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TWI528936B - A system for cutting ligaments or soft tissues within the body - Google Patents

A system for cutting ligaments or soft tissues within the body Download PDF

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Publication number
TWI528936B
TWI528936B TW102113558A TW102113558A TWI528936B TW I528936 B TWI528936 B TW I528936B TW 102113558 A TW102113558 A TW 102113558A TW 102113558 A TW102113558 A TW 102113558A TW I528936 B TWI528936 B TW I528936B
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Taiwan
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cutting element
cutting
retrieval tool
ligament
distal
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TW102113558A
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Chinese (zh)
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TW201440719A (en
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Joseph Guo
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Joseph Guo
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Description

一種用於切割身體內的韌帶或軟組織的系統A system for cutting ligaments or soft tissues in the body

本發明涉及一種外科手術系統。更具體地說,本發明涉及一種用於切割身體內的韌帶或軟組織的系統,該系統通過最小的介入手段橫切韌帶,例如腕韌帶,通常通過鬆開所述腕韌帶來治療腕管綜合症。The present invention relates to a surgical system. More particularly, the present invention relates to a system for cutting ligaments or soft tissues in a body that crosses a ligament, such as a wrist ligament, with minimal interventional means, typically by releasing the wrist ligament to treat carpal tunnel syndrome .

通常由於手部的經常性的、持續性的重複動作,導致許多人的手腕和腕管的軟組織受損。手部和手腕動作的重複性導致的損傷被統稱為累積重複性應力綜合症或重複性勞損。一種人們最熟悉和常見的手腕損傷稱為腕管綜合症,腕管綜合症使得手部產生疼痛、不適、神經傳導紊亂和功能障礙等情形,有時也會使手臂產生上述情形。這類情形的最常見的症狀包括手部間歇地疼痛和麻木。
當從前臂延伸到手部的正中神經在手腕處受到壓迫或擠壓時,就會發生腕管綜合症。正中神經在人的拇指、食指、中指和無名指中提供感覺。正中神經控制傳向拇指和這些其他手指的手掌側的知覺以及傳向手部中的一些肌肉的神經脈衝,這些肌肉使得手指和拇指能夠移動。正中神經通過微脈管系統接收血液、氧和營養,微脈管系統存在於包圍神經纖維的結締組織中。神經纖維受到的壓力增大會使微脈管收縮,並且會減少流向正中神經的血液。長期缺乏氧和營養會導致嚴重的神經損傷。
正中神經穿過腕管,腕管是位於手腕內的管,其三側被腕骨包圍,第四側被稱為橫向腕韌帶的纖維鞘包圍。除了正中神經以外,手部中的九個屈肌腱也穿過該管。當受到壓迫時,正中神經會在手部和手腕中產生疼痛、無力或麻木,這些疼痛、無力或麻木還會沿著手臂向上輻射。正中神經可能因腕管本身的尺寸減小、或者腕管的容納物的尺寸增大(即,例如屈肌腱和包圍這些屈肌腱的滑潤組織腫脹)、或者上述兩者而受到壓迫。例如,刺激屈肌腱或使屈肌腱發炎的情形會導致屈肌腱腫脹。受刺激的屈肌腱增厚或者管內的其他組織腫脹使得腕管變窄,從而使正中神經受到壓迫。當手部或手腕改變位置時,腕管的橫截面面積也發生變化。手腕彎曲或者伸長會使橫截面面積變小,從而增大作用在正中神經上的壓力。手腕彎曲還使得屈肌腱產生一定的重新排列,這也會壓迫正中神經。例如,手腕簡單地彎曲90度角會減小腕管的尺寸。如果不治療,那麼腕管綜合症會導致手部發生慢性神經肌肉不適,有時也會導致手臂發生慢性神經肌肉不適。
腕管綜合症的治療方法包括多種非外科方法和外科方法,其中,腕管鬆開是最常見的外科方法之一。這種外科方法涉及切斷橫向腕韌帶以減輕作用在正中神經上的壓力,並且通常通過或者開放式方法或者內窺鏡方法執行。在開放式方法中,切開位於腕管上方的皮膚,然後在直接觀察的情況下橫切橫向腕韌帶。然後用縫合術把皮膚重新連接起來。內窺鏡方法要求在一個或多個位置切開皮膚,以便允許插入內窺鏡和橫切韌帶所需的各種工具。這類工具通常包括組合起來的特殊構造的解剖刀和引導器械。將這類工具插入到目標韌帶的下方、上方、或者上方和下方的適當位置還要求在手部中形成一個或多個通道,這會對周圍的組織造成伴隨的創傷、對神經造成潛在的損傷、以及時間更長的術後康復期。此外,使用解剖刀通常要求解剖刀多次通過通道以完成橫切,這會在被切斷的韌帶表面上形成複雜的切割圖案。
已經提出的介入性較低的技術包括例如使用柔性鋸元件,柔性鋸元件被引入手內部並定位在目標韌帶的附近或者繞在部分目標韌帶上,然後使柔性鋸元件往復運動以切割組織。與刀類器械相比,由鋸類器械形成的切口的一個明顯缺點是會固有地產生鋸縫。從鋸縫中去除的物質或者沉積在手術位置內和手術位置附近,或者通過必須採取的額外步驟取出。此外,由鋸類器械產生的切割表面趨向於比較粗糙和帶有擦傷,切割表面上的微創傷會增加發炎反應(浮腫、紅斑,發熱和疼痛),會導致局部組織粘連和結疤,這會延長康復時間或者使康復過程變複雜。
作為另外一種選擇,有一種利用拉緊的線、繩或者細絲切割韌帶的方法。通過拉緊切割元件,或者通過使拉緊的切割元件往復運動來進行切割。與這種方法的缺點是切割元件的佈置使得與目標韌帶相鄰的其他部分也進入了切割範圍,並且很難形成切口始點。最佳的路徑應當使切割元件僅僅載入於目標韌帶上並將切割力集中在切口始點。另外使用拉緊裝置做切割時也會造成不必要增大的傷口。
因此,需要一種新的系統,通過針孔穿透皮膚抵達韌帶等組織,並將其切斷,同時對周圍組織僅產生微小的影響,從而實現平滑的、似利刀成型的切口。
Often due to the frequent, continuous repetitive movements of the hand, the soft tissues of many people's wrists and carpal tunnels are damaged. The damage caused by the repetitiveness of hand and wrist movements is collectively referred to as cumulative repetitive stress syndrome or repetitive strain. One of the most familiar and common wrist injuries is called carpal tunnel syndrome. Carpal tunnel syndrome causes pain, discomfort, nerve conduction disorder and dysfunction in the hands, and sometimes causes the arm to produce the above situation. The most common symptoms of this type of condition include intermittent pain and numbness in the hands.
Carpal tunnel syndrome occurs when the median nerve extending from the forearm to the hand is compressed or squeezed at the wrist. The median nerve provides a sense in the human thumb, index finger, middle finger, and ring finger. The median nerve controls the perception of the palm side of the thumb and these other fingers and the nerve impulses that are transmitted to some of the muscles in the hand that allow the fingers and thumb to move. The median nerve receives blood, oxygen, and nutrients through the microvasculature, which is present in the connective tissue surrounding the nerve fibers. An increase in the pressure on the nerve fibers causes the microvasculature to contract and reduces the flow of blood to the median nerve. Long-term lack of oxygen and nutrition can cause severe nerve damage.
