavities are arranged in one-to-one correspondence with the secondary channels, all the buffer cavities are isolated from each other, and any one buffer cavity is correspondingly communicated with one filling port;
or the buffer cavity is a continuous annular cavity channel arranged along the circumferential direction of the sheath tube main body, and the channel inlet of any secondary channel is communicated with the buffer cavity.
Optionally, an end of the sheath tube main body facing away from the tube connection structure is provided as a bendable section, and the ureteral guiding sheath further comprises a bending adjustment mechanism for controlling the bending degree of the bendable section.
Optionally, the bending adjustment mechanism is disposed on the joint.
The invention also provides a ureteral operation system, which comprises the ureteral guide sheath, and further comprises at least one of perfusion equipment, an endoscope, a lithotripsy optical fiber, a long conical inner core, negative pressure suction equipment and a guide wire.
Optionally, the ureteral guiding sheath comprises a long conical inner core, and the long conical inner core is sleeved in the main channel of the medical sheath.
Optionally, a hydrophilic coating is attached to the front end of the long conical inner core.
Compared with the prior art, the invention has the following technical effects:
The medical sheath tube provided by the invention has novel and reasonable structure, can realize the basic guiding function of the sheath tube by arranging the main channel, is mainly used for the medical instruments to pass through, provides guiding, protecting and other corresponding functions for the medical instruments such as various soft mirrors, various hard mirrors, various non-endoscope catheters and the like positioned in the sheath tube, can meet the fluid perfusion or surgical instrument passing function of the sheath tube by arranging the secondary channel, simultaneously, as the free part of the secondary channel can deform according to different application scenes, realizes the closable function of the secondary channel, the normal channel function of the secondary channel can be reserved when the secondary channel is opened, and the free part which is easy to deform can deform and be attached to the tube wall (inner wall or outer wall) of the sheath tube main body when the secondary channel is closed, so that the secondary channel is arranged on the outer wall of the sheath tube main body, the space of the main channel in the sheath tube main body is not occupied by the secondary channel, the influence of the secondary channel on the normal passing of the instruments or fluid in the main channel can be effectively avoided, and the requirements of the outer diameter of the sheath tube as small as possible on the outer diameter of the sheath tube main body are met.
In some aspects of the disclosure, the distal end of the medical sheath is provided with a bendable section. By adopting the flexible design scheme, the problem that the traditional sheath tube cannot be bent to cause the damage to the human body cavity such as ureter and blood vessel is solved, and meanwhile, the problem that the lavage liquid is not smoothly drained in the operation due to the fact that the sheath placement position is not in place can be avoided, and the efficiency and the safety of the operation can be improved.
The ureteral guiding sheath provided by the invention comprises the medical sheath tube, has all the characteristics of the medical sheath tube, and is not described in detail.
The ureteral operation system provided by the invention has the characteristics of a medical sheath tube, and is not described in detail.
Drawings
In order to more clearly illustrate the embodiments of the present invention or the technical solutions in the prior art, the drawings that are needed in the embodiments will be briefly described below, and it is obvious that the drawings in the following description are only some embodiments of the present invention, and other drawings may be obtained according to these drawings without inventive effort for a person skilled in the art.
Fig. 1 is a schematic view of the overall structure of a ureteral surgical system according to an embodiment of the present invention;
fig. 2 is a schematic cross-sectional view of the ureteral surgical system of fig. 1;
FIG. 3 is an enlarged schematic view of FIG. 2A;
Fig. 4 is a schematic view of the overall structure of a ureteral introducer sheath without a bending adjustment mechanism according to an embodiment of the present invention;
fig. 5 is a schematic cross-sectional view of the ureteral introducer sheath of fig. 4;
fig. 6 is a schematic view of the overall structure of a ureteral introducer sheath with a bend adjustment mechanism according to an embodiment of the present disclosure;
fig. 7 is a schematic cross-sectional view of the ureteral introducer sheath of fig. 6;
FIG. 8 is an enlarged schematic view of the structure shown at B in FIG. 7;
FIG. 9 is a schematic diagram of a secondary channel end outlet in a sheath body according to an embodiment of the present invention;
FIG. 10 is a schematic diagram of the structure of the water outlet outside the secondary channel in the sheath body according to the embodiment of the present invention;
FIG. 11 is a schematic diagram of a structure in which the end and the outer side of the secondary channel in the sheath body are simultaneously discharged according to the embodiment of the present invention;
FIG. 12 is a schematic view showing a secondary channel according to an embodiment of the present invention disposed on an inner wall of a sheath body;
FIG. 13 is a schematic view illustrating a secondary channel according to an embodiment of the present invention disposed on an outer wall of a sheath body;
FIG. 14 is a schematic cross-sectional view of a sheath body according to an embodiment of the present invention;
FIG. 15 is a schematic view of a structure of a hinge disclosed in an embodiment of the present invention, wherein a channel outlet is provided at the hinge;
FIG. 16 is a schematic diagram of the outlet of the channel shown in FIG. 15;
FIG. 17 is a schematic view of a structure of a hinge disclosed in an embodiment of the present invention, wherein a channel outlet is provided at both the hinge and the outside;
FIG. 18 is a schematic diagram of the outlet of the channel of FIG. 17;
FIG. 19 is a schematic view of a structure in which channel outlets are simultaneously disposed at a turnup and outside of a turnup, and the channel outlets are spirally distributed outside the turnup according to an embodiment of the present invention;
FIG. 20 is a schematic diagram of the outlet of the channel of FIG. 19;
FIG. 21 is a schematic view of a structure of a sheath body with secondary channels formed on the inner wall thereof and a turnover part according to an embodiment of the present invention;
FIG. 22 is an enlarged schematic view of FIG. 21C;
FIG. 23 is a schematic view showing the structure of section D-D of FIG. 21 when the secondary channel member is a long sheet channel member according to an embodiment of the present invention;
FIG. 24 is a schematic view showing the structure of section D-D of FIG. 21 when the secondary channel member is a long thin-walled tubular channel member according to an embodiment of the present invention;
