US20040143241A1 - Subcutaneous injection set for use with a reservoir that has a septum - Google Patents

Abstract

An infusion set includes a needle hub with a needle to be inserted in a through passageway of the cannula housing through a sealing surface of a soft cannula. The infusion set includes a guide for centering the needle relative to the cannula sealing surface, a dirt trap, and the through passageway, as well as a locking device for locking the cannula housing and the needle hub together to prevent inadvertent disengagement. The guide includes co-operating guide pins and guide openings and a draft angle on the needle hub. The pins are located on each side of the needle and the through passageway. The connecting tube includes an inner tube of polyethylene and shrink fitted tubing at each end suitable for a solvent bonding layer. The composite can be reinforced with monofilament strands sandwiched between the two tubular layers to prevent kinking, or the inner tube can be formed in a triangular shape. The triangular shape composite is incased in a thin polyester shrink tube.

Description

• The present application is related and claimed priority to U.S. application Ser. No. 09/675,159, filed Sep. 29, 2000; U.S. application serial number 60\195,702, filed Apr. 7, 2000; U.S. application serial number 60\188,624, filed Mar. 13, 2000; and U.S. application serial number 60\176,538, filed Jan. 18, 2000, the entire contents of each of which is incorporated by reference herein.[0001]
BACKGROUND OF THE INVENTION
• 1. Field of the Invention[0002]
• The present invention relates to medical connectors and infusion sets.[0003]
• 2. Brief Description of the Related Art[0004]
• In general, whenever a therapeutic fluid is to be delivered subcutaneously to a patient form an external source, a passageway, such as that provided by a hollow needle or other type of cannula or catheter device, must be first inserted through the skin of the patient in order to provide a passageway or channel through which the fluid may pass from its source external to the patient to the desired subcutaneous location under the skin of the patient. Once this passageway has been installed, the desired infusion system may be used in conjunction with an appropriate catheter connecting the external source of fluid with the passageway leading to the subcutaneous delivery point to deliver the fluid to the patient at an appropriate delivery rate.[0005]
• Unfortunately, several problems associated with infusing fluids into the patient as described above are usually encountered. Most systems require the patient to use a syringe that is fitted with a thread or luer fitting. The patient must fill the syringe and attach the catheter to it. However, in doing so the medication can become contaminated and is therefore no longer sterile. Non-sterile solutions can lead to infection. In addition the inconvenience of having to fill the syringe in the first place, and then attach and prime the catheter is difficult for many patients.[0006]
• In the early 1990's prefilled insulin cartridges were first introduced by insulin manufacturing companies for use in insulin pens. These cartridges are prefilled and make their use very convenient for the patient. The difficulty is that the prefilled cartridges need to have a septum to allow the medication to remain sterile.[0007]
• The recent popularity of insulin infusion pumps as an alternative to multiple daily injections for insulin-dependent diabetics requires the use of such an injection set to deliver insulin from a small, portable insulin infusion pump to the subcutaneous injection location. However, these devices require the patient to fill a syringe, which defeats the sterility of the mixture. Furthermore, there exists a substantial problem with the use of injection sets, as described above, in that flexible PVC is not completely insulin-compatible. This is in contrast to hard PVC, which is safe for use with insulin. While the exact nature of the reaction exhibited by insulin in contact with flexible PVC has not been determined with certainty, it is believed that the insulin, which is pH sensitive, reacts with CO[0008]₂, the flow of which therethrough is not inhibited by flexible PVC. In addition, the large quantities of plasticizer used in flexible PVC may result in a leaching problem when used with insulin.
• Since flexible PVC is not a barrier for CO[0009]₂, the CO₂which flows through the flexible PVC tubing will react with the insulin, causing the insulin to aggregate and to precipitate out of solution. Such precipitation of the insulin will likely cause clotting and blockage in the tube or in the needle, thereby inhibiting the flow of insulin to the subcutaneous depot.
• Heat will also accelerate the clotting process of insulin in flexible PVC tubing without the pH change caused by CO[0010]₂. The reason for this has not been finally determined, but it may be due to zinc in the insulin forming zinc chloride. In any event, heat will further compound the situation faced by delivery of insulin through flexible PVC tubing.
• The amount of insulin exiting the injection set will therefore vary considerably, with portions of the insulin becoming attached to the interior of the tube and eventually coating the interior of the tube, even if blockage does not occur. Over time, the situation will improve somewhat assuming blockage of the tube per se does not occur, but the amount of insulin actually delivered to the patient will vary considerable even with the best of circumstances. It may therefore be appreciated that the use of a flexible PVC tubing injection set to deliver insulin from an insulin infusion pump is neither desirable nor medically acceptable.[0011]
• Other substances exhibit reactions when delivered through flexible PVC tubing. Lipids and proteins have adverse reactions with flexible PVC delivery systems, and nitroglycerin also reacts to some degree with a flexible PVC environment.[0012]