The median nerve passes through the carpal tunnel, which is a tube located in the wrist. The three sides are surrounded by the carpal bone, and the fourth side is surrounded by a fibrous sheath called the lateral carpal ligament. In addition to the median nerve, nine flexor tendons in the hand also pass through the tube. When stressed, the median nerve can cause pain, weakness, or numbness in the hands and wrists that can radiate upward along the arm. The median nerve may be compressed by a decrease in the size of the carpal tunnel itself, or an increase in the size of the contents of the carpal tunnel (i.e., swelling of the flexor tendon and the smooth tissue surrounding these flexor tendons), or both. For example, a situation in which the flexor tendon is stimulated or the flexor tendon is inflamed can cause swelling of the flexor tendon. Stimulation of the stimulated flexor tendon or swelling of other tissues within the tube causes the carpal tunnel to narrow, thereby compressing the median nerve. The cross-sectional area of the carpal tunnel also changes when the hand or wrist changes position. Bending or stretching of the wrist causes the cross-sectional area to become smaller, thereby increasing the pressure acting on the median nerve. Bending the wrist also causes a certain rearrangement of the flexor tendon, which also forces the median nerve. For example, simply bending the wrist at a 90 degree angle will reduce the size of the carpal tunnel. If left untreated, carpal tunnel syndrome can cause chronic neuromuscular discomfort in the hand and sometimes cause chronic neuromuscular discomfort in the arm.
The treatment of carpal tunnel syndrome includes a variety of non-surgical methods and surgical methods, of which carpal tunnel loosening is one of the most common surgical methods. This surgical approach involves cutting the transverse carpal ligament to relieve pressure on the median nerve and is typically performed by either an open or endoscopic approach. In the open procedure, the skin above the carpal tunnel is cut and the transverse carpal ligament is transected with direct visualization. Then use suture to reattach the skin. Endoscopic methods require the skin to be cut at one or more locations to allow for the insertion of the endoscope and the various tools required to transect the ligament. Such tools typically include a combination of specially constructed scalpels and guiding instruments. Inserting such tools below, above, or above and below the target ligament also requires the formation of one or more channels in the hand that can cause concomitant trauma to the surrounding tissue, potential damage to the nerve, And a longer postoperative recovery period. In addition, the use of a scalpel typically requires the scalpel to pass through the passage multiple times to complete the transection, which creates a complex cut pattern on the surface of the severed ligament.
Techniques that have been proposed to be less invasive include, for example, the use of a flexible saw element that is introduced into the interior of the hand and positioned adjacent to or around a target ligament, and then reciprocating the flexible saw element to cut tissue. A significant disadvantage of incisions formed by saw-type instruments compared to knife-type instruments is that they inherently create a kerf. Substances removed from the kerf are either deposited in the surgical site and near the surgical site, or removed by additional steps that must be taken. In addition, the cutting surface produced by the sawing device tends to be rough and bruised, and micro-injury on the cutting surface increases the inflammatory response (edema, erythema, fever and pain), which can lead to local tissue adhesions and scarring, which can be prolonged. Rehabilitation time can complicate the healing process.
Alternatively, there is a method of cutting a ligament using a tensioned wire, string or filament. Cutting is performed by tensioning the cutting element or by reciprocating the tensioned cutting element. A disadvantage with this method is that the arrangement of the cutting elements is such that other portions adjacent to the target ligament also enter the cutting range and it is difficult to form the starting point of the slit. The optimal path should be such that the cutting element is only loaded onto the target ligament and the cutting force is concentrated at the beginning of the incision. In addition, the use of a tensioning device for cutting also causes an unnecessary increase in wounds.
Therefore, there is a need for a new system that penetrates the skin through a pinhole to reach a tissue such as a ligament and cuts it, while having only a minor effect on the surrounding tissue, thereby achieving a smooth, knife-like incision.

