Method and disposable apparatus for guiding needles

Information

  • Patent Grant
  • 6758817
  • Patent Number
    6,758,817
  • Date Filed
    Wednesday, September 11, 2002
    22 years ago
  • Date Issued
    Tuesday, July 6, 2004
    20 years ago
Abstract
An apparatus and method for guiding a needle in conjunction with a biopsy using a medical imaging device, where a non-reusable needle guide, which is relatively inexpensive which grasps the sheathed bracket firm, and holds the same in a set position based upon a bullet-nose lock.
Description




BACKGROUND OF INVENTION




In recent years, handheld medical imaging transceivers, such as ultrasound and gamma ray transceivers, have been used extensively for various medical imaging situations.




In the past, the physician or medical professional typically will cover an ultrasound transceiver with a sterile sheath. Usually under the sheath is a mounting bracket attached to the transceiver. A needle guide is then typically attached over the sheath and coupled to the underlying bracket.




While these needle guides have been used extensively in the past, they do have some drawbacks. First of all, these needle guides require considerable attention and hand-to-eye coordination to be properly used. Additionally, these types of needle guides are often relatively expensive.




Consequently, there exists a need for improved methods and apparatus for guiding needles in an efficient manner.




SUMMARY OF INVENTION




It is an object of the present invention to provide an apparatus and method for guiding a needle in an efficient manner.




It is a feature of the present invention to include a plastic spring-like member.




It is another feature of the present invention to include, on the front side of the needle path, an enlarged base for guiding a needle into a grasping mechanism.




It is another feature of the present invention to include an enlarged base on a backside of the needle path for protecting the sheath from puncture by the moving needle.




It is another feature of the present invention to include a base-to-bracket attachment mechanism which is adapted for positive attachment to the bracket with a predetermined grasping force in a non-reusable manner.




It is an advantage of the present invention to achieve improved efficiency in guiding needles.




The present invention is an apparatus and method for guiding needles, designed to satisfy the aforementioned needs, provide the previously stated objects, include the above-listed features, and achieve the already articulated advantages. The present invention is carried out in a “physician burden-less” manner in a sense that the burden on a physician or other medical professional in guiding needles during the process of insertion into the needle guide, has been greatly reduced. Additionally, the system is carried out in an inexpensive manner in the sense that the use of plastic members for providing spring biasing for a needle grasping member is used to replace expensive metal springs. Finally, the present invention is carried out in a disposable manner in the sense that the base and the clamp used to couple to the sheathed bracket are designed to be used only once and then discarded.




Accordingly, the present invention is an apparatus and method including a needle guide with a plastic biasing member, enlarged base portions, and base-to-bracket locks which are non-reusable.











BRIEF DESCRIPTION OF DRAWINGS




The invention may be more fully understood by reading the following description of the preferred embodiments of the invention, in conjunction with the appended drawings wherein:





FIG. 1

is a partial cut-away side view of the apparatus of the present invention in a closed orientation.





FIG. 2

is a side view of the needle guide of

FIG. 1

, in an open orientation prior to closing.





FIG. 3

is a perspective view of a needle guide of

FIG. 2

, which has a top enlarged sheath puncture protecting area and a bottom enlarged sheath puncture protecting area.





FIG. 4

is a perspective view of the reverse side of the needle guide of FIG.


1


.





FIG. 5

is a perspective view of an alternate embodiment of the needle guide of the present invention, which is configured to mate with a bracket different from the bracket depicted in FIG.


1


.





FIG. 6

is a perspective view of a reverse side of the needle guide of FIG.


5


.











DETAILED DESCRIPTION




Now referring to the drawings wherein like numerals refer to like matter throughout, and more specifically referring to

FIG. 1

, there is shown a needle guide, bracket and medical imaging transceiver system of the present invention generally designated


100


. The system


100


includes a medical imaging transceiver


102


which could be any type of imaging system or device, and a transceiver bracket


104


which is coupled to said medical imaging transceiver


102


for the purpose of facilitating coupling with needle guides and other instruments. Transceiver bracket


104


can be coupled to medical imaging transceiver


102


in any suitable manner, such as clamps, screws, adhesive, etc. Transceiver/bracket covering sterile sheath


106


is disposed about transceiver bracket


104


and medical imaging transceiver


102


in a well-known manner. Needle guide assembly


110


is shown having a movable base portion


120


, stationary base portion


130


and a needle grasping member


140


, all of which could be made of any suitable material; however, a plastic material is preferred.




