JPH03501219A - Slanted cavity catheter - Google Patents

Abstract

(57) [Summary] This bulletin contains application data before electronic filing, so abstract data is not recorded.

Description

[Detailed description of the invention] a plurality of spaced spaced holes located at the forward end of the body spaced from the tip; a hole such that a portion of the wall of the body is visible when viewed perpendicular to the axis of the body; When the catheter is slightly stretched with the stylet, the hole will not open automatically. The wall of the body is angled such that the foramen reopens when the body closes and releases tension on the catheter. extends through the catheter, thereby minimizing tissue damage during insertion of the catheter and minimizing tissue damage. This prevents growth within the lumen of the catheter, thereby preventing growth from within the lumen system or The catheter improves fluid flow into the cavity.

2. The catheter of claim 1, wherein the hole is relative to the longitudinal axis of the body. A catheter characterized in that it extends through the wall at an angle of about 35 degrees.

3. The catheter of claim 1, wherein the hole is about 120 mm with respect to the periphery of the body. A catheter characterized in that it is arranged in degree-spaced rows.

4. The catheter according to claim 1, wherein the front end of the main body has at least the hole. made of a wireless non-conductive material in a surrounding area to allow the catheter to be placed within the lumen system. A catheter characterized in that it facilitates monitoring during treatment.

5. The catheter according to claim 1, wherein the main body is adapted to be inserted into a forward end of the catheter. A catheter characterized in that it includes means for indicating depth.

6. A catheter according to claim 5, wherein said means monitor the position of the catheter. A catheter characterized in that it includes a marker made of a wireless non-conductive material for facilitating .

7. Using a method that brings the brain within the cavity of the human brain close to the cerebrospinal fluid.

The process of drilling an orifice into the skull just anterior to the pupillary suture line of the skull.

The guide assembly guides the catheter tangentially to the skull at the orifice location. guiding the catheter in a direction perpendicular to a plane defined by the catheter. The tube is accurately drilled into the cavity at the initial insertion point to minimize brain tissue damage and The tether has a wall thickness sufficient to contain and transport fluid therein and is inserted into the cavity. a plurality of chips provided at the forward end and spaced apart from the chip; holes spaced apart from each other, each said hole extending from said wall when viewed perpendicularly to the axis of said body. Extends through the wall thickness at an angle such that part of the thickness is visible; This allows the location and shape of the catheter pore to be determined by the villous tissue or ependymal structure. Preventing or minimizing tissue growth and increasing fluid flow into or out of the cavity. The method described above, characterized in that it enables.

8. The method of claim 7, wherein the guide assembly comprises a tubular means and a guide assembly for the tubular means. a support means, the method further comprising: supporting means surrounding the orifice in a spaced apart manner; Place the catheter loosely on the human skull and orifice through the tubular means. the supporting means and the tubular means being operated by the tubular means. Oriented at right angles to the imaginary plane defined by the tangent to the skull at the location of the refice. Relates so that the catheter is guided through the orifice in a direction independent of the orifice The method, characterized in that:

9. The method of claim 7, wherein the tubular means is provided with a support arm comprising a plurality of legs of equal length. supporting by steps and inserting a removable insert into the tubular means; and reducing the diameter of the.

10. In the method according to claim 7, a stylus is provided to assist in catheter insertion. Use a wire to stretch the catheter so that the hole is flat, and then The method further comprises the step of further reducing tissue damage.

11. The method according to claim 7, wherein the main body of the catheter is located at the front end of the catheter. the method includes means for directing the insertion depth of the catheter into the lumen; The method, characterized in that it includes the step of inserting the same depth.

12. The method according to claim 11, wherein the indicating means includes a radio non-conductive mark. and wherein the method includes the step of monitoring the position of the catheter within the cavity. The said method as a characteristic.

13. An apparatus for manufacturing a hollow elongated member having a plurality of holes, A hollow elongated member is inserted into the plurality of holes at predetermined positions to form the plurality of holes. a second hollow elongated member including means for forming the hollow elongated member in the position, orientation and predetermined dimensions; an element, the hole forming means of the second element being guided by the first element and having at least is also partially accommodated to achieve said predetermined position, orientation and dimension. The said device having a characteristic.

14. The apparatus of claim 13, wherein the second element is within a hollow elongate member. means for cutting the plurality of holes in the first element, the cutting means cutting one or more holes in the first element. are received and guided within matching holes, whereby said plurality of holes are placed in predetermined positions. , an orientation and a dimension.

15. The apparatus of claim 14, wherein the cutting means comprises a plurality of elongated tubes. , the first element is of a slightly larger diameter and length than the hollow elongated member. each includes a retaining block having one elongated hole, so that said member is easily and removable. a plurality of aligned holes of the cutting means; It has dimensions corresponding to the number of tubes and slightly larger, which makes it easier for the reading tube to be attached to and removed from the container. removably cutting the hole through the hollow elongated member at a predetermined angle; The device characterized in that:

16. The apparatus of claim 13, wherein the first element is a retaining assembly. , means for supporting a portion of the hollow elongated member near the location where the hole is formed; , support means substantially completely surrounding the hollow elongated member; provided adjacent the support means to guidely direct the first element through the support means; means for cutting into contact with the hollow elongated member at a predetermined angle; and said directing means; operatively associated with the support means to pre-preserve a portion of the hollow elongate member relative to the second element; and the second element includes a cutting assembly. The device characterized by:

17. The apparatus of claim 16, wherein the retaining assembly is smaller than the hollow elongated member. an elongated hole of very large dimensions, the member being easily and removably inserted into the hole; said directing means corresponds to said rod but has a slightly larger size. The rod can be easily and removably penetrated to cut the hole into the hollow elongated member. The directing means has three sets of elongated holes, and each The pairs are spaced apart from each other and extend 120 degrees along the circumference of the hollow elongated member. The device is characterized in that it is provided with holes spaced apart in stripes.

