HK1142796B - Surgical kits - Google Patents

Abstract

A kit for implantation of material into a body, a kit for extraction of tissue from a body and a tissue transplantation kit. A method for implanting material into a body, a method for extracting tissue from a body and a method for transplanting tissue into a body.

Description

Surgical kit

Technical Field

The present invention relates to an extraction kit, an implantation kit and a transplantation kit. The invention also relates to a method for extracting tissue, a method for implanting material and a method for transplanting tissue.

Any material suitable for implantation into the human body may be implanted into the human body using the implantation kit and method of implanting the material. Preferably, the implant is into tissue, such as muscle, dermis, bone, cartilage and fat.

Any tissue can be extracted from a human body using the extraction kit and the method of extracting tissue. Tissue transplantation may be performed by using the transplantation kit and the method of transplanting tissue.

Background

Fat transplantation, which is currently performed, is mostly performed by sucking fat from a human body, centrifuging/cleaning the fat to obtain a fat cell concentrate, and injecting the concentrate into the human body, preferably with a needle. The problem with this transplantation method is that 60-100% of the injected fat will be absorbed by the body within 1 year.

It is known that partial or core fat (i.e. fat that is not centrifuged/cleaned but has an intact morphology/structure, is not absorbed in a corresponding manner when transplanted into the human body. Animal studies have shown that the degree of absorption is below 5%. See Fagrell, d.; ensestrom, s.; bertgren, A. et al, 1996, "Fatcylinder translation" at page 90, Vol.98 of Plastic and Reconstructive Surgery: an experimental laboratory study of three different types of fat transplantation.

One problem with transplanted tissue is that it is difficult to extract tissue of a suitably small size. Another problem relates to sufficiently accurate implantation into tissue.

US5269316 shows a surgical tool for removing, transplanting or implanting dermal, adipose, cartilage or foreign body material. The tool is composed of three separable adjacent parts, the first part is a hollow scalpel, the second part is a hollow tube communicated with the hollow scalpel, and the third part is a hard part tapered into a sharp needle.

The hollow scalpel and the rigid sharp needle may be separated from one end, the hollow tube and hollow scalpel being separable along their length after removal of the hollow scalpel and sharp needle portions.

When the tool is used, the sharp needle portion is fixed in the surgical drill, so that the hollow scalpel can be introduced into the body in a first position, by drilling through the skin, then through the tissue to be extracted, and finally out through the skin in a second position, thus creating two wounds in the skin. Since it does not seem that any air is expelled from the interior of the hollow tube, the tissue to be extracted will be quickly blocked by the air cushion present in the hollow tube as it moves into the hollow tube, thus making it difficult to see how this can be done in practice.

Thereafter, the tool is removed from the drill bit, rotated and instead secured to the hollow scalpel. Drilling is then started with the pointed needle portion at the location of the body where implantation is to be performed. The tool is guided through the skin at a first location, along the path of the implant, and out through the skin at a second location, thereby creating the other of the two wounds in the skin.

Removing the drill bit and separating the hollow scalpel and the sharp needle portion from the hollow tube placed inside the human body. The hollow tube is then again partially broken in half within the body and the hollow tube is then removed from the body leaving the graft tissue inside the body. This separation seems to be rather difficult to perform and also leads to enlargement of the implantation chamber during separation of the two parts, since these parts need to be pushed radially apart to separate them.

A problem with this surgical tool is that it creates two holes in the skin, both when extracting tissue and when implanting tissue. Another problem is that the needle portion is sharp, which results in bleeding of the tissue surrounding the implanted tissue, which makes the result of the implantation dangerous, increasing the risk of necrosis and/or rejection of the implanted tissue by the body. The risk of injury to nerves, blood vessels and surrounding tissue is also increased. In summary, this seems to be a very limited approach.

In a recent article a new method for extracting and implanting core fat is described. This article is published in Plastic and Reconstructive Surgery in 7 months of 2007. Entitled "Facial Augmentation with Fat Core Graft: (preliminary reports of facial filling using core fat transplantation), Baham Guyuron and Ramsey K.

The authors of this article used a 1ml syringe and cut its tip off with an oscillating saw. A small incision is made at the extraction site of the body and the surgeon rotates and advances the syringe while gently pushing the plunger of the syringe to deliver fat.

A space was created at the implantation site using infant young's plum-baum (Baby Metzenbaum) scissors or the same syringe containing the extracted fat and the syringe was introduced into the space. The plunger of the syringe is used to transfer fat into the newly manufactured space while the syringe is removed. The syringe was introduced into the newly created space up to four times, transferring about 1ml of core fat each time.

One problem with this approach is that since the angled syringe is blunt, it can only be used for fat, and that also means that it will not be useful for smaller sizes. Another problem is that when creating a space in the tissue at the implantation site, the tissue is separated by scissors, which scissors create a larger access than needed for implantation, and it is difficult to create a longer or deeper space with scissors. Or it may separate the tissue as the angled syringe is pushed into the tissue. The tissue can be injured and bleed. There is also a risk of trauma to nerves, blood vessels and surrounding tissue.

