CA1313100C - Hemostatic sheath for a biopsy needle - Google Patents
Hemostatic sheath for a biopsy needleInfo
- Publication number
- CA1313100C CA1313100C CA000599103A CA599103A CA1313100C CA 1313100 C CA1313100 C CA 1313100C CA 000599103 A CA000599103 A CA 000599103A CA 599103 A CA599103 A CA 599103A CA 1313100 C CA1313100 C CA 1313100C
- Authority
- CA
- Canada
- Prior art keywords
- cannula
- needle
- biopsy
- distal portion
- site
- Prior art date
- Legal status (The legal status is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the status listed.)
- Expired - Lifetime
Links
Classifications
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
- A61B10/00—Other methods or instruments for diagnosis, e.g. instruments for taking a cell sample, for biopsy, for vaccination diagnosis; Sex determination; Ovulation-period determination; Throat striking implements
- A61B10/02—Instruments for taking cell samples or for biopsy
- A61B10/0233—Pointed or sharp biopsy instruments
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
- A61B17/00—Surgical instruments, devices or methods, e.g. tourniquets
- A61B17/0057—Implements for plugging an opening in the wall of a hollow or tubular organ, e.g. for sealing a vessel puncture or closing a cardiac septal defect
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
- A61B17/00—Surgical instruments, devices or methods, e.g. tourniquets
- A61B2017/00004—(bio)absorbable, (bio)resorbable, resorptive
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
- A61B17/00—Surgical instruments, devices or methods, e.g. tourniquets
- A61B17/12—Surgical instruments, devices or methods, e.g. tourniquets for ligaturing or otherwise compressing tubular parts of the body, e.g. blood vessels, umbilical cord
- A61B2017/12004—Surgical instruments, devices or methods, e.g. tourniquets for ligaturing or otherwise compressing tubular parts of the body, e.g. blood vessels, umbilical cord for haemostasis, for prevention of bleeding
Abstract
ABSTRACT OF THE INVENTION
A hemostatic gelatin sheath is fitted as a portion of an outer cannula over the distal portion of the inner cut-ting cannula of a biopsy needle. Positioning means associ-ated with the cannulas accurately deposits the hemostatic sheath at the position where the biopsy specimen was taken and the needle with the specimen therein is then withdrawn.
The in situ sheath minimizes bleeding from the biopsy site before the gelatin is absorbed by the body.
A hemostatic gelatin sheath is fitted as a portion of an outer cannula over the distal portion of the inner cut-ting cannula of a biopsy needle. Positioning means associ-ated with the cannulas accurately deposits the hemostatic sheath at the position where the biopsy specimen was taken and the needle with the specimen therein is then withdrawn.
The in situ sheath minimizes bleeding from the biopsy site before the gelatin is absorbed by the body.
Description
~3~3100 A H M OSTATIC SHEATH FOR
A RIOPSY NEEDLE
This invention relates generslly to surgical needles and more particularly to a biopsy needle construction and a method for performing a biopsy usin~ the needle canstruction which minimizes hemorrhagic complications.
The invention i6 particularly applicable for removin~
tissue and like specimens from the human body and will be described with psrticular reference thereto. ~owever, it will be ~ppreciated by those skilled in the srt that the invention has broader application and may be used for selec-tive extrsction of tissue samples and the like from other livin~ mstter, such as animsl6, snd conceptually is applica-ble in a brosd sense to sny surgical procedure requirin~
insertion of instruments snd the like into any organ where the tissue ma~ be punctured.
INCORrORATlON BY REFERENCE
U.S. Pstent No. 4,708,147 dated November 24, 1987;
3,358,648 dated December 19, 1967 and 3,106,483 dated Octo-ber 8, 1963.
BAC~GROUND
Generally speaking, biopsy needles fall into one of two types, sn end cutting needle, commonly referred to as a"Menghini" needle, or, a side cut needle such as the type co~mercially known as `'Tru-cut" needles. Fundsmentally, an end cuttin~ needle includes a hollow cutting cannula hsving an especially configured, circumferentially sharpened, open end at the distsl portion thereof. A stylette is conven-tionally inserted into the hollow shsft of the csnnula in its "at rest" or unactuated position and generally extends flush with the ~pen cutting edge o~ ~he cannula to clo~e the open end. Wi~h the stylette thu~ lnserted, the end cutting needle is inserted into the patient until the needle reaches the site of the lesion where the biopsy specimen is to be taken. The stylette is withdrawn and the needle further inserted into the lesion with the result that tissue i8 cut and fills the now open cutting end of the csnnula 8S it travels a slight l~istance through the lesion to collect the specimen. A suction device can be applied to the proximal portion of the cannula to withdraw the tissue sample thus ~aken. Alternatively, the cannula can be rotated to sever the tissue and the cannula withdrawn from the site. In a typical side cut needle, there is a "solid" inner cannula within an outer cannula and the inner cannula has a shaped pointed end with a cutting groove formed in the dis~al por-tion of the inner cannula behind the pointed end. The side cut needle is inserted into the patient until the needle reaches the site of the lesion where the biopsy sample is to be taken. The inner cannula is then advanced into the le-sion to the point where the specimen is to be taken and ro-tated so that the cutting groove severs the tissue. The outer cannula advances over the inner cannula thus contain-ing or entrapping the specimen within the ~roove of the in-ner cannula and the outer cannula, and the needle is then withdrawn from the site. There are many biopsy needle de-signs commercially available or described in the literature.
For example, it is known to provide an inner cannula within the cuttin~ cannula of the end cutting needle which uses movable jaws extending beyond the distsl end of the cuttin cannula to sever and extract the biopsy specimen. "Hybrid"
cannulas are also known. Fundamentally, if the biopsy spec-imen is removed through the cutting end of the cannula it is known and will be referred to hereinafter as a "end-cutting"
needle and if the sample is taken from the side of the nee-dle, the needle will be referred to hereinafter as a "side-1313tOO
,.
cutting" needle. The invention described herein is applica-ble to al] end-cuttin~ and side-cuttin~ biop~y needle~.
~ ecau6e most biopsy needles reliably function to remove biopsy specimens, the major concern today with biop6y nee-dles and the procedures governing the use thereof centersabout hemorrhsging complications caused by or attributed to the biopsy. The complications arise from severing blood vessel6 while positioning the needle and while 6evering the specimens and the re6ultant bleeding cau6ed thereby. To accurately guide the biop6y needle, percutaneous procedures have been developed to permit vi6ual radiological observa-tion of the instrument in6ide the body. In conjunction with CT guided biop6ies, biopsy needles have been especially de-6igned to provi~de good CT 6canning image6. An example of such a needle i6 di6closed in my earlier U.S. Patent No.
4,708,147 dated November 24, 1987. The reader may refer to my prior patent for a more detailed explanation of various hemorrhagic complications resulting from the organ from which th~3 biopsy specimen is taken.
It is difficult to accurately estimate the incident rate of hemorrhagic complication6 with conventional biopsy needles becau6e of the variations of the needle designs in use, the patient selection and the somewhat different biopsy technique6 employed. However, 6upport within the literature can be found for quoting a five percent (5%) complication rste in blind liver biop6ies which may be perhaps even high-er for blind kidney biopsies. In my 6tudies of guided biop-sie6 u6ing image 6canning techniques, I would es~imate the complication rate to drop to about 1.5%. While this repre-sent6 a gignificant decrease, thi6 problem, to which my in-vention is directed, i6 not resolved.
Within the prior art, the use of gelatin as a substance for making medication capsule6 for internal u6e and adapted to be a~sorbed by enzyme action or other physiological procosses within th~ ~ocly is well known. Also, the u8e of Relutin mat~ri~l ~or various surgical technlques has been ~ell documented. In particular, the use of a gelatin mate-rial in a "sponge" form or as a foam i6 commercially avail-able from the Upjohn Company under the trademark "GELFOAM".
GELFOAM with and without: thrombin, a protein which is active at the last stage o~ clot formation and function~ to chan~e fibrinogen to fibrin, has been used in surgery in virtually all organ sys~ems including prostrate, hrain, musculoskeletal, vascular graphs and other areas without adverse complications. The use of gelatin as a coating for a fabric, blood-vessel graft is disclosed in U.S. Patent 3,106,483 to Kline et al dated October 8, 1963.
The use of hlardened gelatin as forming a part of a surgical instrument is disclosed in U.S. Patent 3,358,684 to Marshall dated December 19, 1967. In Marshall, the distal cutting edge of a cannula which is used as a parenteral injection device is formed from a thiolated gelatin material. Specifically, the gela-tin distal tip punctures a vein, and eventually dissolves, leaving the proximal portion of the cannula within the vein for administering parenteral solutions. The cannula can be thus left in situ without vein damage which would otherwise arise from the presence of a sharp needle or the removal of the needle. ln this sense, the prior art recognizes that it is known to use gelatin as a surgical instrument which can be dissolved at the insertion site.
SUMMARY OF THE INVENTION
Accordingly, it is a principal object of the invention to provide a needle for biopsy sampling purposes which re-duces hemorrhagic complications arising from the puncture Li' F'~
, 1313100 site in the or~an which re~ult when ~he biop~y specimen i~
taken.
This object is achieved in a biopsy needle which may best be explained by the relative position of its parts be-fore, during snd after the biopsy iB taken, Fundam~ntally,the needle hss an unactuated position defined by the posi-tion of its parts prior to insertion of the ne~dle in the patient, an actuated position defined by its parts position when the sample is being taken and a retracted position de-fined again by the position of its parts when the needle isremoved from the biopsy site. Generally speaking, the nee-dle of the present invention has an inner cutting cannula (which may or may not be hollow depending upon the type of needle) having a distal portion for insertion into the biop-sy site and a contiguous proximal portion extending from thedistal portion. The distal portion in t~rn is defined as that length of the inner cannula which is inserted into the patient in the actuated position of the needle and the distal portion csrries the means for taking the biopsy sam-ple, i.e. side or end cutting. At least one outer hollowcannula coaxial with and receiving the inner cannula is pro-vided. The outer cannula has a proximal portion and a sepa-rable distal portion. Positioning means associated with the proximal portions of either the inner or outer cannulas or both are manipulated by the physician as the needle is in-serted into the site, the biopsy taken and the needle re-tracted so that the distal portion of the outer cannula is separated from the proximal portion and remains at the biop-sy site when the needle is in its retracted position. The distal portion of the inner cannula is made of a biodegrad-able gelatin material which acts to minimize bleeding from the biopsy site b~fore the gelatin material dissolves. In accordance with another feature of the invention, the gela-tin material can include the protein thrombin as one of the :, 1313100 X-783~
sub~tance thereof which enhsnces or increases temdency of the blood e~snating from the biopsy site to clot.
