Patent Publication Number: US-2023136282-A1

Title: Thermoformed medical syringe

Description:
DRAWINGS 
     Other objects and advantages of the present invention will become apparent from the following detailed description of the preferred embodiments thereof taken in conjunction with the accompanying drawings wherein: 
       FIG.  1    is an axonometric view of a syringe body in accordance with one embodiment of the invention; 
       FIG.  2    is an axonometric view of the thermoformed syringe of  FIG.  1    with a sheath in place; 
       FIG.  3    is a longitudinal, cross-sectional, side view of the thermoformed syringe of  FIG.  2   ; 
       FIG.  4    is an axonometric view of a thermoformed syringe showing the absence of the distension without inserted plunger, and without the sheath; 
       FIG.  5    is a side, axonometric view of a thermoformed sheath; 
       FIG.  6    is a longitudinal cross-sectional, side view of the sheath&#39;s engagement indentions; 
       FIG.  7    is an axonometric view of a syringe&#39;s plunger; 
       FIG.  8    is a traverse, cross-sectional view of the tubular plunger shaft with lateral wings; 
       FIG.  9    is a longitudinal, cross-sectional view of the tubular plunger shaft with lateral wings; 
       FIG.  10    is an axonometric view of a syringe in accordance with an alternative embodiment of the invention; 
       FIG.  11    is an axonometric view of the thermoformed syringe of  FIG.  10    with a sheath in place; 
       FIG.  12    is a longitudinal cross-sectional, side view of the thermoformed syringe of  FIG.  11   ; 
       FIG.  13    is an axonometric view of a thermoformed syringe showing the absence of the distension without inserted plunger, and without the sheath; 
       FIG.  14    is an axonometric, side view of a syringe sheath with side apertures; 
       FIG.  15    is an axonometric view of an injection molded plunger; 
       FIG.  16    is a detail cross-sectional view showing the syringe plunger in  FIG.  15   &#39;s sealing interface; 
       FIG.  17    is an axonometric view of a single axis sealed syringe with a domed sealed end wall in accordance with an alternative embodiment of the invention; 
       FIG.  18    is an axonometric view of the syringe in  FIG.  17    with its sheath in place; 
       FIG.  19    is a side, longitudinal cross-sectional, side view of the thermoformed syringe of  FIG.  18   ; 
       FIG.  20    is an axonometric view of a thermoformed syringe showing the absence of distention without inserted plunger, and without the sheath; 
       FIG.  21    is an axonometric, side view of the thermoformed sheath of  FIG.  18   ; 
       FIG.  22    is a longitudinal cross-sectional, side view of the sheath revealing its engagement indentions; 
       FIG.  23    is an axonometric view of an injection molded plunger with domed distal surface; 
       FIG.  24    is a traverse, cross-sectional view of the molded plunger shaft revealing its seal interface; 
       FIG.  25    is an axonometric view of a thermoformed syringe with conical end wall showing the absence of distention without inserted plunger, and without the sheath; 
       FIG.  26    is a side, longitudinal cross-sectional, side view of the thermoformed syringe of  FIG.  25   ; 
       FIG.  27    is an axonometric view of an injection molded plunger with conical distal surface; 
       FIG.  28    is an axonometric view of an indention sealed syringe in accordance with an alternative embodiment of the invention; 
       FIG.  29    is an axonometric view of the thermoformed syringe of  FIG.  25    with a sheath in place; 
       FIG.  30    is a longitudinal cross-sectional, side view of the thermoformed syringe of  FIG.  29   ; 
       FIG.  31    is an axonometric view of a thermoformed syringe showing the absence of distensions without inserted plunger, and without its sheath; 
       FIG.  32    is an axonometric, side view of a syringe sheath; 
       FIG.  33    is an axonometric view of an extruded, tubular plunger with optional cap; 
       FIG.  34    is a longitudinal, cross-sectional view of the syringe plunger in  FIG.  30    showing its sealing interface; 
       FIG.  35    is an axonometric view of a syringe with integral sheath in accordance with an alternative embodiment of the invention with an integral sheath; 
       FIG.  36    is a longitudinal, cross-sectional, side view of the thermoformed syringe of  FIG.  35   ; 
       FIG.  37    is an axonometric, plan view of a thermoformed syringe showing the die-cut sheath prior to thermoforming; 
       FIG.  38    is an axonometric, side view of the integral, thermoformed sheath of  FIG.  35     
       FIG.  39    is an enlarged, cross-sectional, side view of the sheath in the transporting posture; 
       FIG.  40    is an axonometric, side view of the thermoformed syringe with a retracted sheath of  FIG.  35     
       FIG.  41    is an enlarged, longitudinal, cross-sectional, detail view of the thermoformed syringe of  FIG.  35    showing rotational interference of the retracted sheath; 
       FIG.  42    is a plan view of the sheath with a transporting cannula engagement; 
