Medical Device Packaging With Window For Insertion Of Reusable Component

• US 20120110824A1
• Filed: 06/02/2011
• Published: 05/10/2012
• Est. Priority Date: 11/05/2010
• Status: Active Grant

• Current Assignee: Cilag Gmbh International (Johnson & Johnson)
• Original Assignee: Ethicon Endo-Surgery LLC (Johnson & Johnson)
• Inventors: Smith, Bret W., Plescia, David N., Stokes, Michael J., Rhee, Sora, Dietz, Timothy G., Felder, Kevin D., Aldridge, Jeffrey L., Tanghal, Emmanuel V.
• Granted Patent: US 9,089,338 B2
• Time in Patent Office: Days
• US Class Current: 29/464
• 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 17/2909 Handles
• 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 2017/00084 Temperature
• 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 2050/005 : with a lid or cover
• CPC Class Codes: A61B 2050/0065 : Peelable cover
• CPC Class Codes: A61B 2050/0068 : Cooperating dimples
• 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 2090/0813 : Accessories designed for easy sterilising, i.e. re-usable
• CPC Class Codes: A61B 2090/0814 : Preventing re-use
• 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: H01M 50/227 : Organic material
• CPC Class Codes: H01M 50/247 : specially adapted for portable devices, e.g. mobile phones, computers, hand tools or pacemakers
• CPC Class Codes: H01M 50/278 : Organic material
• CPC Class Codes: H01M 50/531 : Electrode connections inside a battery casing
• 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

A system for inserting components into a medical device includes a container and an attachment member. The attachment member is coupled to a sidewall having an opening and is configured to be coupled to a medical device. Utilizing the attachment member and opening, an insertable component may be inserted into a medical device within the container while limiting the risk of contamination to the interior of the container. Alternatively, a cutting knob and an alignment member mounted to a container may be used. Cutting knob and alignment member are coupled and a knife on cutting knob is rotated about alignment member to create an opening in the container to access the interior of the medical device. Another alternative includes sandwiching an insertable component between an attachable member and the medical device while the attachable member and medical device are contained within flexible packaging that may be torn away.

Claims

1. A system for insertion of insertable components into a medical device, the system comprising:

(a) a container, wherein the container defines an interior; and

(b) a medical device sealed within the interior of the container;

wherein the exterior of the medical device and the interior of the container are sterile;

wherein the medical device is configured to receive an electrical component;

wherein the container defines an opening configured to permit selective insertion of a non-sterile electrical component into the medical device while the medical device is within the container and without compromising the sterility of the exterior of the medical device.

2. The system of claim 1, wherein the container comprises a base and a plurality of sidewalls extending from the base, wherein the opening is defined in one of the sidewalls, the system further comprising:

(a) a first cover detachably secured relative to the plurality of sidewalls;

(b) an attachment member, wherein the attachment member is coupled to the sidewall defining the opening, wherein the attachment member defines an opening corresponding to the opening formed through the sidewall; and

(c) a second cover detachably attached to an exterior surface of the sidewall defining the opening;

wherein the opening of the sidewall and the opening of the attachment member are configured to permit an insertable component to be inserted therethrough and into the medical device.

3. The system of claim 2, wherein the attachment member comprises:

(i) a cylindraceous portion having first end and a second end, wherein the cylindraceous portion is disposed through the opening of the sidewall,

(ii) a rim extending outwardly from the first end of the cylindraceous portion, wherein the rim is configured to abut against the exterior surface of the sidewall defining the opening, and

(iii) threading formed on an exterior portion of the second end of the cylindraceous portion.

4. The system of claim 3, wherein the medical device includes threading, wherein the threading of the cylindraceous portion is configured to complement the threading of the medical device.

5. The system of claim 2, wherein the sidewall defining the opening further comprises a retention feature protruding from the exterior surface of the sidewall, wherein the retention feature is configured to restrict movement of the attachment member relative to the sidewall defining the opening.

6. The system of claim 5, wherein the attachment member comprises a retention portion, an attachment portion, and a cylindraceous portion, wherein the retention portion is configured to couple with the retention feature.

