Abstract
A method of making a catheter includes obtaining a hollow tube having a proximal section, a distal section, an elongated conduit, and one or more fluid openings formed in the distal section of the hollow tube that are in fluid communication with the elongated lumen. The method includes inserting a mandrel within the elongated lumen, positioning a first visible marker over an outer surface of the hollow tube at a junction of the proximal and distal sections of the hollow tube, and placing a sacrificial material over the first visible marker to completely cover the first visible marker. Heat is applied for shrinking the sacrificial material, which, in turn, compresses the first visible marker against the outer surface of the hollow tube, and for least partially melting the first visible marker for fusing the first visible marker to the outer surface of the hollow tube.
Claims
1. A method of making a catheter having a visible marker for distinguishing proximal and distal sections of said catheter comprising: obtaining a hollow tube having a proximal section, a distal section, an elongated conduit extending through the hollow tube from the proximal section to the distal section, and one or more fluid openings formed in a wall of the distal section of said hollow tube that are in fluid communication with the elongated lumen; inserting a mandrel within the elongated lumen of said hollow tube; positioning a first visible marker over an outer surface of said hollow tube at a junction of the proximal and distal sections of said hollow tube; placing a sacrificial material over said first visible marker so that said first visible marker is completely covered by said sacrificial material; applying heat to said sacrificial material, said first visible marker, and said hollow tube for shrinking said sacrificial material to compress said first visible marker against the outer surface of said hollow tube, and at least partially melt said first visible marker to fuse said first visible marker to the outer surface of said hollow tube.
2. The method as claimed in claim 1, further comprising: after fusing said first visible marker to the outer surface of said hollow tube, removing said sacrificial material to fully expose said first visible marker; and removing said mandrel from the elongated lumen of said hollow tube.
3. The method as claimed in claim 1, further comprising: said first visible marker comprising a visible marker collar having a first length; said sacrificial material comprising a sacrificial tube having a second length that is greater than the first length; said hollow tube having a third length that is greater than the second length.
4. The method as claimed in claim 3, further comprising: while applying the heat, at least partially constraining one or more sections of said hollow tube that are located beyond the first length of said visible marker collar for preventing said hollow tube from shrinking along its longitudinal axis and expanding in a radial direction.
5. The method as claimed in claim 1, wherein said hollow tube and said first visible marker are made of the same polymeric material, and wherein said sacrificial material comprises PTFE.
6. The method as claimed in claim 1, wherein said first visible marker comprises a dye or a pigment that defines a first color.
7. The method as claimed in claim 6, wherein said hollow tube is made of a translucent or transparent material.
8. The method as claimed in claim 6, wherein said hollow tube has a second color that contrasts with the first color of said first visible marker.
9. The method as claimed in claim 1, wherein said first visible marker comprises a visible marker collar that extends around an outer surface of said hollow tube.
10. The method as claimed in claim 9, wherein said hollow tube has an outer diameter, and wherein said tube-shaped collar has a central opening that defines an inner diameter that is equal to or slightly larger than the outer diameter of said hollow tube.
11. The method as claimed in claim 1, further comprising: disposing a second visible marker within the elongated lumen of said hollow tube, wherein said second visible marker extends between the junction of the proximal and distal sections of said hollow tube and a distal end of said hollow tube; securing a distal end of said second visible marker to the distal end of said hollow tube.
12. The method as claimed in claim 1, wherein said mandrel has an outer diameter that closely matches an inner diameter of the elongated lumen of said hollow tube for supporting said hollow tube and preventing said hollow tube from collapsing inwardly when fusing said first visible marker to the outer surface of said hollow tube.
13. The method as claimed in claim 1, further comprising attaching a needle to a proximal end of said hollow tube.
14. The method as claimed in claim 1, further comprising implanting the distal section of said hollow tube inside a patient.
15. The method as claimed in claim 1, wherein the heat is applied within a temperature range of 190-220 degrees Celsius for about 4-16 seconds.
16. The method as claimed in claim 15, wherein the heat is applied at 205 degrees Celsius for about 10 seconds.
17. The method as claimed in claim 1, wherein the applying heat step further comprises disposing said sacrificial material between opposing heat emitting surfaces of first and second heater blocks, wherein the opposing heat emitting surfaces are spaced away from one another by a distance of about 1.5-3.0 mm.
18. The method as claimed in claim 1, wherein said first visible marker comprises a polymer material, and wherein the heat is applied within a temperature range of about +/−15 degrees Celsius from the Melt Point of said polymer material of said first visible marker for about 4-16 seconds.
19. The method as claimed in claim 18, wherein the heat is applied within a temperature range of about +/−1.0 degrees Celsius from the Melt Point of said polymer material of said first visible marker for about 10 seconds.
20. A method of making a catheter having a visible marker for distinguishing proximal and distal sections of said catheter comprising: obtaining a hollow tube having a proximal section, a distal section, an elongated conduit extending through the hollow tube from the proximal section to the distal section, and one or more fluid openings formed in a wall of the distal section of said hollow tube and are in fluid communication with the elongated lumen; inserting a mandrel within the elongated lumen of said hollow tube for supporting an inner diameter of said hollow tube and preventing said hollow tube from collapsing inwardly into the elongated lumen; positioning a visible marker collar over an outer surface of said hollow tube at a junction of the proximal and distal sections of said hollow tube; placing a sacrificial tube over said visible marker collar, wherein said sacrificial tube has a greater length than said visible marker collar so that said visible marker collar is completely covered by said sacrificial tube; applying heat to said sacrificial tube, said visible marker collar, and said hollow tube for shrinking said sacrificial tube to compress said visible marker collar against the outer surface of said hollow tube and at least partially melt said visible marker collar to fuse said visible marker collar to the outer surface of said hollow tube.
