Medical device with feature for sterile acceptance of non-sterile reusable component

• US 9,072,523 B2
• Filed: 06/02/2011
• Issued: 07/07/2015
• Est. Priority Date: 11/05/2010
• Status: Active Grant

• Current Assignee: Cilag Gmbh International (Johnson & Johnson)
• Original Assignee: Ethicon Endo-Surgery, Inc. (Johnson & Johnson)
• Inventors: Houser, Kevin L., Stulen, Foster B., Dannaher, William D., Smith, Bret W., Plescia, David N., Stokes, Michael J., Rhee, Sora, Dietz, Timothy G., Felder, Kevin D., Anderson, Christopher B., Aldridge, Jeffrey L.
• Primary Examiner(s): Wilson, Lee D
• Assistant Examiner(s): HONG, HENRY Y
• Application Number:
  US13/151,512
• Publication Number:
  US 20120110810A1
• Time in Patent Office: 1,496 Days
• Field of Search: 292/71, 292/80, 292/815, 220/256.1, 220/257.51, 220/259.1, 220/259.2, 220/264, 220/254.5, 220/838, 220/254.3, 220/831, 220/236, 220/257.1, 220/257.2, 220/359.1, 220/359.2, 220/254.1, 206/438, 206/366, 128/830, 128/840
• US Class Current: 1/1
• CPC Class Codes: A61B 17/00234 for minimally invasive surgery A61B17/0218, A61B17/0469, A61B17/12013, A61B17/1285, A61B17/29, A61B17/320016 take precedence
• CPC Class Codes: A61B 17/064 Surgical staples, i.e. penetrating the tissue
• CPC Class Codes: A61B 17/2812 with a single pivotal connection A61B17/29 takes precedence
• CPC Class Codes: A61B 17/285 combined with cutting implements
• CPC Class Codes: A61B 17/320068 using mechanical vibrations, e.g. ultrasonic A61B17/22012 takes precedence; dental tooth drilling devices operated by vibration A61C3/03; removing intra-ocular material using mechanical vibrations A61F9/00745
• CPC Class Codes: A61B 17/320092 with additional movable means for clamping or cutting tissue, e.g. with a pivoting jaw
• CPC Class Codes: A61B 18/00 Surgical instruments, devices or methods for transferring non-mechanical forms of energy to or from the body eye surgery A61F9/007; ear surgery A61F11/00
• CPC Class Codes: A61B 18/04 by heating by applying electromagnetic radiation A61B18/18; hyperthermia using electric or magnetic fields, radiation or ultrasound A61N
• CPC Class Codes: A61B 18/12 by passing a current through the tissue to be heated, e.g. high-frequency current
• CPC Class Codes: A61B 18/1206 Generators therefor
• CPC Class Codes: A61B 18/1233 with circuits for assuring patient safety
• CPC Class Codes: A61B 18/14 Probes or electrodes therefor
• CPC Class Codes: A61B 18/1442 Probes having pivoting end effectors, e.g. forceps
• CPC Class Codes: A61B 18/1445 at the distal end of a shaft, e.g. forceps or scissors at the end of a rigid rod
• CPC Class Codes: A61B 2017/00017 Electrical control of surgical instruments
• CPC Class Codes: A61B 2017/00022 Sensing or detecting at the treatment site
• CPC Class Codes: A61B 2017/00084 Temperature
• CPC Class Codes: A61B 2017/00119 alarm; indicating an abnormal situation
• CPC Class Codes: A61B 2017/00128 related to intensity or progress of surgical action
• CPC Class Codes: A61B 2017/00221 with wireless transmission of data, e.g. by infrared radiation or radiowaves
• CPC Class Codes: A61B 2017/00398 : using powered actuators, e.g. stepper motors, solenoids
• CPC Class Codes: A61B 2017/0046 : with a releasable handle; with handle and operating part separable for prosthetic joint-implanting tools A61F2/4603
• CPC Class Codes: A61B 2017/00473 : Distal part, e.g. tip or head A61B2017/00464 takes precedence
• CPC Class Codes: A61B 2017/00477 : Coupling A61B2017/0046 takes precedence
• CPC Class Codes: A61B 2017/00482 : with a code
• CPC Class Codes: A61B 2017/00734 : battery operated
• CPC Class Codes: A61B 2017/0084 : low friction A61B2017/00853 takes precedence
• CPC Class Codes: A61B 2017/291 : the position of the handle being adjustable with respect to the shaft
• CPC Class Codes: A61B 2017/2929 : with a head rotatable about the longitudinal axis of the shaft
• CPC Class Codes: A61B 2017/293 : with means preventing relative rotation between the shaft and the actuating rod
• CPC Class Codes: A61B 2017/2931 : with releasable head
• CPC Class Codes: A61B 2017/2933 : camming or guiding means
• CPC Class Codes: A61B 2017/294 : Connection of actuating rod to jaw, e.g. releasable
• CPC Class Codes: A61B 2017/320069 : for ablating tissue
• CPC Class Codes: A61B 2017/320071 : with articulating means for working tip
• CPC Class Codes: A61B 2017/320094 : additional movable means performing clamping operation
• CPC Class Codes: A61B 2017/320095 : with sealing or cauterizing means
