Drug-delivery cannula assembly

Abstract

A drug-delivery cannula assembly includes a cannula housing adapted for receiving at least one obturator shaft of an obturator assembly therethrough, one or more cannulae, and a supply line coupled to the cannula housing. The cannula housing is adapted for receiving one or more obturator shafts of an obturator assembly therethrough. The one or more cannulae define a longitudinal axis and a passageway aligned with the longitudinal axis. The one or more cannulae each include a proximal end coupled to the cannula housing. The cannula housing is configured to fluidly-couple the one or more cannulae to a source of a drug delivery supply for supplying drugs via the supply line to the one or more cannulae.

Claims

1. A drug-delivery cannula assembly, comprising: a cannula housing defining a plurality of proximal openings, a plurality of distal openings, and a side opening, each of the plurality of distal openings being longitudinally aligned with a respective one of the plurality of proximal openings, each of the distal openings disposed in an arrangement corresponding to an arrangement of a plurality of obturator shafts of an obturator assembly, the cannula housing including a seal element disposed within a proximal portion of the cannula housing, the cannula housing configured to receive an obturator shaft of the plurality of obturator shafts of the obturator assembly through a respective one of the plurality of proximal openings and the seal element; a plurality of cannulae, each of the plurality of cannulae defining a longitudinal axis and a passageway aligned with the longitudinal axis, each of the plurality of cannulae including a proximal end coupled to the cannula housing at one of the plurality of distal openings, each of the plurality of cannulae configured to receive a respective obturator shaft of the plurality of obturator shafts of the obturator assembly through the passageway; and a supply line coupled to the cannula housing at the side opening, wherein the cannula housing is configured to fluidly-couple each of the plurality of cannulae to a drug source for supplying drugs via the supply line to each of the plurality of cannulae.

2. The drug-delivery cannula assembly of claim 1, wherein the passageway of each of the plurality of cannulae is configured to slideably receive a respective obturator shaft of the plurality of obturator shafts of the obturator assembly.

3. The drug-delivery cannula assembly of claim 1, wherein the passageway of each of the plurality of cannulae is configured to permit introduction of at least one surgical instrument used in performing a surgical procedure.

4. The drug-delivery cannula assembly of claim 1, wherein the cannula housing is adapted to releaseably engage the plurality of cannulae.

5. A drug-delivery cannula assembly, comprising: a cannula housing defining a plurality of proximal openings, a plurality of distal openings, and a side opening, each of the plurality of distal openings being longitudinally aligned with a respective one of the proximal openings, each of the distal openings disposed in an arrangement corresponding to an arrangement of a plurality of ablation probes of an ablation device, the cannula housing including a seal element disposed within a proximal portion of the cannula housing, the cannula housing configured to receive an ablation probe of the plurality of ablation probes of the ablation device through a respective one of the plurality of first proximal openings and the seal element; a plurality of cannulae, each of the plurality of cannulae defining a longitudinal axis and a passageway aligned with the longitudinal axis, each of the plurality of cannulae including a proximal end coupled to the cannula housing at one of the plurality of distal openings, each of the plurality of cannulae configured to receive a respective ablation probe of the plurality of ablation probes of the ablation device through the passageway; and a supply line coupled to the cannula housing at the side opening, wherein the cannula housing is configured to fluidly-couple each of the plurality of cannulae to a drug source for supplying drugs via the supply line to each of the plurality of cannulae.

