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Contents
1. One exemplary group of materials with this gas permeability property includes silicon based organic polymers also known as silicon oils They are flexible strong and can retain their strength through a wide range of temperatures In addition to gas permeability they are also very resistant to chemicals and ultraviolet rays Silicon based organic polymers are liquid impermeable and do not allow bacteria or other harmful substances to pass making them useful in medical applications such as the present invention 0032 One such silicon based organic polymer for use in the present invention is polydimethylsiloxane also known as dimethicone or its trade name SILICON ELASTOMER Its density ranges from 1 1 to 1 5 g cm Since the density of polidimethylsiloxane is proportional to its gas permeabil ity a less dense version 1 1 to 1 3 g cm is preferred 0033 Another group of materials suitable for this inven tion is microporous polyolefins Unlike regular polyolefins these microporous polyolefins have tortuous sub micron size passageways extending from one surface side to the other This allows the passage of gas and vapor while prohibiting the passage of particles and liquids The microporous polyolefin material can be made by taking a microporous polyolefin matrix and sufficiently filling the Apr 24 2008 pores with a moisture vapor permeable liquid imperme able hydrophilic material to prevent the passage of water and othe2. which prevents slipping in any direction FIG 2G shows another embodiment of a hatch pattern FIG 2D shows a series of wavy ribs running longitudinal with the surface of the sheath 100 which performs the functions of the pattern in FIG 2A but with an added ability to prevent movement in the transverse direction FIG 2E shows a series of bumps or projections covering the surface of the sheath 100 which provides the user with larger obtrusions for even more grip If the surface of the sheath is wet these bumps will serve as dry pads for the fingers while the moisture rests in the valleys in between FIG 2F shows a series of ribs in a tread like pattern much like the bottom of a pair of running shoes or a tire which is another technique of preventing slipping in any direction Many of these patterns have ribs or ridges or the like These ribs or ridges should stand high enough to prevent slipping it the given direction but not so high as to interfere with the user s ability to move the catheter through the center or the sheath s ability to collapse to the proximal end during insertion 0031 Yet another exemplary embodiment of the present invention is a sheath of specified thickness made from a gas permeable material such as in simultaneously pending US patent application Ser No 10 entitled Cath eter Assembly by the same inventor as in the present invention and which is incorporated by reference herein in its entirety
3. and would prefer to perform self catheterization For many the level of risk and discomfort of repeated catheterizations carried out over the course of a day at 3 6 hour intervals for example are offset by the accompanying convenience privacy and self reliance achieved with self catheterization However some major difficulties arise in the current self catheteriza tion techniques These difficulties include the lack of satis factory catheterization kits the problem of maintaining the required level of sanitation during the procedure difficulty in handling the catheter during insertion and the difficulty of performing the procedure under conditions of restricted space and privacy 0006 In the assisted or non self catheterizations pres ently employed in hospitals use of a catheterization tray is common practice This tray typically includes a sterile drape gloves a conventional catheter antiseptic solution swabs lubricant forceps an underpad and a urine collec tion container Assisted catheterization is usually performed with the patient in a supine position The nurse typically grabs the patient s genitalia with one hand while using the other hand to insert the catheter into the patient s urethra Thus the nurse has only limited dexterity for manipulating the catheter in and around the patient s urethra Maintaining a sterile field using sterile technique during the procedure can be a problem The cath tray
4. end of the catheter 102 during insertion To avoid rips and tears in the sheath 100 from normal use a sheath 100 thickness of 0 0020 may be used as a minimum sheath thickness Avoiding problems of pulling the sheath 100 back to expose the catheter 110 depends on the user s manual dexterity A wide range of thicknesses is possible but users with limited manual dex terity are usually not comfortable with a sheath thickness greater than 0 0065 Further experiments have shown that a sheath thickness of 0 0040 to 0 0045 allows those with limited manual dexterity ease of use while still offering a strong resistance against rips and tears 0026 An exemplary embodiment of a conventional assembly for a catheter with a sheath is shown in FIG 1A The proximal end of the sheath 101 surrounds the proximal tip of the catheter 111 and is dosed at the end The distal end of the sheath 102 is attached near the distal end of the urethra insertable portion of the catheter 180 with plastic or elasto meric ties or bands 140 or heat sealed The distal end of the sheath 102 could also be attached to the outlet 120 if the catheter employs one This outlet 120 could then be used to attach a urine bag or the like 0027 In order to perform a catheterization using this device the user should first open the proximal end of the sheath 100 exposing the proximal end of the catheter 111 as shown in FIG 1B The user then holds the proximal tip of the catheter 1