Filling the space multiple times is difficult and it is difficult to find the space each time, especially when the space is cut with scissors. Each time the syringe is inserted into this space, there is a risk of further dissection of the tissue. Implantation is difficult to control, for example to place an accurate amount of fat at an accurate location.

When using a blunt tip, it is necessary to exert a strong negative pressure on the extracted fat with the plunger of the syringe, which operation, and the last step of extraction, can damage the fat when it is separated from the body. It is not possible to control the extraction of the tissue since it is not possible to know from which site the fat will be separated from the body, whether outside the extraction tube, inside the extraction tube or at its inner end. It is also not possible to control the shape of the extracted tissue, since it is evident from the drawings herein that fat has different cross-sectional dimensions in its length direction.

Any bleeding or damage to the fat at the implantation site will increase the risk of rejection of the fat at the implantation site.

Fat transplantation techniques and clinical results described by Baham Guyuron and Ramsey k.majzoub indicate that the procedure is crude. The extraction technique is limited to a specific size of adipose tissue that is damaged and not sharply cut. This fat implantation is prone to bleeding at the implantation site, and the position of the implanted material is not precisely controlled.

Disclosure of Invention

The kit and method of the present invention address at least some of these issues.

The present invention relates to a kit for implantation in the human body and comprises a penetration rod for making a cavity in the human body, which penetration rod can be placed inside an implantation tube. The implant tube maintains the formed cavity. The kit further comprises a container insertable into the implantation tube. The container contains a material to be implanted in the cavity formed.

With this kit it will be possible to implant material by making only one small opening in the skin. Minimizing openings in the skin is often an advantage, especially when the kit is used in orthopaedic surgery. Another advantage is that the surrounding tissue is protected by the implantation tube when inserting the container containing the material to be implanted, thus reducing the risk of separating the tissue and facilitating the insertion of the container.

The implantation kit may further comprise a piston that will aid in the process of removing the implantation tube and container to hold the implanted tissue in place in the created cavity.

The implantation kit also eliminates the problem of multiple implantations of cavities of the same appropriate size as the implantation kit and material, and is selected for only one implantation.

Sutures with one or two needles may be incorporated into the implantation kit. The sutures may also help to hold the implant material in place within the cavity created during removal of the implant tube and container. The suture may be used in place of and/or in conjunction with the piston. The suture can also be used to pull the material into place in the formed cavity. In use the needle creates a needle hole in the skin at a location spaced from the implanted opening. As will be appreciated by those skilled in the art, the skin immediately closes the needle hole directly when the needle and suture are removed.

Preferably the piercing rod has a blunt piercing end. When the body is pierced instead of cutting tissue, the piercing rod will separate the tissue with a blunt piercing end. Thus, the cavity can be made without or with little bleeding. This is an advantage, since bleeding may obstruct the connection between the implant and the body, thereby increasing the risk of rejection of the implant and/or increasing the risk of necrosis if the implant is tissue. The blunt piercing tip also reduces the risk of injury to nerves, blood vessels, and surrounding tissue.

If desired, the implant tube may have a non-circular cross-section, such as a flattened oval cross-section. The penetration rod of the kit will have a corresponding cross-section when mounted inside the implantation tube. In this way, it is possible to create a cavity of the desired shape and to fill the resulting cavity with a suitable implant, so that the implant fills the resulting cavity in the desired shape. The formed cavity may be filled with a piece of implant that fits the shape of the formed cavity. Repeated filling of the formed cavity is not required. Implantation and outcome can thus be controlled in an excellent manner. The container of the extraction kit may be made of a soft material to deform into the shape of the implantation tube.

The invention also relates to a kit for extracting tissue from a human body, comprising an extraction tube having a sharp entrance end of a spatula or knife for extracting tissue, and a cutting or avulsion member for cutting off the tissue to be extracted at the entrance end when the extraction tube is placed in the human body. The kit also has the advantage that only one small opening is made in the skin.

The use of such a sharp entry end of the extraction tube will reduce any risk of damaging the tissue to be extracted and thus increase the chance of successful implantation. In the present invention, the tissue will be cut into a single piece. The sharp entrance end makes it possible to extract tissues other than fat, such as muscle, dermis, bone, cartilage. The sharp entrance end makes it possible to extract also small-sized tissues. Preferably, the extraction tube is also used in the implantation kit as a container in the implantation kit.

The kit preferably comprises a container for containing the extracted tissue. The container will be placed inside the extraction tube in use. The container may preferably also be used in the implantation kit.

In a conceivable embodiment, the extraction tube is provided with a separate sharp entry end. When the extraction tube is made of a plastic material, the plastic material may be difficult to sharpen to the extent required in certain applications, such as syringes, in which case such a separate sharp entry end may be advantageous. The single sharp entrance end may be made of a metal suitable for high sharpening.