本發明涉及以最小創傷的方式切斷例如韌帶等軟組織。本發明的系統不需要對皮膚進行任何切開操作、對目標韌帶周圍的組織的損傷最小、能夠使目標韌帶形成平滑的似利刀成型的切口、不需要縫合並且可在診所條件下容易且快速地實施。
更具體地說,本發明涉及將細小的、柔性的、線狀的切割組件引入身體內,並將其圍繞目標韌帶。隨後操作切割組件的端部,橫切韌帶,生成平滑的、似利刀成型的切口。本發明的特殊構造的回取工具使得能夠在對周圍組織造成的破壞或損傷最小的情況下,容易且快速地引導切割元件並將其佈置到圍繞目標韌帶的位置。回取工具部件包括細長的剛性針狀的遠端部分,在靠近回取工具的遠端的位置,在回取工具中形成有開口的針眼型的接脫結構。這種接脫結構的尺寸設置成使回取工具與切割元件接合,並且當回取工具受到拉力作用而移動時保持與切割元件接合。
在橫切橫向腕韌帶時,首先使用回取工具刺破手部的皮膚,在靠近韌帶的近端並與韌帶側向相鄰的位置形成第一通道位置。然後,沿著剛好位於韌帶下方的路徑將回取工具插入手部穿過腕管,並且使其在剛好位於韌帶的遠端處的第二通道位置從手部伸出。通過利用例如超聲波成像裝置執行的定位措施顯示回取工具在手部內的位置以及特別是回取工具相對於韌帶的位置,以便能夠精確地操縱回取工具。回取工具的接脫機構與一段切割元件接合,從而通過所述第二通道位置將切割元件形成的回折結構拉入手內。切割元件的零彎曲半徑允許形成儘可能不占空間的回折結構。回折結構被拉到韌帶下方並且被從第一通道位置拉出,然後使切割元件與回取工具脫開,並且將切割元件的第一自由端穿過手部拉出。將回取工具再次插入手部並沿著韌帶的上介面伸到第二通道位置,使得回取工具與第二段切割元件接合,並且將切割元件的回折結構拉入手部內、越過韌帶上方並從第一通道位置拉出。切割元件的第二自由端穿過手部、越過韌帶的上方並從第一通道位置被拉出,就完成了圍繞韌帶佈置切割元件的操作,使得切割元件處於用於橫切的位置。回取工具和切割元件的橫截面非常小,並且這種工具被引入和定位在手部內的方法的介入性非常小,從而大大降低了損傷正中神經以及從其分支出來的較小神經的風險。此外,切割元件僅通過兩個很小的穿孔定位並且通過這兩個穿孔之一執行橫切,這使得康復時間變得最短,並且使得形成的疤痕基本上可以忽略。
切割組件的物理性質被選擇為能夠實現無鋸縫地切斷韌帶。切割元件的小直徑和高抗拉強度使得能夠通過操縱切割元件的端部來橫切韌帶。可以將不相等的力交替地施加在切割元件的兩個端部上,以產生往復切割動作。作為另外一種選擇,可以用比另一個端部更大的力拉動一個端部,以便向一個方向拉動切割元件,從而使切割元件切斷韌帶。作為另外一種選擇,可以用同樣大小的力同時拉動兩個端部,以便拉動切割組件穿過韌帶。切割元件的平滑的、不產生磨蝕的表面使得能夠實現刀狀切口而不會形成鋸縫,從而在切割部位和附近也不會伴隨地沉積分離的物質。
還可改進本發明以進一步簡化手術過程。例如,可以改變圍繞韌帶佈置切割元件的步驟的順序,使得回取工具首先越過韌帶的上部並回取切割元件的第一端的回折部位,然後再使回取工具穿過腕管以回取切割元件的第二端的回折部位。此外,可以在切割元件的第二端上連接剛性穿線定位工具,以利於在完全位於手部內並從而更靠近韌帶的遠端邊緣的位置使回取工具與切割元件接合,從而使對與韌帶相鄰的任何組織產生的橫切最小。還可以在回取工具上作標記以便允許當接脫元件處於手部內時確定其方位,從而提高回取工具與切割元件接合的能力。此外,可以採用圍繞切割元件的一部分的保護管,以保護位於近端入口和韌帶之間的組織。可以使切割元件的兩個端部都穿過單個保護管,或者可以使切割元件的每個端部穿過其自己的保護管。
通過下面參考附圖對優選實施例的詳細描述可以明顯地看出本發明的這些和其他優點,這些附圖以實例示出本發明的原理。
The present invention relates to cutting soft tissues such as ligaments in a minimally invasive manner. The system of the present invention does not require any incision to the skin, minimal damage to tissue surrounding the target ligament, can form a sharp, knife-shaped incision that smoothes the target ligament, does not require suturing, and can be easily and quickly performed under clinic conditions. Implementation.
More specifically, the present invention relates to the introduction of a small, flexible, linear cutting assembly into the body and surrounding it around the target ligament. The ends of the cutting assembly are then manipulated to traverse the ligaments to create a smooth, knife-like cut. The specially constructed retrieval tool of the present invention enables easy and rapid guidance of the cutting element and placement to a position around the target ligament with minimal disruption or damage to surrounding tissue. The retrieval tool component includes an elongated, rigid needle-like distal portion that is formed with an open pin-eye contact structure in the retrieval tool adjacent the distal end of the retrieval tool. The detachment structure is sized to engage the retrieval tool with the cutting element and to remain engaged with the cutting element as the retrieval tool is moved by the pulling force.
When transversing the transverse carpal ligament, the skin of the hand is first pierced using a retrieval tool, forming a first channel position near the proximal end of the ligament and laterally adjacent the ligament. The retrieval tool is then inserted into the hand through the carpal tunnel along a path just below the ligament and is projected from the hand at a second channel position just at the distal end of the ligament. The position of the retrieval tool within the hand and in particular the position of the retrieval tool relative to the ligament is displayed by means of a positioning measure performed by, for example, an ultrasound imaging device, so that the retrieval tool can be accurately manipulated. The pick-up mechanism of the retrieval tool engages a length of cutting element to pull the fold-back structure formed by the cutting element into the hand through the second channel position. The zero bend radius of the cutting element allows the formation of a foldback structure that does not take up as much space as possible. The foldback structure is pulled under the ligament and pulled out of the first channel position, then the cutting element is disengaged from the retrieval tool and the first free end of the cutting element is pulled through the hand. Re-inserting the retrieval tool into the hand and extending along the upper interface of the ligament to the second channel position, causing the retrieval tool to engage the second segment of the cutting element and pulling the retraction structure of the cutting element into the hand, over the ligament and from The first channel position is pulled out. The second free end of the cutting element passes through the hand, over the ligament and is pulled out of the first channel position, completing the operation of arranging the cutting element around the ligament such that the cutting element is in a position for transection. The cross-section of the retrieval tool and the cutting element is very small, and the method of introduction and positioning of such a tool in the hand is very small, greatly reducing the risk of damaging the median nerve and the smaller nerves branching therefrom. Furthermore, the cutting element is positioned only by two small perforations and cross-cutting is performed by one of the two perforations, which makes the healing time shortest and makes the scar formed substantially negligible.
The physical properties of the cutting assembly are selected to enable the ligament to be cut without kerf. The small diameter and high tensile strength of the cutting element enable transection of the ligament by manipulating the end of the cutting element. Unequal forces can be alternately applied to both ends of the cutting element to create a reciprocating cutting action. Alternatively, one end can be pulled with a greater force than the other end to pull the cutting element in one direction, thereby causing the cutting element to sever the ligament. Alternatively, both ends can be pulled simultaneously with the same amount of force to pull the cutting assembly through the ligament. The smooth, non-abrasive surface of the cutting element enables a knife-like cut to be made without the formation of a kerf, so that the separated material is not concomitantly deposited at or near the cutting site.
The invention may also be modified to further simplify the surgical procedure. For example, the sequence of steps of arranging the cutting elements around the ligament can be altered such that the retrieval tool first passes over the upper portion of the ligament and retrieves the folded back portion of the first end of the cutting element, and then passes the retrieval tool through the carpal tube to retrieve the cutting The folded back portion of the second end of the component. Additionally, a rigid threading positioning tool can be attached to the second end of the cutting element to facilitate engagement of the retrieval tool with the cutting element at a location that is entirely within the hand and thereby closer to the distal edge of the ligament, thereby aligning the ligament with the ligament Any organization in the neighborhood produces the smallest cross-cutting. It is also possible to mark the retrieval tool to allow its orientation to be determined when the removal element is in the hand, thereby increasing the ability of the retrieval tool to engage the cutting element. Additionally, a protective tube surrounding a portion of the cutting element can be employed to protect tissue between the proximal inlet and the ligament. Both ends of the cutting element can be passed through a single protective tube, or each end of the cutting element can be passed through its own protective tube.
These and other advantages of the present invention will be apparent from the following description of the preferred embodiments of the invention.