In accor~ance with another feature o~ the invention, the outer cannula of the present invention either replaces the outer cannula o~ the existinR biopsy needle, such aR the Menghini end cutting needle, or is an additional cannula receiving the existing outer cannula (now intermediate cannula) of the existing biopsy needle, such as the Tru-Cut side cutting needle. Accordingly, the concept of an outer cannula containing, as the distal portion thereof, a detach-able sheath, positioned in situ by the outer cannula expands the potential application of the hemostatic ~heath to other surgical type instruments such as scopes which are designed to puncture an organ.
In accordance wi~h still snother aspect of the inven-tion, in the unactuated position of the biopsy needle, the distal portion of the outer cannula, i.e., the hemostatic sheath, f its over the inner cannula ~ut is spaced from the distal end ,of the proximal portion of the outer cannula.
The presence of the ~pace or gap form6 part of the position-ing means associated with the needle to assure the surgeon, e~pecially for blind biopsies, that the hemostatic sheath, in the needle retracted position, has separated from the inner cannula.
In accordance with an e~fiential feature of the inven-tion, the cross sectional area of the hemostatic sheath iB
lar~er than the cross sectional area of the puncture formed by the inner cannula. When the hemo~tatic sheath is po~i-tioned by the positioning means at the biopsy site, the out-er surfaces of the hemostatic sheath compress the bleeding tissue surrounding the biopsy site to minimize bleeding from the organ. Within several seconds, the sheath absorbs body fluid and begins to swell increasing the tamponade effect to occlude the flow of blood from the site. Additionally, it is believed that because the hemoststic sheath is a foreign . . . .
.
body, the sheath acts as a nidus for platelet aggregation which assists in blood clotting whether or not thrombin is added as one of the s~lbstances of the gelatin material of the sheflth. By this geometric arrangement, a known sub-stance, gelatin, is used to prevent bleedin~ before it harm-lessly dissolves, in a conventional manner, within the body.
In accordance with a more specific feature of the in-ventionJ the hemostatic sheath's outer cylindrical surface has tiny radially outward projections or barbs extending therefrom which prevents the hemostatic sheath from leaving the biopsy site when the inner cannula is retracted. Other modifications to the configuration of outer cannula, includ-ing the sheath are disclosed, for purposes of enhancing the positioning means of the needle. Specifically, the gap re-ferred to above is maintained throughout the needle inser-tion to provide the surgeon with a sensitory feel indicating proper positioning of the sheath within the lesion.
Still yet another specific feature of the invention is attributed to the fact that the gelatin material of the hemostatic sheath develops a low coefficient of friction when the material is moist or wet while the materi~l is hard when dry. The low coefficient of friction of the sheath?
permits the sheath to be easily inserted in the biopsy 6ite, and the inner cannula retracted, while the hemostatic sheath, in its hard state, can be sized for application to the inner cannula to define the aforementioned gap in the unactuated position of the needle.
In accordance with a broader feature of the invention, a method for performing a biopsy using a hemostatic sheath is disclosed. The method broadly comprises manipulating the cannulas of a biopsy needle to achieve the aforedescribed positions of the needle to insure accurate placement of the hemostatic sheath within the biopsy site to avoid hemorrhagic complications.
x-7838 In accordance with ~till another aspect of the inven-tion, ~he sheath conceiv~bly could ~unction, in ~ddition to ~ hemo~atic purpose, a~ 8 vent for purposes of initially admitting or directing gases from the penetrated or biop~ied organ therethrough in a harmless manner. Conceptually, the sheath could prevent the lung from inadvertently collap~ing during ~ biopsy.
It is thus an ob~ect of the invention to provide a hemostatic sheath for use with any biopsy needle which sheath is deposited at the biopsy site to prevent bleeding therefrom.
It is another object of the invention to provide a method for taking a biopsy 6pecimen which deposits a hemostatic sheath at the biopsy site.
15Still another object of the invention is to provide a biop~y needle which can ac~urately position, in situ, a por-tion of the needle which acts as a hemostatic sheath.
Still snother object of the invention is to provide a modified biopsy needle which permits placement of a hemostatic sheath within the biopsy site in a relatively easy manner and without undue resistance.
Still another feature of the invention is to provide a biopsy needle which can be readily mass produced without undue expen~e.
25Still yet another object of the invention is to provide a hemostatic sheath which can be readily applied to any con-ventional biopsy needle.
A still further object of the invention is to provide a sheath for use with any surgical instrument which penetrates an organ to enhance blood clotting and avoid hemorrhagic complications ari~ing from use of the instrument.
Another ob~ect of the invention i8 to provlde B ~heath for use with any instrument and a method for use thereof which positions the sheath at the ~ite of the puncture to prevent hemorrhagic complication~ arising from the puncture, ~ ~ .
and also, in certai.n applications, to provide an initial vent fro directing gases from the punctured organ in a harm-less manner.
Further objects and advantages of the invention will become apparent to those skilled in the art from reading and understanding the following detailed description of species thereof and from the accompanying drawings which illustrate preferred embodiment,s that the invention may take ln physi-cal form and in certain parts and arrangement of parts.
BRIEF DESCRIPTION OF THE DRAWINGS
FIGURES 1 through 4 show the invention applied to a side-cutting biopsy needle and the various po6itions of the needle as the biopsy is taken;
~IGU~E 5 is a cross sectional view principally of the distal portion of the needle shown in FIGIJRES 1-4;
FIGURE 6 is a cross sectional view of the invention shown in an in situ position;
FIGURES 7 and 7a are cross sectional view~ of various portions of the distal portion of a biopsy needle of the end cutting type illustrating various embodiments of the inven-tion; snd FIGURES 8 and 9 show the invention applied to an end-cutting biopsy needle.
DETAILED DESCRIPTION OF THE INVENTION
Referring now to the drawings wherein the showings are for the purpose of illustrating preferred embodiments of the invention only and not for the purpose of limiting the same, there is shown in FI~URES 1-5 and 8-9 a biopsy needle 10 gener~lly defined as comprising an inner or cutting cannula 12 which is coaxially received within an outer cannula 13.
Cutting cannula 12 has a.~distal portion 16 and contiguous ...-.-X-783~
therewith a main or proxim~l port~on 17, Di~t~l portion 16 has an entry end 19 so that needle 10 c~n entcr or puncture the site of th~ biopsy and a cutting ed~,e 20 which functions to sever t:he tissue in the lesion for collecting a biopsy sample.
For t,he slde-cutting needle illustrated in FIGURES 1-5, and as best shown in FIGURE 5, cutting cannula 12 iB 9hOWll as a solid, cylindrical ~ember co-axially received, in a conventional telescoping manner, within an intermediate cannula 14. Intermediate cannula 14 i9 co-axially received within outer cannula 13~ but as will be noted hereafter, does not telescopically move in a significant manner rela-tive to outer cannula 13. For orientation purposes, inter-mediate cannula 14 has a distal end 23 and a proximal end 24. The entry end 19 of cutting cannula 12 is shaped as a pointed end and cutting ed~e 20 is defined by the wall edges of the cannula left after a circumferentially snd longitudi-nally extending segment has been removed from cutting cannula 12. The exposed wall edges or cutting edges 20 of cutting cannula 12 are sharpened in accordance with normal practice. For definitional purposes, distal portion 16 is defined as that body portion of cutting cannula 12 which extends from entry end 1~ to the end of cutting edge 20, and proximal portion 17 is contiguous with and extends there-from. The term "cutting cannula" i8 meant to 8pply to all biopsy needles or medical instruments to which an outersheath can be fitted for purposes of working the invention as described hereafter. Thus, cutting cannula 12 is meant to include and does include various accessories normally used with the cannula such as a stylette, if one is to be used, or vacuum appendages associated with cutting cannula 12 for extracting the biopsy sample. Also meant to be in-cluded within the term "cutting cannula" sre end cutting biopsy needles which have movable jaws at the entry end or hybrid biop~y needle~ such a~ thc type di~clo8ed ~n my prior patent referred to nbove.
Re~rrin~ now to FIGUR~S 1-4, prox~mal portion 17 of cutting cannula 12 is attached to a positioning mechanism which is ~hown in its fundamental, simplest form for ea~e in explanation. It is contemplated that spring actuated po~i-tioning mechaniRms now developed for conventional biopsy needles can be modified by those 6killed in the art to pro-vide the de6ired needle positioning as illustrated in the drawings which is achieved by hand manipulation. The bottom end 21 of proximal portion 17 of cutting cannula 12 is fixed or rigidly connected to an obturator having an obturator handle 26 and an "X"-shaped plunger portion 28 which is telescopically received within a stem 30 having a base por-tion 31 ending in a configured ea6ily grippable cannula han-dle 32. Plunger portion 28 has a length at least equal to the length of the distal portion 16 of cutting cannula 12.
As shown in FIGURES 1-4, by grasping cannula handle 32 and obturator hsndle 26, the surgeon can move cutting edge 20 to a forward or retracted position relative to outer cannula 13 and intermediate cannula 14. Not 6hown, but contemplated a6 being attached to cutting cannula 12 either at proximal por-tion 17 or to obturator 25 for actuation at some position thereof, may be a vacuum conduit for applying suction to the interior of cutting cannula 12 for purposes of removing the biopsy specimen taken or as6uring positioning of the biopsy 6pecimen within cutting cannuls 12. As described thus far, the biopsy needle 10 i6 60mewhat conventional a6 is the po-6itioning mechanism.