• One solution which has been proposed to the problem has been through the use of polyethylene tubing, which does not cause a reaction with insulin passing therethrough. Polyethylene is a barrier to CO[0013]₂, and the major problem of CO₂passing through the tubing is thereby eliminated. Additionally, the problem of clotting of the insulin due to heat is also substantially minimized.
• Several problems have arisen with the use of epoxy bonded polyethylene infusion sets, all of which are due to the relative disadvantage of the epoxy bonding process to a solvent bonding process. First of all, an epoxy bond is simply not as strong as a solvent bond. Secondly, epoxy bonds have substantial aging problems, which limit shelf life of the injection set. Since the epoxy bond loses its mechanical bonding properties over time, the injection set will become less sturdy, with the potential for the tubing coming loose from the needle increasing substantially over time. Thirdly, batch control of epoxy used in epoxy bonding is time consuming and cumbersome. Finally, epoxy bonding or “potting” is a more expensive process than solvent bonding, resulting in a product having an economic disadvantage relative to a product made by solvent bonding.[0014]
• It is thereby apparent that there exists a substantial need for an injection set for delivery of insulin (or other fluids exhibiting reactions when flowed through flexible PVC tubing), which injection set utilizes polyethylene tubing to inhibit reaction and subsequent degradation of insulin flowing therethrough.[0015]
SUMMARY OF THE INVENTION
• According to a first exemplary embodiment, a medication infusion set comprises a base tube having an exterior surface, a proximal end, a distal end, and an inner lumen extending between the proximal and distal ends, the base tube formed of a material selected from the group consisting of polyethylene and polypropylene, a rigid cannula having a proximal end, a distal end, and a lumen extending between the proximal and distal ends, the cannula proximal end positioned in the base tube lumen, and a tube of a heat shrinkable material positioned on the base tube exterior surface at least in a region of the base tube in which the cannula is inserted, the heat shrinkable tube having been heat shrunk to the exterior of the base tube and compressing the base tube and the cannula together to form a seal.[0016]
• According to a second exemplary embodiment, an infusion device comprises a housing including a proximal end, a distal end, two lateral sides, and a bore extending between the proximal end and the distal end, a soft cannula having a proximal end, a distal end, and a lumen extending between the proximal end and the distal end, the cannula positioned in part in the housing bore with the cannula distal end outside of the housing, and a locking device attached to a lateral side of the housing, the locking device including a locking finger and a lever, the lever extending distally and the locking finger extending proximally, the locking finger including a distally facing surface.[0017]
• According to a third exemplary embodiment, a connecting device comprises a hub including a proximal end face, a distal end face, two lateral sides, and a bore extending between the proximal end and the distal end, a rigid cannula including a proximal end, a distal end, and a lumen extending between the proximal end and the distal end, the rigid cannula mounted in the hub bore with the rigid cannula distal end exterior of the hub, a pin extending distally from the hub distal end face and offset laterally from the rigid cannula, and a proximally facing surface on one of the lateral sides positioned between the proximal end face and the distal end face.[0018]
• According to a fourth exemplary embodiment, a process of forming a medical infusion set comprises the steps of inserting an end of a rigid cannula into the lumen of a length of tubing, and heat shrinking a tube of heat shrinkable material over the portion of the tubing in which the end of the rigid cannula is positioned to compress the tubing onto the rigid cannula.[0019]
• Still other objects, features, and attendant advantages of the present invention will become apparent to those skilled in the art from a reading of the following detailed description of embodiments constructed in accordance therewith, taken in conjunction with the accompanying drawings.[0020]
BRIEF DESCRIPTION OF THE DRAWINGS
• The invention of the present application will now be described in more detail with reference to preferred embodiments of the apparatus and method, given only by way of example, and with reference to the accompanying drawings, in which:[0021]
• FIG. 1 illustrates a perspective view of a first embodiment of an infusion set and connector in accordance with the present invention;[0022]
• FIG. 2 illustrates a longitudinal cross-sectional view of the set of FIG. 1;[0023]
• FIGS. 3 and 4 illustrate top plan views, with portions broken away in FIG. 4, of another embodiment of an infusion set in accordance with the present invention;[0024]
• FIG. 5 is a top plan view of a portion of the devices illustrated in FIG. 4;[0025]
• FIG. 6 is a front elevational view of the device in FIG. 5;[0026]
• FIG. 7 is a rear (upsidedown) elevational view of the device in FIG. 5;[0027]
• FIG. 8 is a left side elevational view of the device in FIG. 5;[0028]
• FIG. 9 is a cross-sectional view, taken at line[0029]9-9 in FIG. 5;
• FIGS. 10 and 11 illustrate enlarged views of portions of the device illustrated in FIG. 5;[0030]
• FIG. 12 illustrates a top plan view of a portion of the device illustrated in FIG. 4;[0031]
• FIG. 13 illustrates a side elevational (upsidedown) view of the portion in FIG. 12;[0032]
• FIG. 13[0033]aillustrates another portion of the device in FIG. 12;
• FIG. 14 illustrates a front elevational view of the device in FIG. 12;[0034]