Movable base portion


120


includes a bullet-nose receiving hole


122


therein which, when viewed through the cut-away portion outlined by cut-away line


121


, includes a bullet-nose removal inhibitor surface


123


. Movable base portion


120


also includes a movable base handle end


124


which pivots about movable base pivot point


126


. On an opposing end from movable base handle end


124


is movable base bracket grasping surface


128


, which is configured to grasp a surface of transceiver bracket


104


when movable base handle end


124


is disposed in a closed and locked orientation.




Needle guide assembly


110


includes stationary base portion


130


, which includes a stationary base biasing portion


132


, which has a stationary base bracket mating portion


134


and a stationary base spring biasing member


136


. Stationary base spring biasing member


136


is configured to provide a biasing force on needle grasping member


140


. Stationary base portion


130


further includes a stationary lock end


137


having a bullet-nose lock male member


139


. Bullet-nose lock male member


139


are well known in the art for providing positive attachment between items in a manner that separation of the items results in a destruction of the future capability of the bullet-nose lock male member


139


to firmly attach the items, which mates with bullet-nose removal inhibitor surface


123


of bullet-nose receiving hole


122


in movable base portion


120


. Stationary base portion


130


further includes a stationary base needle entrance-guiding channel


138


disposed along an outside top edge of stationary base portion


130


.




Disposed above stationary base portion


130


is needle grasping member


140


, which has a needle grasping end


142


with a needle receiving void


144


therein disposed in axial alignment with stationary base needle entrance-guiding channel


138


, so that a needle can be simultaneously in both stationary base needle entrance-guiding channel


138


and needle receiving void


144


. Needle grasping member


140


includes a needle grasping member handle end


146


, which when depressed toward stationary base biasing portion


132


, causes needle grasping end


142


to pivot about needle grasping member pivot point


148


. Stationary base spring biasing member


136


provides a resisting force upon needle grasping member handle end


146


, which urges needle grasping end


142


into contact with stationary base portion


130


.




Now referring to

FIG. 2

, there is shown needle guide assembly


110


of

FIG. 1

wherein movable base portion


120


is oriented in an open position prior to being closed and locked.




Now referring to

FIG. 3

, there is shown a perspective view of the needle guide assembly


110


of FIG.


2


. Stationary base portion


130


is shown having a top enlarged sheath puncture protecting area


302


and a bottom enlarged sheath puncture protecting area


304


. Top enlarged sheath puncture protecting area


302


and bottom enlarged sheath puncture protecting area


304


may be optional features, depending upon the particular needs of a particular application. Since the transceiver/bracket covering sterile sheath


106


(

FIG. 1

) is disposed adjacent to stationary base portion


130


, the top enlarged sheath puncture protecting area


302


and the bottom enlarged sheath puncture protecting area


304


perform the functions of shielding transceiver/bracket covering sterile sheath


106


from puncture at a location of transceiver/bracket covering sterile sheath


106


where risk of puncture by the needle during insertion is highest. In a preferred embodiment, top enlarged sheath puncture protecting area


302


and bottom enlarged sheath puncture protecting area


304


extend at least one-fourth (¼) of an inch beyond the needle grasping member. In a most preferred embodiment of the present invention, top enlarged sheath puncture protecting area


302


extends at least three-eighths (⅜) of an inch beyond the needle grasping member


140


.





FIG. 4

is a perspective view of the reverse side of the needle guide of

FIG. 1

, in a closed and locked position.





FIG. 5

is a perspective view of an alternate embodiment of the present invention where the components labeled the same as in

FIGS. 1-4

are similar in function, but have differing shape and orientation.