Cutting cannula 12 is telescopically received within intermediate cannula 14 which is then co-axially received within an outer sheath or outer cannula 13. Outer cannula 13 ha6 two separate or separable portions defined as a proximal portion 35 and a distal portion 36. Proximal por-tion 35 in turn has 8 distal end 38 adjacent distal portion .
36 and a proximal end 39 a~ th~ oppo9~te end thereof which i5 fixedly secur~d as by glue to ~ pu~h~r handle 40 o~ the positioning m~ans. Similarly, proximal ~nd 24 of ~ntermedi-ate cannula 14 is likewise fixed to pusher handle 40. Thus intermediate and outer cannulas 14, 13 move as a unit. Ac-cordin~ly, when movement of the side cutting needle of FIG-URES 1-5 will be explained, reference will only be made to outer cannula 13, it being understood that intermediate cannula 14 will similarly move therewith. As can be seen from FIGURES 1-4, pusher handle 40 can telescopically move outer cannula 13 relative to cutting cannula 12. Proximal portion 35 can be constructed from any suitable plastic ma-terial or metal such as stainless steel, or preferably, a biodegradable gelatin material such as GELFOAM.
Referring now to FIGURE 5 and in the preferred embodi-ment of the invention, distal portion 36 of outer cannula 13 is a separate, generally cylindrical mass of biodegradable gelatin adjacent proximal portion 35 of outer cannula 13 and as noted proximal portion 35 and distal portion 36 together, for definitional purposes, comprise outer cannula 13.
Distal portion 36 alternatively msy be referred to as a hemostatic sheath and the two terms will be used inter-changeably throughout the specifications. As noted above, hemostatic sheath 36 is made of a conventionally available biodegradable gelatin witb either a pork or beef base with conventional additives depending upon the dissolueion time desired for sheath 36. An acceptable gelatin material which is available in a foam or sponge form from the Upjohn Compa-ny under the trademark GELFOA~I. The GELFOA~I material would have to be made in hardened form. An acceptable hardened thiolated gelatin material which could also be used as the sheath material is described in U.S. Letters Patent 3,106,483 dated October 8, 1963.
Hemostatic sheath 36 has an entry end 43 which is the end which first enters the biopsy site and a proximal end 44 which is adjscent di~tal end 38 o~ prox~mfll por~ion 35. The length o~ hemo~tatic ~hc~th 36 m~y vu~y depending upon the biopsy taken, but as ~ mini~um, thc l~ngth of hemostatic sheath 36 should preferably be as long as t~e len~th of the biopsy specimen taken. For cutting cannula 12 of the side cutting type in FIGURE 5, the length of hemostatic she~th 36 should probably be at least equal to the length of cuttinp, edge 20. In the unactuated, "~t rest" or uninserted posi-tion of needle ~0, proximal end 44 of hemostatic sheath 36 is spaced a slight distance away from distal end 38 of proximal portion 35 to define a circumferentially extendin~
gap or space 46 existing between distal and proximal por tions 35, 36. In practicel gap 46 can occur by simply siz-in8 the inside diflme~er of hemostatic sheath 36 relative to the outside diameter of distal portion 16 of cutting cannula 12 so that he~ostatic sheath 36 can initially slide onto cutting cannula 12 when wet. Alternatively, the inside di-ameter of hemoststic sheath 36 could be formed with a slight taper increasing the sheath's fit at proximal end 44 thus maintaining gap 46. When so constructed, gap 46 will de-crease when hemostatic sheath 36 is inserted into the biopsy site. Two additional modifications are shown in FIGURES 7 and 7a and described hereafter which can be employed to pos-itively maintain gap 46 if desired.
Entry end 43 of hemostatic sheath 36 is preferably formed as a flat surface perpendicular to the length of hemostatic sheath 36 as shown in FIGURE 5 or, alternatively, depending upon th~ hardness of the lesion at the site where the biopsy is to be taken (i.e. bone marrow) entry end 43, could be tapered as shown in FIGURE 7. Also, the edge sur-face 45 of entry end 43 will generally lie in one plane, althou~,h edge surface 45 could assume a curvilinear or ta-pering configurstion. However, because the coefficient of friction of the gelatin of hemostatic sheath 36 is reduced when wet and hemostatic sheath 36 will be wet as it enters the biopsy site and encounters bleeding from the slte, it i8 not believed n~ce~s~ry ~o ~orm cd~c surface 45 as a cutting ed6e~ In point o~ fact it is desired that edge sur~ace 45 not act as a cutting edge ~uch as is necessary in Marshall' 8 patent because the tissue surrounding the biopsy sp~cimen is to be displaced and compressed by the outer cylindrical sur-face of hemostatic sheath 36. If the tissue iB s~in cut by edge surface 45 further bleeding will ensue. Thus, the par-ticular type of biopsy and the hardness of the lesion at which the biopsy is taken, will determine the exact shape of entry end 43 and ed8e surface 45 but the shape ~ill be such as to permit compression of the tissue at the biopsy site while permitting easy entry of hemostatic sheath 36 into the lesion.
Referring now to FIGURES 1-4, the unactuated position of biopsy needle 10 is shown in FIGURE 1. In this position cutting edge 20 of cutting cannula 12 is adjacent tissue 50, pusher handle 40 is against cannula handle 32 and plunger portion 28 is in a retracted position. Maintaining cannula handle 32 and pusher handle 40 at approximately the same elevation, obturator handle 26 is slided into stem 30 so that distal portion 16 of cutting cannula 12 enters lesion 50 whereat the biopsy is taken in the normal manner (FIGURE
A RIOPSY NEEDLE
This invention relates generslly to surgical needles and more particularly to a biopsy needle construction and a method for performing a biopsy usin~ the needle canstruction which minimizes hemorrhagic complications.
The invention i6 particularly applicable for removin~
tissue and like specimens from the human body and will be described with psrticular reference thereto. ~owever, it will be ~ppreciated by those skilled in the srt that the invention has broader application and may be used for selec-tive extrsction of tissue samples and the like from other livin~ mstter, such as animsl6, snd conceptually is applica-ble in a brosd sense to sny surgical procedure requirin~
insertion of instruments snd the like into any organ where the tissue ma~ be punctured.
INCORrORATlON BY REFERENCE
U.S. Pstent No. 4,708,147 dated November 24, 1987;
3,358,648 dated December 19, 1967 and 3,106,483 dated Octo-ber 8, 1963.
BAC~GROUND
Generally speaking, biopsy needles fall into one of two types, sn end cutting needle, commonly referred to as a"Menghini" needle, or, a side cut needle such as the type co~mercially known as `'Tru-cut" needles. Fundsmentally, an end cuttin~ needle includes a hollow cutting cannula hsving an especially configured, circumferentially sharpened, open end at the distsl portion thereof. A stylette is conven-tionally inserted into the hollow shsft of the csnnula in its "at rest" or unactuated position and generally extends flush with the ~pen cutting edge o~ ~he cannula to clo~e the open end. Wi~h the stylette thu~ lnserted, the end cutting needle is inserted into the patient until the needle reaches the site of the lesion where the biopsy specimen is to be taken. The stylette is withdrawn and the needle further inserted into the lesion with the result that tissue i8 cut and fills the now open cutting end of the csnnula 8S it travels a slight l~istance through the lesion to collect the specimen. A suction device can be applied to the proximal portion of the cannula to withdraw the tissue sample thus ~aken. Alternatively, the cannula can be rotated to sever the tissue and the cannula withdrawn from the site. In a typical side cut needle, there is a "solid" inner cannula within an outer cannula and the inner cannula has a shaped pointed end with a cutting groove formed in the dis~al por-tion of the inner cannula behind the pointed end. The side cut needle is inserted into the patient until the needle reaches the site of the lesion where the biopsy sample is to be taken. The inner cannula is then advanced into the le-sion to the point where the specimen is to be taken and ro-tated so that the cutting groove severs the tissue. The outer cannula advances over the inner cannula thus contain-ing or entrapping the specimen within the ~roove of the in-ner cannula and the outer cannula, and the needle is then withdrawn from the site. There are many biopsy needle de-signs commercially available or described in the literature.
For example, it is known to provide an inner cannula within the cuttin~ cannula of the end cutting needle which uses movable jaws extending beyond the distsl end of the cuttin cannula to sever and extract the biopsy specimen. "Hybrid"
cannulas are also known. Fundamentally, if the biopsy spec-imen is removed through the cutting end of the cannula it is known and will be referred to hereinafter as a "end-cutting"
needle and if the sample is taken from the side of the nee-dle, the needle will be referred to hereinafter as a "side-1313tOO
,.
cutting" needle. The invention described herein is applica-ble to al] end-cuttin~ and side-cuttin~ biop~y needle~.
~ ecau6e most biopsy needles reliably function to remove biopsy specimens, the major concern today with biop6y nee-dles and the procedures governing the use thereof centersabout hemorrhsging complications caused by or attributed to the biopsy. The complications arise from severing blood vessel6 while positioning the needle and while 6evering the specimens and the re6ultant bleeding cau6ed thereby. To accurately guide the biop6y needle, percutaneous procedures have been developed to permit vi6ual radiological observa-tion of the instrument in6ide the body. In conjunction with CT guided biop6ies, biopsy needles have been especially de-6igned to provi~de good CT 6canning image6. An example of such a needle i6 di6closed in my earlier U.S. Patent No.
4,708,147 dated November 24, 1987. The reader may refer to my prior patent for a more detailed explanation of various hemorrhagic complications resulting from the organ from which th~3 biopsy specimen is taken.
It is difficult to accurately estimate the incident rate of hemorrhagic complication6 with conventional biopsy needles becau6e of the variations of the needle designs in use, the patient selection and the somewhat different biopsy technique6 employed. However, 6upport within the literature can be found for quoting a five percent (5%) complication rste in blind liver biop6ies which may be perhaps even high-er for blind kidney biopsies. In my 6tudies of guided biop-sie6 u6ing image 6canning techniques, I would es~imate the complication rate to drop to about 1.5%. While this repre-sent6 a gignificant decrease, thi6 problem, to which my in-vention is directed, i6 not resolved.