18. The apparatus of claim 16, wherein the positioning means comprises the hollow elongate member. to prevent the end of the block from being inserted beyond a predetermined point into the elongated hole of the retaining block. the retaining block is a machined metal cube; said elongated hole extends along a diagonal through the center of the cube; extend along a diagonal across the face of the cube of the holding block, and the directing means three sets of elongate holes, each set being spaced apart from each other and extending through the hollow elongate member; said hole being provided with holes spaced about 120 degrees along the periphery of said Device.

19. The apparatus of claim 13, wherein the second element is located within the hollow elongate section. and a removable insert having an elongated body forming a hollow interior portion of the timber.

a plurality of rond-like members extending from the main body to form the plurality of holes; The first element partially accommodates the rond-like member and supports the insert as a hollow member. 12. The device, characterized in that it includes a plurality of alignment holes positioned within the holding means.

20. The apparatus of claim 19, wherein the first element has an open end and a closed end. the insert is introduced into said cylinder from the open end; A polymerizable liquid is formed by forming a hollow space corresponding to the dimensions of the perforated elongated member. is introduced from the open end and hardens within the hollow space, thereby curing the perforated hollow space. The device, characterized in that a material is formed.

21. The apparatus of claim 13, wherein the first element is a mold assembly. , shaping a hollow elongate member by substantially completely surrounding said hollow elongate member; forming and supporting means; and a second forming and supporting means disposed at least partially within the forming and supporting means. a plurality of guide holes for accommodating and properly orienting the elements; a means for allowing a polymerizable liquid to be introduced into the mold assembly; and a second element form a hollow space between them corresponding to the dimensions of the perforated hollow member. However, the member is formed by hardening of the polymerizable liquid within the hollow space. said means and the second element is a rod hand forming a plurality of holes having predetermined dimensions and shapes. step by step, and means for forming and supporting an aperture in the elongate member.

22. The device according to claim 20, comprising the rod means and the hole forming means of the insert. and is made of a material capable of withstanding the temperatures generated by the polymerization of the polymerizable liquid. the forming and supporting means includes a hollow elongated cylinder having an open end and a closed end; and inserts such that each rod means extends into a respective guide hole in the cylinder. is introduced into said open end, and the bore of the cylinder and the rod means of the insert are connected to the bore forming means. said device, characterized in that it is oriented helically around the periphery of the device.

23. The device according to claim 20, wherein the rod means and the hole forming means of the insert are provided. and is made of a material capable of withstanding the temperatures generated by the polymerization of the polymerizable liquid. the forming and supporting means includes a hollow elongated cylinder having an open end and a closed end; and inserts such that each rod means extends into a respective guide hole in the cylinder. is introduced into said open end, and the bore of the cylinder and the rod means of the insert are connected to the bore forming means. said device characterized in that it is oriented helically around the periphery of the device.

24. The apparatus of claim 20, wherein the polymerizable liquid comprises silicone. , the insert is made of injection-molded polyamide material and has a corresponding bore in the cylinder. rod means of the insert are oriented at 120 degree intervals around the periphery of the aperture forming means; The hole in the cylinder and the corresponding rod means in the insert are aligned with each other in the hole forming means. Said device, characterized in that said device is arranged at said intervals along its length.

Specification Slanted cavity catheter Tsui - Arashi Ichibun Issara The present invention particularly features an inclined hole that facilitates access and drainage of the brain to cerebrospinal fluid. and a method of making and using the same.

i”L stage UJA- The four ventricles in the human brain are spaces that communicate with each other. Cerebrospinal fluid (C3F) is produced and circulated.

Ventriculostomy or catheter The procedure of locating the brain within the cavity of the box forms a major part of the neurosurgeon's technique. empty cavity The technique of placing surgical catheters into the brain cavity forms a major part of neurosurgery.

The technique for placing a cavity catheter is intracerebral pressure monitoring (ICP), which allows the brain to drain cerebrospinal fluid. Including extraction and blocking techniques and injection techniques of pharmaceutical therapeutics.

Draining the brain of cerebrospinal fluid is important for patients with congenital or acquired cerebral edema. drain the brain of cerebrospinal fluid Extraction is possible only through an intracranial catheter, which directly reduces intracerebral pressure. The intracavity catheter used for drainage of cerebrospinal fluid receives 0 gA, which is a life-supporting means. In the case of the peripheral subcutaneous drainage system, i.e. the peritoneal cavity, the circulatory system through the heart, or (ICP) is discharged to the external exhaust system. The standard procedure for air lumen catheters is the Wilkins (R obert H, Wilkins, 5etti S, Rangachary )'s book, Techniques of Ventral Drilling Puncture) (McGraw-Hill, 1984), Chapter 13, Section A. has been done.