       FIG.  43    is a sectioned, front view of the sheath with a locking, disposal, cannula engagement; 
       FIG.  44    is a plan view of the sheath with a transporting cannula engagement 
       FIG.  45    is a sectioned, front view of the sheath with a locking, disposal, cannula engagement; 
       FIG.  46    is a longitudinal, side view of the thermoformed, tubular plunger with a frustoconical plug seal; 
       FIG.  47    is a longitudinal, cross-sectional, side view of the thermoformed, tubular plunger in  FIG.  45   ; 
       FIG.  48    is an axonometric view of a syringe using heat shrink, extruded tubing in accordance with an alternative embodiment of the invention; 
       FIG.  49    is a longitudinal, cross-sectional, side view of the thermoformed syringe of  FIG.  48   ; 
       FIG.  50    is an axonometric, side view of the thermoformed, tubular sheath; 
       FIG.  51    is an expanded axonometric, side view of the thermoformed, tubular plunger with a pierceable, sealing grommet and optional pierceable cap; 
       FIG.  52    is an expanded, axonometric, cross-sectional, side view of the thermoformed, tubular plunger from  FIG.  51   ; 
       FIG.  53    is a cross sectional view of the plunger shaft revealing the central, access lumen, guiding fins, and lumen support members. 
    
    
     DETAILED DESCRIPTION 
     Referring now particularly to the drawings, wherein like reference characters refer to like parts, and initially to  FIGS.  1 ,  2 , and  3   , there will be seen axonometric and cross-sectional views of a thermoformed syringe  10  in accordance with one preferred embodiment of the invention. The syringe  10  in  FIGS.  1 ,  2 , and  3    comprises a tubular body  11  having a flanged, proximal opening  17  and a truncated, thermally sealed distal end  19  with a linear, fluid passageway  24  within the sealing flange  23  fluidly communicating with an axially aligned cannula  29  (needle); and an axially sliding plunger  34  within a barrel  12  providing a sealing means to define a fluid chamber  33 . The barrel  12  comprises a length of extruded tubing  13  with a uniform interior diameter  14  within a thin, resilient sidewall  15 . A thermoformed, peripheral flange  18  of proximal opening  17  maintains the circular nature of the barrel  12  and assists holding the syringe  10  during filling and administering an injection. A slight flare  26  in sidewall  15  assists insertion of the plunger  34  prior to thermoforming end wall  20 . The barrel  12 &#39;s distal end  19  is thermoformed and sealed under slight, axial pressure over the plunger  34 &#39;s seal ring  42  producing a smooth, truncated end wall  20  with a distal passageway  24  with a slight, distal flare  28 . The seal  21  has a linear profile. Two, opposing, elliptical selvages  22  are formed flanking the distal end wall  20  as a result of the end wall&#39;s compression when sealing. They become the positioning posts for the cannula&#39;s sheath  44 . To assemble the cannula, lateral compression is applied about the seal selvages  22  causing the neck  27  and distal flare  28  of the passageway  24  to open and receive the cannula  29 . When released the neck portion  27  retracts and grips the cannula  29  and maintains the cannula&#39;s posture prior to being attached and sealed within the distal flair  28  with an applied adhesive  32 . Now referring to  FIGS.  7 ,  8  and  9   , the plunger  34  is a thermoformed, extruded tube  35  with a distal, integral, fluid sealing flange  37  with occluding plug  39  and a proximal, integral, finger pad ring  36 . The fluid seal is established by the resiliency of the barrel sidewall  15  and the seal interface  42  supported by rigid, plunger sealing flange  37 . Integral, lateral, radiating fins  38  of the extruded, tubular shaft  35  ensure the plunger  34 &#39;s axial travel within the tubular body  11  maintaining its fluid tight seal with the resilient, barrel sidewall  15 . The distention  16  occurring in the barrel  12 &#39;s resilient sidewall  15  with plunger  34 &#39;s travels is caused by the dimensional interference of the sealing flange  37 &#39;s interface  42  and the barrel  12 &#39;s interior diameter  14 . This is the basis of the fluid tight seal.  FIG.  4    reveals a barrel  12 &#39;s smooth sidewall  15  without an inserted plunger  34 . The cannula  29  has one end  30  sufficiently sharp to pierce the patient&#39;s skin and the other end  31  blunt to receive the affixing adhesive  32 .  FIGS.  2  and  5    reveal a cannula sheath  44  of extruded tubing  47  with a circumference  48  sufficient to pass over the syringe body  11 &#39;s seal selvage  22 . A thermal seal  51  closes the distal end  52  and partially wraps the sides  53  to restrict its axial travel onto the syringe  10  protecting the cannula tip  30 . Toward the proximal end  49 , four, opposing, transverse indentions  54  engage the flanged, selvage section  22  for securement. To assemble, the sheath  44  is axially slid onto the syringe body  11 until the indentions  54  engage the selvage  22 . To remove, simply reverse the procedure. 