FIG. 6

is a reverse side of the needle guide of

FIG. 5

which is obtained by rotating the device of

FIG. 5

so that the opposite side of needle grasping member handle end


146


is found on the left side of the drawing.




In operation, the apparatus and method of the present invention as described and shown in

FIGS. 1-3

, could function as follows:




A transceiver bracket


104


is mounted on a medical imaging transceiver


102


. A transceiver/bracket covering sterile sheath


106


is pulled over the medical imaging transceiver


102


and transceiver bracket


104


combination. Stationary base portion


130


is mated with transceiver bracket


104


by first engaging stationary base bracket mating portion


134


with transceiver bracket


104


, and then movable base handle end


124


is pivoted so that movable base bracket grasping surface


128


contacts the sheathed transceiver bracket


104


, and stationary lock end


137


is disposed adjacent the movable base handle end


124


. Bullet-nose lock male member


139


is thereby inserted into bullet-nose receiving hole


122


and mates with bullet-nose removal inhibitor surface


123


. A needle is placed against top enlarged sheath puncture protecting area


302


and moved into stationary base needle entrance-guiding channel


138


where it is readily guided into needle-receiving void


144


. The needle exits needle-receiving void


144


, traverses bottom enlarged sheath puncture protecting area


304


, and is then available for interaction with a patient. Once the procedure is finished, the needle can be removed by pressing needle grasping member handle end


146


, which causes needle grasping end


142


to move from stationary base portion


130


, thereby permitting disengagement of the needle from the needle guide assembly


110


.




Throughout this description, reference is made to a medical imaging system, because it is believed that the beneficial aspects of the present invention would be most readily apparent when used in connection with medical imaging; however, it should be understood that the present invention is not intended to be limited to imaging, and should be hereby construed to include other medical tools, equipment and methodologies as well, where it is desirable to guide a needle.




It is thought that the method and apparatus of the present invention will be understood from the foregoing description and that it will be apparent that various changes may be made in the form, construct steps, and arrangement of the parts and steps thereof, without departing from the spirit and scope of the invention or sacrificing all of their material advantages. The form herein described is merely a preferred exemplary embodiment thereof.



