Multipurpose Device

Abstract

A multipurpose device for preventing or treating deep vein thrombosis, extremity edema, and breathing conditions is provided herein. The multipurpose device includes a respiratory device, such as a flutter valve or a spirometer, having a mouthpiece or nasal breathing piece, a pump connected to the respiratory device by first tubing, a release valve connected to the pump by second tubing, and one or more third tubing(s) connected to the release valve.

Claims

1. A multipurpose device comprising: a respiratory device; a pump connectable to the respiratory device by first tubing; a release valve connected to the pump by second tubing; and one or more third tubing(s) connected to the release valve.

2. The device according to claim 1, wherein the respiratory device is a spirometer.

3. The device according to claim 2, wherein the spirometer is an incentive spirometer, a peak flow spirometer, a windmill-type spirometer, a tilt-compensated spirometer, or fully electronic spirometer.

4. The device according to claim 3, wherein the spirometer is an incentive spirometer.

5. The device according to claim 1, wherein the respiratory device is a flutter valve.

6. The device according to claim 1, wherein the respiratory device comprises a mouthpiece or a nasal breathing piece.

7. The device according to claim 6, wherein the mouthpiece is a disposable mouthpiece, permanent mouthpiece, or a one-way valve mouthpiece.

8. The device according to claim 1, wherein the respiratory device comprises a receptor for an insert adjacent to the mouthpiece or nasal breathing piece.

9-13. (canceled)

14. The device according to claim 1, wherein the respiratory device comprises graduated color or markings and an indicator ball or plunger.

15. The device according to claim 1, wherein any one or more of the first tubing, second tubing, and third tubing(s) is/are variable length.

16. The device according to claim 1, wherein the first tubing is expandable.

17. The device according to claim 1, wherein the pump is a billow-type pump, an accordion-type pump, or a manual pneumatic pump.

18. The device of claim 17, wherein the pump is capable of being actuated by hand, foot, or thigh.

19. The device according to claim 1, wherein the one or more third tubing(s) comprises graduated color or markings and an indicator ball or plunger.

20. The device according to claim 1, wherein the one or more third tubing(s) comprises a connector at the terminal end(s).

21. The device according to claim 1, further comprising one or more compression stockings connected to the one or more third tubing(s) by the connector at the terminal end(s).

22. The device according to claim 1, wherein the first tubing connecting the pump to the respiratory device comprises a connector that is capable of disconnecting the first tubing from the pump.

23-24. (canceled)

25. A method of using the device according to claim 1, comprising: inserting the mouthpiece or nasal breathing piece of the device into the mouth or nose of a user; and inhaling and/or exhaling by the user via the respiratory device.

26. The method of claim 25, wherein when the device further comprises one or more compression stockings connected to the one or more third tubing(s) by the connector at the terminal end(s), the method further comprises activating the pump to load the one or more compression stockings with air.

27-29. (canceled)

30. The method of claim 26, wherein the user is being treated to prevent deep vein thrombosis.

31-32. (canceled)

Description

BRIEF DESCRIPTION OF THE DRAWINGS

[0018] The present disclosure can be understood from the following detailed description when read in connection with the accompanying drawings. It is emphasized that, according to common practice, the various features of the drawings are not to scale. On the contrary, the dimensions of the various features are arbitrarily expanded or reduced for clarity. Included in the drawings are the following FIGURES:

[0019] FIG. 1 shows a representative multipurpose device.

DESCRIPTION OF EMBODIMENTS

[0020] Various terms relating to aspects of the present disclosure are used throughout the specification and claims. Such terms are to be given their ordinary meaning in the art, unless otherwise indicated. Other specifically defined terms are to be construed in a manner consistent with the definition provided herein.

[0021] Various publications, including patents, published applications, technical articles and scholarly articles are cited throughout the specification. Each of these cited publications is incorporated herein by reference in its entirety and for all purposes.

[0022] As used herein, the singular forms a, an, and the include plural referents unless expressly stated otherwise.

[0023] The present disclosure provides multipurpose devices 500 comprising: a respiratory device 520; a pump 540 connected to the respiratory device 520 by first tubing 550; a release valve 560 connected to the pump 540 by second tubing 570; and one or more third tubing(s) 580 connected to the release valve 560.