     The syringe  110  in  FIGS.  10 ,  11 , and  12    comprises a tubular body  111  having a flanged, proximal opening  117  and a truncated, thermally sealed distal end  119  with a nonlinear, fluid passageway  124  through the sealing flange  123  fluidly communicating with an axially aligned cannula  129  (needle); and an axially sliding plunger  134  with a sealing interface  142  to define a fluid chamber  133  within barrel  112 . The barrel  112  comprises a length of extruded tubing  113  with a uniform, interior diameter  114  and a thin, resilient sidewall  115 . The thermoformed, peripheral flange  118  of proximal opening  117  maintains the circular nature of the barrel  112  and assists holding the syringe  110  during filling and administering an injection. A slight flare  26  in sidewall  15  assists insertion of the plunger  34  prior to thermoforming end wall  20 . The barrel&#39;s distal end  119  is thermoformed and sealed under slight, axial pressure over the plunger  134 &#39;s seal disc  139  with a central, frustoconical stanchion  140  producing a smooth, end wall  120  with a distal, frustoconical passageway  124 . The barrel seal  121  has a nonlinear profile creating a more rigid, canular posture within end wall  120 . Two, opposing, elliptical selvages  122  are formed flanking the distal end wall  120  as a result of the end wall compression when sealing. They become the positioning posts for the cannula&#39;s sheath  144 . To assemble the cannula  129  into the body  111 , lateral compression is applied about the seal selvage  122  and seal flange  123  with frustum  125  to initiate the opening of the distal flare  128  of the passageway  124  to receive the cannula  129 . When released the neck portion  127  retracts and grips the cannula  129  to maintain the cannula&#39;s posture prior to being attached and sealed within the distal flare  128  with an applied adhesive  132 . Now referring to  FIGS.  15  and  16   , the plunger  134  is injection molded with a central, cruciform shaft  135  supporting opposing, integral discs: proximally a finger pad  136  and distally a seal  139 . The cruciform legs  138  within the tubular body  111  ensure the normal, axial travel of the sealing disc  139 . The seal disc interface  142  must be free of surface irregularities, like a parting line  143 . This is accomplished with a mold core undercut in the B-side of the mold base forming the seal interface  142  detail. When ejected, the sealing interface  142  and supporting seal disc  139  slightly compress to overcome the undercut and the plunger  134  tumbles from the B-side mold base. 
     The distention  116  occurring in the barrel&#39;s, resilient sidewall  115  with plunger  134  movement is caused by the dimensional interference of the sealing disc  139 &#39;s interface  142  and the barrel  112 &#39;s interior diameter  114 . This is the basis of the fluid tight seal.  FIG.  13    reveals a smooth, body  111  sidewall  115  when the plunger  134  is not inserted into the barrel  112 . The cannula  129  has one end  130  sufficiently sharp to pierce the patient&#39;s skin and the other end  131  blunt to receive the affixing adhesive  132 .  FIGS.  10  and  14    reveal a cannula sheath  144  of extruded tubing  147  with a circumference  148  sufficient to pass over the syringe body&#39;s  111  seal selvage  122 . Peripheral flange  150  strengthens the sheath  144 &#39;s proximal opening  149  to further secure its attachment. Thermal seal  151  closes the distal end  152  and partially wraps the sides  153  to restrict its axial travel onto the syringe  110  protecting the cannula tip  130 . Toward the proximal end  149  are two, opposing, transverse apertures  154  which engage the flanged, selvage section  122 . To assemble, the sheath  144  is slightly compressed about the top and bottom to clear the body&#39;s sealing, selvage  122  as it&#39;s axially slid onto the syringe body  111 , and then released for the side-apertures  154  to engage the selvage  122  for attachment. To remove, simply reverse the procedure. 