Within the prior art, the use of gelatin as a substance for making medication capsule6 for internal u6e and adapted to be a~sorbed by enzyme action or other physiological procosses within th~ ~ocly is well known. Also, the u8e of Relutin mat~ri~l ~or various surgical technlques has been ~ell documented. In particular, the use of a gelatin mate-rial in a "sponge" form or as a foam i6 commercially avail-able from the Upjohn Company under the trademark "GELFOAM".
GELFOAM with and without: thrombin, a protein which is active at the last stage o~ clot formation and function~ to chan~e fibrinogen to fibrin, has been used in surgery in virtually all organ sys~ems including prostrate, hrain, musculoskeletal, vascular graphs and other areas without adverse complications. The use of gelatin as a coating for a fabric, blood-vessel graft is disclosed in U.S. Patent 3,106,483 to Kline et al dated October 8, 1963.
The use of hlardened gelatin as forming a part of a surgical instrument is disclosed in U.S. Patent 3,358,684 to Marshall dated December 19, 1967. In Marshall, the distal cutting edge of a cannula which is used as a parenteral injection device is formed from a thiolated gelatin material. Specifically, the gela-tin distal tip punctures a vein, and eventually dissolves, leaving the proximal portion of the cannula within the vein for administering parenteral solutions. The cannula can be thus left in situ without vein damage which would otherwise arise from the presence of a sharp needle or the removal of the needle. ln this sense, the prior art recognizes that it is known to use gelatin as a surgical instrument which can be dissolved at the insertion site.
SUMMARY OF THE INVENTION
Accordingly, it is a principal object of the invention to provide a needle for biopsy sampling purposes which re-duces hemorrhagic complications arising from the puncture Li' F'~
, 1313100 site in the or~an which re~ult when ~he biop~y specimen i~
taken.
This object is achieved in a biopsy needle which may best be explained by the relative position of its parts be-fore, during snd after the biopsy iB taken, Fundam~ntally,the needle hss an unactuated position defined by the posi-tion of its parts prior to insertion of the ne~dle in the patient, an actuated position defined by its parts position when the sample is being taken and a retracted position de-fined again by the position of its parts when the needle isremoved from the biopsy site. Generally speaking, the nee-dle of the present invention has an inner cutting cannula (which may or may not be hollow depending upon the type of needle) having a distal portion for insertion into the biop-sy site and a contiguous proximal portion extending from thedistal portion. The distal portion in t~rn is defined as that length of the inner cannula which is inserted into the patient in the actuated position of the needle and the distal portion csrries the means for taking the biopsy sam-ple, i.e. side or end cutting. At least one outer hollowcannula coaxial with and receiving the inner cannula is pro-vided. The outer cannula has a proximal portion and a sepa-rable distal portion. Positioning means associated with the proximal portions of either the inner or outer cannulas or both are manipulated by the physician as the needle is in-serted into the site, the biopsy taken and the needle re-tracted so that the distal portion of the outer cannula is separated from the proximal portion and remains at the biop-sy site when the needle is in its retracted position. The distal portion of the inner cannula is made of a biodegrad-able gelatin material which acts to minimize bleeding from the biopsy site b~fore the gelatin material dissolves. In accordance with another feature of the invention, the gela-tin material can include the protein thrombin as one of the :, 1313100 X-783~
sub~tance thereof which enhsnces or increases temdency of the blood e~snating from the biopsy site to clot.
In accor~ance with another feature o~ the invention, the outer cannula of the present invention either replaces the outer cannula o~ the existinR biopsy needle, such aR the Menghini end cutting needle, or is an additional cannula receiving the existing outer cannula (now intermediate cannula) of the existing biopsy needle, such as the Tru-Cut side cutting needle. Accordingly, the concept of an outer cannula containing, as the distal portion thereof, a detach-able sheath, positioned in situ by the outer cannula expands the potential application of the hemostatic ~heath to other surgical type instruments such as scopes which are designed to puncture an organ.
In accordance wi~h still snother aspect of the inven-tion, in the unactuated position of the biopsy needle, the distal portion of the outer cannula, i.e., the hemostatic sheath, f its over the inner cannula ~ut is spaced from the distal end ,of the proximal portion of the outer cannula.
The presence of the ~pace or gap form6 part of the position-ing means associated with the needle to assure the surgeon, e~pecially for blind biopsies, that the hemostatic sheath, in the needle retracted position, has separated from the inner cannula.
In accordance with an e~fiential feature of the inven-tion, the cross sectional area of the hemostatic sheath iB
lar~er than the cross sectional area of the puncture formed by the inner cannula. When the hemo~tatic sheath is po~i-tioned by the positioning means at the biopsy site, the out-er surfaces of the hemostatic sheath compress the bleeding tissue surrounding the biopsy site to minimize bleeding from the organ. Within several seconds, the sheath absorbs body fluid and begins to swell increasing the tamponade effect to occlude the flow of blood from the site. Additionally, it is believed that because the hemoststic sheath is a foreign . . . .
.
body, the sheath acts as a nidus for platelet aggregation which assists in blood clotting whether or not thrombin is added as one of the s~lbstances of the gelatin material of the sheflth. By this geometric arrangement, a known sub-stance, gelatin, is used to prevent bleedin~ before it harm-lessly dissolves, in a conventional manner, within the body.
In accordance with a more specific feature of the in-ventionJ the hemostatic sheath's outer cylindrical surface has tiny radially outward projections or barbs extending therefrom which prevents the hemostatic sheath from leaving the biopsy site when the inner cannula is retracted. Other modifications to the configuration of outer cannula, includ-ing the sheath are disclosed, for purposes of enhancing the positioning means of the needle. Specifically, the gap re-ferred to above is maintained throughout the needle inser-tion to provide the surgeon with a sensitory feel indicating proper positioning of the sheath within the lesion.
Still yet another specific feature of the invention is attributed to the fact that the gelatin material of the hemostatic sheath develops a low coefficient of friction when the material is moist or wet while the materi~l is hard when dry. The low coefficient of friction of the sheath?
permits the sheath to be easily inserted in the biopsy 6ite, and the inner cannula retracted, while the hemostatic sheath, in its hard state, can be sized for application to the inner cannula to define the aforementioned gap in the unactuated position of the needle.
In accordance with a broader feature of the invention, a method for performing a biopsy using a hemostatic sheath is disclosed. The method broadly comprises manipulating the cannulas of a biopsy needle to achieve the aforedescribed positions of the needle to insure accurate placement of the hemostatic sheath within the biopsy site to avoid hemorrhagic complications.
x-7838 In accordance with ~till another aspect of the inven-tion, ~he sheath conceiv~bly could ~unction, in ~ddition to ~ hemo~atic purpose, a~ 8 vent for purposes of initially admitting or directing gases from the penetrated or biop~ied organ therethrough in a harmless manner. Conceptually, the sheath could prevent the lung from inadvertently collap~ing during ~ biopsy.
It is thus an ob~ect of the invention to provide a hemostatic sheath for use with any biopsy needle which sheath is deposited at the biopsy site to prevent bleeding therefrom.
It is another object of the invention to provide a method for taking a biopsy 6pecimen which deposits a hemostatic sheath at the biopsy site.
15Still another object of the invention is to provide a biop~y needle which can ac~urately position, in situ, a por-tion of the needle which acts as a hemostatic sheath.
Still snother object of the invention is to provide a modified biopsy needle which permits placement of a hemostatic sheath within the biopsy site in a relatively easy manner and without undue resistance.
Still another feature of the invention is to provide a biopsy needle which can be readily mass produced without undue expen~e.
25Still yet another object of the invention is to provide a hemostatic sheath which can be readily applied to any con-ventional biopsy needle.
A still further object of the invention is to provide a sheath for use with any surgical instrument which penetrates an organ to enhance blood clotting and avoid hemorrhagic complications ari~ing from use of the instrument.
Another ob~ect of the invention i8 to provlde B ~heath for use with any instrument and a method for use thereof which positions the sheath at the ~ite of the puncture to prevent hemorrhagic complication~ arising from the puncture, ~ ~ .
and also, in certai.n applications, to provide an initial vent fro directing gases from the punctured organ in a harm-less manner.
Further objects and advantages of the invention will become apparent to those skilled in the art from reading and understanding the following detailed description of species thereof and from the accompanying drawings which illustrate preferred embodiment,s that the invention may take ln physi-cal form and in certain parts and arrangement of parts.
BRIEF DESCRIPTION OF THE DRAWINGS
FIGURES 1 through 4 show the invention applied to a side-cutting biopsy needle and the various po6itions of the needle as the biopsy is taken;
~IGU~E 5 is a cross sectional view principally of the distal portion of the needle shown in FIGIJRES 1-4;
FIGURE 6 is a cross sectional view of the invention shown in an in situ position;
FIGURES 7 and 7a are cross sectional view~ of various portions of the distal portion of a biopsy needle of the end cutting type illustrating various embodiments of the inven-tion; snd FIGURES 8 and 9 show the invention applied to an end-cutting biopsy needle.
DETAILED DESCRIPTION OF THE INVENTION
Referring now to the drawings wherein the showings are for the purpose of illustrating preferred embodiments of the invention only and not for the purpose of limiting the same, there is shown in FI~URES 1-5 and 8-9 a biopsy needle 10 gener~lly defined as comprising an inner or cutting cannula 12 which is coaxially received within an outer cannula 13.
Cutting cannula 12 has a.~distal portion 16 and contiguous ...-.-X-783~
therewith a main or proxim~l port~on 17, Di~t~l portion 16 has an entry end 19 so that needle 10 c~n entcr or puncture the site of th~ biopsy and a cutting ed~,e 20 which functions to sever t:he tissue in the lesion for collecting a biopsy sample.