10...手部10. . . hand

12...腕管12. . . Carpal tunnel

14...骨頭14. . . bone

16...橫向腕韌帶16. . . Lateral carpal ligament

18...正中神經18. . . Median nerve

20...屈肌腱20. . . Flexor tendon

22...回取工具twenty two. . . Retrieval tool

24...遠端部分twenty four. . . Remote part

26...把手26. . . handle

28...接脫結構28. . . Pick-up structure

29...頂端29. . . top

30...遠端30. . . remote

32...標記32. . . mark

34...切割元件34. . . Cutting element

34a、34b...端部34a, 34b. . . Ends

36...穿線定位工具36. . . Threading positioning tool

38...剛性遠端38. . . Rigid distal end

40...把手40. . . handle

42...入口42. . . Entrance

44...出口44. . . Export

46、48...回折結構46, 48. . . Foldback structure

50...保護管50. . . Protective tube

52...遠端附件52. . . Remote accessory

54...皮下注射針54. . . Hypodermic needle

56...鎖定機構56. . . Locking mechanism

58...柄部58. . . Handle

60...部分60. . . section

第1圖是手部的腕管區域的剖視圖;
第2圖是本發明的回取工具的實施例的立體圖;
第3圖是本發明的切割組件的實施例的立體圖;
第4A圖至第4H圖是帶有顯示的腕韌帶的手部的立體圖,示出了用於執行本發明的方法的步驟的順序;
第5A圖至第5C圖是手部和橫向腕韌帶的剖視圖,示出了用於執行本發明的方法的步驟;
第6A圖和第6B圖是手部和橫向腕韌帶的剖視圖,示出了利用保護管的可選的實施例;以及
第7A圖和第7B圖是回取工具的可選的實施例的高倍放大的剖視圖。
Figure 1 is a cross-sectional view of the carpal tunnel area of the hand;
Figure 2 is a perspective view of an embodiment of the retrieval tool of the present invention;
Figure 3 is a perspective view of an embodiment of the cutting assembly of the present invention;
4A through 4H are perspective views of a hand with a wrist ligament shown, showing the sequence of steps for performing the method of the present invention;
5A-5C are cross-sectional views of the hand and transverse carpal ligaments showing the steps for performing the method of the present invention;
6A and 6B are cross-sectional views of the hand and transverse carpal ligament showing an alternative embodiment utilizing a protective tube; and FIGS. 7A and 7B are high magnifications of an alternative embodiment of the retrieval tool Enlarged section view.