In one embodiment, the cutting member may be provided to the container for cutting off the tissue to be extracted at its inlet end when the extraction tube and container are placed in the human body. It is also conceivable that the cutting member is provided in both the extraction tube and the container.

In one embodiment, the cutting member comprises a suture provided at the access end of the container and the access end of the extraction tube. The method is such that the container and the extraction tube are rotated relative to each other, thereby "strangler" the tissue and cutting it off. Further examples of different embodiments of the cutting member are detailed below.

It is also contemplated that the extraction kit includes a piercing rod if extraction at a particular location is desired, such as extraction of a particular type of tissue. The piercing rod can then be placed inside the extraction tube (and possibly the container) to pierce a path into a specific location without cutting any tissue. At a particular location where the penetration rod is pulled out, the extraction tube may begin cutting the particular tissue.

The invention further relates to a tissue transplantation kit for tissue transplantation, comprising an extraction tube with a sharp entry end of a spatula or knife for extracting tissue, and a cutting or avulsion member for cutting off the tissue to be transplanted at the entry end when the extraction tube is placed in the human body. The tissue transplantation kit further includes a puncture rod positionable inside the implantation tube for creating a cavity within a human body. The implant tube maintains the formed cavity. The kit further comprises a container insertable into the implantation tube. The container contains tissue to be implanted into the formed cavity. It is conceivable that the extraction duct constitutes the container.

By using the kit it is possible to transplant tissue by making only one small opening at the extraction site on the skin and one small opening at the implantation site in the human body. The implantation kit may also include any of the suggested embodiments discussed above for the features of the implantation kit and the extraction kit.

Preferably, the interior of the extraction tube, the implantation tube and the container have low friction surfaces. The lower the friction the better to facilitate pushing tissue or material into the extraction tube or container. The same is true for procedures in which tissue or material is indwelling from the implantation tube or container.

The invention also relates to a method of implanting a material into a human body. The method is performed by placing the penetration rod in an implantation tube and subsequently creating a cavity in the body by means of the combination of the penetration rod and the implantation tube. The penetration rod is then removed from the implantation tube and the material to be implanted is inserted into the implantation tube, which tube maintains the formed cavity. As a final step, the implant tube is removed.

Preferably, the material to be implanted is in a container, which is inserted into the implantation tube while the implantation tube maintains the formed cavity in the human body. Thereafter, as a final step, the implantation tube and the container are removed.

To slow the movement of the implantation tube and any container, a piston may be used to hold the implant material in place in the final step.

In one embodiment, the suture may be attached to the implant material at its leading end by a needle attached to the suture, preferably a suture with a needle at each end. One or two needles are inserted through the implant when it is placed in the body, out through the front end of the implant and further out through the skin, leaving the material inside the body with sutures in the final step. It is also possible to use both a piston and a suture. The use of sutures also enables the material to be pulled into place in the cavity formed.

The invention also relates to a method for extracting tissue from a human body. The method is performed by opening the skin of a person and inserting an extraction tube with a sharp entry end of a spatula or knife. Thereafter, while the extraction tube is still in the body, the tissue to be extracted is cut off at the entry end of the extraction tube with a cutting or avulsion member. Finally, the extraction tube with the tissue present inside is removed. The extraction tube may also be used as the container for the implantation method.

Preferably, the container is inserted into the extraction tube before the extraction tube is inserted into the human body. The container may also be used in the implantation method. In the method of extracting tissue, a piece of tissue is cut out in a suitable size so that it fills the formed cavity in a desired shape. There is no need to repeatedly fill the formed cavity.

Finally, the invention further relates to a method for transplanting tissue into a human body. The method is performed by opening the skin of a human body and inserting an extraction tube. Thereafter, while the extraction tube is still in the body, the tissue to be extracted is cut off at the entry end of the extraction tube with a cutting or avulsion member. The extraction tube with the tissue inside is then removed.

As a next step, the penetration rod is inserted into the implantation tube and a cavity is created in the body by this combination. The penetration rod is then removed from the implantation tube and the tissue to be implanted is inserted into the implantation tube, which tube maintains the formed cavity. As a final step, the implantation tube is removed and the body part is automatically closed around the implanted tissue.

In this way, a cavity of a desired shape can be produced, and the formed cavity can also be filled with a piece of cut-out suitable tissue, so that the tissue fills the formed cavity in the desired shape. Repeated filling of the formed cavity is not required. The transplantation and outcome can thus be controlled in an excellent way.

The implantation method may also include any suggested steps of the above-discussed features of the implantation and extraction methods.