For t,he slde-cutting needle illustrated in FIGURES 1-5, and as best shown in FIGURE 5, cutting cannula 12 iB 9hOWll as a solid, cylindrical ~ember co-axially received, in a conventional telescoping manner, within an intermediate cannula 14. Intermediate cannula 14 i9 co-axially received within outer cannula 13~ but as will be noted hereafter, does not telescopically move in a significant manner rela-tive to outer cannula 13. For orientation purposes, inter-mediate cannula 14 has a distal end 23 and a proximal end 24. The entry end 19 of cutting cannula 12 is shaped as a pointed end and cutting ed~e 20 is defined by the wall edges of the cannula left after a circumferentially snd longitudi-nally extending segment has been removed from cutting cannula 12. The exposed wall edges or cutting edges 20 of cutting cannula 12 are sharpened in accordance with normal practice. For definitional purposes, distal portion 16 is defined as that body portion of cutting cannula 12 which extends from entry end 1~ to the end of cutting edge 20, and proximal portion 17 is contiguous with and extends there-from. The term "cutting cannula" i8 meant to 8pply to all biopsy needles or medical instruments to which an outersheath can be fitted for purposes of working the invention as described hereafter. Thus, cutting cannula 12 is meant to include and does include various accessories normally used with the cannula such as a stylette, if one is to be used, or vacuum appendages associated with cutting cannula 12 for extracting the biopsy sample. Also meant to be in-cluded within the term "cutting cannula" sre end cutting biopsy needles which have movable jaws at the entry end or hybrid biop~y needle~ such a~ thc type di~clo8ed ~n my prior patent referred to nbove.
Re~rrin~ now to FIGUR~S 1-4, prox~mal portion 17 of cutting cannula 12 is attached to a positioning mechanism which is ~hown in its fundamental, simplest form for ea~e in explanation. It is contemplated that spring actuated po~i-tioning mechaniRms now developed for conventional biopsy needles can be modified by those 6killed in the art to pro-vide the de6ired needle positioning as illustrated in the drawings which is achieved by hand manipulation. The bottom end 21 of proximal portion 17 of cutting cannula 12 is fixed or rigidly connected to an obturator having an obturator handle 26 and an "X"-shaped plunger portion 28 which is telescopically received within a stem 30 having a base por-tion 31 ending in a configured ea6ily grippable cannula han-dle 32. Plunger portion 28 has a length at least equal to the length of the distal portion 16 of cutting cannula 12.
As shown in FIGURES 1-4, by grasping cannula handle 32 and obturator hsndle 26, the surgeon can move cutting edge 20 to a forward or retracted position relative to outer cannula 13 and intermediate cannula 14. Not 6hown, but contemplated a6 being attached to cutting cannula 12 either at proximal por-tion 17 or to obturator 25 for actuation at some position thereof, may be a vacuum conduit for applying suction to the interior of cutting cannula 12 for purposes of removing the biopsy specimen taken or as6uring positioning of the biopsy 6pecimen within cutting cannuls 12. As described thus far, the biopsy needle 10 i6 60mewhat conventional a6 is the po-6itioning mechanism.
Cutting cannula 12 is telescopically received within intermediate cannula 14 which is then co-axially received within an outer sheath or outer cannula 13. Outer cannula 13 ha6 two separate or separable portions defined as a proximal portion 35 and a distal portion 36. Proximal por-tion 35 in turn has 8 distal end 38 adjacent distal portion .
36 and a proximal end 39 a~ th~ oppo9~te end thereof which i5 fixedly secur~d as by glue to ~ pu~h~r handle 40 o~ the positioning m~ans. Similarly, proximal ~nd 24 of ~ntermedi-ate cannula 14 is likewise fixed to pusher handle 40. Thus intermediate and outer cannulas 14, 13 move as a unit. Ac-cordin~ly, when movement of the side cutting needle of FIG-URES 1-5 will be explained, reference will only be made to outer cannula 13, it being understood that intermediate cannula 14 will similarly move therewith. As can be seen from FIGURES 1-4, pusher handle 40 can telescopically move outer cannula 13 relative to cutting cannula 12. Proximal portion 35 can be constructed from any suitable plastic ma-terial or metal such as stainless steel, or preferably, a biodegradable gelatin material such as GELFOAM.
Referring now to FIGURE 5 and in the preferred embodi-ment of the invention, distal portion 36 of outer cannula 13 is a separate, generally cylindrical mass of biodegradable gelatin adjacent proximal portion 35 of outer cannula 13 and as noted proximal portion 35 and distal portion 36 together, for definitional purposes, comprise outer cannula 13.
Distal portion 36 alternatively msy be referred to as a hemostatic sheath and the two terms will be used inter-changeably throughout the specifications. As noted above, hemostatic sheath 36 is made of a conventionally available biodegradable gelatin witb either a pork or beef base with conventional additives depending upon the dissolueion time desired for sheath 36. An acceptable gelatin material which is available in a foam or sponge form from the Upjohn Compa-ny under the trademark GELFOA~I. The GELFOA~I material would have to be made in hardened form. An acceptable hardened thiolated gelatin material which could also be used as the sheath material is described in U.S. Letters Patent 3,106,483 dated October 8, 1963.
Hemostatic sheath 36 has an entry end 43 which is the end which first enters the biopsy site and a proximal end 44 which is adjscent di~tal end 38 o~ prox~mfll por~ion 35. The length o~ hemo~tatic ~hc~th 36 m~y vu~y depending upon the biopsy taken, but as ~ mini~um, thc l~ngth of hemostatic sheath 36 should preferably be as long as t~e len~th of the biopsy specimen taken. For cutting cannula 12 of the side cutting type in FIGURE 5, the length of hemostatic she~th 36 should probably be at least equal to the length of cuttinp, edge 20. In the unactuated, "~t rest" or uninserted posi-tion of needle ~0, proximal end 44 of hemostatic sheath 36 is spaced a slight distance away from distal end 38 of proximal portion 35 to define a circumferentially extendin~
gap or space 46 existing between distal and proximal por tions 35, 36. In practicel gap 46 can occur by simply siz-in8 the inside diflme~er of hemostatic sheath 36 relative to the outside diameter of distal portion 16 of cutting cannula 12 so that he~ostatic sheath 36 can initially slide onto cutting cannula 12 when wet. Alternatively, the inside di-ameter of hemoststic sheath 36 could be formed with a slight taper increasing the sheath's fit at proximal end 44 thus maintaining gap 46. When so constructed, gap 46 will de-crease when hemostatic sheath 36 is inserted into the biopsy site. Two additional modifications are shown in FIGURES 7 and 7a and described hereafter which can be employed to pos-itively maintain gap 46 if desired.
Entry end 43 of hemostatic sheath 36 is preferably formed as a flat surface perpendicular to the length of hemostatic sheath 36 as shown in FIGURE 5 or, alternatively, depending upon th~ hardness of the lesion at the site where the biopsy is to be taken (i.e. bone marrow) entry end 43, could be tapered as shown in FIGURE 7. Also, the edge sur-face 45 of entry end 43 will generally lie in one plane, althou~,h edge surface 45 could assume a curvilinear or ta-pering configurstion. However, because the coefficient of friction of the gelatin of hemostatic sheath 36 is reduced when wet and hemostatic sheath 36 will be wet as it enters the biopsy site and encounters bleeding from the slte, it i8 not believed n~ce~s~ry ~o ~orm cd~c surface 45 as a cutting ed6e~ In point o~ fact it is desired that edge sur~ace 45 not act as a cutting edge ~uch as is necessary in Marshall' 8 patent because the tissue surrounding the biopsy sp~cimen is to be displaced and compressed by the outer cylindrical sur-face of hemostatic sheath 36. If the tissue iB s~in cut by edge surface 45 further bleeding will ensue. Thus, the par-ticular type of biopsy and the hardness of the lesion at which the biopsy is taken, will determine the exact shape of entry end 43 and ed8e surface 45 but the shape ~ill be such as to permit compression of the tissue at the biopsy site while permitting easy entry of hemostatic sheath 36 into the lesion.
Referring now to FIGURES 1-4, the unactuated position of biopsy needle 10 is shown in FIGURE 1. In this position cutting edge 20 of cutting cannula 12 is adjacent tissue 50, pusher handle 40 is against cannula handle 32 and plunger portion 28 is in a retracted position. Maintaining cannula handle 32 and pusher handle 40 at approximately the same elevation, obturator handle 26 is slided into stem 30 so that distal portion 16 of cutting cannula 12 enters lesion 50 whereat the biopsy is taken in the normal manner (FIGURE
2). (If biopsy needle 10 was equipped with a stylette the stylette would have been removed while cutting cannula 12 wa6 moved in lesion 50 to the site of the biopsy sample.) The cannula is then rotated in the conventional manner to permit cutting edge 20 to extract the biopsy sample or spec-imen. (Additionally~ a vacuum could be applied to the in-side diameter of cutting cannula 12.) In any event, whenthe biopsy specimen is taken or i6 physically severed and within cutting cannula 12, needle 10 is actuated into its retracted position. For a side cutting biopsy needle two steps are required to reach the retracted position. With the obturaor handle 26 maintained at approximately the same 1313~00 position, pusher handle 40 and cnnnulu handle 32 are graspcd and mov~d to~ether. Proxi~al portion 35 contacts hemostatic sheath (reducing gap 46) and filides hemostatic sheath 36 over cutting cannula 12 to again cover distal portion 16 of cutting cannula 12 (FIGURE 3). Intermediate cannula 14 is likewise disposed over cutting cannula 12 as in the conven-tional mode. A~ain, the positionin~ mechanis~ shown, less outer cannula 13 is conventional.
When hemostatic sheath 36 travels into the biopsy site, the tissue in the site iB compressed. That i9, when the biopsy specimen was taken, a generally cylindrically shaped void was created in lesion 50. The surface of the tissue defining the void shape contains blood vessels which were severed by needle 10. Because of the geometric arrangement of cutting cannula 12 and hemostatic sheath 36, the cross-sectional diameter of the void is approximately equal to the inside diameter of hemostatic sheath 36. Thus, the cross-sectional area of herlostatic sheath 36 as shown in FIGURE 6, forms an annulus the outer surface 49 of which displaces the tissue containing the severed blood vessels and that tissue is being compressed as it is being displaced and the com-pression acts to retard bleeding. Also, gap 46 gives a slight sen6ation felt in pusher handle 40 and cannula handle 32 by the surgeon to indicate that the sheath has travelled to almost its exact position within the biopsy site. This is helpful when conducting blind biopsies. This also en-sures lengthwise positioning of hemostatic sheath 36.
