Disclosure of Invention
The invention discloses an expansion balloon catheter which comprises a catheter and a guide wire penetrating through the interior of the catheter, wherein one end of the catheter is fixedly connected with an operation part, the outer side of the far end of the catheter far away from the operation part is coated with a balloon, a catheter cavity and a balloon inner cavity are communicated through a communication structure arranged on the catheter, the guide wire comprises a first guide wire and a second guide wire which are separated from each other in the balloon inner cavity, the rear end of the first guide wire is connected with a plug-pull structure of the operation part, and the second guide wire is fixed at the other end of the catheter through a fixing process.
Preferably, the catheter is divided into a first tube and a second tube in the tube area in the balloon, the rear end of the first tube is fixedly connected to the operation portion, the outer wall of the second tube is fixedly connected to the balloon, the cross section between the first tube and the second tube forms a communicating channel relatively, the communicating channel serves as a communicating structure to communicate the catheter cavity with the inner cavity of the balloon, and the insertion depth of the second guide wire inserted into the first tube is larger than the separation distance between the first tube and the second tube when the balloon 4 is inflated.
Furthermore, one or more through holes are arranged on the tube wall of the catheter in the balloon, the through holes are used as a communicating structure to communicate the catheter cavity with the balloon inner cavity, and the through holes 14 are arranged between the end part of the second guide wire inserted into the first tube body and the joint of the first tube body and the balloon.
Preferably, a developing ring is arranged at the connecting position of the front end of the saccule and the second pipe body, and the interior of the catheter in the area of the developing ring is closed.
Preferably, a tip catheter is arranged on one side of the catheter far away from the operating part, a second guide wire extends into the tip catheter, and the end, located in the tip catheter, of the second guide wire is 0.5mm-2mm away from the top end of the tip catheter.
Preferably, a tip catheter is arranged on one side of the catheter far away from the operating part, the second guide wire extends to the outside of the tip catheter far away from the operating part, and the part, located outside the tip catheter, of the second guide wire is arranged to be of a spheroid structure.
Preferably, the operation part comprises a handheld part, and the catheter is arranged in the handheld part in a penetrating mode to form a liquid channel communicated with the inner cavity of the balloon.
Furthermore, a two-way cock is arranged at the rear end of the handheld part, a cock through hole is arranged on a plug of the two-way cock, and when the cock through hole is coaxial with the pipe orifice of the guide pipe, a liquid channel is opened; when the cock through hole is vertical to the pipe orifice of the conduit, the liquid passage is closed.
Preferably, the outer circumference of the catheter at the rear end of the balloon is provided with scale marks.
Further, the rear end of operation portion is equipped with the external screw thread, and the screw cap can be cup jointed to the external screw thread, and the screw cap is connected with the rear end of first seal wire as plug structure, and first seal wire is extracted to the accessible dismantlement screw cap.
In summary, the dilatation balloon catheter of the present invention comprises the first guide wire and the second guide wire which are separated from each other, the first guide wire can be inserted into and pulled out from the opening at the rear end of the catheter, so that the guide wire cavity and the infusion cavity can share the same catheter cavity, and the infusion cavity does not need to be additionally arranged, or a protection film does not need to be additionally arranged on the surface of the guide wire to protect the guide wire, so that the diameter of the dilatation balloon catheter of the present embodiment is greatly reduced, so that the dilatation balloon catheter of the present invention can be inserted into a narrow tube or cavity to be dilated in a human body through an instrument channel of an endoscope, thereby realizing visual operation, and having good practical value.
Can be used for dilating the narrow tracts of the respiratory system (air passage) of the urinary system (ureter) and the digestive system (bile duct and pancreatic duct).
In order to make the aforementioned and other objects of the present invention comprehensible, preferred embodiments accompanied with figures are described in detail below.
Detailed Description
The following description of the embodiments of the present invention is provided for illustrative purposes, and other advantages and effects of the present invention will become apparent to those skilled in the art from the present disclosure.
The exemplary embodiments of the present invention will now be described with reference to the accompanying drawings, however, the present invention may be embodied in many different forms and is not limited to the embodiments described herein, which are provided for complete and complete disclosure of the present invention and to fully convey the scope of the present invention to those skilled in the art. The terminology used in the exemplary embodiments illustrated in the accompanying drawings is not intended to be limiting of the invention. In the drawings, the same units/elements are denoted by the same reference numerals.