Drawings

The invention will be described in more detail by way of examples according to embodiments of the invention and with reference to the accompanying drawings, in which:

fig. 1 shows an implantation kit comprising an implantation tube, a penetration rod and a container for receiving a material to be implanted,

figure 2 shows a piston suitable for incorporation into the implantation kit of figure 1,

figure 3 shows the combination of a penetration rod inserted into an implant and its cross-section,

figure 4 shows the combination of the container inserted into the implantation tube and its cross-section,

figure 5 shows an extraction tube with a sharp entry end of a spatula,

figure 6 shows a container suitable for incorporation into an extraction kit comprising the extraction tube shown in figure 5,

figure 7 shows the combination of the container inserted into the extraction duct and its cross-section,

figure 8a shows a second embodiment of the sharp entrance end of the extraction tube,

figure 8b shows a third embodiment of the sharp entrance end of the extraction tube and a first embodiment of a cutting member for cutting off the tissue to be extracted,

figure 9 shows the container in more detail,

figure 10a shows a second embodiment of a cutting member for cutting off tissue to be extracted,

figure 10b shows a top view of a second embodiment of a cutting member for cutting off tissue to be extracted,

figure 10c shows a third embodiment of a cutting member for cutting off the tissue to be extracted,

figure 10d shows a fourth embodiment of a cutting member for cutting off the tissue to be extracted,

figure 10e shows a fifth embodiment of a cutting member for cutting off the tissue to be extracted,

figure 10f shows a method of cutting tissue with the cutting member of the fifth embodiment,

figure 10g shows a variant of the cutting member of the fifth embodiment,

figure 10h shows a variant of the cutting member of the fifth embodiment,

figure 10i shows a variant of the cutting member of the fifth embodiment,

figure 10j shows a variant of the cutting member of the fifth embodiment,

figure 10k shows a sixth embodiment of a cutting member for cutting off the tissue to be extracted,

figure 10l shows a seventh embodiment of a cutting member for cutting off the tissue to be extracted,

figure 11a shows a first embodiment of the penetration rod in detail,

figure 11b shows a second embodiment of the penetration rod,

figure 11c shows a third embodiment of the penetration rod,

figure 12a shows the piston in more detail,

figure 12b shows a second embodiment of the piston,

figure 13 shows a suture with two needles attached to a piece of material to be implanted,

figure 14a shows in detail a first embodiment of the implant,

figure 14b shows in detail a second embodiment of the implant,

figure 15a shows an implantation kit comprising an implantation kit according to figure 1 and an extraction kit according to figure 5,

figure 15b shows a piston suitable for incorporation in the implantation kit,

figure 16a shows an extraction tube consisting of a syringe with a sharp entry end of a spatula or scraper,

figure 16b shows an extraction tube connected to a tear-off member that applies a negative pressure to the end of the extraction tube opposite the access end.

Detailed Description

In fig. 1 an implantation kit is shown comprising an implantation tube 1, a penetration rod 2 and a container 3 for containing a material to be implanted. The penetration rod 2 is preferably stiff, or at least the penetration end 4 is stiff and/or covers the cross-section of the rod 2.

Turning to fig. 11a, b and c, wherein fig. 11a shows the penetration rod 2 and the enlarged penetration tip 4 in detail, a preferred embodiment of a blunt penetration tip is shown. The piercing rod 2 separates tissue with the blunt piercing tip 4 rather than cutting the tissue while piercing the body. A cavity can thus be produced with little or no bleeding.

This is an advantage, since bleeding may obstruct the connection between the implant and the body, increasing the risk that the implant is subject to rejection and/or necrosis when the implant is tissue. The blunt piercing tip 4 also reduces the risk of damage to nerves, blood vessels and surrounding tissue. The penetration rod 2 may be provided with some kind of connection means 5, such as a groove 5 as shown, for connecting the implantation tube 1.

The cross-section of the penetration tube 2 may be circular or have any other suitable shape, such as a flattened oval as shown in fig. 11b, depending entirely on the cavity in which the implant is received. The penetration rod 2 may be straight, but may also be slightly curved in its longitudinal direction (not shown).

When implanted at a location in the body where it is difficult to separate the tissues from each other, such as inside the dermis/dermis or between the dermis/dermis and the bone, another type of piercing end 4 may be required, such as a sharp end and/or a forked end 4' as shown in fig. 11 c.

Fig. 14a and b show the implant 1 in more detail. Preferably the tube has a circular cross-section, although it is also conceivable that the implant 1 has the same cross-section as the penetration rod 2, or that the implant 1 is malleable so that the implant 1 can be adjusted to the shape of the penetration rod 2. The front end 28 is the end that is inserted into the human body. The implant is preferably internally smooth to provide a low coefficient of friction.

In fig. 14b an implant 1 with a flattened oval cross-section is shown, which implant 1 fits into the puncture rod shown in fig. 11 b. Preferably the implantation tube 1 is provided with some kind of connection means for connecting the penetration rod 2, in the shown embodiment the implantation tube 1 has a hole 7 therein, preferably near the outer end 8 of the implantation tube 1. When using a flat oval penetration rod 2 and a corresponding implant tube, the cavity formed will have a corresponding shape and the implant will fill this space. In this way it is possible to control the implantation and to modify the cavity for each specific case.