FIG. 25 is a schematic view of the cross-sectional D-D structure of FIG. 21 when the secondary channel element disclosed in the embodiment of the present invention is a thin-walled fire-fighting water ribbon channel element;
FIG. 26 is a schematic cross-sectional view of a secondary channel according to an embodiment of the present invention when the inner wall of the sheath body is uniformly circumferentially distributed;
FIG. 27 is a schematic cross-sectional view of a secondary channel according to an embodiment of the present invention when the outer wall of the sheath body is uniformly circumferentially distributed;
FIG. 28 is a schematic view of a connection portion of a secondary channel according to an embodiment of the present invention;
Fig. 29 is a schematic structural view of a connection portion of a secondary channel according to an embodiment of the present invention;
FIG. 30 is a schematic view of a connection portion of a secondary channel according to an embodiment of the present invention;
fig. 31 is a schematic view of the operation of a disclosed guidewire in accordance with an embodiment of the present invention as it is deployed into the renal pelvis;
fig. 32 is a schematic view of the ureteral introducer sheath of the present disclosure as it is being placed along a guidewire into the renal pelvis;
Fig. 33 is a schematic view of a ureteral introducer sheath according to an embodiment of the present invention after placement in the renal pelvis;
fig. 34 is a schematic view of a ureteral introducer sheath according to an embodiment of the present disclosure, with the sheath body reaching a stone;
Fig. 35 is a schematic view of the operation of the disclosed lithotripsy fiber along the main passageway of the sheath body into the renal pelvis in accordance with an embodiment of the present invention;
Fig. 36 is a schematic view illustrating an operation of the endoscope when the distal end of the endoscope is withdrawn from the sheath body according to the embodiment of the present invention.
Wherein, the reference numerals are as follows:
100. 200 ureter guiding sheath;
1. A sheath body, 11, a sensor mounting hole, 12, a bendable section;
2. A main channel;
3. secondary channel, 31, free part, 32, connecting part, 321, point-like connecting part, 322, sheet-like connecting part, 323, linear connecting part, 33, channel inlet, 34, channel outlet, 35, long sheet channel member, 36, long thin wall tubular channel member, 37, thin wall fire water band channel member, 38, turnover part;
4. Joint, 41, guide channel, 42, pipe connection structure, 421, buffer cavity, 43, filling port, 44, fluid discharge port, 45, pressure regulating structure, 46, sealing cap;
5. a bending adjusting mechanism 51, a traction rope;
6. A long conical inner core;
7. Renal pelvis;
8. a guide wire.
Detailed Description
The following description of the embodiments of the present invention will be made clearly and completely with reference to the accompanying drawings, in which it is apparent that the embodiments described are only some embodiments of the present invention, but not all embodiments. All other embodiments, which can be made by those skilled in the art based on the embodiments of the invention without making any inventive effort, are intended to be within the scope of the invention.
The invention aims to provide a medical sheath tube so as to solve the problem that the design scheme of a perfusion channel on the existing sheath tube cannot meet clinical requirements, namely the outer diameter of the sheath tube is as small as possible and the inner diameter of the sheath tube is as large as possible.
Another object of the present invention is to provide a ureteral introducer sheath having the above medical sheath.
It is still another object of the present invention to provide a ureteral surgical system having the ureteral introducer sheath described above.
In order that the above-recited objects, features and advantages of the present invention will become more readily apparent, a more particular description of the invention will be rendered by reference to the appended drawings and appended detailed description.
Example 1
As shown in fig. 1 to 14, the present embodiment provides a medical sheath, which includes a sheath body 1, and the sheath body 1 has a main channel 2 and a secondary channel 3, wherein the main channel 2 is opened in the sheath body 1 to form an inner cavity of the sheath body 1, the main channel 2 is generally disposed along an axial direction of the sheath body 1 and is used for passing fluid or a surgical instrument, the secondary channel 3 includes a free portion 31 that is easy to deform and a connection portion 32 that is in contact with and connected to the sheath body 1, the secondary channel 3 has a channel inlet 33 and a channel outlet 34, when an initial state of the secondary channel 3 is in a closed state, the free portion 31 is deformed by filling fluid or the surgical instrument into the secondary channel through the channel inlet 33 to open the secondary channel 3, whereas when the initial state of the secondary channel 3 is in an open state, an external force is applied (when the secondary channel 3 is disposed on an inner wall of the sheath body 1, so-called "external force" is a squeezing force generated on the secondary channel 3 when the main channel 2 normally passes through the fluid or the surgical instrument), and when the secondary channel 3 is disposed on an outer wall of the sheath body 1, the body "is in a state of the sheath body" is in a state of the free state, the free channel 31 is capable of being deformed by the human body. The medical sheath tube can realize the basic guiding function of the sheath tube by arranging the main channel 2, mainly for the medical instruments to pass through, and provide guiding, protecting and other corresponding functions for the medical instruments such as various soft mirrors, various hard mirrors, various non-endoscope catheters and the like positioned in the sheath tube, and can meet the fluid filling or auxiliary instrument passing function of the sheath tube by arranging the secondary channel 3 at the periphery of the main channel 2, meanwhile, as the free part 31 of the secondary channel 3 can deform according to different application scenes, the closable function of the secondary channel 3 is realized, the secondary channel 3 is opened to keep the normal channel function, the free part 31 which is easy to deform when the secondary channel 3 is closed can deform to be attached to the wall (inner wall or outer wall) of the sheath tube main body 1, so that the outer wall of the sheath tube main body 1 of the secondary channel 3 is arranged at the outer wall of the sheath tube main body 1, the space of the main channel 2 in the sheath tube main body 1 is not occupied by the secondary channel 3, and the influence of the secondary channel on the normal passing of the instruments or fluid in the main channel 2 can be effectively avoided. It should be noted that, according to actual use requirements, the fluids that can be communicated in the main channel 2 and the secondary channel 3 may be the same or different, and the fluids may be liquid, liquid-solid mixed state or paste state with flowing performance, the secondary channel 3 is mainly perfusate, and the main channel 2 is generally filled with a washing liquid or perfusate containing impurities such as stones, pathological tissues and the like.