• FIG. 15 illustrates a top plan view of an insertion device in accordance with the present invention;[0035]
• FIG. 16 illustrates a side elevational view of the device illustrated in FIG. 15;[0036]
• FIG. 17 illustrates a top plan view of a plug in accordance with the present invention;[0037]
• FIG. 18 illustrates a front elevational view of the plug illustrated in FIG. 17;[0038]
• FIG. 19 illustrates a cross-sectional view taken at line[0039]19-19 in FIG. 18;
• FIG. 20 illustrates a longitudinal cross-sectional view of a cannula in accordance with the present invention;[0040]
• FIG. 21 illustrates a perspective view of a pen needle in accordance with the present invention;[0041]
• FIG. 22 illustrates a longitudinal cross-sectional view of the pen needle illustrated in FIG. 21;[0042]
• FIG. 23 illustrates yet another device in accordance with the present invention;[0043]
• FIG. 24 illustrates a perspective view of a portion of the device illustrated in FIG. 23;[0044]
• FIG. 25 illustrates a longitudinal cross-sectional view of the portion of FIG. 24;[0045]
• FIG. 26 illustrates a portion of the device illustrated in FIG. 25;[0046]
• FIG. 27 illustrates yet another aspect of the present invention;[0047]
• FIG. 28 illustrates an enlarged top plan view of a portion of the device illustrated in FIG. 23;[0048]
• FIG. 29 illustrates a side view, partially in cross-section, of the portion illustrated in FIG. 28;[0049]
• FIG. 30 illustrates a longitudinal cross-sectional view along line[0050]30-30 in FIG. 29;
• FIG. 31 illustrates a cross-sectional view of a tube in another aspect of the present invention;[0051]
• FIGS. 32 and 33 illustrate yet further aspects of the present invention; and[0052]
• FIGS. 34 and 35 illustrate portions of a device in accordance with the present invention.[0053]
DESCRIPTION OF THE PREFERRED EMBODIMENTS
• Referring to the drawing figures, like reference numerals designate identical or corresponding elements throughout the several figures.[0054]
• The present invention relates to a disposable injection set that offers the ability for the patient to infuse from a prefilled insulin cartridge without compromising the sterility of medication to be infused. Also, utilization of prefilled medication cartridges to provide a source of infusion material makes it easy and convenient to use by the average patient. The utilization of a cannula to pierce the septum of the medication cartridge provides the sterile means for connecting the catheter to the cartridge and by combining it with the soft or flexible catheter with needles fixed on both ends permits the development of a convenient and sterile infusion device. The cannula that is inserted into the skin of a patient is held at its insertion location with a low profile holding pad or housing. The opposite end has a threaded connector with a cannula fixed in it that permits communication between the fluid in the reservoir and the catheter. The cannula on the threaded connector is positioned so that the tubing of the catheter is fixed over the cannula and attached by adhesive to the catheter tubing. The adhesive is selected from a set of epoxies or solvent adhesive that are capable of bonding to the soft tubing. The adhesive needs to create the appropriate bond and be capable of being sterilized. The solvent bondable shrink tube is then placed over the end of the tube and heated to produce a secure joint, and the adhesive is applied to the outer surface of the shrink tube and inserted into the connector.[0055]
• Turning now to the drawing figures, FIGS. 1 and 2 illustrates a perspective view and a longitudinal cross-sectional view, respectively, of a[0056]first embodiment100 of an infusion apparatus in accordance with the present invention. Generally, theapparatus100 includes amedication delivery device102, into which amedication ampule108 is releasably installed, and a catheter infusion set104. Themedication delivery device102 can be any of numerous such devices which receive amedication ampule108, including “pen” type injectors, programmable medication pumps, and those described in U.S. application serial No. 60/156,535, filed Sep. 29, 1999, U.S. application serial No. 60/170,570, filed Dec. 13, 1999, U.S. application serial No. 60/177,762, filed Jan. 24, 2000, and Attorney Docket No. 032994-012, filed Sep. 29, 2000, “Reusable Medication Delivery Device”, to Joel Douglas et al., the entire contents of each of which are incorporated by reference herein.
• The[0057]device102 includes aholder106 which releasably holds themedication ampule108 therein so that the ampule'sseptum112 is exposed and accessible to be pierced and accessed in a known fashion. Similarly, thepiston110 of theampule108 is accessible so that it can be moved to expel medication from the ampule, again in a known fashion. Thedevice102 includesexternal threads114 so that a medical connector, described in greater detail below, can be releasably attached to the device to access the ampule's contents through theseptum112.
• The catheter infusion set[0058]104 includes aproximal connector116 having a cylindrical collar orshroud118, which hasinternal threads120 which mate withexternal threads114. A piercingelement122, e.g., a needle, extends proximally from theconnector116. A distal catheter, cannula, needle, or othertubular element124 extends from the distal end of theset104, and is in fluid communication with the piercingelement122 via atube130. As can be seen in FIG. 1, thecatheter124 extends at an angle α to the longitudinal axis of the device (when laid straight). Angle α is preferably between about 15 degrees and about 90 degrees, and more preferably is about 30 degrees, so that the catheter can reside comfortably in the subcutaneous tissue layers of a patient. Aholding pad126 having anadhesive face128 is connected to thecatheter124 by any of numerous ways, preferably by an adhesive136 (see FIG. 2). At the proximal end of theset104, thetube130 is secured to adistal portion138 of theconnector116.