Another conceivable embodiment of the implant 1 has some transparent parts (not shown) so that the amount of implant is visible through this part. Referring to fig. 16a, there may also be a length or volume measurement scale along the length of the extraction tube 9 and/or any transparent portion.

In fig. 3 is shown a situation where the penetration rod 2 is inside the implantation tube 1. For example, the two parts 2, 1 are connected to each other by means of a pin 6, which pin 6 is inserted through a hole 7 in the implantation tube 1 and into or through the penetration rod 5.

The container 3 is also shown in more detail in fig. 1, and its different embodiments are shown in fig. 9 and 10 a. The container 3 is preferably a thin walled tube and is preferably provided with a stop 8, for example in the form of a sphere as shown in fig. 9 or as an additional external sleeve as shown in fig. 10a, so as not to allow the container to be inserted deep into the implantation tube 1 or into an extraction tube 9 as will be described below. The access end 29 is located at the opposite end of the catch 8.

The container 3 may be circular or any other suitable shape in cross-section or may be made of a ductile material, so that the container 3 can be inserted into an implantation tube 1, for example, having another cross-sectional shape, and thus form the shape of the implantation tube 1. The container 3 may for example be made of a plastic suitable for medical use.

An embodiment of the container 3 is also conceivable, which container 3 has some transparent parts (not shown) so that the amount of implant is visible through this part. It is also possible to have a measuring scale of length or volume along the length of the container 3 and/or any transparent portion (not shown).

A piston 10 is also preferably provided in the implantation kit. See fig. 2, which is preferably a stiff rod, and more particularly fig. 12a, having a channel 11 along its length at its edge. When the piston 10 is working in conjunction with the extraction duct 1 and/or the container 3, air can flow in the channel 11.

The piston 10 may instead have a piston portion 26 with a slightly smaller cross-section than the implant 1 and/or the interior of the container 1. Referring to fig. 12b, the remainder of the length of the piston may have a smaller cross-section than the piston portion 26, such as rod 27.

Referring to fig. 13, it is also contemplated to incorporate the needle 12 and suture 13 into the implantation kit for attachment to the material to be implanted. In fig. 4 is shown a situation in which the container 3 is inside the implantation tube 1.

When using the implantation kit according to the invention, the penetration rod 2 is inserted into the implantation tube 1 and preferably both are connected to each other. If necessary, an opening is made in the skin and the combination of the implant 1 and the penetration rod 2 is inserted into the body at the desired location, thereby creating a cavity in the body. When the combination of the implant 1 and the penetration rod 2 is positioned at the desired location in the body, the penetration rod 2 is pulled out.

The implant 1 stays in the body and maintains the cavity made by the combination. After which the material to be implanted is inserted into the implantation tube 1, the implantation tube 1 is pulled out of the human body and the material to be implanted is left inside the human body. Preferably the material to be implanted is located in the container 3. Thus, the container 3 is inserted into the implantation tube 1, and both the implantation tube 1 and the container 3 are pulled out of the human body to leave the material to be implanted inside the human body.

In order to slow the pulling out of the implantation tube 1 and possibly the container 3 and to leave the material to be implanted in the cavity formed in the body, a piston 10 may be used to hold the material in place. This can be done, for example, by inserting the piston 10 into the outer end of the implant 1 and the outer end of the container 3 (if used), while pulling the implant 1 and the container 3 (if used) along the outside of the piston.

Another way to slow down the pulling out of the implantation tube 1 and, if used, the container 3 is to use a suture 13, see fig. 13, which is connected to the material to be implanted at its front end.

The suture 13 is preferably provided with a needle 12 at each end, which can be pulled 13 through the front end of the material to be implanted and two needles 12 can be inserted through the implant 1, out through its inner end and further out through the skin when the implant 1 is in the body. The material to be implanted can thus be pulled into place or remain inside the body during withdrawal with the suture 13. When the implant is in place, one side of the suture 13 is cut to disengage one needle, and the suture 13 can be pulled out of the body in two pieces. If desired, the suture 13 may be combined with the use of the piston 10.

An important advantage with this implantation kit and method is that only one wound will be made on the skin. If a needle 12 and suture 13 are used, it is obvious that the needle body will not cause such a wound.

In fig. 5, an extraction tube 9 with a sharp entry end 14 of a spatula is shown. It is also conceivable to have a chamfered entry end 14 (not shown). In fig. 8a and 8b further embodiments of the extraction duct 9 are shown. The cross-section of the extraction tube 9 is preferably circular, since a circular shape facilitates extraction of tissue when the extraction tube 9 is manually rotated. The interior of the extraction tube 9 is preferably smooth to provide a low coefficient of friction. The extraction tube 9 can also be used, for example, in the implantation kit, constituting the container 3.