The secondary channel 3 is closed, and does not mean that the channel inlet 33 and the channel outlet 34 of the secondary channel 3 are closed to the outside communication state, but means that the internal space of the secondary channel 3 is eliminated, so that the internal space of the main channel 2 is not occupied or the outer diameter of the sheath body 1 is enlarged.
In this embodiment, the two ends of the main channel 2 are open, and the two end openings of the main channel 2 may be located at two axial end portions of the sheath body 1 (i.e., the two ends of the main channel 2 are respectively disposed through two axial ends of the sheath body 1), at this time, the sheath body 1 is a pipe with two open ends. The sheath body 1 may have at least one closed end, and the opening of the main channel 2 at the corresponding end is opened at the side wall of the sheath body 1 near the closed end. As a preferable scheme, two ends of the main channel 2 in the scheme respectively penetrate through two axial ends of the sheath tube main body 1, and the channel wall of the main channel 2 is the inner wall of the sheath tube main body 1. The primary channel 2 has a larger average cross-sectional area or internal volume than the secondary channel 3 in the situation of use.
In this embodiment, the secondary channel 3 may be provided only on the outer wall of the sheath body 1, only on the inner wall of the sheath body 1, or both the inner and outer walls of the sheath body 1. In view of the small diameter of the sheath body 1 itself and high requirement for dimensional accuracy of the structure, it is generally only necessary to provide the secondary channel 3 on the outer wall or the inner wall of the sheath body 1.
Further, in this embodiment, the secondary channel 3 is formed by connecting at least one long sheet-like secondary channel component with the tube wall (inner wall or outer wall) of the sheath tube main body 1, the secondary channel component is a long sheet-like channel component 35, the connection portion 32 is formed at the connection portion of the long sheet-like channel component 35 and the sheath tube main body 1, the rest portion of the long sheet-like channel component 35 is not connected with the sheath tube main body 1 to form the free portion 31, the size of the gap between the free portion 31 and the tube wall of the sheath tube main body 1 is different according to the deformation state of the free portion 31, and it should be noted that the deformation of the free portion 31 can be realized by the elastic property of the material of the long sheet-like channel component 35 itself, for example, the long sheet-like channel component 35 is made of a compliant material (such as PVC, latex, silica gel) or a semi-compliant material, and the elastic deformation of the long sheet-like channel component 35 is mainly represented by a thinned wall thickness and a volume. The deformation of the free portion 31 may also be achieved by changing the position of the free portion 31, for example, the long sheet channel member 35 is made of a non-compliant material (such as Polyethylene (PE), polyurethane, nylon (Nylon, duralynTM) and polyethylene terephthalate), at this time, the long sheet channel member 35 has poor elasticity, and is attached to the wall of the sheath body 1, so that the free portion 31 can be closed, and fluid or an instrument is introduced into the secondary channel 3, so that the free portion 31 can be expanded, and when the free portion 31 is converted between the closed state and the expanded state, the wall thickness is basically unchanged, but is driven by an external force to change the position, thereby changing the shape. As can be seen from the above description, the difference between the non-compliant material and the semi-compliant material is that the free portion 31 made of the compliant material and the semi-compliant material can automatically rebound to be attached to the wall of the sheath body 1 after the fluid or the instrument is withdrawn, so as to realize the closing, and the free portion 31 made of the non-compliant material can be restored to be attached to the wall of the sheath body 1 by an external force after the fluid or the instrument is withdrawn, so as to realize the closing. The secondary channel 3 is closed to the extent that it can be fully closed or can be mostly closed, at least without significantly affecting the internal space of the primary channel 2 or excessively increasing the outer diameter of the sheath body 1.
In general, the long sheet passage member 35 extends in the axial direction of the sheath body 1, and may be parallel to the axial direction of the sheath body 1 or may be spirally wound around the axis of the sheath body 1 on the wall of the sheath body 1. Preferably, the long sheet passage member 35 is arranged parallel to the axial direction of the sheath body 1, and correspondingly, the secondary passage 3 formed between the long sheet passage member 35 and the sheath body 1 is also arranged parallel to the axial direction of the sheath body 1. Both sides in the width direction of the long sheet passage member 35 are connected to the wall of the sheath body 1 to form the connection portions 32, and the connection portions 32 extend entirely in the axial direction of the sheath body 1, and in general, the number of secondary passages 3 formed between one long sheet passage member 35 and the sheath body 1 can be adjusted by changing the number of connection portions 32 formed by connection between the long sheet passage member 35 and the sheath body 1, and it is generally preferable that only one secondary passage 3 is formed between one long sheet passage member 35 and the sheath body 1 every two adjacent connection portions 32. The secondary channel 3 is provided with a channel inlet 33 at a position close to the axial first end (the end far from the affected part and close to the doctor, also called as "proximal end") of the sheath body 1 during operation, and the secondary channel 3 is provided with a channel outlet 34 at a position close to the axial second end (the end far from the doctor, also called as "distal end") of the sheath body 1 during operation. The channel inlet 33 and the channel outlet 34 may be formed in the free portion 31 of the long sheet channel member 35 or may be formed in the wall of the sheath body 1 at the corresponding position, depending on the positions of the long sheet channel member 35 provided on the inner and outer walls of the sheath body 1.