Unless otherwise defined, terms (including technical and scientific terms) used herein have the same meaning as commonly understood by one of ordinary skill in the art to which this invention belongs. Further, it will be understood that terms, such as those defined in commonly used dictionaries, should be interpreted as having a meaning that is consistent with their meaning in the context of the relevant art and will not be interpreted in an idealized or overly formal sense.
First embodiment
As shown in fig. 1, a first embodiment of the present invention discloses an dilatation balloon catheter, which comprises a guide wire 2 penetrating through a catheter 1 and the catheter 1, wherein one end of the catheter 1 is fixedly connected with an operation part 3, a balloon 4 is arranged in the outer side of the far end of the catheter 1 far away from the operation part 3, the cavity of the catheter 1 is communicated with the inner cavity of the balloon 4 through a communication structure arranged on the catheter 1, the guide wire 2 comprises a first guide wire 21 and a second guide wire 22 which are separated from each other, the rear end of the first guide wire 21 is connected to the operation part 3 in an insertion and extraction manner through an insertion and extraction structure, and the second guide wire 22 is fixed at the other end of the catheter 1 through a fixing process.
The guide wire 2 comprises a first guide wire 21 and a second guide wire 22 which are separated from each other, the first guide wire 21 can be inserted into and pulled out of through a plug structure arranged on the operation part 3, when the dilatation balloon catheter is inserted into a human body, the first guide wire 21 can be inserted into the catheter cavity through the plug structure arranged on the operation part 3, the catheter cavity is used as a guide wire cavity for penetrating the guide wire, the guide wire is used for guiding and inserting, the first guide wire 21 can be pulled out during liquid injection, the catheter cavity is used as a liquid injection cavity for injecting liquid, so that the guide wire cavity and the liquid injection cavity can share the same catheter cavity, the liquid injection cavity is not required to be additionally arranged, or a protective film is not required to be additionally arranged on the surface of the guide wire for protecting the guide wire, therefore, the diameter of the dilatation balloon catheter of the embodiment is greatly reduced, and the dilatation balloon catheter of the embodiment can be inserted into a, and realizing the visual operation.
The liquid injected into the balloon is preferably normal saline, when the normal saline is injected into the catheter, the normal saline enters from the rear end of the catheter 1, the front end of the catheter 1 is of a closed structure, the normal saline flows out from a communication structure arranged on the catheter and is accumulated in the balloon 4, so that the balloon 4 is expanded outwards, and when the normal saline is extracted from the inside of the catheter, the balloon 4 is contracted to the original state.
Wherein, the inside hollow structure that is of pipe 1, and the front end of pipe 1 is enclosed construction, and the rear end of pipe 1 is open structure, and guide wire 2 is worn to establish inside pipe 1, and pipe 1 cavity and 4 inner chambers of sacculus are linked together by the intercommunication structure that sets up on pipe 1.
Specifically, as shown in fig. 1, in the present embodiment, the catheter 1 is separated into a first tube 11 and a second tube 12 in a tube region of the balloon 4, a rear end of the first tube 11 is fixedly connected to the operation portion 3, an outer wall of the second tube 12 is fixedly connected to the balloon 4, a cross section between the first tube 11 and the second tube 12 relatively forms a communication channel 13, and the communication channel 13 serves as a communication structure to communicate the cavity of the catheter 1 with the inner cavity of the balloon 4.
As shown in fig. 1, the rear end of the second guide wire 22 is inserted into the first tube 11 along the axis of the catheter 1, the insertion depth of the second guide wire 22 into the first tube 11 is greater than the separation distance between the first tube 11 and the second tube 12 when the balloon 4 is inflated, when the second tube 12 is longitudinally displaced forward, the second guide wire 22 is longitudinally displaced forward together with the first tube 11, the first tube 11 is relatively displaced backward along the axis of the catheter 1 at this time, because the second guide wire 22 extends from the inside of the second tube 12 to the inside of the first tube 11, and the insertion depth of the second guide wire 22 into the first tube 11 is greater than the separation distance between the first tube 11 and the second tube 12 when the balloon 4 is inflated, it can be ensured that the whole catheter does not bend and deform at the cross section of the catheter, and good connection and guidance effects are achieved.