5. helps the user hold the catheter 470 in place while inserting it into the urethra The guiding tip 430 has a throughbore 420 in the center which the catheter 470 can slide through 0037 One such embodiment of the guiding tip 430 is illustrated in FIG 4B At the proximal end of the guiding tip is a collar 410 with a size of about ten to fifteen millimeters which rests on the outside of the urethra during insertion At the proximal end of the collar 410 is a short tube 420 just wider than the catheter 470 This tube 420 ends in a rounded top with two cuts in the top 421 When the catheter 470 is pushed through the top the tube 420 splits into four tabs 422 allowing the catheter 470 to pass Towards the distal end of the guiding tip 430 there is also a reservoir portion 430 The distal half of the reservoir is a hollow cylinder 431 while the proximal half is a hollow frustoconical section 432 The reservoir portion 431 contains the same lubricant 130 held inside the sheath 400 This makes the guiding tip 430 longer and bulkier and gives the user more to hold onto while sliding the catheter 470 through On the outside of the reservoir 431 texture can be added for extra gripping Other embodiments of the guiding tip can be found in U S Pat No 6 090 075 entitled Disposable urinary catheterization assembly issued to House which is incorporated by ref erence herein in its entirety 0038 In other embodiments the catheter 110 will be c
6. procedure is impractical for use with some individuals having certain spastic and voluntary muscle disorders 0007 Many individuals with spinal cord injuries or other neurological diseases routinely perform intermittent cath eterization several times a day using conventional catheters or kits and the clean technique In the clean technique the Apr 24 2008 urethral area is initially swabbed with an antiseptic and efforts are made to avoid contamination of the catheter during the procedure The user s hands are not sterile and a sterile field is not maintained Clean technique is used instead of sterile technique generally for two reasons First it is very difficult if not impossible for individuals per forming self catheterization to adhere strictly to sterile tech nique Secondly these individuals are required to catheterize themselves between 3 and 6 times a day The cost of a new sterile catheter and the accessories required to perform sterile catheterization can become excessively expensive for some users Sometimes an individual will reuse a cleaned catheter As a result the use of clean technique often results in contamination and subsequent infection of the urinary tract causing significant morbidity and cost to the patient and society 0008 Thus there is a need in the healthcare industry for a catheter assembly that enables all users particularly those users with limited dexterity to grip the cat
7. 11 with the sheath 100 between the user s hand and the catheter 110 and pulls the sheath 100 with the other hand As the user pulls the sheath 100 which is attached to the catheter at its distal end 113 the catheter 110 will be pushed through the sheath 100 and into the urethra causing the sheath 100 to bunch up at the proximal end 101 For embodiments utilizing a guiding tip FIG 4 at the proximal end of the catheter 111 a catheterization can be performed without opening the proximal end of the sheath 101 The user can simply push the catheter 110 through the guiding tip 150 and into the urethra 0028 This process continues until the catheter 110 runs all the way through the urethra and into the bladder Once inside fluid from the bladder will stream into the catheter through the opening 112 at the proximal tip of the catheter 111 Provided the catheter distal end 113 is lower in altitude than the catheter proximal end 111 fluid will flow through the catheter out the outlet 120 and into a receptacle When the bladder has been drained of all fluid the catheter 110 is then pulled out of the urethra by the user and disposed 0029 Another exemplary embodiment of the present invention is a textured sheath of specified thickness such as in simultaneously pending U S patent application Ser No 10 entitled Catheter Assemblies Having Protective Sheaths by the same inventor as in the present invention and which is incorporated