Coronary catheters are generally used as hollow lumen catheters. A small hole is drilled in the bone anterior to the pupillary line suture of the operculum, that is, in front of the cavity. is inserted into the anterior end of the transverse cavity through a borehole. Hollow holes are selected The diameter of the catheter should be slightly larger than the About 1 cm anterior to the suture line, 10 to 12 cm above the nasofrontal suture line. m, approximately 2-3 c+m from the centerline of the non-dominant hemisphere. A hollow hole was formed For example, after cauterizing the dura, a sharp blade is used to remove the dura and the inferior membrane. Open and set aside the arachnoids.

The lateral cavity of the human brain forms a curve parallel to the curve of the skull, i.e. The shape of the cavity is parallel to the curve of the surface of the skull 6 so that it is parallel to the surface of the skull at the point of insertion. A catheter guided perpendicular to the plane enters the cavity.

In detail, a line passing through the borehole at right angles to the surface of the skull traverses the lateral cavity. .

A technique for more precisely positioning the catheter is disclosed in U.S. Pat. No. 4,613,324. Disclosed in the specification. The device includes a guide assembly, the guide assembly defining a lateral cavity. The catheter and tight seal when placed over the orifice drilled into the skull on the anterior end of the the closure device and the temporary formed by the tangent to the skull at the location of the orifice. and is adapted to be guided into the lateral cavity through the orifice at an angle perpendicular to the imaginary plane. The corresponding method is to insert an orifice into the skull just anterior to the pupillary suture of the skull. A cavity catheter containing a sealing device is passed through the orifice laterally. A catheter including the steps of insertion into a cavity and a sealing device is a guide assembly according to the invention. The temporary formed by the tangent to the skull at the location of the orifice by the body It is guided through the orifice at an angle perpendicular to the imaginary plane.

Various catheters are known for insertion into cavities. Catheters are typically is a hollow tube with multiple openings on the empty side, i.e., the inflow end, which allows cerebrospinal fluid to flow through the brain. from the catheter to the patient's bloodstream or into the peritoneal cavity, or to an external drainage system. Allow it to flow.

However, this catheter is prone to failure due to blockage of the opening at the inflow end, which is usually Villous or ependymal tissue within the cavity is inserted into the catheter. This is caused by growth within the opening at the inlet end of the tube. This tissue is removed when the catheter is empty. After being inserted into the cavity, the opening at the inflow end of the catheter is occluded within a relatively short period of time, and the cavity is closed. The brain loses its ability to reduce excess pressure due to the accumulation of cerebrospinal fluid.

Furthermore, the opening of conventional catheters is perpendicular to the length of the catheter. , there was a risk of abrading brain tissue during insertion.

The tendency for the cavity catheter opening to become occluded by brain tissue is due to the opening in the catheter wall. By sloping the pipe to eliminate line-of-sight flow from the outside to the inside of the pipe, It is possible to reduce Furthermore, if the rows of openings are spaced 120 degrees apart, the tissue within the cavity can be directly accessed. Growth is virtually eliminated.

Additionally, the opening may be tilted away from the direction of insertion of the catheter into the brain. and can reduce the tendency to abrade brain tissue. In addition, catheter A probe needle (integrated with the catheter for positioning in the brain) is used to measure The hole is occluded upon insertion by stretching, and removal of the stylet closes the catheter. It is possible for the hole to open when the tension is released.

Therefore, it can be placed within the brain cavity of the human body to prevent excessive fluid flow into or from the brain. There is a need for a catheter that solves the problems of conventional cavity control catheters. The present invention provides a novel and original simple solution that overcomes the problems of prior art catheters. Provide technology.

Presentation "1" and hawk-! The present invention is a catheter that can be placed inside the brain cavity to contain and transport fluid. a flexible elongate body having a wall of sufficient thickness to allow the body to be inserted into the cavity; the front end and the tip, and the front end of the body spaced from the tip. and spaced apertures. Each opening extends through the wall at an angle and A portion of the wall thickness is made visible when viewed perpendicular to the axis of the body. child The arrangement is such that the main body is slightly stretched with a stylet when inserted. This allows the opening to be closed and minimizes damage to brain tissue during insertion. difference In addition, the growth of villus tissue within the cavity within the catheter opening is inhibited and Improving fluid flow to or from a cavity.

Preferably each aperture extends through the wall at an angle of approximately 35 degrees to the longitudinal axis of the body. However, the plurality of openings form a plurality of rows. The row of openings extends around the body at a 120 degree angle. They are spaced around the edges to maximize structural strength at the forward end of the catheter.

Optionally, the front end of the body is made of radio non-conductive material at least in the area surrounding the opening. The insertion depth of the anterior end of the catheter into the body is 0 to facilitate monitoring of the catheter position. Proper placement will be facilitated by providing a means to indicate this. Insertion depth indicating means is wireless non-conductive It may also be used as a marking on the adhesive material to further monitor the position of the catheter. becomes easier.

The present invention also relates to a method for bringing the brain within the cavity of a human skull into close proximity to cerebrospinal fluid; The method involves drilling and guiding an orifice into the skull just anterior to the suture line of the pupil line of the skull. The assembly limits the catheter by a tangent to the skull at the orifice location. The catheter is guided at an initial point of insertion, including steps perpendicular to a defined plane. It accurately penetrates the skull and causes minimal damage to brain tissue. The above-mentioned cath A properly positioned catheter and aperture shape will allow the tissue inside the cavity to Desirable because it minimizes growth within the opening, fluid into and from the cavity. increase the flow.