[0024] In some embodiments, the respiratory device 520 is a breathing device to encourage pulmonary inspiration and/or expiratory therapy. In some embodiments, the respiratory device 520 is a spirometer. In some embodiments, the spirometer is an incentive spirometer, a peak flow spirometer, a windmill-type spirometer, a tilt-compensated spirometer, or a fully electronic spirometer. In some embodiments, the spirometer is an incentive spirometer. In some embodiments, the spirometer is a peak flow spirometer. In some embodiments, the spirometer is a windmill-type spirometer. In some embodiments, the spirometer is a tilt-compensated spirometer. In some embodiments, the spirometer is a fully electronic spirometer. The spirometer can be any of the commercially available spirometers.

[0025] In some embodiments, the respiratory device 520 is a flutter valve. The flutter valve can be any of the commercially available flutter valves.

[0026] In some embodiments, the respiratory device 520, such as the flutter valve or the spirometer, comprises an air import 510, such as a nasal breathing piece or a mouthpiece. In some embodiments, the air import 510 is a nasal breathing piece. In some embodiments, the air import 510 is a mouthpiece. In some embodiments, the mouthpiece is a disposable mouthpiece, a permanent mouthpiece, a mask mouthpiece, a nasal breathing piece, or a one-way valve mouthpiece. In some embodiments, the mouthpiece is a disposable mouthpiece. In some embodiments, the mouthpiece is a permanent mouthpiece. In some embodiments, the mouthpiece is a mask mouthpiece. In some embodiments, the mouthpiece is a one-way valve mouthpiece. The air import 510 can be any of the commercially available air imports.

[0027] In some embodiments, the respiratory device 520, such as the flutter valve or the spirometer, comprises graduated color or markings 600 and an indicator ball or plunger 590. Upon inhaling or exhaling, the indicator ball or plunger 590 can travel within the respiratory device 520 and the length traveled and force can be determined by examining the graduated color or markings 600 on the respiratory device 520. The distance the indicator ball or plunger 590 moves can be an indication of the intensity of the inhale or exhale. In some embodiments, the respiratory device 520, such as the flutter valve or the spirometer, comprises a whistle indicator (not shown). The whistle indicator is configured to produce a whistle noise upon inhaling or exhaling. The loudness of the whistle can be an indication of the intensity of the inhale or exhale.

[0028] In some embodiments, the respiratory device 520, such as the flutter valve or the spirometer, comprises a receptor 610 for an insert adjacent to the air import 510. The receptor 610 serves as a chamber for containing the insert. In some embodiments, the receptor 610 can be an aerosol receptor, a mist or vapor receptor, or a plunger. In some embodiments, the air can be warmed. In some embodiments, the receptor 610 can be provided with positive pressure ventilation, such as integration with an airbag or manual or pneumatic method of increasing the force of inspiration into the airway. In some embodiments, the insert is a scented disc or a medicated disc.

[0029] In some embodiments, the scented disc includes, but is not limited to, mint, lemon, lavender, jasmine, rosemary, cinnamon, peppermint, and other food flavoring such as grape, cherry, lemon, lime, etc.

[0030] In some embodiments, the medicated disc is impregnated with an anxiolytic, a bronchodilator, a sedative, or an analgesic.

[0031] In some embodiments, the bronchodilator is a short-acting bronchodilator or a long-acting bronchodilator. In some embodiments, short-acting bronchodilators include, but are not limited to, Proventil or Ventolin (salbutamol/albuterol), Xopenex (levosalbutamol/levalbuterol), Maxair (pirbuterol), Primatene Mist (epinephrine), Asthmanefrin, Primatene Mist replacement (racemic epinephrine), Bronkaid (ephedrine), or terbutaline. In some embodiments, the long-acting bronchodilator is Serevent (salmeterol), Spiropent (clenbuterol), formoterol, bambuterol, and indacaterol. In some embodiments, the bronchodilator is albuterol.