Further, in this embodiment, a long sheet channel member 35 may be provided on the sheath body 1 according to actual requirements, and a secondary channel 3 is correspondingly formed, and since the sheath body 1 is generally a circular tube, it is preferable that the secondary channel 3 spans 1/4 to 1/3 of the circular arc of the entire circumference of the sheath body 1. Accordingly, a plurality of long sheet passage members 35 may be arranged on the sheath body 1 in the circumferential direction thereof as required, each long sheet passage member 35 forming one secondary passage 3. As a further preferable aspect, when a plurality of secondary channels 3 are provided on the sheath body 1, they are preferably uniformly distributed at intervals along the circumferential direction of the sheath body 1.
In the present embodiment, the connection portion 32 formed by connecting the long sheet passage member 35 to the wall of the sheath body 1 is preferably formed by combining one or more of the dot-shaped connection portion 321, the sheet-shaped connection portion 322, and the linear connection portion 323. The connecting portion 32 is formed by a single longer linear connecting portion 323 or by a plurality of shorter linear connecting portions 323 connected in series as shown in fig. 28, the connecting portion 32 is formed by a plurality of dot-shaped connecting portions 321 arranged along the axial direction of the sheath main body 1 as shown in fig. 29, the connecting portion 32 is formed by a single longer sheet-shaped connecting portion 322 or by a plurality of shorter sheet-shaped connecting portions 322 connected in series as shown in fig. 30, and the sheet-shaped connecting portion 322 has a larger width and is connected more firmly than the linear connecting portion 323. In addition to the above arrangement, the connection portion 32 may be formed by combining a plurality of the dot-shaped connection portions 321, the sheet-shaped connection portions 322, and the linear connection portions 323, for example, one half of the dot-shaped connection portions 321 and the other half of the line-shaped connection portions 323 are provided, and the dot-shaped connection portions 321, the sheet-shaped connection portions 322, and the linear connection portions 323 constituting the connection portion 32 may be regularly arranged or irregularly arranged as needed, as long as the secondary channels 3 can be sealed. The dot-shaped connecting portion 321, the sheet-shaped connecting portion 322, and the linear connecting portion 323 may be directly connected to the sheath body 1 by the long sheet passage member 35 by a bonding or welding process, or may be connected by other connecting members.
In the actual production process, the long sheet channel member 35 may also be directly integrally formed with the sheath body 1, such as integrally extruded, where the long sheet channel member 35 is closed with the sheath body 1 is used as the connecting portion 32, and where the long sheet channel member 35 is separated from the sheath body 1 is used as the engaging and disengaging portion 31 of the long sheet channel member 35.
In this embodiment, the two ends of the long sheet channel member 35 generally extend to the two axial ends of the sheath body 1 respectively and are not longer than the two axial ends of the sheath body 1, and correspondingly, the secondary channel 3 also extends to the two axial ends of the sheath body 1 and is not longer than the two axial ends of the sheath body 1. As shown in fig. 9-11, in the structure of the long sheet channel member 35 disposed on the inner wall of the sheath body 1, one end of the long sheet channel member 35 near the proximal end of the sheath body 1 is in close connection with the inner wall of the sheath body 1, the channel inlet 33 of any one secondary channel 3 is opened on the side wall of the proximal end of the sheath body 1 and is communicated with the interior of the secondary channel 3, one end of the long sheet channel member 35 near the distal end of the sheath body 1 can be in close connection with the inner wall of the sheath body 1, and at this time, the channel outlet 34 of any one secondary channel 3 is opened on the side wall of the distal end of the sheath body 1, so as to realize the water outlet mode of the outer side of the distal end of the sheath. The long sheet channel part 35 can be arranged at one end close to the far end of the sheath tube main body 1 (namely, the long sheet channel part 35 is not closed with the inner wall of the sheath tube main body 1), the opening can be used as a channel outlet 34 to directly drain water to realize a water outlet mode at the far end of the sheath tube, and in order to improve the flushing, rotary suction and the like effects brought by the liquid outlet at the far end of the sheath tube, the channel outlet 34 can be formed on the side wall of the far end of the sheath tube main body 1 on the basis of keeping the opening of the end of the secondary channel 3, so that the water outlet mode at the outer side part and the end of the far end of the sheath tube is realized. According to the use requirement, a channel outlet 34 can be formed in the free part of the long sheet channel part 35, which is close to the distal end of the sheath tube main body 1, so as to realize the internal water outlet of the distal end of the sheath tube, and the internal water outlet mode can be simultaneously realized by matching with the end water outlet mode and the outer side water outlet mode. When the side wall of the distal end of the sheath tube main body 1 is provided with the channel outlets 34, the channel outlets 34 can be uniformly distributed in the axial direction and the circumferential direction of the sheath tube main body 1, and can also be spirally distributed around the axial direction of the sheath tube main body 1 so as to realize rotational flow water outlet. The channel outlet 34 is additionally arranged on the side wall of the distal end of the sheath tube main body 1, so that the distal end of the sheath tube main body 1 is softer and is easier to bend to enter a non-straight cavity such as a renal pelvis through UPJ.