Description

BRIEF DESCRIPTION OF THE DRAWINGS

(1) Objects and features of the presently-disclosed drug-delivery cannula assemblies suitable for use with electrosurgical devices, e.g., ablation devices, and electrosurgical systems including the same will become apparent to those of ordinary skill in the art when descriptions of various embodiments thereof are read with reference to the accompanying drawings, of which:

(2) FIG. 1 is a bottom perspective view of an obturator assembly and a drug-delivery cannula assembly, shown separated, the drug-delivery cannula assembly configured to receive the obturator assembly, in accordance with an embodiment of the present disclosure;

(3) FIG. 2 is a bottom perspective, assembled view of the drug-delivery cannula assembly including the obturator assembly of FIG. 1 in accordance with an embodiment of the present disclosure;

(4) FIG. 3 is a bottom perspective view of an ablation device and a drug-delivery cannula assembly, shown separated, the drug-delivery cannula assembly configured to receive the ablation device, in accordance with an embodiment of the present disclosure;

(5) FIG. 4 is a bottom perspective, partially assembled view of the drug-delivery cannula assembly including the ablation device of FIG. 1 in accordance with an embodiment of the present disclosure;

(6) FIG. 5 is a bottom perspective, assembled view of the drug-delivery cannula assembly including the ablation device of FIG. 1 in accordance with an embodiment of the present disclosure; and

(7) FIG. 6 is top perspective view of the drug-delivery cannula assembly of FIG. 1, shown with a distal end portion of an electrode array of an ablation device, such as the ablation device of FIG. 1, in accordance with an embodiment of the present disclosure;

(8) FIG. 7 is perspective view of a drug-delivery device and a cannula assembly, shown separated, the cannula assembly configured to receive the drug-delivery device, in accordance with an embodiment of the present disclosure;

(9) FIG. 8 is perspective view of another embodiment a drug-delivery device and the cannula assembly of FIG. 7, shown separated, with a handle member of the drug-delivery device coupled to a supply line for supplying agents to the drug-delivery device, in accordance with an embodiment of the present disclosure;

(10) FIG. 9 is cross-sectional view of a drug eluting rod and a pusher rod disposed in association with the cannula assembly of FIG. 7, shown in a first configuration, in accordance with an embodiment of the present disclosure; and

(11) FIG. 10 is cross-sectional view of the drug eluting rod and the pusher rod shown in FIG. 9 disposed in association with the cannula assembly of FIG. 7, shown in a second configuration, in accordance with an embodiment of the present disclosure.

DETAILED DESCRIPTION

(12) Hereinafter, embodiments of the presently-disclosed drug-delivery cannula assembly suitable for use with electrosurgical devices, e.g., ablation devices, and electrosurgical systems including the same are described with reference to the accompanying drawings. Like reference numerals may refer to similar or identical elements throughout the description of the figures. As shown in the drawings and as used in this description, and as is traditional when referring to relative positioning on an object, the term “proximal” refers to that portion of the apparatus that is closer to the user and the term “distal” refers to that portion of the apparatus that is farther from the user.

(13) The principles of the present disclosure are applicable to a variety of surgical devices adapted for providing access to a surgical site within a patient's body. These devices include trocar assemblies, access cannulae, catheters, scopes, etc. The presently-disclosed drug-delivery cannula assemblies are contemplated for use in various surgical procedures, e.g., minimally invasive procedures or open surgical procedures. Portions of the presently disclosed drug-delivery cannula assemblies may be disposable, replaceable and/or reusable.

(14) FIGS. 1 and 2 show an obturator assembly 15 and a drug-delivery cannula assembly 10 in accordance with an embodiment of the present disclosure. Drug-delivery cannula assembly 10, which is described in more detail later in this description, generally includes a cannula housing 31 and one or more cannulae 12. Cannula housing 31 may be formed of any suitable material or combination of materials by any suitable process. In some embodiments, as shown in FIGS. 1 through 6, drug-delivery cannula assembly 10 includes three elongated, substantially cylindrically-shaped cannulae 12. In some embodiments, the cannula housing 31 may be adapted to releaseably engage the cannulae 12.