[0032] In some embodiments, the anxiolytic is a barbiturate, a benzodiazepine, a carbamate, an opioid, an antidepressant, or a sympatholytic. In some embodiments, antidepressants include, but are not limited to, selective serotonin reuptake inhibitors, serotonin-norepinephrine reuptake inhibitors, tricyclic antidepressants, tetracyclic antidepressants, or monoamine oxidase inhibitors. In some embodiments, barbiturates include, but are not limited to, allobarbital, amobarbital, aprobarbital, alphenal, barbital, brallobarbital, pentobarbital, phenobarbital, secobarbital, and thiopental. In some embodiments, benzodiazepines include, but are not limited to, Xanax (alprazolam), Lectopam or Lexotan (bromazepam), Librium (chlordiazepoxide), Klonopin or Rivotril (clonazepam), Tranxene (clorazepate), Valium (diazepam), Dalmane (flurazepam), Ativan (lorazepam), Serax or Serapax (oxazepam), Restoril (temazepam), and Halcion (triazolam). In some embodiments, carbamates include, but are not limited to, meprobamate (Miltown, Equanil), tybamate, and lorbamate. In some embodiments, opioids include, but are not limited to, codeine, morphine, thebaine, oripavine, buprenorphine, etorphine, hydrocodone, hydromorphone, oxycodone, oxymorphone, diacetylmorphine, nicomorphine (morphine dinicotinate), dipropanoylmorphine (morphine dipropionate), diacetyldihydromorphine, acetylpropionylmorphine, desomorphine, methyldesorphine, dibenzoylmorphine, dihydrocodeine, ethylmorphine, heterocodeine, fentanyl, alphamethylfentanyl, alfentanil, sufentanil, remifentanil, carfentyl, sufentanil, ohmefentanyl, Meperidine (pethidine), ketobemidone, MPPP, allylprodine, prodine, PEPAP, promedol, propoxyphene, dextropropoxyphene, dextromoramide, bezitramide, piritramide, methadone, dipipanone, levomethadyl acetate (LAAM), difenoxin, diphenoxylate, loperamide, lefetamine, menthol, meptazinol, mitragynine, tilidine, tramadol, tapentadol, eluxadoline, AP-237, and 7-hydroxymitragynine. Selective serotonin reuptake inhibitors include, but are not limited to, Celexa (citalopram), Lexapro (escitalopram), Prozac (fluoxetine), Luvox (fluvoxamine), Paxil (paroxetine), and Zoloft (sertraline). Serotonin-norepinephrine reuptake inhibitors include, but are not limited to, venlafaxine and duloxetine. Tricyclic antidepressants include, but are not limited to, imipramine, amitriptyline, nortriptyline, and desipramine. Tetracyclic antidepressants include, but are not limited to, mirtazapine. Monoamine oxidase inhibitors include, but are not limited to, phenelzine, isocarboxazid, tranylcypromine, and moclobemide. Sympatholytics include, but are not limited to alpha-adrenergic agonists such as clonidine and guanfacine. Additional anxiolytics include, but are not limited to, mebicar, fabomotizole, selank, bromantane, emoxypine, azapirones (such as Buspar (buspirone) and Sediel (tandospirone)), pregabalin, menthyl isovalerate, and propofol.

[0033] In some embodiments, the sedative is a barbiturate such as, for example, benzylbutylbarbiturate, butalbital, amobarbital, pentobarbital, secobarbital, sodium thiopental, and phenobarbital. In some embodiments, the sedative is a benzodiazepine such as, for example, clonazepam, diazepam, estazolam, flunitrazepam, lorazepam, midazolam, nitrazepam, oxazepam, triazolam, temazepam, chlordiazepoxide, alprazolam, clobazam, clorazepate, and etizolam. In some embodiments, the sedative is a nonbenzodiazepine hypnotic such as, for example, eszopiclone, zaleplon, zolpidem, and zopiclone. In some embodiments, the sedative is an orexin antagonist such as, for example, suvorexant. In some embodiments, the sedative is a first generation antihistamine such as, for example, diphenhydramine, dimenhydrinate, doxylamine, promethazine, hydroxyzine, brompheniramine, and chlorpheniramine. In some embodiments, the sedative is a general anesthetic such as, for example, nitrous oxide, sevoflurane, halothane, xenon, enflurane, chloroform, isoflurane, methoxyflurane, desflurane, ethyl chloride, cyclopropane, chloral hydrate, ketamine, esketamine, etomidate, propofol, and chlorobutanol. In some embodiments, the sedative is a herbal sedative such as, for example, Duboisia hopwoodii, chamomile, Prostanthera striatiflora, catnip, Kava (Piper methysticum), valerian, cannabis, Passiflora spp. (Passiflora incarnata), Physochlaina (P. infundibularis), and validol. In some embodiments, the sedative is methaqualone or analogues thereof such as, for example, afloqualone, cloroqualone, diproqualone, etaqualone, methaqualone, methylmethaqualone, mebroqualone, mecloqualone, and nitromethaqualone. In some embodiments, the sedative is a skeletal muscle relaxant such as, for example, baclofen, meprobamate, carisoprodol, cyclobenzaprine, metaxalone, methocarbamol, tizanidine, chlorzoxazone, orphenadrine, gabapentin, and pregabalin. In some embodiments, the sedative is an opioid such as, for example, tramadol, tapentadol, morphine, hydromorphone, oxymorphone, oxycodone, hydrocodone, methadone, propoxyphene, meperidine, fentanyl, codeine, carfentanil, remifentanil, alfentanil, sufentanil, and opium. In some embodiments, the sedative is an antidepressant such as, for example, amitriptyline, trazodone, mirtazapine, doxepin, desipramine, imipramine, clomipramine, amoxapine, trimipramine, nortriptyline, and nefazodone. In some embodiments, the sedative is an antipsychotic such as, olanzapine, clozapine, thiothixene, haloperidol, fluphenazine, prochlorperazine, trifluoperazine, loxapine, quetiapine, and asenapine. In some embodiments, the sedative is another 2-methyl-2-butanol (2M2B) such as, for example, ethanol, glutethimide, GHB, and dextromethorphan.