• CPC Class Codes: A61B 2018/00178 : Electrical connectors
• CPC Class Codes: A61B 2018/0019 : vibrating
• CPC Class Codes: A61B 2018/00589 : Coagulation
• CPC Class Codes: A61B 2018/00595 : Cauterization
• CPC Class Codes: A61B 2018/00601 : Cutting
• CPC Class Codes: A61B 2018/00607 : Coagulation and cutting with the same instrument
• CPC Class Codes: A61B 2018/00702 : Power or energy
• CPC Class Codes: A61B 2018/00791 : Temperature
• CPC Class Codes: A61B 2018/00988 : Means for storing information, e.g. calibration constants, or for preventing excessive use, e.g. usage, service life counter
• CPC Class Codes: A61B 2018/1226 : powered by a battery
• CPC Class Codes: A61B 2018/1253 : monopolar
• CPC Class Codes: A61B 2018/126 : bipolar
• CPC Class Codes: A61B 2018/1412 : Blade
• CPC Class Codes: A61B 2018/1455 : having a moving blade for cutting tissue grasped by the jaws
• CPC Class Codes: A61B 2034/2048 : using an accelerometer or inertia sensor
• CPC Class Codes: A61B 2034/254 : being adapted depending on the stage of the surgical procedure
• CPC Class Codes: A61B 2050/005 : with a lid or cover
• CPC Class Codes: A61B 2050/0065 : Peelable cover
• CPC Class Codes: A61B 2050/0067 : Types of closures or fasteners
• CPC Class Codes: A61B 2050/0076 : having additional locking means
• CPC Class Codes: A61B 2050/008 : Pegs inserted, e.g. forced, into openings
• CPC Class Codes: A61B 2050/3007 : Stackable casings
• CPC Class Codes: A61B 2050/3008 : having multiple compartments
• CPC Class Codes: A61B 2090/0803 : Counting the number of times an instrument is used
• CPC Class Codes: A61B 2090/0807 : Indication means
• CPC Class Codes: A61B 2090/0813 : Accessories designed for easy sterilising, i.e. re-usable
• CPC Class Codes: A61B 2090/0814 : Preventing re-use
• CPC Class Codes: A61B 2090/372 : Details of monitor hardware
• CPC Class Codes: A61B 2090/502 : Headgear, e.g. helmet, spectacles
• CPC Class Codes: A61B 34/25 : User interfaces for surgical systems
• CPC Class Codes: A61B 46/10 : specially adapted for instruments, e.g. microscopes
• CPC Class Codes: A61B 50/30 : Containers specially adapted for packaging, protecting, dispensing, collecting or disposing of surgical or diagnostic appliances or instruments for wound clamps A61B17/10; for ligaturing clips A61B17/122; packages or dispensers for surgical gloves or finger-stalls A61B42/40
• CPC Class Codes: A61B 90/08 : Accessories or related features not otherwise provided for
• CPC Class Codes: A61B 90/40 : Apparatus fixed or close to patients specially adapted for providing an aseptic surgical environment
• CPC Class Codes: A61N 7/00 : Ultrasound therapy lithotripsy A61B17/22, A61B17/225; massage using supersonic vibration A61H23/00 ; using ultrasound for introducing media into the body A61M37/0092
• CPC Class Codes: G16H 20/40 : relating to mechanical, radiation or invasive therapies, e.g. surgery, laser therapy, dialysis or acupuncture
• CPC Class Codes: G16H 40/63 : for local operation
• CPC Class Codes: H01M 10/425 : Structural combination with electronic components, e.g. electronic circuits integrated to the outside of the casing printed circuits H05K1/00
• CPC Class Codes: H01M 10/46 : Accumulators structurally combined with charging apparatus circuits for charging H02J7/00
• CPC Class Codes: H01M 10/48 : Accumulators combined with arrangements for measuring, testing or indicating the condition of cells, e.g. the level or density of the electrolyte constructional details of current conducting connections for detecting conditions inside cells or batteries, e.g. details of voltage sensing terminals, H01M50/569
• CPC Class Codes: H01M 2220/30 : Batteries in portable systems, e.g. mobile phone, laptop
• CPC Class Codes: H02J 2310/23 : The load being a medical device, a medical implant, or a life supporting device
• CPC Class Codes: H02J 7/0044 : specially adapted for holding portable devices containing batteries H02J7/0045 takes precedence
• CPC Class Codes: H02J 7/0045 : concerning the insertion or the connection of the batteries
• CPC Class Codes: H02J 7/0048 : Detection of remaining charge capacity or state of charge [SOC]
• CPC Class Codes: Y02E 60/10 : Energy storage using batteries
• CPC Class Codes: Y10T 29/49005 : Acoustic transducer
• CPC Class Codes: Y10T 29/49895 : Associating parts by use of aligning means [e.g., use of a drift pin or a "fixture"]
• CPC Class Codes: Y10T 29/53913 : Aligner or center

