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Method and device for intracorporeal device for intracorporeal morselling of tissue and/or calculi during endoscopic surgical procedures    
United States Patent5320627   
Link to this pagehttp://www.wikipatents.com/5320627.html
Inventor(s)Sorensen; John T. (Costa Mesa, CA); Crease; John (Huntington Beach, CA); Spaeth; Edmund E. (Orange, CA); Rondinone; Joseph F. (Mission Viejo, CA)
AbstractA method and device for reducing the size of tissues and/or other materials contained within an intracorporeally positioned organ or artificial containment sac. In one embodiment, the device comprises an elongate cutting tool having a rotatable cutting head or impactor positioned on the distal end of the tool and, optionally, having one or more aspiration/infusion lumens extending longitudinally through the elongate shaft of the tool. In a second embodiment, the device may comprise (a) a separate guide/aspiration/infusion cannula initially insertable into the organ or sac and (b) a separate elongate cutting device which is insertable through and extractable from the prepositioned guide/aspiration/infusion cannula. An automatically deployable protective assembly may be positioned at the distal tip of either embodiment of the device so as to form a protective cage around the rotatable cutting head or impactor. Such protective cage is configured to prevent the cutting head or impactor from causing damage to the surrounding organ or sac. This invention also includes an artificial containment sac which may be inserted into a body cavity through a natural opening or small incision and which may subsequently be utilized as a bag-like container for tissues, organs, tumors, calculi or other materials which are to be treated by the device of the invention and removed from the body.
   














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Drawing from US Patent 5320627
Method and device for intracorporeal device for intracorporeal

     morselling of tissue and/or calculi during endoscopic surgical

     procedures - US Patent 5320627 Drawing
Method and device for intracorporeal device for intracorporeal morselling of tissue and/or calculi during endoscopic surgical procedures
Inventor     Sorensen; John T. (Costa Mesa, CA); Crease; John (Huntington Beach, CA); Spaeth; Edmund E. (Orange, CA); Rondinone; Joseph F. (Mission Viejo, CA)
Owner/Assignee     EndoMedix Corporation (Irvine, CA)
Patent assignment
All assignments
Publication Date     June 14, 1994
Application Number     08/032,756
PAIR File History     Application Data   Transaction History
Image File Wrapper   Patent Term   Fees
Litigation
Filing Date     March 17, 1993
US Classification     606/128 600/564 604/22 606/127 606/167 606/170 606/180
Int'l Classification     A61B 017/32
Examiner     Cohen; Lee S.
Assistant Examiner     Casler; Brian L.
Attorney/Law Firm     Buyan; Robert D.
Address
Parent Case     This is a continuation of copending application Ser. No. 07/639,494, filed on Jan. 9, 1991, now abandoned.
Priority Data    
USPTO Field of Search     606/128 606/159 606/170 606/171 606/180 606/127 606/167 604/22 128/751 128/752
Patent Tags     intracorporeal intracorporeal morselling tissue calculi during endoscopic surgical procedures
   
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ReferenceRelevancyCommentsReferenceRelevancyComments
4923462
Stevens
606/159
May,1990

[0 after 0 votes]
4811735
Nash
606/128
Mar,1989

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4679558
Kensey
606/128
Jul,1987

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What is claimed is:

1. A device for morselling material contained within an intracorporeally positioned sac, said device comprising:

a tubular cannula insertable through a body opening into the sac, said cannula having a proximal end, a distal end and at least one lumen extending longitudinally therethrough;

an elongate cutting tool having a rotating cutting head mounted thereon, said cutting tool being insertable through said cannula such that the rotating cutting head is adjacent the distal end of said cannula;

a drive motor connected to said cutting tool for rotationally driving said cutting head to effect morsellation of material which comes into contact with said cutting head;

a rigid protective assembly on the distal end of said cannula, said protective assembly comprising a plurality of rigid tip members movably connected to said cannula and alternately moveable between (i) a "closed" configuration wherein said rigid tip members extend generally forward of the distal end of said cannula and (ii) a "splayed" configuration wherein said tip members diverge apart from one another and outwardly from said closed configuration such that said tip members are spaced apart from one another and form a protective assembly beyond the distal end of said cannula;

said protective assembly being constructed relative to said elongate cutting tool such that, when said elongate cutting tool is inserted through said cannula, said cutting tool will engage and push the protective assembly from its "closed" configuration to its "splayed" configuration, said device including means for limiting the advancement of said rotating cutting head beyond a fully advanced operative position whereat said rotating cutting head is proximal to a distal end of said protective assembly when said protective assembly is in said splayed configuration.

2. The device of claim 1 wherein extraction of the cutting tool from the cannula causes the protective assembly to return to its "closed" configuration.