(15) Obturator assembly 15 is adapted to cooperate with the drug-delivery cannula assembly 10. Obturator assembly 15 includes a hand grip 2 configured to be grasped by the user, three obturator shafts 6 connected to the hand grip 2 and having a distal end, which may include a sharpened tip portion. In some embodiments, as shown in FIGS. 1 and 2, a penetrating member 8 is disposed adjacent to the distal end of the obturator shafts 6. Obturator shaft 6 may be formed of any substantially rigid material, such as metal, e.g., medical grade stainless steel or titanium, or any suitable rigid polymeric material. The shape and size of the obturator shaft 6 and the penetrating member 8 may be varied from the configuration depicted in FIGS. 1 and 2.

(16) Hand grip 2 is generally configured to be grasped by the user, and may be provided with a cushioned, slip-resistant member. A cushioned member (not shown) may be formed from a thermoplastic elastomer, e.g., Versaflex™ or Santaprene™, and over-molded onto the hand grip 2 of the obturator assembly 15. Alternatively, a cushioned member may be formed of other cushioned or pliant materials, e.g., elastomeric or synthetic materials, including isoprenes, nitrile or silicon containing material, etc. The cushioned member may be fastened to the hand grip 2 using any suitable fastening techniques, e.g., physical, chemical or mechanical, including adhesives, welding, screws, etc. The shape and size of the hand grip 2 may be varied from the configuration depicted in FIGS. 1 and 2.

(17) In some embodiments, a lower portion 24 of the hand grip 2 of the obturator assembly 15 may be configured for mating engagement with an upper portion 36 (FIG. 6) of the cannula housing 31 of the drug-delivery cannula assembly 10, e.g., to improve stability, enhance safety, and/or provide surgeons with enhanced ease of use. In some embodiments, the lower portion 24 of the hand grip 2 may be configured with one or more pins (not shown) for engaging one or more pin-receiving holes (not shown) in the upper portion 36 (FIG. 6) of the cannula housing 31 for releaseably coupling the obturator assembly 15 and the drug-delivery cannula assembly 10. Additionally, or alternatively, the upper portion 36 of the cannula housing 31, or a portion thereof, and/or the lower portion 24 of the hand grip 2, or a portion thereof, may formed of a magnetic material, e.g., any material capable of producing a magnetic field. Various mechanisms for releaseably coupling the obturator assembly 15 and the drug-delivery cannula assembly 10 may be employed.

(18) Each of the cannulae 12 defines a longitudinal axis “A-A” (FIGS. 1 and 3) and includes an upper (proximal) end 16 defining an inlet opening, a lower (distal) end 14 defining an outlet opening 17, and a passageway 11 of generally tubular shape extending from the inlet opening to the outlet opening 17 along the longitudinal axis “A-A”. Passageway 11 is configured to slideably receive the obturator shaft 6 of the obturator assembly 15. Passageway 11 is configured to permit introduction of one or more surgical instruments used in performing a surgical procedure.

(19) In some embodiments, the cannulae 12 may include a converging or frusto-conical section extending from the upper end 16. Cannula housing 31 may be adapted to releaseably engage an outer surface of the converging or frusto-conical section. Additionally, or alternatively, the hand grip 2 of the obturator assembly 15 may include a distal end portion 24 configured to engage an inner surface of the converging or frusto-conical section such that the obturator assembly 15 is releaseably securable thereto.

(20) Cannulae 12 are illustrated in FIGS. 1 through 6, as being of monolithic construction. In alternative embodiments, the cannulae 12 may be formed of multiple components and/or multiple materials. The shape and size of the cannulae 12 may be varied from the configuration depicted in FIGS. 1 through 6. One or more of the cannulae 12 may include a seal “S” mounted adjacent to the upper end 16 thereof. Any suitable seal type may be utilized including septum seals, gel seals, flapper valves, duck-bill seals, etc.

(21) In FIG. 3, the drug-delivery cannula assembly 10 of FIGS. 1 and 2 is shown with an electrosurgical device 100. Electrosurgical device 100 is operatively connected via a transmission line to an electrosurgical power generating source 28, e.g., a microwave or radio frequency (RF) electrosurgical generator. Power generating source 28 may be any generator suitable for use with electrosurgical devices and may be configured to provide various frequencies of energy. In some embodiments, electrosurgical device 100 (also referred to herein as ablation device 100) is disposed in fluid communication with a coolant source (not shown).