In the second step necessary to reach the retracted position (FIGURE 4), pusher handle 40 is maintained at the same position and cannula handle 32 is moved or retracted until obturator handle 26 contacts base portion 31 whereat needle 10 is removed with the biop~y specimen intact. The presence of gap 46 provides a lost motion type of connection which insures that inner cannula 12 reaches its retracted position and thus separates hemostatic sheath 36 at the biopsy site (the lo~t ~lo~ion rasultinR rom di~lunition of gap 46 is mor~ reAdily discernible wi~h rospect to the cnd cuttin~, needle shown in FIGURES 8 ~nd 9). That i8, when obturator handle 26 moved distal portion 16 of cutting cannula 12 into lesion 50, it traveled a fixed axial dis-tance. When hemostatic sheath 36 was moved over di~tal por~
tion 16 of cutting cannula 12, cannula handle 32 ~nd pusher handle 40 moved the fixed axial distance plus the distance of gap 46. This increased the length of plunger portion 28 extending from stem 30 the axial distance of gap 46. When cuttin~ cannula 12 is retracted from lesion 50 in FIGURE 4, the plunger distance is then taken up when obturator handle 26 contacts stem 30 to insure separstion of hemostatic sheath 36 from needle 10.
Referring now to FIGURES 8 and 9, sn end cutting biopsy needle 10 is provided with a hemostatic sheath 36 and like parts will be designated by like numbers where possible. In the end cutting or Menghini needle configuration of FIGURES
8 ar.d 9, obturator 25 is replaced by a hub member 60 affixed to bottom end 29 of cutting cannula 12. Hub 60 can be hol-low for insertion of a stylette 62. The hemostatic sheath 36 is inserted over cutting cannula 12 with gap 46 as de-scribed for side cutting biopsy needle 10 of FIGURES 1-5.
FIGURE 8 illustrates end cutting biopsy needle 10 in its unactuated position, it being assumed that stylette 62 is inserted within cutting cannula 12 to provide a solid entry end 19, and the circumferential edge of entry end 19 iB
formed as cutting edge 20. With stylette 62 inserted, push-er handle 40 and hub 60 are held together and end cutting biopsy needle 10 inserted in the unactuated position in le-sion 50 to a point just before the biopsy specimen is to be taken. At this position (not shown) stylette 6~ is removed and cutting and outer cannulas 12, 13 are moved, without relative movement, (i.e. pusher handle 40 and hub member 60 together) while the biopsy is taken through entry end 19 of 1 3t 31 00 X-7838 cutting cnnnula 12 in the normfll fa~hion. The len~th o~
hemostatic sheath 36 will at lenst prcEerflbly be equ~l to ~he travel of needle 10 wi~h stylette 62 removed. Thus, the actuated position and unactuated position of end cutting biopsy needle 10 are generally the same (less the take-up in gap 46). Af~er the biopsy specimen is collected through vacuum or through the motion of needle 10 vis-a-vis rotation of cutting edge 20, pusher handle 40 iB maintair~ed in the same position as in the actuated position and hub member 6~
is moved to a retracted position (FIGURE 8). ~9 in FIGURE
4, this motion places hemostatic sheath 36 at the site where the biopsy specimen was taken and insures (as was done for the side needle) that entry end 19 of cutting cannula 12 iæ
within proximal portion 35 of outer cannula 13.
It is believed that the hemostatic effect resulting from the precise, in situ placement of hemostatic sheath 36 occur as a result of several factors. First, there is a blood clotting attributed to the mechanical insertion of hemostatic sheath 36. As noted above, when cutting cannula 12 extracts the biopsy specimen, the tissue is cut and ves-sels are severed at the edge of the tissue which borders on the margin of the tissue core. As shown in FIGURE 6, when hemostatic sheath 36 is properly positioned, entry end 43 pushes against the edge of the tissue which has been cut by cutting cannula 12. This provides a compression of the tis-sue which is bleeding simply because the cross-sectional area of hemostatic sheath 36 circumscribes and thus com-presses the bleeding surface. This tends to stop the sur-faces from bleeding. Importantly, within a few seconds and for a long as a few minutes, the gelatin will absorb the blood and swell and thus expand both externally and inter-nally to occupy the space indicated by the dotted lines 55 shown in FIGURE 6. This produces a tamponade effect further acting to occlude the hole in the tissue and any vessels in the area. Finally, hemostatic sheath 36 in the plain gelatin form i8 a forei~n body which ~ct~ a~ a nidus for platelet aggre~ation and s~imulat~ blood clottin~. All of th~se factors will act to reduce hemo~rhaglc complications when hemostatic sheath 36 is formed from a plastic, biode-gradable gelatin without any additional additives or sub-stances added to the gelatin. By the time the hemostatic sheath is absorbed or dissolved wlthin the body, the bleed-ing from the biopsy site will h~ve stopped.
In order to enhance the last mentioned feature, and as noted above, thrombin can be added as one of the component substances of the gelatin material oP hemostatic sheath 36.
As is known, thrombin is a proteln which i8 active at the last stage of clot formation and functions to change fibrinogen to fibrin. Because hemostatic sheath 36 with thrombin added is very thromgenic, hemostatic sheath 36 is also very active at the very last phase of blood clotting.
Thus, deficiencies and coagulation factors such as factor VIII, prothrombin which occurs with liver disease, etc., do not interfere with the blood clotting formation. Addition-ally, using thrombin as the substance of hemostatic sheath36 will provide active receptors which attract platelets snd improve the aggregation of platelets. Thus, a small amount of thrombin when employed in hemostatic sheath 36 can almost be effective to eliminate clotting factors from any cause.
Considering the intense forms of therapy now used in oncology, the significance of the invention in reducing pain and suffering of the patient and the potential life saving implications thereof should not be underestimated.
While the invention has been described in its broad sense, there are several modifications and alterations which can be made to enhance the mechanical performance of biopsy needle 10 employing hemoststic shesth 36. A schematic il-lustration of several modifications are shown in FIGURES 7 and 7a. In FIGURE 7, the outer circumferential ~urface 70 of hemostatic sheath 36 can be formed witb protrusions 72 . .
X-7~38 which are shflped in the form of ~arb~ permitting in~r~ss of hemostatic sheath 36 into the site of the biopfiy while pre-ven~ing egress therefrom.
Another modification shown in FIGURE 7 is that distal end 38 of proximal portion 35 of outer cannuls 13 can be made of a resilient plas~ic type material with sn offset 74 at distal end 38 which brings distal end 38 slightly away from the outer cylindrical surface 75 of cutting cannula 12.
When entry end 19 of cutting cannula 12 i9 retrscted, offset 74 will snap over entry end 19. This snapping action will clearly indicate to the surgeon that biopsy needle 10 is in its retracted position and consequently, hemostatic sheath 36 properly positioned in the biopsy site. This provides a positive sensitory feel to the surgeon through needle 10, which is helpful when conducting blind biopsies. In connec-tion with or without use of offset 74, it is possible to neck down distal end 38 of proximal portion 35 as at 77 and proximal end 44 of hemostatic sheath 36 as at 78 to provide a stationary gap 46 while maintainin8 a columnar relation-ship between proximal portion 35 and distal portion orhemostatic sheath 36 of outer cannula 13. The stationary gap 46 will be maintained as the hemostatic sheath 36 is positioned over distal portion 16 of cutting cannula 12.
Should lesion 50 be harder than the surrounding tissue, 8 sensitory vibration may be felt by the surgeon as gap 46 passes into lesion 50 to assure the surgeon that hemostatic sheath 36 is properly positioned within the biopsy site.
In connection with necked down portion 78 of he~ostatic sheath 36, it is also possible to reduce the diameter of a portion thereof to make the same a frangible connection which becomes severed by the snapping action of offset 74 over the entry end 19 of cutting cannula 12 when cutting cannula 12 is moved to its retracted position. This pro-vides a one piece outer cannula 13 which may have assembly and manufacturing advantages over the two piece design ~ 1313100 illustrated in thc other cmb~dimentfi. The modi~lcation~
thus described in FIGURES 7 and 7fl insure the positive posi-tionin~ of he~tatic sheath 36 at its correct in situ posi-tion. However, it should be noted that the presence of distal portion 35 of outer cannula 13 a8 illustrated in FIG-U~ES 1-5 and 7 and 8 functions in and of it~elf to preci~ely position hemostatic sheath 36.
Thus, it is apparent that many modification~ may be incorporated into the hemostatic sheath and the biopsy nee-dle used with the hemostatic sheath without departing fromthe spirit or the essence oP my invention. For example and as alluded to above, the actuating mechanism employed with the biopsy needle to po~ition the sheath can be spring actu-ated. Conceptually, an outer cannula does not have to be provided for the side cutting needle. The intermediate cannula 14 could have a radial outwardly pro3ect rib or seat to receive hemostatic sheath 36. Intermediate cannula 14 with a sheath seat would then function as outer cannula 13.
It is my intention to include all such modifications and alterations insofar as they come within the scope of the present invention.
It is thus the essence of my invention to provide a hemostatic sheath for use in a biopsy needle or like instru-ment to avoid hemorrhagic complications resulting from the surgical procedure using the needle or like instrument.
When hemostatic sheath 36 travels into the biopsy site, the tissue in the site iB compressed. That i9, when the biopsy specimen was taken, a generally cylindrically shaped void was created in lesion 50. The surface of the tissue defining the void shape contains blood vessels which were severed by needle 10. Because of the geometric arrangement of cutting cannula 12 and hemostatic sheath 36, the cross-sectional diameter of the void is approximately equal to the inside diameter of hemostatic sheath 36. Thus, the cross-sectional area of herlostatic sheath 36 as shown in FIGURE 6, forms an annulus the outer surface 49 of which displaces the tissue containing the severed blood vessels and that tissue is being compressed as it is being displaced and the com-pression acts to retard bleeding. Also, gap 46 gives a slight sen6ation felt in pusher handle 40 and cannula handle 32 by the surgeon to indicate that the sheath has travelled to almost its exact position within the biopsy site. This is helpful when conducting blind biopsies. This also en-sures lengthwise positioning of hemostatic sheath 36.