3. The device of claim 1 wherein said tip members are biased toward said closed configuration and wherein said protective assembly and cutting tool are correspondingly sized and configured such that when inserted through the cannula, said cutting tool will exert pressure on said protective assembly so as to overcome said bias and to cause said protective assembly to move from its "closed" configuration and to its "splayed" configuration.

4. The device of claim 3 wherein said protective assembly and said cutting tool are further sized and configured such that, when extracted from said cannula, said cutting tool will no longer exert pressure on said protective assembly, thereby allowing the biased tip members to return to their "closed" configuration.

5. The device of claim 1 wherein said elongate cutting tool further comprises:

a generally tubular bearing sleeve having a distal end and a proximal end;

a rotatable drive shaft extending longitudinally through said bearing sleeve and having said cutting head attached thereto;

said rotatable cutting head being disposed beyond the distal end of said bearing sleeve.

6. The device of claim 5 wherein said generally tubular bearing sleeve comprises a plurality of ball bearings mounted within a tubular sleeve to facilitate rotation of said drive shaft therein.

7. The device of claim 5 wherein said generally tubular bearing sleeve comprises a plurality of rod-type bearings mounted within said bearing sleeve to facilitate rotation of said drive shaft therein.

8. The device of claim 5 wherein said generally tubular bearing sleeve comprises a plurality of non-rotating bushings mounted within said bearing sleeve to facilitate rotation of said drive shaft therein.

9. The device of claim 1 wherein said tubular cannula further comprises:

a cap member mountable on the proximal end of said cannula to seal the proximal end of said cannula lumen.

10. The device of claim 1 further comprising a tubular aspiration/infusion port formed in the cannula and in fluid communication with the cannula lumen to permit infusion and aspiration of fluids through said cannula lumen.

11. The device of claim 1 wherein said cannula is sized to pass through a standard laparoscopy portal.

12. The device of claim 11 wherein said cannula is less than 1 cm in diameter.

13. The device of claim 1 wherein said rotatable cutting head comprises first, second, third, and fourth lateral members formed in a cross-configuration.

14. The device of claim 13 wherein said rotatable cutting head further comprises at least one strut extending forwardly from at least one of said lateral members.

15. The device of claim 14 wherein at least two of said lateral members have leading edges which are beveled.

16. The device of claim 14 wherein all lateral members have leading edges which are beveled.

17. The device of claim 14 wherein each strut has a leading edge which is beveled.

18. The device of claim 17 wherein at least one of said lateral members is pitched so as to cause material to be pulled in a proximal direction upon rotation of said cutting head.

19. The device of claim 1 wherein said rotatable cutting head comprises an impactor having a central hub connected to said drive motor and a plurality of impactor elements attached to and extending outwardly from said central hub.

20. The device of claim 1 wherein said protective assembly is formed of plastic material.

21. The device of claim 1 wherein said distal tip members are configured such that when said protective assembly is in said "closed" configuration there remains sufficient open space between said distal tip members to permit aspiration and infusion of fluid and debris therethrough.

22. The device of claim 1 wherein said tubular cannula and said elongate cutting tool are sized relative to one another such that, when said elongate cutting tool is operatively inserted within said cannula, there will remain sufficient space between said cannula and said cutting tool to allow infusion and aspiration of fluid therethrough.

23. The device of claim 1 wherein said tubular cannula is greater than 8 French in diameter.

24. The device of claim 1 wherein said tubular cannula is approximately 1 cm in diameter.

25. The device of claim 1 wherein said cutting head is approximately 0.5-0.9 cm in width at its widest point.

26. The device of claim 1 wherein said drive motor is capable of driving said elongate cutting tool at various speeds.

27. The device of claim 1 wherein said drive motor is a variable speed electric motor.

28. The device of claim 1 wherein said cutting head is a rotational cutting head and wherein said drive motor is attached to said elongate cutting tool so as to rotate said cutting head at least one rotational speed between 20,000 and 100,000 rpm.

29. The device of claim 28 wherein said motor is sized and adapted to drive said cutting head at a speed of approximately 80,000 rpm.