本發明涉及以介入性最小的方式切割軟組織,並且不需要使用解剖刀、鋸或者內窺鏡。本發明特別適合用於切割韌帶,最適合用於在治療腕管綜合症中鬆開橫向腕韌帶。
第1圖是手部10的腕管區域的剖視圖。腕管12是手部10的手腕和手掌的一個區域,該區域由U形的一組骨頭14形成,這些骨頭形成腕管的硬底部和兩個壁部。腕管的頂部由連接在腕骨上的橫向腕韌帶16形成。拇指和其他手指的正中神經18和屈肌腱20位於腕管的內部。腕管的尺寸變小或者腕管容納物的尺寸增大使得正中神經受到壓迫,從而引起腕管綜合症。可通過例如橫切韌帶來鬆開韌帶,從而減輕這種壓迫。
第2圖是本發明的回取工具22的優選實施例的立體圖。該回取工具主要包括細長的剛性針狀的遠端部分24和位於近端的把手26。遠端部分24具有靠近其遠端30設置的開口針眼型的接脫結構28。接脫結構28由在回取工具22的遠端部分24的外表面內形成的開口針眼構成,以便使遠端部分24呈現出儘量平滑的外表面,從而在將回取工具22插入組織或從組織中拉回時使造成創傷的可能性最小。遠端部分24可以如所示的實施例中示出的那樣具有尖的頂端29。作為另外一種選擇,頂端可具有鈍頭的構造。接脫結構28從遠端30稍稍向後偏離。可以在把手26上設置標記32以區分靠近回取工具22的遠端30的接脫結構28的方向。遠端部分24的長度選擇為大於橫向腕韌帶的寬度。遠端部分24的直徑選擇為不大於約1毫米。
第3圖是本發明的切割元件34的立體圖,在切割元件34上連接有可選的剛性穿線定位工具36。切割元件具有柔性的、小直徑的、線狀結構,其具有高的抗拉強度和平滑的表面,其表面粗糙度不大於50微米。切割元件可包括單絲或者通過編織或其他方式連接起來的多根纖維或者股線,其中,每根股線具有平滑的表面以呈現出比較平滑的、不產生磨蝕的表面。其物理性質包括:彎曲半徑小於韌帶厚度的一半,優選為零;直徑小於約1.0毫米,優選小於0.5毫米;以及抗拉強度大於500Mpa。切割元件可包括纖維或者由棉形成的紗線、絲、玻璃纖維、碳纖維、各種塑膠纖維或者金屬纖維。更具體地說,可以使用織物纖維、合成纖維、礦物纖維、聚合物纖維、微纖維形成切割組件。可選的穿線定位工具36包括剛性遠端38,剛性遠端38的直徑足夠小以便能夠伸入並被保持在回取工具22的接脫結構28內。把手40靠近定位工具36的近端設置,以使得能夠抓住和操作定位工具36。
第4A圖至第4H圖示出了實施本發明的優選方法。在對手部10的靠近和包圍橫向腕韌帶16的區域進行麻醉後,如第4A圖所示,使回取工具22的遠程30與手部的最靠近目標韌帶的近端邊緣的部位接觸。圖中顯示出韌帶僅僅是為了清楚的目的,因為在整個過程中沒有實施切開操作以便以任何方式露出韌帶以供查看。此外,使用成像裝置(如例如常用於各種成像用途的超聲波裝置)顯示回取工具相對於韌帶的位置,但圖中沒有示出成像裝置以防止其遮擋手術位置,這也是為了清楚的目的。優選的是,回取工具在距橫向腕韌帶的近端邊緣約30毫米的位置進入手部內,這是因為隨後能夠以較淺的角度進入腕管,從而在達到腕管後不需要調整回取工具的角度,並且使對組織的創傷最小。此外,這還允許更容易地對回取工具成像。
在第4B圖中,回取工具通過入口42(第一通道位置,或第一位置)進入手部內,剛好在韌帶下方穿過腕管並且穿過出口44(第二通道位置,或第二位置)伸出。在回取工具22選擇為具有尖的頂端29的情況下,可通過直接使回取工具穿過皮膚來形成入口42和出口44。在使用的回取工具具有鈍末端的情況下,需要尖的器械來形成入口並引導回取工具進入手部。圖中還示出了切割元件34與靠近回取工具的遠端的接脫結構28接合。在該具體實施例中,切割元件的遠端上沒有連接剛性穿線定位工具。
如第4C圖所示,在切割元件34與接脫結構28接合之後,從手部中拉回回取工具22,以便將由切割元件形成的回折結構46通過出口44拉入手部內,穿過腕管並從入口42拉出。如第4D圖所示,然後,將回折結構46與回取工具22脫開,在保持住切割元件的一個端部34a不動的情況下,拉動回折結構46以將切割元件34的與端部34a相反的端部34b從手部拉出。
第4E圖示出了方法的後續步驟,其中,再次將回取工具通過入口42插入手部內,越過韌帶16的上介面並通過出口44從手部伸出。將切割元件34的從韌帶下方伸出的部分與回取工具34的接脫結構28接合。
如第4F圖所示,在切割組件34再次與接脫結構28接合之後,從手部中拉回回取工具22,以便將由切割元件形成的回折結構48通過出口44拉入手部內,穿過腕管並從入口42拉出。如第4G圖所示,然後,使回折結構48與回取工具脫開,在保持住切割元件的一個端部34b不動的情況下,拉動回折結構以將切割元件的端部34a從手部拉出。由此切割元件處於圍繞韌帶16的位置,以便執行隨後的操作以進行橫切。如第4H圖所示,切割元件的端部34a、34b可簡單地由使用者抓住、可纏繞在使用者的手或手指上以便牢固地抓住、或者可以與把手連接以實現最大的抓握和控制。可以將不平衡的力交替地施加在切割元件的兩個端部34a、34b上,以使切割組件往復運動。作為另外一種選擇,可以用比另一個端部更大的力拉動一個端部,以便向一個方向拉動切割元件,從而使切割元件切穿韌帶。作為另外一種選擇,可以用同樣大小的力同時拉動兩個端部34a和34b,以便拉動切割組件穿過韌帶。當完成橫切之後,只需要通過入口42拉出切割元件即可。在入口42和出口44上分別纏上小繃帶,從而完成整個過程。
在可選的實施例中,如第5A圖所示,作為第4C圖所示的步驟的改型,回取工具22沒有完全從入口42拉出。回取工具被拉出到剛好足以露出接脫結構28、並且允許由切割組件34形成的回折結構46與回取工具脫開並被拉出的位置,而遠程30的大部分還留在皮膚下麵。結果,在回取工具到達韌帶16的上表面之前,回取工具更可能沿著同一路徑移動,這會使得在插入回取工具時以及完成橫切的步驟中對涉及的組織造成的創傷和破壞更小。
在可選的實施例中,如第5B圖所示,作為第4E圖所示的步驟的改型,回取工具22沒有伸到穿過出口44以與切割組件34接合。相反地,切割組件34在手部內、優選在儘可能靠近橫向腕韌帶16的遠端的位置與回取工具22接合。圖中示出的回取工具的接脫結構28的開口方向朝向觀察者。把手26上的標記允許使用者確定接脫結構的方向,而不用直接查看回取工具的遠程。通過使切割元件34在靠近韌帶的遠端的位置與回取工具接合,然後拉動切割元件34越過韌帶的上介面,使得在切割元件和韌帶之間儘量環繞較少的多餘組織,從而在橫切韌帶時對組織造成的創傷更小。
作為第5B圖所示的優選實施例的進一步的改進,第5C圖示出了使用聯接有剛性穿線定位工具36的切割元件34。如通過超聲波成像所確定的,一旦回取工具的遠端30就位,使得接脫結構28剛好位於橫向腕韌帶的遠端邊緣的遠程,則拉動切割組件34的位於入口42之外的端部34b,以便將相反的端部34a和與端部34a相連的剛性穿線定位工具36拉入出口44。一旦定位工具36的剛性遠端38到達所示的適當深度,借助定位工具在超聲波成像下的可視性和觸覺回饋能夠更容易地使切割元件34與回取工具22接合,其中,所述觸覺回饋是在回取工具22的剛性遠端部分24與定位工具36的剛性遠端38之間發生接觸時產生的。一旦確認切割元件34與回取工具22的接脫結構28接合,就從出口44拉出定位工具36,只留下切割元件34位於接脫結構28內。將切割元件34與定位工具36分離,隨後拉出回取工具22,使得由切割元件形成的回折結構被拉動穿過韌帶上方的通道並從入口42拉出,然後拉動回折結構以將切割元件的自由端34a穿過手部從入口42拉出,以便將切割元件佈置成圍繞目標韌帶。
在切割元件34被選擇成具有大於零的彎曲半徑的情況下,可能需要首先向手部內引入零彎曲半徑的引導線,然後按照上面關於設置實際的切割元件所述的方式將引導線設置成圍繞韌帶。一旦這種引導線就位,就將引導線的一端與切割元件的一端直接連接並且拉出引導線,以便用切割元件替換引導線。這種方法允許使入口的尺寸最小,否則的話,需要擴大入口的尺寸以便容納由非零彎曲半徑的切割元件形成的較大的回折結構46、48。
如第6A圖和第6B圖所示,用於實施本發明的另一個可選的優選方法包括使用一個或多個保護管50,保護管50設置為在入口42處圍繞切割組件34。切割元件的兩個端部可穿過單個保護管(第6A圖),或者每個端部穿過其自己的保護管(第6B圖)。當向切割組件施加張緊力並拉動切割元件、或者使切割元件往復運動以進行橫切時,保護管50用於保護周圍的組織不受損傷。當切割元件在入口42內或入口42周圍產生一定的彎曲時,保護管特別起作用。選擇具有柔性但能夠經得住切割元件的切割的薄壁管作為保護管。
如第7A圖和第7B圖所示,在另一個可選的優選實施例中,改型的回取工具包括皮下注射針54和安裝在皮下注射針54上的遠端附件52,遠端附件52具有鈍頭的頂端。皮下注射針初始用於形成入口42、注射麻醉劑和/或液體(例如鹽溶液),以便使手術位置膨脹,從而將各種組織和成分分開,使得更易於將切割組件佈置就位。完成注射後,將皮下注射針從身體伸出以形成出口44。將遠端附件52插入到皮下注射針內並通過鎖定機構56將其鎖定就位(第7B圖)。這種鎖定機構可具有多種形式中的任何形式,包括通過圖中所示的柄部58的波浪形構造形成的過盈配合。如第4C圖所示,在切割元件與回取工具的接脫結構28接合之後,拉回皮下注射針以便將回折結構46拉入手部內。回取工具的遠端附件52的部分60的外徑可選擇為與皮下注射針的外徑大致匹配,從而產生平滑的過渡。
雖然描述和展示了本發明的具體形式,但是,對本領域的技術人員來說很明顯,在不偏離本發明的教導和範圍的情況下,可以做出各種改型。例如可以改變步驟的順序以使得回取工具首先越過橫向腕韌帶的上表面並回取由切割元件形成的回折結構,然後,回取工具再越過橫向腕韌帶的下表面。可以形成另外的入口以便更易於使切割元件對目標形成環繞。各通道位置中的任何一個通道位置都可用作切割元件的兩個端部的最終出口。此外,本發明的方法和具有適當尺寸的回取工具可用於橫切其他組織以執行例如但不限於扳機指鬆開手術、跗管鬆開手術和足底筋膜鬆開手術。本發明的系統和方法可以容易地適用於切斷其他軟組織,如例如人和動物的肌肉、腱、脈管和神經。因此,本發明的保護範圍僅由後附申請專利範圍限定。
The present invention relates to cutting soft tissue in a manner that is minimally invasive and does not require the use of a scalpel, saw or endoscope. The invention is particularly suitable for use in cutting ligaments and is most suitable for use in the treatment of carpal tunnel syndrome to loosen the transverse carpal ligament.
FIG. 1 is a cross-sectional view of the carpal tunnel region of the hand 10. The carpal tunnel 12 is an area of the wrist and palm of the hand 10 that is formed by a U-shaped set of bones 14, which form the hard bottom and the two walls of the carpal tunnel. The top of the carpal tunnel is formed by a transverse carpal ligament 16 attached to the carpal bone. The median nerve 18 and flexor tendon 20 of the thumb and other fingers are located inside the carpal tunnel. The size of the carpal tunnel becomes smaller or the size of the carpal tunnel contents is increased to cause the median nerve to be compressed, thereby causing carpal tunnel syndrome. This compression can be mitigated by, for example, loosening the ligaments transversely to the ligament.
2 is a perspective view of a preferred embodiment of the retrieval tool 22 of the present invention. The retrieval tool primarily includes an elongated rigid needle shaped distal portion 24 and a proximally located handle 26. The distal portion 24 has an open pin-eye attachment structure 28 disposed adjacent its distal end 30. The detachment structure 28 is formed by an open eye formed in the outer surface of the distal end portion 24 of the retrieval tool 22 to provide the distal portion 24 with a smoothest outer surface for insertion of the retrieval tool 22 into the tissue or from Pulling back in the tissue minimizes the possibility of trauma. The distal portion 24 can have a pointed tip 29 as shown in the illustrated embodiment. Alternatively, the tip can have a blunt configuration. The pick-up structure 28 is slightly offset rearward from the distal end 30. Indicia 32 may be provided on the handle 26 to distinguish the direction of the pick-up structure 28 adjacent the distal end 30 of the retrieval tool 22. The length of the distal portion 24 is selected to be greater than the width of the transverse carpal ligament. The diameter of the distal portion 24 is selected to be no greater than about 1 mm.