Description
BRIEF DESCRIPTION OF THE DRAWINGS
[0105] FIG. 1A is a top view of a section of a catheter used for draining and infusing fluids, the catheter including a hollow tube having fluid openings spaced along the length of the hollow tube, in accordance with one embodiment of the present patent application.
[0106] FIG. 1B is a cross-sectional view of the hollow tube of the catheter shown in FIG. 1A.
[0107] FIG. 2A shows a first stage of a method of making a catheter having a visible marker for indicating the start of a soaker region on the catheter, in accordance with one embodiment of the present patent application.
[0108] FIG. 2B is a cross-sectional view of the subassembly shown in FIG. 2A.
[0109] FIG. 3A shows a second stage of a method of making a catheter having a visible marker for indicating the start of a soaker region on the catheter, in accordance with one embodiment of the present patent application.
[0110] FIG. 3B is a cross-sectional view of the subassembly shown in FIG. 3A.
[0111] FIG. 4A shows a third stage of a method of making a catheter having a visible marker for indicating the start of a soaker region on the catheter, in accordance with one embodiment of the present patent application.
[0112] FIG. 4B is a cross-sectional view of the subassembly shown in FIG. 4A.
[0113] FIG. 5A shows a fourth stage of a method of making a catheter having a visible marker for indicating the start of a soaker region on the catheter, in accordance with one embodiment of the present patent application.
[0114] FIG. 5B is a cross-sectional view of the subassembly shown in FIG. 5A.
[0115] FIG. 6A shows a fifth stage of a method of making a catheter having a visible marker for indicating the start of a soaker region on the catheter, in accordance with one embodiment of the present patent application.
[0116] FIG. 6B is a cross-sectional view of the subassembly shown in FIG. 6A.
[0117] FIG. 7A shows a sixth stage of a method of making a catheter having a visible marker for indicating the start of a soaker region on the catheter, in accordance with one embodiment of the present patent application.
[0118] FIG. 7B is a cross-sectional view of the subassembly shown in FIG. 7A.
[0119] FIG. 8A shows a seventh stage of a method of making a catheter having a visible marker for indicating the start of a soaker region on the catheter, in accordance with one embodiment of the present patent application.
[0120] FIG. 8B is a cross-sectional view of the subassembly shown in FIG. 8A.
[0121] FIG. 9A shows an eighth stage of a method of making a catheter having a visible marker for indicating the start of a soaker region on the catheter, in accordance with one embodiment of the present patent application.
[0122] FIG. 9B is a cross-sectional view of the subassembly shown in FIG. 9A.
[0123] FIG. 10A shows a ninth stage of a method of making a catheter having a visible marker for indicating the start of a soaker region on the catheter, in accordance with one embodiment of the present patent application.
[0124] FIG. 10B is a cross-sectional view of the subassembly shown in FIG. 10A.
[0125] FIG. 11 is a perspective view of a catheter including a hollow tube having a proximal section, a distal section with a soaker region, and a visible marker tube at a junction of the proximal and distal sections to provide a visual indication of the start of the soaker region of the catheter, in accordance with one embodiment of the present patent application.
[0126] FIG. 12 is a cross-sectional view of the catheter and the visible marker tube shown in FIG. 11.
[0127] FIG. 13A is a schematic view of a soaker region of a catheter including a visible marker tube secured to an outer surface of a hollow tube of the catheter and a visible marker filament disposed within a lumen of the catheter and secured to a sealed distal end of the hollow tube of the catheter, in accordance with one embodiment of the present patent application.
[0128] FIG. 13B is a cross-sectional view of the catheter, the visible marker tube, and the visible marker filament shown in FIG. 13A.
[0129] FIG. 14 is a perspective view of a catheter having a proximal section, a distal section with a soaker region, a visible marker tube secured to an outer surface of a hollow tube of the catheter, and a visible marker filament disposed within an elongated lumen of the catheter and secured to a distal end of the hollow tube of the catheter to provide two visible markers that indicate the start of the soaker region of the catheter, in accordance with one embodiment of the present patent application.
[0130] FIG. 15A is a schematic view of a soaker region of a catheter including a visible marker filament disposed within an elongated lumen of the catheter, the visible marker filament having a distal end that is secured to a distal end of a hollow tube of the catheter, in accordance with one embodiment of the present patent application.
[0131] FIG. 15B is a cross-sectional view of the catheter and the visible marker filament shown in FIG. 15A.
[0132] FIG. 16 is a perspective view of a catheter including a hollow tube having a proximal section, a distal section with a soaker region, and a visible marker filament disposed within an elongated lumen of the hollow tube of the catheter and secured to a distal end of a hollow tube of the catheter to provide a visual indication of the start of the soaker region of the catheter, in accordance with one embodiment of the present patent application.
[0133] FIG. 17A shows a heating system during a first stage of a method of fusing a visible marker tube to an outer surface of a hollow tube of a catheter to provide a visual indicator of the start of a soaker region on the catheter, in accordance with one embodiment of the present patent application.