30. A device insertable through an opening in a mammalian body to effect morselling of matter within said mammalian body, said device comprising:

a tubular cannula insertable through said opening, said cannula having a proximal end, a distal end, a longitudinal axis, and at least one lumen extending longitudinally therethrough;

a protective assembly formed on the distal end of said cannula, said protective assembly being alternately moveable between a "closed" configuration wherein said protective assembly is sufficiently compact to be inserted through said opening and a "splayed" configuration wherein said protective assembly diverges outwardly from the longitudinal axis of said cannula to define a protective zone within said protective assembly and proximal to a distal end of said protective assembly beyond the distal end of said cannula;

an elongate morselling apparatus having a distal end whereon a moving head is positioned;

said morselling apparatus being configured relative to said protective assembly such that the act of inserting said morselling apparatus through said cannula causes said protective assembly to move from said "close" configuration to said "splayed" configuration; and

said morselling apparatus being insertable, distal end first, into the proximal end of said tubular cannula and advanceable threrethrough, said device including means for limiting the advancement of said moving head beyond a fully advanced operative position whereat said moving head is proximal to the distal end of said protective assembly within said protected zone.

31. The device of claim 30 wherein said protective assembly is spring-biased to said "closed" configuration and wherein said morselling apparatus is configured to exert pressure on said protective assembly in a manner which overcomes said bias and causes said protective assembly to move from its "closed" configuration to its "splayed" configuration.

32. The device of claim 30 wherein said spring-bias of said protective assembly is operative to return said protective assembly from said "splayed" configuration to said "closed" configuration upon extraction of said morsellation apparatus from said cannula.

33. The device of claim 32 wherein said moving head of said morselling apparatus is operative to rotate at a speed between 20,000-100,000 r.p.m.

34. The device of claim 30 wherein said moving head on the distal end of said morselling apparatus comprises a rotating cutting head.

35. The device of claim 30 wherein said opening in said mammalian body is less than 1 cm in diameter, and wherein said protective assembly, is less than 1 cm in transverse dimension when in said closed configuration.

36. The device of claim 30 wherein said protective assembly, is greater than 1 cm in transverse dimension when in said "splayed" configuration.
 Description Submit all comments and votes
 


FIELD OF THE INVENTION

The present invention relates generally to medical equipment and more particularly to a device which may be inserted into the body through an existing orifice or small incision and subsequently utilized to pulverize, granulate, smash, crush, shatter, grind, tear, shred, cut, mulch, liquidize, or otherwise reduce the size of surgically excised tissues (e.g. organs, tumors, adhesions), calculi (e.g. kidney stones, bladder stones, gallstones) or other matter contained within a sac-like anatomical structure or artificial containment bag positioned within the body.

BACKGROUND OF THE INVENTION

The development of modern endoscopic instrumentation has significantly affected the manner in which many surgical procedures are performed. Indeed, many procedures which have traditionally required large surgical incisions (e.g. laparotomy) may now be performed endoscopically, by inserting an endoscopic viewing device (e.g. a laparoscope, arthroscope, bronchoscope, etc.) along with various surgical instruments through natural body openings or small incisions.

The development of modern endoscopic surgical procedures has enabled surgeons to perform major operative procedures at relatively low risk, without the need for deep muscle relaxation and with minimal blood loss and minimal post-operative discomfort.

In particular, recent advancements in laparoscopic technology have enabled surgeons to perform various intra-abdominal surgical procedures through one or more relatively small (e.g. 1 cm) laparoscopy incisions rather than through the traditional, relatively large (e.g. 5-20 cm) laparotomy incision. Although the laparoscopic technology is advanced enough to permit surgeons to laparoscopically excise various tissues and/or organs within a body cavity, (e.g. tumor removal, appendectomy, nephrectomy, cholecystectomy, etc.) the ultimate success and feasibility of such laparoscopic surgery is often confounded by the fact that the excised tissue, organ or other matter may simply be too large to be extracted from the body cavity through the relatively small (e.g. 1 cm) laparoscopy incision. In such instance, it may be necessary to enlarge the laparoscopy incision in order to effect extraction and removal of the excised tissue or other matter. Such need for enlargement of the laparoscopy incision partially negates the benefits of performing the procedure laparoscopically because enlargement of the incision is likely to cause additional post-operative discomfort and is likely to increase post-operative recovery time.

Similar problems in extracting and removing tissue or organs may be experienced in other contemporary endoscopic surgical procedures, including those which are performed through natural body openings such as the oral cavity, urethra, vagina, rectum, etc.