3 is a perspective view of the cutting element 34 of the present invention with an optional rigid threading positioning tool 36 attached to the cutting element 34. The cutting element has a flexible, small diameter, wire-like structure with high tensile strength and a smooth surface with a surface roughness of no more than 50 microns. The cutting elements can comprise monofilaments or a plurality of fibers or strands that are joined by weaving or other means, wherein each strand has a smooth surface to present a relatively smooth, non-abrasive surface. Physical properties include: a bend radius less than half the thickness of the ligament, preferably zero; a diameter less than about 1.0 mm, preferably less than 0.5 mm; and a tensile strength greater than 500 MPa. The cutting element may comprise fibers or yarns formed from cotton, silk, fiberglass, carbon fibers, various plastic fibers or metal fibers. More specifically, woven fabrics, synthetic fibers, mineral fibers, polymer fibers, microfibers can be used to form the cutting assembly. The optional threading positioning tool 36 includes a rigid distal end 38 that is sufficiently small in diameter to be able to extend into and be retained within the pick-up structure 28 of the retrieval tool 22. The handle 40 is disposed proximate the proximal end of the positioning tool 36 to enable the positioning tool 36 to be grasped and manipulated.
Figures 4A through 4H illustrate preferred methods of practicing the invention. After anesthesia is applied to the region of the hand 10 and the region surrounding the lateral carpal ligament 16, as shown in Fig. 4A, the distal end 30 of the retrieval tool 22 is brought into contact with the portion of the hand that is closest to the proximal edge of the target ligament. The ligaments are shown for clarity only, as no incision is performed throughout the procedure to expose the ligaments in any way for viewing. Furthermore, the position of the retrieval tool relative to the ligament is displayed using an imaging device such as, for example, an ultrasonic device commonly used for various imaging purposes, but the imaging device is not shown to prevent it from obstructing the surgical position, which is also for the purpose of clarity. Preferably, the retrieval tool enters the hand at a position about 30 mm from the proximal edge of the transverse carpal ligament, since the carpal tunnel can then be accessed at a shallower angle so that no adjustments need to be made after the carpal tunnel is reached. The angle of the tool and minimizes trauma to the tissue. In addition, this also allows for easier imaging of the retrieval tool.
In Figure 4B, the retrieval tool enters the hand through the inlet 42 (the first channel position, or the first position), just below the ligament through the carpal tunnel and through the outlet 44 (the second channel position, or the second position) ) stretched out. Where the retrieval tool 22 is selected to have a pointed tip 29, the inlet 42 and the outlet 44 can be formed by directly passing the retrieval tool through the skin. Where the retrieval tool used has a blunt end, a sharp instrument is required to form the inlet and guide the retrieval tool into the hand. Also shown is the engagement of the cutting element 34 with the detachment structure 28 proximate the distal end of the retrieval tool. In this particular embodiment, the rigid threading positioning tool is not attached to the distal end of the cutting element.
As shown in FIG. 4C, after the cutting element 34 is engaged with the detachment structure 28, the retrieval tool 22 is pulled back from the hand to pull the retraction structure 46 formed by the cutting element into the hand through the outlet 44, through the carpal tunnel. And pulled out from the entrance 42. As shown in Fig. 4D, the foldback structure 46 is then disengaged from the retrieval tool 22, and the foldback structure 46 is pulled to hold the end portion 34a of the cutting element 34 while holding one end 34a of the cutting element stationary. The opposite end 34b is pulled out of the hand.
Figure 4E shows a subsequent step of the method in which the retrieval tool is again inserted into the hand through the inlet 42 over the upper interface of the ligament 16 and out of the hand through the outlet 44. The portion of the cutting element 34 that projects from below the ligament is engaged with the detachment structure 28 of the retrieval tool 34.
As shown in FIG. 4F, after the cutting assembly 34 is again engaged with the detachment structure 28, the retrieval tool 22 is pulled back from the hand to pull the retraction structure 48 formed by the cutting element into the hand through the outlet 44, through the wrist. The tube is pulled out from the inlet 42. As shown in Fig. 4G, the foldback structure 48 is then disengaged from the retrieval tool, and while the one end 34b of the cutting element is held stationary, the foldback structure is pulled to pull the end 34a of the cutting element from the hand. Out. Thereby the cutting element is in a position around the ligament 16 in order to perform a subsequent operation for cross-cutting. As shown in Fig. 4H, the ends 34a, 34b of the cutting element can simply be grasped by the user, can be wrapped around the user's hand or fingers for secure grasping, or can be attached to the handle for maximum grasping. Grip and control. Unbalanced forces can be alternately applied to the two ends 34a, 34b of the cutting element to reciprocate the cutting assembly. Alternatively, one end can be pulled with a greater force than the other end to pull the cutting element in one direction, thereby cutting the cutting element through the ligament. Alternatively, the two ends 34a and 34b can be pulled simultaneously with the same amount of force to pull the cutting assembly through the ligament. After the cross-cutting is completed, it is only necessary to pull the cutting element through the inlet 42. A small bandage is wound around the inlet 42 and the outlet 44, respectively, to complete the entire process.
In an alternative embodiment, as shown in FIG. 5A, as a modification of the step shown in FIG. 4C, the retrieval tool 22 is not completely pulled out of the inlet 42. The retrieval tool is pulled out to a position just enough to expose the detachment structure 28 and allow the foldback structure 46 formed by the cutting assembly 34 to be disengaged and pulled out of the retrieval tool, while the majority of the remote 30 remains under the skin . As a result, the retrieval tool is more likely to move along the same path before the retrieval tool reaches the upper surface of the ligament 16, which can cause trauma and damage to the tissue involved in the insertion of the retrieval tool and the completion of the transection step. small.