A catheter according to this method includes a tubular means and a support means for the tubular means. Use internal assembly. Therefore, the method of the invention does not require fixing the support means to the skull of the human body. a step of arranging the orifices in a manner surrounding them at intervals; guiding the ether through the tubular means into the orifice and into the cavity. and a support means and a tubular means, wherein the catheter is adapted to pass through an orifice by the tubular means. perpendicular to the plane bounded by the tangent to the skull at the location of the orifice through and are associated with each other such that they are independently guided with respect to the orifice in the same direction. child The tubular means is supported by a support means comprising a plurality of legs of the same length for done to.

Additionally, the method of the present invention reduces the diameter of the tubular hand to accommodate the catheter. Inserting the catheter, including inserting a removable insert into the stage. Stretch the catheter using a stylet to assist with The opening can be flattened to reduce damage to brain tissue during insertion. Desired arrangement In this position, the catheter body includes means for indicating the insertion depth of the forward end of the catheter. 1 The method of the present invention includes the step of inserting a catheter into a cavity to a predetermined depth. .

The indicating means may be a wireless non-conductive display, thereby indicating that the catheter is in the cavity. location is monitored.

The present invention further provides a catheter having a plurality of angled holes in a flexible elongate body. Related to manufacturing equipment.

The catheter is a hollow, elongated member with a plurality of angled holes near one end. Ru. One embodiment of the apparatus includes an insert and a mold assembly, the insert having a rod means forming a plurality of apertures of predetermined dimensions and shapes; forming and supporting means, the rod means being predetermined relative to the aperture forming means; A hollow elongated member is positioned at a predetermined position, direction, and dimension. It is adapted to accommodate a plurality of apertures.

The mold assembly includes means for forming and supporting a hollow elongated member and at least partially a plurality of rod means within the forming means for accommodating the rod means and properly orienting the insert; Polymerizable liquid can be introduced into the guide hole and the gap between the insert and the mold assembly and preferably means for forming the catheter by polymerization. The rod means and the hole forming means are integrated and the temperature that occurs during polymerization of a liquid that can be polymerized is Made of material that can withstand

The forming and supporting means comprises a hollow elongated cylinder having an open end and a closed end. The insert is introduced into the open end and the rod means guide each of the cylinders. It is made to extend into the hole. The rod means and the ring should be spaced in defined steps. You can stay there.

The invention also relates to an apparatus for forming holes in a hollow elongate member, the apparatus comprising: the retaining assembly includes a means for cutting a plurality of holes of desired dimensions; and a retaining assembly; substantially completely surrounding and supporting a portion of the elongated member adjacent to the location where the hole is formed; means for guiding the cutting assembly through the supporting means adjacent to the supporting means; means for oriented and cutting contact with the hollow elongate member at a predetermined angle; operatively associated with the guiding means and the supporting means to cut a portion of the hollow elongated member into a cutting assembly; A hollow elongated member is disposed within the retention assembly in a predetermined orientation with respect to the positioning so that multiple holes with predetermined positions, directions, and dimensions are formed. including means for

Preferably the retaining assembly is of a size and dimension somewhat larger than the bore of the hollow elongated member. a retaining block having an elongated opening such that the member is easily and removably removable. The cutting assembly is adapted to be inserted into the elongated opening and includes a plurality of elongated rods. shall be taken as a thing. The directing means correspondingly includes a plurality of elongated guide openings in the rod of the cutting assembly. A hollow elongated member having a corresponding opening size and dimensions somewhat larger. The rod can be easily and removably penetrated when cutting a hole in the hole.

゛ The positioning means is such that the hollow elongated member is pre-positioned within the elongated opening in the holding block. It includes a stopper member that prevents it from being inserted beyond the point where the cubic Desirable when the shape has an elongated opening extending along a diagonal through the center of the cube .

In the most preferred construction, the directing means has three sets of elongated openings, each set facing each other. The hollow elongated member has stripes spaced apart at intervals of 120 degrees along its circumference. This makes it possible to provide a wide array of holes. i.e. an elongated aperture in each set of directing means. extends along a diagonal across the face of the cube of the holding block to achieve this result. Ru.

amount of days Preferred embodiments of the invention will be described below with reference to the accompanying drawings.

FIG. 1 is a perspective view showing the catheter of the present invention.

FIG. 2 is a cross-sectional view taken along line 2--2 in FIG.

Figure 3 shows the i! 3-3 is a cross-sectional view along line 3-3.

FIG. 4 is a perspective view showing a device for holding the catheter during cutting of the opening.

FIG. 5 is a top view of the apparatus of FIG. 4.

Figure 6 is a cross-sectional view taken along w & 6-6 in Figure 5, showing the device for cutting an opening in the catheter. Figure shown.

Figure 7 shows the perforation in the side wall of the catheter when the catheter is placed in the retention device of Figure 4. FIG.

FIG. 8 is a perspective view of a symmetrical mold insert according to the present invention.

FIG. 9 is a perspective view of a helical mold insert according to the present invention.

FIG. 10 is a cross-sectional view of a molded housing used with the insert of FIG. 8;

FIG. 11 is a cross-sectional view of a molded housing used with the insert of FIG. 9;

FIG. 12 is a cross-sectional view of the mold taken along line 12--12 of FIG.

FIG. 13 is a cross-sectional view of the mold taken along line 13--13 of FIG.