8. US 20080097411A1 as United States a2 Patent Application Publication co Pub No US 2008 0097411 A1 House 43 Pub Date Apr 24 2008 54 CATHETER ASSEMBLIES HAVING SIZED Publication Classification SHEATHS 51 Int Cl 76 Inventor Jamie Glen House Colorado AGIM 27 00 2006 01 Springs CO US 62 US Gs jee ae ie tea te 604 544 Correspondence Address 57 ABSTRACT MOAZZAM amp ASSOCIATES LLC bos 7601 LEWINSVILLE ROAD SUITE 304 Devices and methods are disclosed for a catheterization MCLEAN VA 22102 process particularly useful for self performed catheteriza tions A catheter is enclosed in a sheath made with a specific 21 Appl No 11 526 056 thickness This sheath is thick enough to avoid rips and tears from normal use yet thin enough to allow those with even 22 Filed Sep 25 2006 limited manual dexterity to use the catheter with ease Patent Application Publication Apr 24 2008 Sheet 1 of 4 US 2008 0097411 A1 Patent Application Publication Apr 24 2008 Sheet 2 of 4 US 2008 0097411 A1 Patent Application Publication Apr 24 2008 Sheet 3 of 4 US 2008 0097411 A1 311 301 312 311 312 Patent Application Publication Apr 24 2008 Sheet 4 of 4 US 2008 0097411 A1 US 2008 0097411 Al CATHETER ASSEMBLIES HAVING SIZED SHEATHS BACKGROUND OF THE INVENTION 0001 1 Field of the Invention 0002 The present invention relates generally to catheter assemblies More particularly t
9. by reference herein in its entirety This texture is essentially any topography of a non uniform elevation Uniform elevation would be any surface that is flat and smooth which increases the likelihood that the surface is either slippery or can be made slippery quickly by contact with moisture either on the user s hand or else where The textured sheath seeks to employ surfaces that have ridges bumps notches or any other type of substan tially non flat or non smooth surface to enhance the contact and grip with a user s hand and fingers US 2008 0097411 Al 0030 There are many possible textures for the sheath 100 These textures can be placed on the inside of the sheath as well providing a user with grip on the catheter FIG 2A shows a series of ribs running parallel with the surface of the sheath 100 which is the basic technique for providing grip preventing slipping perpendicular to the movement of the catheter 110 If used on the inside of the catheter the parallel ribs will give the user enough grip to manipulate the catheter while still allowing it to slide forward through the sheath FIG 2B shows a series of ribs running perpendicular to the surface of the sheath 100 The perpendicular ridges prevent slipping against the movement of the catheter 110 It also allows the sheath to fold up more easily as the sheath compresses towards the proximal end during insertion FIG 2C shows a series of ribs interwoven in a hatch pattern
10. erspective view of a catheter surrounded by a gas permeable sheath with the sheath pulled back to expose the catheter 0022 FIG 4A shows an external perspective view of a catheter surrounded by a sheath attached to a guide tip at the proximal end according to an exemplary embodiment of the present invention 0023 FIG 4B shows a close up view of a guiding tip according to an exemplary embodiment of the present invention DETAILED DESCRIPTION OF THE INVENTION 0024 The present invention is a sheath 100 for a catheter 110 or catheter assembly of a specified thickness In par ticular the present invention includes devices and methods for urinary catheterization for patients who want to self catheterize in a sterile and safe manner yet do not have the manual dexterity to complete the process efficiently In order to achieve the level of sterility required to avoid infection a sheath 100 is used to cover the portion 180 of the catheter that is insertable into the urethra The sheath 100 can cover the catheter 110 from time of storage until full insertion The user can pull the catheter 110 through the sheath 100 without touching the catheter 110 itself 0025 The thickness of the sheath according to the present invention yields a sheath 100 that is strong enough to Apr 24 2008 withstand the forces of normal use and with enough flex ibility to allow even those with limited manual dexterity to slide the sheath 100 to the distal
11. hat gives these users enough gripping ability to easily hold the sheath with their hand s while pulling the catheter through This allows users with lower manual dexterity to complete the self catheterization process efficiently and with ease 0015 Another exemplary embodiment of the present invention is a gas permeable sheath of a specified thickness A catheter using a sheath made from a gas permeable yet liquid impermeable material will allow excess air inside the catheter to leak through the sheath without compromising the integrity and thus the sterility of the sheath relieving the build up of air at the distal end of the sheath BRIEF DESCRIPTION OF THE DRAWINGS 0016 FIG 1A shows an external perspective view of a catheter surrounded by a sheath according to an exemplary embodiment of a conventional assembly 0017 FIG 1B shows an external perspective view of a catheter surrounded by a sheath with the sheath pulled back to expose the catheter 0018 FIGS 2A 2G show close up views of a surface texture of a sheath according to various exemplary embodi ments of the present invention 0019 FIG 2H shows an external perspective view of a catheter surrounded by a sheath with a box showing the section exploded in FIGS 2A 2G 0020 FIG 3A shows an external perspective view of a catheter surrounded by a gas permeable sheath according to an exemplary embodiment of the present invention 0021 FIG 3B shows an external p