To extract the tissue, the human skin is incised and an extraction tube 9 is inserted into the opening, preferably in a manually rotated manner, or by means of a drill device. When a suitable amount of tissue has been filled into the extraction tube 9, the cutting member 17 will cut the tissue to be extracted close to the access end 14. The cutting member 17 will be described later.

The entrance end 14 has a sharp edge, which can be made by sharpening the extraction tube 9 itself at the entrance end 14 as shown in fig. 5, or by providing a separate cutter 15, such as the cutter shown in fig. 8 a. In another embodiment, see fig. 8b or 16a, a trephine blade (16) is provided at the access end 14 of the extraction tube 9 to create a sharp access end 14. As previously mentioned, the cutter 15 or trephine 16 may be beveled (not shown).

To obtain a suitable filling cavity, the access end may be straight, as shown, or have a larger diameter, like a funnel, to obtain the maximum volume of soft tissue. It is also conceivable to have a smaller tip diameter to reduce the risk of hard or harder tissue getting stuck.

Another conceivable embodiment of the extraction tube 9 has some transparent portions so that the amount of implant is visible through this portion. Referring to fig. 16a, there may also be a length or volume measurement scale along the length of the extraction tube 9 and/or any transparent portion.

A separate feature is also shown in fig. 8 b. This feature relates to a cutting member 17 for cutting off the tissue to be extracted. The cutting member 17 may of course be provided in any suitable embodiment of the extraction duct 9.

The cutting means shown in fig. 8b comprises a suture 18 or the like arranged along the inner diameter of the extraction tube 9. It may be releasably held in place, for example by being squeezed between the trephine blade 16 or cutter 15 and the extraction tube 9. Or it may be releasably held in place, for example by use of any suitable adhesive.

One end 20 of the suture 18 passes through the hole 19 in the extraction tube 9 and is advanced along the outside of the extraction tube 9 at least approximately the same length as the extraction tube. It is also conceivable to advance the long end 20 of the suture 18 along the inside of the extraction tube 9. The opposite end 21 of the suture 18 is preferably fixed to the wall of the extraction tube 9.

When the extraction tube 9 is placed inside the body with the appropriate amount of tissue inside the extraction tube 9, the surgeon grasps the long end 20 of the suture 18 and pulls it outward. The loop of suture 18 inside the extraction tube 9 will relax and "strangler" the tissue to cut it off.

The extraction kit preferably further comprises a container 3, see fig. 6, which container 3 can for instance also be used in the implantation kit. The container 3 is shown in more detail in fig. 6 and different embodiments of the container 3 are shown in fig. 9 and 10 a. The container 3 is preferably a thin walled tube and is preferably provided with a catch 8, the catch 8 being for example spherical as shown in fig. 9 or an additional outer sleeve as shown in fig. 10a, so as not to insert the container too deep into the implantation tube 1 or the extraction tube 9. The container 3 preferably has an outer diameter just smaller than the inner diameter of the extraction tube 9.

When the container 3 is used in the extraction kit, as shown in fig. 7, it is placed inside the extraction tube 9 before extraction of the tissue begins. For extracting the tissue, the human skin is incised and an extraction tube 9 with a container is inserted, preferably by manual rotation. The container 3 is preferably internally smooth to provide a low coefficient of friction.

When a suitable amount of tissue has been filled into the extraction tube 9 and the container 3, the cutting member 17 will cut the tissue to be extracted close to the access end 14. Above, one embodiment of the cutting means 17 provided to the extraction tube 9 has been described, and the cutting means will now be further described.

In fig. 10a, a suture 18 or the like is arranged along an edge 22 around the diameter of the container 3, forming a second embodiment of a cutting member 17 for cutting off the tissue to be extracted. The cutting member may be releasably held in place by, for example, any suitable adhesive.

Turning to fig. 10b, the cutting member 17 is shown, together with a top view of the container 3. The longer end 20 of the suture 18 is advanced along the outside of the container 3 at least approximately the same length as the container 3. The opposite end 21 of the suture 18 is preferably fixed to the wall of the container 3.

When the extraction tube 9 and container 3 are placed inside the body and the appropriate amount of tissue is in the extraction tube 9 and container 3, the surgeon grasps the long end 20 of the suture 18 and pulls it out. The loop of suture 18 inside the extraction tube 9 will relax and "strangler" the tissue to cut it off.

See the third embodiment shown in fig. 10c, it is also possible to have both ends 20, 21 of the suture 18 advanced outside the container 3 in the length direction thereof. Alternatively, instead of fixing the end 21 to the container 3, the end 21 may be in the shape of a small coil 23 as in the fourth embodiment shown in fig. 10 d. Embodiments of the cutting means are also suitable for the extraction duct 9.

Another conceivable embodiment of a cutting member 17 is shown in fig. 10 e. In this fifth embodiment, the suture 18 is secured at one end 24 to the extraction tube 9 and at the other end 25 to the container 3, both ends preferably being close to the access end 14. For example, the suture 18 can be releasably held on the rim 22 of the container 3 by a suitable adhesive.