When the long sheet channel member 35 is disposed on the inner wall of the sheath tube body 1, in addition to the above-described arrangement form of the long sheet channel member 35, one end of the long sheet channel member 35 located at the distal end of the sheath tube body 1 may be further folded and connected with the distal end of the sheath tube body 1 to form a folded portion 38, the folded portion 38 wraps the distal end of the sheath tube body 1 from the inner side and the outer side, the channel outlet 34 is opened in the folded portion 38, and specifically, the channel outlet 34 is distributed in at least one of a first position, a second position and a third position of the folded portion 38, where the first position is located on a portion of the folded portion 38 located on the outer wall of the sheath tube body 1, the second position is located on a portion of the folded portion 38 located on the inner wall of the sheath tube body 1, and the third position is located at the folded portion 38. As shown in fig. 15 and 16, the channel outlet 34 is opened at the third position of the turndown 38, that is, the channel outlet 34 is located at the turndown position of the turndown 38, so that the water outlet mode of the distal end of the sheath tube can be realized. As shown in fig. 17 and 18, the channel outlet 34 is opened at the first position and the third position of the turnup portion 38 at the same time, that is, the channel outlet 34 is located at the portion of the turnup portion 38 located at the outer wall of the sheath body 1 and the turnup portion of the turnup portion 38, so that the mode of simultaneously discharging water from the outer side and the end of the distal end of the sheath can be realized. As shown in fig. 19 and 20, the difference from the solutions shown in fig. 17 and 18 is that the channel outlets 34 are spirally distributed on the portion of the turnup 38 located on the outer wall of the sheath tube main body 1, so that when the mode of simultaneously discharging water from the outer side and the end of the distal end of the sheath tube is realized, the rotational flow water discharge can be further realized. When the long sheet channel member 35 is connected to the distal end of the sheath body 1 by folding, the inner and outer sides of the sheath body 1 are communicated by providing a water hole in the wall of the sheath body 1, as shown in fig. 17, the end of the long sheet channel member 35 and the inner wall of the distal end of the sheath body 1 are sealed to form an inner sealing portion, and then folded outwards, and finally the edge of the end of the long sheet channel member 35 and the outer wall of the distal end of the sheath body 1 are sealed to form an outer sealing portion, as shown in fig. 17, a height difference is formed between the outer sealing portion and the inner sealing portion, the inner sealing portion is located above the outer sealing portion, and a water hole is provided in the side wall of the sheath body 1 between the inner sealing portion and the outer sealing portion, so that the liquid in the secondary channel 3 in the sheath body 1 is drained into the cavity between the distal end of the sheath body 1 and the folded portion 38, and then the liquid is discharged through the folded portion 38 or the outer channel outlet 34.
In this embodiment, when the long sheet channel member 35 is disposed on the outer wall of the sheath body 1, the form (including the form of forming the turndown portion and the form of forming the turndown portion of the long sheet channel member 35 extending only to the end of the sheath body 1, and not forming the turndown portion) is substantially the same as that when the long sheet channel member 35 is disposed on the inner wall of the sheath body 1, the difference is that the long sheet channel member 35 is disposed outside the sheath body 1, the opening position of the channel outlet 34 is adaptively changed (the channel outlet 34 is mostly directly opened on the free portion of the long sheet channel member 35), and the rest is the same as that when the long sheet channel member 35 is disposed on the inner wall of the sheath body 1, which will not be described in detail.
It should be noted that the long sheet passage member 35 is a layer of a complete material that is attached to the wall of the sheath body 1 so as not to leak. The cross section of the formed secondary channel 3 can be any shape such as a circle, an ellipse and the like in the open state.
In this embodiment, a temperature sensor and/or a pressure sensor may be further provided on the sheath body 1 as needed. As shown in fig. 14, a sensor mounting hole 11 is formed in the wall of the sheath tube body 1, and a temperature sensor and/or a pressure sensor can be mounted.
In this embodiment, the sheath body 1 may be provided as a tearable sheath (also referred to as a tearable sheath). The inner wall surface and/or the outer wall surface of the sheath body 1 may be further provided with a hydrophilic coating.
In this embodiment, the medical sheath may be applied in a natural lumen including a blood vessel, an airway, a lacrimal passage, an auditory canal, and a digestive tract, or in a third gap of a living body, as required, that is, the medical sheath may be used as a vascular sheath, an airway sheath, a lacrimal passage sheath, an auditory canal sheath, a digestive canal sheath, or a ureteral sheath, so as to achieve different clinical use forms.
In the use process of the medical sheath, when the medical instrument in the main channel 2 completely withdraws or retreats to the proximal end position of the main channel 2, fluid can be injected into the secondary channel 3 from outside and flows out through the channel outlet 34 of the secondary channel 3 to play a corresponding medical role in drug delivery such as flushing, antibiosis, anticoagulation and the like, and a tubular medical tool can be inserted into the secondary channel 3 to play a corresponding medical role in suction, flushing, drug delivery, image acquisition, tissue ablation and the like. The principle and effect of the use of the medical sheath as a ureteral sheath will be described specifically below by taking the aforementioned medical sheath as an example of a urological operation.
In the medical sheath, since the free portion 31 in each secondary channel 3 is in a closable structure, a dynamic gap (which can be opened or closed as required) is formed between the free portion 31 and the inner wall of the sheath body 1. When the endoscope (generally a soft mirror) works in the main channel 2 of the sheath tube main body 1, when no liquid is injected into the secondary channel 3, the free part 31 of the endoscope is in an attached state tightly attached to the inner wall of the sheath tube main body 1, the internal space of the main channel 2 is basically not occupied, when the broken stone is to a certain extent, the endoscope is retracted to the near end of the main channel 2, a large enough space is reserved for attracting the broken stone, and meanwhile, the liquid is poured into the secondary channel 3 through the channel inlet 33, so that the free part 31 of the secondary channel 3 is expanded by the water pressure, and is in a free state to be in fluid pouring, and in the pouring process, the expansion degree of the free part 31 can be controlled by controlling the size of the fluid flow rate in combination with the deformation characteristic of the free part 31, so as to further control the size of the internal space of the main channel 2, and further meet the requirement of balanced pouring amount and fluid discharge amount in operation. By the technical scheme, the ureteral sheath tube not only can discharge gravels with larger sizes, but also can realize continuous perfusion, so that fluid perfusion and fluid discharge in operation are performed simultaneously, and meanwhile, the secondary channel 3 adopts a closable design and can be kept in a closed state when fluid is not filled, so that the problems that the existing perfusion channel is formed in the inner sheath wall, the volume is fixed, the volume is not reduced even if the fluid is not filled, the inner sheath space is occupied, and the operation of a soft lens is influenced are solved.