[0134] FIG. 17B shows a heating system during a second stage of a method of fusing a visible marker tube to an outer surface of an elongated body of a catheter to provide a visual indicator of the start of a soaker region on the catheter, in accordance with one embodiment of the present patent application.
[0135] FIG. 17C shows a heating system during a third stage of a method of fusing a visible marker tube to an outer surface of an elongated body of a catheter to provide a visual indicator of the start of a soaker region on the catheter, in accordance with one embodiment of the present patent application.
[0136] FIG. 17D shows a heating system during a fourth stage of a method of fusing a visible marker tube to an outer surface of an elongated body of a catheter to provide a visual indicator of the start of a soaker region on the catheter, in accordance with one embodiment of the present patent application.
[0137] FIG. 17E shows a heating system during a fifth stage of a method of fusing a visible marker tube to an outer surface of an elongated body of a catheter to provide a visual indicator of the start of a soaker region of the catheter, in accordance with one embodiment of the present patent application.
[0138] FIG. 18 is a cross-sectional view of a heating system used for fusing a visible marker tube to an outer surface of an elongated body of a catheter to provide a visual indicator of the start of a soaker region on the catheter, in accordance with one embodiment of the present patent application.
[0139] FIG. 19A is a top view of a section of a catheter including a hollow tube having spaced slits formed in an outer wall of the hollow tube, the spaced slits being configured for draining and infusing fluid, in accordance with one embodiment of the present patent application.
[0140] FIG. 19B is a cross-sectional view of the catheter having spaced slits shown in FIG. 19A.
DETAILED DESCRIPTION OF PREFERRED EMBODIMENTS
[0141] Referring to FIGS. 1A and 1B, in one embodiment, a section of a catheter 100 preferably includes a hollow tube 102 including an outer wall 104 having an outer surface 106 and an inner surface 108 that surrounds an elongated lumen 110 that extends along the length of the catheter 100. In one embodiment, a fluid may pass through the elongated lumen 110 for draining fluid (e.g., bodily fluids) from a patient and/or infusing fluid (e.g., therapeutic fluids) into a patient.
[0142] In one embodiment, the catheter 100 is desirably made of an absorbable, biocompatible polymer so that the catheter will absorb and will not have to be removed from the patient at the end of a therapy period.
[0143] In one embodiment, the catheter 100 may be tube-shaped. In one embodiment, the catheter 100 may include a flexible tube. In one embodiment, when viewed in cross-section, the outer wall 104 of the catheter 100 may have the shape of a circle or oval.
[0144] In one embodiment, the hollow tube 102 of the catheter 100 preferably includes a plurality of fluid openings 112 that extend through the outer wall 104. In one embodiment, the fluid openings 112 are in fluid communication with the elongated lumen 110. In one embodiment, the fluid openings extend from the inner surface 108 to the outer surface 106 of the outer wall 104. In one embodiment, the fluid openings 112 may be spaced from one another along the length of the catheter 100. The size of the fluid openings may vary along the length of the catheter.
[0145] In one embodiment, the fluid openings 112 may be in alignment with one another along the length of the hollow tube 102 of the catheter 100, or may be spaced from one another around the perimeter of the outer wall 104 of the hollow tube 102 of the catheter 100. In one embodiment, the fluid openings 112 may be spaced in a random pattern along the length of the hollow tube 102.
[0146] In one embodiment, each of the fluid openings 112 is preferably in fluid communication with the elongated lumen 110 for enabling fluid to be drained through the fluid openings 112 and into the elongated lumen and/or for enabling fluid that is directed into the lumen 110 to pass through the fluid openings 112 for infusing the fluid into a patient.
[0147] In one embodiment, the catheter 100 may have a proximal section that is configured for being located outside of a patient and a distal section that is configured for remaining inside a patient for draining fluid and/or infusing fluid. In one embodiment, the spaced fluid openings 112 may be located in only the distal section of the catheter 100, which is adapted to remain inside a patient. In one embodiment, the distal section of the catheter that has the fluid openings 112 may be referred to as a “soaker region” of the catheter.
[0148] In one embodiment, the catheter 100 preferably has a total length of about 10-40 inches, and more preferably about 24 inches.
[0149] In one embodiment, the distance D.sub.1 between adjacent, spaced fluid openings 112 may be about 4-25 millimeters, and more preferably about 4-12 millimeters. In one embodiment, the spaced fluid openings may be the same size (i.e., same diameter). In one embodiment, the spaced fluid egress openings may have different sizes (i.e., different diameters).
[0150] In one embodiment, the size of the fluid openings increases between the proximal end and the distal end of the hollow tube 102. The sizes of the fluid openings may become progressively larger along the length of the hollow tube (e.g., progressively larger between the proximal end the distal end of the hollow tube), with smaller openings near a fluid source and larger openings further away from the fluid source for maintaining a constant flow of fluid from the fluid openings.
[0151] Referring to FIG. 1B, in one embodiment, the outer surface 106 of the outer wall 104 of the hollow tube 102 preferably defines an outer diameter OD of about 0.8 millimeters. In one embodiment, the inner surface 108 of the outer wall 104 of the hollow tube 102 preferably defines an inner diameter ID.sub.1 of about 0.5 millimeters. In one embodiment, the outer diameter OD defined by the outer wall 104 of the hollow tube 102 is about 1.5-2× greater than the inner diameter ID.sub.1 defined by the inner surface 108 of the outer wall 104 of the hollow tube 102. In one embodiment, the outer wall 104 of the hollow tube 102 preferably has a thickness Ti of about 0.100-0.150 millimeters and more preferably about 0.140 millimeters.