     The syringe  210  in  FIGS.  17 ,  18 ,  19 ,  23 ,  24 , and  25    comprises a resilient, tubular body  211  having a flanged, proximal opening  217  and a domed, thermally sealed distal end  219  with a linear, fluid passageway  224  through the sealing flange  223  fluidly communicating with an axially aligned cannula  229  (needle); and an axially sliding plunger  234  with a sealing means  239  within barrel  212  to define a fluid chamber  233 . The barrel  212  comprises a length of extruded tubing  213  with a uniform interior diameter  214  within a thin, resilient sidewall  215 . A thermoformed, peripheral flange  218  of proximal opening  217  maintains the circular nature of the barrel  212  and assists holding the syringe  210  during filling and administering an injection. The domed, distal end wall  220  consists of two conjoined, circular parabolic sections; or the conic, distal end wall  222  consists of two, conjoined, conic sections. These result from being axially sealed over the inserted, molded plunger  234 &#39;s distal sealing member  239  with a distal extension  241  or  240 , respectively, of matching profile for full medicant evacuation. The linear seal  221  is interrupted to provide a liquid passageway  224  through the seal flange  223  with a distal, adhesive flair  228 . For assembly, the cannula  229  is partially inserted into the passageway  224  with slight lateral compression about the seal flange  223  and secured with adhesive  232 . Now referring to  FIGS.  23  and  24   , the plunger  234  is injection molded with a central, cruciform shaft  235  supporting opposing, integral discs: proximally a finger pad  236  and distally a seal  239 . The cruciform legs  238  within the tubular body  211  ensure the normal, axial travel of the sealing disc  239 . The seal disc interface  242  must be free of surface irregularities, like a parting line  243 . This is accomplished with a mold core undercut in the B-side of the mold base forming the seal interface  242  detail. When ejected, the sealing interface  242  and supporting seal disc  239  slightly compress to overcome the undercut and the plunger  234  tumbles from the B-side mold base. The fluid seal is established by the resiliency of the barrel sidewall  215  and the seal interface  242  supported by rigid, plunger sealing flange  239 . The distention  216  occurring in the barrel  212 &#39;s, resilient sidewall  215  with plunger  234 &#39;s travels is caused by the dimensional interference of the sealing flange  237 &#39;s interface  242  and the barrel  212 &#39;s interior diameter  214 .  FIG.  20    reveals a barrel  212 &#39;s, smooth sidewall  215  without an inserted plunger  234 . The cannula  229  has one end  230  sufficiently sharp to pierce the patient&#39;s skin and the other end  231  blunt to receive the affixing adhesive  232 .  FIGS.  21  and  22    reveal a cannula sheath  244  of extruded tubing  247 . A thermal seal  251  closes the distal end  252  and partially wraps the sides  253  to restrict its axial travel onto the syringe  210  protecting the cannula tip  230 . Toward the proximal end  249 , two, opposing, transverse indentions  254  engage the seal flange  223  for securement. To assemble, the sheath  244  is axially slid onto the syringe body  211  until the indention  254 &#39;s sloped surfaces  255  engage the selvage  222 . To remove, simply reverse the procedure. 