In this embodiment, since the catheter 1 is divided into two sections in the area of the balloon 4, during the injection process, the balloon 4 expands outward and lengthways extends, and the second tube 12 can also longitudinally move forward, so that the balloon 4 cannot bend due to the pulling deformation of the catheter, and after the balloon 4 is inserted into a narrow tube or a cavity such as a ureter in a human body, the balloon can expand uniformly, and the stress on each side wall of the narrow tube or the cavity is uniform. The pipe 1 of having avoided among the prior art is a whole by the separation design of two sections pipes, when 4 expansions of sacculus vertically extend, pipe 1 becomes vertical tensile deformation, because the material of pipe 1 and sacculus 4 is different, the sacculus bending deformation after the deformation of pipe 1 can make the inflation, the power of strutting on surface is inhomogeneous when leading to 4 expansions of sacculus, make the narrow body or each lateral wall atress of cavity that need expand in the human body uneven, cause the effect of diagnosing not good, arouse that the patient is more uncomfortable.
The second guide wire 22 is inserted into the first tube 11, and the second guide wire 22 is inserted into the first tube 11 to a depth greater than the separation distance between the first tube 11 and the second tube 12 when the balloon 4 is inflated. The second guide wire 22 can be ensured not to be separated from the first tube body 11 when the balloon 4 is expanded, so that the first tube body 11 and the second tube body 12 are basically kept on the central axis of the catheter 1 when being separated, and further the balloon 4 is ensured not to be bent and deformed when being expanded, so that the stress on each side wall of the narrow tube body or the cavity to be expanded is more uniform, and the diagnosis and treatment effect is greatly improved.
The communicating channel 13 can serve as a communicating structure to communicate the cavity of the catheter 1 with the inner cavity of the balloon 4, so that the guide wire cavity and the liquid injection cavity can share the same catheter cavity, the diameter of the dilatation balloon catheter of the embodiment is greatly reduced, and the dilatation balloon catheter of the embodiment can be inserted into a narrow catheter body or cavity needing to be dilated in a human body through an instrument channel of the endoscope, so that visual operation is realized; can also prevent the air bag 4 from bending and deforming when being injected with liquid for expansion, and has good treatment effect.
One or more through holes 14 are further formed in the tube wall of the first tube body 11 in the balloon 4, and the through holes 14 serve as a communicating structure to communicate the cavity of the first tube body 11 with the inner cavity of the balloon 4. The through hole 14 is provided between the end of the second guide wire 22 inserted into the first tube 11 and the connection between the first tube 11 and the balloon 4, that is, the through hole 14 is provided on the side of the end of the second guide wire 22 inserted into the first tube 11 near the operation portion 3.
In addition, the through hole 14 can be used as a communicating structure to communicate the cavity of the catheter 1 with the balloon 4, so that the guide wire cavity and the liquid injection cavity can share the same catheter cavity, and the diameter of the dilatation balloon catheter of the embodiment is greatly reduced. In addition, when the first guide wire 21 is connected to the insertion and extraction structure of the operation unit 3 and the first tube 11 is drawn out for injection, the first guide wire 21 and the second guide wire 22 do not block the through hole 14, so that the speed of expansion of injection can be greatly increased.
Preferably, as shown in fig. 1, a developing ring 5 is disposed at a connection position of the front end of the balloon 4 and the second tube 12, and in order to determine an accurate position of the balloon 4 moving inside the tube or cavity of the human body when an instrument channel of the endoscope is unavailable, the position of the balloon 4 inside the tube or cavity of the human body can be determined by the developing ring through an X-ray radiography and video recording technology, so as to monitor the position inside the tube or cavity of the human body, thereby achieving the purpose of diagnosis and treatment.
Similarly, a second developing ring (not shown) may be disposed at the connection position of the rear end of the balloon 4 and the catheter 1 according to the requirement, and the two developing rings may be disposed to determine the position of the balloon 4 in the body or cavity of the human body more clearly through the X-ray radiography and video recording technology.
Further, the second guide wire 22 is fixedly connected to the inner side of the developing ring 5 by a fixing process, which includes glue fixing or thermal fusion fixing, or other fixing structures or fixing components may be used to fixedly connect the two.
Furthermore, the interior of the catheter in the coating area of the developing ring 5 is sealed, so that the injected liquid can not enter the front of the developing ring and can only stay in the balloon behind the developing ring 5, the liquid injection speed is accelerated, and the operation time is further shortened.