[0152] In one embodiment, the fluid openings 112 pass completely through the thickness Ti of the outer wall 104 of the hollow tube 102 so that the fluid openings are in fluid communication with the elongated lumen 110 that extends along the length of the hollow tube. In one embodiment, the catheter 100 may be implanted into tissue, and a fluid, such as a therapeutic fluid, may be introduced into the elongated lumen 110 of the hollow tube 102, whereupon the fluid passes through the fluid openings 112 for bathing tissue that surrounds the hollow tube.
[0153] In one embodiment, a catheter having fluid openings is preferably made of an absorbable, biocompatible polymer material. The absorbable polymers may include conventional biocompatible, polymers such as lactide, polylactic acid, polyglycolic acid, glycolide, polydioxanone, polycaproactone, copolymers and blends thereof and the like.
[0154] As noted above, for clarity, FIGS. 1A and 1B show only one section of a catheter. The hollow tube of a catheter may extend to the left and/or the right of the catheter section shown in FIG. 1A. In one embodiment, a catheter having a full length desirably includes a proximal section and a distal section having one or more fluid openings that pass through the outer wall of the hollow tube 102. In one embodiment, the proximal section of the catheter has no fluid openings, and the distal section of the catheter has one or fluid openings.
[0155] In one embodiment, a needle, such as a curved suture needle, may be attached to a proximal end of the proximal section of the catheter. The needle may be used for implanting a catheter inside a patient.
[0156] In one embodiment, one or more visible markers and/or visible demarcations may be provided on and/or assembled with a catheter to offer one or more visual indications of where a particular section (e.g., a soaker region) of a catheter commences. The one or more visible demarcations preferably provide one or more visual indicators to surgical personnel so that the surgical personnel may identify the location of a catheter where the soaker region begins and/or where the fluid openings 112 (FIG. 1A) are located.
[0157] Referring to FIGS. 2A and 2B, in one embodiment, a method of making a catheter having one or more visible markers preferably includes obtaining a catheter 200 including a hollow tube 202. The hollow tube 202 preferably includes an outer wall 204 having an outer surface 206 and an inner surface 208 that surrounds an elongated lumen 210 that extends along the length of the hollow tube 202. Although not shown in FIGS. 2A and 2B, in one embodiment, the catheter 200 preferably includes a plurality of spaced openings that extend along the length of the catheter, which may be similar to the spaced openings 112 shown and described above in FIGS. 1A and 1B.
[0158] Referring to FIGS. 3A and 3B, in one embodiment, a method of making a catheter 200 having one or more visible markers preferably includes inserting a mandrel 214 into the elongated lumen 210 (FIG. 2B) of the hollow tube 202 of the catheter 200.
[0159] In one embodiment, the elongated lumen 210 (FIG. 2B) of the catheter 200 preferably defines an inner diameter ID.sub.1 and the mandrel 214 has an outer diameter OD.sub.1 that substantially matches the inner diameter ID.sub.1 of the lumen of the catheter 200. In one embodiment, the mandrel 214 preferably supports the outer wall 204 of the hollow tube 202 to prevent the catheter from collapsing inwardly as the one or more visible markers are assembled with the catheter.
[0160] Referring to FIGS. 4A and 4B, in one embodiment, a method of making a catheter having one or more visible markers preferably includes positioning a first visible marker, such as a visible marker tube 216, over the outer surface 206 of the outer wall 204 of the hollow tube 202 of the catheter 200. The visible marker tube 216 preferably has an opening that defines an inner diameter ID.sub.2 that is slightly larger than and/or matches the outer diameter OD.sub.2 of the outer surface 206 of the outer wall 204 of the hollow tube 202 of the catheter 200.
[0161] In one embodiment, the first visible marker and the hollow tube of the catheter comprise polymer materials. In one embodiment, the first visible marker and the hollow tube of the catheter comprise the same polymer material (e.g., Monocryl polymer).
[0162] In one embodiment, the visible marker tube 216 is preferably located at a junction 215 of a proximal section 225 and a distal section 235 of the hollow tube 202. Thus, location of the visible marker tube 216 at the junction preferably enables surgical personnel to identify the location on the elongated tube where the distal section 235 (having the spaced fluid openings) starts.
[0163] As shown in FIGS. 4A and 4B, in one embodiment, the mandrel 214 continues to support the inner surface 208 of the outer wall 204 of the hollow tube 202 to prevent the hollow tube from collapsing inwardly into the elongated lumen 210 (FIG. 2B) that extends along the length of the catheter 200.
[0164] Referring to FIGS. 5A and 5B, in one embodiment, a method of making a catheter having one or more visible markers preferably includes placing a sacrificial material, such as a sacrificial tube 218, over both the visible marker tube 216 and the outer surface 206 of the outer wall 204 of the hollow tube 202 of the catheter 200. The sacrificial tube 218 may be made of a material that shrinks when exposed to heat, such as PTFE. In one embodiment, the visible marker tube 216 preferably has a length L.sub.1 and the sacrificial tube 218 preferably has a length L.sub.2 that is greater than the first length L.sub.1 of the visible marker tube. Because it desirably has a greater relative length, the sacrificial tube 218 preferably encompasses the length of the visible marker tube 216 and desirably extends beyond the two ends of the visible marker tube 216.