       FIGS.  28 ,  29 , and  30    reveal another embodiment 310 of a syringe comprising of an extruded, tubular body  311  having a flanged, proximal opening  317 , a closed distal end  319  with a passageway  324 , fluidly communicating with an axially aligned cannula  329  (needle), and an axially sliding, sealing plunger  334  establishing a liquid chamber  333  within the barrel  312 . The barrel  312  comprises a length of extruded tubing  313  with a uniform, interior diameter  314  and a thin, resilient sidewall  315 . A thermoformed, peripheral flange  318  of proximal opening  317  maintains the circular nature of the barrel  312  and assists holding the syringe  310  during filling and administering an injection. The distal end  319  of the extruded tube  313  is folded into the plunger  334 &#39;s distal surface  341  forming indentions  326  and producing multiple, nonplanar, distal flanges  323  which diminish the seal selvage; and is sealed about the base  321  of the seal flanges  323 . This distal structure creates a rigid end wall  320  for cannular posturing with a linear, fluid passageway  324  having a slight, distal flare  328 . To assemble the cannula  329  into the body  311 , axial pressure is applied to the plunger  334  forcing the seal flanges  323  to move distally causing the neck  327  of passageway  324  to open and receive the cannula  329 . When released the neck portion grips the cannula and maintains its posture prior to being attached and sealed within the passageway&#39;s distal flair  328  with an applied adhesive  332 . The cannula  329  has one end  330  sufficiently sharp to pierce the patient&#39;s skin and the other end  331  blunt to receive the affixing adhesive  332 .  FIGS.  33  and  34    show a plunger  333  with a tubular shaft  335  with flanged ends  336  and  339 . The proximal flange  336  exceeds the width of the barrel&#39;s flange  318  for accessibility and becomes the finger pad  336 . The distal flange  339  becomes the sealing interface  342  establishing the fluid-tight seal with the barrel  312 &#39;s resilient sidewall  315 . The distention  316  occurring in the barrel&#39;s resilient sidewall  315  with plunger  334 &#39;s movement is caused by the dimensional interference of the interface  342  and the interior diameter  314 . This is the basis of the fluid tight seal. An occluding plug  343  is pressure fit into the distal end of shaft tube  335 . The occluding plug  243  caps said shaft tube  235  with a distal surface mimicking the end wall  320  contour and becoming the sealing interface with the body sidewalls. A pierceable cap  338  may cover the proximal opening  317  for sealed access. Without a plunger  334  inserted into barrel  312 , a smooth sidewall  315  results and is shown in  FIG.  31   .  FIG.  32    reveal the new, needle sheath  344  also thermoformed from a section of extruded tubing  347  with a circumference  345  sufficient to frictionally fit over the distal flanges  323 . A thermal seal  351  closes the distal end  352 . A pair of opposing, spot seals  354  are placed on the sheath&#39;s sidewall  353  to restrict its axial travel onto the syringe  310  protecting the cannula tip  330 . 
       FIG.  35    is an axonometric view and  FIG.  36    is a longitudinal cross-sectional, side view of another embodiment of a thermoformed syringe  410  with the body  411  having an integral, selectively rotating, cannula (needle) sheath  444 . The syringe&#39;s tubular body  411  is thermoformed using extruded tubing  413  providing a uniform, interior diameter  414  within a thin, resilient sidewall  415 . The body  411  comprises a barrel  412  with a flanged, proximal opening  417 , an intermediary sealed end  419  with a stepped, frustoconical passageway  424  distally accepting a cannula  429 , and a distal, integral, selectively rotating sheath  444 . At the open, proximal end  417  of barrel  412 , a thermoformed, peripheral gripping flange  418  maintains the circular nature of the barrel  412  and assists the holding of the syringe  410  during filling and administering an injection. The intermediary sealed, wall  420  is thermoformed and sealed over the plunger  434 &#39;s seal disc  439 &#39;s frustoconical stanchion mimicking the disc&#39;s distal geometry. The resulting, distal, frustoconical stepped passageway  424  stiffens the barrel  412 &#39;s end wall  420  and provides visual, fluid communication between the fluid chamber  433  and a cannula  429 . As a result of this sealing process with slight axial pressure, two elliptical selvage regions  422  and distal flange  423  are formed flanking and extending from the distal seal  421 .  FIG.  37    reveals the planar flange  423  is arcuately die-cut  445  distally beyond the frustum  425  and thermoformed slightly downward into a selectively rotating, trough sheath  344 .  