7. The system of claim 6, wherein the medical device includes interior threading, wherein the attachment portion comprises exterior threading configured to complement the interior threading of the medical device, wherein the exterior threading of the attachment portion is formed on an exterior surface of the attachment portion.

8. The system of claim 7, wherein the attachment member is configured to deflect at least part of the attachment portion inwardly when the retention portion is squeezed.

9. The system of claim 5, wherein the retention feature permits rotation of the attachment member relative to the sidewall defining the opening while restricting movement of the attachment member relative to the sidewall defining the opening along an axis defined by the attachment member.

10. The system of claim 1, further comprising a component package, the component package comprising:

(i) a base,

(ii) a plurality of sidewalls, wherein the plurality of sidewalls extend from the base,

(iii) a rim, wherein the rim is substantially flat and wherein the rim extends outwardly from the plurality of sidewalls, and

(iv) a cover, wherein the cover is detachably secured to the rim,

wherein the component package is sized and configured to contain an insertable electrical component associated with the medical device,

wherein the rim of the component package is configured to couple with the container adjacent to the opening.

11. The system of claim 10, wherein the container comprises a protrusion extending outwardly from the container adjacent to the opening, wherein the component package further comprises a recess formed in the rim, wherein the recess is sized and configured to receive the protrusion to align the component package relative to the container.

12. The system of claim 11, wherein the recess and the protrusion are configured to provide a friction fit attachment between the container and the component package.

13. The system of claim 10, wherein the cover comprises a pull tab configured to detach the cover from the rim of the component package when the pull tab is pulled in a direction substantially parallel to a plane formed by the cover.

14. The system of claim 13, wherein the cover has a length and includes a plurality of perforations, wherein the plurality of perforations form a pair of parallel perforation lines that extend along the length of the cover.

15. The system of claim 10, wherein the plurality of sidewalls of the component package form a plurality of accordion-like folds.

16. A system for insertion of insertable components into a medical device, the system comprising:

(a) a container comprising a plurality of sidewalls;

(b) a first cover detachably attached to the plurality of sidewalls, wherein the first cover is configured to seal the container to provide and maintain a sterile environment within the container;

(c) an alignment member, wherein the alignment member is coupled to one of the sidewalls; and

(d) a cutting knob, wherein the cutting knob is configured to cooperate with the alignment member and cut an opening in the sidewall associated with the alignment member.

17. The system of claim 16, wherein the cutting knob comprises:

(i) a handle member,

(ii) a knife, and

(iii) an alignment recess.

18. The system of claim 17, wherein the alignment member comprises:

(i) a key, wherein the alignment recess of the cutting knob is configured to receive the key,

(ii) an exterior portion,

(iii) a body portion, wherein the body portion is disposed through an opening in the sidewall, and

(iv) an interior retention member, wherein the exterior portion and the interior retention member are configured to cooperatively retain the alignment member in the opening in the sidewall.

19. The system of claim 18, wherein the alignment member further comprises a seal, wherein the exterior portion is configured to compress the seal to form a hermetic seal with the sidewall associated with the alignment member.

20. A method for maintaining the sterility of a medical device contained within a first package material and an attachable member contained within a second package material while inserting a non-sterile insertable component, wherein the medical device comprises a first interior cavity configured to at least partially receive an insertable component therein, wherein the attachable member comprises a second interior cavity and an attachment feature, wherein the second interior cavity is configured to at least partially receive an insertable component therein, wherein the attachment feature is configured to couple the attachable member with the medical device, wherein the first package material comprises a thin flexible material, and wherein the second package material comprises a thin flexible material, the method comprising:

(a) aligning the medical device in the first package material, the non-sterile insertable component, and the attachable member in the second package material;

(b) pushing the attachable member in the second package material and the medical device in the first package material toward each other and toward the non-sterile insertable component;

(c) coupling the attachment feature of the attachable member with the medical device; and

(d) removing the first package material and the second package material from the coupled medical device and attachable member;

wherein the insertable component is configured to provide electrical power or communication to the medical device.