12. he present invention relates to catheter assemblies having sheaths with particular thick ness 0003 2 Background of the Invention 0004 It has become relatively commonplace for the occasional intermittent or periodic catheterization of an individual s urinary bladder to be employed as opposed to placement and maintenance of an indwelling catheter that continuously drains urine from the bladder Short term or repeated catheterization is appropriate or even required for many persons who are in a hospital setting nursing home doctor s office rehabilitation facility or in their own home For example a patient is sometimes catheterized in order to treat urinary retention evacuate urine or to obtain a sterile urine specimen from a patient 0005 The need for intermittent catheterization of an individual sometimes arises due to problems typically asso ciated with long term use of indwelling catheters such as infections urethral damage and bladder damage Long term use of an indwelling catheter is also a risk factor for bladder cancer This is often the case for persons having a neuro genic urinary condition such as in a spinal cord injury multiple sclerosis stroke trauma or other brain injury Other conditions that interfere with the individual s ability to voluntarily void the bladder may also arise post surgically or as a result of benign prostatic hypertrophy or diabetes Many of these affected individuals are capable of
13. heter assembly and insert a contamination free catheter with decreased difficulty Further the catheter assembly should be easy to use and control while having minimal parts that interfere with the catheterization process 0009 One technique of maintaining complete sterility is the use of a sheath to cover the catheter during the cath eterization process The sheath allows the user to handle the catheter without making actual contact with it 0010 Such sheaths come in various textures and thick nesses Regular use reveals that some sheaths which are vulnerable to rips and tears which compromise the integrity of the sheath Maintaining complete sterility is one of the main purposes of the sheath and any compromise defeats its purpose Since the catheter is meant for use multiple times a day any risk in tears from normal use is unacceptable 0011 Other conventional sheaths are difficult to pull back during insertion of the catheter When inserting the catheter the sheath is pulled back and bunches up near the distal end Towards the end of this process the bunch of sheath can get large making it difficult to pull the sheath back all the way This challenge is magnified for individuals with limited manual dexterity who represent a significant portion of the market for sheathed catheters SUMMARY OF THE INVENTION 0012 The present invention seeks to address some of the shortcomings of conventional catheters which have protec tive
14. oated with a hydrophilic substance commonly known as hydrogel particularly useful on indwelling catheters This hydrophilic coating helps the catheter 110 to hold the lubricant 130 on its surface while inside the urinary tract One such hydrophilic substance that can be used is agarose known also under its trade name BIOGEL A 0039 The foregoing disclosure of the exemplary embodi ments of the present invention has been presented for purposes of illustration and description It is not intended to be exhaustive or to limit the invention to the precise forms US 2008 0097411 Al disclosed Many variations and modifications of the embodi ments described herein will be apparent to one of ordinary skill in the art in light of the above disclosure The scope of the invention is to be defined only by the claims appended hereto and by their equivalents 0040 Further in describing representative embodiments of the present invention the specification may have pre sented the method and or process of the present invention as a particular sequence of steps However to the extent that the method or process does not rely on the particular order of steps set forth herein the method or process should not be limited to the particular sequence of steps described As one of ordinary skill in the art would appreciate other sequences of steps may be possible Therefore the particular order of the steps set forth in the specification should not be con