(22) Ablation device 100 includes an electrode array “E” and a handle assembly 130. Electrode array “E” may include one or more ablation electrodes 110. In some embodiments, as shown in FIG. 3, the electrode array “E” includes three ablation electrodes 110 supported on and/or operatively connected to the handle assembly 130. As shown in FIG. 5, when the ablation device 100 is coupled to the drug-delivery cannula assembly 10, the distal end portion 113 of the ablation electrodes 110 extends distally from the outlet opening 17 of the cannulae 12. The shape, size and number of ablation electrodes 110 of the electrode array “E” may be varied from the configuration depicted in FIG. 3. Ablation device 100 may include additional, fewer, or different components than shown in FIG. 3, depending upon a particular purpose or to achieve a desired result. Examples of ablation device embodiments are shown and described in commonly assigned U.S. patent application Ser. No. 13/834,581, entitled “MICROWAVE ENERGY-DELIVERY DEVICE AND SYSTEM,” filed on Mar. 15, 2013, and U.S. Provisional Application Ser. No. 61/783,921, entitled “MICROWAVE ABLATION CATHETER AND METHOD OF UTILIZING THE SAME,” filed on Mar. 14, 2013, the disclosures of which are herein incorporated by reference in their entireties.

(23) In some embodiments, as shown in FIGS. 3 through 5, a controller 26 is communicatively-coupled to the electrosurgical power generating source 28. Controller 26 may include any type of computing device, computational circuit, or any type of processor or processing circuit capable of executing a series of instructions that are stored in a memory (not shown) associated with the controller 26. Functions of the controller 26 may be integrated with those of the electrosurgical power generating source 28 and/or may be integrated with other electrosurgical system component(s).

(24) As shown in FIGS. 3 through 5, a drug and/or contrast agent supply line 18 is provided to fluidly-couple the drug-delivery cannula assembly 10 to a source of the drug and/or contrast agent delivery supply 48 for supplying drugs and/or contrast agent via the cannula housing 31 to the cannulae 12. A fluid-movement device (not shown) may be fluidly coupled between the source of the drug (and/or contrast agent) and the drug-delivery cannula assembly 10, and the controller 26 may be communicatively-coupled to the fluid-movement device. In some embodiments, the controller 26 may be configured to control operation(s) of the fluid-movement device, e.g., during an ablation procedure based on one or more operating parameters of the electrosurgical power generating source 28.

(25) As shown in FIG. 6, the upper portion 36 of the cannula housing 31 includes three openings 39 defined therein. Each of the openings 39 is configured to receive a penetrating member 8 of an obturator assembly 15 therethrough and configured to receive an ablation electrode 110 of an ablation device 100 therethrough. Cannula housing 31 is configured to support each of the cannulae 12 at a respective opening defined on a lower (distal) portion of the cannula housing 31 such that the upper ends 16 thereof are disposed in fluid communication with the openings 39. In some embodiments, the cannula housing 31 includes an actuator (not shown), such as a slideably moveable member, e.g., thumb-slide actuator, adapted to allow the user to selectively initiate/activate the delivery of drug and/or contrast agent through the drug-delivery cannula assembly 10 to the tissue site.

(26) FIG. 7 shows a drug-delivery device 750 and a cannula assembly 710. Cannula assembly 710 is configured to receive the drug-delivery device 750 therethrough. Cannula assembly 710 includes a cannula housing 731 and a cannula 712. Cannula 712 includes an proximal end 716, a distal end 714 defining an outlet opening 717, and a passageway 711 of generally tubular shape extending from the proximal end 716 to the distal end 714.