• As discussed above, the materials used for[0059]tube130 effect the way that the connection between the tube and theconnector116 can be made. According to one aspect of the present invention, atube132 is heat shrunk over the exterior of thetube130 in the area where the distal portions of piercingelement122 extend into the lumen of thetube130. In one aspect of the invention, thetube132 secures the piercingelement122 and thetube130 together. In another aspect, thetube132 presents an outer surface to which thedistal portions138 of theconnector116 can be solvent bonded, as at134, which outer surface is different from that of thetube130. Thetube132 can extend only a short way distally alongtube130, or can extend distally along the entire length oftube130. According to other aspects of the present invention,tube132 can be formed of any of a number of materials which permits good solvent bonding to theconnector116, such as PVC, polyester, or PTFE.
• The operation of the exemplary embodiment of the present invention described above and illustrated in FIGS. 1 and 2 will now be described with reference thereto. A user or patient inserts a[0060]medication ampule108, such an insulin cartridge, into thedelivery device102, with the ampule'sseptum112 accessible through the device. Thecollar116 is screwed or otherwise placed over the end of thedevice102 so that the piercingelement122 pierces theseptum112 and places the interior of the ampule in fluid communication with thecannula124. The user can then prime theset104, if desired. If theset104 is already in place subcutaneously, the user manipulates thedevice102 to move thepiston110 to deliver an amount of medication to the patient through thecannula124.
• FIGS. 3 and 4 illustrate top plan views, with portions broken away in FIG. 4, of another[0061]embodiment200 of an infusion set in accordance with the present invention.Set200 includes acannula housing202 which holds asoft cannula204 for positioning subcutaneously in a patient. A connectinghub206 is releasably positioned to the proximal end of thecannula housing202. A length oftubing208, preferably flexible, is secured to the proximal portions of the connecting hub. Aproximal connector210 is secured to the proximal end of thetubing208. Theconnector210 includes a cylindrical collar orshroud212, ahub222, and a piercingelement214. Adistal portion226 of the piercingelement214 extends proximally through thehub222 and is in fluid communication with thetubing208. Anextension216 of theconnector210 extends around the proximal portions of thetubing208 and connects the tubing to theconnector210. In one aspect of the present invention, a shrink tube, such astube132 described above, is inserted intoextension216 to facilitate bonding.
• The connecting[0062]hub206 includes distally extendingpins216,218 which are inserted into and mate with complementarily placed and configured holes or bores in thecannula housing202, described in greater detail below. A distally extendinghollow tube220 extends from the connectinghub206, and includesproximal portions224 which are in fluid communication withtubing208. Theproximal portions224 can be secured to thetubing208 in any suitable manner, including utilizing a shrink tube such astube132 and solvent bonding.Hollow tube220 may be sharpened at its distal most end, e.g., be a needle, or can alternatively be blunt.
• Turning now to FIGS.[0063]5-9, several views of thecannula housing202 are illustrated. Specifically, FIG. 5 is a top plan view of the cannula housing; FIG. 6 is a front elevational view; FIG. 7 is a rear (upsidedown) elevational view; FIG. 8 is a left side elevational view; and FIG. 9 is a cross-sectional view, taken at line9-9 in FIG. 5.
• The[0064]cannular housing202 includes a generally frustoconical, distally extendingportion230, through which abore232 extends. Thebore232 is widened at its distal end to form acannula recess234, for reasons which will be discussed further below. The proximal end of thebore232 widens in a frustoconically shapedproximal portion236. Theproximal portion236 is tapered in order to guide a tube, such astube220, when inserted into thebore232 throughproximal opening238. Thehousing202 also includes blind bores for receiving the pins from the connecting hub. When there are two pins,216 and218 as illustrated in FIG. 3, there are two such blind bores244,246, which are sized and positioned to receive the pins. As will be readily appreciated by one of ordinary skill in the art, while one such pin-bore combination is less preferable because it guides thehousing202 andhub206 together less effectively, and more than two pin-bore combinations may provide better registration between the hub and the housing, any number of pins and bores are within the spirit and scope of the present invention.
• The proximal end of the[0065]housing202 includes a pair ofguide extensions242, one on each lateral side of the housing, which together delimit an openproximal space240 sized and shaped to receive portions of the connectinghub206. Eachguide extension242 includes an laterally inwardly directed, slightly taperedguide surface248,250. The guide surfaces248,250 are sized and oriented so that they provide initial guidance to the outer surfaces of thehub206 when the hub andhousing202 are brought together, described in greater detail below.
• The housing also includes at least one, and preferably two[0066]locks252,254, positioned on the lateral sides of the housing. Thelocks252,254 are provided to releasably lock thehub206 to thehousing202 when the hub and housing are properly mated together (see FIG. 4). Thelocks252,254 include releasable lockingfingers256,258 which extend proximally from regions where the locks join with thehousing202. Thefingers256,258 include alocking bearing surface260 which is distally directed for bearing against portions of thehub206 which face proximally (again, see FIG. 4). Adjacent to the locking bearing surface(s)260, eachfinger256,258 is provided with anangled cam surface262. The cam surfaces provide a place for the connectinghub206 to bear against thefingers256,258 and push them laterally outward, to spread the fingers and permit the connecting hub to enter thespace240 when moved distally relative to thehousing202.