The present invention may be used with any type of endoscopic surgical procedure wherein it is desired to remove a mass of tissue or other matter from the body through a relatively small opening. Because the present invention is particularly applicable to intra-abdominal laparoscopic surgical procedures, the invention will be described herein with particular reference thereto. The making of such particular reference to laparoscopic surgical procedures shall not, however, constitute a limitation on the overall description and intended application of the present invention. In fact, in addition to intra-abdominal laparoscopic procedures, the present invention may be usable in many other types of procedures, including but not limited to transurethral removal of bladder stones, standard cholecystotomy and a modified cholecystotomy procedure known as "mini-cholecystostomy" wherein the gallbladder is, under laparoscopic guidance, displaced and sutured onto the peritoneal wall with subsequent formation of an incision or stoma through the abdominal wall, directly into the stone-containing gallbladder. Furthermore, the device of the present invention may be inserted into an organ to reduce and/or remove the contents thereof without the need for initial excision of the organ. For example, the device of the present invention may be inserted directly through the abdominal wall and into the gallbladder, urinary bladder or other sac-like structure wherein the device may be utilized to reduce the size of and/or remove aberrant material (e.g. calculi) contained within the organ, without the need for excision and removal thereof.

i. The General Methodology of Laparoscopic Surgery

Laparoscopy has, for some time, been used in the treatment of gynecologic diseases. More recently, and largely due to the development of highly efficient laser cutting and coagulation devices, laparoscopy has shown promise as a modality for performing various other general surgical procedures which had heretofore been performed through relatively large (e.g. 5-40 cm) laparotomy incisions. Indeed, frequently performed intra-abdominal surgical procedures such as cholecystectomy and appendectomy may now be approached with the laparoscope through a relatively small (e.g. 1 cm) abdominal puncture. The feasibility of performing such operations is, however, dependent upon the ability of the surgeon to extract and remove the excised tissue or organ from the body.

In accordance with standard laparoscopic technique, an inflation needle is initially inserted into the peritoneum and carbon dioxide is passed into the peritoneum to create a distended pneumoperitoneum. Thereafter, a small periumbilical incision is formed and a primary portal or trocar is inserted, through such periumbilical incision, into the distended peritoneum. The laparoscope is then inserted into the peritoneum through the primary umbilical trocar. One or more secondary trocars or accessory portals may also be inserted through one or more secondary incisions or puncture wounds formed in the abdominal wall. Such secondary trocars or accessory portals are generally used for passage of blunt forceps, cannulas and other instruments into the abdomen. After such instruments have been inserted through the accessory portals, the instruments are used to carry out the desired surgical excision and/or manipulation of organs and tissues within the abdomen while the surgeon views the operative site through the previously inserted laparoscope. The surgically excised tissue or other material which is to be removed during the surgical procedure must then be extricated from the body, preferably by extraction through one of the previously made laparoscopy portal incisions.

ii. A Specific Procedure for Laparoscopic Cholecystectomy

One particular laparoscopic surgical procedure which has become relatively common in clinical application is the "laparoscopic cholecystectomy". The laparoscopic cholecystectomy generally requires insertion of a laparoscope through the primary periumbilical portal and various forceps and other operative instruments through the secondary portals. The gallbladder is then grasped with forceps, clips are placed on the cystic artery and bile duct and the gallbladder is subsequently excised. Thereafter, the laparoscope is extracted from the primary portal and relocated to a secondary portal. Forceps are then utilized to move the gallbladder to a position adjacent the periumbilical incision and to exteriorize the neck of the gallbladder through the periumbilical incision. If possible, the entire body of the gallbladder is then extracted through the periumbilical incision. Such extraction of the gallbladder may be complicated, however, in instances where the diseased stone-containing gallbladder is too large to pass through the relatively small (e.g. 1 cm) periumbilical incision. In such instances, it is current practice to insert forceps through the exteriorized neck of the gallbladder to attempt to manually crush and remove some or all of the gallstones. Such manual crushing of the gallstones is time-consuming and may well result in perforation of the gallbladder wall. Alternatively, the surgeon may elect to enlarge the small (e.g. 1 cm) periumbilical incision in order to remove the entire body of the stone-containing gallbladder. Such enlargement of the incision is undesirable and may lead to increased post-operative discomfort.

In view of the problems associated with removing tissue, organs, or other material through a relatively small (e.g. 1 cm) laparoscopy incision, there exists a need in the art for an instrument which may be passed into the peritoneum through the standard (e.g. 1 cm) laparoscopy incision to liquidize and/or pulverize tissue or other material (e.g. gallstones) and to aspirate such liquidized/pulverized material from the body cavity.

One instrument which has previously been devised for liquidizing tissue during endoscopic surgical procedures is described in the literature. K. T. Ison, M. J. Coptcoat, A. Timoney, and J. E. A. Wickham, "The Development and Application of a Surgical Device-The Endoscopic Liquidizer and Surgical Aspirator (ELSA)", Journal of Medical Engineering and Technology, Vol. 13; No. 6 (November/December 1989), pg. 285-289. Such instrument is intended to be inserted through the working channel of an endoscope and incorporates an internal suction lumen along with a rotating cutting head so as to access, liquidize and aspirate tissue through a common instrument which is positioned in and inserted through the working channel of the endoscope.