When the extraction tube 9 and the container 3 are inside the body and an appropriate amount of tissue is inside the extraction tube 9 and the container 3, the surgeon starts to perform a relative rotation between the extraction tube 9 and the container 3, for example rotating the container 3 inside the extraction tube 9. The suture 18 will relax and twist around the tissue to cut the tissue.

One tissue cutting method is shown in fig. 10f, although a variation of the cutting member is shown in fig. 10 j. When the relative rotation between the container 3 and the extraction tube 9 starts, the suture 18 will start to cross the cross section of the container 3. For clarity, it is shown in fig. 10f how the extraction tube 9 is rotated, although in practice it may be more common to rotate the container 3. After one and a half turns, see fig. 10f, a hinge coil 44 is formed, which hinge coil 44 will more and more severely "hinge" the tissue when a larger relative turn is made.

There are conceivable different variations of the fifth embodiment of the cutting member. As shown in fig. 10g, an extraction tube 9 has a through hole 40 through which the suture 18 can be passed. For example, the suture 18 is provided with a catch or knot 41 on the part located outside the extraction tube 9. The catches or knots 41 are larger than the through holes 40 to keep the suture 18 attached to the extraction tube 9 during severing of the tissue.

A suture 18 is also connected to the container 3. For example, the suture 18 may be glued to the inside of the container 3, see fig. 10h, or attached to the container 3 by a second catch or knot 42, see fig. 10 i. The second catch or knot 42 is preferably located on the outside of the container 3 so as not to distract the tissue extraction. If so provided, the suture 18 passes through the through hole 43 near the access end and is drawn up the container 3 over the edge of the container 3. The part outside the container 3 then passes through the through hole 40 of the extraction duct 9. The extraction duct 9 is not shown in fig. 10h-j for clarity of understanding.

Another conceivable connection of the suture 18 to the extraction tube 9 and the container 3 is that, see fig. 10j, the container 3 is provided with two through holes 43 and the suture 18 is made to form a loop with a catch or knot 41 on the outside of the extraction tube 9. It is also conceivable that the extraction tube also has two through holes 40, whereby the loops of suture 18 need only be tied together at the ends, preferably outside the extraction tube.

Tests have shown that a cutting member according to the fifth embodiment and a corresponding method of cutting off tissue by means of a "miller" are advantageous. They are easy to manufacture and easy to handle. There is no need to pull any thread or string along the length of the extraction tube or container. It is also not necessary to deflect the thread or string through an angle of about 90 degrees across any end surface, which may cause the thread or string to become caught or torn apart or at least cause high frictional reaction forces.

A further embodiment of a cutting member is shown in fig. 10 k. A thin-walled cut tube 35, preferably made of metal, is located outside the extraction tube 9. The end closest to the access end 14 of the extraction tube 9 is cut or chamfered axially into the long axis of the insertion cap 36. The cover 36 is pre-bent or radially offset toward the central longitudinal axis. The cutting tube 35 is preferably shorter than the extraction tube 9.

When the interior of the extraction tube 9 then has a sufficient amount of tissue, the cutting tube 35 is pushed towards the access end 14, and when the cover 36 is no longer intercepted by the extraction tube 9, the cover 36 will bend radially inwards over the access end 14, thus cutting off the tissue to be extracted.

A further embodiment of a cutting member is shown in fig. 10 l. A hose 37 with a deflatable ring 38 is arranged outside the extraction duct 9. The collapsible ring 38 is arranged near the entrance end 14 of the extraction tube 9. A push tube 39 is provided between the hose 37 and the extraction tube 9 at a position slightly further from the access end 14 than the deflatable ring 38.

When the interior of the extraction tube 9 then has a sufficient amount of tissue, the push tube 39 is pushed towards the access end 14 and thus pushes the deflatable ring 38 over the edge at the access end 14, which ring thereby deflates and cuts off the tissue to be extracted.

Referring to fig. 16a and 16b, in another embodiment, the extraction tube 9 comprises a tear-off member 30. In fig. 16a, the injector 31 constitutes an extraction tube and has a sharp entry end, in the example a trepan 16. When the desired amount of tissue is extracted and present inside the extraction tube 9, the syringe plunger 32 will be pulled back slightly to apply a negative pressure to the tissue to retain it within the extraction tube 9 while tearing tissue off at its inner end.

If the syringe 31 constitutes the container 3 of the implantation kit, the syringe piston 32 may be used as the piston 10. In another embodiment, it is contemplated that the sharp access end, such as the trepan 16, can be removed.

In fig. 16b, the extraction tube 9 is connected to a tear-off member 30, which tear-off member 30 comprises a tube 33 and a negative pressure providing means 34. The negative pressure providing device 34 is preferably adjustable and automated, and thus can provide a desired intensity of negative pressure for various situations.