[0165] Referring to FIGS. 6A and 6B, in one embodiment, the assembly shown in FIGS. 5A and 5B is desirably exposed to heat, such as from a heating system 220. In one embodiment, the heating system 220 heats the sacrificial tube 218 and the visible marker tube 216. The sacrificial tube 218 is made of a material (e.g., PTFE) that shrinks when exposed to heat. Thus, in response to the heat, the sacrificial tube 218 will shrink in size for compressing the visible marker tube 216 against the outer surface 206 of the hollow tube 202. In addition, the heat is preferable conducted through the sacrificial tube 218 and is transmitted to the visible marker tube 216 for at least partially melting the visible marker tube to fuse, weld and/or attach the visible marker tube 216 to the outer surface 206 of the outer wall 204 of the hollow tube 202 of the catheter 200.
[0166] As noted above, in one embodiment, the heat applied to the sacrificial tube 218 and the visible marker tube 216 may be generated by a heating assembly 220 that includes first and second heater blocks 222A, 222B.
[0167] In one embodiment, the first heater block 222A preferably has an inner face 224A that directs heat toward first sides (e.g., top sides) of the respective sacrificial tube 218 and the visible marker tube 216, which extend around the outer surface 206 of the outer wall 204 of the hollow tube 202 of the catheter 200.
[0168] In one embodiment, the second heater block 222B has an inner face 224B that directs heat toward respective second sides (e.g., undersides) of the respective sacrificial tube 218 and the visible marker tube 216, which extend around the outer surface 206 of the outer wall 204 of the hollow tube 202 of the catheter 200.
[0169] In one embodiment, the inner faces 224A, 224B of the respective first and second heater blocks 222A, 222B oppose one another and may be spaced away from one another by a distance D2 of about 60-120 mils, or about 1.5-3.0 mm. In one embodiment, the sacrificial tube 218, the visible marker tube 216, and a section of the hollow tube 202 are disposed between the opposing inner faces 224A, 224B of the respective first and second heater blocks 222A, 222B.
[0170] In one embodiment, each of the respective first and second heater blocks 222A, 222B desirably has a width W (FIG. 6A) that is greater than the length L.sub.1 (FIG. 5A) of the visible marker tube 216, but less than the length L.sub.2 (FIG. 5A) of the sacrificial tube 218. Thus, the width W of the first and second heater blocks 222A, 222B encompasses the entire length L.sub.1 (FIG. 5A) of the visible marker tube 216, however, the length L.sub.2 (FIG. 5A) of the sacrificial tube 218 desirably extends beyond the bounds of the first and second heater blocks 222A, 222B.
[0171] Referring to FIGS. 7A and 7B, in one embodiment, as the first and second heater blocks 222A, 222B direct heat at the sacrificial tube 218 and the visible marker tube 216, a central region 245 of the sacrificial tube 218 that is generally aligned within the bounds of the first and second heater blocks 222A, 222B shrinks inwardly toward the central axis Ai of the catheter 200. In one embodiment, the outer peripheral regions of the sacrificial tube 218 that lie outside the bounds of the first and second heater blocks 222A, 222B do not shrink like the central region 245 because the outer peripheral regions are exposed to less heat than the central region 245. As the sacrificial tube 218 shrinks inwardly, the sacrificial tube compresses the visible marker tube 216 against the outer surface 206 of the hollow tube 202 of the catheter 200.
[0172] In one embodiment, the heat generated by the heater blocks 222A, 222B preferably passes through the sacrificial tube 218 to reach the visible marker tube 216 for applying thermal energy to the visible marker tube 216. The heat at least partially melts an outer region of the visible marker tube 216 for welding the visible marker tube to the outer surface 206 of the outer wall 204 of the hollow tube 202 of the catheter 200.
[0173] Referring to FIGS. 8A and 8B, in one embodiment, after heat has been applied to the sacrificial tube 218 for shrinking a central region 245 of the sacrificial tube, which, in turn, compresses the visible marker tube 216 inwardly for welding the visible marker tube to the outer surface 206 of the hollow tube 202 of the catheter 200, the catheter assembly may be removed from the heating assembly 220 for undertaking further manufacturing steps.
[0174] Referring to FIGS. 8A and 8B, in one embodiment, after the visible marker tube 216 has been welded to the outer surface 206 of the hollow tube 202, the sacrificial tube 218 may be removed and/or peeled away. FIGS. 8A and 8B show the assembly prior to peeling away the sacrificial tube 218. FIGS. 9A and 9B show the assembly after the sacrificial tube 218 (FIGS. 8A and 8B) has been removed.
[0175] Referring to FIGS. 9A-9B and 10A-10B, after the visible marker tube 216 has been welded to the outer surface 206 of the hollow tube 202 of the catheter 200, the mandrel 214 that has supported the hollow tube 202 from collapsing inwardly into the elongated lumen, may be removed from the elongated lumen. FIGS. 9A and 9B show the assembly prior to removing the mandrel 214. FIGS. 10A and 10B show the catheter assembly after the mandrel has been removed from the lumen 210. After the mandrel has been removed, the catheter assembly 200 preferably includes the hollow tube 202 and the visible marker tube 216 welded to the outer surface 206 of the hollow tube 202. The lumen 210 (FIG. 10B) preferably extends along the length of the catheter 200.