Various other instruments for fragmenting, pulverizing or reducing the size of materials in situ have also been described. Examples of such instruments are found in U.S. Pat. Nos. 4,823,793 (Angulo et al.), 4,681,106 (Kensey), 4,700,705 (Kensey), 4,631,052 (Kensey), 4,002,169 (Kulper).

SUMMARY OF THE INVENTION

The present invention overcomes some or all of the shortcomings of the prior art by providing a device which is insertable through an existing body orifice or small incision and which is usable to pulverize, granulate, smash, crush, shatter, grind, tear, shred, cut, mulch, liquidize or otherwise reduce the size of surgically excised tissues, calculi or other matter contained within a sao-like anatomical structure or intracorporeally positioned artificial containment bag.

In accordance with the invention, there is provided a device comprising an elongate cutting tool having a distal cutting head such as a rotatable cutting head or impactor, disposed thereon. In one embodiment, the elongate cutting tool may optionally incorporate one or more infusion/aspiration lumens running longitudinally therethrough. In another embodiment, there may be provided an aspiration/infusion/guide cannula which is separate from the elongate cutting tool. The separate aspiration/infusion/guide cannula may be preinserted through a body opening into the intracorporeally positioned organ or containment bag and the elongate cutting tool may be inserted through the aspiration/infusion/guide cannula, operated and subsequently extracted. After the cutting tool has been employed to reduce the size of material contained with the organ or sac, such material may be aspirated through the separate aspiration/infusion/guide cannula prior to or after extraction of the cutting tool therefrom.

In accordance with one embodiment of the invention, there is provided a device comprising (a) an elongate cannula insertable through a body opening into the intracorporeally positioned organ or artificial containment bag, (b) an elongate cutting tool having a distal cutting head mounted thereon, said elongate cutting tool being insertable through the elongate cannula such that the cutting head will reside adjacent to the distal end of said cannula, and (c) drive motor which is attachable to the proximal end of the elongate cutting tool for driving the cutting head in a manner that will effect size-reducing treatment of material contained within the intracorporeally positioned organ or artificial containment sao. The cannula portion of the device may further comprise a protective assembly formed on the distal end of the elongate cannula to guard the cutting head and to prevent the cutting head from inadvertently damaging or puncturing the walls of the surrounding containment sac.

Various sizes and types of cutting heads may be provided for effecting various types of applications including, but not limited to, pulverization of kidney stones, pulverization of gallstones, pulverization of bladder stones, liquidization of excised tissues or tumors, etc.

The rotatable cutting head or impactor deployed on the elongate cutting tool may be specifically configured to create a circulatory fluid motion and/or drawing effect so as to effectively pull matter into contact with the rotating cutting head or impactor. Also, the leading edges of such rotating cutting head or impactor may be bevelled or sharpened to facilitate movement of the rotating head or impactor through the surrounding fluid and/or to enhance the matter cutting or matter breaking effect of the rotating head or impactor and/or to enhance the above-described circulatory fluid motion such that matter will be pulled or drawn into contact with the rotating head or impactor. In some embodiments, the rotating head or impactor may comprise a plurality of individual members which emanate outwardly from a central hub or shaft. Such individual members may be twisted, bent or pitched in a manner that will cause the formation of and/or enhancement of the above-described circulatory fluid motion and/or drawing effect whereby matter is pulled or drawn into contact with the rotating head or impactor.

In accordance with a further aspect of the invention, there is provided a method for removing material from an intracorporeally positioned organ or artificial containment sac. Such method comprises insertion of an elongate cutting tool into an intracorporeally positioned organ or artificial containment sac which may be partially exteriorized through a body opening or small incision to contain a quantity of material to be removed therefrom. A rotatable cutting head or impactor on the distal end of the elongate cutting tool is then rotated so as to effect size-reducing treatment of the material contained within the organ or containment sac. Following the size-reducing treatment, the cutting tool is extracted from the cannula and the material is aspirated from the sac through an aspiration cannula which is no larger than the existing body opening or small incision.