U's day Referring to FIG. 1, a catheter 10 is shown for insertion into the brain cavity of a human body. Catheters are used, for example, to drain excess cerebrospinal fluid during treatment of cerebral edema. The present invention is primarily directed to catheters used to access or drain the brain from cerebrospinal fluid. The posterior or outflow end of the catheter relative to the anterior or insertion end of the catheter. Although the description thereof is omitted, it is well known.

Catheter 10 is a flexible, hollow, elongate member with sufficient wall thickness to accommodate fluid. and through-transfer. The anterior end 12 of the catheter opens a plurality of openings 14 within the brain cavity. due to its proximity to cerebrospinal fluid. In this case, the term "proximal" means that the brain is removed from the brain by removing spinal fluid from the brain. to remove or expel drugs or other substances through the opening 14 of the catheter. Aperture 14 is predetermined for directing fluid into the brain to contact the cerebrospinal fluid. The catheter has a good position, shape, and allows for a good continuous flow of fluid through the catheter. Growth of brain tissue blocks the opening when the catheter is placed into the brain cavity. prevent this from happening. In addition, the pore design facilitates catheter placement and allows tissue protection during insertion. damage is small.

As shown in FIGS. 2 and 3, the catheter 10 has three sets of 120 degree stripes spaced apart. A hole is provided. The holes are formed obliquely in the wall of the catheter and along the longitudinal axis. The measured angle is inclined in the direction of insertion into the cavity. Furthermore, the diameter of the hole It is proportional to the thickness of the wall of the teter, and the hole is placed along the longitudinal axis as shown in Figure 3. The interior of the catheter is not directly visible when viewed at right angles.

Forming the hole in this way reduces the risk of abrasion of the brain tissue when inserting the catheter into the cavity. is minimized, and therefore the destruction of brain tissue is minimized. In addition, how much should the catheter be? Stretching closes the hole and prevents tissue from entering the catheter during insertion. be done. A rigid positioning stylet is used to stretch the catheter. It is easily implemented by the catheter when the stylet is retained. The tell body is pulled back somewhat from the insertion end, and the hole becomes somewhat flattened. catheter By preventing direct access to the inside of the brain cells or tissues is prevented from growing.

Problems due to occlusion of catheters with 90 degree or right angle holes according to the prior art Major issues are resolved.

The growth of villous tissue or brain cells causes each set of holes to be offset circumferentially by 120 degrees. Minimizes the possibility of occluding the inner diameter of the catheter even if one or more holes enter it.

The holes are shown at a 35 degree angle to the longitudinal axis of the catheter; This can be changed if the interior of the catheter is not directly visible. This angle is the wall thickness This is also related to the fact that the thicker the wall, the larger the permissible angle range. specific catheter The appropriate angle for is the formula % formula % where d is the hole diameter, t is the catheter wall thickness, and θ is the hole axis. From equation 0, which is the angle it makes with the longitudinal axis of the catheter, the diameter of the passage hole is Must be less than the thickness of the wall of the teter divided by the tangent of the angle, specified The formula to calculate the appropriate angle for the pore size and catheter wall thickness is:

θ=tan*(t/d) It is important that direct proximity is prevented by overlapping the diameter of the hole in the inner wall of the Ru. That is, angles other than 35 degrees may be used, although 35 degrees is particularly advantageous.

By providing apertures to prevent direct access to the interior of the catheter, Reduces the strong integrity of the catheter compared to when direct proximity is provided. It becomes possible to cut holes with large diameters without tightening. Large holes are inside the catheter This increases the flow of cerebrospinal fluid into the brain and reduces the chance that brain cells will grow and block the pores.

Prior art relatively small diameters that provide direct access into the catheter body compared to.

The catheter of the present invention can be prepared using any known method, such as free-hand or guided. It is inserted into the cavity of the brain. Assists in proper positioning and placement of the catheter. A plurality of markers are provided along the length of the catheter body in order to identify the catheter body. The sign is catheter This allows the surgeon to easily determine the insertion depth of the catheter tip. Give precise instructions. By making the sign made of a radio non-conductive material such as balum, The insertion depth of the catheter can be easily monitored by known techniques.

Additionally, if desired, the area around the opening in the front end of the catheter is made of a wireless non-conductive material. The front end of the catheter and the This enables accurate positioning of the chip.

Improvements in the catheter according to the present invention are seen when the catheter is placed in the patient's brain. It does not require any detailed operations. When positioned this way the catheter The growth of brain tissue within the catheter opening has minimal effect on surrounding brain cells. is suppressed. As mentioned above, the catheter can be inserted in any known manner.

Precise catheter positioning using a guide assembly rather than free-hand methods That is advantageous.

U.S. Pat. No. 4,613, for a method and apparatus for inserting a catheter into a cavity; Reference is made to the No. 324 specification. The patent describes a style that facilitates catheter insertion. Let is shown. As mentioned above, the stylet extends the catheter and The opening is flat to minimize damage to brain tissue during insertion. When flattening the catheter There is some reduction in the overall diameter of the tell, which reduces brain tissue damage during insertion. Ru.

A second stylet may be used to guide the catheter into the lumen. Ru. In the prior art, a second stylet was inserted into one of the holes in the forward end of the catheter. It will be done. The holes are difficult to handle because they are formed at a 90 degree angle. second style The front end of the catheter should be positioned parallel and adjacent to the first stylet. This bending makes penetration and insertion into the cavity more difficult. Main departure The slanted hole by the light guides the second stylet in a proximal direction (i.e., in an L-shape). This substantially solves the above-mentioned problems and makes it possible to This greatly facilitates the operation of locating the tail and stylet within the cavity.