[0034] In some embodiments, the analgesic is a non-narcotic analgesic, such as, for example, Tylenol (acetaminophen). In some embodiments, the analgesic is a non-steroidal anti-inflammatory drug (NSAID), such as, for example, Prolensa or Bromday (bromfenac), Cataflam, Voltaren or Zipsor (diclofenac), Dolobid (diflunisal), Lodine or Lodine XL (etodolac), Nalfon (fenoprofen), Ansaid (flurbiprofen), Advil, Cramp End, Dolgesic, Excedrin IB, Genpril, Haltran, Ibren, Ibu, Ibuprin, Ibuprohm, Ibu-Tab, Medipren, Midol IB, Motrin, Nuprin, Pamprin-IB, Q-Profen, Rufen, or Trendar (ibuprofen), Indocin, Indocin SR, or Tivorbex (indomethacin), Actron, Orudis or Oruvail (ketoprofen), Toradol or Sprix (ketorolac), Meclomen (meclofenamate), Ponstel (mefenamic acid), Mobic or Vivlodex (meloxicam), Relafen (nabumetone), Aleve, Anaprox, Anaprox DS, EC-Naprosyn, Naprelan, or Naprosyn (naproxen), Nevanac (nepafenac), Daypro (oxaprozin), Cotylbutazone (phenylbutazone), Feldene (piroxicam), Clinoril (sulindac), and Tolectin or Tolectin DS (tolmetin). In some embodiments, the analgesic is a COX-2 inhibitor, such as, for example, Celebrex (celecoxib). In some embodiments, the analgesic is a narcotic pain medication, such as, for example, Buprenex (buprenorphine), Stadol (butorphanol), Codeine, Hydrocodone, Dilaudid, Dilaudid-5, Dilaudid-HP, Hydrostat IR, or Exalgo ER (hydromorphone), Levo-Dromoran (levorphanol), Demerol (meperidine), Dolophine or Methadose (methadone), Astramorph PF, AVINZA, Duramorph, Kadian, M S Contin, MSIR, Oramorph SR, Rescudose, or Roxanol (morphine), Nubain (nalbuphine), OxyContin, Roxicodone, or Oxecta (oxycodone), Numorphan (oxymorphone), Talwin (pentazocine), Cotanal-65 or Darvon (propoxyphene), and Nucynta (tapentadol). In some embodiments, the analgesic is a central analgesic, such as, for example, Ultram (tramadol) and Ultracet (tramadol and acetaminophen). In some embodiments, the analgesic is a combination, such as, for example, Femcet, Fioricet, Esgic, or Esgic-Plus (butalbital, acetaminophen, and caffeine), Fiorinal (butalbital, aspirin, and caffeine), Fioricet with codeine (butalbital, acetaminophen, caffeine, and codeine), Hydrostal IR or Vicoprofen (hydrocodone and ibuprofen), Embeda (morphine and naltrexone), Troxyca ER (oxycodone and naltrexone), Talwin NX (pentazocine and naloxone), Capital with Codeine, Margesic #3, Phenaphen with Codeine, or Tylenol with Codeine (acetaminophen and codeine), DHCplus (dihydrocodeine, acetaminophen, and caffeine), Allay, Anexsia 5/500, Anexsia 7.5/650, Dolacet, Dolagesic, Duocet, Hycomed, Hydrocet, Hydrogesic, HY-PHEN, Lorcet 10/650, Lorcet-HD, Lortab, Panacet 5/500, Panlor, Stagesic, T-Gesic, Ugesic, Vicodin, or Zydone (hydrocodone and acetaminophen), Endocet, Percocet, Roxicet, Roxilox, Tylox, or Xartemis XR (oxycodone and acetaminophen), Talacen (pentazocine and acetaminophen), Darvocet-N 50, Darvocet-N 100, E-Lor, or Propacet 100 (propoxyphene and acetaminophen), Synalgos-DC (aspirin, caffeine, and dihydrocodeine), Empirin with Codeine (aspirin and codeine), Damason-P, Lortab ASA, or Panasal 5/500 (hydrocodone and aspirin), Endodan, Percodan, Percodan-Demi, or Roxiprin (oxycodone and aspirin), Talwin Compound (pentazocine and aspirin), Darvon Compound-65, PC-Cap, or Propoxyphene Compound-65 (propoxyphene, aspirin, and caffeine).