In accordance with a further aspect of the invention, there is provided a pliable, intracorporeally positionable, artificial containment sac formed of flexible material. The artificial containment sac is preferably sized and configured so as to be insertable through an existing body orifice or small incision, such as a 1 cm laparoscopy incision. In this respect, the artificial containment sac may be constructed so as to be foldable, compressible or otherwise collapsible to a small-diameter configuration which is insertable through a body orifice or small (e.g. 1 cm) laparoscopy incision. After the artificial containment sac has been inserted into the body, through the body orifice or small laparoscopy incision, it may be unfolded, decompressed or otherwise expanded to a fully operative bag-like configuration. Thereafter, a quantity of tissue or other material may be inserted into the containment sac and the sac may be positioned adjacent to, or may be partially exteriorized through, a body opening or incision. The device of the present invention or other type of cutting tool may then be inserted through the body opening or incision and into the containment sac to effect size-reducing treatment of the material contained within the organ or containment sac. In one preferred embodiment, the artificial containment sac comprises a simple bag-like structure having a single open end. A purse string, compressible closure, adhesive or other closure mechanism or closure means is provided for closing off the open end of the bag-like structure after the tissue or other material has been inserted thereinto. In another embodiment, the containment sac may comprise a bag-like body having two or more openings----e.g. one large sealable opening through which a bolus of tissue, tumor, organ or other excised material may be inserted and a second small neck opening or tube which may be at least partially exteriorized through an existing body orifice or small laparoscopy incision. The exteriorized neck portion or tube thus provides a convenient passageway through which an elongate cutting device, such as the device of the present invention, may be inserted into the sac to effect size reducing treatment (e.g. liquidization, pulverization, etc.) and subsequent aspiration of the tissue, tumor, organ or other material contained within the sac.

Further objects and advantages of the present invention will become apparent to those skilled in the art upon reading and understanding the following detailed description and the accompanying drawings.

BRIEF DESCRIPTION OF THE DRAWINGS

FIG. 1 is a perspective view of a first embodiment of the present invention.

FIG. 2 is a side elevational view of the distal portion of a first embodiment of the present invention, wherein a plurality of distal shielding members are disposed in a splayed "operative" configuration.

FIG. 3 is a distal end view of a first embodiment of the present invention wherein a plurality of distal shielding members are disposed in a splayed "operative" configuration.

FIG. 4 is a cross-sectional view through line 4--4 of FIG. 1.

FIG. 5 is a perspective view of a first embodiment of the present invention attached to an alternate pistol-type, hand-held power drive unit.

FIG. 6 is a perspective view of a first example of a rotary impacting member usable in the first embodiment of the present invention.

FIG. 7 is a perspective view of a second example of a rotary impacting member usable in the first embodiment of the present invention.

FIG. 8 is a perspective view of a third example of a rotary impacting member usable in the first embodiment of the present invention.

FIG. 9 is a schematic showing of a first step in the operation of the device of FIGS. 1 or 5, whereby the distal end of the device of the first embodiment of the present invention is about to be inserted into a stone-containing gallbladder, the neck of the gall bladder having been exteriorized through the laparoscopy incision.

FIG. 10 is a schematic showing of a second step in the operation of the-device of FIGS. 1 or 5, whereby the distal end of the device of the first embodiment of the present invention has been inserted into a stone-containing gallbladder and the tip members thereof are disposed in a splayed or open configuration.

FIG. 11 is a schematic showing of the gallbladder of FIG. 10 after the stones contained therein have been fragmented and withdrawn such that the gall bladder may be extracted through the laparoscopy incision.

FIG. 12 is a longitudinal sectional view of a second embodiment of the present invention.

FIG. 13 is a perspective view of a second embodiment of the present invention in its fully assembled "operative" configuration including: (a) a motor/hand piece component, (b) an aspirator/guide cannula and protective cage assembly component, (c) a bearing tube disposed within the aspirator/guide cannula and protective cage assembly unit, d) a drive shaft disposed within the bearing tube and (e) an impactor head disposed on the distal end of the drive shaft.

FIG. 13a is an enlarged view of the cap member attached to the device shown in FIG. 13.

FIG. 14 is a perspective view of the aspirator/guide cannula and protective cage assembly component of the device shown in FIG. 13.

FIG. 15 is a perspective view of the bearing tube assembly component of the device shown in FIG. 13.

FIG. 16 is a perspective view of the drive shaft and impactor head components of the device shown in FIG. 13.

FIG. 17 is an enlarged perspective view of the distal tip of the device shown in FIG. 13.

FIG. 18 is a longitudinal sectional view of the distal tip of the device shown in FIG. 13.

FIG. 19 is an enlarged view of the distal tip portion of the aspirator/guide cannula and protective cage assembly shown in FIG. 14.

FIG. 20 is a longitudinal sectional view of the distal tip portion of the aspirator/guide cannula and protective cage assembly shown in FIG. 14.

FIG. 21 is an enlarged perspective view of the distal tip portion of the bearing tube assembly component shown in FIG. 15.

FIG. 22 is a sectional view of the distal portion of the bearing tube assembly of FIG. 21.

FIG. 23 is an enlarged view of the distal tip portion of the drive shaft and the impactor head component of FIG. 16.

FIG. 24 is a longitudinal sectional view of the distal tip portion of FIG. 23 showing a preferred seal assembly which interfaces between the drive shaft component of FIG. 16 and bearing tube component of FIG. 15.