The catheter of the present invention can be easily manufactured with high precision by using the retaining device according to the present invention. It can be produced at 100%. Figure 5 shows a machined metal block, i.e. a cube. From one corner of the cube to the opposite corner showing a retaining device 20 in the form of 22 The hole 24 extends diagonally. The diameter of the hole 24 is slightly less than the diameter of the catheter 10. be large enough to provide sufficient support for the catheter when forming the inclined hole in the catheter wall. .

FIG. 6 shows a cutting device 30, which includes a handle 32 and a plurality of hollow tubular cutting elements. 34, each cutting element having a sharp tip 36. The tubular cutting element 34 is cubic It extends through a guide hole 28 on one surface of the body 22 and contacts the catheter 10 . 7th As shown, the tubular cutting element 34 penetrates the wall of the catheter at a predetermined angle. Form the hole in position and shape.

A prior art catheter has one set of, for example, four sets spaced 90 degrees along its circumference. It has holes. This weakens the strength and structural integrity of the catheter tip. One hole on both sides of the catheter (180 degrees apart) is made by a tool. and processed at the same time. As a result, the holes on one side have a larger diameter than the holes on the other side. subordinate Thus, two sets of large-diameter holes and two sets of small-diameter holes are formed.

This causes the brain to lose the uniform flow of cerebrospinal fluid, making it easier for small holes to become blocked and for catheters to This may cause malfunction of the module.

The present invention provides uniform stripes spaced exactly 120 degrees apart at desired angles on the body of the catheter. The above problem is solved by forming three sets of holes. This allows the hole to The flow rate is increased, the strength and integrity of the catheter body is improved, and the catheter is Easy to insert and position within the cavity of the

4 to 6 show various embodiments of providing guide holes 28 in the faces of the cube, as desired. Preferably, the guide holes are provided along the diagonal lines of the top surface and two side surfaces of the cube 22. , so that each set of holes is striped 120 degrees apart along the circumference of the catheter body. It will be done so that 35 degrees to the longitudinal axis of the catheter, as previously described. Angular holes are advantageous.

This device cuts the hole at the proper angle and at precise spacing along the circumference of the catheter. We guarantee that. To cut the hole, simply place the catheter in the holding block 20. The cutting element 34 of the cutting device w30 can be introduced into the guide hole 28 by If the cutting device 30 is removed after drilling 10, the hole with the correct direction and shape can be easily and quickly created. Formed reproducibly. Mass production is easy using this equipment. be.

The device described above is suitable for forming holes in catheters of various materials. thin wall silico When forming a small hole in a catheter, the smoothness of the side wall is important This is important to prevent wear and hole clogging, which is difficult with conventional cutting equipment. 8 The molding device according to the present invention solves this problem, and is shown in FIGS. 8 to 1. This will be described later with reference to FIG. Disposable inserts are modeled before injection of silicone material. placed in the mold assembly. Hold the insert in place until the silicone material hardens. held in place. The insert and catheter are then removed from the mold and The insert is discarded.

This technique allows for relatively smooth and relatively small diameter diagonal holes of any location, orientation and shape. It enables easy manufacturing with high reproducibility.

Figures 8 and 9 show two preferred inserts 50,55. Each insert The tip includes an elongated body portion 52,57 and a plurality of portions extending at a predetermined angle from the body. It has a rond-like extension 52.59. Align the catheter hole longitudinally as previously described. A 35 degree angle to the adaxial line is desirable, so the rond of the insert The shaped extension 52.59 is preferably at a 35 degree angle to the axis of the body member 52.57. degree. The insert in Figure 8 has three rows of holes, and the insert in Figure 9 has a spiral catheter. It shows the holes provided around the body.

Figures 10 to 13 show a mold 60 for the insert 50,55 described above. ．． 80 is shown. Each mold allows insertion of the corresponding insert 50.55 an open end 62.82 forming the insertion end of the catheter; and a closed end 64.84 forming the insertion end of the catheter. has. The mold 60.80 has a plurality of guide holes 66.86, which are arranged in each model. At least partially accommodates the rond-like member 52.59 of the insert 50.55. proposal The lumen 66.86 allows the wall 68.88 of the mold 60.80 to be placed at the desired angle of the catheter. Penetrate and extend at an angle corresponding to .

Prepare multiple molds 60.80 and multiple inserts 50% 55 during manufacturing . Since the mold 60.80 is reusable, it has the desired service life. Basically, you can use any material you like, such as steel and stainless steel. Examples include steel, aluminum, and engineered thermoplastic materials are also suitable. the material is of material that is strong enough to hold the insert and form the catheter. It shall withstand the temperatures due to the expected heat generation during polymerization. The mold material is It must be dimensionally stable over the entire temperature range during curing.

The insert 50.55 is made of self-lubricating material and is used for catheterization. It is desirable to prevent the polymerizable liquid from sticking, this self-lubricating material Easy to mold without damaging the catheter as it has sufficient flexibility It should be insertable and removable. The most desirable material for the insert is injection molded poly. It is an aramid material.

The preferred material for the catheter itself is a polymerizable silicone liquid with significantly lower It has an injection and curing temperature of approximately 38°C (100”F), which means that the curing time is Since it is relatively long, a large number of molds are required to increase productivity. insert are disposable and each insert is used for one catheter. aforementioned The mold is reusable.