In addition, in most cases, the initial state of the secondary channel 3 is a closed state, no gas is retained in the channel, the gas is not brought into the renal pelvis during perfusion, the physiological function of the renal pelvis is not damaged, meanwhile, additional air enters the body, the heat dissipation in the laser treatment process is not facilitated, bacteria are easy to survive and propagate on a gas/liquid interface instead, and infection is easy to occur.
Example 2
The present embodiment proposes a medical sheath, which is different from the first embodiment only in that the secondary channel part adopts a long thin-walled tube shape different from the long thin-walled tube shape of the long thin-sheet channel part 35, that is, the secondary channel 3 is formed by sleeving or sleeving the long thin-walled tube-shaped channel part 36 with the sheath body 1, the connection part 32 is formed at the connection part of the long thin-walled tube-shaped channel part 36 and the tube wall of the sheath body 1, and the free part 31 is formed at the rest part of the long thin-walled tube-shaped channel part 36. The arrangement form of the long sheet passage members 35 can be changed by changing the number and arrangement positions of the long sheet passage members 35 to change the arrangement number and arrangement form of the secondary passages 3 on the sheath main body 1, and it is possible to realize only partial arrangement of the secondary passages 3 on the sheath main body 1. The long thin-wall tubular channel member 36 is different from the sheath tube main body 1, and the whole of the long thin-wall tubular channel member 36 can be sleeved outside the sheath tube main body 1 or inside the sheath tube main body 1, and the annular cavity between the long thin-wall tubular channel member 36 and the sheath tube main body 1 can be integrally used as the secondary channel 3, or the whole annular cavity can be divided into a plurality of mutually independent secondary channels 3 by connecting part of the long thin-wall tubular channel member 36 with the wall of the sheath tube main body 1 to form the connecting part 32. The plurality of secondary channels 3 formed are preferably each arranged parallel to the axial direction of the sheath body 1.
The arrangement of the connecting portion 32 between the long thin-walled tubular passage member 36 and the sheath body 1, the arrangement of the passage outlet 34, the arrangement of the passage inlet 33, and the like are all in communication with the first embodiment, and detailed description thereof will be omitted.
In this embodiment, the long thin-walled tubular channel member 36 may also be integrally formed with the sheath body 1, such as co-extrusion, so that the application field and practical application effect of the medical sheath are the same as those of the first embodiment, and detailed descriptions thereof are omitted herein.
Example 3
The present embodiment proposes a medical sheath, which is different from the first embodiment only in that the secondary channel part adopts a thin-wall fire-fighting water band shape different from the long sheet channel part 35, that is, the secondary channel 3 is formed by connecting at least one thin-wall fire-fighting water band-shaped channel part 37 with the tube wall of the sheath body 1, and the thin-wall fire-fighting water band-shaped channel part 37 is a soft tube structure, which can be expanded when fluid or an instrument is introduced, and is in a collapsed closed state after the fluid or the instrument is discharged. In this scheme, the junction of the thin-wall fire-fighting water band-shaped channel part 37 and the sheath main body 1 forms a connecting part 32, the wall of the thin-wall fire-fighting water band-shaped channel part 37 forms a free part 31, and the inner pipeline of the thin-wall fire-fighting water band-shaped channel part 37 is exactly the secondary channel 3. The thin-walled fire-fighting water band channel members 37 may be uniformly distributed in the circumferential direction of the sheath body 1, or may be arranged only locally in the sheath body 1, as in the long sheet channel members 35.
In this embodiment, the connection portion 32 between the thin-wall fire-fighting water band-shaped channel member 37 and the sheath tube main body 1, the channel outlet 34 and the channel inlet 33 are all in communication with the first embodiment, and detailed description thereof will be omitted.
In this embodiment, the thin-wall fire-fighting water band-shaped channel member 37 may also be integrally formed with the sheath body 1, such as co-extrusion, so that the application field and practical application effect of the medical sheath are the same as those of the first embodiment, and detailed descriptions thereof are omitted herein.
Example 4
The present embodiment proposes a medical sheath, which differs from the first embodiment only in that the secondary channel 3 is constituted by a thin-walled protruding portion co-extruded with the sheath body 1, i.e. the secondary channel 3 is integrally formed with the sheath body 1. The extruded thin-walled protruding portion serves as a free portion 31, which protrudes into or out of the lumen of the sheath body 1. When the thin-wall protruding part is detected to the cavity of the sheath tube main body 1 in the initial state and the secondary channel 3 is in an open state, the thin-wall protruding part can be pressed by medical instruments or fluid entering the main channel 2 to deform, so that the thin-wall protruding part is attached to the inner wall of the main channel 2 connected with the thin-wall protruding part, the secondary channel 3 is in a closed state, the inner space of the main channel 2 is not occupied, the entrance and exit of medical instruments or fluid and the like in the main channel 2 are not influenced, when the thin-wall protruding part is detected to the cavity of the sheath tube main body 1 in the initial state and the secondary channel 3 is in the open state, when the sheath tube main body 1 enters a natural cavity of a human body and the like in use, the outward thin-wall protruding part is pressed by the inner surface of the natural cavity to deform, so that the thin-wall protruding part is attached to the outer wall of the sheath tube main body 1 connected with the thin-wall protruding part, and the secondary channel 3 is in the closed state, and the outer diameter of the sheath tube main body 1 is not enlarged. The secondary channel 3 is closed, and does not mean that the channel inlet 33 and the channel outlet 34 of the secondary channel 3 are closed to the outside communication state, but means that the internal space of the secondary channel 3 is eliminated, so that the internal space of the main channel 2 is not occupied or the outer diameter of the sheath body 1 is enlarged.