In this embodiment, the conduit between the developing ring 5 and the operating portion 3 is usually made of PEEK, and nylon, polyvinylamine, or other materials may be used, preferably PEEK material; the PEEK material has the advantages of thin diameter and good rigidity, so that the size of the conduit behind the developing ring can reach 0.6-1.5 mm, preferably 0.7-1.0 mm, and optimally 0.8 mm; the shore hardness of the conduit can reach 50D-95D; preferably 80D to 90D. The PEEK material can ensure the guide effect of the catheter and further reduce the diameter of the catheter, thereby improving the diagnosis and treatment effect and reducing the pain of patients.
Preferably, as shown in fig. 1, a tip catheter 23 may be disposed on a side of the catheter 1 away from the operation portion 3, the second guide wire 22 extends into the tip catheter 23, a front end of the tip catheter 23 exceeds a top of the second guide wire 22 by about 0.5mm-2mm, that is, a distance from an end of the second guide wire 22 located in the tip catheter 23 to a top end of the tip catheter 23 at a front end of the development ring is 0.5mm-2mm, in an embodiment of the present invention, the tip catheter 23 is made of a soft polymer material, preferably TPU. The tip catheter 23 is made of soft materials, so that damage to the inner wall of the ureter caused by insertion of hard materials can be avoided, the probability of successful operation is improved, and meanwhile, the tip catheter 23 also comprises a part of second guide wires 22 inside, so that the tip catheter has certain rigidity and can guide the catheter to be inserted into a human body. The length range of the front end of the tip catheter 23 exceeding the top of the guide wire is 0.5mm-2mm, if the length is less than 0.5mm, the second guide wire 22 is easy to puncture the top of the catheter in the insertion process, and if the length is more than 2mm, the front end of the catheter is too soft to be inserted, so the length of 0.5mm-2mm is a proper range.
Furthermore, the tip of the tip catheter 23 may be a spheroid structure, and the smooth spherical surface of the spheroid structure may guide the catheter to be inserted into the elongated catheter inserted into the human body to damage the tube or the wall of the cavity.
As shown in fig. 1, in the first embodiment of the present invention, graduation marks are further provided on the outer circumferential surface of the catheter 1 at the rear end of the balloon 4, and the graduation marks may be equidistant graduation marks, so that the insertion depth of the balloon 4 can be observed through endoscopic visualization, and conventionally, the position of the balloon is determined by determining the position of a visualization ring through X-rays. Therefore, in the embodiment of the present invention, only one developing ring 5 can be provided as a spare, the position can be determined by endoscopic development and calibration in a normal case, and the accurate position of catheter insertion can be determined by using the developing ring 5 to assist X-ray only when the scale lines are not clearly seen.
Preferably, the outer wall of the catheter 1 in front of the operation part 3 is provided with scale marks, such as 60cm, 80cm and 100cm shown in fig. 1, for marking the distance of the catheter entering the internal cavity of the human body, and the operator can visually observe the inserted length of the catheter through the scale marks.
The guide wire 2 of the present embodiment is preferably a metal guide wire, and the metal guide wire may be made of a metal material such as nickel-titanium alloy or stainless steel, and more preferably nickel-titanium alloy. Nitinol is a shape memory alloy, which is a special alloy that can automatically return its plastic deformation to its original shape at a certain temperature. The expansion and contraction rate of the stainless steel is more than 20%, the fatigue life of the stainless steel reaches 7 th power of 1 x 10, the damping characteristic of the stainless steel is 10 times higher than that of a common spring, and the corrosion resistance of the stainless steel is superior to that of the best medical stainless steel at present, so that the stainless steel can meet the application requirements of various engineering and medicine, and is a very excellent functional material. The memory alloy has the unique shape memory function, and also has the excellent characteristics of wear resistance, corrosion resistance, high damping, superelasticity and the like. The nickel-titanium alloy is used as the metal guide wire, so that the service life of the instrument can be greatly prolonged, and the loss rate of the instrument is reduced.