In the second step necessary to reach the retracted position (FIGURE 4), pusher handle 40 is maintained at the same position and cannula handle 32 is moved or retracted until obturator handle 26 contacts base portion 31 whereat needle 10 is removed with the biop~y specimen intact. The presence of gap 46 provides a lost motion type of connection which insures that inner cannula 12 reaches its retracted position and thus separates hemostatic sheath 36 at the biopsy site (the lo~t ~lo~ion rasultinR rom di~lunition of gap 46 is mor~ reAdily discernible wi~h rospect to the cnd cuttin~, needle shown in FIGURES 8 ~nd 9). That i8, when obturator handle 26 moved distal portion 16 of cutting cannula 12 into lesion 50, it traveled a fixed axial dis-tance. When hemostatic sheath 36 was moved over di~tal por~
tion 16 of cutting cannula 12, cannula handle 32 ~nd pusher handle 40 moved the fixed axial distance plus the distance of gap 46. This increased the length of plunger portion 28 extending from stem 30 the axial distance of gap 46. When cuttin~ cannula 12 is retracted from lesion 50 in FIGURE 4, the plunger distance is then taken up when obturator handle 26 contacts stem 30 to insure separstion of hemostatic sheath 36 from needle 10.
Referring now to FIGURES 8 and 9, sn end cutting biopsy needle 10 is provided with a hemostatic sheath 36 and like parts will be designated by like numbers where possible. In the end cutting or Menghini needle configuration of FIGURES
8 ar.d 9, obturator 25 is replaced by a hub member 60 affixed to bottom end 29 of cutting cannula 12. Hub 60 can be hol-low for insertion of a stylette 62. The hemostatic sheath 36 is inserted over cutting cannula 12 with gap 46 as de-scribed for side cutting biopsy needle 10 of FIGURES 1-5.
FIGURE 8 illustrates end cutting biopsy needle 10 in its unactuated position, it being assumed that stylette 62 is inserted within cutting cannula 12 to provide a solid entry end 19, and the circumferential edge of entry end 19 iB
formed as cutting edge 20. With stylette 62 inserted, push-er handle 40 and hub 60 are held together and end cutting biopsy needle 10 inserted in the unactuated position in le-sion 50 to a point just before the biopsy specimen is to be taken. At this position (not shown) stylette 6~ is removed and cutting and outer cannulas 12, 13 are moved, without relative movement, (i.e. pusher handle 40 and hub member 60 together) while the biopsy is taken through entry end 19 of 1 3t 31 00 X-7838 cutting cnnnula 12 in the normfll fa~hion. The len~th o~
hemostatic sheath 36 will at lenst prcEerflbly be equ~l to ~he travel of needle 10 wi~h stylette 62 removed. Thus, the actuated position and unactuated position of end cutting biopsy needle 10 are generally the same (less the take-up in gap 46). Af~er the biopsy specimen is collected through vacuum or through the motion of needle 10 vis-a-vis rotation of cutting edge 20, pusher handle 40 iB maintair~ed in the same position as in the actuated position and hub member 6~
is moved to a retracted position (FIGURE 8). ~9 in FIGURE
4, this motion places hemostatic sheath 36 at the site where the biopsy specimen was taken and insures (as was done for the side needle) that entry end 19 of cutting cannula 12 iæ
within proximal portion 35 of outer cannula 13.
It is believed that the hemostatic effect resulting from the precise, in situ placement of hemostatic sheath 36 occur as a result of several factors. First, there is a blood clotting attributed to the mechanical insertion of hemostatic sheath 36. As noted above, when cutting cannula 12 extracts the biopsy specimen, the tissue is cut and ves-sels are severed at the edge of the tissue which borders on the margin of the tissue core. As shown in FIGURE 6, when hemostatic sheath 36 is properly positioned, entry end 43 pushes against the edge of the tissue which has been cut by cutting cannula 12. This provides a compression of the tis-sue which is bleeding simply because the cross-sectional area of hemostatic sheath 36 circumscribes and thus com-presses the bleeding surface. This tends to stop the sur-faces from bleeding. Importantly, within a few seconds and for a long as a few minutes, the gelatin will absorb the blood and swell and thus expand both externally and inter-nally to occupy the space indicated by the dotted lines 55 shown in FIGURE 6. This produces a tamponade effect further acting to occlude the hole in the tissue and any vessels in the area. Finally, hemostatic sheath 36 in the plain gelatin form i8 a forei~n body which ~ct~ a~ a nidus for platelet aggre~ation and s~imulat~ blood clottin~. All of th~se factors will act to reduce hemo~rhaglc complications when hemostatic sheath 36 is formed from a plastic, biode-gradable gelatin without any additional additives or sub-stances added to the gelatin. By the time the hemostatic sheath is absorbed or dissolved wlthin the body, the bleed-ing from the biopsy site will h~ve stopped.
In order to enhance the last mentioned feature, and as noted above, thrombin can be added as one of the component substances of the gelatin material oP hemostatic sheath 36.
As is known, thrombin is a proteln which i8 active at the last stage of clot formation and functions to change fibrinogen to fibrin. Because hemostatic sheath 36 with thrombin added is very thromgenic, hemostatic sheath 36 is also very active at the very last phase of blood clotting.
Thus, deficiencies and coagulation factors such as factor VIII, prothrombin which occurs with liver disease, etc., do not interfere with the blood clotting formation. Addition-ally, using thrombin as the substance of hemostatic sheath36 will provide active receptors which attract platelets snd improve the aggregation of platelets. Thus, a small amount of thrombin when employed in hemostatic sheath 36 can almost be effective to eliminate clotting factors from any cause.
Considering the intense forms of therapy now used in oncology, the significance of the invention in reducing pain and suffering of the patient and the potential life saving implications thereof should not be underestimated.
While the invention has been described in its broad sense, there are several modifications and alterations which can be made to enhance the mechanical performance of biopsy needle 10 employing hemoststic shesth 36. A schematic il-lustration of several modifications are shown in FIGURES 7 and 7a. In FIGURE 7, the outer circumferential ~urface 70 of hemostatic sheath 36 can be formed witb protrusions 72 . .
X-7~38 which are shflped in the form of ~arb~ permitting in~r~ss of hemostatic sheath 36 into the site of the biopfiy while pre-ven~ing egress therefrom.
Another modification shown in FIGURE 7 is that distal end 38 of proximal portion 35 of outer cannuls 13 can be made of a resilient plas~ic type material with sn offset 74 at distal end 38 which brings distal end 38 slightly away from the outer cylindrical surface 75 of cutting cannula 12.
When entry end 19 of cutting cannula 12 i9 retrscted, offset 74 will snap over entry end 19. This snapping action will clearly indicate to the surgeon that biopsy needle 10 is in its retracted position and consequently, hemostatic sheath 36 properly positioned in the biopsy site. This provides a positive sensitory feel to the surgeon through needle 10, which is helpful when conducting blind biopsies. In connec-tion with or without use of offset 74, it is possible to neck down distal end 38 of proximal portion 35 as at 77 and proximal end 44 of hemostatic sheath 36 as at 78 to provide a stationary gap 46 while maintainin8 a columnar relation-ship between proximal portion 35 and distal portion orhemostatic sheath 36 of outer cannula 13. The stationary gap 46 will be maintained as the hemostatic sheath 36 is positioned over distal portion 16 of cutting cannula 12.
Should lesion 50 be harder than the surrounding tissue, 8 sensitory vibration may be felt by the surgeon as gap 46 passes into lesion 50 to assure the surgeon that hemostatic sheath 36 is properly positioned within the biopsy site.
In connection with necked down portion 78 of he~ostatic sheath 36, it is also possible to reduce the diameter of a portion thereof to make the same a frangible connection which becomes severed by the snapping action of offset 74 over the entry end 19 of cutting cannula 12 when cutting cannula 12 is moved to its retracted position. This pro-vides a one piece outer cannula 13 which may have assembly and manufacturing advantages over the two piece design ~ 1313100 illustrated in thc other cmb~dimentfi. The modi~lcation~
thus described in FIGURES 7 and 7fl insure the positive posi-tionin~ of he~tatic sheath 36 at its correct in situ posi-tion. However, it should be noted that the presence of distal portion 35 of outer cannula 13 a8 illustrated in FIG-U~ES 1-5 and 7 and 8 functions in and of it~elf to preci~ely position hemostatic sheath 36.
Thus, it is apparent that many modification~ may be incorporated into the hemostatic sheath and the biopsy nee-dle used with the hemostatic sheath without departing fromthe spirit or the essence oP my invention. For example and as alluded to above, the actuating mechanism employed with the biopsy needle to po~ition the sheath can be spring actu-ated. Conceptually, an outer cannula does not have to be provided for the side cutting needle. The intermediate cannula 14 could have a radial outwardly pro3ect rib or seat to receive hemostatic sheath 36. Intermediate cannula 14 with a sheath seat would then function as outer cannula 13.
It is my intention to include all such modifications and alterations insofar as they come within the scope of the present invention.
It is thus the essence of my invention to provide a hemostatic sheath for use in a biopsy needle or like instru-ment to avoid hemorrhagic complications resulting from the surgical procedure using the needle or like instrument.