[0035] In some embodiments, the respiratory device 520 comprises a variable sense valve or e-monitoring chip (not shown). Such a valve or chip can be configured to record breathing information (e.g., breathing rate, intensity of inhale or exhale, device use compliance, etc.) and/or transmit such information to medical professionals. In some embodiments, the variable sense valve or e-monitoring chip can monitor the chemical composition of the exhaled air for purposes such as, for example, compliance to medication, breath analysis, and bacterial analysis (e.g., to check for pneumonia or dental caries risk). Various variable sense valve or e-monitoring chip or pressure monitors are commercially available.

[0036] In some embodiments, the pump 540 is a billow-type pump, an accordion-type pump, or a manual pneumatic pump. In some embodiments, the pump 540 is a billow-type pump. In some embodiments, the pump 540 is an accordion-type pump. In some embodiments, the pump 540 is a manual pneumatic pump. In some embodiments, the pump 540 is an electrical air pump. In some embodiments, the pump 540 is manual pump such as a bicycle type pump. In some embodiments, the pump 540 is capable of being actuated by hand, foot, or thigh. In some embodiments, the pump 540 further comprises one or more straps (not shown). In some embodiments, the straps are self-retaining straps. The straps can be configured to secure the pump 540 to the body of the user. In some embodiments, the pump can be powered by a single battery or a plurality of batteries, such as a portable battery or portable batteries. In some embodiments, the battery or batteries can be non-rechargeable or rechargeable.

[0037] In some embodiments, the first tubing 550 connecting the pump 540 to the respiratory device 520 comprises a connector (not shown) that is capable of disconnecting the first tubing 550 from the pump 540. The connector can be permanently located on the first tubing 550 such that when the first tubing 550 is disconnected from the pump 540, the first tubing 550 retains the connector. Alternately, the connector can be permanently located on the pump 540 such that when the first tubing 550 is disconnected from the pump 540, the pump 540 retains the connector. The connector allows the breathing function of the device 500 to be separated from the compression function of the device 500. The connector allows interchangeability of various breathing components with various compression components. In some embodiments, a kit can comprise the breathing function of the device 500, or the compression function of the device 500, or both the breathing function of the device 500 and the compression function of the device 500. In these kits, the connector can either be permanently located on the first tubing 550 such that when the first tubing 550 is disconnected from the pump 540, the first tubing 550 retains the connector, or the connector can be permanently located on the pump 540 such that when the first tubing 550 is disconnected from the pump 540, the pump 540 retains the connector.

[0038] In some embodiments, the release valve 560 comprises a variable sense valve or e-monitoring chip 620. Such a valve or chip 620 can be configured to record compression information (e.g., compression levels, compression times, device use compliance, etc.) and/or transmit such information to medical professionals. Variable sense valves and e-monitoring chips 620 can be any of the commercially available variable sense valves and e-monitoring chips.