• The[0067]locks252,254 also includelevers264 on their proximal ends, opposite thefingers256,258. The cantilevered levers264 are positioned laterally spaced from thehousing202 so that there arespaces266 between the levers and the housing into which the levers can be flexed. Flexure of thelevers264 laterally inward cause thefingers256,258 to flex laterally outward, thus permitting the connectinghub206 to enter and exit thespace240 more easily. As will be readily appreciated by one of ordinary skill in the art, pulling proximally on the connectinghub206, when positioned in thespace240, with sufficient force will also result in thefingers256,258 spreading apart and the hub being released from thehousing202 and thelocks252,254.
• As illustrated in FIGS. 6, 8, and[0068]9, thesoft cannula204, in some aspects of the present invention, is angled relative to thebottom surface268 of thehousing202 at an angle β, wherein β can be any acute angle, and can be the same as a.
• FIGS. 10 and 11 illustrate enlarged views of portions of the connecting[0069]hub206. Specifically, FIG. 10 illustrates thelocks254, including thechannel270 between thefinger258 and thehousing202. FIG. 11 illustrates thebore232, without thesoft cannula204 positioned in the bore.
• FIGS.[0070]12-13aillustrate the connectinghub206. More specifically, FIG. 12 illustrates a top plan view of the connectinghub206; FIG. 13 illustrates a side elevational (upsidedown) view; FIG. 13aillustrates a portion of the hub; and FIG. 14 illustrates a front elevational view. As discussed above, pins216,218 andtube220 extend from thehub206. Thehub206 includes lockingsurfaces280 which are oriented and positioned so that the bearing surfaces260 of the lockingfingers256,258 will bear against the locking surfaces280 when the hub is positioned in thespace240. Cam surfaces282 are also provided on the distal end of thehub206 to bear against the cam surfaces262 of thefingers256,258, as described above.
• The[0071]hub206 includes aproximal portion284 to which thetubing208 is attached, preferably in a permanent manner. A longitudinally extending lumen or bore286 extends from the proximal end to the distal end of thehub206. The lumen is sized to receive thetubing208 therein, with theproximal end224 of thetube220 in fluid communication with the lumen of the tubing. Although astraight bore286 can be used, it is preferable that the bore include ashoulder292 along its length, with aproximal portion288 and anintermediate portion290 on either side of the shoulder. Theintermediate portion290 can be of a smaller inner diameter than theproximal portion288 so that thetubing208 is radially compressed.Intermediate portion290 can also have a slightly tapered inner diameter, so that the radial compression of the tubing is greater at the shoulder than elsewhere along thebore286. Thebore286 also includes adistal portion296, in which a needle hub orpositioning block294 is mounted.
• FIG. 13[0072]aillustrates that, in one aspect of the invention, theblock294 can have abeveled side300 to assist in aligning thetube220 at the same angle as thesoft cannula204. FIGS. 13 and 14 illustrate that thehub206 can optionally have a slantedtop surface298.
• FIGS. 15 and 16 illustrate a top plan view and a side elevational view, respectively, of an insertion device[0073]302 used to insert the soft cannula into the patient, preferably subcutaneously. The device302 includes a needle orstylet304 extending distally from aninsertion handle306. The insertion handle306 is substantially the same shape and size as thehub206, and includes a pair ofpins308,310, substantially similar topins216,218. The needle orstylet304 is of a length so that the sharpened distalmost end of the needle or stylet extends beyond the distalmost end of thesoft cannula204 when theinsertion handle306 is mounted on thehousing202, in the same manner as the connectinghub206 is mounted to the housing in FIG. 4. A proximal end of the needle orstylet304 is preferably within thehandle306. According to yet another aspect of the present invention, theneedle304 can include ascore line314 along its length so that the needle can be broken off and used as an infusion needle. Thehandle306 would then require a lumen similar tolumen286 in FIG. 12.
• FIGS.[0074]17-19 illustrate several views of a plug in accordance with one aspect of the present invention. More specifically, FIG. 17 illustrates a top plan view of aplug330; FIG. 18 illustrates a front elevational view of the plug, and FIG. 19 illustrates a cross-sectional view taken at line19-19 in FIG. 18. The outside size and shape ofplug330 is the same as theinsertion handle306 and the connectinghub206, described above. Theplug330 includes a pair ofpins332,334 to mate withblind bores244,246, described above. Theplug330 includes a central pluggingelement336 having a preferably conical orfrustoconical tip338 extending distally from the pluggingelement336. The pluggingelement336 is formed of a somewhat soft material which is somewhat compressible, so that when theplug330 is mounted to thehousing220 in the manner ofhub206 and handle306, the plugging element will enter into and seal the proximal portions ofbore232. By way of example and not of limitation,element338 can be formed of a medical grade silicon rubber. Thus, theplug330 can be used to seal thebore232, and therefore access to the patient's body by dirt and pathogens is greatly restricted when connectinghub206 is disconnected from thehousing202.