Claims (19)
1. A biopsy needle for taking a biopsy specimen from a patient, said needle having an unactuated position defined by the relative position of its parts prior to insertion in the patient, an actuated position defined by the relative position of its parts while said specimen is being taken and a retracted position defined by the relative position of its parts when said needle is removed from the site where the biopsy was taken, said needle comprising:
a) an inner cutting cannula having a distal portion for insertion into said site and a contiguous proximal por-tion extending from said distal portion, said distal portion defined as that length of said inner cannula which is in-serted into said patient in said actuated position, and in-cluding means to sever said specimen from said patient;
b) an outer hollow cannula co-axial with and receiving said inner cannula, said outer cannula having a proximal portion and a separable distal portion, said distal portion being separated from said proximal portion and remaining at said site in said retracted position of said needle;
c) positioning means associated with said proximal portions of said inner and outer cannulas to cause movement of one of said cannulas relative to the other when said nee-dle moves from one of said positions to the other; and d) said distal portion of said inner cannula being made of bioabsorbable gelatin material for minimizing bleed-ing of said patient from said biopsy site.
a) an inner cutting cannula having a distal portion for insertion into said site and a contiguous proximal por-tion extending from said distal portion, said distal portion defined as that length of said inner cannula which is in-serted into said patient in said actuated position, and in-cluding means to sever said specimen from said patient;
b) an outer hollow cannula co-axial with and receiving said inner cannula, said outer cannula having a proximal portion and a separable distal portion, said distal portion being separated from said proximal portion and remaining at said site in said retracted position of said needle;
c) positioning means associated with said proximal portions of said inner and outer cannulas to cause movement of one of said cannulas relative to the other when said nee-dle moves from one of said positions to the other; and d) said distal portion of said inner cannula being made of bioabsorbable gelatin material for minimizing bleed-ing of said patient from said biopsy site.
2. The biopsy needle of claim 1 wherein said gelatin material includes thrombin as a substance thereof.
3. The biopsy needle of claim 1 wherein said distal portion of said inner cannuls has a rear end adjacent said inner cannula's proximal portion when said needle is in its unactuated position and a front end opposite said read end;
said means for severing said specimen leaving a gener-ally cylindrical void in the tissue of the patient;
said distal portion of said inner cannula being gener-ally cylindrical having initially an inside diameter approx-imately equal to the diameter of said cylindrically shaped void; and said positioning means effective to position said distal portion overlying said void whereby said tissue sur-rounding said void is compressed to minimize bleeding.
said means for severing said specimen leaving a gener-ally cylindrical void in the tissue of the patient;
said distal portion of said inner cannula being gener-ally cylindrical having initially an inside diameter approx-imately equal to the diameter of said cylindrically shaped void; and said positioning means effective to position said distal portion overlying said void whereby said tissue sur-rounding said void is compressed to minimize bleeding.
4. The biopsy needle of claim 3 wherein said distal portion swells in size before dissolving in the patient.
5. The biopsy needle of claim 1 wherein said position-ing means including at least one barb-like protrusion in said exterior surface of said outer cannula's distal portion for positively retaining said portion in said patient when said needle is in its retracted position.
6. The biopsy needle of claim 1 wherein said outer cannula comprises a first intermediate hollow cannula and a second larger outer cylindrical cannuls co-axial with and receiving said intermediate cannula, said inner cannula telescopingly received within said intermediate cannula, said forward end of said inner cannula is preconfigured into a sharpened end for penetrating said patient, said means to sever said sample includes a longitudinally extending sharp-ened groove in said distal portion of said inner cannula behind said forward end, said groove receiving said specimen in said actuated position.
7. The biopsy needle of claim 1 wherein said forward end of said inner cannula is preconfigured into a hollow sharpened end for penetrating said patient, said end receiv-ing said sample in said actuated position.
8. The biopsy needle of claim 6 wherein said means for positioning includes inner cannula means attached to the proximal end of said inner cannula for moving said inner cannula relative to said outer cannula to said actuated po-sition, outer cannula means attached to the proximal end of said outer cannula for moving, said outer cannula relative to said inner cannula when said needle is in said actuated po-sition, said inner cannula means further effective with said outer cannula means to deposit said distal portion of said outer cannula at said site in said retracted position.
9. The biopsy needle of claim 7 wherein said means for positioning further includes cannula means attached to the proximal portion of one of said cannulas to cause said inner and outer cannulas to move together into said actuated posi-tion and inner cannula means secured to said inner cannula to cause said inner cannula to axially move relative to said outer cannula into said retracted position.
10. The biopsy needle of claim 1 wherein said proximal portion of said outer cannula is made of biodegradable gela-tin material.
11. The biopsy needle of claim 1 wherein said posi-tioning means further includes a circumferentially extending space between said distal portion and said proximal portion of said outer cannula for locating the position of said in-ner cannula at said site in said retracted position of said needle.
12. The biopsy needle of claim 5 wherein said posi-tioning means further includes a circumferentially extending space between said distal portion and said proximate portion of said outer cannula for locating the position of said in-ner cannula at said site in said retracted position of said needle.
13. The biopsy needle of claim 12 further including frangible means connecting said proximate portion of said distal portion of said outer cannula to one another when said needle is in its unactuated position and defining said space, said frangible means severed when said needle is in its retracted position.
14. A biopsy needle or like instrument comprising an inner cannula disposed within an outer cannula, said outer cannula having a proximate portion and a removable distal portion, means for depositing said distal portion at the site where said needle punctures an organ after said needle has been removed, said distal portion being of a bioabsorb-able gelatin material to minimize bleeding complications resulting from the use of said needle.
15. The biopsy needle of claim 14 wherein said gelatin material includes thrombin as a substance thereof.
16. The biopsy needle of claim 15 wherein a position-ing space exists between said distal and said proximate por-tions.
17. A method for performing a biopsy comprising the steps of:
providing an inner cutting cannula and an outer hollow cannula co-axially receiving said inner cannula, said outer cannula having a gelatin hemostatic sheath at its distal end adjacent a proximal portion thereof;
moving said inner and said outer cannulas together to a point adjacent the lesion where said biopsy specimen is to be taken;
axially moving said cutting cannula while maintaining said outer cannula stationary to the site where said speci-men is to be taken;
severing the specimen at said site and positioning same within said cutting cannula;
maintaining said cutting cannula generally stationary while axially moving said outer cannula to a position whereat said sheath overlies said specimen; and simultaneously withdrawing said cutting and said outer cannula from said site while leaving said sheath at said site.
providing an inner cutting cannula and an outer hollow cannula co-axially receiving said inner cannula, said outer cannula having a gelatin hemostatic sheath at its distal end adjacent a proximal portion thereof;
moving said inner and said outer cannulas together to a point adjacent the lesion where said biopsy specimen is to be taken;
axially moving said cutting cannula while maintaining said outer cannula stationary to the site where said speci-men is to be taken;
severing the specimen at said site and positioning same within said cutting cannula;
maintaining said cutting cannula generally stationary while axially moving said outer cannula to a position whereat said sheath overlies said specimen; and simultaneously withdrawing said cutting and said outer cannula from said site while leaving said sheath at said site.
18. The method of claim 17 wherein said specimen is severed through the end of said cutting cannula.
19. The method of claim 17 wherein said specimen is severed at the side of said needle.
Applications Claiming Priority (2)
| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| US199,130 | 1980-10-22 | ||
| US07/199,130 US4838280A (en) | 1988-05-26 | 1988-05-26 | Hemostatic sheath for a biopsy needle and method of use |
Publications (1)
| Publication Number | Publication Date |
|---|---|
| CA1313100C true CA1313100C (en) | 1993-01-26 |
Family
ID=22736347
Family Applications (1)
| Application Number | Title | Priority Date | Filing Date |
|---|---|---|---|
| CA000599103A Expired - Lifetime CA1313100C (en) | 1988-05-26 | 1989-05-09 | Hemostatic sheath for a biopsy needle |
Country Status (6)
| Country | Link |
|---|---|
| US (1) | US4838280A (en) |
| CA (1) | CA1313100C (en) |
| DE (1) | DE3917051A1 (en) |
| FR (1) | FR2631811B1 (en) |
| GB (1) | GB2218910B (en) |
| IT (1) | IT1231691B (en) |
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| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| US2814296A (en) * | 1954-04-15 | 1957-11-26 | S & R J Everett & Co Ltd | Surgical needles |
| US3106483A (en) * | 1961-07-27 | 1963-10-08 | Us Catheter & Instr Corp | Synthetic blood vessel grafts |
| US3358684A (en) * | 1965-03-12 | 1967-12-19 | Marshall Gerald | Parenteral injection devices |
| EP0019104A3 (en) * | 1979-05-19 | 1980-12-10 | Intermedicat GmbH | Biopsy needle for sampling histological specimens |
| US4650488A (en) * | 1984-05-16 | 1987-03-17 | Richards Medical Company | Biodegradable prosthetic device |
| US4708147A (en) * | 1985-02-25 | 1987-11-24 | Haaga John R | Universal biopsy needle |
| DE8623592U1 (en) * | 1986-09-03 | 1987-10-01 | Schnepp-Pesch, Wolfram, 7505 Ettlingen, De | |
| DE3632197A1 (en) * | 1986-09-23 | 1988-03-31 | Rainer Dr Hofmann | Punching or cutting biopsy cannula |
-
1988
- 1988-05-26 US US07/199,130 patent/US4838280A/en not_active Expired - Lifetime
-
1989
- 1989-05-09 CA CA000599103A patent/CA1313100C/en not_active Expired - Lifetime
- 1989-05-18 GB GB8911491A patent/GB2218910B/en not_active Expired - Lifetime
- 1989-05-25 FR FR898906858A patent/FR2631811B1/en not_active Expired - Lifetime
- 1989-05-25 IT IT8947996A patent/IT1231691B/en active
- 1989-05-25 DE DE3917051A patent/DE3917051A1/en active Granted
Also Published As
| Publication number | Publication date |
|---|---|
| DE3917051A1 (en) | 1989-12-07 |
| GB8911491D0 (en) | 1989-07-05 |
| US4838280A (en) | 1989-06-13 |
| GB2218910B (en) | 1991-09-25 |
| GB2218910A (en) | 1989-11-29 |
| FR2631811A1 (en) | 1989-12-01 |
| IT1231691B (en) | 1991-12-19 |
| IT8947996A0 (en) | 1989-05-25 |
| FR2631811B1 (en) | 1991-07-19 |
| DE3917051C2 (en) | 1991-09-26 |
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