[0039] In some embodiments, the one or more third tubing(s) 580 comprise graduated color or markings 630 and an indicator ball or plunger 640. Upon activating the pump 540, the indicator ball or plunger 640 can travel within the third tubing(s) 580 and the length traveled can be determined by examining the graduated color or markings 630 on the third tubing(s) 580. The distance the indicator ball or plunger 640 moves can be an indication of the intensity of the compression of the compression stockings (not shown). In some embodiments, the one or more third tubing(s) 580 comprises a connector (not shown) at the terminal end(s). The connector connects the third tubing 580 to a compression stocking. In some embodiments, one or more compression stockings are connected to the one or more third tubing(s) 580 by the connector at the terminal end(s).

[0040] The first tubing 550, second tubing 570, and third tubing(s) 580 can be made of any material that is impermeable to air, such as, for example, various plastics. first tubing 550, second tubing 570, and third tubing(s) 580 can be made of an expandable material (e.g., natural or synthetic rubber, polymer, foam, nylon, latex, silicone, etc.). The first tubing 550, second tubing 570, and third tubing(s) 580 can be any of the commercially available tubings. In addition, the first tubing 550, second tubing 570, and third tubing(s) 580 can be of variable length and can be made of expandable material.

[0041] The present disclosure also provides methods of using any of the devices 500 described herein comprising: inserting the air import 510 of the device 500 into the mouth or nose of a user; and inhaling or exhaling by the user via the respiratory device 520. In embodiments whereby the device 500 further comprises one or more compression stockings connected to the one or more fourth tubing(s) 580 by the connector at the terminal end(s), the method further comprises activating the pump 540 to load the one or more compression stockings with air. In some embodiments, compression stockings are filled up to a pressure of about 20 mmHg. In some embodiments, compression stockings are filled up to a pressure of about 30 mmHg. In some embodiments, compression stockings are filled up to a pressure of about 40 mmHg. In some embodiments, compression stockings are filled up to a pressure of about 50 mmHg. In some embodiments, compression stockings are filled up to a pressure of about 60 mmHg. In some embodiments, compression stockings are filled up to a pressure of about 70 mmHg.

[0042] In some embodiments, atalectasis is being treated or prevented in the user. In some embodiments, the user has asthma or chronic obstructive pulmonary disease and is undergoing breathing exercises. In some embodiments, the user is undergoing relaxation breathing therapy or diversion therapy. In some embodiments, the device is used to prevent or slow the progression of pneumonia. In some embodiments, the user is being treated to prevent deep vein thrombosis. In some embodiments, the device is used to prevent or slow the progression of lymphedema.

[0043] In some embodiments, the device 500 can be used by an athlete or entertainment performer in order to increase respiratory function and/or reduce edema and/or prevent DVT formation.

[0044] The present disclosure also provides methods of treating or preventing atalectasis comprising using any of the multipurpose devices described herein. The present disclosure also provides methods of treating asthma or preventing an asthma attack comprising using any of the multipurpose devices described herein. The present disclosure also provides methods of treating or preventing chronic obstructive pulmonary disease comprising using any of the multipurpose devices described herein. The present disclosure also provides methods of inducing relaxation or diversion comprising using any of the multipurpose devices described herein. The present disclosure also provides methods of treating or preventing deep vein thrombosis comprising using any of the multipurpose devices described herein. The present disclosure also provides methods of preventing or slowing the progression of pneumonia comprising using any of the multipurpose devices described herein. The present disclosure also provides methods of preventing or slowing the progression of lymphedema comprising using any of the multipurpose devices described herein. The present disclosure also provides methods of recuperating after an athletic training session comprising using any of the multipurpose devices described herein.

[0045] The compression stockings described herein can be any of the commercially available compression stockings. In some embodiments, the compression stocking is a pneumatic compression stocking. In some embodiments, the compression stocking is for compressing a limb. The limb can be any limb of a mammal, particularly a human, such as an arm or a leg. In some embodiments, the limb is a leg. In some embodiments, the limb is the lower portion of a leg (i.e., blow the knee). In some embodiments, the compression stocking can be in the form of a sock, stocking, sleeve, shirt, band, legging, or pants.

[0046] The present disclosure is not limited to the embodiments described and exemplified above, but is capable of variation and modification within the scope of the appended claims.