[0176] Referring to FIG. 11, a catheter 300 preferably includes a hollow tube 302 having a proximal end 330 and a distal end 332. The catheter 300 preferably includes a visible marker tube 316 that is welded to an outer surface of the hollow tube 302, such as by using one or more steps of the methods shown and described above in FIGS. 2A-10B. The catheter 300 preferably includes a distal section 334 that extends between the visible marker tube 316 and the distal end 332 of the hollow tube 302. In one embodiment, the distal section 334, which may also be referred to as the soaker region of the catheter, preferably includes a plurality of spaced fluid openings 112 (FIG. 1A) that are located between the visible marker tube 316 and the distal end 332 of the hollow tube 302. Fluids may be drained from a patient or infused into a patient via the spaced fluid openings.
[0177] In one embodiment, the catheter 300 preferably includes a proximal section 336 that extends between the visible marker tube 316 and the proximal end 330 of the hollow tube 302. In one embodiment, the proximal section 336 of the catheter preferably has no spaced fluid openings, which is in contrast to the fluid openings located that are located within the distal section 334 of the hollow tube 302 of the catheter 300.
[0178] In one embodiment, a tissue anchor (not shown) may be secured to an end (e.g., the distal end) of the hollow tube 302.
[0179] Referring to FIG. 12, in one embodiment, the visible marker tube 316 is desirably welded and/or attached to the outer surface 306 of the hollow tube 302 of the catheter 300. The application of heat to the visible marker tube 316 desirably changes the composition of the material used to make the visible marker tube. In FIG. 12, a cross-section of the visible marker tube 316 depicts a thermal ring 340, which shows how the material within an interior region of the visible marker tube 316 is transformed by heat to promote securing the visible marker tube to the outer surface 306 of the outer wall 304 of the hollow tube 302 of the catheter 300.
[0180] Referring to FIGS. 13A and 13B, in one embodiment, an elongated catheter 400 preferably includes a visible marker tube 416 that is secured to an outer surface 406 of a hollow tube 402, such as by using the methods shown and described above in FIGS. 2A-10B. In addition, the catheter 400 preferably includes a visible marker filament 425 (e.g., a dyed polymer fiber) that is disposed within the elongated lumen 410 of the catheter 400. The distal end 432 of the hollow tube 402 is crimped for sealing the distal end of the hollow tube of the catheter. The crimped distal end preferably engages the distal end of the visible marker filament 425 for securing the visible marker filament to the distal end 432 of the hollow tube 202, thereby ensuring that the visible marker filament 425 is fixed in place within the elongated lumen 410 of the hollow tube 402 of the catheter 400. In one embodiment, the visible marker filament 425 may be centrally located within the elongated lumen 410.
[0181] In one embodiment, the visible marker filament 425 is a dyed polymer. In one embodiment, the visible marker tube 416 and the visible marker filament are dyed the same color (e.g., violet). In one embodiment, the visible marker filament 425 and the visible marker tube 416 comprise a dyed Monocryl polymer having about 0.04-0.05% D&C Violet 2, as defined in 21 CFR 74.1602.
[0182] FIG. 14 shows a perspective view of the catheter 400 shown and described above in FIGS. 13A and 13B. The catheter 400 preferably includes the hollow tube 402 having a proximal end 430 and a distal end 432 that is sealed. The catheter preferably includes the visible marker tube 416 that is welded to the outer surface 406 (FIG. 13B) of the hollow tube 402 for enabling medical personnel to distinguish between the distal section 434 and the proximal section 436 of the catheter, and for identifying the start of the distal section 434 (i.e., the soaker region) of the catheter 400.
[0183] The proximal section 436 of the catheter extends between the visible marker tube 416 and the proximal end 430 of the hollow tube 402. In one embodiment, the proximal section 432 of the catheter 400 does not have spaced openings extending through an outer wall of the hollow tube 402 so that the proximal section 432 may not be used to drain fluid from and/or infuse fluid into a patient.
[0184] In one embodiment, the distal section 434 of the catheter preferably includes a plurality of spaced openings 112 (FIG. 1A) that are formed in the outer wall of the hollow tube 402 and that extend between the visible marker tube 416 and the crimped distal end 432 of the hollow tube 402. In addition, the catheter 400 preferably includes the visible marker filament 425 (FIGS. 13A and 13B) that extends within the distal section 434 of the catheter. Thus, the embodiment shown in FIG. 14 has two visual indicators that enable medical personnel to locate the start of the distal section 434 (i.e., the soaker region) of the catheter, namely, the visible marker tube 416 and the visible marker filament 425.
[0185] Referring to FIGS. 15A and 15B, in one embodiment, a catheter 500 preferably includes a hollow tube 502 having an elongated lumen 510 that extends along the length thereof. The catheter 500 preferably includes a visible marker filament 525 that is disposed within the elongated lumen 510. In one embodiment, the distal end 532 of the hollow tube 502 is crimped for securing a distal end of the visible marker filament 525 to the distal end 532 of the hollow tube 502. Crimping the distal end 532 of the hollow tube 502 preferably fixes the distal end of the visible marker filament 525 to the hollow tube 502 and prevents the marker filament 525 from floating freely within the elongated lumen 510 of the catheter 500.