FIGS.  38  and  40    reveal the sheath&#39;s attachment sections are living hinges  446  providing selective posturing of the sheath  443  by a rotating interference between the proximal, central trough region  455  and the cannula base  431  due to arcuate cut  445 .  FIGS.  38 ,  39 ,  40 , and  41    reveal that as the sheath  444  rotates, the interference causes a lengthening and distortion of the living hinges  446 . Once over center, the interference lessens and the living hinges  446  retract, selectively posturing the sheath  444 . To assemble the cannula, the sheath  444  is rotated to its stowed position to expose the distal flare  428  and lateral compression is applied about the seal selvage  422  causing neck  427  and distal flare  428  of the passageway  424  to open and receive the cannula  429 . When released the neck portion  427  retracts and grips the cannula  429  maintaining the cannula&#39;s posture prior to being attached and sealed within the distal flair  428  with an applied adhesive  432 . The cannula  429  has one end  430  sufficiently sharp to pierce the patient&#39;s skin and the other end  431  blunt to receive the affixing adhesive  432 .  FIGS.  42 ,  43 ,  44 , and  45    demonstrate the sheath  444  and cannula  429  engagement for transporting and disposal of the syringe  410 . In the sheath&#39;s sidewall length  458 , tab  460  is inwardly formed with two slots  462  and  463  of sufficient depth to engage the cannula  429 . The trough has an intermediate, downward offset  461  to separate the engagement intentions of the individual slots  462  and  463 . Slot  462  selectively engages the cannula  429  for safe transporting and slot  463  locks over the cannula  429  for secure, syringe disposal. Locking requires an intentional, outward distortion of the trough sidewalls  458  for the locking slot  463  to engage the cannula  429 . The trough distal end  457  supports seal  456  to prevent axial exposure of cannula tip  430 .  FIGS.  46  and  47    show a plunger  434  with a tubular shaft  435  with flanged ends  436  and  439 . The proximal flange  436  exceeds the width of the barrel flange  418  for accessibility and becomes the finger pad  436 . The distal flange  439  becomes the sealing interface  442  establishing the fluid-tight seal with the barrel  412 &#39;s resilient sidewall  415 . The distention  316  occurring in the barrel&#39;s resilient sidewall  415  with plunger  434 &#39;s movement is caused by the dimensional interference of the interface  442  and the interior diameter  414 . This is the basis of the fluid tight seal. A pierceable, occluding plug  443  is pressure fit into the distal end of shaft tube  435 . A pierceable cap  448  may cover the proximal opening  447  for sealed access. 
       FIG.  48    is an axonometric view and  FIG.  49    is a longitudinal cross-sectional, side view of another embodiment of a syringe  510  using extruded, heat shrink tubing  513  to form the body  511 . The tubular body  511  has a uniform diameter  514  within a thin, resilient sidewall  515 . Its open, proximal end  517  is peripherally flanged  518  for rigidity and gripping ease when holding the syringe  510  during filling and administering an injection. The distal end  519  is closed by heat shrinking over the circular, seal interfaces  542  of the grommet  540  supported by the sealing flange  539 . Slightly up on its base, the cannula  529  is held within the tapering tip of a positioning fixture while the tube  513  is heat shrank around the plunger  534 &#39;s seal flange  539 &#39;s interface  543 , the frustoconical, capping grommet  540 , cannula base  531 , and tapering tip. This produces an end wall  520  with a frustum  525  having a distal neck  527  posturing the cannula  529 , and an adhesive/sealer reservoir  528  created by the retraction of the fixturing tip. The cannula  529  is affixed by placing an adhesive/sealer  532  in the reservoir  528 . The distention  516  occurring in the barrel&#39;s, resilient sidewall  515  with plunger  534 &#39;s movement is caused by the dimensional interference of the grommet  569 &#39;s sealing interface  542  and the barrel  512 &#39;s interior diameter  514 . This is the basis of the fluid tight seal.  FIGS.  51 ,  52  and  53    show a multi-lumen plunger  534  using an extruded tubular shaft  535  with center lumen  537 , flanged ends  538  and  539 , a perforable, distal, frustoconical, capping grommet  540 , a proximal, perforable cap  548 , at least three radiating, guide/stabilizing fins  545  ensuring axial, plunger travel. The proximal flange  538  with cap  548  becomes the finger pad  536  and exceed the width of the barrel flange  518  for accessibility and the grommet  540  supported by the distal flange  539  establishes a fluid-tight seal with the barrel&#39;s resilient sidewall  515 .  FIG.  50    reveals a new, cannular sheath  544  of heat shrink, extruded tubing  547 . The open, proximal end  549  is heat shrank over the frustum  525  and the flared, adhesive reservoir  528 , and the distal end  552  is heat shrank closed for cannular protection.