In an alternative embodiment, as shown in FIG. 5B, as a modification of the step shown in FIG. 4E, the retrieval tool 22 does not extend through the outlet 44 to engage the cutting assembly 34. Conversely, the cutting assembly 34 engages the retrieval tool 22 within the hand, preferably at a location as close as possible to the distal end of the lateral carpal ligament 16. The opening direction of the pick-up structure 28 of the retrieval tool shown in the drawing faces the viewer. The indicia on the handle 26 allows the user to determine the orientation of the pick-up structure without directly viewing the remote of the retrieval tool. By engaging the cutting element 34 with the retrieval tool at a location near the distal end of the ligament, and then pulling the cutting element 34 over the upper interface of the ligament, as much as possible to wrap less excess tissue between the cutting element and the ligament, thereby transversing The ligaments cause less trauma to the tissue.
As a further improvement of the preferred embodiment illustrated in FIG. 5B, FIG. 5C illustrates the use of a cutting element 34 coupled with a rigid threading positioning tool 36. As determined by ultrasound imaging, once the distal end 30 of the retrieval tool is in place such that the attachment structure 28 is located remotely from the distal edge of the lateral carpal ligament, the end of the cutting assembly 34 that is outside the inlet 42 is pulled. 34b, in order to pull the opposite end 34a and the rigid threading positioning tool 36 connected to the end 34a into the outlet 44. Once the rigid distal end 38 of the positioning tool 36 reaches the appropriate depth shown, the cutting element 34 can be more easily engaged with the retrieval tool 22 by the visibility and tactile feedback of the positioning tool under ultrasound imaging, wherein the tactile feedback This is produced when contact occurs between the rigid distal end portion 24 of the retrieval tool 22 and the rigid distal end 38 of the positioning tool 36. Once the cutting element 34 is confirmed to engage the detachment structure 28 of the retrieval tool 22, the positioning tool 36 is pulled from the outlet 44 leaving only the cutting element 34 within the detachment structure 28. Separating the cutting element 34 from the positioning tool 36, and subsequently pulling the retrieval tool 22 such that the folded back formation formed by the cutting element is pulled through the channel above the ligament and pulled out of the inlet 42 and then pulled back the folding structure to The free end 34a is pulled through the hand from the inlet 42 to arrange the cutting element to surround the target ligament.
Where the cutting element 34 is selected to have a bend radius greater than zero, it may be necessary to first introduce a guide line of zero bend radius into the hand and then set the guide line around in the manner described above with respect to setting the actual cutting element. ligament. Once such a guide wire is in place, one end of the guide wire is directly connected to one end of the cutting element and the guide wire is pulled out to replace the guide wire with the cutting element. This method allows the size of the inlet to be minimized, otherwise the inlet is required to be sized to accommodate the larger fold-back structures 46, 48 formed by cutting elements of non-zero bend radii.
As shown in FIGS. 6A and 6B, another alternative preferred method for practicing the present invention includes the use of one or more protective tubes 50 that are disposed to surround the cutting assembly 34 at the inlet 42. Both ends of the cutting element can pass through a single protective tube (Fig. 6A), or each end can pass through its own protective tube (Fig. 6B). The protective tube 50 serves to protect surrounding tissue from damage when a tension is applied to the cutting assembly and the cutting element is pulled or the cutting element is reciprocated for transection. The protective tube acts particularly when the cutting element creates a certain bend in or around the inlet 42. A thin-walled tube that is flexible but capable of withstanding the cutting of the cutting element is selected as the protective tube.
As shown in Figures 7A and 7B, in another alternative preferred embodiment, the modified retrieval tool includes a hypodermic needle 54 and a distal attachment 52 mounted on the hypodermic needle 54, distal attachment 52 has a blunt tip. The hypodermic needle is initially used to form the inlet 42, inject an anesthetic, and/or a liquid (e.g., a saline solution) to expand the surgical site, thereby separating the various tissues and components, making it easier to position the cutting assembly in place. After the injection is completed, the hypodermic needle is extended from the body to form the outlet 44. The distal attachment 52 is inserted into the hypodermic needle and locked in place by the locking mechanism 56 (Fig. 7B). Such a locking mechanism can take any of a variety of forms, including an interference fit formed by the undulating configuration of the handle 58 shown in the figures. As shown in Fig. 4C, after the cutting element is engaged with the retrieval structure 28 of the retrieval tool, the hypodermic needle is pulled back to pull the foldback structure 46 into the hand. The outer diameter of the portion 60 of the distal attachment 52 of the retrieval tool can be selected to substantially match the outer diameter of the hypodermic needle, resulting in a smooth transition.
While the invention has been described with respect to the specific embodiments of the embodiments of the present invention For example, the sequence of steps can be changed such that the retrieval tool first passes over the upper surface of the transverse carpal ligament and retrieves the folded back formation formed by the cutting elements, and then the retrieval tool passes over the lower surface of the transverse carpal ligament. Additional inlets may be formed to make it easier to form the cutting elements around the target. Any one of the channel positions can be used as the final outlet for both ends of the cutting element. Moreover, the methods of the present invention and retrieval tools of appropriate size can be used to transect other tissues to perform, for example, but not limited to, trigger finger release surgery, fistula release surgery, and plantar fascia release surgery. The systems and methods of the present invention can be readily adapted to sever other soft tissues such as, for example, the muscles, tendons, vessels, and nerves of humans and animals. Therefore, the scope of the invention is limited only by the scope of the appended claims.