• The size and taper of plugging[0075]element336 andtip338 are preferably selected to plug and seal with taperedportion236, although the size and taper can also be selected to seal and plug thebore232 at the junction ofbore232 andtaper236, the junction oftaper236 andproximal opening238, theopening238 itself, or any combination of these structures by forming pluggingelement336 with a complementary shape. According to yet another aspect of the present invention, the material out of which pluggingelement336 is formed can be doped with an antimicrobial or similar compound to inhibit the growth of microorganisms on the plugging element itself or on the surfaces against which it seats.
• FIG. 20 illustrates a cross-sectional view of[0076]soft cannula204. Thesoft cannula204 includes alongitudinally extending lumen350, which extends between aproximal end352 and adistal end354. A positioning and retention bead, ring, or lug356 is formed on the outer surface of thecannula204, and is sized to fit intorecess234 of thehousing202. Thebead356, in one aspect of the present invention, is sized relative to therecess234 so that the bead can securely hold thecannula204 in thehousing202. In another aspect of the present invention, thebead356 assists in positioning thedistal end354 of thecannula204 at a predetermined distance from thehousing202. In yet another aspect of the present invention, thecannula204 is permanently mounted in thebore232 by any of numerous ways, such as solvent or adhesive bonding, ultrasonic welding, heat staking, or the like.
• The[0077]cannula204, in yet another aspect of the present invention, includes arestriction surface358 formed on the inner surface of thelumen350 near or at theproximal end352 of the cannula. Therestriction surface358 is formed by a reduction in the inner diameter of thelumen350 to a diameter which is only slightly smaller to slightly larger than the outer diameter oftube220. By forming the inner diameter of thelumen350 and the outer diameter oftube220, and optionally of needle orstylet304, so that they are nearly the same, the clearance between the two surfaces is too small for liquids such as blood and aqueous solutions of medications to flow. According to yet another aspect of the present invention, the change in diameter can be formed on the outside of thetube220, and optionally on the outside of needle orstylet304. Thus, one aspect of the present invention is a seal against the passage of fluid in and out of thehousing202 along thecannula204, other than through thelumen350.
• The operation of the exemplary embodiment of the present invention described above and illustrated in FIGS.[0078]3-20 will now be described with reference thereto. The operation of theset200 is similar in many respects to set104. Initially, thehousing202 is mounted to thehandle306 so that the distal end of the needle orstylet304 extends distally from the distal end of thesoft cannula204. As discussed above, therestriction358 and the external surface of the needle orstylet304 provide a fluid seal. Theflaps436 of thedust door430 have been previously pushed aside by the needle orstylet304. Thesoft cannula204 andhousing202 can then be inserted into a patient, e.g., subcutaneously, in a manner well-appreciated by one of ordinary skill in the art. Thehandle306 is then retracted proximally by pressing laterally inwardly on one or both of thelevers264, which releases the handle from thehousing202. Theflags436 return to their generally planar configuration, inhibiting dust and dirt from entering the device.
• The connecting[0079]hub206, with thetubing208 andconnector210, is then inserted into thespace240, laterally displacing the lockingfingers256,258. With thepins216,218 in thebores244,246, the guide surfaces248,250 guide the outer surfaces of thehub206 as the hub moves distally. The lockingfingers256,258 then snap over the locking surfaces280, securing thehub206 to thehousing202 with thetube220 extending through thesoft cannula202. The outer surface of thetube220 and therestriction358 form a fluid seal, as described, and theflaps436 again are moved aside by thetube220. Theconnector210 can then be attached to a septum of a medication ampule, and medication delivered through thetubing208, through thesoft cannula202, and to the patient.
• After the medication infusion described above, the[0080]hub206 can be removed proximally by pressing on thelevers264, as described above, to release the hub from thehousing202. Theplug330 can then be installed in place, as described above, with the pluggingelement338 moving aside theflaps436 and forming a seal with one of the proximal structures of thehousing202. Thehousing202 andcannula204 are then prepared for later infusion, while sterility of the site is enhanced or maintained.
• FIGS. 21 and 22 illustrate a[0081]pen needle370 according to yet another aspect of the present invention. FIG. 21 illustrates a perspective view of thepen needle370; FIG. 22 illustrates a longitudinal cross-sectional view. Thepen needle370 includes a cylindrical collar orshroud372 having anopen end378, ahub374 forming a part of aclosed end380 of the collar, and a two-endedneedle376 extending through the hub with one end within the collar. Thepen needle370 also includes anannular groove376 formed in the inner surface of the collar, and receives in the groove a dust door described in greater detail below. Thepen needle370 can be used in the place ofset104, described above with reference to FIGS. 1 and 2, by placing thecollar372 around the septum of an ampule so that theneedle376 pierces the septum. The other end of theneedle376 can be inserted into a patient, and an infusion of medication delivered to the patient.
• FIG. 23 illustrates yet another infusion set[0082]400 in accordance with other aspects of the present invention. The infusion set400 can be used with amedication delivery device102 as described above which includes a medication ampule having a septum. The infusion set400 includes an infusion needle orcannula402 at a distal end, aholding pad404 to secure the infusion needle to a patient,tubing406 extending proximally from and in fluid communication with theinfusion needle402, and aproximal connector408 connected to the proximal end of the tubing. As discussed in greater detail above, thetubing406 may be attached to the proximal connector using shrink tubing and solvent bonding, for example.