The secondary channels 3 may be provided in the same manner as the long sheet channel members 35, and may be uniformly distributed in the circumferential direction of the sheath body 1, or may be arranged only partially in the sheath body 1.
In this embodiment, the arrangement of the channel outlet 34 and the arrangement of the channel inlet 33 on the secondary channel 3 are all in communication with the first embodiment, and detailed description thereof will be omitted herein.
In this embodiment, the application field and the practical application effect of the medical sheath are the same as those of the first embodiment, and detailed descriptions thereof are omitted herein.
Example 5
In this embodiment, on the basis of the medical sheath disclosed in any one of embodiments 1 to 4, one end, i.e., the distal end, of the sheath body 1 for extending into the body cavity is provided as a bendable section 12. The bendable section 12 can be bent passively under external pressure such as a physiological cavity or the like, or can be bent actively by an active steering knob or slider. In addition, in the medical sheath, a plurality of secondary channels 3 are generally uniformly distributed in the circumferential direction of the sheath body 1, even if the bendable section 12 at the distal end of the sheath body 1 is bent, the secondary channels 3 at the bending points are extruded, and part of the secondary channels 3 still exist at one side of the sheath body 1, which is far away from the bending direction, so that the normal function of perfusion fluid can be ensured.
The distal end of the medical sheath tube adopts a bendable design scheme, so that the problem that the traditional ureter guiding sheath cannot be bent to cause ureter injury is solved, the problem that the lavage liquid in operation is not smooth due to the fact that the sheath placement position is not in place can be avoided, and the efficiency and the safety of ureter surgery can be improved.
Example 6
The embodiment provides a ureteral guiding sheath 200, which comprises a joint 4 and a medical sheath tube as disclosed in any one of embodiments 1-4, wherein a guiding channel 41 is formed on the joint 4, one end of the guiding channel 41 is sleeved at one axial end (namely the proximal end) of the sheath tube main body 1 through a tube connecting structure 42, a buffer cavity 421 in sealing butt joint with a channel inlet 33 is formed on the tube connecting structure 42, and a filling port 43 communicated with the buffer cavity 421 and a fluid outlet 44 communicated with the main channel 2 are also formed on the joint 4. The fluid discharge port 44 is also provided with a pressure regulating structure 45. The fluid outlet 44 is typically connected to a negative pressure device, and the pressure regulating structure 45 can regulate the magnitude of the negative pressure suction. The pressure adjusting structure 45 adopts a conventional pressure adjusting structure, such as a negative pressure valve, and the like, which will not be described herein.
In this embodiment, the buffer chamber 421 may serve as a fluid buffer. The buffer chambers 421 can be disposed in one-to-one correspondence with the secondary channels 3, and all the buffer chambers 421 are isolated from each other, and any buffer chamber 421 is correspondingly connected to a filling port 43. In addition to this form, the buffer chamber 421 may be provided as a continuous annular chamber channel arranged along the circumferential direction of the sheath body 1, with the channel inlet 33 of any one of the secondary channels 3 communicating with the buffer chamber 421. Only one filling port 43 is provided in the joint 4 and is in communication with the buffer chamber 421. The preferred buffer chamber 421 of this embodiment is a continuous annular channel, and by injecting fluid into the single injection port 43, all secondary channels 3 can be simultaneously injected, which is beneficial to improving the operation efficiency and the operation effect.
In this embodiment, the guide channel 41 is the main channel of the connector 4, and the filling port 43 and the fluid discharge port 44 are branch channels provided in the guide channel 41. Surgical instruments and the like used in surgery are generally introduced into the main channel 2 of the medical sheath through the guide channel 41. In the unused state, the end of the guide channel 41, which is far away from the pipe connecting structure 42, is provided with a sealing cap 46 for sealing, so that the dustproof effect is achieved.
When the ureter guiding sheath 200 is adopted for urinary surgery, the sheath body 1 is firstly placed into the renal pelvis 7, the matched endoscope or accessory enters the target position of the renal pelvis 7 through the main channel 2, the perfusion opening 43 is externally connected with perfusion liquid (the perfusion liquid can be injected into the perfusion opening 43 through perfusion equipment, manual work, natural gravity and the like), the fluid outlet 44 can be connected with external negative pressure equipment, and the pressure regulating structure 45 can regulate the pressure in the renal pelvis according to the requirement. When the broken stone reaches a certain degree, the endoscope is retracted to the near end of the main channel 2, a large enough space is reserved for attracting the broken stone, and the liquid can be poured into the channel inlet 33 through the pouring opening 43, so that the free part 31 of the secondary channel 3 is expanded by the water pressure to be in a spreading free state, and the requirement of balanced pouring quantity and backwater quantity in operation is met. Simultaneously, the liquid drives the crushed stone to be discharged out of the body through the main channel 2 and the fluid discharge port 44 in sequence. Since the space in the main channel 2 is not occupied, the reflux amount of the fluid in the sheath can be ensured.
Example 7
On the basis of embodiment 6, in the ureteral guiding sheath 200 proposed in this embodiment, one end, i.e., the distal end, of the sheath body 1 for extending into the human body lumen is provided as the bendable section 12. The bendable section 12 can be bent passively under external pressure such as a physiological cavity or the like, and can be bent actively by actively controlling the bending adjustment mechanism 5. In addition, in the medical sheath, a plurality of secondary channels 3 are generally uniformly distributed in the circumferential direction of the sheath body 1, and even if the bendable section 12 at the distal end of the sheath body 1 is bent, part of the secondary channels 3 still exist at one side of the sheath body 1 deviating from the bending direction to keep normal functions, so that the normal circulation of perfusion fluid can be ensured.