[0186] In one embodiment, the visible marker filament 525 is made of a polymer material, such as Monocryl or polydioxanone (PDS). In one embodiment, the visible marker filament 525 comprises a dyed Monocryl polymer having about 0.04-0.05% D&C Violet 2, as defined in 21 CFR 74.1602.
[0187] Referring to FIG. 16, in one embodiment, the catheter 500 preferably includes a hollow tube 502 having a proximal end 530 and a distal end 532. In one embodiment, the visible marker filament 525 is disposed within the distal section 534 of the catheter 500 for enabling medical personnel to locate the start of the soaker region of the hollow tube 502. In addition, the visible marker filament 525 desirably provides a visual indicator of the length of the soaker region of the catheter 500, which, as noted above, is a section of the catheter that has spaced openings (FIG. 1A) for draining a fluid from and/or infusing a fluid into a patient.
[0188] In one embodiment, the distal end 532 of the hollow tube 502 may be crimped and/or sealed for securing the visible marker filament 525 within the elongated lumen of the hollow tube 502 so that the visible marker filament 525 is fixed to the distal end of the catheter 500.
[0189] In one embodiment, a needle 535 (e.g., a curved suture needle) may be secured to the proximal end 530 of the hollow tube 502 of the catheter 500. The needle 535 may be used for passing the catheter through a patient for implanting the catheter in a patient.
[0190] In one embodiment, a method of delivering a therapeutic fluid to tissue may include using the needle to form a first tissue opening at the first end of the wound and pulling the hollow tube completely through the first tissue opening until a tissue anchor abuts against tissue at the first end of the wound.
[0191] In one embodiment, a method of delivering a therapeutic fluid to tissue desirably includes passing the needle through a skin layer of a patient so that the needle and the proximal end of the hollow tube are located outside the patient.
[0192] In one embodiment, a method of delivering a therapeutic fluid to tissue may include cutting the proximal end of the hollow tube for detaching the needle from the hollow tube, and introducing a therapeutic fluid into the cut proximal end of the hollow tube so that the therapeutic fluid flows into the elongated lumen and passes through the fluid openings located within the soaker region of the catheter for infusing tissue (e.g., a wound) with the therapeutic fluid.
[0193] Infections associated with orthopedic implants can be disastrous for a patient, often resulting in severe consequences including reoperation, amputation, or death. Delivery of therapeutic fluids, such as local antibiotics, directly to the infected site at elevated doses, which would be hazardous if delivered systemically, but safe when delivered locally, can be accomplished using the catheters disclosed herein.
[0194] Inoperable tumors often leave patients with limited choices. Delivery of high dose chemotherapeutic agents or immune therapies (e.g., modified T-cells) directly to the tumor may provide a benefit not available before. The bioabsorbable catheters disclosed herein may be used to provide this type of local delivery of therapeutic fluids.
[0195] Post-op pain management with opioids is often not ideal for several reasons including risk of addiction, severe constipation, and cognitive impairment. The delivery of local anesthetics directly to the wound site with the catheters disclosed herein preferably provides a mechanism for reducing opioid use while minimizing patient pain and suffering.
[0196] In one embodiment, a catheter disclosed herein may be coated and/or impregnated with an antimicrobial agent for preventing bacterial colonization. In one embodiment, a preferred antimicrobial agent is triclosan. In one embodiment, a vapor process may be used for applying a triclosan antimicrobial agent to a catheter, such as a polymer catheter made of polydioxanone or polycaprolactone. In one embodiment, antimicrobial agents used for catheters may include, but are not limited to, triclosan, chlorohexadiene, povidone iodine, and/or silver compounds.
[0197] Referring to FIG. 17A, in one embodiment, a heating assembly 620 may be utilized for generating and applying heat for securing a visible marker tube to an outer surface of a hollow tube 602 of a catheter 600. As noted above, the visible marker tube may be utilized for designating the beginning of a distal section (i.e., a soaker region) of a catheter. In one embodiment, a mandrel 614 is passed through an elongated lumen of the hollow tube 602 of the catheter 600. In one embodiment, a first clamp 650A is utilized for fixing a first end of the catheter 600 and a second clamp 650B may be utilized for fixing a second section of the catheter 600. The first and second clamps 650A, 650B may hold the hollow tube 602 under tension.
[0198] In one embodiment, the heating assembly 620 preferably includes first and second heater blocks 622A, 622B that are adapted to heat a region of the assembly that includes the visible marker tube 216 and the sacrificial tube 218 (FIG. 7A) that are assembled over the outer surface of the hollow tube 602.
[0199] Each of the heater blocks 622A, 622B preferably includes a heating element that is embedded in an aluminum heating block. One of the heating elements is located in the first heater block 622A and one of the heating elements is located in the second heater block 622B. The respective heating elements embedded in the aluminum heating blocks are electrically connected to a control system via the conductive wires 675A, 675B (shown in red). The heater assembly 620 preferably includes a temperature feedback loop using 100k thermistors embedded in each of the two aluminum heating blocks.
[0200] Each heater block 622A, 622B preferably includes an insulating silicone case 685 that is in place for safety (e.g., to prevent burns) and for heat retention. The insulating silicone cases are only on the exterior of the heater blocks and not within a gap that is located between the opposing faces of the heater blocks. The catheter is preferably positioned within the gap for securing the visible marker tube to the outer surface of the hollow tube of the catheter.