Claims
  • 1. A medical imaging system comprising:a transceiver bracket coupled with a medical imaging transceiver; a transceiver/bracket covering sterile sheath disposed over said medical imaging transceiver and said transceiver bracket; a stationary base portion disposed over said transceiver/bracket covering sterile sheath and engaging said transceiver bracket via a first point of engagement and a second point of engagement; wherein said second point of engagement comprises a movable base portion which includes a movable base bracket grasping surface which mates with transceiver bracket and a movable base handle end, such that a manipulation of movable base handle end results in movement of movable base bracket grasping surface in and out of engagement with said transceiver bracket; a lock comprising a stationary component coupled to said stationary base portion and a movable component coupled to said movable base portion; one of said stationary component and said movable component having a resilient latch portion which mates with a latch mating surface, such that said resilient latch portion is mated with said latch mating surface until an unlatching force is applied to said resilient latch portion, such that permanent damage is done to said resilient latch portion, thereby permitting relative motion between said movable base portion and said stationary base portion and prohibiting future use of said stationary base portion and said movable base portion in a locked combination.
  • 2. A system of claim 1 wherein said resilient latch portion is a bullet-nose male locking member.
  • 3. A system of claim 1 further comprising a needle grasping member which is configured as a pivoting clamp to hold a needle in a defined location with respect to said stationary base portion.
  • 4. A system of claim 3 wherein said stationary base portion comprises a top enlarged sheath puncture protecting area having a stationary base needle entrance-guiding structure coupled thereto, such that said stationary base needle entrance-guiding structure is oriented such that a needle placed therein receives guidance toward said defined location with respect to said stationary base portion.
  • 5. A system of claim 4 further comprising a bottom enlarged sheath puncture protecting area disposed on said stationary base portion.
  • 6. A system of claim 5 further comprising a plastic source of biasing force between said stationary base portion and said movable base portion.
  • 7. A system of claim 6 wherein said resilient latch portion is a bullet-nose male locking member.
  • 8. A medical imaging system comprising:a medical imaging transceiver; a transceiver bracket coupled to said medical imaging transceiver; a transceiver/bracket covering sterile sheath disposed over said medical imaging transceiver and said transceiver bracket; a stationary base portion, comprising a stationary base biasing portion which includes a stationary base spring biasing member; said stationary base portion further comprising a stationary base bracket mating portion; a stationary lock end, having a bullet-nose lock male member thereon; said stationary base portion further having a top enlarged sheath puncture protecting area having a stationary base needle entrance-guiding V-shaped channel therein; said needle guide entrance-guiding V-shaped channel being V-shaped when viewed from at least two orthogonal directions; a movable base portion, which is pivotally coupled to said stationary base portion at a movable base pivot point; said movable base portion comprising a movable base handle end and a movable base bracket grasping surface which are on opposite sides of said movable base pivot point; said movable base portion having a bullet-nose receiving hole therein which is configured to grasp said bullet-nose lock male member when inserted therein; said bullet-nose lock male member being configured to grasp said bullet-nose receiving hole until a separation force is applied between said bullet-nose lock male member and said movable base handle end, which causes a permanent destruction of future locking capabilities of said bullet-nose lock male member; a needle grasping member comprising a needle grasping end and a needle grasping member handle end, which are disposed on opposite sides of a needle grasping member pivot point; said needle grasping end having a needle-receiving void therein which is disposed adjacent a vertex of said V-shaped channel in said top enlarged sheath puncture protecting area; and, said stationary base spring biasing member providing a biasing force causing a needle disposed in said V-shaped channel and said needle-receiving void to be retained by said needle grasping end.