In this embodiment, the bending adjustment mechanism 5 may be disposed separately from the joint 4, or may be disposed directly on the joint 4. In order to promote integration, compactness and portability of the ureteral introducer sheath 200, it is preferred that the bending adjustment mechanism 5 is provided on the adapter 4 and on the wall of the guiding channel 41. The bending adjustment mechanism 5 comprises a haulage rope 51 and a haulage rope haulage mechanism, wherein the haulage rope 51 is arranged in the sheath body 1 in a penetrating way and is attached to the inner wall of the sheath body 1, and the haulage rope 51 does not influence the passage of fluid or instruments in the main channel 2. The traction rope 51 is preferably a soft metal wire, such as an iron wire, a copper wire, etc., one end of the traction rope 51 is connected with the bendable section 12, and the other end is connected with a traction rope traction mechanism, and the traction rope traction mechanism can regulate and control the bending degree of the bendable section 12 by pushing and pulling the traction rope 51 (can control the bendable section 12 to be bent into an arc with a central angle of 180-270 degrees, and can also control the bendable section 12 to be restored to a flat state). The traction rope traction mechanism can be a sliding block which is in sliding connection with the pipe wall of the guide channel 41, the sliding block can slide along the axial direction of the guide channel 41 to linearly push and pull the traction rope 51, and the traction rope traction mechanism can also be a knob which is in rotating connection with the pipe wall of the guide channel 41, and the winding and unwinding of the traction rope 51 on the rotary shaft of the knob can be realized by rotating the knob, so that the effect of dragging the bendable section 12 is achieved. In practice, the bending direction and degree of bending of the bendable section 12 can be controlled by adjusting the number of the traction ropes 51 or the connection position of the traction ropes 51 and the bendable section 12.
The distal end of the medical sheath tube adopts a bendable design scheme, so that the problem that the traditional ureter guiding sheath cannot be bent to cause ureter injury is solved, the problem that the lavage liquid in operation is not smooth due to the fact that the sheath placement position is not in place can be avoided, and the efficiency and the safety of ureter surgery can be improved.
Example 8
This embodiment proposes a ureteral surgical system 100 comprising, as disclosed in embodiment 7, a ureteral introducer sheath 200, in addition to at least one of a perfusion apparatus (supplying perfusion fluid), an endoscope, a lithotripsy fiber, a long conical inner core 6, a negative pressure suction apparatus, and a guidewire 8. Wherein the long conical inner core 6 is generally sleeved in the main channel 2 of the medical sheath, and the front end (distal end) of the long conical inner core 6 is generally attached with a hydrophilic coating.
The ureteral operation system 100 includes a ureteral guide sheath 200, an endoscope (typically, a ureteroscope), a lithotripsy fiber, a long tapered inner core 6, a negative pressure suction device, and a guide wire 8 as disclosed in example 7, and a method of using the same will be specifically described. When the ureteral surgical system 100 is used, the steps are as follows:
step 1, as shown in fig. 31, a guide wire 8 is placed into the renal pelvis 7 using an associated medical instrument;
Step 2, as shown in fig. 32, inserting a guide wire 8 into the central hole of the guide sheath dilator, and inserting the guide ureter guide sheath 200 into the renal pelvis 7 along the guide wire 8 and reaching the target position;
step 3, as shown in fig. 33, the dilator is withdrawn, the negative pressure suction device is connected with the fluid discharge port 44, and the perfusion device is connected with the perfusion port 43;
step 4, opening the negative pressure suction equipment and the perfusion equipment;
step 5, introducing an endoscope and other auxiliary instruments into the main channel 2, and pushing the distal end of the sheath tube main body 1 in the ureter guiding sheath 200 to reach the calculus in an endoscope visual state, wherein as shown in fig. 34, the bendable section 12 is bent in the process that the distal end of the sheath tube main body 1 reaches the calculus, and the bending process can be assisted by the bending adjusting mechanism 5;
step 6, as shown in fig. 35, the lithotripsy optical fiber enters the renal pelvis 7 along the endoscope working channel to lithotripsy the target calculus, and the lithotripsy optical fiber is sequentially discharged outside the body through the sheath gap and the fluid outlet 44 under the suction of negative pressure;
step 7, as shown in fig. 36, when there is crushed stone which cannot be discharged from the sheath gap, the endoscope can be withdrawn to the tail end position of the joint 4, but the endoscope is not completely withdrawn, so that the front end of the endoscope is made to leave the communication port between the fluid discharge port 44 and the joint 4, and the crushed stone is prevented from being influenced to be discharged from the fluid discharge port 44;
And 8, completely withdrawing the endoscope from the guiding sheath after the broken stone is discharged, and adjusting the bending degree and the bending direction of the bendable section 12 by the bending adjusting mechanism 5 in an auxiliary way to realize the safe withdrawal of the sheath body 1 in the renal pelvis 7 in the ureter guiding sheath 200.
Therefore, the ureteral operation system 100 of the present embodiment can perform perfusion and suction simultaneously during the operation process, so as to greatly improve the operation efficiency and shorten the operation time.
It should be noted that it will be apparent to those skilled in the art that the present invention is not limited to the details of the above-described exemplary embodiments, but may be embodied in other specific forms without departing from the spirit or essential characteristics thereof. The present embodiments are therefore to be considered in all respects as illustrative and not restrictive, the scope of the invention being indicated by the appended claims rather than by the foregoing description, and all changes which come within the meaning and range of equivalency of the claims are therefore intended to be embraced therein.
The principles and embodiments of the present invention have been described in detail with reference to specific examples, which are provided herein to facilitate understanding of the principles and embodiments of the present invention and to provide further advantages and practical applications for those of ordinary skill in the art in light of the present teachings. In view of the foregoing, this description should not be construed as limiting the invention.