[0201] In one embodiment, the heater blocks 622A, 622B are sold as part number Ender 3-Extruder under the brand name RICHOOSE at Amazon.com: 3D Printer Parts Ender 3 Hotend Assembled Ender 3 Pro Extruder Kit 24V 40 W for Creality Ender 3/Ender 3 Pro with Silicon Cover and 0.4 mm Nozzles: Industrial & Scientific.
[0202] Referring to FIGS. 17B and 17C, in one embodiment, the heater assembly 620 preferably includes a step motor 652 that moves the first and second heater blocks 622A, 622B into alignment with the sacrificial tube and the visible marker tube, which, in turn, are positioned at a location that designates the start of the distal section and/or soaker region of the catheter.
[0203] Referring to FIG. 17C, in one embodiment, the first and second heater blocks 622A, 622B generate heat that is directed at the sacrificial tube and the visible marker tube for shrinking the sacrificial tube so that it compresses the visible marker tube into the outer surface of the hollow tube 602 of the catheter 600. In one embodiment, the first and second heater blocks 622A, 622B are configured to apply heat to the assembly within a range of about 190-220 degrees Celsius for about 6-14 seconds. In a more preferred embodiment, the first and second heater blocks 622A, 622B are configured to apply heat to the assembly at a temperature of about 205 degrees Celsius for about 10 seconds. In one embodiment, the heat preferably passes through the sacrificial tube and an outer region of the visible marker tube for at least partially melting the visible marker tube for securing the visible marker tube to the outer surface of the hollow tube of the catheter.
[0204] In one embodiment, the first visible marker (e.g., a visible marker collar) may be made of Monocryl and the heat is applied within a temperature range of 190-220 degrees Celsius for about 4-16 seconds, and more preferably at 205 degrees Celsius for about 10 seconds.
[0205] In one embodiment, the first visible marker (e.g., a visible marker collar) may be made of a polymer material (e.g., PDS) and the heat is applied within a temperature range of about +/−15 degrees Celsius from the Melt Point (or melting peak temperature) of the polymer material of the first visible marker for about 4-16 seconds, and more preferably within a temperature range of about +/−1.0 degrees Celsius from the Melt Point (or melting peak temperature) of the polymer material of the first visible marker for about 10 seconds.
[0206] Referring to FIGS. 17D and 17E, after an appropriate level of heat has been applied to the sacrificial tube and the visible marker tube for securing the visible marker tube to the outer surface of the hollow tube 602 of the catheter 600, the step motor 652 preferably retracts the first and second heater block 622A, 622B so that the catheter 600 with the visible marker tube secured to the hollow tube 602 of the catheter may be removed from its fixed position between the first and second clamps 650A, 650B. The first and second clamps 650A, 650B may be loosened and/or opened for removing the catheter assembly from the clamps of the heater system. In one embodiment, before or after the catheter 600 is removed from the clamps 650A, 650B, the mandrel 614 may be removed from the elongated lumen of the hollow body 602 of the catheter 600.
[0207] Referring to FIG. 18, in one embodiment, a heating system 720 for fusing a visible marker tube 716 to an outer surface 706 of an elongated body 702 of a catheter 700 may include a first heater block 722A that overlies a topside of the catheter 700, a second heater block 722B that underlies a bottom of the catheter 700 and a third heater block 722C that directs heat at a lateral side of the catheter 700. The three heater blocks 722A-722C preferably direct heat at a sacrificial tube 718 made of heat shrink material (e.g., PTFE) that is positioned over the visible marker tube 716. As heat is applied to the sacrificial tube 718, the sacrificial tube compresses inwardly onto the visible marker tube 716. In addition, the heat passes into the material of the visible marker tube for at least partially melting the material of the visible marker so as to secure the visible marker tube 716 to the outer surface 706 of the hollow tube 702 of the catheter 700.
[0208] Referring to FIGS. 20A and 20B, in one embodiment, a catheter 800 may be used for draining and/or infusing fluid. The catheter 800 desirably includes a hollow tube 802 having an outer wall 804 with an outer surface 806 and an inner surface 808 that surrounds an elongated lumen 810 that extends along the length of the catheter 800. In one embodiment, the catheter 800 preferably includes a plurality of spaced, elongated slits 812 that are formed in the outer wall 804 of the hollow tube 800. In one embodiment, the elongated slits 812 having greater respective lengths than widths. The spaced, elongated slits 812 preferably extend completely through the outer wall 804 from the outer surface 806 to the inner surface 808 so that fluid flowing through the central lumen 810 may pass through the spaced, elongated slits 812 for being infused into a patient. In one embodiment, the elongated slits 812 may be used to drain fluid from a patient and the drained fluid may be removed via the lumen 810.
[0209] The catheter 800 shown in FIG. 20A depicts only a section of a catheter that lies within a soaker region. The entire length of the catheter 800 is not shown. In one embodiment, the elongated slits 812 are located in a distal section of the catheter, as shown by the distal section 334 in FIG. 11.
[0210] While the foregoing is directed to embodiments of the present invention, other and further embodiments of the invention may be devised without departing from the basic scope thereof, which is only limited by the scope of the claims that follow. For example, the present invention contemplates that any of the features shown in any of the embodiments described herein, or incorporated by reference herein, may be incorporated with any of the features shown in any of the other embodiments described herein, or incorporated by reference herein, and still fall within the scope of the present invention.