(27) Drug-delivery device 750 includes a housing member 751 and a delivery needle 752 having a distal end 754 and a proximal end 756 coupled to the housing member 751. Housing member 751 defines a chamber 753 therein. In some embodiments, the chamber 753 is configured to contain an agent for delivery through the delivery needle 752 to tissue (not shown).

(28) FIG. 8 shows a drug-delivery device 850 and the cannula assembly 710 shown in FIG. 7. Drug-delivery device 850 includes a housing member 851 and a delivery needle 852 having a distal end 854 and a proximal end 856 coupled to the housing member 851. Housing member 851 defines a chamber 853 therein. A supply line 818 is coupled to the housing member 851 such that the chamber 853 is disposed in fluid communication with the supply line 818. In some embodiments, the supply line 818 may be coupled to a source of drug and/or contrast agent delivery supply (not shown) for supplying drugs and/or contrast agent via the housing member 851 to the delivery needle 852.

(29) FIGS. 9 and 10 show a drug eluting rod 980 and a pusher rod 960 disposed, in part, within the passageway 711 of the cannula assembly 710 of FIG. 7. Drug eluting rod 980 includes a proximal end 916 and a distal end 984 having a plurality of barbed members 985 extending distally outwardly therefrom. The shape, size and number of barbed members 985 may be varied from the configuration depicted in FIGS. 9 and 10.

(30) The pusher rod 960 includes a rod member 961 having a distal end 764, e.g., configured to engage the proximal end 916 of the drug eluting rod 980. In some embodiments, as shown in FIGS. 9 and 10, pusher rod 960 includes an end cap 962, e.g., configured to engage the cannula housing 731 (FIG. 7) of the cannula assembly 710. In some embodiments, the end cap 962 is configured to engage the cannula housing 731 for the purpose of limiting the axial translation of the rod member 961 within the passageway 711 of the cannula assembly 710, e.g., to position the drug eluting rod 980 within tissue (not shown).

(31) A variety of drug agents may be delivered by devices according to embodiments of the present disclosure. Some examples of drug agents which may be delivered by devices according to embodiments of the present disclosure include chemotherapeutic agents such as without limitation cisplatin, paclitaxel, doxorubicin, fluorouracil, as well as other compounds such as without limitation prochlorperzine edisylate, ferrous sulfate, aminocaproic acid, mecamylamine hydrochloride, procainamide hydrochloride, amphetamine sulfate, methamphetamine hydrochloride, benzamphetamine hydrochloride, isoproterenol sulfate, phenmetrazine hydrochloride, bethanechol chloride, methacholine chloride, pilocarpine hydrochloride, atropine sulfate, scopolamine bromide, isopropaniide iodide, tridihexethyl chloride, phenformin hydrochloride, methylphenidate hydrochloride, theophylline cholinate, cephalexin hydrochloride, diphenidol, meclizine hydrochloride, prochlorperazine maleate, phenoxybenzamine, thiethylperzine maleate, anisindone, diphenadione erythrityl tetranitrate, digoxin, isofluorophate, acetazolamide, methazolamide, bendroflumethiazide, chloropromaide, tolazamide, chlormadinone acetate, phenaglycodol, allopurinol, aluminum aspirin, methotrexate, acetyl sulfisoxazole, erythromycin, hydrocortisone, hydrocorticosterone acetate, cortisone acetate, dexamethasone and its derivatives such as betamethasone, triamcinolone, methyltestosterone, 17-S-estradiol, ethinyl estradiol, ethinyl estradiol 3-methyl ether, prednisolone, 17-oc-hydroxyprogesterone acetate, 19-nor-progesterone, norgestrel, norethindrone, norethisterone, norethiederone, progesterone, norgesterone, norethynodrel, aspirin, indornethacin, naproxen, fenoprofen, sulindac, indoprofen, nitroglycerin, isosorbide dinitrate, propranolol, timolol, atenolol, aiprenolol, cimetidine, clonidine, imipramine, levodopa, chlorpromazine, methyldopa, dihydroxyphenylalanine, theophylline, calcium gluconate, ketoprofen, ibuprofen, cephalexin, erythromycin, haloperidol, zomepirac, ferrous lactate, vincamine, diazepam, phenoxybenzamine, diltiazem, mitrinone, capropril, mandol, quanbenz, hydrochlorothiazide, ranitidine, flurbiprofen, fenufen, fluprofen, tolmetin, alciofenac, mefenamic, flufenamic, difiuinal, nimodipine, nitrendipine, nisoldipine, nicardipine, felodipine, lidoflazine, tiapamil, gallopamul, amlodipine, mioflazine, lisinoipril, enalapril, enalaprilat, captopril, ramipril, famotidine, nizatidine, sucralfate, etintidine, tetratolol, minoxidil, chlordazepoxide, diazepam, amitriptyline, and imipramine; opioids such as meperidine, hydrocodone, oxycodone, and semi-synthetic opioids such as oxymorphone, hydromorphone, opiates such as morphine and codeine, opioid antagonists such as without limitation naltrexone, nalbuphine, naloxone as well as opioid agonist/antagonist compounds such as buprenorphine, and synthetic analgesics such as methadone, tramadol, fentanyl and sufentanil.