FIG. 25 is a longitudinal sectional view of a portion of the bearing tube component of FIG. 15, having the drive shaft component of FIG. 16 disposed therein.

FIG. 26 is a schematic showing of a first step in the operation of the device of FIG. 13, whereby the aspirator/guide cannula and protective cage assembly has been inserted into a stone-containing gallbladder.

FIG. 27 is a schematic representation of a second step in the operation of the device of FIG. 13 whereby the bearing tube, drive shaft and impactor head assemblies have been advanced through the aspirator/guide cannula, causing the protective cage assembly to open to a splayed "operative" configuration.

FIG. 28a is a perspective view of a first embodiment of an artificial containment sac of the present invention.

FIG. 28b is a perspective view of a second embodiment of an artificial containment sac of the present invention.

DETAILED DESCRIPTION OF TWO PREFERRED EMBODIMENTS

The following detailed descriptions and the accompanying drawings are provided for purposes of illustrating and describing a presently preferred embodiment of the invention and are not intended to limit the scope of the invention in any way.

i. A First Embodiment

Referring now to FIGS. 1-8, one presently preferred device 10 of the present invention comprises an elongate cutting and aspiration device which is detachably connectable to a hand-held drive unit 12a (FIG. 1), 12b (FIG. 5). The hand-held drive unit 12a, 12b may be formed in a generally cylindrical handle type configuration 12a or may be formed as a pistol grip type configuration 12b. Those skilled in the art will recognize that other configurations are likewise suitable.

An elongate cylindrical shaft or housing 14 has a proximal end P and a distal end D. The portion of the shaft 14 near the distal end D thereof comprises a plurality of openable and closeable tip members 16a, 16b, 16c and 16d (best shown in FIG. 3) which operate to form a protective assembly or cage around the cutting head or impactor 26a, 26b, 26c. Such tip members 16a, 16b, 16c and 16d are alternately deployable in a "closed" configuration as shown in FIG. 1 or an "open" configuration as shown in FIGS. 2 and 3.

A drive shaft 24 is rotatably disposed and supported within the elongate cylindrical housing 14. A plurality of bearings or bushings 20 may be disposed within the elongate housing 14 to support and/or facilitate rotation of the drive shaft.

Upper and lower infusion and/or aspiration lumens 18a, 18b (FIG. 4) extend longitudinally through the elongate shaft 14 of the device 10 so as to provide passageways through which fluids may be infused (distally) and/or air, fluids, debris or other matter may be aspirated (proximally) and subsequently removed or discarded. Both infusion/aspiration lumens 18a, 18b may be separately accessible through separate side arm connectors 20 or, as in the embodiment shown, both lumens 18a, 18b may terminate in a common internal collection manifold, reservoir or void formed within the proximal portion P of the elongate shaft 14. In such embodiment a single side arm connector 20 opens into such common manifold within the proximal portion of shaft 14 to provide for concomitant infusion/withdrawal through both lumens 18a, 18b. An ancillary infusion or aspiration apparatus, such as a suction tube 22, infusion tube or syringe may be attached to side arm connector 20 to effect the desired infusion or aspiration through lumens 18a, 18b.

When it is desired to aspirate material proximally through the lumens 18a, 18b the tube 22 may comprise a suction or vacuum tube attached to standard wall suction, a dedicated suction pump or other suction means whereby the operator may apply continuous and/or intermittent suction through the lumens 18a and/or 18b.

Additionally, it will be appreciated that the device may be provided with both a fluid supply lumen 18a or 18b and a separate aspiration lumen 18a or 18b, so that fluid may be infused (distally) through one lumen into the intracorporeal containment sac (e.g. natural organ or artificial sac) while fluid/stone fragments/debris or other material is simultaneously or intermittently aspirated (proximally) through a separate lumen. Such concomitant infusion and aspiration may effect a lavage-like washing of the interior of the organ or sac into which the device 10 has been inserted so as to efficiently remove or extract fluid, debris, stone fragments or other matter therefrom.

While it is preferable to incorporate one or more infusion and/or aspiration lumens 18a, 18b within the elongate shaft 14 as shown, it will be appreciated that such lumens 18a, 18b are optional features of the device 10 and may be eliminated altogether.