By providing a negative pressure in the extraction tube during extraction, the filling process of the extraction tube 9 will be eased, which may be desirable, especially when extracting hard tissue or small sized tissue.

It is also conceivable that the extraction kit comprises a penetration rod 2 when extraction at a specific location is desired, for example for extracting a certain tissue. The piercing rod 2 can then be placed inside the extraction tube 9 (and possibly the container 3) for piercing a path into said specific location without cutting any tissue. At the specific location the penetration rod 2 is pulled out and the extraction tube 9 may start cutting the specific tissue.

In fig. 15a an implantation kit is shown comprising an extraction tube 9, a container 3, an implantation tube 1 and a penetration rod 2. In fig. 15b the piston 10 is also incorporated in the implantation kit.

When tissue is transplanted from a preferred site of a human body to a second site of the human body, the extraction tube 1 is inserted into the first site of the human body, preferably in a manually rotated manner. When the appropriate amount of tissue has been filled into the extraction tube 9, the cutting member 17 or the avulsion member 30 will cut the tissue to be extracted close to the entry end 14. After which the extraction tube 9 is removed from the body to bring out the extracted tissue.

At the site of the body where implantation is desired, preferably by cutting the skin, the penetration rod 2 inside the implantation tube 1 is inserted into the body to create a cavity for the tissue to be implanted. The penetration rod 2 is then removed, leaving the implant 1 inside the body to maintain the formed cavity. The extracted tissue to be implanted, obtained from the extraction tube 9, is inserted into the implantation tube 1, and finally the implantation tube 1 is removed from the body, leaving the implanted tissue in said formed cavity.

Preferably, the container 3 is used in this method. If so, the container 3 is placed inside the extraction tube 9 before the extraction tube 9 is inserted into the human body, so that the extracted tissue becomes present in the container 3.

When the extracted tissue is present in the container 3, it is preferable to implant the extracted tissue by using the container 3. Thus, the container 3 with the extracted tissue is removed from the extraction tube 9 and inserted into the implantation tube 1 while the implantation tube 1 is located in said formed cavity. After which both the implantation tube 1 and the container 3 are removed from the body, leaving the implanted tissue in the formed cavity.

In another preferred method of transplanting tissue, the piston also serves to hold the tissue in place while removing the implant 1 and any container 3. Alternatively, or also when the implant 1 is in the body, the suture 13 is connected to the tissue and one or two needles 12 are inserted through the implant 1, out through its entrance end 14 and further out through the skin, so that the tissue can be pulled into place through the suture or contained inside the body while removing the implant 1 and any container 3.

Claims (11)

1. A kit for implanting a material into the human body, characterized in that the kit comprises an implantation tube (1), a puncture rod (2) and a container (3), the puncture rod (2) being placeable inside the implantation tube (1) for making a cavity in the human body, the implantation tube (1) maintaining the formed cavity, and the container (3) for containing the material to be implanted in the formed cavity being insertable into the implantation tube (1) when the puncture rod (2) is not present in the implantation tube (1).

2. The kit according to claim 1, further comprising a piston (10) for holding the implant material in place in the formed cavity during removal of the implant tube (1) and container (3).

3. A kit according to claim 1 or 2, further comprising a suture (13) and at least one needle (12) for pulling the material into position in the formed cavity and/or for holding the implant material in place in the formed cavity during removal of the implant tube (1) and container (3).

4. A kit according to claim 1 or 2, wherein the penetration rod (2) has a blunt penetration end (4).

5. A kit according to claim 1 or 2, wherein the implantation rod (1) has a non-circular cross-section and the penetration rod (2) has a corresponding cross-section, mounted inside the implantation tube (1).

6. A kit for extracting tissue from a human body, characterized in that the kit comprises an extraction tube (9), the extraction tube (9) having a sharp entrance end (14) of a spatula or knife for extracting tissue, and a cutting member (17) or a tear-off member (30) for cutting off the tissue to be extracted at the entrance end (14) when the extraction tube (9) is placed in the human body, the extraction tube (9) constituting a container (3) being usable in the kit for implantation according to claim 1.

7. Kit according to claim 6, further comprising a container (3) for containing the extracted tissue, said container (3) being placed inside the extraction tube (9) in use and being usable in a kit for implantation according to claim 1.

8. A kit according to claim 7, wherein the extraction tube (9) is provided with separate sharp entry ends (15, 16).

9. A kit according to claim 6, 7 or 8, wherein the cutting member (17) is provided at the container (3) and the extraction tube (9) for cutting off tissue to be extracted at its entry end (29) when the extraction tube (9) and container (3) are placed in a human body.

10. A kit according to claim 9, wherein the cutting means (17) comprises a suture (18) provided between the access end (29) of the container (3) and the extraction tube (9).

11. A tissue transplantation kit comprising an extraction kit according to any one of claims 6-8 and an implantation kit according to any one of claims 1-5.