10...手部10. . . hand

16...橫向腕韌帶16. . . Lateral carpal ligament

22...回取工具twenty two. . . Retrieval tool

28...接脫結構28. . . Pick-up structure

34...切割元件34. . . Cutting element

42...入口42. . . Entrance

44...出口44. . . Export

Claims (26)

一種用於切割身體內的韌帶的系統,包括:柔性的線狀切割元件,其具有平滑的表面;回取工具,其具有剛性針狀的遠端部分,所述遠端部分的長度足以使其從與所述韌帶橫向相鄰的第一位置延伸到與所述韌帶橫向相鄰並與所述第一位置相對的第二位置,並且所述遠端部分的頂端能夠使其從所述第一位置進入身體、沿著所述韌帶的一側邊沿移動並從所述第二位置伸出身體,並且所述遠端部分的接脫結構可以使其在所述第二位置處與所述切割元件接合,在其沿原路徑退回到所述第一位置的過程中與所述切割組件保持接合,並使其在退回到所述第一位置的體外處與所述切割組件脫開;成像裝置,其能夠顯示所述回取工具相對於所述韌帶的位置。A system for cutting a ligament in a body, comprising: a flexible linear cutting element having a smooth surface; a retrieval tool having a rigid needle-like distal portion, the distal portion being of sufficient length to Extending from a first position laterally adjacent the ligament to a second position laterally adjacent to the ligament and opposite the first position, and a top end of the distal portion enabling it to be from the first position Positioning into the body, moving along a side edge of the ligament and extending from the second position, and the distal portion of the detachment structure can be at the second position with the cutting Engaging the component in engagement with the cutting assembly during its return to the first position along the original path and disengaging it from the cutting assembly prior to retracting to the first position; imaging device It is capable of displaying the position of the retrieval tool relative to the ligament. 如申請專利範圍第1項所述的系統,其中,所述切割組件的直徑小於0.5毫米。The system of claim 1, wherein the cutting assembly has a diameter of less than 0.5 mm. 如申請專利範圍第1項所述的系統,其中,所述切割組件的彎曲半徑為零。The system of claim 1, wherein the cutting assembly has a bending radius of zero. 如申請專利範圍第1項所述的系統,其中,所述切割組件的彎曲半徑小於所述韌帶的厚度的一半。The system of claim 1, wherein the cutting assembly has a bend radius that is less than half the thickness of the ligament. 如申請專利範圍第1項所述的系統,其中,所述切割組件的抗拉強度大於500Mpa。The system of claim 1, wherein the cutting assembly has a tensile strength greater than 500 MPa. 如申請專利範圍第1項所述的系統,其中,在所述切割元件上連接有一個剛性穿線定位工具,所述定位工具使所述回取工具的遠端部分與所述切割元件在所述第二位置附近在身體內接合,然後在所述回取工具沿原路徑退回前使所述定位工具與所述切割元件分離。The system of claim 1, wherein a rigid threading positioning tool is attached to the cutting element, the positioning tool having the distal end portion of the retrieval tool and the cutting element in the The second position is engaged within the body and the positioning tool is then separated from the cutting element before the retrieval tool is retracted along the original path. 如申請專利範圍第1項所述的系統,其中,所述切割元件的表面粗糙度不大於50微米。The system of claim 1, wherein the cutting element has a surface roughness of no greater than 50 microns. 如申請專利範圍第1項所述的系統,其中,所述接脫結構是位於所述回取工具的遠端部分的遠端附近的開口針眼型的接脫結構。The system of claim 1, wherein the detachment structure is an open pin-eye detachment structure located near a distal end of the distal end portion of the retrieval tool. 如申請專利範圍第1項所述的系統,其中,所述回取工具包括注射針和能夠與所述注射針聯接的遠端附件,所述遠端附件具有所述接脫結構。The system of claim 1, wherein the retrieval tool comprises an injection needle and a distal attachment engageable with the injection needle, the distal attachment having the detachment structure. 如申請專利範圍第9項所述的系統,其中,所述遠端附件具有鈍頭的頂端。The system of claim 9, wherein the distal attachment has a blunt tip. 如申請專利範圍第1項所述的系統,其中,所述回取工具的遠端部分的直徑不大於1毫米。The system of claim 1, wherein the distal end portion of the retrieval tool has a diameter of no more than 1 mm. 如申請專利範圍第1項所述的系統,其中,所述成像裝置包括超聲波成像裝置。The system of claim 1, wherein the imaging device comprises an ultrasound imaging device. 如申請專利範圍第1項所述的系統,還包括:薄壁的柔性的保護管,所述切割元件從所述保護管中穿過,並且所述保護管的成型材料使得當所述切割元件在所述保護管內移動時所述保護管不被所述切割元件切割。The system of claim 1, further comprising: a thin-walled flexible protective tube through which the cutting element passes, and the molding material of the protective tube is such that the cutting element The protective tube is not cut by the cutting element when moving within the protective tube. 一種用於切割身體內的軟組織的系統,包括:柔性的線狀切割元件,其具有平滑的表面;回取工具,其具有剛性針狀的遠端部分,所述遠端部分的長度足以使其從與所述軟組織橫向相鄰的第一位置延伸到與所述軟組織橫向相鄰並與所述第一位置相對的第二位置,並且所述遠端部分的頂端能夠使其從所述第一位置進入身體、沿著所述軟組織的一側邊沿移動並從所述第二位置伸出身體,並且所述遠端部分的接脫結構可以使其在所述第二位置處與所述切割元件接合,在其沿原路徑退回到所述第一位置的過程中與所述切割組件保持接合,並使其在退回到所述第一位置的體外處與所述切割組件脫開;成像裝置,其能夠顯示所述回取工具相對於所述軟組織的位置。A system for cutting soft tissue within a body, comprising: a flexible linear cutting element having a smooth surface; a retrieval tool having a rigid needle-like distal portion, the distal portion being of sufficient length to Extending from a first position laterally adjacent to the soft tissue to a second position laterally adjacent to the soft tissue and opposite the first position, and a top end of the distal portion enabling it to be from the first position Positioning into the body, moving along a side edge of the soft tissue and extending from the second position, and the distal portion of the detachment structure can be at the second position with the cutting Engaging the component in engagement with the cutting assembly during its return to the first position along the original path and disengaging it from the cutting assembly prior to retracting to the first position; imaging device It is capable of displaying the position of the retrieval tool relative to the soft tissue. 如申請專利範圍第14項所述的系統,其中,所述切割組件的直徑小於0.5毫米。The system of claim 14, wherein the cutting assembly has a diameter of less than 0.5 mm. 如申請專利範圍第14項所述的系統,其中,所述切割組件的彎曲半徑為零。The system of claim 14, wherein the cutting assembly has a bend radius of zero. 如申請專利範圍第14項所述的系統,其中,所述切割組件的彎曲半徑小於所述軟組織的厚度的一半。The system of claim 14, wherein the cutting assembly has a bend radius that is less than half the thickness of the soft tissue. 如申請專利範圍第14項所述的系統,其中,所述切割組件的抗拉強度大於500Mpa。The system of claim 14, wherein the cutting assembly has a tensile strength greater than 500 MPa. 如申請專利範圍第14項所述的系統,其中,在所述切割元件上連接有一個剛性穿線定位工具,所述定位工具使所述回取工具的遠端部分與所述切割元件在所述第二位置附近在身體內接合,然後在所述回取工具沿原路徑退回前使所述定位工具與所述切割元件分離。The system of claim 14, wherein a rigid threading positioning tool is attached to the cutting element, the positioning tool having the distal end portion of the retrieval tool and the cutting element in the The second position is engaged within the body and the positioning tool is then separated from the cutting element before the retrieval tool is retracted along the original path. 如申請專利範圍第14項所述的系統,其中,所述切割元件的表面粗糙度不大於50微米。The system of claim 14, wherein the cutting element has a surface roughness of no greater than 50 microns. 如申請專利範圍第14項所述的系統,其中,所述接脫結構是位於所述回取工具的遠端部分的遠端附近的開口針眼型的接脫結構。The system of claim 14, wherein the detachment structure is an open pin-eye detachment structure located near a distal end of the distal end portion of the retrieval tool. 如申請專利範圍第14項所述的系統,其中,所述回取工具包括注射針和能夠與所述注射針聯接的遠端附件,所述遠端附件具有所述接脫結構。The system of claim 14, wherein the retrieval tool comprises an injection needle and a distal attachment engageable with the injection needle, the distal attachment having the detachment structure. 如申請專利範圍第22項所述的系統,其中,所述遠端附件具有鈍頭的頂端。The system of claim 22, wherein the distal attachment has a blunt tip. 如申請專利範圍第14項所述的系統,其中,所述回取工具的遠端部分的直徑不大於1毫米。The system of claim 14, wherein the distal end portion of the retrieval tool has a diameter of no more than 1 mm. 如申請專利範圍第14項所述的系統,其中,所述成像裝置包括超聲波成像裝置。The system of claim 14, wherein the imaging device comprises an ultrasound imaging device. 如申請專利範圍第14項所述的系統,還包括:薄壁的柔性的保護管,所述切割元件從所述保護管中穿過,並且所述保護管的成型材料使得當所述切割元件在所述保護管內移動時所述保護管不被所述切割元件切割。The system of claim 14, further comprising: a thin-walled flexible protective tube through which the cutting element passes, and the molding material of the protective tube is such that the cutting element The protective tube is not cut by the cutting element when moving within the protective tube.
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