(32) Some other examples of drug agents which may be delivered by devices according to embodiments of the present disclosure include vitamin and supplements such as vitamins B-12 (cyanocobalamin) and D2, anti-virals such as without limitation acyclorvir and zidovudine; proteins and peptides such as without limitation insulin, colchicine, glucagon, thyroid stimulating hormone, parathyroid and pituitary hormones, calcitonin, renin, prolactin, corticotrdphin, thyrotropic hormone, follicle stimulating hormone, chorionic gonadotropin, gonadotropin releasing hormone, bovine somatotropin, porcine somatotropin, oxytocin, vasopressin, GRE, prolactin, somatostatin, lypressin, pancreozymin, luteinizing hormone, LHRH, LHRH agonists and antagonists, leuprolide, interferons, interleukins, growth hormones such as human growth hormone, bovine growth hormone and porcine growth hormone, fertility inhibitors such as the prostaglandins, fertility promoters, growth factors, coagulation factors, human pancreas hormone releasing factor, analogs and derivatives of these compounds, and pharmaceutically acceptable salts of these compounds, or their analogs or derivatives. On the molecular level, the various forms of the beneficial agent may include uncharged molecules, molecular complexes, and pharmaceutically acceptable acid addition and base addition salts such as hydrochlorides, hydrobromides, acetate, sulfate, laurylate, oleate, and salicylate. Examples of acidic compounds which may be delivered by devices according to embodiments of the present disclosure include salts of metals, amines or organic cations. Derivatives such as esters, ethers and amides may also be used.

(33) A drug agent for delivery by devices according to embodiments of the present disclosure may be used alone or mixed with other agents. A drug agent for delivery by the presently-disclosed devices may include pharmaceutically acceptable excipients, polymeric carriers and/or additional ingredients, such as antioxidants, stabilizing agents, permeation enhancers, polysaccharides, proteins, nucleotides like aptamers, and fatty acids, etc., and fabricated into different forms, such as solution, suspension, gel, colloidal dispersion like liposome, or micro- and nano-particles for controlled delivery of the drug agent. A drug agent for delivery by the presently-disclosed devices may include a thermo-sensitive metal depositor or any such compound that increases the sensitivity of the target tissue, e.g., tumor, to ablation.

(34) A drug agent for delivery by the presently-disclosed devices may include a cryoablation agent, e.g., liquid nitrogen, and may prove complementary to thermal ablation that uses electrosurgical energy at RF or microwave frequencies.

(35) Although embodiments have been described in detail with reference to the accompanying drawings for the purpose of illustration and description, it is to be understood that the inventive processes and apparatus are not to be construed as limited thereby. It will be apparent to those of ordinary skill in the art that various modifications to the foregoing embodiments may be made without departing from the scope of the disclosure.