Power unit 12a, 12b may be operatively connected to the proximal end P of the elongate shaft 14 by any feasible mechanical, magnetic or other connection means by which the power unit 12a, 12b may engage and rotatably drive shaft 24 so as to cause resultant rotation of the impactor head 26a, 26b, 26c. The power unit 12a, 12b comprises an outer housing 28a, 28b wherein a small electric or pneumatic motor is mounted. The electric or pneumatic motor is sized and adapted to drive the drive shaft at a fixed speed or may be capable of driving the drive shaft at variable speeds as desired. The electric or pneumatic motor (not shown) is connected to a drive assembly which mechanically, magnetically, or by other means, drives shaft 24a (FIG. 2 and FIG. 6), 24b (FIG. 8), 24c (FIG. 7) in a rotary fashion. An electrical power cord or pneumatic pressure line 30a, 30b is connected to the power unit 12a, 12b so as to provide the necessary pneumatic or electrical power to the motor disposed within housings 28a, 28b and on/off or variable speed control trigger 21a, 21b actuates the motor.

The "pistol grip" power unit 12b shown in FIG. 5 incorporates an "enable switch" 31 which must be closed in order for the motor disposed within housing 28b to be actuated. As shown, the hand grip 33 may be pulled back to depress enable switch 31, thereby closing the enable switch 31 and allowing the motor to be actuated upon depression of trigger 21b. If the enable switch 31 is not closed, compression of trigger 21b will be ineffectual, and will not result in actuation of the motor.

In the first embodiment, the tip members 16a, 16b, 16c, and i6d are hinge mounted or otherwise pivotally connected to the distal end D of the elongate shaft 14 so as to be alternately deployable in a closed configuration (FIG. 1) or an open configuration (FIGS. 2 and 3). When in the closed configuration, the outer surfaces of the tip members 16a, 16b, 16c and 16d form a smooth, cylindrical surface which is generally continuous with and emanates forward to the outer surface of the elongate shaft 14 so as to permit smooth, unencumbered introduction of the distal portion of the elongate shaft 14 into the gallbladder or other sac through a small (e.g. 1 cm) incision or opening.

When the tip members 16a, 16b, 16c, 16d are deployed in their "open" or splayed configuration they will form a protective cage around the rotating head or impactor 26a, 26b, 26c to prevent the head or impactor from damaging or puncturing a surrounding organ or artificial containment sac. Also, it is preferable that the distal tip members 16a, 16b, 16c, 16d be configured such that, when deployed in said open or splayed configuration, will form an abutment means which, upon attempted proximal withdrawal of the device, will abut against the neck of the organ or sac and/or the body wall so as to prevent the device from being accidentally withdrawn during use and also to maintain proper positioning of the cutting head (i.e. the operator may purposely withdraw the instrument to a point where the open tip members 16a-16d abut against the body wall thereby ensuring that the cutting head is at or near the top of the organ or artificial sac and not near the fundus or bottom wall thereof as may result in damage or puncture of the organ or artificial sac.

The embodiment of the invention shown in FIGS. 1 and 5 may incorporate any suitable means for controlling the opening and closing of the distal tip members 16a-16d. For example, in the embodiment shown in FIG. 1 wherein the generally cylindrical motor drive hand piece 12a is employed, a rotatable dial member 23 may be attached to one or more advanceable/retractable members 15 which extend through the elongate shaft 14 and are attached at their distal ends to the tip members 16a-16d. The advanceable/retractable members 15 are connected to the dial member 23 by gears or other mechanical transfer arrangement such that turning of the dial member 23 in one direction (e.g. clockwise) will cause proximally directed advancement of the members 15, thereby forcing the distal end pieces 16a-16d to pivot on hinged connections to their open or splayed configuration shown in FIGS. 2 and 3. Thereafter, turning of the dial 23 in its opposite direction (e.g. counter-clockwise) will cause the members 15 to retract in a distal direction, thereby pulling the distal end pieces 16a-16d back to their original closed configuration as shown in FIG. 1.

Alternately, in embodiments which incorporate a pistol grip-type hand piece 12b, a separate protective assembly trigger 33 may be employed. Such trigger 33 may be connected by way of rack and pinion gears or other mechanical interconnection to one or more members 15 extending longitudinally through the elongate shaft 14 of the device such that, when the trigger 33 is retracted against the hand piece the members 15 will advance in the distal direction causing the distal end pieces to open into their splayed configuration. Alternately, when the trigger 33 is allowed to return to its resting position, as shown, the member(s) 15 will retract within the elongate shaft 14 in a proximal direction, thereby allowing the distal end member 16a-16d to return to their closed position.

As an alternative to the advanceable/retractable members 15 shown, the hand-actuatable dial 23 or trigger 33 may be operatively connected to any other suitable type of mechanism capable of opening and closing the tip members 16a, 16b, 16c and 16d. Such other types of mechanism may include a cable and pulley system having cable(s) running longitudinally through the device 10 and attached to the dial 23 or trigger 33 to effectuate alternate opening