Abstract

An apparatus maintains the sterility of a medical device while providing for the insertion of an insertable component into the medical device. The apparatus includes a medical device having a housing sized to contain the insertable component, an active feature, a cap, and a hinge member. A container encases the medical device within a device recess, a cap recess, and a container cover. The insertable component may be inserted into the housing while limiting potential contact with the exterior of the medical device. An alternative assembly comprises an insertion assembly having a handle and the insertable component detachably attached thereto. The medical device comprises a housing, an active feature, and a flexible member. An insertion tube is insertable within the flexible member to limit contact when the insertable component is inserted into the housing. Yet another configuration includes a resiliently hinged door assembly releasable by a release button.

Claims

1. An apparatus for maintaining sterility of a medical device while providing for insertion of an insertable component into the medical device, the apparatus comprising:

(a) a medical device, wherein the medical device comprises;

(i) a housing, wherein the housing is sized to contain at least part of an insertable component,

(ii) an active feature selectively activated or controlled by an insertable component contained in the housing,

(iii) a cap, wherein the cap is sized and configured to couple to and seal the housing, wherein the cap is movable from an open position to a closed position, and

(iv) a hinge member, wherein the hinge member pivotably couples the housing with the cap; and

(b) a container, wherein the container comprises;

(i) a device recess, wherein the device recess is sized and configured to contain the housing,

(ii) a cap recess, wherein the cap recess is sized and configured to contain the cap when the cap is in the open position, and

(iii) a first container cover, wherein the first container cover is sized and configured to removably cover both the device recess and the cap recess;

wherein the first container cover is configured to cooperate with the container in a manner sufficient to maintain sterility of the medical device within the container.

2. The apparatus of claim 1, wherein the hinge member comprises a resilient hinge resiliently biased to urge the cap from the open position to the closed position.

3. The apparatus of claim 2, wherein the container further comprises a second container cover, wherein the second container cover is sized and configured to removably cover to the cap recess.

4. The apparatus of claim 1, wherein the medical device further comprises an elastic member, wherein the elastic member has a first end and a second end, wherein the first end of the elastic member is attached to a portion of the housing, and wherein the second end of the elastic member is attached to a portion of the cap.

5. The apparatus of claim 4, wherein the housing further comprises a retention feature, wherein the retention feature is configured to retain an insertable component within the housing when an insertable component is inserted therein.

6. The apparatus of claim 5, wherein the retention feature comprises a spring and a latch member.

7. The apparatus of claim 4, wherein the container further comprises a second container cover, wherein the second container cover is sized and configured to removably cover the cap recess.

8. The apparatus of claim 7, wherein the elastic member is made of a material selected from a group consisting of silicone rubber, ethylene propylene diene rubber (EPDM), nitrile rubber, styrene-butadiene rubber, butyl rubber, chloroprene, polychloroprene, polybutadiene rubber, or isoprene rubber.

9. The apparatus of claim 1, wherein the first container cover has a first end and a second end, wherein the first container cover further comprises a pull tab having a first and second end, wherein the first end of the pull tab is attached to the second end of the first container cover, wherein the second end of the pull tab is attached to a portion of the cap.

10. The apparatus of claim 1, wherein the container further comprises a second container cover, wherein the second container cover is sized and configured to removably attach to the cap recess, wherein the second container cover has a first end and a second end, wherein the second container cover further comprises a pull tab having a first and second end, wherein the first end of the pull tab is attached to the second end of the second container cover, wherein the second end of the pull tab is attached to a portion of the cap.

11. The apparatus of claim 10, wherein the pull tab is adhesively attached to both the second container cover and the cap.

12. The apparatus of claim 1, wherein the cap comprises a resilient member, wherein the housing comprises a recess sized and configured to receive the resilient member, and wherein the cap is detachably attached to the housing when the resilient member is inserted into the recess.

13. The apparatus of claim 1, wherein the insertable component comprises a power source.

14. The apparatus of claim 1, wherein the first container cover is adhesively attached to the container.

15. The apparatus of claim 1, wherein the container comprises a blister tray, wherein the blister tray is formed of a single homogeneous continuum of material.