During manufacturing, the insert is placed in the mold and the rod member is inserted into the guide hole of the mold. After positioning properly.

A polymerizable liquid is introduced into the gap between the insert and the mold. Liquid polymerizes and hardens to form a catheter.

The insert and catheter were removed from the mold and the insert was destroyed. The final catheter product is thus obtained.

The molding technique described above provides the following effects.

(1) The pore of the catheter should have any shape and size with respect to the axis of the catheter. For example, a spiral shape.

90 degree deviation, 120 degree deviation, etc. can be easily obtained.

(2) The angle of the hole with respect to the axis of the catheter is changed between the insert and the mold. It can be easily changed by This means that the angle of the hole relative to the hole diameter is This makes it possible to optimally determine the degree of cell growth as a function of cell growth. This relationship was explained earlier As shown in the formula.

(3) This device causes flashing on the inner diameter of the catheter. No excess material from flushing remains on the exterior surface of the catheter and is easily removed can do.

(4) With this device, each catheter can be manufactured with small manufacturing tolerances, and the structure between each device There is almost no change in , so reproducibility during mass production is high.

Although the above-mentioned present invention effectively achieves the above-mentioned object, those skilled in the art will realize various modifications. , various modifications that are easy to modify and fall within the true spirit and technical scope of the present invention include: within the scope of the present invention.

FIG./ FIG.8 FIG, 10 FIG, 11 international search report lmm-^”””-”’PCT/US8B103063

Claims (24)