15. r liquids through the polyolefin material while readily permitting moisture vapor as in U S Pat No 4 613 544 entitled Waterproof moisture vapor permeable sheet material and method of making the same issued to Bur leigh which is incorporated by reference herein in its entirety 0034 FIG 3A features a sheath 300 made from a gas permeable liquid impermeable material 350 This material 350 will allow the air built up inside the sheath to escape to the outside atmosphere 360 at a rate fast enough for the user to complete the catheterization process without undue pause as illustrated in FIG 3B 0035 In yet another exemplary embodiment the sheath 100 will be filled with enough lubricant 130 to coat the insertable length of the catheter 180 This will be a water based lubricant of the type used on rectal thermometers and enemas such as KY JELLY As the catheter 110 is pushed through the sheath 100 the lubricant 130 is pushed through as well lubricating the insertable portion of the catheter 180 on its way into the urethra The lubricant 130 will ease the process of sliding the catheter 110 into the urethra by reducing the friction between the catheter 110 and the urethra By reducing the friction the user can insert the catheter 110 faster and with less pain 0036 In yet another exemplary embodiment featured in FIG 4A the catheter 470 will have a guiding tip 430 at the proximal end of the catheter 471 The guiding tip 430
16. sheaths One such way which is described herein is through presentation of a given range in which these prob lems are eliminated A sheath of a thickness large enough to avoid rips and tears from normal use yet thin enough to allow those with even limited manual dexterity to use the catheter with ease is utilized in a catheter system The sheath will remain in between the user s hand and the catheter during insertion preventing direct contact with the catheter The sheath is also impervious to body fluids atmospheric air and microorganisms which ensures sterility after manu facture This invention can be utilized in all catheter assem bly systems including but not limited to indwelling and intermittent catheter systems as well as in patient and out patient designs 0013 Furthermore the present invention can include components that further ease the catheterization process Particular exemplary components include lubrication so the catheter slides smoothly down the urinary tract and a US 2008 0097411 Al guiding tip which may also have a lubricant reservoir to give the user something solid to line up the catheter to the urethra Also a hydrophilic coating is used on the catheter of certain embodiments to hold the lubricant onto the catheter while in the urinary tract 0014 An exemplary embodiment of the present inven tion is a sheath of specified thickness with a textured surface A textured surface is employed in the sheath t
17. strued as limitations on the claims In addition the claims directed to the method and or process of the present inven tion should not be limited to the performance of their steps in the order written and one skilled in the art can readily appreciate that the sequences may be varied and still remain within the spirit and scope of the present invention What is claimed is 1 A catheter assembly comprising a catheter and a sheath having a thickness between 0 0020 and 0 0065 surrounding and enclosing at least a portion of the catheter 2 The catheter assembly in claim 1 wherein the sheath has a thickness between 0 0040 and 0 0045 3 The catheter assembly in claim 1 wherein the sheath has a textured surface 4 The catheter assembly in claim 3 wherein the texture is a non smooth surface 5 The catheter assembly in claim 4 wherein the texture is composed of ridges 6 The catheter assembly in claim 1 wherein the sheath is made of a liquid impermeable material that is sterile or able to withstand sterility treatment impermeable to bacteria and other contaminants and gas permeable Apr 24 2008 7 The catheter assembly in claim 1 wherein the sheath is made from a silicon based organic polymer 8 The catheter assembly in claim 7 wherein the silicon based organic polymer is polymethylsiloxane 9 The catheter assembly in claim 8 wherein the polym ethylsiloxane has a density of 1 1 to 1 3 g cm 10 The cathe
18. ter assembly in claim 1 wherein the sheath is made from a microporous polyolefin 11 The catheter assembly in claim 10 wherein the polyolefin is polypropylene 12 The catheter assembly in claim 11 wherein the polypropylene density is 0 87 to 0 9 g cm 13 A urinary catheter assembly comprising a sterile flexible catheter and a sheath having a thickness between 0 0020 and 0 0065 surrounding and enclosing at least a portion of the catheter 14 The catheter assembly in claim 13 wherein the sheath has a thickness between 0 0040 and 0 0045 15 The catheter assembly in claim 13 wherein the sheath has a textured surface 16 The catheter assembly in claim 13 wherein the sheath is made of a liquid impermeable material that is sterile or able to withstand sterility treatment impermeable to bacteria and other contaminants and gas permeable 17 The catheter assembly in claim 13 wherein the sheath is made from a silicon based organic polymer 18 The catheter assembly in claim 13 wherein the sheath is made from a microporous polyolefin 19 An intermittent urinary catheter assembly comprising a sterile flexible catheter and a sheath having a thickness between 0 0020 and 0 0065 surrounding and enclosing at least an insert able portion of the catheter 20 The catheter assembly in claim 19 wherein the sheath has a thickness between 0 0040 and 0 0045
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