• FIGS.[0083]24-26 illustrate details of the infusion set400 of FIG. 23. More specifically, FIG. 24 illustrates a perspective view of theconnector408; FIG. 25 illustrates a longitudinal cross-sectional view of the connector; and FIG. 26 illustrates a portion of the connector. Theconnector408 includes a cylindrical collar orshroud412 which has anopen end414 and aclosed end416. Anannular shoulder418 is formed in theclosed end416, and a distaltubular extension420 extends distally from the closed end. Theextension420 includes alumen422 communicating the open portion of thecollar412 with the distal end of the connector. Thelumen422 can have a constant inner diameter, or can include a distal reducedinner diameter portion424 which, as described above with reference to bore286, can assist in forming a seal with thetubing406 when the tubing is inserted into thelumen422. Afluid transfer device426 is mounted in theconnector408 in theannular shoulder418, and is secured to the connector, such as by glueing, ultrasonic welding, or the like.
• Turning to FIG. 26, the[0084]fluid transfer device426 includes a sharpenedproximal end428 to pierce a septum of a medication ampule, such asseptum112. Thedistal end432 of theshaft430 can be either sharpened or blunt. Alumen434 extends between the sharpened proximal428 and distal432 ends. A mountingblock436 is mounted to theshaft430, and has a size and a shape to fit toannular shoulder418.
• FIG. 27 illustrates, in a manner similar to FIG. 2, how a[0085]tube450 can be joined to a needle orrigid cannula452. With the end of theneedle454 within thelumen458 of thetube450, atube456 of shrinkable material is positioned over the outside of the tube so that it overlaps both the tube and the needle. By shrinking thetube456, thetube450 is clamped down onto the shank of theneedle452, securing the two together. Thereafter, the outer surface of thetube456 can be used to secure the assembly to another component, such as by solvent bonding.
• FIG. 28 illustrates a top plan view of the distal infusion end of[0086]set400, FIG. 29 illustrates a side view, partially in section of the distal end ofset400, and FIG. 30 illustrates a cross-section view taken at line30-30 in FIG. 29. As can be seen in FIG. 29,tubing406 is formed to be kink-resistant, as described in greater detail below. A hub438 fluidly communicates thetubing406 with the needle orcannula402. FIG. 30 illustrates that the holdingpads404 include an outeradhesive layer410, to secure the device to a patient.
• FIG. 31 illustrates a cross-sectional view of[0087]tubing406 according to one aspect of the present invention. Thetubing406 is formed to have a cross-sectional shape that makes the tubing resistant to kinking. In FIG. 31, thetubing406 has a triangular cross-section. A piece ofshrink tube422 is illustrated positioned around thetube406 prior to being shrunk down onto the outer surface of the tubing, for the reasons presented herein. By way of example and not of limitation,inner tube406 can be formed of a polyethylene or polypropylene, and theouter shrink tube422 can be formed of a PVC, polyester, or PTFE. FIGS. 32 and 33 illustrate yet further aspects of the present invention. In FIG. 32,tubing406 is formed of abase tube420, ashrink tube422 around the base tube, and at least one filaments, wires, or the like424 between the base tube and the shrink tube. Thefilaments424 strengthen the tube and assist in preventing kinking. In FIG. 33, thefilaments424 have been removed, with theshrink tube422 acting to assist in preventing kinking. The shrink tube is422 is then shrunk over thebase tube420, resulting in a strengthenedtubing406.
• FIGS. 34 and 35 illustrate a[0088]dust door430 according to yet another aspect of the present invention. Thedoor430 is formed of athin sheet432 of relatively strong and pliable material, which includes intersectingslits434 which together form two or more flaps436. By way of example and not of limitation,sheet432 can be formed of Mylar of about 0.003 inches thickness. Thedoor430 is, in certain aspects of the present invention, preferably installed inopening238,378, or the open end ofcollar116, and prevents dust and dirt from entering these openings. Referring to FIG. 5 andopening238, when it is desired to insert, for example,tube220 into thebore232, theflaps436 are pushed aside by the advancingtube220 without interfering with assembly of the device and without piercing the flaps. When thetube220 is retracted, theflaps436 resume their generally planar configuration.
• The operation of the exemplary embodiment of the present invention described above and illustrated in FIGS.[0089]23-35 will now be described with reference thereto. The use of the embodiments of FIGS.23-35 is similar to the use of the embodiments of FIGS. 1 and 2. A user or patient inserts amedication ampule108, such an insulin cartridge, into thedelivery device102, with the ampule'sseptum112 accessible through the device. Theconnector408 is screwed or otherwise placed over the end of thedevice102 so that the piercingelement428 pierces theseptum112 and places the interior of the ampule in fluid communication with thecannula402. The user can then prime theset400, if desired. If theset400 is already in place subcutaneously, the user manipulates thedevice102 to move thepiston110 to deliver an amount of medication to the patient through thecannula124.
• While the invention has been described in detail with reference to preferred embodiments thereof, it will be apparent to one skilled in the art that various changes can be made, and equivalents employed, without departing from the scope of the invention.[0090]