[Claims] 1. A catheter placed within a host that is filled with fluid to contain and transport fluid. a flexible elongate having a forward end and a tip for insertion into the host; The main body and a plurality of spaced spaced holes located at the forward end of the body spaced from the tip; a hole such that a portion of the wall of the body is visible when viewed perpendicular to the axis of the body; When the catheter is slightly stretched with the stylet, the hole will not open automatically. The wall of the body at an angle such that the pore reopens when the body releases the force of the relative catheter extends through the catheter, thereby minimizing tissue damage during insertion of the catheter and minimizing tissue damage. This prevents growth within the lumen of the catheter, thereby preventing growth from within the lumen system or The catheter improves fluid flow into the cavity. 2. A catheter according to claim 1, wherein the aperture is oriented relative to the longitudinal axis of the body. A catheter characterized in that it extends through the wall at an angle of about 35 degrees. 3. The catheter of claim 1, wherein the pores are approximately 120 mm in diameter with respect to the circumference of the body. A catheter characterized in that it is arranged in degree-spaced rows. 4. 2. The catheter of claim 1, wherein the forward end of the body includes at least the hole. made of a wireless non-conductive material in a surrounding area to allow the catheter to be placed within the lumen system. A catheter characterized in that it facilitates monitoring during treatment. 5. A catheter according to claim 1, wherein the body is adapted for insertion at the forward end of the catheter. A catheter characterized in that it includes means for indicating depth. 6. A catheter according to claim 5, wherein said means facilitates monitoring of the position of the catheter. A catheter characterized in that it includes a marker made of a wireless non-conductive material for facilitating . 7. In a method that approaches the cerebrospinal fluid in the cavity of the human brain, drilling an orifice in the skull just anterior to the pupillary line suture of the bone; The guide assembly guides the catheter tangentially to the skull at the orifice location. guiding the catheter in a direction perpendicular to a plane defined by the catheter. The tube is accurately drilled into the cavity at the initial insertion point to minimize brain tissue damage and The tether has a wall thickness sufficient to contain and transport fluid therein and is inserted into the cavity. a plurality of chips provided at the forward end and spaced apart from the chip; holes spaced apart from each other, each said hole extending from said wall when viewed perpendicularly to the axis of said body. Extends through the wall thickness at an angle such that part of the thickness is visible; This allows the location and shape of the catheter pore to be determined by the villous tissue or ependymal structure. Preventing or minimizing tissue growth and increasing fluid flow into or out of the cavity The method described above, characterized in that it enables. 8. 8. The method of claim 7, wherein the guide assembly includes a tubular means and a guide assembly for the tubular means. a support means, the method further comprising: supporting means surrounding the orifice in a spaced apart manner; Place the catheter loosely on the human skull and orifice through the tubular means. the supporting means and the tubular means being operated by the tubular means. Oriented at right angles to the imaginary plane defined by the tangent to the skull at the location of the refice. Relates so that the catheter is guided through the orifice in a direction independent of the orifice The method, characterized in that: 9. 8. A method as claimed in claim 7 in which the tubular means is provided with a supporting arm comprising a plurality of legs of equal length. supporting by steps and inserting a removable insert into the tubular means; and reducing the diameter of the. 10. 8. The method of claim 7, wherein a style is used to assist catheter insertion. Use a knife to stretch the catheter so that the hole is flat, and remove the brain tissue at the time of insertion. The method, characterized in that it includes the step of further reducing damage to the fabric. 11. 8. The method of claim 7, wherein the body of the catheter is located at the front end of the catheter. and means for indicating an insertion depth, wherein the method pre-positions the catheter within the cavity. The method, characterized in that it includes the step of inserting the same depth. 12. 12. The method of claim 11, wherein the indicating means includes a radio non-conductive marker. characterized in that the method includes the step of monitoring the position of the catheter within the cavity; The said method. 13. An apparatus for manufacturing a hollow elongated member having a plurality of holes, supporting a hollow elongated member at a predetermined position and orientation to form the plurality of holes; a first element including means for holding; The plurality of holes are formed in a hollow elongated member at predetermined positions and directions and with predetermined dimensions. a second element including means for forming a hole in the first element; guided and at least partially accommodated by the element to the predetermined position and orientation; Said device, characterized in that the dimensions are achieved. 14. 14. The apparatus of claim 13, wherein the second element is within a hollow elongated member. and means for cutting the plurality of holes. The cutting means cuts one or more alignments within the first element. received and guided within mating holes, whereby said plurality of holes are placed at predetermined positions; Said device, characterized in that it is formed in directions and dimensions. 15. 15. The apparatus of claim 14, wherein the cutting means comprises a plurality of elongate tubes; a first element having a slightly larger diameter and length than said hollow elongated member; also includes a retaining block having an elongated hole, said member being easily and removable. a plurality of aligned holes are supported by being inserted into the holes, and the plurality of aligned holes are inserted into the tube of the cutting means. corresponding to the number of tubes and having slightly larger dimensions, which allows the tube to be easily and easily removed. cutting the hole at a predetermined angle into the hollow elongate member so as to allow the hole to pass through the hollow elongate member; The said device characterized by the above-mentioned. 16. 14. The apparatus of claim 13, wherein the first element is a retaining assembly; means for supporting a portion of the hollow elongated member near the location where the hole is formed; , support means substantially completely surrounding the hollow elongated member; provided adjacent the support means to guidely direct the first element through the support means; means for cutting into contact with the hollow elongated member at a predetermined angle; and said directing means; operatively associated with the support means to pre-preserve a portion of the hollow elongate member relative to the second element; and the second element includes a cutting assembly. The device characterized by: 17. 17. The apparatus of claim 16, wherein the retaining assembly is slightly smaller than the hollow elongated member. an elongated hole of large dimensions such that the member can be easily and removably inserted into the hole; said directing means corresponds to said rod but has slightly larger dimensions. the hole is cut into the hollow elongated member through which the rod is easily and removably cut. including a plurality of elongated guide holes for enabling the directing means to have three sets of elongated holes, each set are spaced apart from each other to the hollow elongated member at 120 degree intervals along its periphery. The device is characterized in that it is provided with a hole in which a hole is placed. 18. 17. Apparatus according to claim 16, wherein the positioning means is located within the hollow elongated member. Prevents the end from being inserted beyond a predetermined point into the elongated hole of the retaining block the retaining block is a machined metal cube and the front The elongated hole extends along a diagonal through the center of the cube, and the elongated hole of the directing means Each set extends along a diagonal across the face of the cube of the holding block, and the directing means are three a set of elongated holes, each set being spaced apart from each other and extending through said hollow elongated member; The device is characterized in that the holes are provided along the periphery and are spaced approximately 120 degrees apart. Place. 19. 14. The apparatus of claim 13, wherein said second element comprises said hollow elongate member. a removable insert having an elongated body forming a hollow interior portion of the a plurality of rod-shaped members extending from the main body to form the plurality of holes; A first element partially accommodates the rod-like member and supports the insert as a hollow member. 12. The device comprising a plurality of alignment holes positioned within the means. 20. 20. The apparatus of claim 19, wherein the first element has an open end and a closed end. the insert is introduced into said cylinder from the open end; A polymerizable liquid is formed by forming a hollow space corresponding to the dimensions of the perforated elongated member. is introduced from the open end and hardens within the hollow space, thereby curing the perforated hollow space. The device, characterized in that a material is formed. 21. 14. The apparatus of claim 13, wherein the first element is a mold assembly; shaping a hollow elongate member by substantially completely surrounding said hollow elongate member; forming and supporting means; and a second forming and supporting means disposed at least partially within the forming and supporting means. a plurality of guide holes for accommodating and properly orienting the elements; a means for allowing a polymerizable liquid to be introduced into the mold assembly; and a second element form a hollow space between them corresponding to the dimensions of the perforated hollow member. and the member is formed by curing of the polymerizable liquid within the hollow space. and the second element is a rod hand forming a plurality of holes having predetermined dimensions and shapes. step by step, and means for forming and supporting an aperture in the elongated member. 22. 21. The apparatus of claim 20, comprising rod means and insert hole forming means. are made of a material capable of withstanding the temperatures generated by polymerization of said polymerizable liquid. , the forming and supporting means includes a hollow elongated cylinder having an open end and an associated end; , the insert is arranged such that each rod means extends into a respective guide hole of the cylinder. introduced into the open end, the bore of the cylinder and the rod means of the insert are connected to the bore forming means. Said device, characterized in that it is oriented helically around its periphery. 23. 21. The apparatus of claim 20, comprising rod means and insert hole forming means. are made of a material capable of withstanding the temperatures generated by polymerization of said polymerizable liquid. , the forming and supporting means includes a hollow elongated cylinder having an open end and a closed end; , the insert is arranged such that each rod means extends into a respective guide hole of the cylinder. introduced into the open end, the bore of the cylinder and the rod means of the insert are connected to the bore forming means. Said device, characterized in that it is oriented helically around its periphery. 24. 21. The apparatus of claim 20, wherein the polymerizable liquid comprises silicone. The insert is made of injection molded polyamide material and has a corresponding inlet hole in the cylinder. the rod means of the sert are oriented at 120 degree intervals around the periphery of the hole forming means; The hole in the cylinder and the corresponding rod means in the insert are the length of the hole forming means. The devices are arranged at the intervals along the length.