  • 9. A method of guiding a needle with respect to a medical imaging transceiver, comprising the steps of:providing a medical imaging transceiver and a transceiver bracket disposed in a transceiver/bracket covering sterile sheath; providing a stationary base portion having a stationary base bracket mating portion and a lock member; engaging said stationary base bracket mating portion to said transceiver bracket; moving a movable base portion, coupled to said stationary base portion such that a movable base bracket grasping surface on said movable base portion engages said transceiver bracket; moving said movable base portion further such that said lock member prohibits said movable base portion from motion away from said stationary base portion, unless a force which permanently damages said lock member is applied thereto; inserting a needle into a needle-retention area which is disposed outwardly of said stationary base portion; performing a medical procedure using said needle and said medical imaging transceiver; removing said needle from said needle-retention area; applying a force on said lock member which permanently damages said lock member; and, discarding said lock member.
US Referenced Citations (60)
Number Name Date Kind
2451183 Tantimonaco Oct 1948 A
2536963 Stephens Jan 1951 A
3017887 Heyer Jan 1962 A
3538915 Frampton et al. Nov 1970 A
3556079 Omizo Jan 1971 A
4029084 Soldner Jun 1977 A
4058114 Soldner Nov 1977 A
4108165 Kopp et al. Aug 1978 A
4132496 Casto Jan 1979 A
4249539 Vilkomerson et al. Feb 1981 A
4289139 Enjoji et al. Sep 1981 A
4332248 DeVitis Jun 1982 A
4363326 Kopel Dec 1982 A
4402324 Lindgren et al. Sep 1983 A
4408611 Enjoji Oct 1983 A
4469106 Harui Sep 1984 A
4489730 Jingu Dec 1984 A
4491137 Jingu Jan 1985 A
4497325 Wedel Feb 1985 A
4504269 Durand Mar 1985 A
4542747 Zurinski et al. Sep 1985 A
4567896 Barnea et al. Feb 1986 A
4635644 Yagata Jan 1987 A
4742829 Law et al. May 1988 A
4781067 Cichanski Nov 1988 A
4838506 Cooper Jun 1989 A
4865590 Marmar Sep 1989 A
4877033 Seitz, Jr. Oct 1989 A
4883059 Stedman et al. Nov 1989 A
4898178 Wedel Feb 1990 A
4899756 Sonek Feb 1990 A
4911173 Terwilliger Mar 1990 A
4970907 Flynn Nov 1990 A
5052396 Wedel et al. Oct 1991 A
5076279 Arenson et al. Dec 1991 A
5088178 Stolk Feb 1992 A
5088500 Wedel et al. Feb 1992 A
5161764 Roney Nov 1992 A
5235987 Wolfe Aug 1993 A
5343865 Gardineer et al. Sep 1994 A
D362064 Smick Sep 1995 S
5469853 Law et al. Nov 1995 A
5623931 Wung et al. Apr 1997 A
D383968 Bidwell et al. Sep 1997 S
5758650 Miller et al. Jun 1998 A
5871448 Ellard Feb 1999 A
5910113 Pruter Jun 1999 A
5924992 Park et al. Jul 1999 A
5941889 Cermak Aug 1999 A
5968016 Yerfino et al. Oct 1999 A
D424693 Pruter May 2000 S
6095981 McGahan Aug 2000 A
6102867 Dietz et al. Aug 2000 A
6139544 Mikus et al. Oct 2000 A
6203499 Imling et al. Mar 2001 B1
6296614 Pruter Oct 2001 B1
6311084 Cormack et al. Oct 2001 B1
6361499 Bates et al. Mar 2002 B1
6371968 Kogasaka et al. Apr 2002 B1
20010034530 Malackowski et al. Oct 2001 A1
Foreign Referenced Citations (1)
Number Date Country
WO 9934735 Jul 1999 WO
Non-Patent Literature Citations (18)
Entry
“Hitting the Mark with Realtime Guidance”, Civco PROgram, Drawer Q, Kalona, IA 52247.
“ultrasoundsupplies.com” brochure of Civco Medical Instruments Co.
“General Purpose Needle Guides and Transducer Covers” brochure of Civco Medical Instruments, Sonosite Cross-Reference Information.
“Needle Guidance Systems, Transducer Covers, GE Medical Systems”, gemedicalsystems.com brochure of Civco Medical Instruments, Solutions for Imaging.
UltraGuide 1000 System 4-page brochure, UltraGuide Ltd., Tirant Hacarmel Industrial Park, PO Box 2070, Tirat Hacarmel 30200, Israel.
UltraGuide 1000 2-page brochure, UltraGuide Ltd., Tirat Hacarmel Industrial Park, PO Box 2070, Tirat Hacarmel 30200, Israel.
Three-page web page of amedic.se printed on Nov. 5, 2002.
Disposable Transrectal Needle Guide, Civco Medical Instruments Co., Inc., Medical Parkway, 102 Highway 1 South, Kalona, IA 52247.
Maggi & Maggi II Plus, Sterile General Purpose Biopsy Needle Guides, Civco Medical Instrument Co., Inc., Medical Parkway, 102 Highway 1 South, Kalona, IA 52247.
Aloka Needle Guide/Probe Cover Kits, Civco Medical Instruments Co., Inc., Medical Parkway, 102 Highway 1 South, Kalona, IA 52247.
Multi Pro 2000, Multi-Purpose Ultrasound Linear Tracking Instrument, Civco Medical Instruments Co., Inc., 418 B Avenue, Kalona, IA 52247.
“US-Guide, Free-hand Guidance for Ultrasound Interventions” brochure from UltraGuide Smart Guidance Solutions.
“Dedicated Breast Ultrasound, USI Introduces A Revolution In Breast Ultrasound . . . Vista” by USI The Breast Imaging Co.
Program for Medical Ultrasound Professionals, Winter 1995, Civco Medical Instrument Co., Inc., Medical Parkway, 102 Highway 1 South, Kalona, IA 52247.
“Ultra-Pro™ Sterile General Purpose Biopsy Needle Guide”, CIVCO Medical Instruments Co., Medical Parkaw, 102 Highway 1 South, Kalona, IA 52247.
Solutions for Ultrasound, CIVCO Medical Instruments Co., Inc., Medical Parkway, 102 Highway 1 South, Kalona, IA 52247.
“Endocavity Needle Guide Kits” brochure of Civco Medical Instruments, copyright 2000, Solutions for Imaging.
“Civcoscan, Product News and Special Offers from CIVCO” brochure of Civco Medical Instruments, Winter 2001.