Claims (17)

What is claimed is:

1. A medication infusion set comprising:

a base tube having an exterior surface, a proximal end, a distal end, and an inner lumen extending between the proximal and distal ends, the base tube formed of a material selected from the group consisting of polyethylene and polypropylene;

a rigid cannula having a proximal end, a distal end, and a lumen extending between the proximal and distal ends, the cannula proximal end positioned in the base tube lumen; and

a tube of a heat shrinkable material positioned on the base tube exterior surface at least in a region of the base tube in which the cannula is inserted, the heat shrinkable tube having been heat shrunk to the exterior of the base tube and compressing the base tube and the cannula together to form a seal.

2. A medication infusion set in accordance withclaim 1, further comprising:

a connector including a cylindrical collar having a hollow interior, a closed end, and an open end, the distal end of the rigid cannula extending through the collar closed end and into the hollow interior; and

a solvent based adhesive bonding the connector to the heat shrunk tube.

3. A medication infusion set in accordance withclaim 1, further comprising:

a soft cannula having a proximal end, a distal end, and a lumen extending between the proximal end and distal ends, the soft cannula proximal end in fluid communication with the base tube distal end.

4. A medication infusion set in accordance withclaim 1, wherein the heat shrinkable material is selected from the group consisting of PVC, polyester, and PTFE.

5. A medication infusion set in accordance withclaim 1, further comprising at least one filament between the heat shrunk tube and the base tube and extending along the base tube.

6. A medication infusion set in accordance withclaim 1, wherein the base tube has a triangular cross-sectional shape.

7. An infusion device comprising:

a housing including a proximal end, a distal end, two lateral sides, and a bore extending between the proximal end and the distal end;

a soft cannula having a proximal end, a distal end, and a lumen extending between the proximal end and the distal end, the cannula positioned in part in the housing bore with the cannula distal end outside of the housing;

a locking device attached to a lateral side of the housing, the locking device including a locking finger and a lever, the lever extending distally and the locking finger extending proximally, the locking finger including a distally facing surface.

8. An infusion device in accordance withclaim 7, wherein the housing bore includes a proximal opening, and further comprising a dust door positioned adjacent to the bore proximal opening, the dust door formed of a resilient and flexible material, the dust door including a planar sheet having at least one slit through the sheet to form at least two flaps.

9. An infusion device in accordance withclaim 7, wherein the soft cannula lumen has a first inner diameter and a second smaller inner diameter, the second inner diameter being in a region adjacent the cannula proximal end.

10. An infusion device in accordance withclaim 7, wherein the soft cannula further comprises an exterior surface and a bead extending from the exterior surface between the proximal and distal ends.

11. A connecting device comprising:

a hub including a proximal end face, a distal end face, two lateral sides, and a bore extending between the proximal end and the distal end;

a rigid cannula including a proximal end, a distal end, and a lumen extending between the proximal end and the distal end, the rigid cannula mounted in the hub bore with the rigid cannula distal end exterior of the hub;

a pin extending distally from the hub distal end face and offset laterally from the rigid cannula;

a proximally facing surface on one of the lateral sides positioned between the proximal end face and the distal end face.

12. A connecting device in accordance withclaim 11, further comprising a length of tubing having a proximal end, a distal end, and a lumen extending between the proximal end and the distal end, the tubing distal end positioned in the hub bore and in fluid communication with the rigid cannula lumen.

13. A connecting device in accordance withclaim 11, wherein the pin is a first pin, and further comprising a second pin extending distally from the hub distal end face and offset laterally from the rigid cannula and from the first pin.

14. A process of forming a medical infusion set, comprising the steps of:

inserting an end of a rigid cannula into the lumen of a length of tubing;

heat shrinking a tube of heat shrinkable material over the portion of the tubing in which the end of the rigid cannula is positioned to compress the tubing onto the rigid cannula.

15. A process in accordance withclaim 14, wherein the tubing is formed of a material selected from the group consisting of polyethylene and polypropylene.

16. A process in accordance withclaim 14, wherein the heat shrinkable material is selected from the group consisting of PVC, polyester, and PTFE.

17. A process in accordance withclaim 14, further comprising:

solvent bonding a connector to the heat shrunk tube, the connector including a collar through which the another end of the rigid cannula extends.

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