As shown in fig. 3, the operation portion 3 of the dilatation balloon catheter of the present embodiment includes a hand-held portion 31, and the catheter is inserted into the hand-held portion 31 to form an injection liquid passage communicating with the inner cavity of the balloon 4. The design of the hand-held portion 31 is convenient for the operator to hold and operate. Further, as can be seen from fig. 1, the handheld portion 31 is a conical body structure, that is, as shown in the figure, the diameter of the handheld portion 31 gradually and smoothly decreases from the rear end to the front end, and the design of the conical body structure conforms to the ergonomic design, so that the operator can hold the dilation balloon catheter to operate more conveniently and comfortably. It will be appreciated by those skilled in the art that the shape of the handheld portion 31 is not limited to the conical shape illustrated in the present embodiment, and may be designed in other shapes to facilitate handheld operation.
Preferably, a two-way cock 32 is arranged at the rear end of the handheld part 31, a cock through hole is arranged on a cock of the two-way cock 32, and the cock of the two-way cock is rotated to open the liquid channel when the cock through hole is coaxial with the nozzle of the catheter 1; when the tap through hole is perpendicular to the orifice of the catheter 1, the liquid passage is closed. As shown in fig. 1, the two-way cock 32 is fixed to the rear end of the hand-held portion by a nut, and an injection instrument is connected to the two-way cock 32, and when the two-way cock is rotated to open the liquid passage, liquid can be injected through the inside of the catheter cavity of the injection instrument, and in practice, the injection instrument can be used with a water injection pump of 20 atmospheres; when the two-way cock is rotated to close the liquid channel, on one hand, external pollutants, dust and the like can be prevented from entering the ureter through the catheter 1 to cause the infection of the thin film on the inner wall of the ureter, and on the other hand, the expansion pressure can be maintained to prevent the liquid in the balloon 4 from flowing out, so that the shape of the plugging balloon 4 is stable. Compared with the existing injection structure, the two-way cock 32 has the advantages that the opening or closing of the injection inlet is controlled by pushing and pulling the handle or other structures, the connection between the handle and the catheter is non-fixed, and the handle is easy to damage when being continuously pushed and pulled; the two-way catheter 32 of the present invention opens and closes the liquid channel by rotating, and has simple structure, easy operation and prolonged service life.
As shown in fig. 3, the end of the handle 31 and the end of the two-way cock 32 are both standard null interfaces, which can be used to connect an injection device such as a water injection pump. The Null interface has strong universality and can be configured with different appliances.
Furthermore, the rear end of the operation part 3 is provided with an external thread 33, the external thread 33 can be sleeved with a screw cap 35, and the screw cap is connected with the rear end of the first guide wire 21 as a plug structure, so that an operator can screw the screw cap 32 to drive the first guide wire 21 to move outwards in the operation process, and then the first guide wire is pulled out; or after the first guide wire is inserted, the screw cap 35 is screwed to be fixed to the external thread 33. It will be appreciated by those skilled in the art that the insertion and extraction structure of the first guide wire 21 is not limited to the screw cap provided in the present embodiment, but includes other insertion and extraction structures that can achieve the same function.
As shown in fig. 3, the operation unit 3 further includes a stress diffusion tube 34, the stress diffusion tube 34 is provided at the distal end of the hand-held portion 31, and the catheter 1 is inserted into the stress diffusion tube 34. The function of the device is to avoid the damage of the catheter 1 caused by overlarge stress from the base, improve the operation hand feeling of an operator and prevent the cost loss caused by the loss of the device. The stress diffusion tube is cylindrical or conical with a hollow inner part, the outer diameter of the conical body is gradually reduced towards the back and towards the front, the stress diffusion tube can be smoothly transited and connected with the handheld part 31 in shape, the stress is more uniform, and the appearance is more attractive.
Second embodiment
The second embodiment of the invention discloses an expansion balloon catheter, which comprises a guide wire 2 arranged in the catheter 1 in a penetrating manner, wherein one end of the catheter 1 is fixedly connected with an operation part 3, a balloon 4 is arranged in the outer side of the far end of the catheter 1 far away from the operation part 3, the cavity of the catheter 1 is communicated with the inner cavity of the balloon 4 through a communication structure arranged on the catheter 1, the guide wire 2 comprises a first guide wire 21 and a second guide wire 22 which are separated from each other, the rear end of the first guide wire 21 is connected with a plug-pull structure at the rear end of the operation part 3, and the second guide wire 22 is fixed in the catheter 1 through a fixing process.
This embodiment is a modification of the first embodiment, and as shown in fig. 2, is different from the first embodiment in that: the side of the catheter 1 far away from the operating part 3 is provided with a tip catheter 23, the second guide wire 22 far away from the operating part 3 extends to the outside of the tip catheter 23, and the part of the second guide wire 22 outside the tip catheter 23 is provided with a spheroid structure 6, namely the head of the second guide wire 22 is welded or integrally formed with the spheroid structure 6, namely the guide wire with a ball head is formed.
This achieves the following effects: 1. the material of the conduit is reduced, and the cost is reduced; 2. the thinner guide wire can better play a role in guiding in the insertion process; 3. the design of the spheroid structure furthest avoids the friction damage to the inner wall of the ureter caused by the insertion of the long guide wire. Preferably, the guide wire 2 is a metal guide wire, and the metal guide wire may be made of a metal material such as nitinol or stainless steel, and more preferably nitinol. Nitinol is a shape memory alloy, which is a special alloy that can automatically return its plastic deformation to its original shape at a certain temperature. The expansion and contraction rate of the stainless steel is more than 20%, the fatigue life of the stainless steel reaches 7 th power of 1 x 10, the damping characteristic of the stainless steel is 10 times higher than that of a common spring, and the corrosion resistance of the stainless steel is superior to that of the best medical stainless steel at present, so that the stainless steel can meet the application requirements of various engineering and medicine, and is a very excellent functional material. The memory alloy has the unique shape memory function, and also has the excellent characteristics of wear resistance, corrosion resistance, high damping, superelasticity and the like. The nickel-titanium alloy is used as the metal guide wire, so that the service life of the instrument can be greatly prolonged, and the loss rate of the instrument is reduced.
In summary, the dilatation balloon catheter provided by the invention comprises the first guide wire and the second guide wire which are separated from each other, the first guide wire can be inserted into and pulled out of the opening at the rear end of the catheter, so that the guide wire cavity and the liquid injection cavity can share the same catheter cavity, the liquid injection cavity does not need to be additionally arranged, or a protective film does not need to be additionally arranged on the surface of the guide wire to protect the guide wire, the diameter of the dilatation balloon catheter provided by the invention is greatly reduced, the dilatation balloon catheter can be inserted into a narrow tube body or cavity needing to be dilated in a human body through an instrument channel of an endoscope, the visualization operation is realized, and the endoscope has a good practical value.
The dilatation balloon catheter can be used for dilatation of body lumen stenosis of a urinary system (ureter), a digestive system (bile duct and pancreatic duct) and a respiratory system (airway), but is not limited to the dilatation, and the dilatation balloon catheter can also be used as a plugging device, for example, the front end of the catheter 1 is inserted into a gap between the ureter wall and a calculus, when the upstream of the calculus reaches even a large renal pelvis, a first guide wire can be pulled out from an opening at the rear end of the catheter, the catheter is used as a liquid injection cavity to inject physiological saline, so that the balloon 4 entering the upstream of the calculus or the renal pelvis is dilated and is expanded and plugged in the upstream ureter of the calculus, and fragments and flushing liquid of the downstream calculus cannot enter the renal pelvis, and the escape of ureter calculus stones is prevented; or after the saccule of the renal pelvis cavity is expanded, the near end of the catheter 1 is properly pulled to block the renal pelvis outlet at the junction of the renal pelvis and the ureter, so that stones, stone fragments and washing liquid of any ureter cannot enter the renal pelvis cavity, then the stone breaking treatment of the ureter stones is carried out, for example, the laser optical fiber stone breaking is carried out, after the stone treatment is finished, the liquid in the saccule is extracted, and then the catheter is extracted. In actual operation, can select many times expansion sacculus to adjust the sacculus size for the sacculus is laminated with ureter inner wall better, and closely shutoff ureter calculus prevents that the ureter rubble from escaping upward, and the operation of being convenient for improves the rubble success rate. .
In addition, the above-described embodiments of the present invention are merely illustrative of the principles and effects of the present invention, and are not to be construed as limiting the present invention. Modifications and variations can be made to the above-described embodiments by those skilled in the art without departing from the spirit and scope of the present invention. Accordingly, it is intended that all equivalent modifications or changes be made by those skilled in the art without departing from the spirit and technical spirit of the present invention, and be covered by the claims of the present invention.